A Phase 2 Peri-Operative Study of Treatment With Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Patients With Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)

This study is researching an investigational drug called REGN2810, also known as cemiplimab, and when combined with another investigational drug called REGN3767, also known as fianlimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on a type of skin cancer known as cutaneous squamous cell carcinoma (CSCC).
The aim of the study is to see if cemiplimab or cemiplimab in combination with fianlimab can eliminate or reduce the number of living cancer cells in tumor(s) if taken before surgery.
The study is looking at several other research questions, including:
* Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make it possible to have a less extensive surgery or a different treatment plan after surgery
* Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make the cancer less likely to come back after surgery
* What side effects may happen from taking the cemiplimab or cemiplimab in combination with fianlimab
* How much of the cemiplimab or cemiplimab in combination with fianlimab is in the blood at different times
* Whether the body makes antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)

Start Date14 Nov 2024

Sponsor / Collaborator

Regeneron Pharmaceuticals, Inc.

NCT06571708 / Not yet recruitingPhase 2IIT

A Phase 2, Randomized, Open-label Study of Gemcitabine/Cisplatin Plus Cemiplimab (REGN2810, Anti-PD-1) With or Without Fianlimab (REGN3767, Anti-LAG-3) for Organ Preservation in Patients With Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)

The goal of this clinical trial is to learn if gemcitabine/cisplatin plus cemiplimab with or without fianlimab works to treat bladder cancer in adults. The main question it aims to answer is: Can gemcitabine, cisplatin, and cemiplimab with or without fianlimab treat bladder cancer?
Participants will be randomly selected (like the loss of a coin) to treatment with gemcitabine, cisplatin, cemiplimab, and fianlimab or gemcitabine, cisplatin, and cemiplimab.
Participants will:
* Undergo transurethral resection of bladder tumor (TURBT) followed by the start of treatment, receive 4 cycles of treatment (21 day cycles)
* After 4 cycles of treatment, patients will undergo repeat maximal TURBT with imaging
* Participants with a complete response will continue maintenance cemiplimab or cemiplimab/fianlimab for 13 more cycles with imaging every 3 months
* Participants without a complete clinical response will undergo cystectomy (bladder surgery).

Start Date01 Nov 2024

Sponsor / Collaborator

Columbia University

[+1]

NCT06190951 / RecruitingPhase 2/3

A Phase 2 and Phase 3 Peri-operative Trial of Fianlimab and Cemiplimab Compared With Anti-PD1 Alone in Patients With Resectable Stage III and IV Melanoma

This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with an approved medication called pembrolizumab. These types of study drugs are collectively known as immune checkpoint inhibitors. The study is focused on participants with a type of skin cancer known as melanoma.
The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to pembrolizumab as peri-operative therapy in participants with high-risk melanoma.
The study is looking at several other research questions, including:
* What side effects may happen from receiving the study drug(s).
* How much study drug(s) is in the blood at different times.
* Whether the body makes antibodies against the study drug(s) (which could make the drug less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections.
* How administering the study drugs might improve quality of life.

Start Date18 Sep 2024

Sponsor / Collaborator

Regeneron Pharmaceuticals, Inc.

100 Clinical Results associated with Fianlimab

100 Translational Medicine associated with Fianlimab

100 Patents (Medical) associated with Fianlimab

Literatures (Medical) associated with Fianlimab

20 Aug 2024·JOURNAL OF CLINICAL ONCOLOGY

Phase I Study of Fianlimab, a Human Lymphocyte Activation Gene-3 (LAG-3) Monoclonal Antibody, in Combination With Cemiplimab in Advanced Melanoma

Article

Author: Lewis, Karl D ; Paccaly, Anne ; Lowy, Israel ; Kim, Kevin B ; Salvati, Mark ; Brennan, Laura ; Mani, Jayakumar ; Fang, Fang ; Weise, Amy ; Yushak, Melinda ; Chen, Shuquan ; Rabinowits, Guilherme ; Mehmi, Inderjit ; Fiaschi, Nathalie ; Spira, Alexander I ; Jankovic, Vladimir ; Mehnert, Janice ; McKean, Meredith ; Gullo, Giuseppe ; Papadopoulos, Kyriakos P ; Kroog, Glenn ; Thomas, Sajeve S ; Fury, Matthew G ; Hamid, Omid ; Crown, John ; Middleton, Mark R ; Kaczmar, John ; Masinde, Sheila ; Wang, Fang ; Kim, Tae Min ; Lakhani, Nehal J ; Lee, Dae Ho

PURPOSE:

Coblockade of lymphocyte activation gene-3 (LAG-3) and PD-1 receptors could provide significant clinical benefit for patients with advanced melanoma. Fianlimab and cemiplimab are high-affinity, human, hinge-stabilized IgG4 monoclonal antibodies, targeting LAG-3 and PD-1, respectively. We report results from a first-in-human phase-I study of fianlimab and cemiplimab safety and efficacy in various malignancies including advanced melanoma.

METHODS:

Patients with advanced melanoma were eligible for enrollment into four cohorts: three for patients without and one for patients with previous anti–PD-1 therapy in the advanced disease setting. Patients were treated with fianlimab 1,600 mg and cemiplimab 350 mg intravenously once every 3 weeks for up to 51 weeks, with an optional additional 51 weeks if clinically indicated. The primary end point was objective response rate (ORR) per RECIST 1.1 criteria.

RESULTS:

ORRs were 63% for patients with anti–PD-1–naïve melanoma (cohort-6; n = 40; median follow-up 20.8 months), 63% for patients with systemic treatment–naïve melanoma (cohort-15; n = 40; 11.5 months), and 56% for patients with previous neo/adjuvant treatment melanoma (cohort-16; n = 18, 9.7 months). At a median follow-up of 12.6 months for the combined cohorts (6 + 15 + 16), the ORR was 61.2% and the median progression-free survival (mPFS) 13.3 months (95% CI, 7.5 to not estimated [NE]). In patients (n = 13) with previous anti–PD-1 adjuvant therapy, ORR was 61.5% and mPFS 12 months (95% CI, 1.4 to NE). ORR in patients with previous anti–PD-1 therapy for advanced disease (n = 15) was 13.3% and mPFS 1.5 months (95% CI, 1.3 to 7.7). Treatment-emergent and treatment-related adverse events ≥grade 3 (G3) were observed in 44% and 22% of patients, respectively. Except for increased incidence of adrenal insufficiency (12%-G1-4, 4%-G3-4), no new safety signals were recorded.

CONCLUSION:

The current results show a promising benefit-risk profile of fianlimab/cemiplimab combination for patients with advanced melanoma, including those with previous anti–PD-1 therapy in the adjuvant, but not advanced, setting.

01 Nov 2019·Molecular cancer therapeuticsQ2 · MEDICINE

Preclinical Development of the Anti-LAG-3 Antibody REGN3767: Characterization and Activity in Combination with the Anti-PD-1 Antibody Cemiplimab in Human PD-1xLAG-3–Knockin Mice

Q2 · MEDICINE

Article

Author: Woodruff, Amy ; Olson, William C. ; Dai, Jie ; Potocky, Terra ; MacDonald, Douglas ; Mohrs, Markus ; Hermann, Aynur ; Halasz, Gabor ; Thurston, Gavin ; Martin, Joel ; Hong, Seongwon ; Ioffe, Ella ; Allbritton, Omaira ; Poueymirou, William ; Rafique, Ashique ; Burova, Elena ; Liu, Matt ; Ullman, Erica ; Murphy, Andrew ; Pei, Jerry

Abstract:

In the tumor microenvironment, multiple inhibitory checkpoint receptors can suppress T-cell function, thereby enabling tumor immune evasion. Blockade of one of these checkpoint receptors, PD-1, with therapeutic antibodies has produced positive clinical responses in various cancers; however, the efficacy of this approach can be further improved. Simultaneously targeting multiple inhibitory checkpoint receptors has emerged as a promising therapeutic strategy. Here, we report the development and characterization of REGN3767, a fully human IgG4 antibody targeting LAG-3, another inhibitory receptor on T cells. REGN3767 binds human and monkey LAG-3 with high affinity and specificity and blocks the interaction of LAG-3 with its ligand, MHC class II. In an engineered T-cell/antigen-presenting cell bioassay, REGN3767 alone, or in combination with cemiplimab (REGN2810, human anti-PD-1 antibody), blocked inhibitory signaling to T cells mediated by hLAG-3/MHCII in the presence of PD-1/PD-L1. To test the in vivo activity of REGN3767 alone or in combination with cemiplimab, we generated human PD-1xLAG-3 knockin mice, in which the extracellular domains of mouse Pdcd1 and Lag3 were replaced with their human counterparts. In these humanized mice, treatment with cemiplimab and REGN3767 showed increased efficacy in a mouse tumor model and enhanced the secretion of proinflammatory cytokines by tumor-specific T cells. The favorable pharmacokinetics and toxicology of REGN3767 in nonhuman primates, together with enhancement of antitumor efficacy of anti-PD-1 antibody in preclinical tumor models, support its clinical development.

CLINICAL CANCER RESEARCH

First-in-Human Dose-Escalation Study of Fianlimab, an Antilymphocyte Activation Gene-3 Antibody, with Cemiplimab in Patients with Advanced Malignancies

Article

Author: Jankovic, Vladimir ; Lynce, Filipa ; Gullo, Giuseppe ; Lowy, Israel ; Mani, Jayakumar ; Paccaly, Anne ; Wang, Ding ; Gonzalez Ortiz, Ana ; Kroog, Glenn ; Dowlati, Afshin ; Chen, Shuquan ; Maki, Robert G. ; Ulahannan, Susanna ; Masinde, Sheila ; Yap, Timothy A. ; Kelly, Karen ; Johnson, Melissa Lynne ; Sims, Tasha ; Papadopoulos, Kyriakos P. ; Park, Haeseong ; Malhotra, Jyoti ; Williamson, Stephen ; Lakhani, Nehal J.

Abstract:

Purpose::

Preclinical data indicate that fianlimab (antilymphocyte activation gene-3) plus cemiplimab (anti–PD-1) enhances antitumor activity. Here, we report prespecified final analyses of the dose-escalation part of a first-in-human, phase 1 study (NCT03005782) of fianlimab as monotherapy and in combination with cemiplimab in patients with advanced malignancies.

Patients and Methods::

Adult patients received 1 to 40 mg/kg of fianlimab plus 350 mg of cemiplimab every 3 weeks (Q3W) across various dose-escalation schedules. Primary objectives were the rate of dose-limiting toxicities, adverse events (including immune mediated), deaths, laboratory abnormalities, and pharmacokinetics. Secondary outcomes were objective response rate, best overall response, duration of response, and antidrug antibody variables.

Results::

Seventy-eight patients were enrolled (fianlimab + cemiplimab, n = 47; fianlimab monotherapy, n = 31). One patient treated with 3 mg/kg fianlimab + cemiplimab experienced dose-limiting toxicities, including increased blood creatine phosphokinase and myasthenic syndrome. No maximum tolerated dose was reached. Any-grade treatment-emergent adverse events occurred in 90% of patients with fianlimab monotherapy, in 87% of patients with fianlimab + cemiplimab, and in 87% of patients who transitioned from monotherapy to combination therapy. Fianlimab pharmacokinetics were dose proportional and similar in monotherapy and combination therapy. Across patients who received fianlimab + cemiplimab, five achieved a partial response, three of whom experienced a response after transitioning from monotherapy to combination therapy. Fianlimab 1,600 mg Q3W (20 mg/kg in an 80-kg individual) is the selected dose for phase 2 and phase 3 studies.

Conclusions::

Fianlimab as monotherapy and in combination with cemiplimab demonstrated acceptable safety and preliminary antitumor activity, which is generally consistent with previous reports of cemiplimab.

News (Medical) associated with Fianlimab

31 Oct 2024

·www.globenewswire.com

Regeneron Reports Third Quarter 2024 Financial and Operating Results

Third quarter 2024 revenues increased 11% to $3.72 billion versus third quarter 2023Third quarter 2024 Dupixent® global net sales (recorded by Sanofi) increased 23% to $3.82 billion versus third quarter 2023Third quarter 2024 U.S. net sales for EYLEA HD® and EYLEA® increased 3% versus third quarter 2023 to $1.54 billion, including $392 million from EYLEA HDThird quarter 2024 Libtayo® global net sales increased 24% to $289 million versus third quarter 2023Third quarter 2024 GAAP diluted EPS increased 30% to $11.54 and non-GAAP diluted EPS(a) increased 8% to $12.46 versus third quarter 2023; third quarter 2024 includes unfavorable $0.43 impact from acquired IPR&D chargeFDA approved Dupixent as first-ever biologic therapy in U.S. for treatment of inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotypePositive results reported for Dupixent pivotal trials in chronic spontaneous urticaria (CSU) and bullous pemphigoid (BP); CSU sBLA resubmitted and BP sBLA submission planned for fourth quarter 2024 TARRYTOWN, N.Y., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the third quarter of 2024 and provided a business update. "Regeneron had a strong third quarter marked by 11% revenue growth. We continued to deepen the impact of our commercialized medicines this quarter, with ongoing leadership for our retinal franchise, expanded global reach of Libtayo, and notable growth from Dupixent," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. "Over one million patients around the globe are currently being treated with Dupixent, with more to come following the approvals for COPD in the U.S., Europe and China. Our remarkably diverse clinical portfolio now includes approximately 40 product candidates and many pivotal studies underway. We continue to invest in the world-class research and development engine that drives our scientific and clinical productivity, with data expected over the next twelve months in diseases as varied as non-small cell lung cancer, thrombosis, retinal vein occlusion, severe allergy, COPD, melanoma, and obesity." Financial Highlights ($ in millions, except per share data) Q3 2024 Q3 2023 % ChangeTotal revenues $3,721 $3,363 11%GAAP net income $1,341 $1,008 33%GAAP net income per share - diluted $11.54 $8.89 30%Non-GAAP net income(a) $1,462 $1,329 10%Non-GAAP net income per share - diluted(a) $12.46 $11.59 8% "Our strong third quarter financial performance was highlighted by double-digit revenue growth and continued investment in our growing pipeline," said Christopher Fenimore, Senior Vice President, Finance and Chief Financial Officer of Regeneron. "We remain focused on translating cutting-edge science into differentiated medicines that have the greatest potential to serve patients, while deploying capital with the goal of maximizing shareholder returns, primarily through investing in innovation coupled with opportunistic share repurchases." Business Highlights Key Pipeline ProgressRegeneron has approximately 40 product candidates in clinical development, including a number of marketed products for which it is investigating additional indications. Updates from the clinical pipeline include: EYLEA HD (aflibercept) 8 mg The Company announced positive three-year (156-week) data from an extension study of the Phase 3 PHOTON trial in patients with diabetic macular edema (DME). At three years, the longer-term data showed the vast majority of EYLEA HD patients who entered the extension study sustained the visual gains and anatomic improvements achieved by the end of the second year. Of the EYLEA HD patients who completed the full 156 weeks of treatment, 48% were assigned a dosing interval of ≥20 weeks at the end of the third year. The results were presented at the American Academy of Ophthalmology (AAO) Annual Meeting. Dupixent (dupilumab) In September 2024, the U.S. Food and Drug Administration (FDA) approved Dupixent as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype. With this approval, Dupixent is the first biologic medicine approved in the United States, European Union (EU), and China to treat these patients.In September 2024, the FDA approved Dupixent as an add-on maintenance treatment for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending expanded approval of Dupixent in the EU to treat children aged 1 to 11 years with eosinophilic esophagitis (EoE). The European Commission (EC) is expected to announce a final decision in the coming months.The Company and Sanofi announced that a confirmatory Phase 3 trial met the primary and key secondary endpoints for the investigational treatment of patients with uncontrolled, biologic-naïve CSU receiving background therapy with antihistamines, showing treatment with Dupixent resulted in a nearly 50% reduction in itch and urticaria activity scores from baseline. This positive trial confirms results from the first Phase 3 trial of Dupixent in this setting and these data supported the recent resubmission of a supplemental Biologics License Application (sBLA) to the FDA.The Company and Sanofi announced that a Phase 3 trial in bullous pemphigoid met the primary and all key secondary endpoints evaluating the investigational use in adults with moderate-to-severe disease. In the trial, five times more Dupixent patients achieved sustained disease remission compared to those on placebo. This trial will support global regulatory submissions, including the anticipated fourth quarter 2024 submission in the United States. Oncology Programs In August 2024, the EC approved Ordspono™ (odronextamab) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy.The Company announced five-year results from the final pre-specified overall survival (OS) analysis of a Phase 3 trial, which evaluated Libtayo (cemiplimab) monotherapy versus chemotherapy as a first-line treatment for certain adults with advanced non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression. The results were presented at the IASLC 2024 World Conference on Lung Cancer.The Company submitted a regulatory application in Japan for Libtayo for first-line advanced NSCLC (monotherapy and chemotherapy combination).A Phase 2 study for Libtayo in neoadjuvant NSCLC was initiated.The Company presented new, two-year results at the European Society for Medical Oncology (ESMO) Annual Meeting, evaluating the investigational combination of fianlimab, an antibody to LAG-3, and Libtayo in adults with advanced melanoma across three independent expansion cohorts of a first-in-human, multi-cohort trial. These longer-term results show high clinical activity, including deepening responses, per a blinded independent central review.In August 2024, the FDA issued a Complete Response Letter (CRL) for the BLA for linvoseltamab, a bispecific antibody targeting BCMA and CD3, in R/R multiple myeloma that has progressed after at least three prior therapies. The sole approvability issue identified is related to findings from a pre-approval inspection at a third-party fill/finish manufacturer. Resolution of this issue will be required for both FDA and EC regulatory approvals. Other Programs A Phase 3 study was initiated for pozelimab, an antibody to C5, in combination with cemdisiran, an siRNA therapy, in geographic atrophy.A Phase 2 study for REGN7999, an antibody to TMPRSS6, for the treatment of iron overload in patients with beta-thalassemia was initiated. Third Quarter 2024 Financial Results Revenues ($ in millions) Q3 2024 Q3 2023 % ChangeNet product sales: EYLEA HD - U.S. $392 $43 *EYLEA - U.S. 1,145 1,448 (21%)Total EYLEA HD and EYLEA - U.S. 1,537 1,491 3%Libtayo - Global 289 232 25%Praluent® - U.S. 53 40 33%Evkeeza® - U.S. 32 19 68%Inmazeb® - Global 35 4 *Total net product sales 1,946 1,786 9% Collaboration revenue: Sanofi 1,263 1,065 19%Bayer 391 377 4%Other 6 (3) *Other revenue 114 138 (17%)Total revenues $3,720 $3,363 11% * Percentage not meaningful Total EYLEA HD and EYLEA net product sales in the U.S. increased 3% in the third quarter of 2024 compared to the third quarter of 2023. EYLEA HD was approved by the FDA in August 2023 and net product sales in the third quarter of 2024 were driven by the transition of patients from other anti-VEGF products, including EYLEA, as well as new patients naïve to anti-VEGF therapy. Net product sales of EYLEA in the third quarter of 2024 were adversely impacted by a lower net selling price compared to the third quarter of 2023. In addition, third quarter 2024 total EYLEA HD and EYLEA net product sales were favorably impacted by approximately $40 million as a result of higher wholesaler inventory levels for EYLEA HD at the end of the third quarter of 2024 compared to the end of the second quarter of 2024, partially offset by lower wholesaler inventory levels for EYLEA. Sanofi collaboration revenue increased in the third quarter of 2024, compared to the third quarter of 2023, due to an increase in the Company's share of profits from commercialization of antibodies, which were $1.09 billion in the third quarter of 2024, compared to $863 million in the third quarter of 2023. The change in the Company's share of profits from commercialization of antibodies was driven by higher profits associated with an increase in Dupixent sales. Sanofi collaboration revenue in the third quarter of 2023 was positively impacted by the recognition of the final $50 million sales-based milestone. Refer to Table 4 for a summary of collaboration revenue. Operating Expenses GAAP % Change Non-GAAP(a) % Change($ in millions) Q3 2024 Q3 2023 Q3 2024 Q3 2023 Research and development (R&D) $1,272 $1,075 18% $1,146 $954 20%Acquired in-process research and development (IPR&D) $56 $100 (44%) * * n/aSelling, general, and administrative (SG&A) $714 $641 11% $613 $534 15%Cost of goods sold (COGS) $262 $225 16% $217 $181 20%Cost of collaboration and contract manufacturing (COCM) $229 $212 8% * * n/aOther operating expense (income), net $8 $(1) ** $— * ** * GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been recorded.** Percentage not meaningful GAAP and non-GAAP R&D expenses increased in the third quarter of 2024, compared to the third quarter of 2023, driven by the advancement of the Company's clinical pipeline, including late-stage oncology programs, and higher headcount and headcount-related costs.Acquired IPR&D for the third quarter of 2024 included a $45 million development milestone in connection with the Company's collaboration agreement with Sonoma Biotherapeutics, Inc. Acquired IPR&D expense in the third quarter of 2023 related to a $100 million development milestone in connection with the Company's collaboration with Alnylam Pharmaceuticals, Inc.GAAP and non-GAAP SG&A expenses increased in the third quarter of 2024, compared to the third quarter of 2023, due to higher commercialization-related expenses to support the Company's launch of EYLEA HD and higher headcount and headcount-related costs partly related to the Company's international commercial expansion.GAAP and non-GAAP COGS increased in the third quarter of 2024, compared to the third quarter of 2023, primarily due to higher start-up costs for the Company's Rensselaer, New York fill/finish facility. Other Financial Information GAAP other income (expense) included the recognition of net unrealized gains on equity securities of $135 million in the third quarter of 2024, compared to $100 million of net unrealized losses in the third quarter of 2023. GAAP and Non-GAAP other income (expense) also included interest income of $187 million in the third quarter of 2024, compared to $134 million in the third quarter of 2023. In the third quarter of 2024, the Company's GAAP effective tax rate (ETR) was 10.2%, compared to 9.3% in the third quarter of 2023. The GAAP ETR increased in the third quarter of 2024, compared to the third quarter of 2023, due to a lower benefit from income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate. In the third quarter of 2024, the non-GAAP ETR was 10.7%, compared to 11.9% in the third quarter of 2023. GAAP net income per diluted share was $11.54 in the third quarter of 2024, compared to $8.89 in the third quarter of 2023. Non-GAAP net income per diluted share was $12.46 in the third quarter of 2024, compared to $11.59 in the third quarter of 2023. A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release. During the third quarter of 2024, the Company repurchased shares of its common stock and recorded the cost of the shares, or $738 million, as Treasury Stock. As of September 30, 2024, $2.9 billion remained available for share repurchases under the Company's share repurchase program. 2024 Financial Guidance(c) The Company's full year 2024 financial guidance consists of the following components: 2024 Guidance Prior UpdatedGAAP R&D $5.020–$5.170 billion $5.055–$5.145 billionNon-GAAP R&D(a) $4.500–$4.600 billion $4.525–$4.575 billionGAAP SG&A $2.920–$3.060 billion $2.930–$3.020 billionNon-GAAP SG&A(a) $2.550–$2.650 billion $2.550–$2.600 billionGAAP gross margin on net product sales(d) Approximately 86% UnchangedNon-GAAP gross margin on net product sales(a)(d) Approximately 89% UnchangedCOCM(e)* $850–$910 million $860–$900 millionCapital expenditures* $750–$820 million $700–$740 millionGAAP effective tax rate 8%–9% UnchangedNon-GAAP effective tax rate(a) 10%–11% Unchanged * GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been or are expected to be recorded. A reconciliation of full year 2024 GAAP to non-GAAP financial guidance is included below: Projected Range($ in millions) Low HighGAAP R&D $5,055 $5,145 Stock-based compensation expense 520 540 Acquisition and integration costs 10 30 Non-GAAP R&D $4,525 $4,575 GAAP SG&A $2,930 $3,020 Stock-based compensation expense 340 360 Acquisition, integration, and other costs 40 60 Non-GAAP SG&A $2,550 $2,600 GAAP gross margin on net product sales Approximately 86% Approximately 86%Stock-based compensation expense 1% 1%Intangible asset amortization expense 1% 1%Acquisition and integration costs <1% <1%Non-GAAP gross margin on net product sales Approximately 89% Approximately 89% GAAP ETR 8% 9%Income tax effect of GAAP to non-GAAP reconciling items 2% 2%Non-GAAP ETR 10% 11% (a)This press release uses non-GAAP R&D, non-GAAP SG&A, non-GAAP COGS, non-GAAP gross margin on net product sales, non-GAAP other operating (income) expense, net, non-GAAP other income (expense), net, non-GAAP ETR, non-GAAP net income, non-GAAP net income per share, total revenues excluding Ronapreve™(b), and free cash flow, which are financial measures that are not calculated in accordance with U.S. Generally Accepted Accounting Principles (GAAP). These non-GAAP financial measures are computed by excluding certain non-cash and/or other items from the related GAAP financial measure. The Company also includes a non-GAAP adjustment for the estimated income tax effect of reconciling items. A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release.The Company makes such adjustments for items the Company does not view as useful in evaluating its operating performance. For example, adjustments may be made for items that fluctuate from period to period based on factors that are not within the Company's control (such as the Company's stock price on the dates share-based grants are issued or changes in the fair value of the Company's investments in equity securities) or items that are not associated with normal, recurring operations (such as acquisition and integration costs). Management uses these non-GAAP measures for planning, budgeting, forecasting, assessing historical performance, and making financial and operational decisions, and also provides forecasts to investors on this basis. With respect to free cash flows, the Company believes that this non-GAAP measure provides a further measure of the Company's ability to generate cash flows from its operations. Additionally, such non-GAAP measures provide investors with an enhanced understanding of the financial performance of the Company's core business operations. However, there are limitations in the use of these and other non-GAAP financial measures as they exclude certain expenses that are recurring in nature. Furthermore, the Company's non-GAAP financial measures may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented by the Company should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with GAAP. (b)The casirivimab and imdevimab antibody cocktail for COVID-19 is known as REGEN-COV® in the United States and Ronapreve in other countries. Roche records net product sales of Ronapreve outside the United States. (c)The Company's 2024 financial guidance does not assume the completion of any business development transactions not completed as of the date of this press release. (d)Gross margin on net product sales represents gross profit expressed as a percentage of total net product sales recorded by the Company. Gross profit is calculated as net product sales less cost of goods sold. (e)Corresponding reimbursements from collaborators and others for manufacturing of commercial supplies is recorded within revenues. Conference Call Information Regeneron will host a conference call and simultaneous webcast to discuss its third quarter 2024 financial and operating results on Thursday, October 31, 2024, at 8:30 AM Eastern Time. Participants may access the conference call live via webcast, or register in advance and participate via telephone, on the "Investors and Media" page of Regeneron's website at www.regeneron.com. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company's website for at least 30 days. About Regeneron Pharmaceuticals, Inc. Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, Regeneron's unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in Regeneron's laboratories. Regeneron's medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using its proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. Regeneron is shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling Regeneron to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit www.regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook, or X. Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products") and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates") and research and clinical programs now underway or planned, including without limitation EYLEA HD® (aflibercept) Injection 8 mg, EYLEA® (aflibercept) Injection, Dupixent® (dupilumab), Libtayo® (cemiplimab), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab), Veopoz® (pozelimab), Ordspono™ (odronextamab), itepekimab, fianlimab, garetosmab, linvoseltamab, REGN5713-5714-5715, nexiguran ziclumeran (NTLA-2001), Regeneron's other oncology programs (including its costimulatory bispecific portfolio), Regeneron's and its collaborators' earlier-stage programs, and the use of human genetics in Regeneron's research programs; the likelihood and timing of achieving any of the anticipated milestones described in this press release; safety issues resulting from the administration of Regeneron's Products and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron's Product Candidates in clinical trials; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, including those listed above and/or otherwise discussed in this press release; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates (including biosimilar versions of Regeneron's Products); uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties on the commercial success of Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; the ability of Regeneron’s collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron's Product Candidates; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance, including GAAP and non-GAAP R&D, GAAP and non-GAAP SG&A, GAAP and non-GAAP gross margin on net product sales, COCM, capital expenditures, and GAAP and non-GAAP ETR; the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on Regeneron's business; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the fiscal year ended December 31, 2023 and its Form 10-Q for the quarterly period ended September 30, 2024. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals). Non-GAAP Financial Measures This press release and/or the financial results attached to this press release include amounts that are considered "non-GAAP financial measures" under SEC rules. As required, Regeneron has provided reconciliations of such non-GAAP financial measures. Contact Information: Ryan Crowe Christina ChanInvestor Relations Corporate Affairs914-847-8790 914-847-8827ryan.crowe@regeneron.com christina.chan@regeneron.com TABLE 1 REGENERON PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)(In millions) September 30, December 31, 2024 2023Assets: Cash and marketable securities $18,287.4 $16,241.3Accounts receivable, net 6,107.1 5,667.3Inventories 3,018.0 2,580.5Property, plant, and equipment, net 4,439.2 4,146.4Intangible assets, net 1,120.1 1,038.6Deferred tax assets 3,015.1 2,575.4Other assets 1,455.0 830.7Total assets $37,441.9 $33,080.2 Liabilities and stockholders' equity: Accounts payable, accrued expenses, and other liabilities $4,577.4 $3,818.6Finance lease liabilities 720.0 720.0Deferred revenue 834.6 585.6Long-term debt 1,984.0 1,982.9Stockholders' equity 29,325.9 25,973.1Total liabilities and stockholders' equity $37,441.9 $33,080.2 TABLE 2 REGENERON PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)(In millions, except per share data) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Revenues: Net product sales $1,946.4 $1,786.1 $5,626.3 $5,226.2 Collaboration revenue 1,660.1 1,438.3 4,450.9 4,133.1 Other revenue 114.2 138.3 335.6 323.6 3,720.7 3,362.7 10,412.8 9,682.9 Expenses: Research and development 1,271.5 1,075.3 3,719.9 3,261.8 Acquired in-process research and development 56.2 100.0 87.2 156.1 Selling, general, and administrative 714.4 640.5 2,162.2 1,893.6 Cost of goods sold 262.3 224.5 760.5 625.3 Cost of collaboration and contract manufacturing 228.8 211.9 644.6 673.5 Other operating expense (income), net 8.0 (0.5) 37.9 (1.6) 2,541.2 2,251.7 7,412.3 6,608.7 Income from operations 1,179.5 1,111.0 3,000.5 3,074.2 Other income (expense): Other income (expense), net 327.3 17.6 866.0 32.2 Interest expense (13.8) (17.8) (44.7) (54.7) 313.5 (0.2) 821.3 (22.5) Income before income taxes 1,493.0 1,110.8 3,821.8 3,051.7 Income tax expense 152.4 103.0 326.9 257.7 Net income $1,340.6 $1,007.8 $3,494.9 $2,794.0 Net income per share - basic $12.40 $9.48 $32.36 $26.16 Net income per share - diluted $11.54 $8.89 $30.23 $24.57 Weighted average shares outstanding - basic 108.1 106.3 108.0 106.8 Weighted average shares outstanding - diluted 116.2 113.4 115.6 113.7 TABLE 3 REGENERON PHARMACEUTICALS, INC.RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited)(In millions, except per share data) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 GAAP R&D $1,271.5 $1,075.3 $3,719.9 $3,261.8 Stock-based compensation expense 123.7 107.4 369.1 356.0 Acquisition and integration costs 2.0 13.5 11.1 17.7 Non-GAAP R&D $1,145.8 $954.4 $3,339.7 $2,888.1 GAAP SG&A $714.4 $640.5 $2,162.2 $1,893.6 Stock-based compensation expense 83.1 74.4 251.9 224.5 Acquisition, integration, and other costs 18.2 32.4 46.7 58.5 Non-GAAP SG&A $613.1 $533.7 $1,863.6 $1,610.6 GAAP COGS $262.3 $224.5 $760.5 $625.3 Stock-based compensation expense 18.3 22.1 57.4 64.1 Acquisition and integration costs 0.5 0.9 1.7 1.4 Intangible asset amortization expense 26.1 20.7 74.4 59.0 Charges related to REGEN-COV — — — (10.0)Non-GAAP COGS $217.4 $180.8 $627.0 $510.8 GAAP other operating expense (income), net $8.0 $(0.5) $37.9 $(1.6)Change in fair value of contingent consideration 8.0 — 37.9 — Non-GAAP other operating expense (income), net $— $(0.5) $— $(1.6) GAAP other income (expense), net $313.5 $(0.2) $821.3 $(22.5)(Gains) losses on investments, net (134.7) 127.0 (331.2) 324.5 Non-GAAP other income (expense), net $178.8 $126.8 $490.1 $302.0 GAAP net income $1,340.6 $1,007.8 $3,494.9 $2,794.0 Total of GAAP to non-GAAP reconciling items above 145.2 398.4 519.0 1,095.7 Income tax effect of GAAP to non-GAAP reconciling items (23.4) (77.1) (84.4) (211.5)Non-GAAP net income $1,462.4 $1,329.1 $3,929.5 $3,678.2 Non-GAAP net income per share - basic $13.53 $12.50 $36.38 $34.44 Non-GAAP net income per share - diluted $12.46 $11.59 $33.53 $31.90 Shares used in calculating: Non-GAAP net income per share - basic 108.1 106.3 108.0 106.8 Non-GAAP net income per share - diluted 117.4 114.7 117.2 115.3 RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited) (continued) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Revenue reconciliation: Total revenues $3,720.7 $3,362.7 $10,412.8 $9,682.9 Global gross profits earned in connection with sales of Ronapreve 0.5 — 1.4 222.2 Other — (5.7) — (9.5)Total revenues excluding Ronapreve $3,720.2 $3,368.4 $10,411.4 $9,470.2 Effective tax rate reconciliation: GAAP ETR 10.2% 9.3% 8.6% 8.4%Income tax effect of GAAP to non-GAAP reconciling items 0.5% 2.6% 0.9% 2.9%Non-GAAP ETR 10.7% 11.9% 9.5% 11.3% Nine Months Ended September 30, 2024 2023 Free cash flow reconciliation: Net cash provided by operating activities $3,157.7 $3,504.3 Capital expenditures (556.3) (467.2) Free cash flow $2,601.4 $3,037.1 TABLE 4 REGENERON PHARMACEUTICALS, INC.COLLABORATION REVENUE (Unaudited)(In millions) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Sanofi collaboration revenue: Regeneron's share of profits in connection with commercialization of antibodies $1,088.3 $863.0 $2,880.6 $2,250.6 Sales-based milestones earned — 50.0 — 50.0 Reimbursement for manufacturing of commercial supplies 175.1 151.5 438.2 506.0 Total Sanofi collaboration revenue 1,263.4 1,064.5 3,318.8 2,806.6 Bayer collaboration revenue: Regeneron's share of profits in connection with commercialization of EYLEA 8 mg and EYLEA outside the United States 367.6 349.9 1,054.5 1,031.0 Reimbursement for manufacturing of ex-U.S. commercial supplies 23.2 27.2 67.4 79.7 Total Bayer collaboration revenue 390.8 377.1 1,121.9 1,110.7 Other collaboration revenue: Global gross profits earned from Roche in connection with sales of Ronapreve 0.5 — 1.4 222.2 Other 5.4 (3.3) 8.8 (6.4) Total collaboration revenue $1,660.1 $1,438.3 $4,450.9 $4,133.1 TABLE 5 REGENERON PHARMACEUTICALS, INC.NET PRODUCT SALES OF REGENERON-DISCOVERED PRODUCTS (Unaudited)(In millions) Three Months Ended September 30, 2024 2023 % Change U.S. ROW(g) Total U.S. ROW Total (Total Sales)EYLEA HD and EYLEA(a) $1,536.9 $931.7 $2,468.6 $1,490.9 $872.2 $2,363.1 4%Dupixent(b) $2,824.7 $992.5 $3,817.2 $2,366.3 $731.3 $3,097.6 23%Libtayo(c) $194.5 $94.1 $288.6 $144.1 $88.3 $232.4 24%Praluent(d) $52.9 $138.5 $191.4 $40.4 $125.1 $165.5 16%Kevzara(b) $72.7 $47.4 $120.1 $52.4 $43.3 $95.7 25%REGEN-COV(e) $— $1.2 $1.2 $— $— $— *Other products(f) $68.2 $23.2 $91.4 $23.4 $15.5 $38.9 135% Nine Months Ended September 30, 2024 2023 % Change U.S. ROW Total U.S. ROW Total (Total Sales)EYLEA HD and EYLEA(a) $4,473.2 $2,688.9 $7,162.1 $4,424.8 $2,605.6 $7,030.4 2%Dupixent(b) $7,652.9 $2,797.5 $10,450.4 $6,369.6 $2,002.4 $8,372.0 25%Libtayo(c) $536.1 $313.8 $849.9 $384.0 $241.0 $625.0 36%Praluent(d) $179.0 $405.6 $584.6 $121.1 $330.6 $451.7 29%Kevzara(b) $187.8 $136.1 $323.9 $148.5 $125.2 $273.7 18%REGEN-COV(e) $— $3.5 $3.5 $— $613.2 $613.2 (99%)Other products(f) $124.4 $61.7 $186.1 $64.0 $48.9 $112.9 65% Note: The table above includes net product sales of Regeneron-discovered products. Such net product sales are recorded by the Company or others, as further described in the footnotes below.* Percentage not meaningful(a) The Company records net product sales of EYLEA HD and EYLEA in the United States, and Bayer records net product sales outside the United States. The Company records its share of profits in connection with sales outside the United States within Collaboration revenue.(b) Sanofi records global net product sales of Dupixent and Kevzara, and the Company records its share of profits in connection with global sales of such products within Collaboration revenue.(c) The Company records global net product sales of Libtayo and pays Sanofi a royalty on such sales. Prior to July 1, 2022, Sanofi recorded net product sales of Libtayo outside the United States. Included in this line item for the nine months ended September 30, 2023 is approximately $6 million of first quarter 2023 net product sales recorded by Sanofi in connection with sales in certain markets outside the United States (Sanofi recorded net product sales in such markets during a transition period).(d) The Company records net product sales of Praluent in the United States. Sanofi records net product sales of Praluent outside the United States and pays the Company a royalty on such sales, which is recorded within Other revenue.(e) Roche records net product sales outside the United States and the Company records its share of gross profits from sales, which is recorded within Collaboration revenue.(f) Included in this line item are products which are sold by the Company and others. Refer to "Third Quarter 2024 Financial Results" section above for a complete listing of net product sales recorded by the Company. Not included in this line item are net product sales of ARCALYST®, which are recorded by Kiniksa; net product sales of ARCALYST were $103 million for the second quarter of 2024.(g) Rest of world (ROW)

Clinical ResultPhase 3Drug ApprovalFinancial Statement

24 Sep 2024

·www.prnewswire.com

Optimism Grows in the Fight Against Cancer as Breakthroughs and Funding Increase

USA News Group Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Sept. 24, 2024 /PRNewswire/ -- USA News Group – Optimism is on the rise in fight against cancer, as researchers are making progress across the field of oncology. Helping to spur on the momentum, philanthropists recently gave a historic $150 million for pancreatic cancer research to City of Hope, while Stanford experts are calling for more massive federal funding increases to cancer research. According to the latest Cancer Progress Report from the American Association for Cancer Research, the USA has seen a 33% reduction in the overall cancer death rate from 1991 to 2021. Working behind the scenes are several biotech and biopharma companies who've recently made significant developments in the field of oncology, including O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Nurix Therapeutics, Inc. (NASDAQ: NRIX), Incyte Corporation (NASDAQ: INCY), Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), and Foghorn Therapeutics Inc. (NASDAQ: FHTX). Building on the impressive momentum from its BRACELET-1 breast cancer study, O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) continues to advance its flagship therapy, pelareorep, toward a pivotal, registration-enabling study. The recent BRACELET-1 Phase 2 trial results have generated a surge of optimism, with over half of the patients in the pelareorep arm still alive at the study's end—a remarkable achievement that underscores the potential of this innovative cancer therapy. The median overall survival (OS) for patients treated with pelareorep combined with paclitaxel has not yet been reached, with estimates suggesting a 32-month survival benefit compared to just 18 months for the control arm. This outcome, along with a 64% two-year survival rate for the pelareorep group, highlights the therapy's potential to significantly improve patient outcomes in HR+/HER2- advanced or metastatic breast cancer. "The fact that the median overall survival was not reached because more than half the patients were still alive at the end of the study is a remarkable achievement for us," said Wayne Pisano, Interim CEO and Chair of Oncolytics' Board of Directors. "It shows just how promising pelareorep treatment can be for extending the lives of breast cancer patients. This is further exemplified by the near doubling of the 2-year survival rate for patients who received pelareorep combination therapy." These promising results mirror the earlier success of the IND-213 study, which secured FDA Fast Track Designation for pelareorep in 2017. Combined, these two trials reinforce the growing belief in pelareorep's ability to make a substantial impact in oncology. Within the latest update on pelareorep's latest breast cancer study were plenty of reasons to build optimism, corroborating results of its previous randomized IND-213 breast cancer study that led to an FDA Fast Track Designation in 2017. "Taken together, the BRACELET-1 results provide compelling support for the potential of pelareorep-based combination therapy to benefit patients with advanced or metastatic HR+/HER2- breast cancer," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Having recently discussed with the FDA key design elements for our next breast cancer study, in combination with the strong survival data from the BRACELET-1 and IND-213 studies, we are confident in our plan to conduct a registration-enabling study to assess pelareorep-based combination therapy in patients with advanced HR+/HER2- breast cancer." As Oncolytics pushes forward, the stage is now set for the next chapter in pelareorep's journey—a registration-enabling study that could bring this promising therapy closer to becoming a vital tool in the fight against breast cancer. Clinical stage biopharma company Nurix Therapeutics, Inc. (NASDAQ: NRIX) is developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases. Recently, Nurix presented at the ADC & Radiopharmaceuticals Pharma & Biotech Partnering Summit in Boston, with a presentation titled Targeted Protein Degraders as Next Generation Antibody Payloads. Back in Q2 2024, Nurix also presented positive clinical data at the European Hematology Association Congress (EHA2024) supporting a potential best-in-class profile for NX-5948, its orally bioavailable degrader of Bruton's tyrosine kinase (BTK), for the treatment of chronic lymphocytic leukemia (CLL). NX-5948 demonstrated an objective response rate (ORR) of 69.2% in heavily pretreated chronic lymphocytic leukemia (CLL) patients, including in patients with Bruton's tyrosine kinase (BTK) inhibitor resistance mutations and patients with central nervous system (CNS) i "The data presented at EHA2024, reaffirm the best-in-class potential of our protein degradation platform to address the limitations of current inhibitors against challenging targets such as Bruton's tyrosine kinase," said Arthur T. Sands, M.D., Ph.D., President and CEO of Nurix. "We enter the second half of 2024 well positioned to develop our lead clinical program, NX-5948, into pivotal clinical trials in CLL in 2025 and to continue to advance our wholly owned pipeline of clinical assets, preclinical programs and strategic collaboration programs with Gilead, Sanofi and Pfizer." Recently at the ESMO 2024 Congress, Incyte Corporation (NASDAQ: INCY) gave a mini-oral presentation sharing promising results for its CDK2 inhibitor INCB123667 showing promising evidence of clinical activity in patients with advanced solid tumors, notably ovarian cancer. Of the 37 evaluable participants with platinum-resistant ovarian cancer, nine participants (24.3%) experienced an overall response (OR; 2 complete responses [CR] and 7 partial responses [PRs]). The highest OR rate of 31.3% (5 responders, including 2 CRs) was found in the 50mg BID cohort (16 evaluable participants). Additionally, a disease control rate (DCR) of 75.7% (28/37) was achieved in patients with ovarian cancer. "The early-stage clinical activity of INCB123667 represents an exciting and promising breakthrough for patients with ovarian cancer," said Pablo Cagnoni M.D., President, Head of Research and Development, Incyte. "We believe this novel CDK2 inhibitor has the potential to be a foundational treatment for platinum-resistant ovarian cancer, offering a new and differentiated treatment for patients who currently have limited treatment options. We look forward to advancing the development of INCB123667 for the treatment of patients with ovarian cancer both as a single agent and in combination." At both the ESMO 2024 Congress and IASLC 2024 World Conference on Lung Cancer (WCLC), Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) presented progress across its differentiated oncology portfolio and pipeline. Regeneron first shared five-year survival data on Libtayo (PD-1 inhibitor) first-line monotherapy in advanced non-small cell lung cancer (NSCLC) at IASLC 2024, then shared longer-term results with investigational fianlimab (LAG-3 inhibitor) plus Libtayo from initial trial in advanced melanoma showing high clinical activity, including deepening responses, per a blinded independent central review. "The breadth of our presentations at ESMO and WCLC underscore our progress in advancing treatment approaches for cancer that have the potential to be among the best in their class," said Israel Lowy, MD, PhD, Clinical Development Unit Head, Oncology, at Regeneron. "At WCLC, five-year outcomes for Libtayo monotherapy in advanced NSCLC reinforce its position as the anti-PD-1 backbone of our oncology portfolio. At ESMO, the latest two-year data for our LAG-3 inhibitor fianlimab combined with Libtayo show persistent and high clinical activity in advanced melanoma patients. As our portfolio and pipeline mature, the insights from these data are helping us advance our differentiated and novel combination approaches – all with the goal of transforming care for those living with cancer." Within its Q2 2024 financial and corporate update, Foghorn Therapeutics Inc. (NASDAQ: FHTX) stated it expects topline Phase 1 dose escalation data for its FHD-286 in combination with decitabine in relapsed and/or refractory AML patients to come in Q4 2024, and dosing of its first patient in a Phase 1 trial for FHD-909, a potential first-in-class SMARCA2 selective inhibitor for a primary target population in SMARCA4 mutated NSCLC to come in H2 2024. "We anticipate topline data from our Phase 1 combination trial with FHD-286 in patients with relapsed and/or refractory AML in the fourth quarter of 2024," said Adrian Gottschalk, President and CEO of Foghorn. "We believe FHD-286 has the potential to be a first-in-class, mutation-agnostic differentiation therapeutic. Additionally, the IND for FHD-909 cleared in May and we anticipate FHD-909 to be the first SMARCA2 selective inhibitor to enter the clinic. Dosing of the first patient in our Phase 1 trial, with primary target population in SMARCA4 mutated NSCLC, is planned for the second half of the year. We are also on track to initiate IND-enabling studies in the fourth quarter of 2024 for our Selective CBP degrader program targeting tumors harboring EP300 mutations including bladder, gastric and endometrial cancers." Article Source: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCE USA News Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 1Fast TrackPhase 2

17 Sep 2024

·endpts.com

Sun, surprises and new summits at Europe’s biggest cancer conference

BARCELONA — More than 33,000 oncologists, medical researchers, biopharma leaders and other delegates attended Europe’s largest cancer meeting over the past few days in Spain, with more than 181 countries represented. It was the European Society for Medical Oncology’s second consecutive year in the country. The sun shined every day this time, though, unlike last year’s cloudy and rainy vibes in Madrid. The perfect weather served as a good backdrop for the 10th anniversary of immunotherapies’ role in saving and prolonging the lives of cancer patients. A decade after that initial I/O class launched, the medicines are still making impacts in new areas, with the world’s top-selling drug, Merck’s Keytruda, still the subject of a few presidential symposiums at this year’s ESMO. Questions remain about the longer-term future of Keytruda — though a looming subcutaneous form could prolong its tenure — as Summit Therapeutics’ partner Akeso presented more data on its antibody ivonescimab that beat Merck’s megablockbuster in a head-to-head trial in China. The data have sparked a surge in interest for VEGF approaches, giving a leg up to Covid standout BioNTech and a little biotech known as Instil Bio. Speaking of BioNTech, a new study also showed that Covid mRNA vaccines may help boost the effects of immunotherapy in cancer patients. Some attendees remarked that they were expecting this year’s ESMO to be a little quiet, at least compared to last year’s buzzy confab , when antibody-drug conjugates stole the show and radiopharmaceuticals had a few key readouts. But the congress ended up having its moments. While this year’s edition unfolded with no major deals, a few studies invigorated the delegates. That included one discussant’s claims of researchers “ cherry-picking ” patients in an analysis on a LAG-3 drug; GSK and iTeos breathing some life back into the TIGIT field ; and Pfizer saying it will move into Phase 3 with an experimental drug for cancer cachexia , a common wasting condition that has no approved treatments. And the ESMO president unveiled the society’s newest side conference: an AI and Digital Oncology meeting that will kick off next year. Below are some more on-the-ground highlights of ESMO, which took place at the Fira Barcelona Gran Via. For the medical practitioners and drug developers who double as architecture buffs, this year’s venue had a much prettier facade than the 2023 meeting in Madrid . A decade in, immunotherapy is getting harder: Regeneron’s Izzy Lowy told Endpoints News that in immunotherapy, “we’ve gotten the low-hanging fruit, and now the challenge is building on that.” He added that the company’s strategy is to take multiple different approaches and combinations to get results. Regeneron presented longer follow-up data to its Opdualag challenger, a combination of Libtayo and LAG-3 antibody fianlimab, in melanoma. Separate booths for AbbVie and ImmunoGen: Despite closing the $10 billion acquisition seven months ago, the companies still had individual booths — and on opposite sides of the massive hall. In an interview, AbbVie leaders highlighted the “talent wars” going on in the crowded ADC field, but they believe quality will attract workers. The company stressed the importance of taking a biomarker approach to clinical development. Coffee: It was everywhere, and the whole venue smelled like it. At least the cups weren’t American-sized ones. Standing O? Not this year: There was no get-up-and-clap moment like last year’s thunderous applause for a Padcev-Keytruda win in first-line bladder cancer. Novartis’ Apple Vision Pros: The Swiss pharma giant let attendees test out the eye tech so they could see a virtualization of a cancer patient receiving its radioligand therapy. The drugmaker also had a display with a fictionalized newspaper named “KISQALI TODAY,” with the headlines “No news is good news” and “Data worth sharing” for its breast cancer drug. Boehringer Ingelheim’s big booth: The family-owned German drugmaker had a relatively sizable booth after years of buying up small cancer biotechs and fleshing out its pipeline. Boehringer’s global head of oncology Itziar Canamasas told Endpoints that the company is investing about €1 billion in oncology R&D a year. Boehringer declined to confirm this number after the interview. Food, food, food: Kyle from Chicago appreciated the smell of pizza in between halls, thanks to a food truck with a small pizza oven. Attendees could also grab tapas from a little eatery named Mosquito (for “exotic” bites). There were green and healthy stands as well. Purple, but doomy press area: A vibrant purple carpet, about a block in length, welcomed visitors to the press area, but some interview spaces gave off interrogation room vibes thanks to their gray and exposed cinder block walls. Daiichi once again sponsored the conference WiFi: The Japan-based ADC behemoth sponsored last year’s ESMO wireless internet. The company’s booth was across from Merck, or MSD as it’s known here. The two became partners at the start of last year’s conference in a multibillion-dollar deal. Never enough chairs: The conferences must be doing this on purpose. Editor’s note: This story was updated to note that Boehringer declined to confirm how much it invests in oncology R&D.

AcquisitionVaccineImmunotherapyPhase 3

100 Deals associated with Fianlimab

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Carcinoma	Phase 3	US	Regeneron Pharmaceuticals, Inc.	30 Jun 2023
Advanced Lung Non-Small Cell Carcinoma	Phase 3	AU	Regeneron Pharmaceuticals, Inc.	30 Jun 2023
Advanced Lung Non-Small Cell Carcinoma	Phase 3	CA	Regeneron Pharmaceuticals, Inc.	30 Jun 2023
Advanced Lung Non-Small Cell Carcinoma	Phase 3	GE	Regeneron Pharmaceuticals, Inc.	30 Jun 2023
Advanced Lung Non-Small Cell Carcinoma	Phase 3	IL	Regeneron Pharmaceuticals, Inc.	30 Jun 2023
Advanced Lung Non-Small Cell Carcinoma	Phase 3	MY	Regeneron Pharmaceuticals, Inc.	30 Jun 2023
Advanced Lung Non-Small Cell Carcinoma	Phase 3	KR	Regeneron Pharmaceuticals, Inc.	30 Jun 2023
Advanced Lung Non-Small Cell Carcinoma	Phase 3	TW	Regeneron Pharmaceuticals, Inc.	30 Jun 2023
Advanced Lung Non-Small Cell Carcinoma	Phase 3	TH	Regeneron Pharmaceuticals, Inc.	30 Jun 2023
Advanced Lung Non-Small Cell Carcinoma	Phase 3	TR	Regeneron Pharmaceuticals, Inc.	30 Jun 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03005782 (ESMO2024) Manual	Not Applicable	Melanoma LAG3 Positive \| PD-L1	98	fianlimab 1600 mg + cemiplimab 350 mg	dxcfujvsda(ugxbchlxsq) = eaonwituyl ucvlbvetce (xifwjhvxik ) View more	Positive	14 Sep 2024
NCT03005782 (Pubmed) Manual	Phase 1	Melanoma Adjuvant	-	Fianlimab 1,600 mg + Cemiplimab 350 mg (anti-PD-1-naïve melanoma)	ttirvmwtuq(svfyofveaa) = kxwzoniokw kqedhxisdw (tkgpbqudgz ) View more	Positive	20 Jun 2024
				Fianlimab 1,600 mg + Cemiplimab 350 mg (systemic treatment-naïve melanoma)	ttirvmwtuq(svfyofveaa) = oltpsuxngo kqedhxisdw (tkgpbqudgz )
NCT03005782 (Phase 1 study of fianlimab (anti-LAG-3) in combination with cemiplimab (anti-PD-1) in patients with advanced HNSCC, ASCO2024)	Phase 1	Squamous Cell Carcinoma of Head and Neck	30	Fianlimab 1600 mg + Cemiplimab 350 mg	siakuurcov(rtyrsbsgft) = In cohort 12, there was one death due to grade 5 respiratory failure attributable to aspiration pneumonia fxekgryzgm (zfqtoeqgvw )	Positive	24 May 2024
NCT03005782 (ASCO_GU2024) Manual	Phase 1	Renal Cell Carcinoma	30	fianlimab 1600 mg + cemiplimab 350 mg (anti–PD-1/PD-L1-naïve)	hevnroakxd(fgdpiilxlu) = sguhddqvad jqztgzlrqq (ufyoqtbjfs ) View more	Positive	25 Jan 2024
				fianlimab1600 mg + cemiplimab 350 mg (anti–PD-1/L1-experienced)	cafzmqyxbk(ntrafhxwha) = updkkxqhsx lovlvrgxif (nfinpqvfxp ) View more
NCT03005782 (FIH POC study1, NEWS) Manual	Phase 1	Metastatic melanoma	98	fianlimab+cemiplimab (Cohort MM1(Initial))	ndtztmdbba(jsldtoukhk) = pvnrleouwx goickcqnaj (zhnozlbluq ) View more	Superior	08 Jan 2024
				fianlimab+cemiplimab (Cohort MM2(Confirmatory))	ndtztmdbba(jsldtoukhk) = wjmiericzu goickcqnaj (zhnozlbluq ) View more
NCT03005782 (ASCO2023) Manual	Phase 1	Locally Advanced Melanoma	98	Fianlimab 1600 mg + Cemiplimab 350 mg	lwmmrmobpi(uivbhofudq) = rsbhqgfuaf zzewgyvljl (ltoujklnrh ) View more	Positive	31 May 2023
				Fianlimab 1600 mg + Cemiplimab 350 mg (with prior iCPIs )	irxtqsdink(wwoesvxmxh) = uotdwfeyfe yrfpqaljlm (hbudwplmbf )
NCT03005782 (ASCO2023) Manual	Phase 1	Locally Advanced Melanoma	98	Cemiplimab-RWLC+Fianlimab	sgjagsixcc(gosqxrukeo) = 32.7% airnzxvzlh (gceymgdmyu ) View more	Positive	26 May 2023
				Cemiplimab-RWLC+Fianlimab (pts with any prior adj Tx)
Phase 1 study (AAD2023)	Phase 1	Melanoma	-	fianlimab 1600 mg + cemiplimab 350 mg	zmzsxkztpv(xnocbttkeu) = uoajavdosm inriujnkxk (paihdishzz ) View more	-	17 Mar 2023
NCT03005782 (ESMO_IO2022) Manual	Phase 1	Melanoma	80	fianlimab+cemiplimab (pts with liver mets at BL)	ivbnttckoh(jdbolxsfum) = eltuaatwjr tiifgprfta (earsohoxrg, 2.8 - NE) View more	Positive	08 Dec 2022
				fianlimab+cemiplimab (pts with LDH>ULN at BL)	ivbnttckoh(jdbolxsfum) = ewhstwaepp tiifgprfta (earsohoxrg, 7.3 - NE) View more
NCT03005782 (ESMO_IO2022) Manual	Phase 1	Non-Small Cell Lung Cancer	30	Fianlimab 1600 mg+Cemiplimab 350 mg (EC1)	tohvqzkbtn(ubwmyfkudl) = rfirkboffn zqfkvnlbsr (pynbvoqbfr ) View more	Positive	08 Dec 2022
				Fianlimab 1600 mg+Cemiplimab 350 mg (treatment-naive)	tohvqzkbtn(ubwmyfkudl) = poahuyioqd zqfkvnlbsr (pynbvoqbfr )

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