A Phase II Open Label, Randomized Study Testing the Efficacy of Retifanlimab in Combination with Bevacizumab and Hypofractionated Radiotherapy in Patients with Recurrent GBM

This phase II trial tests how well retifanlimab with bevacizumab and hypofractionated radiotherapy, compared to bevacizumab and hypofractionated radiotherapy alone, works in treating patients with glioblastoma that has come back after a period of improvement (recurrent). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving retifanlimab with bevacizumab and hypofractionated radiotherapy may work better in treating patients with recurrent glioblastoma than bevacizumab and hypofractionated radiotherapy alone.

Start Date02 Oct 2024

Sponsor / Collaborator

National Cancer Institute

NCT06290622 / WithdrawnPhase 1IIT

PD-1, LAG-3 and TIM-3 Checkpoint Blockade in DLBCL Post Chimeric Antigen Receptor T-cEll Therapy fAilUre (PLATEAU Study)

This study is investigating the optimal dose and the advantage in combining investigational immunotherapy drugs known as Retifanlimab, INCAGN02385 and INCAGN02390 to improve the responses to CAR T-cell therapy. Additionally, the study will investigate that triple checkpoint blockade of PD-1, TIM-3 and LAG-3 molecules will overcome CAR T-cell therapy resistance in patients with suboptimal responses.

Start Date30 Aug 2024

Sponsor / Collaborator

The University of Alabama at Birmingham

NCT06389799 / RecruitingPhase 2IIT

A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma

Dedifferentiated liposarcomas (DDLPS) are aggressive soft tissue sarcomas with no effective medical treatment options.
Immunotherapy with checkpoint inhibitors, so-called PD-1 inhibitors, have shown some effect in DDLPS in previous studies. Effect of immunotherapy can be improved by combining it with other types of tumor drugs. Medicines that inhibit signaling via the FGF receptor, so-called FGFR inhibitors, have shown a tumor-slowing effect in DDLPS in early studies. FGFR inhibitors can also induce changes that make the tumor more available to treatment with immunotherapy.
The study aims to investigate whether the combination of an FGFR inhibitor, pemigatinib, with a PD-1 inhibitor, retifanlimab can provide a tumor-slowing effect in patients with advanced DDLPS who have progressed on first-line treatment.

Start Date20 Jun 2024

Sponsor / Collaborator

Lund University Hospital

100 Clinical Results associated with Retifanlimab

100 Translational Medicine associated with Retifanlimab

100 Patents (Medical) associated with Retifanlimab

Literatures (Medical) associated with Retifanlimab

31 Dec 2024·mAbs

Antibodies to watch in 2024

Article

Author: Kaplon, Hélène ; Crescioli, Silvia ; Wang, Lin ; Reichert, Janice M. ; Visweswaraiah, Jyothsna ; Chenoweth, Alicia

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

01 Jul 2024·ESMO Open

Open-label, dose-escalation FIGHT-101 study of pemigatinib combined with targeted therapy, chemotherapy, or immunotherapy in patients with advanced malignancies

Article

Author: Tian, C ; Subbiah, V ; Papadopoulos, K P ; Saleh, M ; Mettu, N B ; Morgensztern, D ; Silverman, I M ; Veronese, M L ; Barve, M ; Gutierrez, M ; Spanggaard, I ; Roychowdhury, S

BACKGROUND:

Pemigatinib is an oral, potent, selective fibroblast growth factor receptor (FGFR) 1-3 inhibitor. FIGHT-101, a three-part, open-label, first-in-human, phase I/II study (NCT02393248), evaluated pemigatinib in patients with advanced solid tumors. In parts 1 and 2, pemigatinib monotherapy had a manageable safety profile and antitumor activity in FGFR-altered tumors. Part 3 (pemigatinib combination therapies) results are presented here.

PATIENTS AND METHODS:

Patients received 9, 13.5, or 20 mg oral once-daily pemigatinib on continuous or intermittent schedules with gemcitabine and cisplatin (pemi/gem/cis), docetaxel (pemi/doc), trastuzumab (pemi/tras), pembrolizumab (pemi/pembro), or retifanlimab (pemi/reti) irrespective of whether the tumor was confirmed as FGFR altered. Primary endpoints were safety and pharmacodynamics. Secondary endpoints were investigator-assessed tumor objective response rates (ORRs) and pharmacokinetics (PK).

RESULTS:

Of 65 enrolled patients (pemi/gem/cis, n = 8; pemi/doc, n = 7; pemi/tras, n = 6; pemi/pembro, n = 26; pemi/reti, n = 18), all discontinued. Treatment-emergent adverse events (TEAEs) were generally consistent with individual drug AEs. Serious and grade ≥3 TEAEs occurred in 0%-85.7% and 33.3%-100.0% of patients across treatment groups, respectively. All pemigatinib combinations demonstrated steady-state PK comparable to monotherapy. Pharmacodynamic effects in all pemigatinib combinations, except pemi/gem/cis, were consistent with monotherapy. Less inhibition of FGFR2α phosphorylation was observed with this combination. ORRs (95% confidence interval) were 37.5% [8.5% to 75.5% (pemi/gem/cis)], 14.3% [0.4% to 57.9% (pemi/doc)], 0% (pemi/tras), 26.9% [11.6% to 47.8% (pemi/pembro)], and 11.1% [1.4% to 34.7% (pemi/reti)]. All groups had instances of tumor shrinkage. ORRs in assessable patients with FGFR rearrangements and mutations were 50% and 33%, respectively.

CONCLUSIONS:

Pemigatinib combination therapy showed no unexpected toxicities. PK and pharmacodynamics were mostly consistent with pemigatinib monotherapy. Pemi/gem/cis (37.5%) and pemi/pembro (26.9%) had the highest ORR; most responders had FGFR alterations.

01 May 2024·European Urology Oncology

Retifanlimab in Advanced Penile Squamous Cell Carcinoma: The Phase 2 ORPHEUS Study

Article

Author: López-Montero, Laura ; Páez López-Bravo, David ; Climent, Miguel A ; Necchi, Andrea ; Alcalá-López, Daniel ; Gómez de Liaño, Alfonso ; Sampayo-Cordero, Miguel ; Cuéllar-Rivas, Miler Andrés ; Giannatempo, Patrizia ; Maroto, Pablo ; Castellano, Daniel ; García Del Muro, Xavier ; P Valderrama, Begoña ; Mina, Leonardo

BACKGROUND AND OBJECTIVE:

Patients with advanced penile squamous cell carcinoma (PSCC) have poor outcomes and very limited therapeutic options are available. Most PSCC cases have high PD-L1 expression, which is associated with worse prognosis. Immunotherapy targeting PD-L1 could benefit patients with PSCC. Our aim was to evaluate the efficacy and safety of the anti-PD-1 antibody retifanlimab in patients with advanced/metastatic PSCC.

METHODS:

ORPHEUS was a single-arm, multicenter, phase 2 trial in 18 patients with advanced/metastatic PSCC, previously untreated with anti-PD-1/anti-PD-L1 agents. Patients received retifanlimab 500 mg intravenously every 4 wk for up to 2 yr. The primary endpoint was the objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors v1.1. Secondary endpoints included the clinical benefit rate (CBR), disease control rate, duration of response (DoR), time to response, progression-free survival (PFS), overall survival (OS), maximum tumor shrinkage, and safety. The Wilson method was used for the primary endpoint, and the Clopper-Pearson and Kaplan-Meier methods for secondary endpoints.

KEY FINDINGS AND LIMITATIONS:

Median follow-up was 7.2 mo. The ORR was 16.7% (95% confidence interval [CI] 5.8-39.2); three patients had a partial response. Median DoR was 3.3 mo (range 1.8-8.5). The CBR was 22.2% (95% CI 6.4-47.6%). Median PFS was 2.0 mo (95% CI 1.6-3.3) and median OS was 7.2 mo (95% CI 3.0-9.8). One patient (5.6%) experienced grade 3 treatment-related adverse events (AEs). There were no grade >= 4 treatment-related AEs. The small sample size is the main limitation.

CONCLUSIONS AND CLINICAL IMPLICATIONS:

Single-agent retifanlimab exhibited signals of clinical activity in advanced/metastatic PSCC, with no new safety signals. Further investigation of retifanlimab in this setting is warranted.

PATIENT SUMMARY:

Advanced penile cancer of the squamous cell type is a rare tumor with poor prognosis. The aggressiveness of this cancer is usually associated with high levels of a protein called PD-L1. We investigated whether retifanlimab, an immunotherapy drug against PD-1, has activity against this type of penile cancer. Tumor regression or stabilization occurred in one-third of the patients and the side effects were manageable.

News (Medical) associated with Retifanlimab

11 Dec 2024

·www.globenewswire.com

BriaCell Presents Unprecedented Overall Survival Data in Metastatic Breast Cancer in Spotlight Poster at 2024 SABCS®

Median overall survival (OS) to date of 13.4 months for Phase 2 patients treated with the Phase 3 formulation (15.6 months for those treated since 2022), double that of comparable patients in the literatureFinal Phase 2 OS calculation is pending as many patients remain alive well over 1 year after starting the studyMedian OS of 13.7 months in breast cancer patients with central nervous system (CNS) metastasis treated with the Bria-IMT™ regimen alone or in combination with an immune check point inhibitor (CPI)Five BriaCell posters (four today and one on Dec 13th) showcase robust survival and clinical benefit data, plus key biomarker data from Phase 2 trial of Bria-IMT™ in metastatic breast cancer (MBC)Biomarkers identify patients who benefit from treatments with the Bria-IMT™ regimenNo toxicity related discontinuations PHILADELPHIA and VANCOUVER, British Columbia, Dec. 11, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, is pleased to showcase its impressive survival and clinical benefit data in MBC patients, including those with CNS metastases, treated with the Bria-IMT™ plus CPI regimen. The data is featured in BriaCell’s “Spotlight” poster presentation session, at the 2024 San Antonio Breast Cancer Symposium® (SABCS®) held at Henry B. Gonzalez Convention Center, San Antonio, TX. “Metastatic breast cancer remains an essentially incurable disease, with a significant unmet medical need in patients who are relapsed/refractory to recently approved therapies such as CPIs and antibody-drug conjugates (ADCs),” stated Dr. William V. Williams, BriaCell’s President & CEO. “We are very pleased with the Bria-IMT™ combination regimen’s tolerability profile, and most importantly its outstanding clinical activity in heavily pre-treated patients who failed other therapeutic options.” “In addition to our striking survival data in MBC patients, we are excited by potential biomarkers for early identification of patients who would benefit from treatment with the Bria-IMT™ combination regimen,” noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. “We expect to replicate Phase 2’s impressive survival and clinical benefit data in our ongoing pivotal Phase 3 study.” “While CNS metastatic disease has historically had a very poor prognosis, our clinical data to date, shows solid survival and clinical benefit in patients with CNS metastasis,” stated Sailaja Kamaraju, MD, Assistant Professor of Medicine at the Medical College of Wisconsin, Division of Hematology and Oncology. “We are optimistic that the Bria-IMT™ combination regimen, with its unique targeted mechanism of action, may be able to produce meaningful clinical and survival benefits in other cancer patients with CNS metastases who have lost hope with little to no other therapeutic options.” The data presented is from the fully enrolled BriaCell Phase 2 combination study of Bria-IMT™ plus CPI. An aggregate of 54 MBC patients were enrolled in the study – all treated with the Bria-IMT™ combination regimen {11 patients received KEYTRUDA® (pembrolizumab), and 43 patients received Incyte’s retifanlimab with one patient cross over from the KEYTRUDA® study to retifanlimab}. Data is available on all 54 of these heavily pre-treated metastatic breast cancer patients (average number of prior treatments = 6). Of these 54 patients, 37 were treated with the formulation currently under investigation in BriaCell’s ongoing pivotal Phase 3 study in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06072612). Final median overall survival calculation for the patients in the Phase 2 portion of the study is pending, as most of these patients remain alive over 1 year following their start on the study. No Bria-IMT™ related discontinuations have been reported to date. The details about the Spotlight presentation and other poster sessions are as follows: Abstract Number: SESS-1071 (Spotlight Poster)Title: Overall survival results of Bria-IMT™ allogenic whole cell-based cancer vaccineTime: Wednesday, December 11, 2024 7:00 AM – 8:30 AM CSTPresentation ID: PS3-06 Bria-IMT™ regimen’s impressive OS and tolerability in MBC patients Median overall survival (OS) to date of 13.4 months for Phase 2 patients treated with the Phase 3 formulation (15.6 months for those treated since 2022 with the Phase 3 formulation) double that of comparable patients in the literature (Cortes J, et al. Annals of Oncology 2018; Kazmi S, et al. Breast Cancer Res Treat. 2020; O’Shaughnessy J et al. Breast Cancer Res Treat. 2022; Tripathy D, et al. JAMA Oncol. 2022; Bardia A, et al. J Clin Oncol. 2024)Final Phase 2 OS calculation is pending as many patients remain alive well over 1 year after starting the studyMedian overall survival (OS) for patients who received the Phase 3 formulation in the Phase 2 portion of the study who also developed an immune response to the vaccine as measured by delayed-type hypersensitivity (DTH) not yet reached with >1 year follow-up13.7 months median OS in MBC patients with central nervous system (CNS)/intracranial tumors treated with the Bria-IMT™ regimen with or without a CPIObjective response rates (ORR) and clinical benefit rates (CBR) were observed across all MBC patient subsets, but positive clinical outcomes were more prominent in HER2+ and HR+/HER2- patient subsetsBria-IMT™ regimen was well-tolerated and produced clinical benefit in heavily pretreated MBC patientsPatients who developed a DTH response had lower neutrophil to lymphocyte ratio (NLR), suggesting improved clinical benefit in these patientsDelayed-type hypersensitivity (DTH) response, and circulating tumor cells (CTC) levels were significantly different between patients who responded vs those who did not respond to the Bria-IMT™ combination regimen In conclusion, clinical findings to date support the potential safety and efficacy of Bria-IMT™, along with its potential use in CNS metastases, as well as the possible use of biomarkers to predict clinical outcomes in BriaCell’s ongoing pivotal Phase 3 study in MBC. Abstract Number: SESS-1431Title: Identification of antigenic determinants in SV-BR-1 derived cellular breast cancer vaccinesTime: Wednesday, December 11, 2024 5:30 – 7:00 PM CSTPresentation ID: P2-06-02 Summary: BriaCell successfully identified immunogenic (i.e. immune system activating) peptides in patients treated with Bria-IMT™, a cell-based cancer vaccine, and showed Bria-IMT™’s ability to produce a targeted immune response against tumor antigens. Key immunogenic peptides detected included those with post-translational modifications (PTMs), such as citrullination and cysteinylation, an important type of neoantigen that may be shared across many patients with cancerHighlighted the advantage of cell-based cancer vaccines over RNA and peptide-based vaccines including their ability to present a broad and diverse repertoire of antigens (i.e. both conventional and unconventional types)Cell-based cancer vaccines also display unknown, patient-specific neoantigens that are hard to reproduce with RNA or peptide vaccinesDiverse antigen presentation produces a robust, polyclonal immune response, engaging both CD8+ and CD4+ T cells against multiple tumor target In conclusion, scientific data presented suggests that the unique mechanism of cell-based cancer vaccines may reduce cancer cells’ immune escape and may potentially lead to strong and long-lasting clinical outcomes in cancer patients. Abstract Number: SESS-2217Title: PD-L1 upregulation in circulating tumor associated cells predicts for clinical outcomes in a phase I/II clinical trial using SV-BR-1-GM vaccine with the checkpoint inhibitor retifanlimab in metastatic breast cancer patients, an interim analysisTime: Wednesday, December 11, 2024 12:00 – 2:00 PM CSTPresentation ID: P1-01-17 Summary:Interim analysis after at least one year of Bria-IMT™ plus CPI regimen shows the following: Significantly lowered levels of circulating tumor cells (CTCs) and cancer associated macrophage-like cells (CAMLs) in 40% of heavily pre-treated MBC patientsLower CTCs/CAMLs levels were significantly correlated with better survival outcomes (i.e. better PFS and trended for better OS)Bria-IMT™ appeared to increase PD-L1 levels in 15 patients which correlated with better clinical responses to combination treatment with the anti-PD-1 check point inhibitor retifanlimab In conclusion, clinical data support the combination regimen in our ongoing pivotal Phase 3 study and suggests CTCs and CAMLs and PD-L1 levels may be relevant indicators of clinical outcome in MBC patients treated with Bria-IMT™ plus CPI. Abstract Number: SESS-1068Abstract Title: ASTRO-VAC CNS: Bria-IMT™ in the management of tumor agnostic metastatic CNS lesionsTime: Wednesday, December 11, 2024 5:30 – 7:00 PM CSTPresentation ID: P2-10-24 Results: The poster provides the details of a planned Phase 2 study design expanding the use of Bria-IMT™ + CPI to tumor agnostic cancer patients (i.e. kidney cancer, brain cancer, etc.) with central nervous system (CNS) metastasis. To view the posters, please visit https://briacell.com/scientific-publications/. About BriaCell Therapeutics Corp. BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/. Safe Harbor This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including those about the potential safety and efficacy of Bria-IMT™, along with its potential use in CNS metastases; biomarkers assisting with early identification of patients who would benefit from treatment with the Bria-IMT™ combination regimen; BriaCell expecting to replicate Phase 2’s survival and clinical benefit data in its ongoing pivotal Phase 3 study and the Company’s plans to share the data in the coming months; the Bria-IMT™ combination regimen’s ability to produce meaningful clinical and survival benefits in other cancer patients with CNS metastasis; the Company’s ongoing evaluation of biomarkers to predict clinical outcomes in its ongoing pivotal Phase 3 study in MBC; cell-based cancer vaccines potentially reducing cancer cells’ immune escape and leading to strong and long-lasting clinical outcomes in cancer patients; and CTCs, CAMLs and PD-L1 levels having the potential to be relevant indicators of clinical outcomes in MBC patients treated with Bria-IMT™ plus CPI are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements, such as those are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company’s most recent Management’s Discussion and Analysis, under the heading “Risk Factors” in the Company’s most recent Annual Information Form, and under “Risks and Uncertainties” in the Company’s other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company's profiles on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law. Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release. Contact Information Company Contact:William V. Williams, MDPresident & CEO1-888-485-6340info@briacell.com Media Relations:Jules AbrahamCORE IRjulesa@coreir.com Investor Relations Contact:CORE IRinvestors@briacell.com

Phase 2ImmunotherapyPhase 3Clinical ResultVaccine

09 Dec 2024

·endpts.com

Enanta's mid-stage win in pediatric RSV; Carisma to lay off 34% of staff

Plus, news about Innovent Biologics, Relmada Therapeutics, Zevra Therapeutics, Incyte and Bionical Emas: Enanta’s Ph2 win in RSV: The company’s oral N-protein inhibitor achieved a 1.4 log decline in viral load at day five versus placebo in the mid-stage trial in pediatric respiratory syncytial virus. A prespecified analysis of patients randomized within three days of symptom onset showed a decline of 1.2 log compared with placebo. Adverse events with Enanta’s zelicapavir and placebo were similar, and there were no treatment discontinuations or study withdrawals owing to side effects. — Elizabeth Cairns Carisma Therapeutics to lay off 34% of its workforce: The Philadelphia biotech will let go of 23 employees and stop developing its lead asset, a CAR-monocyte program called CT-0525. The biotech had expected to have initial data from its Phase 1 trial of the asset in the first quarter of 2025. It will now focus on an in vivo macrophage engineering platform for potential applications in fibrosis, cancer and autoimmune diseases. — Kyle LaHucik Innovent Biologics details early-stage data for its ADC: It said IBI343, Innovent’s anti-CLDN18.2 antibody-drug conjugate, produced an overall objective response rate of 32.6% in 43 patients with CLDN18.2-positive advanced pancreatic ductal adenocarcinoma who had been previously treated. The data, presented at the ESMO Asia Congress, also demonstrated a confirmed ORR of 23.3% and confirmed disease control rate of 81.4%. Among 26 patients, median progression-free survival was 5.3 months; overall survival data are not yet mature. — Elizabeth Cairns Relmada Therapeutics looks for alternatives: The Florida biotech is ending its Phase 3 trials in major depression disorder after saying last week that the rapid-acting NMDA drug was likely to fail . It will also seek strategic alternatives, which could include a sale of assets, reverse merger or other deals. Relmada said it will keep running its Phase 1 in metabolic disease. — Kyle LaHucik Zevra Therapeutics says goodbye to two execs: The biotech parted ways with its chief development officer Christal M.M. Mickle and chief scientific officer Sven Guenther as part of a reprioritization. It also let go an undisclosed number of people in CMC and clinical development. It had 65 full-time workers at the end of 2023. — Kyle LaHucik Incyte’s PD-1 antibody-chemo combo wins in non-small cell lung cancer: The Phase 3 trial met the primary endpoint of overall survival and all secondary endpoints in patients with previously untreated metastatic NSCLC. Patients taking the Zynyz-chemotherapy combination achieved a median overall survival of 18.1 months compared to 13.4 months in the placebo arm. Secondary endpoints included overall response rate and duration of response. Incyte plans to submit a supplemental BLA to the FDA next year. — Katherine Lewin Bionical Emas divests CRO to UK private equity firm: Kester Capital is buying Bionical’s clinical research organization, dubbed EMAS Pharma, which will now operate as an independent business. The sale will allow Bionical to focus on its “core” businesses, including its early access programs and clinical trial supply units. No financial details were disclosed. — Anna Brown Janux Therapeutics raised $402.5 million in its public offering, up from the $300 million it initially planned to raise. — Jaimy Lee

Clinical ResultPhase 3Phase 1AcquisitionADC

26 Nov 2024

·www.globenewswire.com

BriaCell 2024 SABCS® Spotlight Poster to Showcase Positive Overall Survival Data Across All Patient Subtypes in Metastatic Breast Cancer

SABCS® “Spotlight” poster to be presented on Wednesday, December 11, 2024 7:00 AM – 8:30 AM CST highlights positive BriaCell survival and clinical benefit data across all metastatic breast cancer patient subtypes Median overall survival of 13.4 months exceeds historical controls. Phase 2 final median overall survival calculation is pending, as many patients remain alivePotential identification of biomarkers to predict responseFive poster presentations to feature increased presence of cancer fighting CD8+ “killer” T cell in metastatic breast cancer tumors, response in central nervous system (CNS) metastases and additional Bria-IMT™ clinical data from the Phase 2 trial of Bria-IMT™ + immune check point inhibitor in metastatic breast cancer Collaboration with the Medical College of Wisconsin will investigate use of Bria-IMT™ + CPI in any cancer patient with central nervous system (CNS) metastases PHILADELPHIA and VANCOUVER, British Columbia, Nov. 26, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, will be highlighting its positive overall survival and clinical benefit data in metastatic breast cancer (MBC) patients including those with CNS metastasis (not shown on the abstracts) who were treated with the Bria-IMT™ plus immune checkpoint inhibitor (CPI) combination in its “Spotlight” poster presentation session, at the 2024 San Antonio Breast Cancer Symposium® (SABCS®) held at Henry B. Gonzalez Convention Center, San Antonio, TX. “In the Phase 2 study, the Bria-IMT™ combination regimen significantly increased overall survival versus comparable published benchmarks. Additionally, objective response rate and clinical benefit rate data, support the potential benefit of Bria-IMT™ plus CPI in patients with this difficult-to-treat cancer,” stated Saranya Chumsri, MD, Principal Investigator, and Professor of Oncology, Mayo Clinic. “We plan to confirm the impressive clinical data in the BriaCell pivotal Phase 3 study as we continue to explore the use of Bria-IMT™ regimen across all breast cancer subtypes.” “At BriaCell, we are committed to finding therapeutic options for difficult-to-treat metastatic breast cancer patients,” stated Dr. William V. Williams, BriaCell’s President & CEO. “BriaCell’s clinical data demonstrating impressive overall survival in all patient subsets including very difficult to treat patient populations, such as those who have failed prior checkpoint inhibitor and/or antibody-drug conjugate therapy, reinforces our confidence in the potential use of the combination regimen in MBC patients. Additionally, clinical benefit was seen across metastatic breast cancer subtypes including HER2+, HR+/HER2-, and even in triple-negative breast cancer (TNBC) patients. Bria-IMT™ may provide a significant contribution to the lives of patients and their families fighting this incurable disease.” The details about the submitted abstracts are as follows: Abstract Number: SESS-1071 (Selected as Spotlight Poster)Title: Overall survival results of Bria-IMT allogenic whole cell-based cancer vaccineTime: Wednesday, December 11, 2024 7:00 AM – 8:30 AM CSTPresentation ID: PS3-06 Abstract Summary: 54 patients were enrolled with 22 patients in phase 1 and 32 patients in phase 2.11 patients were treated with pembrolizumab and 44 patients with retifanlimab (1 patient received pembrolizumab and later retifanlimab).The Bria-IMT™ combination regimen was well tolerated.The Bria-IMT™ regimen demonstrated promising results across all subtypes of breast cancer with favorable safety profiles.Patients receiving the pivotal Phase 3 Bria-IMT™ combination regimen (n=37) showed significantly higher median overall survival (OS) (13.4), an objective response rate (ORR) of 9.5% and a clinical benefit rate (CBR) of 55%.Final median overall survival calculation for the Phase 2 study is pending, as many patients remain alive.Among 36 patients with post-dose cancer-associated circulating tumor cell (CTC) data, patients with post-dose CTC count < 5 had a significantly better OS compared with a CTC count > 5 (13.4 vs. 5.5 months, P 0.01).Patients with positive delayed type hypersensitivity (DTH), an inflammatory marker to measure the response to Bria-IMT™ immunization, had significantly better OS. “Our clinical findings support the use of the current Phase 3 formulation,” noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. “We plan to confirm the potential use of key biomarkers to predict patient clinical outcomes in the Bria-IMT™ plus CPI ongoing pivotal Phase 3 study (NCT06072612) in metastatic breast cancer.” Abstract Number: SESS-1431Title: Identification of antigenic determinants in SV-BR-1 derived cellular breast cancer vaccinesTime: Wednesday, December 11, 2024 5:30 – 7:00 PM CSTPresentation ID: P2-06-02 Abstract Number: SESS-2217Title: PD-L1 upregulation in circulating tumor associated cells predicts for clinical outcomes in a phase I/II clinical trial using SV-BR-1-GM vaccine with the checkpoint inhibitor retifanlimab in metastatic breast cancer patients, an interim analysisTime: Wednesday, December 11, 2024 12:00 – 2:00 PM CSTPresentation ID: P1-01-17 Abstract Number: SESS-1068Abstract Title: ASTRO-VAC CNS: Bria-IMT in the management of tumor agnostic metastatic CNS lesionsTime: Wednesday, December 11, 2024 5:30 – 7:00 PM CSTPresentation ID: P2-10-24 Abstract Number: SESS-1069Title: Bria-IMT CD8+ tumor infiltrating lymphocytes turn “Cold” tumor “Hot” in metastatic breast cancerTime: Friday, December 13, 2024 12:00 PM – 2:00 PM CSTPresentation ID: P5-10-12 Following presentations, the posters can be viewed at the following: https://briacell.com/scientific-publications/. About BriaCell Therapeutics Corp. BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/. Safe Harbor This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including those about BriaCell’s potential use of key biomarkers to predict patient clinical outcomes in the Bria-IMT™ plus CPI ongoing pivotal Phase 3 study; BriaCell’s potential use of the combination regimen in MBC patients; BriaCell conducting a poster presentation at the 2024 San Antonio Breast Cancer Symposium®, and the contents of such presentation; the potential benefit of Bria-IMT™ plus CPI in cancer patients; BriaCell’s plans to confirm the clinical data in their pivotal Phase 3 study; BriaCell’s Phase 3 study exploring the use of the Bria-IMT™ regimen across all breast cancer subtypes; and the Bria-IMT™ regimen having the potential to provide a significant contribution to the lives of cancer patients are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements, such as those are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company’s most recent Management’s Discussion and Analysis, under the heading “Risk Factors” in the Company’s most recent Annual Information Form, and under “Risks and Uncertainties” in the Company’s other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company's profiles on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law. Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release. Contact Information Company Contact:William V. Williams, MDPresident & CEO1-888-485-6340info@briacell.com Media Relations:Jules AbrahamCORE IRjulesa@coreir.com Investor Relations Contact:CORE IRinvestors@briacell.com

Clinical ResultPhase 2ImmunotherapyPhase 3Vaccine

100 Deals associated with Retifanlimab

External Link

KEGG	Wiki	ATC	Drug Bank
D11827	-	-	DB15766

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Metastatic Merkel Cell Carcinoma	US	Incyte Corp.	22 Mar 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Endometrial Carcinoma	Phase 3	CN	Zai Lab (Shanghai) Co., Ltd.	20 Sep 2021
Anal canal squamous cell carcinoma	Phase 3	US	Incyte Corp.	12 Jan 2021
Anal canal squamous cell carcinoma	Phase 3	JP	Incyte Corp.	12 Jan 2021
Anal canal squamous cell carcinoma	Phase 3	AU	Incyte Corp.	12 Jan 2021
Anal canal squamous cell carcinoma	Phase 3	BE	Incyte Corp.	12 Jan 2021
Anal canal squamous cell carcinoma	Phase 3	DK	Incyte Corp.	12 Jan 2021
Anal canal squamous cell carcinoma	Phase 3	FR	Incyte Corp.	12 Jan 2021
Anal canal squamous cell carcinoma	Phase 3	DE	Incyte Corp.	12 Jan 2021
Anal canal squamous cell carcinoma	Phase 3	IT	Incyte Corp.	12 Jan 2021
Anal canal squamous cell carcinoma	Phase 3	NO	Incyte Corp.	12 Jan 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03328026 (SABCS2024 \| GlobeNewswire) Manual	Phase 1/2	Metastatic breast cancer	54	Bria-IMT regimen with pembrolizumab/retifanlimab	mdwkqyfboy(yiznjvrprm) = vzrfalmbzw jwqvdtiyzt (aajuswalmk )	Positive	11 Dec 2024
				Bria-IMT regimen with pembrolizumab/retifanlimab (without IFN incubation; phase 3 formulation)	mdwkqyfboy(yiznjvrprm) = kbuiatkzjw jwqvdtiyzt (aajuswalmk ) View more
NCT04438824 (ESMO2024) Manual	Phase 2	Dedifferentiated Liposarcoma	28	Palbociclibretifanlimab	kvzkttfhvv(viprsogszd) = xkfdqqyvla babvhgyhsv (ffuqsdvjao, 4.7 - 33.6) View more	Positive	13 Sep 2024
NCT03328026 (ASCO2024) Manual	Phase 1/2	Metastatic breast cancer \| Advanced breast cancer CAMLs \| CTCs	54	SV-BR-1-GMegimen with oriretifanlimabce	gmkdmppgxk(dhhdpfomaw) = jrzdardrrt hecatnbgbm (vwjeuvnqiv ) View more	Positive	24 May 2024
NCT04634825 (CTgov)	Phase 2	Squamous cell carcinoma of head and neck metastatic	62	Enoblituzumab+Retifanlimab (Retifanlimab Cohort)	sgaseamcyq(ennayxkrma) = rjdrgdjhgq kxkjsdyzbw (ewnihfstuj, rbbsfnzmia - yialiwnfdt) View more	-	20 Dec 2023
				Enoblituzumab+Tebotelimab (Tebotelimab Cohort)	hgmikkenzh(fyxhaocdsb) = ptuogmmsqm mqhpxsyyzr (pvxzbrdemb, lunnjlaava - abnqtfnvhr) View more
NCT03059823 (POD1UM-101, ESMO 12023 \| ESMO 22023) Manual	Phase 1	Mismatch repair-deficient Endometrial Carcinoma \| Microsatellite instability-high Endometrial Carcinoma MSI-High \| Deficient DNA Mismatch Repair (dMMR)	76	Retifanlimab 500 mg	yatahkplhy(sslurfkuim) = gkgrjsghle snevtekqur (rxkrxzdnsn, 32 - 55)	Positive	22 Oct 2023
NCT04225039 (ASCO2023) Manual	Phase 2	Recurrent Glioblastoma	32	INCAGN01876+Retifanlimab+FSRT (single-arm, primary efficacy cohort)	yeerfnthzi(ofsgzepaqj) = drterzshuy cpzbiqjynt (hfihfxbkga, 2.1 - 6.2) View more	Negative	26 May 2023
				INCAGN01876+Retifanlimab+FSRT (two-arm neoadjuvant window-of-opportunity cohort)	yeerfnthzi(ofsgzepaqj) = nkkyoxarps cpzbiqjynt (hfihfxbkga ) View more
NCT04370704 (ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	HR-positive/HER2-low Solid Tumors	21	INCAGN02385 350 mg+INCAGN02390 400 mg	yniktaigmw(qceudaqpjm) = occurred in 1 pt in part 1 (grade [G] 3 vasculitis) and 1 pt in part 2 (G3 myocarditis and pericardial effusion) ojajdlaoqr (tdlctcyciy ) View more	Positive	26 May 2023
				retifanlimab 500 mg+INCAGN02385 350 mg+INCAGN02390 400 mg
NCT04577014 (ASCO 12023 \| ASCO 22023) Manual	Phase 2	Locally Advanced Soft Tissue Sarcoma First line	43	Retifanlimab+gemcitabine+docetaxel	vvvcmcmgkl(flxylqaita) = vutyaujciy wrkubmcrdb (wxfjlqknqw ) View more	Positive	26 May 2023
NCT04231981 (ORPHEUS, ASCO 12023 \| ASCO 22023) Manual	Phase 2	Squamous Cell Carcinoma of the Penis	18	Retifanlimab	nmcnsupddk(uhoqzcqvkt) = kbokanwncb xebttojvpz (noolhkoyns, 5.8 - 39.2) View more	Positive	26 May 2023
NCT03599713 (POD1UM-201, CTgov)	Phase 2	Metastatic Merkel Cell Carcinoma	107	retifanlimab (Chemotherapy: Naïve)	hilvbiakyl(fqlujuusni) = tkxdvunquj lnwplnlqpn (yznwwqxpkl, iydcwthasb - qstextdlug) View more	-	03 May 2023
				retifanlimab (Chemotherapy: Refractory)	cwkeyxzkbp(nkcjrzterf) = vswojitbko yvzikjiqws (yiuaferpds, mdyoqhnhdg - bztdxupzev) View more

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