A Phase 2, Open-Label Study to Evaluate the Safety and Antitumor Activity of Praluzatamab Ravtansine (CX-2009) in Advanced HR-Positive/HER2-Negative Breast Cancer and of Praluzatamab Ravtansine as Monotherapy and in Combination With Pacmilimab (CX-072) in Advanced Triple-Negative Breast Cancer (CTMX-2009-002)

A Phase 2, clinical study in advanced, metastatic breast cancer that will evaluate CX-2009 monotherapy in both Hormone Receptor(HR) positive/HER2 negative breast cancer and in TNBC, and evaluate CX-2009+CX-072 in TNBC

Start Date29 Dec 2020

Sponsor / Collaborator

CytomX Therapeutics, Inc.

NCT03993379

/ TerminatedPhase 2

A Phase 2, Open-Label, Multi-cohort Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors

To obtain evidence of antitumor effect of CX-072 in combination with anticancer therapy in adult patients with solid tumor based upon overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST)

Start Date20 Nov 2019

Sponsor / Collaborator

CytomX Therapeutics, Inc.

100 Clinical Results associated with CX-072

100 Translational Medicine associated with CX-072

100 Patents (Medical) associated with CX-072

Literatures (Medical) associated with CX-072

01 Sep 2024·EXPERT OPINION ON THERAPEUTIC TARGETS

Combined cancer immunotherapy based on targeting adenosine pathway and PD-1/PDL-1 axis

Review

Author: Fathi, Mehrdad ; Zarei, Asieh ; Salehi, Zahra ; Gholamin, Sharareh ; Moghimi, Ata ; Jadidi-Niaragh, Farhad ; Jalali, Pooya

INTRODUCTION:

Cancer immunotherapy has revolutionized the field of oncology, offering new hope to patients with advanced malignancies. Tumor-induced immunosuppression limits the effectiveness of current immunotherapeutic strategies, such as PD-1/PDL-1 checkpoint inhibitors. Adenosine, a purine nucleoside molecule, is crucial to this immunosuppression because it stops T cells from activating and helps regulatory T cells grow. Targeting the adenosine pathway and blocking PD-1/PDL-1 is a potential way to boost the immune system's response to tumors.

AREAS COVERED:

This review discusses the current understanding of the adenosine pathway in tumor immunology and the preclinical and clinical data supporting the combination of adenosine pathway inhibitors with PD-1/PDL-1 blockade. We also discuss the challenges and future directions for developing combination immunotherapy targeting the adenosine pathway and the PD-1/PDL-1 axis for cancer treatment.

EXPERT OPINION:

The fact that the adenosine signaling pathway controls many immune system processes suggests that it has a wide range of therapeutic uses. Within the next five years, there will be tremendous progress in this area, and the standard of care for treating malignant tumors will have switched from point-to-point therapy to the integration of immunological networks comprised of multiple signaling pathways, like the adenosine axis.

01 Oct 2021·Clinical cancer research : an official journal of the American Association for Cancer ResearchQ1 · MEDICINE

First-in-Human Study of the Biodistribution and Pharmacokinetics of 89Zr-CX-072, a Novel Immunopet Tracer Based on an Anti–PD-L1 Probody

Q1 · MEDICINE

Article

Author: Kist de Ruijter, Laura ; Giesen, Danique ; Gietema, Jourik A. ; Kok, Iris C. ; Hooiveld-Noeken, Jahlisa S. ; Brouwers, Adrienne H. ; Nguyen, Margaret T.L. ; Lu, Hong ; Jalving, Mathilde ; de Vries, Elisabeth G.E. ; de Groot, Derk J.A. ; Elias, Sjoerd G. ; Vasiljeva, Olga ; Lub-de Hooge, Marjolijn N.

Abstract:

Purpose::

CX-072, a PD-L1–targeting Probody therapeutic, is engineered to be activated by tumor proteases that remove a masking peptide. To study effects on biodistribution and pharmacokinetics, we performed 89Zr-CX-072 positron emission tomography (PET) imaging.

Experimental Design::

Patients received ∼1 mg, 37 MBq 89Zr-CX-072 plus 0, 4, or 9 mg unlabeled CX-072 and PET scans at days 2, 4, and 7. After that, treatment comprised 10 mg/kg CX-072 q2 weeks (n = 7) + 3 mg/kg ipilimumab q3w 4× (n = 1). Normal organ tracer uptake was expressed as standardized uptake value (SUV)mean and tumor uptake as SUVmax. PD-L1 expression was measured immunohistochemically in archival tumor tissue.

Results::

Three of the eight patients included received 10-mg protein dose resulting in a blood pool mean SUVmean ± SD of 4.27 ± 0.45 on day 4, indicating sufficient available tracer. Tumor uptake was highest at day 7, with a geometric mean SUVmax 5.89 (n = 113) and present in all patients. The median follow-up was 12 weeks (4–76+). One patient experienced stable disease and two patients a partial response. PD-L1 tumor expression was 90% in one patient and ≤1% in the other patients. Mean SUVmean ± SD day 4 at 10 mg in the spleen was 8.56 ± 1.04, bone marrow 2.21 ± 0.46, and liver 4.97 ± 0.97. Four patients out of seven showed uptake in normal lymph nodes and Waldeyer's ring. The tracer was intact in the serum or plasma.

Conclusions::

89Zr-CX-072 showed tumor uptake, even in lesions with ≤1% PD-L1 expression, and modest uptake in normal lymphoid organs, with no unexpected uptake in other healthy tissues.

01 Jul 2021·Journal for immunotherapy of cancerQ2 · MEDICINE

CX-072 (pacmilimab), a Probody^®PD-L1 inhibitor, in advanced or recurrent solid tumors (PROCLAIM-CX-072): an open-label dose-finding and first-in-human study

Q2 · MEDICINE

ArticleOA

Author: Naing, Aung ; Autio, Karen A ; Ott, Patrick A ; Garcia-Corbacho, Javier ; Uboha, Nataliya ; De Vries, Elisabeth G E ; LoRusso, Patricia ; Eskens, Ferry A L M ; Thistlethwaite, Fiona ; Durm, Greg ; Hannah, Alison L ; Stroh, Mark ; Randhawa, Manreet ; Bendell, Johanna ; Arkenau, Hendrik-Tobias ; Gil-Martin, Marta ; Spira, Alexander ; Boni, Valentina

Background:

Probody®therapeutics are antibody prodrugs that are activated in the tumor microenvironment by tumor-associated proteases, thereby restricting the activity to the tumor microenvironment and minimizing ‘off-tumor’ toxicity. We report dose-escalation and single-agent expansion phase data from the first-in-human study of CX-072 (pacmilimab), a Probody checkpoint inhibitor directed against programmed death-ligand 1 (PD-L1).

Methods:

In the dose-escalation phase of this multicenter, open-label study (NCT03013491), adults with advanced solid tumors (naive to programmed-death-1/PD-L1 or cytotoxic T-lymphocyte-associated antigen 4 inhibitors) were enrolled into one of seven dose-escalation cohorts, with pacmilimab administered intravenously every 14 days. The primary endpoints were safety and determination of the maximum tolerated dose (MTD). In the expansion phase, patients with one of six prespecified malignancies (triple-negative breast cancer [TNBC]; anal squamous cell carcinoma [aSCC]; cutaneous SCC [cSCC]; undifferentiated pleomorphic sarcoma [UPS]; small bowel adenocarcinoma [SBA]; and thymic epithelial tumor [TET]); or high tumor mutational burden (hTMB) tumors were enrolled. The primary endpoint was objective response (Response Evaluation Criteria In Solid Tumors v.1.1).

Results:

An MTD was not reached with doses up to 30 mg/kg. A recommended phase 2 dose (RP2D) of 10 mg/kg was chosen based on pharmacokinetic and pharmacodynamic findings in the expansion phase. Ninety-eight patients enrolled in the expansion phase: TNBC (n=14), aSCC (n=14), cSCC (n=14), UPS (n=20), SBA (n=14), TET (n=8), and hTMB tumors (n=14). Of 114 patients receiving pacmilimab at the RP2D, grade ≥3 treatment-related adverse events (TRAEs) were reported in 10 patients (9%), serious TRAEs in six patients (5%), and treatment discontinuation due to TRAEs in two patients (2%). Grade ≥3 immune-related AEs occurred in two patients (rash, myocarditis). High PD-L1 expression (ie, >50% Tumor Proportion Score) was observed in 22/144 (19%) patients. Confirmed objective responses were observed in patients with cSCC (n=5, including one complete response), hTMB (n=4, including one complete response), aSCC (n=2), TNBC (n=1), UPS (n=1), and anaplastic thyroid cancer (n=1).

Conclusions:

Pacmilimab can be administered safely at the RP2D of 10 mg/kg every 14 days. At this dose, pacmilimab had a low rate of immune-mediated toxicity and showed signs of antitumor activity in patients not selected for high PD-L1 expression.

Trial registration number:

NCT03013491.

News (Medical) associated with CX-072

27 Mar 2023

·www.biospace.com

CytomX Therapeutics Reports Full Year 2022 Financial Results and Provides Business Update

- Internal focus on next generation therapeutic pipeline including ongoing Phase 1 for CX-904 (EGFRxCD3) and anticipated IND filings for CX-2051 (EpCAM-directed ADC) and CX-801 (Interferon alpha-2b) in the second half of 2023 - - Bristol Myers Squibb advances Anti-CTLA-4 non-fucosylated Probody®, BMS-986288, from Phase 1 to Phase 2 clinical evaluation as lead, next-generation CTLA-4 program - - Continued progress in strategic alliances including first clinical candidate milestone in Probody T-Cell Bispecific collaboration with Astellas and initiation of Regeneron and Moderna collaborations - - CytomX to evaluate future development opportunities for CX-2029 (conditionally activated CD71-directed ADC) and pursue additional strategies for CD71 targeting following AbbVie’s decision not to advance the program into additional clinical studies - - CytomX to host conference call today at 5 p.m. EST / 2 p.m. PST SOUTH SAN FRANCISCO, Calif., March 27, 2023 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc., (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, today reported full year 2022 financial results and provided a business update. “2022 was an important year of transition for CytomX as we proactively restructured our organization to maximize long-term success and value creation. We entered 2023 with considerable momentum across our therapeutic pipeline including our first Probody T-cell bispecific in the clinic and preparing for two new, wholly-owned IND filings anticipated this year. We continue to optimize and leverage our leading Probody platform to create high impact therapeutic candidates with the potential to maximize overall benefit for patients. With our recently announced collaborations with Moderna and Regeneron, we are further extending the reach of our science, broadening our pipeline, and bringing important non-dilutive capital into the company. These accomplishments underscore our leadership in conditionally activated, localized biologic therapies and we look forward to a year of strong execution in 2023 that will also include a reassessment of our CX-2029 and CD71 strategy following AbbVie’s decision not to further advance the program,” said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX Therapeutics. Fourth Quarter Business Highlights and Recent Developments CX-904, T-cell-engaging bispecific (TCB) EGFRxCD3, Phase 1 clinical study ongoing – CX-904 is a conditionally activated TCB designed to target the epidermal growth factor receptor (EGFR) on cancer cells and the CD3 receptor on T cells within the tumor microenvironment. CX-904 is being evaluated by CytomX in an ongoing Phase 1 study in patients with advanced solid tumors. The first patient was dosed in May 2022 and the dose escalation portion of the study continues to advance and is now in the 3+3 stage having successfully completed initial single patient cohorts. The continued progression of CX-904 is a key priority for the company in 2023 with the primary goal of assessing safety and determining a recommended dose, or doses, for subsequent expansions in select tumor types. This program is partnered with Amgen in a global co-development alliance with CytomX retaining the right to opt into a profit share in the U.S. IND filings anticipated in 2H 2023 for Wholly Owned CX-801, Interferon (IFN) alpha-2b, and CX-2051, EpCAM-directed ADC – For CytomX’s next generation molecules, the company has selected the previously validated anti-cancer targets, EpCAM and IFNa2b, respectively, that have been limited in their potential due to systemic toxicities. In the molecular design of CX-2051 and CX-801, we have incorporated our platform expertise and clinical learnings to optimize predicted therapeutic index in order to potentially broaden the clinical utility of these promising agents through localization to the tumor microenvironment. CytomX anticipates filing INDs for both programs in the second half of 2023. BMS advancement of BMS-986288 to Phase 2 – In February 2023, BMS published pipeline updates that included moving the Anti-CTLA-4 non-fucosylated Probody®, BMS-986288, from Phase 1 to Phase 2. BMS prioritized the BMS-986288 Probody® program over the other two molecules in its CTLA-4 pipeline – the Probody®, BMS-986249, and the antibody, BMS-986218. CX-2029: Updated Phase 2 data and next steps – CX-2029 is a conditionally activated ADC directed toward CD71, the transferrin receptor. In January 2023, updated Phase 2 results were announced from the cohort expansion study which included squamous esophageal cancer, squamous non-small cell lung cancer (sqNSCLC), and head and neck squamous cell carcinoma (HNSCC). The Phase 2 data demonstrated encouraging clinical activity in unselected, heavily pre-treated patients with tumors of squamous histology including a 21% objective response rate (ORR) in squamous esophageal cancer and a 10% ORR in squamous non-small cell lung cancer (sqNSCLC). The adverse event (AE) pro consistent with Phase 1 observations with anemia (82.6% all grade, 76.1% grade 3+) being the most common treatment related adverse event (TRAE). On March 21, 2023, AbbVie notified the company that it would not advance CX-2029 into additional clinical studies and provided notice of termination of the 2016 CD71 License and Collaboration Agreement. As a result of the termination, CytomX will regain full rights to CD71 and has an exclusive option to re-acquire full rights to CX-2029. CytomX will evaluate potential next steps for CX-2029 as well as pursue next-generation strategies for targeting CD71. CytomX and AbbVie have also concluded their research activities under a 2016 Discovery License and Collaboration Agreement. Clinical candidate milestone achievement in Astellas TCB collaboration – In January 2023, Astellas nominated a collaboration clinical candidate, the first Probody® TCB molecule to progress in the alliance, triggering a $5 million dollar milestone payment to CytomX. CytomX and Astellas are collaborating on additional conditionally activated TCB programs, and CytomX is eligible to receive future preclinical, clinical, and commercial milestones. CytomX retains a cost share and co-commercialization option on a select number of targets. New strategic research collaboration with Moderna – In December 2022, CytomX entered a collaboration and licensing agreement to create investigational mRNA-based conditionally activated therapies utilizing Moderna’s mRNA technologies and CytomX’s Probody® therapeutic platform. The research collaboration will leverage core scientific advances at Moderna and CytomX with the strategy of encoding potent, masked biologics with mRNA, for the potential treatment of oncology and non-oncology conditions. CytomX received an upfront payment of $35 million, including $5 million of pre-paid research funding, and is eligible to receive up to approximately $1.2 billion in future development, regulatory, and commercial milestone payments, along with tiered royalties on global net sales of any products that are commercialized under the agreement. Moderna has the option to participate in a future CytomX equity financing, subject to certain terms, conditions and regulatory requirements. New strategic research collaboration with Regeneron – In November 2022, CytomX entered its collaboration with Regeneron to enable the development of investigational next-generation bispecific immunotherapies using CytomX’s Probody® and Regeneron's Veloci-Bi® platforms. The Probody® platform has the potential to widen the therapeutic window and minimize on-target, off-tumor effects for these next-generation T-cell engaging therapies, potentially addressing tumor types that have historically been unresponsive to immunotherapy. CytomX received a $30 million upfront payment in December 2022 and is eligible for up to approximately $2 billion in research, development, regulatory and sales-based milestones. Priorities for 2023 CX-904 (EGFRxCD3): Continue patient enrollment and dose escalation in ongoing Phase 1 study File 2 New INDs (wholly-owned): CX-801 (IFNa2b) and CX-2051 (EpCAM) projected in the second half of 2023 CX-2029 (CD71 ADC): Determine next steps for CD71 program, including CX-2029 Next-Generation CTLA-4 Program: Continued clinical progress for BMS-986288 Collaborations: Initiation of R&D activities with our newest collaborators, Regeneron and Moderna, and ongoing activities with Astellas, Amgen and BMS Full Year 2022 Financial Results Cash, cash equivalents and investments totaled $194 million as of December 31, 2022, compared to $305 million as of December 31, 2021 and $194 million as of September 30, 2022. The cash balance at December 31, 2022 includes the $30 million upfront payment received under the Regeneron agreement, but excludes the $35 million cash payment received under the Moderna agreement in the first quarter of 2023. Total revenue was $53.2 million for the year ended December 31, 2022, compared to $37.3 million in 2021. The increase in revenue was driven by higher estimated percentages of completion for the research and development programs in the company’s collaborations with AbbVie, Astellas and Bristol Myers Squibb, partially offset by decreased revenue under the Amgen Agreement driven by a lower estimated percentage of completion for the CX-904 program due to an increase in the projected hours-to-completion. Research and development expenses decreased by $2.5 million during year ended December 31, 2022, to $111.6 million compared to $114.2 million in 2021. The decrease in research and development expenses was driven by a decrease in clinical trial and lab contract services for CX-2009, CX-072, CX-2029, CX-904 and pre-clinical programs, offset by $5.3 million of restructuring expenses. General and administrative expenses increased by $3.6 million during the year ended December 31, 2022 to $42.8 million compared to $39.2 million in 2021 primarily driven by $2.4 million of restructuring expenses and a $1.0 million increase in professional expenses related to new collaboration agreements. Overall expenses related to the company restructuring announced in July 2022 were $7.7 million consisting primarily of employee-related expenses and severance benefits. The restructuring is substantially complete as of December 31, 2022. On March 27, 2023, CytomX Therapeutics, Inc. filed an amended 2021 Annual Report on Form 10-K/A which included restated financial statements for the years ended December 31, 2019, 2020, and 2021 and the quarterly periods for 2020 and 2021. CytomX’s 2022 Annual Report on Form 10-K includes restated interim information for the 2022 quarterly periods. Please refer to the 2021 Form 10-K/A and 2022 Form 10-K for a full description of the restatement and the corresponding financials. The financial results contained in this press release reflect the restated financial statements in CytomX’s most recent SEC filings. Conference Call & Webcast CytomX management will host a conference call and simultaneous webcast today at 5 p.m. ET (2 p.m. PT) to discuss the financial results and provide a business update. Participants may access the live webcast of the conference call from the Events and Presentations page of CytomX’s website at . Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. An archived replay of the webcast will be available on the Company’s website. About CytomX Therapeutics CytomX is a clinical-stage, oncology-focused biopharmaceutical company focused on developing novel conditionally activated, biologics localized to the tumor microenvironment. By pioneering a novel class of conditionally activated biologics, powered by its Probody® technology platform, CytomX’s goal is to transcend the limits of current cancer treatments. CytomX’s robust and differentiated pipeline comprises five therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), T-cell engaging bispecific antibodies (“TCBs”), and immune modulators such as cytokines and checkpoint inhibitors (“CPIs”). CX-2029 is an investigational conditionally activated antibody-drug conjugate (ADC) directed toward CD71. CytomX’s clinical pipeline also includes cancer immunotherapeutic candidates against validated targets such as the CTLA-4-targeting Probody therapeutic BMS-986288, partnered with Bristol Myers Squibb, as well as CX-904, a conditionally activated T-cell-engaging bispecific antibody targeting the epidermal growth factor receptor (EGFR) on tumor cells and the CD3 receptor on T cells, which is partnered with Amgen. In addition, CytomX has a diverse preclinical portfolio of wholly-owned assets including CX-801, an interferon alpha-2b Probody cytokine that has broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors and CX-2051, a conditionally activated ADC directed toward EpCAM, with potential applicability across multiple EpCAM-expressing epithelial cancers. CytomX has also established strategic collaborations with multiple leaders in oncology, including Amgen, Astellas, Bristol Myers Squibb, Regeneron and Moderna. For more information about CytomX and how it is working to make conditionally activated treatments the new standard-of-care in the fight against cancer, visit and follow us on LinkedIn and Twitter. CytomX Therapeutics Forward-Looking Statements This press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond our control, and may cause the actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements, including those related to the future potential of partnerships or collaboration agreements. Accordingly, you should not rely on any of these forward-looking statements, including those relating to the potential benefits, safety and efficacy or progress of CytomX’s or any of its collaborative partners’ product candidates, including CX-2029, BMS-986288, CX-904, CX-801, and CX-2051, the potential benefits or applications of CytomX’s Probody platform technology, CytomX’s ability to develop and advance product candidates into and successfully complete clinical trials, including the ongoing and planned clinical trials of CX-2029, BMS-986288, and CX-904, and the timing of the commencement of clinical trials, initial and ongoing data availability, investigational new drug applications and other development milestones. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the unproven nature of CytomX’s novel Probody Platform technology; CytomX’s clinical trial product candidates are in the initial stages of clinical development and its other product candidates are currently in preclinical development, and the process by which preclinical and clinical development could potentially lead to an approved product is long and subject to significant risks and uncertainties, including the risk that the COVID-19 worldwide pandemic may continue to negatively impact the business, research and clinical operations of CytomX or its partners, including the development of preclinical drug candidates due to delays in and disruption of research activities and the development of clinical drug candidates due to delays in or disruption of clinical trials, including impacts on the enrollment of patients in clinical trials or other clinical trial disruptions; the possibility that the results of preclinical research and early clinical trials may not be predictive of future results; the possibility that CytomX’s clinical trials will not be successful; the possibility that current preclinical research may not result in additional product candidates; CytomX’s dependence on the success of CX-2029, BMS-986288, CX-904, CX-801, and CX-2051; CytomX’s reliance on third parties for the manufacture of the Company’s product candidates; and possible regulatory developments in the United States and foreign countries. Additional applicable risks and uncertainties include those relating to our preclinical research and development, clinical development, and other risks identified under the heading "Risk Factors" included in CytomX’s Annual Report on Form 10-K filed with the SEC on March 27, 2023. The forward-looking statements contained in this press release are based on information currently available to CytomX and speak only as of the date on which they are made. CytomX does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise. Probody is a U.S. registered trademark of CytomX Therapeutics, Inc. Investor Contact: Chris Ogden SVP, Finance and Accounting cogden@cytomx.com Direct: (317) 767-4764 Investor and Media Contact: Stern Investor Relations Stephanie Ascher stephanie.ascher@sternir.com 212-362-1200 CYTOMX THERAPEUTICS, INC. STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share data) Year Ended December 31, 2022 2021 Revenues $ 53,163 $ 37,312 Operating expenses: Research and development 111,649 114,194 General and administrative 42,849 39,160 Total operating expenses 154,498 153,354 Loss from operations (101,335 ) (116,042 ) Interest income 1,678 255 Other income (expense), net 340 (83 ) Loss before income taxes (99,317 ) (115,870 ) Benefit from income taxes - - Net loss $ (99,317 ) $ (115,870 ) Other comprehensive income (loss): Unrealized gain (loss) on available-for-sale investments, net of tax $ 252 $ (195 ) Total comprehensive loss $ (99,065 ) $ (116,065 ) Net loss per share, basic and diluted $ (1.51 ) $ (1.81 ) Shares used to compute net loss per share, basic and diluted 65,739,844 64,146,848 CYTOMX THERAPEUTICS, INC. BALANCE SHEETS (in thousands, except share and per share data) December 31, December 31, 2022 2021 Assets Current assets: Cash and cash equivalents $ 193,650 $ 205,530 Short-term investments — 99,696 Accounts receivable 35,986 790 Prepaid expenses and other current assets 7,466 4,285 Total current assets 237,102 310,301 Property and equipment, net 5,072 5,960 Intangible assets, net 875 1,021 Goodwill 949 949 Restricted cash 917 917 Operating lease right-of-use asset 15,949 19,362 Other assets 27 901 Total assets $ 260,891 $ 339,411 Liabilities and Stockholders' Equity (Deficit) Current liabilities: Accounts payable $ 2,809 $ 2,818 Accrued liabilities 28,532 34,236 Deferred revenues, current portion 121,267 40,816 Total current liabilities 152,608 77,870 Deferred revenue, net of current portion 180,059 243,944 Operating lease liabilities - long term 13,975 18,056 Total liabilities 346,642 339,870 Commitments and contingencies Stockholders' equity (deficit) Convertible preferred stock — — Common stock 1 1 Additional paid-in capital 637,117 623,344 Accumulated other comprehensive income (loss) 10 (242 ) Accumulated deficit (722,879 ) (623,562 ) Total stockholders' equity (deficit) (85,751 ) (459 ) Total liabilities and stockholders' equity (deficit) $ 260,891 $ 339,411

Phase 1License out/inClinical ResultImmunotherapyPhase 2

22 Mar 2023

·www.businesswire.com

HR Positive/ Her2 Negative Breast Cancer - Pipeline Insight, 2023 - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "HR Positive/ Her2 Negative Breast Cancer - Pipeline Insight, 2023" clinical trials has been added to ResearchAndMarkets.com's offering. This "HR Positive/ HER2 Negative Breast Cancer - Pipeline Insight, 2023" report provides comprehensive insights about 50+ companies and 53+ pipeline drugs in HR Positive/ HER2 Negative Breast Cancer pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Geography Covered Global coverage HR Positive/ HER2 Negative Breast Cancer: Overview Three common tests employed to test for HER2 levels are chromogenic in situ hybridization (CISH), immunohistochemistry (IHC) and fluorescent in situ hybridization (FISH). Depending on the levels of HER2 or ERBB2 in the laboratory test breast cancer is classified as HER2 or ERBB2 positive or HER2 negative breast cancer. In HER2 or ERBB2 receptors in a normal breast maintains growth, division and repairing while in HER2 or ERBB2 positive breast cancer over-expression of HER2 or ERBB2 is seen. In case of HER2 negative breast cancer the levels of HER2 protein is in normal. The present goal of therapy for early HR+/HER2- breast cancer (BC) is to optimize disease-free survival (DFS) and overall survival (OS) rates with the currently available therapies while avoiding any relevant long-term sequalae. Local therapies have evolved toward less aggressive techniques (i.e. breast-preserving surgery, sentinel lymph node biopsy and intraoperative radiotherapy), which significantly reduce the long-term sequalae observed with more radical treatments. Endocrine therapy (ET) is still the cornerstone of adjuvant treatment because it significantly reduces BC relapse and mortality. Adjuvant chemotherapy is today recommended only for a particular subset of patients with a high risk of recurrence with ET alone, identified through genomic assays, age and/or disease stage. Bisphosphonates reduce the risk of bone metastasis and produce a slight although statistically significant improvement in survival in postmenopausal women. The CDK 4/6 inhibitor abemaciclib has been recently approved by the US FDA for patients at high risk of relapse. The report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the HR Positive/ HER2 Negative Breast Cancer pipeline landscape is provided which includes the disease overview and HR Positive/ HER2 Negative Breast Cancer treatment guidelines. The assessment part of the report embraces, in depth HR Positive/ HER2 Negative Breast Cancer commercial assessment and clinical assessment of the pipeline products under development. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence HR Positive/ HER2 Negative Breast Cancer R&D. The therapies under development are focused on novel approaches to treat/improve HR Positive/ HER2 Negative Breast Cancer. HR Positive/ HER2 Negative Breast Cancer Emerging Drugs Chapters This segment of the HR Positive/ HER2 Negative Breast Cancer report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. HR Positive/ HER2 Negative Breast Cancer Emerging Drugs Camizestrant: AstraZeneca Camizestrant is a potent, next-generation oral SERD and pure ER? antagonist, that has demonstrated anti-cancer activity across a range of preclinical models, including those with ER-activating mutations. The asset has been shown to promising anti-tumour profile when administered alone or in combination with palbociclib and thus, the company is running a Phase III trial for the same. Dato-DXd: Daiichi Sankyo, Inc. Datopotamab deruxtecan (Dato-DXd) is an investigational currently in Phase III for HR-positive, HER2- negative breast cancer. It is a TROP2 directed antibody drug conjugate (ADC) designed using Daiichi Sankyo's proprietary DXd ADC technology, datopotamab deruxtecan is one of the three lead ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca's ADC scientific platform. Datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads, an exatecan derivative, via tetrapeptide-based cleavable linkers. CX-2009: CytomX Therapeutics CX-2009 is a Probody drug conjugate that consists of a humanized anti-CD166 monoclonal antibody conjugated to DM4, a potent microtubule inhibitor known to be active against multiple cancer types. It is currently being tested in Phase II trial in Advanced HR-Positive/HER2-Negative Breast Cancer and of Praluzatamab Ravtansine as Monotherapy and in Combination with Pacmilimab (CX-072) in Advanced Triple-Negative Breast Cancer. RGT-419B: Regor Therapeutics RGT-419B is a new generation of CDK inhibitor with an optimized kinase activity spectrum. The clinical development program of RGT-419B is designed to address the unmet medical needs of patients who are refractory or have relapsed after previous treatment, providing new opportunities to improve survival and quality of life for patients with advanced/metastatic breast cancer. It is currently being tested in Phase I trial in in subjects with Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced/Metastatic Breast Cancer. HR Positive/ HER2 Negative Breast Cancer: Therapeutic Assessment This segment of the report provides insights about the different HR Positive/ HER2 Negative Breast Cancer drugs segregated based on following parameters that define the scope of the report, such as: Major Players in HR Positive/ HER2 Negative Breast Cancer There are approx. 50+ key companies which are developing the therapies for HR Positive/ HER2 Negative Breast Cancer. The companies which have their HR Positive/ HER2 Negative Breast Cancer drug candidates in the most advanced stage, i.e. phase III include, AstraZeneca. Phases The report covers around 53+ products under different phases of clinical development like Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration HR Positive/ HER2 Negative Breast Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Intra-articular Intraocular Intrathecal Intravenous Ophthalmic Oral Parenteral Subcutaneous Topical Transdermal Molecule Type Products have been categorized under various Molecule types such as Oligonucleotide Peptide Small molecule Product Type Drugs have been categorized under various product types like Mono, Combination and Mono/Combination. HR Positive/ HER2 Negative Breast Cancer: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses HR Positive/ HER2 Negative Breast Cancer therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging HR Positive/ HER2 Negative Breast Cancer drugs. HR Positive/ HER2 Negative Breast Cancer Report Insights HR Positive/ HER2 Negative Breast Cancer Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs HR Positive/ HER2 Negative Breast Cancer Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Questions Answered Current Treatment Scenario and Emerging Therapies: How many companies are developing HR Positive/ HER2 Negative Breast Cancer drugs? How many HR Positive/ HER2 Negative Breast Cancer drugs are developed by each company? How many emerging drugs are in mid-stage, and late-stage of development for the treatment of HR Positive/ HER2 Negative Breast Cancer? What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the HR Positive/ HER2 Negative Breast Cancer therapeutics? What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? What are the clinical studies going on for HR Positive/ HER2 Negative Breast Cancer and their status? What are the key designations that have been granted to the emerging drugs? Key Players Regor Therapeuics Seagen Inc. CytomX Therapeutics Taizhou EOC Pharma Chia Tai Tianqing Pharmaceutical Group AstraZeneca Daiichi Sankyo, Inc. Tyme, Inc. Seagen Inc. Context Therapeutics Eisai Inc. Shanghai Hengrui Pharmaceutical Co., Ltd. Jiangsu Simcere Pharmaceutical Co., Kind Pharmaceuticals Merus N.V. Atossa Therapeutics Roche Ellipses Pharma Key Products RGT-419B SGN-B7H4V CX-2009 EOC202 TQB3616 Camizestrant Dato-DXd SM-88 SGN-B7H4V Onapristone Giredestrant H3B-6545 Z-endoxifen MCLA-128 EP0062 HRS8807 SCR-6852 AND019 For more information about this clinical trials report visit https://www.researchandmarkets.com/r/g7co1l About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Phase 1Phase 2Phase 3

26 Jan 2023

·www.biospace.com

CytomX Therapeutics Announces Milestone Achievement in Probody® T-Cell Engaging Bispecific (TCB) Collaboration with Astellas

-Achievement of clinical candidate is the first in the multi-target collaboration and triggers a $5 million milestone payment to CytomX- -CytomX-retained US co-commercialization and economic rights for select programs- SOUTH SAN FRANCISCO, Calif., Jan. 26, 2023 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, today announced that it achieved a clinical candidate milestone under its TCB agreement with Astellas Pharma US, Inc. The clinical candidate is the first Probody® TCB molecule to progress in the collaboration and will trigger a $5 million dollar milestone payment to CytomX. CytomX and Astellas are also collaborating on additional conditionally activated TCB programs with CytomX eligible to receive future preclinical, clinical and commercial milestones. CytomX retains a cost share and co-commercialization option on a select number of targets. “We are pleased with the achievement of the first Probody® TCB clinical candidate in our collaboration with Astellas and that our discovery and research capabilities in this important modality continue to deliver next-generation, localized drug candidates. We look forward to continuing to partner with Astellas in advancing novel TCBs towards the clinic and potentially making a significant contribution in bringing the power of T-cell engaging therapies to a broader set of patients with cancer,” said Dr. Marcia P. Belvin, Ph.D., senior vice president and head of research at CytomX. “The progress with Astellas highlights our strategy to create value through a broad, diversified pipeline of wholly-owned and partnered therapeutic programs as well as expanding our research and development efforts in the field of TCBs. T-cell engaging therapies hold tremendous promise; however, the potency of this modality can lead to widespread activation of the immune system and a narrow therapeutic window. Localizing T-cell activity to the tumor microenvironment could result in important breakthroughs for patients, and the Probody® platform has potential to address this challenge,” said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX Therapeutics. About CytomX Therapeutics CytomX is a clinical-stage, oncology-focused biopharmaceutical company dedicated to destroying cancer differently. By pioneering a novel class of conditionally activated biologics, powered by its Probody® technology platform, CytomX’s goal is to transcend the limits of current cancer treatments. CytomX’s robust and differentiated pipeline comprises seven therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), T-cell engaging bispecific antibodies (“TCBs”), and immune modulators such as cytokines and checkpoint inhibitors (“CPIs”). CX-2029 is an investigational conditionally activated antibody-drug conjugate (ADC) directed toward CD71 and is being developed in collaboration with AbbVie. CytomX’s clinical pipeline also includes cancer immunotherapeutic candidates against validated targets such as the CTLA-4-targeting Probody therapeutics, BMS-986249 and BMS-986288, partnered with Bristol Myers Squibb, as well as CX-904, a conditionally activated T-cell-engaging bispecific antibody targeting the epidermal growth factor receptor (EGFR) on tumor cells and the CD3 receptor on T cells, which is partnered with Amgen. In addition, CytomX has a diverse preclinical portfolio of wholly-owned assets including CX-801, an interferon alpha-2b Probody cytokine that has broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors and CX-2051, a conditionally activated ADC directed toward EpCAM, with potential applicability across multiple EpCAM-expressing epithelial cancers. CytomX has also established strategic collaborations with multiple leaders in oncology, including AbbVie, Amgen, Astellas, Bristol Myers Squibb, Regeneron and Moderna. For more information about CytomX and how it is working to make conditionally activated treatments the new standard-of-care in the fight against cancer, visit and follow us on LinkedIn and Twitter. CytomX Therapeutics Forward-Looking Statements This press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond our control, and may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements, including those related to the future potential of partnerships or collaboration agreements. Accordingly, you should not rely on any of these forward-looking statements, including those relating to the potential benefits, safety and efficacy or progress of CytomX’s or any of its collaborative partners’ product candidates, including CX-2029, BMS-986249, BMS-986288, pacmilimab, CX-904, CX-801, and CX-2051, the potential benefits or applications of CytomX’s Probody platform technology, CytomX’s ability to develop and advance product candidates into and successfully complete clinical trials, including the ongoing and planned clinical trials of CX-2029, BMS-986249, BMS-986288, pacmilimab, and CX-904, and the timing of the commencement of clinical trials, initial and ongoing data availability, investigational new drug applications and other development milestones. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the unproven nature of CytomX’s novel Probody Platform technology; CytomX’s clinical trial product candidates are in the initial stages of clinical development and its other product candidates are currently in preclinical development, and the process by which preclinical and clinical development could potentially lead to an approved product is long and subject to significant risks and uncertainties, including the risk that the COVID-19 worldwide pandemic may continue to negatively impact the business, research and clinical operations of CytomX or its partners, including the development of preclinical drug candidates due to delays in and disruption of research activities and the development of clinical drug candidates due to delays in or disruption of clinical trials, including impacts on the enrollment of patients in clinical trials or other clinical trial disruptions; the possibility that the results of preclinical research and early clinical trials may not be predictive of future results; the possibility that CytomX’s clinical trials will not be successful; the possibility that current preclinical research may not result in additional product candidates; CytomX’s dependence on the success of CX-2029, BMS-986249, BMS-986288, pacmilimab, CX-904, CX-801, and CX-2051; CytomX’s reliance on third parties for the manufacture of the Company’s product candidates; and possible regulatory developments in the United States and foreign countries. Additional applicable risks and uncertainties include those relating to our preclinical research and development, clinical development, and other risks identified under the heading "Risk Factors" included in CytomX’s Quarterly Report on Form 10-Q filed with the SEC on November 8, 2022. The forward-looking statements contained in this press release are based on information currently available to CytomX and speak only as of the date on which they are made. CytomX does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise. Probody is a U.S. registered trademark of CytomX Therapeutics, Inc. CytomX Contact: Chris Ogden SVP, Finance and Accounting cogden@cytomx.com 317-767-4764 Investor and Media Contact: Stern Investor Relations Stephanie Ascher stephanie.ascher@sternir.com 212-362-1200

ImmunotherapyLicense out/in

100 Deals associated with CX-072

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced breast cancer	Phase 2	United States	CytomX Therapeutics, Inc.	29 Dec 2020
Advanced breast cancer	Phase 2	Spain	CytomX Therapeutics, Inc.	29 Dec 2020
Advanced Triple-Negative Breast Carcinoma	Phase 2	United States	CytomX Therapeutics, Inc.	29 Dec 2020
Advanced Triple-Negative Breast Carcinoma	Phase 2	Spain	CytomX Therapeutics, Inc.	29 Dec 2020
Hormone receptor positive HER2 negative breast cancer	Phase 2	United States	CytomX Therapeutics, Inc.	29 Dec 2020
Hormone receptor positive HER2 negative breast cancer	Phase 2	Spain	CytomX Therapeutics, Inc.	29 Dec 2020
HR Positive/HER2 Negative/Node positive breast cancer	Phase 2	United States	CytomX Therapeutics, Inc.	29 Dec 2020
HR Positive/HER2 Negative/Node positive breast cancer	Phase 2	Spain	CytomX Therapeutics, Inc.	29 Dec 2020
Metastatic melanoma	Phase 2	United States	CytomX Therapeutics, Inc.	20 Nov 2019
Metastatic melanoma	Phase 2	Australia	CytomX Therapeutics, Inc.	20 Nov 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03993379 (PROCLAIM-CX-072, CTgov)	Phase 2	Metastatic melanoma \| Unresectable Melanoma	3	CX-072 (Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line)	tiwwyjcsbg = pqxxcaohqp qseifoarhu (bmndgdyets, pdmcoetihu - oaisarmehe) View more	-	01 Dec 2021
NCT03993379 (PROCLAIM-CX-072, CTgov)	Phase 2	Metastatic melanoma \| Unresectable Melanoma	3	Ipilimumab+CX-072 (Cohort A2: CX-072 in Combination With Ipilimumab)	tiwwyjcsbg = bvaxuniuzy qseifoarhu (bmndgdyets, vywpyptkch - bytieoeslo) View more	-	01 Dec 2021
NCT03013491 (PROCLAIM-CX-072, Pubmed \| J Immunother Cancer) Manual	Phase 1/2	Solid tumor	27	ipilimumab+pacmilimab	vipxaxpzly(nmtnucrnzx) = zsbjgfxgel phgzouzmjb (zzfodljyku ) View more	Positive	01 Jul 2021
NCT03993379 (PROCLAIM-CX-072, ASCO 12020 \| ASCO 22020) Manual	Phase 2	HR-positive/HER2-low Solid Tumors	141	CX-072 (< 6M-TD)	fwfogzzunq(sndtzaxoeq) = jfwiptxgko udloqjgehs (wbhpdwywiy ) View more	Positive	29 May 2020
	Phase 2	HR-positive/HER2-low Solid Tumors	141	CX-072 (≥6M-TD)	fwfogzzunq(sndtzaxoeq) = uhubjjutje udloqjgehs (wbhpdwywiy ) View more	Positive	29 May 2020
NCT03013491 (PROCLAIM-CX-072, ASCO2018)	Phase 1/2	HR-positive/HER2-low Solid Tumors	9	CX-072 + ipi	oumztrfloc(rrnbwjceln) = 4 grade 3 TRAEs were experienced by 2 pts (22%) and included colitis, pneumonitis, and AST and ALT increases (0.3 mg/kg CX-072 + 3 mg/kg ipi) nxqbfilmzc (qwlbpoccov )	Positive	01 Jun 2018

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis