Compugen to Present Pooled Analysis of COM701 in Three Phase 1 Trials in Patients with Platinum Resistant Ovarian Cancer at ESMO 2025

On October 13, 2025 Compugen Ltd. (NASDAQ: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in predictive computational target discovery powered by AI/ML, reported that pooled analysis of previously presented data, supporting the anti-tumor activity and safety profile of COM701 in heavily pre-treated patients with platinum resistant ovarian cancer (PROC), has been published as an abstract released by the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) (Press release, Compugen, OCT 13, 2025, View Source [SID1234656599]).

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The abstract focuses on a pooled analysis of 60 evaluable patients with platinum resistant ovarian cancer from prior COM701 Phase 1 clinical trials. The analysis characterizes the outcomes of patients who derived clinical benefit including progression free survival data. An additional year of follow-up will be included in the poster. The poster will be presented at ESMO (Free ESMO Whitepaper) in Berlin, Germany on October 18, 2025, by Oladapo Yeku, M.D., Ph.D., FACP, FASCO, Assistant Professor of Medicine, Harvard Medical School, and Director of Translational Research, Gynecologic Oncology Program, Massachusetts General Hospital, Boston, MA, and an investigator in Compugen’s ovarian cancer trials.

"The pooled analysis demonstrates that COM701 was well tolerated and showed consistent, durable responses in patients with heavily pretreated platinum-resistant ovarian cancer – particularly in those without liver metastases, representing patients with lower disease burden and potentially less immunosuppressive tumor microenvironment," said Dr. Oladapo Yeku. "The results of the analysis support the rationale for evaluating COM701 as maintenance therapy in earlier lines of treatment. I look forward to discussing this data along with the ongoing MAIA-ovarian trial in Berlin at ESMO (Free ESMO Whitepaper) on Saturday, October 18, 2025."

"There is a gap in care for women with platinum sensitive ovarian cancer who respond to chemotherapy but are ineligible for or cannot tolerate additional maintenance treatment," said Eran Ophir, Ph.D., President, and Chief Executive Officer of Compugen. "These patients have a less compromised immune system, providing the opportunity to harness the unique mechanism of action of COM701 to potentially change the disease trajectory and improve progression free survival. Compugen is currently conducting the MAIA-ovarian trial link assessing COM701 monotherapy as maintenance treatment in relapsed platinum-sensitive ovarian cancer."

Dr. Ophir added, "An interim analysis of the MAIA-ovarian trial is planned once data from approximately 60 participants enable assessment of median progression free survival. Sites have been activated in the U.S. and Israel. To further support enrollment, we recently initiated the activation of sites in France from the French oncology cooperative group ARCAGY-GINECO renowned for a number of recent platinum sensitive ovarian cancer trials. Based on the anticipated enrollment rate, the Company currently estimates interim analysis results at year end 2026. As we continue to focus on execution of our pipeline programs, we anticipate that our cash will support our operating plans well into 2027."

Access the Abstract

The abstract is now available on the publication section of Compugen’s website. The poster will be available on the publication section of Compugen’s website on Saturday October 18, 2025.

Additional ESMO (Free ESMO Whitepaper) Highlights

ESMO 2025 will also feature presentations from companies with differentiated Fc-reduced TIGIT programs, including two oral presentations from Compugen’s partner AstraZeneca with rilvegostomig- Fc reduced PD1/TIGIT bispecific, the TIGIT component of which is derived from Compugen’s clinical stage, COM902.

Lupin Announces Presentation of Phase 1 Data on LNP3693 (STING agonist) at the ESMO Congress 2025

On October 13, 2025 Lupin Limited (Lupin) reported that it will present data from its Phase 1a clinical trial evaluating LNP3693, a STING agonist, at the ESMO (Free ESMO Whitepaper) Congress in Berlin, Germany, from October 17 to October 21, 2025 (Press release, Lupin, OCT 13, 2025, View Source [SID1234656584]). The presentation, titled "A phase 1 dose escalation study of LNP3693 (STING agonist) in patients with advanced or metastatic solid tumors & lymphoma," will be featured in the Investigational Immunotherapy session (Presentation Number 1553P). It can be viewed on October 19, 2025, from 09:00 to 17:00 CEST.

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LNP3693 is an investigational parenteral STING agonist. The presentation will provide qualitative insights into its safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity in patients with solid tumors.

"This marks another important milestone for us. Following our successful presentation of LNP7457, a PRMT5 inhibitor, at ASCO (Free ASCO Whitepaper) in June 2025, it is a privilege to present the findings of another Phase 1 clinical trial for LNP3693, a STING agonist, at ESMO (Free ESMO Whitepaper). ESMO (Free ESMO Whitepaper)’s acknowledgment of the clinical research conducted in India underscores the proficiency of our team in oncology drug discovery, research, and clinical development," said Vinita Gupta, CEO, Lupin.

Details of the Presentation:

Date and Time: Sunday, October 19, 2025, 09:00-17:00 (CEST)
Session Title: A Phase 1 Dose Escalation Study of LNP3693 (STING Agonist) in Patients with Advanced or Metastatic Solid Tumors & Lymphoma
Category: Investigational Immunotherapy
Clinical Trial Registration Number: CTRI/2023/10/059147
Presentation Number: 1553P
Complete data has been provided for presentation at the ESMO (Free ESMO Whitepaper) Congress 2025 and will be addressed during the official session.

All regular abstracts accepted for presentation at the ESMO (Free ESMO Whitepaper) Congress 2025 will be published online via the ESMO (Free ESMO Whitepaper) website on Monday, October 13, at 6:05 p.m. ET (12:05 a.m. CEST). All accepted abstracts will be published online in the ESMO (Free ESMO Whitepaper) Congress 2025 Abstract Book, a supplement to the official ESMO (Free ESMO Whitepaper) journal, Annals of Oncology.

More information regarding the ESMO (Free ESMO Whitepaper) Congress 2025 can be viewed at:
View Source

Nuvalent to Present New Preclinical Data for HER2-Selective Inhibitor, NVL-330, at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

On October 13, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported an upcoming poster presentation further characterizing the preclinical intracranial activity of its novel HER2-selective inhibitor, NVL-330, at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) being held October 22-26, 2025 in Boston (Press release, Nuvalent, OCT 13, 2025, View Source [SID1234656600]).

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Details of the poster presentation are as follows:

Title: Preclinical intracranial activity of NVL-330, a selective HER2 tyrosine kinase inhibitor
Abstract Number: B057
Authors: Yuting Sun*1, Kristin L. Andrews1, Anupong Tangpeerachaikul1, Michael J. Walsh1, Nancy E. Kohl2, Joshua C. Horan1, Henry E. Pelish1
Session: Poster Session B
Session Date and Time: Friday, October 24, 2025, 12:30-4:00 p.m. ET
Location: Exhibit Hall D

*Presenter, corresponding author; 1Nuvalent, Inc., Cambridge, MA, USA; 2Kohl Consulting, Wellesley, MA, USA

Nouscom Presents Positive Phase 2 Results of NOUS-209 Immunotherapy Combined with Pembrolizumab in MSI-H Metastatic Colorectal Cancer Patients Refractory to Anti-PD-1 Therapy, at ESMO 2025

On October 13, 2025 Nouscom, a clinical-stage biotech company developing next-generation neoantigen-targeted off-the-shelf and personalized cancer immunotherapies, reported positive results from a completed Phase 2 trial evaluating NOUS-209 in combination with pembrolizumab for patients with microsatellite instability high (MSI-H) metastatic colorectal cancer (mCRC) who are refractory to anti-PD-1 therapy (Press release, NousCom, OCT 13, 2025, View Source;utm_medium=rss&utm_campaign=nouscom-presents-positive-phase-2-results-of-nous-209-immunotherapy-combined-with-pembrolizumab-in-msi-h-metastatic-colorectal-cancer-patients-refractory-to-anti-pd-1-therapy-at-esmo-2025 [SID1234656585]). Results from this Phase 2 trial will be presented in a poster session at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting, taking place in Berlin, Germany, from 17 to 21 October 2025.

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Study Highlights:

NOUS-209 is an off-the-shelf viral vector-based immunotherapy targeting frameshift peptides specifically expressed on deficient mismatch repair (dMMR)/MSI-H tumors, thereby harnessing the power of the immune system to recognize and eliminate MSI-H cancer cells.
Anti-PD-1 therapy is the approved first-line standard of care in dMMR/MSI-H mCRC, but resistance or relapse can develop, requiring the development of new treatment options.
In this Phase 2 trial, NOUS-209 combined with pembrolizumab was administered to 20 evaluable patients with dMMR/MSI-H mCRC who had progressed on prior anti-PD-1 treatment (77% had received prior single agent anti-PD-1 therapy, 23% received combination therapy with anti-CTLA-4). The median number of prior lines was 2 (1-7).
The primary endpoint was Objective Response Rate (ORR); secondary endpoints included progression-free survival (PFS) and safety, with immunogenicity as an exploratory endpoint.
Key Results:

ORR was 15% (3 partial responses), with a disease control rate (DCR) of 70% (11 stable disease, 6 progressive disease).
Median progression-free survival (PFS) was 6.4 months.
Safety profile remained favorable, with no emerging findings.
Robust immune activation was detected in 80% of patients.
Seven patients (32%) were retreated with NOUS-209 at 6 months; among those, 86% remained in stable disease and 14% had a partial response, with the latter demonstrating induction of a strong, durable and polytopic T cell immune response with a desired effector memory phenotype and correlating with clinical response.
"There remains a high unmet need for effective therapies that can overcome anti-PD-1 resistance and provide durable disease control. These data are promising in this difficult-to-treat patient population given the modest clinical benefit of approved options in the same setting," said Javier Ros, MD PhD, from Vall d’Hebron University Hospital.

"These clinical data are very encouraging. NOUS-209 combined with pembrolizumab has demonstrated meaningful disease control and immune activation in patients who have exhausted anti-PD-1 therapy," said Dr. Sven Gogov, Chief Medical Officer of Nouscom.

"We are excited by the overall positive clinical dataset emerging from the completed clinical trials of NOUS-209, not only in MSI-H mCRC patients but also the Phase 1b/2 results in Lynch Syndrome carriers that were presented earlier this year at AACR (Free AACR Whitepaper). These results support our commitment to advancing NOUS-209 into a registration-enabling study for cancer interception in Lynch Syndrome carriers," said Dr. Marina Udier, Chief Executive Officer of Nouscom.

Details of the abstract and presentation at ESMO (Free ESMO Whitepaper):

Nous-209 immunotherapy with pembrolizumab for microsatellite instability high (MSI-H) metastatic colorectal cancer, refractory to anti-PD-1: Phase II trial results

Poster Number: 802P
Session: Colorectal Cancer Poster Session
Session Time/ Place: Sunday October 19 / 12:00-12:45 (CEST) / Hall 25
The abstract is available on the ESMO (Free ESMO Whitepaper) website.

Atossa Advances Global Patent Strategy for Z-Endoxifen with New Protection in Israel and Ongoing Renewals

On October 13, 2025 Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing new approaches in breast cancer treatment and prevention, reported key progress in its global intellectual-property strategy for Z-endoxifen, including the issuance of an Israeli patent and continued renewals that reinforce protection for the Company’s lead program across major jurisdictions (Press release, Atossa Therapeutics, OCT 13, 2025, View Source [SID1234656601]). The Israeli patent (No. 304863), titled, "Methods for Making and Using Endoxifen," was granted on July 2, 2025, with priority to multiple U.S. provisional applications filed in 2017–2018.

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The allowed claims in Israel include oral, delayed-release (enteric) dosage forms comprising at least 90% by weight Z-endoxifen, with optional impurity limits (<2%), defined release characteristics in gastric and intestinal media, dose strengths (e.g., 1–4 mg and 8 mg), and pharmacokinetic performance targets (e.g., plasma exposures and steady-state levels). The claims also cover manufacturing methods that enrich the Z-isomer via stepwise crystallization and solvent control. These protections align with Atossa’s quality-by-design approach to deliver a consistent, high-purity Z-endoxifen product.

In parallel, Atossa received a Certificate of Patent Renewal from the Israel Patent Office confirming fee payment and renewal status for Patent No. 304863, further supporting the life-cycle management of Z-endoxifen IP in this jurisdiction.

"Strong, durable patents are foundational to our Z-endoxifen strategy," said Steven Quay, M.D., Ph.D., Atossa Therapeutics Chairman and CEO. "This new protection in Israel, together with our broader global filings, covers what we believe are the critical elements of product quality, performance, and manufacturing needed to bring Z-endoxifen to patients and to create long-term value for shareholders."

About the Patent Scope in Israel
The granted patent includes: (i) enteric oral formulations with ≥90% Z-endoxifen; (ii) optional impurity and residual-solvent limits; (iii) stability and delayed-release attributes (acid resistance and intestinal release); (iv) dose ranges including 1–4 mg and 8 mg; (v) PK targets such as steady-state plasma levels and exposure ranges; and (vi) a multi-step crystallization process to enrich the Z-isomer. Collectively, these claims support Atossa’s global protection for Z-endoxifen composition, performance, and process.