On October 13, 2025 Aveta Biomics, a clinicalstage biotechnology company developing first-in-class drugs that reprogram the immune system to fight cancer, reported the poster presentation of new clinical and translational findings from its Phase IIa study of APG-157 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, taking place October 17–21, 2025, in Berlin, Germany (Press release, Aveta Biomics, OCT 13, 2025, View Source [SID1234656579]).

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The company’s poster will highlight data from patients with head and neck squamous cell carcinoma (HNSCC) treated with oral APG-157 as neoadjuvant or induction monotherapy. The results provide the first detailed mechanistic evidence of how APG-157 reshapes the immunecold tumor microenvironment (TME) into an immune-engaged, "hot" state correlating with the observed Event-Free Survival (EFS) outcomes.

"These translational data provide unprecedented insight into APG-157’s multi-axis immune reprogramming in head and neck cancer," said Selda Samakoglu, M.D., Ph.D., Chief Medical Officer of Aveta Biomics. "They reveal how APG-157 orchestrates effector and helper T-cell coordination, collapses PD-L1⁺ epithelial barriers, and repolarizes suppressive macrophages. This mechanism appears to drive the durable responses observed in our Phase IIa study and reinforces the rationale for advancing APG-157 as a monotherapy into our registrational Phase III trial next year."

"The implications of these findings extend well beyond head and neck cancer," added Luis Avila, Ph.D., Chief Scientific Officer of Aveta Biomics. "The broad immune remodeling coupled with the excellent safety profile observed in Phase IIa defines a new therapeutic paradigm. These results support APG-157’s potential as a PD-1–independent, oral immunotherapy capable of producing durable responses across multiple tumor types and enhancing the effectiveness of existing immunotherapies."

PRESENTATION DETAILS:

TITLE: Spatial Profiling of Immune Architecture Reveals APG-157-Induced Anti-Tumor Immune Remodeling in Locally Advanced Head and Neck Cancer

ABSTRACT NUMBER: 1401P
SESSION TITLE: Head and Neck Cancer, excluding Thyroid
LOCATION: Messe Berlin, Poster Area, Hall 25
SESSION DATE AND TIME: Monday, October 20, 2025, 9:00 AM – 12:45 PM

PRESENTERS: • Daniel S. Shin, MD, PhD, Associate Professor, Hematology-Oncology, Baylor College of Medicine, Houston, Texas • Selda Samakoglu, MD, PhD, Chief Medical Officer, Aveta Biomics, Inc.

On October 13, 2025 Arvinas, Inc. (Nasdaq: ARVN) reported that new data for vepdegestrant will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress to be held October 17 through 21, 2025, in Berlin, Germany (Press release, Arvinas, OCT 13, 2025, View Source [SID1234656578]). Vepdegestrant is a novel investigational PROTAC estrogen receptor (ER) degrader which is being developed with Pfizer Inc. (NYSE: PFE) as a potential monotherapy for ER+/HER2- advanced or metastatic breast cancer with estrogen receptor 1 (ESR1) mutations in the second line-plus setting. Ongoing studies are also evaluating vepdegestrant as a monotherapy and as part of combination therapy for ER+/HER2- breast cancer.

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The presentation details are as follows:

Title: Patient-reported outcomes (PROs) with vepdegestrant (VEP) vs fulvestrant (FUL) in patients (pts) with estrogen receptor (ER) 1 gene mutated (ESR1m) ER+/human epidermal growth factor receptor 2 (HER2)− advanced breast cancer (aBC) in the phase 3 VERITAC-2 trial
Presenting Author: Dr. Mario Campone
Presentation Number: 489MO
Presentation Type: Mini oral session
Session: Breast cancer, metastatic
Date: Monday, October 20, 2025
Time: 11:25-11:30 CEST

Title: TACTIVE-N: phase 2 study of neoadjuvant vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, or anastrozole in postmenopausal ER+/human epidermal growth factor receptor 2 (HER2)- localized breast cancer (BC)
Presenting Author: Dr. Peter A. Fasching
Presentation Number: 293MO
Presentation Type: Mini oral session
Session: Breast cancer, early stage
Date: Sunday, October 19, 2025
Time: 10:40-10:45 AM CEST

The full abstracts can be accessed via the ESMO (Free ESMO Whitepaper) online program.

About Vepdegestrant
Vepdegestrant is an investigational, orally bioavailable PROteolysis TArgeting Chimera (PROTAC) estrogen receptor degrader. Vepdegestrant is being developed as a potential monotherapy for ER+/HER2- advanced or metastatic breast cancer with estrogen receptor 1 (ESR1) mutations in the second line-plus setting. Ongoing studies are also evaluating vepdegestrant as a monotherapy and as part of combination therapy for ER+/HER2- breast cancer.

In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant. In September 2025, Arvinas and Pfizer announced their plan to jointly select a third party for the out-licensing and commercialization of vepdegestrant.

The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for vepdegestrant for its use as a monotherapy in the treatment of adults with estrogen receptor–positive (ER+), human epidermal growth factor receptor 2–negative (HER2-), ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. Vepdegestrant has also been granted Fast Track designation by the FDA, supporting the potential for vepdegestrant to offer a meaningful new treatment option for patients with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy.

On October 13, 2025 Artios Pharma Limited ("Artios"), a biopharmaceutical company committed to realizing the therapeutic power of targeting the DNA damage response ("DDR") in cancer, reported an upcoming oral presentation highlighting the company’s DNA polymerase Theta (Polθ) inhibitor, ART6043, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, taking place between October 17-21, 2025, in Berlin, Germany (Press release, Artios Pharma, OCT 13, 2025, View Source [SID1234656576]). ART6043 is a potential first-in-class, selective DNA polymerase domain inhibitor being developed in combination with the PARP inhibitor, olaparib, in patients with cancers that harbor DDR defects.

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The presentation will feature the first clinical results for ART6043 from the Phase 1/2a study (NCT05898399), including safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors. This will be the first time that clinical activity for a therapeutic candidate targeting Polθ in humans will be presented.

Details of the oral presentation:

Abstract Title: First data disclosure of the first-in-class DNA polymerase theta inhibitor, ART6043, as monotherapy and in combination with olaparib, in patients with molecularly-selected advanced solid tumors

Session Category and Title: Mini oral session: Developmental therapeutics

Date: Friday, October 17, 2025

Time: 4:30 – 4:35 PM CEST

Presenter: Dr. Timothy A. Yap, VP and Head of Clinical Development in the Therapeutics Discovery Division at The University of Texas MD Anderson Cancer Center

Location: Heidelberg Auditorium, Hall 6.2

The abstract is available on the ESMO (Free ESMO Whitepaper) Congress website.

Artios will issue a press release detailing the data presented at the conference following the oral presentation at ESMO (Free ESMO Whitepaper).

About ART6043

ART6043 is a potential first-in-class, selective, orally bioavailable, small‑molecule inhibitor of the polymerase domain of DNA polymerase Theta (Polθ), a DNA repair enzyme that is preferentially expressed in cancer cells but is virtually absent in most healthy tissues. By inhibiting Polθ, ART6043 targets microhomology mediated end joining (MMEJ) to exploit tumor dependence on error-prone DNA repair, with broad rationale for use as monotherapy and in combination with PARP inhibition and other DNA-damaging modalities. Artios’ differentiated approach is evaluating ART6043 with olaparib in molecularly defined solid tumors, including settings of BRCA variants and PARP inhibitor resistance, to enhance target engagement and anti-tumor activity while maintaining tolerability.

On October 13, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported the upcoming presentation of data from the Phase 1 REACtiVe-2 trial (NCT05650918) at the ESMO (Free ESMO Whitepaper) Congress 2025, showcasing the immunologic and clinical effects of mitazalimab in combination with dendritic cell therapy in patients with metastatic pancreatic cancer (Press release, Alligator Bioscience, OCT 13, 2025, View Source [SID1234656575]).

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The investigator-sponsored trial, conducted at Erasmus MC Cancer Institute, demonstrated that the combination of mitazalimab and Amphera’s dendritic cell vaccine MesoPher was safe and well-tolerated, with enhanced systemic and local immune responses. Half of the patients achieved stable disease after three administrations, with post-treatment biopsies revealing increased tumor-infiltrating T cells and reduced collagen deposition.

Title: REACtiVe-2: Phase I Evaluation of Dendritic Cell Vaccination and Agonistic CD40 Therapy Following (m)FOLFIRINOX in Metastatic Pancreatic Cancer
Presentation number: 2218P
Date and time: Sunday, 19 October, 12 p.m.-12:45 p.m. CEST.

"These clinical data clearly demonstrate the immune-stimulatory capacity of mitazalimab in patients with pancreatic cancer. They provide important mechanistic support for mitazalimab’s mode of action as a tumor-directed CD40 agonist," said Søren Bregenholt, CEO of Alligator Bioscience. "As we actively pursue out-licensing opportunities, results such as these reinforce mitazalimab’s value proposition in immuno-oncology and its potential in novel combination therapies."

On October 12, 2025 Moderna, Inc. (NASDAQ:MRNA) reported that clinical, safety and translational data from its Phase 1/2 study evaluating mRNA-4359 in combination with pembrolizumab in checkpoint inhibitor-resistant/refractory(CPI-R/R) melanoma patients will be presented at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, October 17-21, 2025, in Berlin, Germany (Press release, Moderna Therapeutics, OCT 12, 2025, https://feeds.issuerdirect.com/news-release.html?newsid=5823943357532273&symbol=MRNA [SID1234656588]). mRNA-4359 is an investigational immune-evasion targeted cancer antigen therapy (CAT) that encodes epitopes of two common immune escape pathways, PD-L1 and IDO1, to elicit antigen-specific T cell responses that may directly kill tumor cells and deplete tumor suppressor cells.

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The presentation includes data from 29 participants with CPI-R/R melanoma who have had ≥1 prior checkpoint inhibitor (CPI) therapy. Participants received the combination therapy at 400 µg (n=14) or 1,000 µg (n=15), given intramuscularly every three weeks for up to nine doses. Across all evaluable patients, the objective response rate (ORR) was 24% and disease control rate (DCR), or the combination of patients achieving tumor response and stable disease, was 60%. Among those with response-evaluable disease and PD-L1+ (TPS≥1%) tumors, the ORR was 67% (6 of 9 participants), with treatment successfully inducing peripheral antigen-specific T cell responses and novel T cell receptor clones. The median duration of response (DOR) was not reached. The improved efficacy in PD-L1+ patients supports PD-L1 as a potential predictive biomarker in this high unmet need population.

"While early, today’s mRNA-4359 melanoma data in highly CPI-refractory metastatic patients are unique in the field and incredibly promising for future development options. We are encouraged by its potential to address such a high unmet need for many patients," said Dr. Kyle Holen, Head of Development, Therapeutics and Oncology, Moderna. "Where other checkpoint inhibitors restore non-specific T cell activity, mRNA-4359 encodes two critical immune escape pathways to help generate new, target-directed T cells. This could enable broader and more durable immune responses for patients who have not had success with prior lines of therapy. We are proud to present these data and to demonstrate the role our mRNA-based therapies could play in transforming the lives of those affected by cancer."

mRNA-4359 in combination with pembrolizumab demonstrated a consistently manageable safety profile, with no new immune-related adverse events (AEs). mRNA-4359 continues to be evaluated in an ongoing phase 1/2 study (NCT05533697) as a monotherapy and in combination with pembrolizumab in patients with advanced melanoma and non-small cell lung cancer (NSCLC).

"After failing to respond to first-line immunotherapy, existing options for PD-L1+ patients are limited, underscoring a clear need for effective, tolerable therapies," said Prof. David J. Pinato, Clinical Professor of Experimental Cancer Therapeutics at Imperial College London and Consultant Medical Oncologist at Imperial College Healthcare NHS Trust and lead author and presenter of the abstract. "mRNA-4359 has the potential to rebalance the tumor microenvironment to overcome this immunotherapy resistance. These data are encouraging as we continue to investigate the potential of mRNA-4359."

The details of the presentation are as follows:

Mini Oral Presentation #1515MO: Clinical Outcomes and PD-L1 Expression Analyses from a Trial of mRNA-4359 Plus Pembrolizumab in Checkpoint Inhibitor-Resistant/Refractory (CPI-R/R) Melanoma

Time: Friday, October 17, 2025, 2:00 – 3:30 PM CET

Location: Nuremberg Auditorium – Hall 5.2

Presenter: David J. Pinato

Moderna’s Oncology Investor & Analyst Event

Moderna will host a live webcast for investors and analysts on Friday, October 17, 2025, at 6:00 PM CET (12:00 PM ET), which will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna’s website for at least 30 days following the presentation.

About mRNA-4359

mRNA-4359 is an immune-evasion targeted cancer antigen therapy that encodes broad epitopes of PD-L1 and IDO1. With its dual mechanism of action, it elicits antigen-specific T-cell responses to simultaneously: (1) kill tumor cells expressing PD-L1 and IDO1, and (2) deplete immunosuppressive cells that shield the tumor from attack. This is hypothesized to rebalance the tumor microenvironment into an immune-permissive state, supporting sustained and durable anti-tumor activity with a manageable safety profile.