On October 16, 2025 Agenus Inc. ("Agenus") (Nasdaq: AGEN), a leader in immuno-oncology, reported it will host a virtual Stakeholder Briefing on Tuesday, October 21, 2025, at 4:00 p.m. ET. The webcast will feature updates from leading experts on recent clinical progress and expanding international access for its immunotherapy combination botensilimab (BOT) and balstilimab (BAL). The session will be moderated by Garo Armen, PhD, Founder, Chairman, and CEO, and conclude with a live Q&A.

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Featured Topics and Speakers

Expanding Immunotherapy’s Reach: ESMO (Free ESMO Whitepaper) 2025 Highlights
Michael S. Gordon, MD, HonorHealth Research Institute

Dr. Gordon will discuss results from his oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, featuring data from over 400 patients treated with BOT/BAL across multiple refractory solid tumors.

Access Beyond Borders: France’s Autorisation d’Accès Compassionnel (AAC) Program and BOT/BAL’s Inclusion
Alexander M.M. Eggermont, MD, PhD, world-renowned immuno-oncologist and former Director General of the Gustave Roussy Cancer Center in France

Professor Eggermont will provide perspective on the French AAC program and its implications for oncologists and patients living with refractory MSS colorectal cancer.
Stakeholder Briefing Details:

Webcast Link | View Source
Pre-registration is not required.

This session marks the second in Agenus’ 2025 Stakeholder Briefing Series, following the August event highlighting corporate strategy, clinical milestones, and the launch of the global Phase 3 BATTMAN trial. A third session will follow in November, continuing the dialogue on BOT/BAL’s progress and corporate milestones.

(Press release, Agenus, OCT 16, 2025, View Source [SID1234656709])

On October 15, 2025 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, reported that it has determined the recommended Phase 2 dose (RP2D) of 1,100 mg once daily for ATRN-119, its oral ATR inhibitor in the monotherapy arm of the ongoing ABOYA-119 Phase 1/2a dose-escalation study, in patients with advanced solid tumors.

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ATR program

Building on the completion of dose escalation and supported by new preclinical data suggesting potential synergistic anti-tumor effects, Aprea is considering further ATRN-119 development in combination approaches that could expand its therapeutic potential. The Company believes ATRN-119’s mechanism of action, favorable safety profile, and pharmacologic characteristics make it an ideal candidate for combination with DNA-damaging agents, including radiation therapy, antibody-drug conjugates and immune checkpoint inhibitors.

As part of this strategic focus, Aprea is pausing further enrollment in both once daily and twice daily monotherapy dosing arms of ABOYA-119. Importantly, patients currently being dosed with ATRN-119 as part of this ongoing clinical trial will continue to have access to therapy without interruption.

The Company is currently in discussions with leading academic centers to explore combining ATRN-119 with radiation in patients with HPV+ head and neck cancer, an indication where synergistic anti-tumor effects have been observed in preclinical data. Additional investigator-led studies evaluating ATRN-119 in combination with an I/O agent and antibody-drug conjugates, are also being explored, based on preclinical evidence that ATR inhibition may enhance anti-tumor immune responses.

Phase 1 monotherapy data in the ABOYA-119 dose-escalation study, ATRN-119 demonstrated:

Favorable tolerability profile with manageable adverse events at the RP2D of 1100 mg once daily
Durable disease stabilization in heavily pretreated patients across multiple tumor types
Dose-proportional pharmacokinetics supporting once-daily dosing
Preliminary signs of clinical activity in biomarker-selected populations
"We are very pleased to have identified the recommended monotherapy Phase 2 dose for ATRN-119, which is an important step in our transition to the next stage of development," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "Based on the growing body of evidence supporting ATR inhibition as a potent sensitizer to DNA-damaging therapies and immunotherapy, we are now considering ATRN-119 in combination approaches that we believe could expand its clinical impact. We believe this candidate’s mechanism, safety profile, and pharmacologic characteristics make it a compelling candidate for pairing with other anti-cancer therapies, including radiation or checkpoint inhibitors, where synergistic anti-tumor effects have been demonstrated preclinically."

A poster titled Updated data from ABOYA-119: A phase 1/2a trial of ATRN-119, a novel macrocyclic ATR inhibitor, in patients with advanced solid tumors harboring DNA damage will be presented at the forthcoming 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) on Friday, October 24, 2025.

WEE1 Program

Aprea continues to advance its lead program, WEE1 kinase inhibitor APR-1051 at full speed. The ongoing Phase 1, first-in-human study (NCT06260514) is actively enrolling patients at three leading clinical sites in the United States. To date, patients with advanced solid tumors harboring specific cancer-associated gene alterations have been treated with APR-1051 at doses up to 150 mg once daily. Early signals of clinical benefit, including disease stabilization in multiple patients, have been observed, supporting continued dose escalation and further clinical evaluation of APR-1051. The Company expects to report clinical data from this study later this month 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) and is planning to further explore safety, pharmacokinetics, and signals of antitumor activity.

(Press release, Aprea, OCT 15, 2025, View Source [SID1234656672])

On October 15, 2025 OncoNano Medicine, Inc. ("OncoNano") reported a late-breaking research poster presentation at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics, to take place in Boston, Massachusetts, October 22 – 26, 2025. Details on the posters are below.

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Presentation Details

Title:

Results from part-1 of ON-5001: a multi-center, dose escalation and dose finding Phase 1 trial of ONM-501, a dual-acting STING agonist, alone or in combination with cemiplimab in patients with solid tumors and lymphoma

Session:
Poster Session A

Date & Time:
Thursday, October 23, 12:30-4 pm

About ONM-501

ONM-501 is a dual-activating agonist of the stimulator of interferon gene ("STING") pathway composed of cGAMP (the endogenous activator of STING) linked to a proprietary pH-activated polymer (the OMNI polymer). ONM-501 is presently being studied in a Phase 1 clinical trial (ON-5001). In preclinical models, the dual activation of STING by ONM-501has been shown to lead to direct anti-tumor effect, as well as leading to an anti-tumor immune response over an extended period of time. Development of ONM-501 was funded in part by the Cancer Prevention and Research Institute of Texas.

(Press release, OncoNano Medicine, OCT 15, 2025, View Source [SID1234656688])

On October 15, 2025 PeptiDream Inc., a public Kanagawa, Japan-based biopharmaceutical company (President: Patrick C. Reid, hereinafter "PeptiDream")(Tokyo: 4587), PDRadiopharma Inc. (President: Masato Murakami, Headquarters: Chuo-ku, Tokyo, Japan, "PDRadiopharma"), a wholly owned subsidiary of PeptiDream, and Curium Group, a world leader in nuclear medicine (CEO: Renaud Dehareng, Headquarters: Boston, Massachusetts, the United States), reported that a registrational Phase 2 clinical trial (jRCT: 2031250225) has been initiated in Japan for 64Cu-PSMA-I&T, a PET radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) expressed on prostate cancer cells.

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64Cu-PSMA-I&T is being assessed as a diagnostic PET imaging agent labeled with the radioisotope Copper-64, being developed with its therapeutic pair, 177Lu-PSMA-I&T. The development is conducted under the strategic collaboration between PDRadiopharma and Curium aiming at advancing innovative radiopharmaceuticals for prostate cancer in Japan.

The open-label, single-arm Phase 2 study will evaluate the sensitivity, specificity, and safety of 64Cu-PSMA-I&T. The trial will enroll approximately 70 patients who have been newly diagnosed with unfavorable intermediate, high or very high-risk prostate cancer and are scheduled for prostatectomy with pelvic lymph node dissection. This study is being conducted as a registrational trial in Japan and will utilize bridging data from Curium’s ongoing global clinical trials.

In parallel, a clinical trial for 177Lu-PSMA-I&T as a therapeutic agent is being planned to evaluate its efficacy and safety in patients with metastatic castration-resistant prostate cancer (mCRPC).

Patrick C. Reid, President & CEO of PeptiDream commented: "Targeted radiopharmaceuticals are rapidly revolutionizing how we both diagnose and treat cancer. At PeptiDream and PDRadiopharma we are focused on expanding our pipeline of these targeted therapies, and we are thrilled to be able to accelerate those efforts by partnering with Curium to bring their prostate cancer targeting radiopharmaceuticals to patients in Japan."

Masato Murakami, President of PDRadiopharma & CMO of PeptiDream commented: "We are excited to initiate the development of 64Cu-PSMA-I&T in Japan. Both 64Cu-PSMA-I&T and 177Lu-PSMA-I&T are considered potential products for diagnosing and treating PSMA-expressing prostate cancer. There is demand in Japan for PSMA PET diagnosis, as many urologists wish to use this imaging modality in clinical practice. In collaboration with Curium, we aim to address this need and utilize radiopharmaceuticals to provide new medical treatments for patients."

Renaud Dehareng, CEO of Curium Group commented: "Conducting these registrational trials, in partnership with PeptiDream and PDRadiopharma, marks a significant milestone in our mission to expand access to cutting-edge radiopharmaceuticals to patients with prostate cancer across Asia. By combining Curium’s global development expertise with PDRadiopharma’s deep local knowledge and infrastructure, we are well-positioned to deliver transformative solutions to prostate cancer patients in Japan."

Global Clinical Trial Progress

For 177Lu-PSMA-I&T, a PSMA-targeting ligand conjugated with the radioisotope Lutetium-177, has been tested by Curium in a global Phase 3 ECLIPSE trial (ClinicalTrials.gov identifier; NCT05204927). It reported that the primary endpoint was met, demonstrating a statistically significant and clinically meaningful benefit for patients with mCRPC.
For 64Cu-PSMA-I&T, trials are being conducted to diagnose biochemical recurrence of prostate cancer (SOLAR RECUR trial, ClinicalTrials.gov identifier NCT06235099) and for men newly diagnosed with unfavorable intermediate to very high-risk prostate cancer, electing to undergo surgery (SOLAR STAGE trial, ClinicalTrials.gov identifier; NCT06235151). The first in human Phase 1/2 SOLAR trial met the co-primary endpoints of region-level correct localization rate and patient-level correct detection rate in patients with histologically-proven metastatic prostate cancer.

(Press release, PeptiDream, OCT 15, 2025, View Source [SID1234656689])

On October 15, 2025 OSE Immunotherapeutics reported its consolidated financial results for the first half of 2025.

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(Press release, OSE Immunotherapeutics, OCT 15, 2025, View Source [SID1234661838])