On October 6, 2025 Theriva Biologics (NYSE American: TOVX), ("Theriva" or the "Company"), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported an upcoming presentation at the 32nd Annual Congress of the European Society of Gene & Cell Therapy (ESGCT), to be held in Seville, Spain from 7-10 October 2025 (Press release, Theriva Biologics, OCT 6, 2025, View Source [SID1234656466]).

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Co-founder of VCN Biosciences S.L. (now Theriva Biologics S.L.) Dr. Ramón Alemany – Head of the Immunotherapy and Virotherapy Group at the ProCURE Program of the Catalan Institute of Oncology (ICO) and the Oncobell Program of the Biomedical Research Institute of Bellvitge (IDIBELL) in Barcelona – will present new mechanistic and preclinical data for VCN-12, a next generation oncolytic adenovirus selected from Theriva’s VCN-X discovery program. VCN-12 is derived from lead clinical product VCN-01 (zabilugene almadenorepvec) and is armed with additional transgenes designed to improve tumor cell lysis, enhance stroma degradation, and augment the antitumor immune response.

Title: "Cancer Virotherapy with Armed Oncolytic Adenoviruses"
Presentation #: INV16
Date and time: Wednesday 08 October 2025, 08:30 am CEST
Session: 3b Virotherapy and Cancer Gene Therapy
Location: Room Parallel B, Seville Exhibition and Conference Centre (Fibes), Seville, Spain
In addition to the scheduled presentation on VCN-12, a recently-published pre-ESGCT meeting monograph details the results of a preclinical study conducted by investigators at the University of Navarra evaluating the intracranial administration of VCN-01 for the potential treatment of brain tumors. The authors highlight the urgent need to develop new and improved therapies for brain cancers and conclude that their findings "provide a strong rationale for its [VCN-01] further development as a therapeutic option for patients with brain tumors" (Palacios-Alonso D et al. (2025) Toxicity and Biodistribution of the Oncolytic Virus VCN-01 Following Intracranial Injection in Syrian Hamsters.

On October 6, 2025 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875) (the "Company"), reported that Yuichi Iwaki, M.D., Ph.D., President and CEO, and David H. Crean, Ph.D., Chief Business Officer, will present a corporate overview at the LD Micro Main Event XIX Investor Conference (Press release, MediciNova, OCT 6, 2025, View Source [SID1234656468]). The conference is being held on October 19 – 22, 2025 at the Hotel Del Coronado in San Diego, CA.

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Presentation Date: Monday, October 20, 2025
Time: 1:30pm Pacific Time
Register to view presentation: Webcast Link

A live webcast of the presentation can be accessed on the investor relations section of the MediciNova website. A replay of the webcast will be archived and available following the event for 90 days.

Drs. Iwaki and Crean will be available for one-on-one meetings throughout the conference.

On October 6, 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 an amendment to its Phase 2 EVANGELINE study of (Z)-endoxifen in premenopausal women with newly diagnosed early-stage ER+/HER2- breast cancer (Press release, Atossa Therapeutics, OCT 6, 2025, View Source [SID1234656469]). The amended, non-registrational design is expected to accelerate objective readouts while reducing projected future study costs, consistent with Atossa’s focus on extending operating runway and deploying capital where it is most impactful. In 2026, Atossa is concentrating its resources on near-term, NDA-enabling activities for investigational (Z)-endoxifen.

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"This amendment is about efficiency, focus, and financial discipline," said Steven Quay, M.D., Ph.D., Atossa’s Chairman and Chief Executive Officer. "By streamlining EVANGELINE, we are rationalizing study spending and concentrating our strong balance sheet on the NDA-enabling package we plan to advance in 2026, without changing our safety oversight or commitment to rigorous data."

Capital Allocation Highlights

Prioritizing runway and catalysts: The amended design is expected to reduce future EVANGELINE study costs and further focus on NDA-enabling work under Atossa’s 2025-2026 operating plan
Faster, objective decision points: Cohort A patients with an initial Ki-67 of > 10% employ a pre-specified two-stage futility rule using short-interval, objective endpoints (e.g., Week-4 Ki-67 ≤10%) to enable earlier go/no-go decisions. Cohort B will be for patients with initial Ki-67 of < 10%
Safety unchanged: There is no change to patient-safety data collection or Data Safety Monitoring Committee (DSMC) oversight with this amendment
Operational focus: A single-arm, open-label structure concentrates efforts on one regimen and the data elements most relevant to a future NDA
EVANGELINE Design Snapshot (As Amended)

Study type: Single-arm, open-label, non-registrational Phase 2 in premenopausal women with ER+/HER2– breast cancer in the pre-surgical setting
Cohort A (signal-seeking): Two-stage futility design assessing the Week-4 Ki-67 ≤10% rate to allow early stop if not promising
Cohort B (estimation): Week-24 objective response (RECIST 1.1, central review)
Rationale: Focus on objective, short-interval endpoints to inform development decisions efficiently while preserving patient safeguards
Study size change: The original EVANGELINE study design included 214 patients. This amendment reduces the patient total to 40-65 patients
Clinical context

EVANGELINE run-in data previously presented at the 2024 San Antonio Breast Cancer Symposium showed a Week-4 Ki-67 ≤10% rate of 86% across evaluated (Z)-endoxifen dose levels with/without Ovarian Function Suppression (OFS). In 2021, Atossa reported an 86% response rate of Ki-67 < 10% for women on low dose (4 mg/day) endoxifen in the same pre-surgery neoadjuvant setting. Published comparators in similar settings report a 41% response rate with tamoxifen and a 78% response rate with an aromatase inhibitor and OFS (Nitz UA, et al., J Clin Oncol. 2022 Aug 10;40(23):2557-2567). However, no efficacy conclusions can be drawn from the ongoing study at this point. There is no change to patient safety data collection or Data Safety Monitoring Committee oversight by this amendment.

ABOUT EVANGELINE

EVANGELINE is a single-arm, open-label, non-registrational Phase 2 study evaluating investigational (Z)-endoxifen in premenopausal women with ER+/HER2– breast cancer in the pre-surgical setting. The trial uses short-interval, objective endpoints with a pre-specified two-stage futility rule to enable faster, data-driven decisions.

Participating U.S. centers include: Mayo Clinic Rochester; Mayo Clinic Arizona; Mayo Clinic Florida; Washington University School of Medicine; St. Elizabeth Healthcare; Bon Secours Cancer Institute; Vanderbilt-Ingram Cancer Center; Henry Ford Cancer Institute; Fred Hutch; Dana-Farber Cancer Institute; Baylor University; University of Arizona; Northwestern University; Avera Cancer Institute; and California Research Institute. For current site activation status and updates, see ClinicalTrials.gov (NCT05607004).

ABOUT (Z)-ENDOXIFEN

(Z)-endoxifen is an investigational, active metabolite of tamoxifen being developed by Atossa for hormone receptor–positive breast-cancer settings. Its safety and efficacy have not been established.

On October 6, 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 a trial in progress of the first in human clinical trial to assess the anti-IL18BP antibody, COM503 (GS-0321) in participants with advanced solid malignancies will be presented at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), taking place between November 7-9, 2025, in National Harbor, Maryland (Press release, Compugen, OCT 6, 2025, View Source [SID1234656470]).

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Poster presentation details:
Abstract Title: A First in human clinical trial to assess the anti-IL18BP antibody, COM503 (GS-0321) in Participants with Advanced Solid Malignancies
Abstract number: 589
Presenter: Dr. Manish Sharma, MD, Co-Director of Clinical Research, START Midwest, Grand Rapids
Date: Friday, November 7, 2025

On October 6, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported that two abstracts have been accepted for presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Anniversary Annual Meeting, to be held 7–9 November 2025 in National Harbor, MD, USA (Press release, Alligator Bioscience, OCT 6, 2025, View Source [SID1234656454]).

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The presentations will feature new data from Alligator’s pipeline programs mitazalimab and ATOR-4066:

Presentation details
Title: CD40 agonist mitazalimab + mFOLFIRINOX in patients with metastatic pancreatic ductal adenocarcinoma: dose characterization based on exposure response and biomarker analysis from the OPTIMIZE-1 study
Abstract number: 530
Time: Saturday, 8 November 2025
Presenter: Yago Pico de Coaña, Medical Science Director, Alligator Bioscience

Title: ATOR-4066, a bispecific antibody targeting CD40 and CEACAM5, induces potent anti-tumor activity that associates with activated intra-tumoral immune cells and disassembly of extracellular tumor matrix
Abstract number: 940
Time: Saturday, 8 November 2025
Presenter: Hampus Andersson, Industrial PhD student, Alligator Bioscience

"We are pleased that data for both mitazalimab and ATOR-4066 have been acknowledged through acceptance at SITC (Free SITC Whitepaper)’s 40th Anniversary Annual Meeting," said Søren Bregenholt, CEO of Alligator Bioscience. "This is an important recognition of the strength of our pipeline and our ambition to develop transformative immunotherapies for cancer patients."
The accepted abstracts will be published on 4 November 2025 at www.sitcancer.org/2025.