On November 4, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported a business update on its lead asset TG4050 developed from its myvac platform, upcoming plans, and its financial position as of September 30, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

TG4050 – INTV: New Data presented at SITC (Free SITC Whitepaper) supports TG4050’s potential role in preventing cancer relapse

Transgene and its partner NEC1 will jointly present a poster on additional immunological data profiling the neoantigen-specific T-cell response after treatment with TG4050 in head and neck cancer at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.

Comprehensive immunogenicity data confirm the ability of TG4050 monotherapy to induce neoantigen-specific cytotoxic CD8+ T-cell responses capable of targeting and eliminating tumor cells – see press release. These CD8+ T cells target multiple neoantigens encoded in the vaccine, have tissue resident cytosignature, and are still detectable up to two years after the start of TG4050 treatment. Overall, these data support the TG4050 mechanism of action that resulted in the reduction of risk of relapse observed in the randomized Phase I study.

These data have been generated from the randomized Phase I part of the ongoing Phase I/II trial evaluating TG4050 as a single agent in the adjuvant treatment of HPV-negative HNSCC, in patients that are in complete response following surgery and adjuvant (chemo-)radiotherapy.

These results follow the positive randomized Phase I data presented in a rapid oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO Annual Meeting – see press release).

The SITC (Free SITC Whitepaper) abstract is available both on the SITC (Free SITC Whitepaper) and Transgene websites. The poster presentation will take place on November 8 at the Conference and will be available on Transgene’s website following the presentation.

Transgene will host a webcast (in English) to discuss the SITC (Free SITC Whitepaper) data on November 14, 2025, from 10:00 a.m. to 11:00 a.m. ET (16:00 to 17:00 CET). The webcast and the replay will be available here and on Transgene‘s website.

Transgene expects to complete the randomization of patients with operable HNSCC in the Phase II part of the trial by early 2026. First immunogenicity data from this Phase II part are expected to be available in H2 2026. The first efficacy data (2-year disease-free survival, DFS) will become available as soon as all patients are evaluable for two-year DFS with either an event (relapse or death) or 2-year follow-up whichever occurs first.

Transgene is currently evaluating the most efficient regulatory pathway to accelerate the development of its lead asset, TG4050, with the goal of bringing it to patients with operable HNSCC as quickly as possible.

myvac platform: Potential to reduce the risk of relapse across multiple operable solid tumors

Transgene’s INTV platform, myvac, could be applied across a range of solid tumors where in many cases a significant unmet medical need remains. In parallel, Transgene is initiating start-up activities for a potential new Phase I trial in a second indication in an early treatment setting, with the aim of initiating once all conditions are met.

BT-001 (oncolytic virus – intratumoral administration): Updated Phase I/II data presented at ESMO (Free ESMO Whitepaper) 2025 demonstrated positive antitumoral activity

Transgene and BioInvent presented a poster on updated clinical results showing the positive antitumoral activity of BT-001 in patients with advanced refractory tumors at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting – see press release.

These updated data from the Phase I trial (NCT04725331) evaluating BT-001 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab)2 showed positive local, abscopal and sustained antitumoral activity in injected and non-injected lesions. Immune-mediated tumor shrinkage is consistent with the mechanistic hypothesis that BT-001, in combination with pembrolizumab, turns "cold" tumors into immunologically active ones.

The poster is available on Transgene’s website.

Transgene and BioInvent are exploring clinical development opportunities for intratumoral administration of BT-001 in collaboration with clinicians.

Key financial elements

In millions of euros Q3
2025 2024
Research Tax Credit 5.8 4.8
Revenue from collaborative and licensing agreements 0.1 -
Other income 0.3 0.2
Operating income 6.13 5.0

During the third quarter of 2025, the Research Tax Credit increased to €5.8 million compared to €4.8 million for the same period in 2024, reflecting the progress of the ongoing Phase II part of the clinical trial evaluating TG4050 in head and neck cancer, with sustained patient enrollment and related expenses, including the manufacturing of individualized batches.

As of September 30, 2025, Transgene had €12.8 million in cash, compared to €16.7 million as of December 31, 2024.

Over the first nine months of 2025, Transgene’s net cash burn4 was €28.8 million (including the prefinancing of the 2024 Research Tax Credit for €5.2 million in June 2025) compared to €31.3 million for the same period in 2024.

Business funded until the end of December 2026

In March 2025, the Company signed a new amendment to the current account advance agreement with its major shareholder TSGH (Institut Mérieux), which increased the total amount of the facility by €15 million to €48 million. As of September 30, 2025, the Company has drawn down €35.5 million from this facility.

With this credit facility and the support of TSGH (Institut Mérieux), Transgene is able to fund its business until the end of December 2026, enabling the Company to deliver significant news flow on its myvac platform over the next 12 months.

(Press release, Transgene, NOV 4, 2025, View Source [SID1234659389])

On November 4, 2025 Dispatch Bio, a biotechnology company developing a universal treatment for solid tumors, reported preclinical data supporting its first therapeutic program planned to enter the clinic, DISP-10, and its first-in-class Flare platform, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 Annual Meeting.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Immunotherapies have had limited success in solid tumors due to the lack of tumor-specific targets and a profoundly immunosuppressive microenvironment. Dispatch’s Flare platform addresses these barriers by systemically delivering a tumor-specific virus that paints a universal synthetic antigen (Flare) on tumor cells, enabling precise recognition by T cells, while reshaping the tumor microenvironment to support immune activity. Data presented at SITC (Free SITC Whitepaper) (Abstract 394) demonstrate strong and consistent tumor labeling, iterative viral amplification and tumor cell clearance across multiple epithelial tumor models.

"These data show that delivering engineered targets specifically to tumor cells allows us to control antigen specificity, while also reprogramming the tumor microenvironment," said Lex Johnson, Ph.D., Co-Founder and Chief Platform Officer. "We are excited to start with CAR T as our first program, and because the Flare approach is modular and not restricted to CAR T cells, it can be extended across multiple immunotherapy modalities."

The company also presented preclinical findings from DISP-10, its first therapeutic candidate (Abstract 393). DISP-10 pairs DV-10, a tumor-targeted virus expressing a modified BCMA antigen (dBCMA) and the immune-stimulatory cytokine IL-18 and chemokine CXCL9, with a clinically validated BCMA-directed CAR T. The viral component installs the target and drives local immune activation, enabling robust CAR T function in solid tumors. DISP-10 demonstrated potent anti-tumor responses in numerous in vitro and in vivo models, with no activity observed in healthy cells. Dispatch plans to initiate a first-in-human Phase 1 study in 2026 to evaluate DISP-10 across multiple solid tumor types.

"DISP-10 creates the right biological context for CAR T cells to function in solid tumors," said Barbra Sasu, Ph.D., Chief Scientific Officer. "The consistency of activity seen with various BCMA-targeted therapies across tumor models gives us confidence in its clinical potential."

(Press release, Dispatch Bio, NOV 4, 2025, View Source [SID1234659405])

On November 4, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that data from the completed Phase 2 cisplatin-resistant advanced recurrent ovarian cancer clinical study utilizing Ampligen (rintatolimod) was accepted in a late-breaking abstract at the 40th Annual SITC (Free SITC Whitepaper) Meeting being held November 5-9, 2025 at National Harbor, MD.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details of the poster presentation are as follows:

Title: A Phase II Trial of Combination Locoregional Chemoimmunotherapy in Recurrent Platinum-Sensitive Ovarian Cancer Triggers a T Lymphotactic Response Correlating with Clinical Outcomes
Presenting Author: Mackenzy M. Radolec, MD, Clinical Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences, UPMC Magee-Women’s Hospital
Abstract Number: 1343
Date: Friday, November 7, 2025
Location: Prince George ABC Exhibit Halls, Gaylord National Resort and Convention Center

For more information about the SITC (Free SITC Whitepaper) Annual Meeting, please visit sitcancer.org.

(Press release, AIM ImmunoTech, NOV 4, 2025, View Source [SID1234659340])

On November 4, 2025 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that the European Patent Office (EPO) has communicated its intent to grant Genprex a patent for the use of Reqorsa Gene Therapy (quaratusugene ozeplasmid) in combination with PD-1 antibodies for the treatment of cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased to continue bolstering our patent estate, which includes multiple patents for the use of REQORSA in combination with both PD-1 and PD-L1 antibodies across many markets," said Thomas Gallagher, Senior Vice President of Intellectual Property and Licensing at Genprex. "This European patent will further strengthen our intellectual property portfolio and the patent protection around REQORSA in order to safeguard our gene therapy with target-specific combination therapy."

This patent will expand on the previously granted patents for REQORSA in combination with PD-1 antibodies, which have been granted in the U.S., Japan, Mexico, Russia, Australia, Chile, China, and Singapore.

REQORSA is initially being developed in combination with prominent, approved cancer drugs to treat lung cancer. In preclinical studies, REQORSA has been shown to be complementary with targeted drugs and immunotherapies. The Company believes REQORSA’s unique attributes position it to provide potential treatments that improve on these current therapies for patients with lung cancer and possibly other cancers.

According to Eurostat, in 2021, nearly a quarter of a million people died from lung cancer in the EU, accounting for almost a fifth of all cancer deaths and accounting for 4.3% of the total number of deaths. According to the European Commission, it is estimated that in the EU-27 countries in 2020, lung cancer accounted for 11.9% of all new cancer diagnoses (excluding non-melanoma skin cancers) and 20.4% of all deaths due to cancer. In addition, lung cancer was the fourth most frequently occurring cancer (after prostate, breast, and colorectal cancers) and the leading cause of cancer death.

According to data from GLOBOCAN 2022, lung cancer stood as the most frequently diagnosed cancer and the primary cause of cancer-related deaths on a global scale with approximately 2.48 million new cases and 1.8 million deaths, respectively. If the incidence and mortality rates remain stable as in 2022, the burden of lung cancer is projected to increase to 4.62 million new cases and 3.55 million deaths by 2050.

(Press release, Genprex, NOV 4, 2025, View Source [SID1234659356])

On November 4, 2025 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that Mark A. Goldsmith, M.D., Ph.D., the company’s chief executive officer and chairman, will participate in two upcoming investor conferences.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details of the company’s participation are as follows:

Guggenheim 2nd Annual Healthcare Innovation Conference
Fireside Chat: Tuesday, November 11 at 9:00 a.m. ET
Jefferies Global Healthcare Conference
Fireside Chat: Tuesday, November 18 at 9:30 a.m. GMT
To listen to a live webcast of any of these events, or access archived webcasts, please visit: View Source Following the live webcasts, replays will be available on the company’s website for at least 14 days.

(Press release, Revolution Medicines, NOV 4, 2025, View Source [SID1234659372])