On March 27, 2024 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported its financial results for 2023, and provides an update on its product pipeline and upcoming plans (Press release, Transgene, MAR 27, 2024, View Source [SID1234655850]).

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"During 2023 Transgene continued to make significant progress, delivering compelling data that confirm the value of our approach to treating cancer using our novel immunotherapies" commented Dr. Alessandro Riva, MD, Chairman and CEO of Transgene.

"At the upcoming AACR (Free AACR Whitepaper) conference in April 2024, we will be presenting additional data from the randomized Phase I study in adjuvant head and neck cancer for our lead therapeutic cancer vaccine, TG4050. Together with our partner NEC we are expanding the Phase I trial in a randomized Phase I/II to further strengthen the initial data in a larger patient population and set the foundation for a registrational development strategy."

"In the second half of 2024 we anticipate the first topline data from our fully enrolled randomized Phase II trial evaluating our shared antigens cancer vaccine TG4001 in HPV-positive anogenital cancers."

"Together with expected Phase I data from our oncolytic virus programs BT-001 and TG6050 this promises to be a key year for Transgene, with further important milestones in 2025 that we believe will enhance the value of our platform. Backed by our extended financial visibility and our strong management team we are confident in our ability to achieve our ambitious goals of delivering transformative therapies for cancer patients. I look forward to sharing updates on our continued progress."

Key events and upcoming milestones
Neoantigen therapeutic cancer vaccine (TG4050)
Additional data from the randomized Phase I trial in adjuvant head and neck cancer to be presented in H1 2024 The trial will be expanded in a randomized Phase I/II trial in the same indication. The Phase II part will start in Q2 2024.

In 2023, highly promising TG4050 data were presented at AACR (Free AACR Whitepaper) and ASCO (Free ASCO Whitepaper) 2023 (see poster here). These data show that this individualized neoantigen cancer vaccine can induce strong immune responses, which are expected to result in longer remission periods for patients.

The initial data from the randomized Phase I trial in the adjuvant treatment of head and neck cancer (NCT04183166) presented at ASCO (Free ASCO Whitepaper) showed that all evaluable patients treated with TG4050 developed a robust and specific immune response against multiple cancer neoantigens and remained disease-free. These data suggest that TG4050 can boost the immune system of patients despite a challenging tumor microenvironment at the time of tumor resection.

Transgene and its partner NEC plan to report updated data at AACR (Free AACR Whitepaper) (poster presentation on April-10, 2024) and the additional data on the 24-month median follow up of patients in H2 2024.

The randomized Phase I trial will be expanded to a randomized Phase I/II trial in the adjuvant setting of head and neck cancer. The Phase II part is expected to start enrolling patients in Q2 2024 within the framework of an extended collaboration between Transgene and NEC.

TG4050 has potential applicability across a range of solid tumors where the medical need is still significant despite the existing therapeutic option including immunotherapies. As a consequence, Transgene is performing preliminary work on a potential new Phase I trial in another undisclosed indication.

Shared antigens cancer vaccine (TG4001)
Transgene has completed the enrollment of 86 patients in the ongoing randomized Phase II trial evaluating TG4001 in HPV-positive anogenital cancers (NCT03260023). Transgene confirms that top line readouts are expected in H2 2024.

In 2023, immunological response data from TG4001 were presented in a poster at ASCO (Free ASCO Whitepaper), confirming that TG4001 can induce de novo immune responses against HPV16 antigens E6 and E7 in patients with advanced HPV16-positive anogenital cancers. Patients with a complete objective response showed strong vaccine-induced immunoreactivity.

Promising results from the previous Phase I/II trial evaluating TG4001 in combination with an immune checkpoint inhibitor were published in the September 2023 issue of the European Journal of Cancer (View Source). This study showed that TG4001 in combination with avelumab is safe and demonstrated antitumor activity in heavily pretreated HPV16-positive cancer patients. It also served as the basis for the ongoing randomized Phase II trial.

Oncolytic Viruses
In 2023, clinical data presented at AACR (Free AACR Whitepaper) confirmed the mechanism of action and the safety of our Invir.IO based oncolytic viruses, which offer a key competitive advantage with the ability to be administered intravenously. These findings support the potential of Invir.IO-based oncolytic viruses to have multiple treatment applications in a broad range of solid tumors, via intravenous, locoregional and intratumoral administration.

TG6050: Initial Phase I data expected in H2 2024, from this novel Invir.IO candidate administered intravenously
A first patient was dosed with TG6050, a novel oncolytic virus from Transgene’s Invir.IO platform, in 2023. This innovative candidate has been designed to express human IL-12, a cytokine known to trigger a potent antitumor immune response, and an anti-CTLA4 antibody. The Phase I Delivir trial (NCT05788926) is evaluating TG6050 in patients with advanced non-small cell lung cancer who have failed standard therapeutic options. Initial data from the trial is expected in H2 2024.

BT-001: Positive single agent data — Part B of the Phase I trial (combination with pembrolizumab) to deliver initial data in H2 2024
Transgene and its partner BioInvent have communicated positive data from Part A (monotherapy) of the ongoing Phase I trial in May 2023 (NCT04725331). Out of 18 patients who received escalating intratumoral doses of BT-001, two showed a decrease of injected lesion size of 50% or more, and eleven had a stabilization of the injected lesion. No safety concerns were reported.

Part B of the Phase I trial in combination with pembrolizumab (KEYTRUDA) started in October 2023. KEYTRUDA is provided by MSD (Merck & Co). Initial data from this part of the trial are expected in H2 2024.

As announced on May 5, 2023, AstraZeneca terminated its oncolytic virus research and development collaboration with Transgene following a strategic review of its pipeline.