2024 Half-Year Results and Business Update
Lead program TG4050 (individualized immunotherapy):
– First signs of clinical benefit in adjuvant head and neck cancer reported at AACR 2024, paved the way for the start of Phase II part of randomized Phase I/II clinical trial in Q2 2024
– Median 24-month follow-up data to be presented in Q4 2024
BT-001 (oncolytic virus): Data presented at ESMO (Sept. 2024) showed promising antitumor activity in solid tumors that failed previous anti-PD(L)-1 treatment
TG4001 (HPV therapeutic cancer vaccine): Randomized Phase II study expected to read out in Q4 2024
Financial visibility confirmed until Q4 2025
Conference call scheduled today at 6 p.m. CET (in English). See details below.
Strasbourg, France, September 24, 2024, 5:45 p.m. CET – Transgene (PARIS:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today publishes its financial results for the six-month period ended June 30, 2024, and provides an update on its product pipeline and upcoming plans.
"Transgene is at the forefront of innovation in cancer immunotherapy and 2024 marks a crucial turning point for the company, as we advance the development of our cutting-edge treatments. Recently, we initiated a global Phase II clinical trial in adjuvant head and neck cancer for our lead asset TG4050, our individualized therapeutic vaccine, leveraging the promising Phase I clinical data. We anticipate the upcoming median 24-month follow-up data from the Phase I patients to be presented before the end of 2024. Additionally, we are encouraged by the antitumor activity shown in the ongoing Phase I study of BT-001 which we presented at ESMO this month. We also eagerly anticipate the upcoming results for TG4001 by the end of the year, which could confirm its potential in the treatment of HPV-associated cancers and further solidify our strategy." commented Dr. Alessandro Riva, MD, Chairman and CEO of Transgene.
Key events and upcoming milestones
Neoantigen therapeutic cancer vaccine: TG4050
In H1 2024, promising randomized Phase I data on TG4050 were presented at AACR 2024 (see poster here). These data provide a robust clinical proof of principle for Transgene's lead candidate in the adjuvant head and neck cancer setting. All patients who received TG4050 remained in clinical remission and disease-free after a median follow-up of 18.6 months, comparing favorably to the observational arm which had 3 out of 16 patients relapse during the same period.
Specific cellular immune responses of CD8+ and CD4+ were detected in 16 out of 17 patients who received TG4050 (16 patients in the treatment arm and one patient from the observation arm treated after relapse) using stringent testing criteria. Immunogenicity (the capacity of treatment to induce immune responses) is key to preventing relapses.
TG4050 also induced persistent immune responses against multiple targets in several patients. In these patients, T cell responses were maintained beyond 211 days (7 months) after the initiation of the treatment. The duration of the immune response is also a key factor to fight disease over time.
Following these promising data, the randomized Phase I trial has been expanded to a randomized Phase I/II trial in the adjuvant setting of head and neck cancer. The Phase II part started enrolling patients in Q2 2024 within the framework of an extended collaboration between Transgene and NEC. Patient enrollment is progressing at a good pace.
Additional data on the 24-month median follow-up of Phase I patients will be reported in Q4 2024.
Although some advancements in the treatment of squamous cell carcinoma of the head and neck have been made, there remains a significant medical need for these patients, including in the adjuvant setting. With the current standard of care, 30% to 40% of patients are expected to relapse within 24 months following surgery and adjuvant therapy. Despite completed Phase III trials, immune checkpoint inhibitors have yet to demonstrate significant benefits for these patients.
TG4050 is the only individualized neoantigen cancer vaccine currently being developed in a randomized trial in the adjuvant treatment of head and neck cancer.
TG4050 has potential applicability across a range of solid tumors where there remains a significant unmet medical need, despite existing therapeutic options, including immunotherapies. As a result, Transgene is conducting preliminary work on a potential new Phase I trial in another undisclosed indication.
Shared antigen cancer vaccine: TG4001
In H1 2024, Transgene has completed the enrollment of 90 patients in the ongoing randomized Phase II trial evaluating TG4001 in HPV-positive anogenital cancers (NCT03260023) in combination with an immune checkpoint inhibitor. Transgene confirms that topline readouts are expected in Q4 2024.
The ongoing trial was launched based on promising results from the previous Phase I/II trial published in the September 2023 issue of the European Journal of Cancer (here). This study showed that TG4001 in combination with avelumab is safe and demonstrated antitumor activity in heavily pretreated HPV16-positive cancer patients.
Oncolytic Viruses
Transgene is developing Invir.IO® oncolytic viruses, that have the potential to address a broad range of solid tumors, via intravenous, locoregional and intratumoral administration.
BT-001 (intratumoral administration):Preliminary data presented at ESMO 2024 demonstrate promising antitumor activity in solid tumors that failed previous anti-PD(L)-1 treatment in ongoing Phase I/IIa trial.
BT-001 is a multifunctional oncolytic virus encoding for an anti-CTLA4 antibody and the cytokine GM-CSF. In September 2024, Transgene and its partner BioInvent presented data showing the first signs of clinical efficacy of BT-001 in the ongoing Phase I trial evaluating this oncolytic virus in monotherapy and in combination with an immune checkpoint inhibitor (see poster here).
These results were obtained in tumors that failed previous anti PD(L)-1 treatment. In monotherapy, BT-001 induced tumor shrinkage in 2 of 6 injected lesions. In combination with KEYTRUDA® (pembrolizumab), partial responses were observed in 2 of 6 patients who failed previous treatment and who also showed tumor shrinkage (partial response) in non-injected lesions. BT-001 was well tolerated both alone and in combination with pembrolizumab.
In addition, BT-001 treatment was able to turn "cold" tumors into "hot" tumors inducing T cell infiltration and a shift to PD(L)-1 positivity in the tumor microenvironment in certain patients. Preliminary translational data indicate that BT-001 replicates ...
