Clinical Trials
34
7 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
7
20.6%
Completed
10
29.4%
Recruiting
10
29.4%
Terminated
7
20.6%
No approval data available
- Updated results from the randomized phase 1 TG4050.02 trial show none of 16 evaluable patients who received immediate adjuvant TG4050 relapsed at a median follow-up of 41 months. - Three of 16 patients in the watchful-waiting control arm experienced recurrence at 6, 7 and 18 months, with no additional relapses in either arm on updated analysis. - No dose-limiting toxicities or grade 3 or higher treatment-related adverse events occurred among 19 patients who received at least one TG4050 injection. - Neoantigen-specific T-cell responses were detected in 73.3% of evaluated vaccinated patients, with responses persisting up to 24 months after the last dose.
- Transgene has broadened its existing collaboration with ProBioGen through an additional license agreement for the AGE1.CR.pIX suspension cell line to enhance its manufacturing capabilities. - The AGE1.CR.pIX platform is a stable avian cell line derived from duck embryo primary cells, developed as an alternative to chicken eggs for large-scale vaccine production. - The cell line grows in chemically defined, animal-component-free medium and is qualified as a GMP master cell bank, supporting reproducible and scalable manufacturing. - The expanded license reflects Transgene's confidence in the technology to prepare for future clinical needs at scale for its individualized cancer vaccine programs.
- The global oncolytic virus therapy market is projected to grow from USD 21.54 million in 2025 to USD 223.5 million by 2035, at a CAGR of 26.36% during 2026–2035. - Oncolytic viruses selectively infect and destroy cancer cells while stimulating systemic anti-tumor immune responses, transforming "cold" tumors into "hot" ones. - A robust clinical pipeline, including cretostimogene grenadenorepvec, CAN-2409, RP1, and Olvi-Vec, is advancing across melanoma, bladder, lung, and other solid tumors. - Recent regulatory milestones, including FDA accelerated approval of TUDRIQEV (RP1) for advanced melanoma, underscore growing momentum in the field.
- Transgene's individualized neoantigen vaccine TG4050 demonstrated 100% two-year disease-free survival when used as adjuvant monotherapy in patients with high-risk, resected HPV-negative head and neck squamous cell carcinoma. - The Phase I trial showed TG4050 induced neoantigen-specific T cell responses in 73% of evaluable patients, with durable cytotoxic and effector responses lasting up to one year after treatment completion. - The comprehensive clinical and translational data from the randomized Phase I/II trial have been published as a preprint on medRxiv, supporting TG4050's potential to prevent cancer relapse through personalized immunotherapy. - TG4050 was well-tolerated with no unexpected safety signals, and the vaccine encodes up to 30 predicted tumor neoantigens delivered via Modified Ankara Virus vector technology.
- Transgene successfully raised €105 million through private placement and public offering to accelerate development of its myvac® individualized therapeutic cancer vaccine platform. - The funding will primarily support ongoing Phase 2 trials in head and neck cancer, with efficacy data expected by Q4 2027/Q1 2028, and launch of Phase 1 trials in new indications. - Key investors include Institut Mérieux's TSGH and the Dassault Group, demonstrating strong institutional confidence in the company's precision medicine approach to cancer immunotherapy. - The capital extends Transgene's financial runway until early 2028 and positions the company to prepare for potential pivotal studies in head and neck cancer.
- Transgene and BioInvent will present updated Phase I data on BT-001, an armed oncolytic virus expressing anti-CTLA-4 antibody, at the ESMO Annual Meeting in Berlin from October 17-21, 2025. - BT-001 demonstrated clinical responses in two out of six refractory patients when combined with pembrolizumab, showing shrinkage of both injected and non-injected lesions. - The treatment successfully converted "cold" tumors into "hot" ones by inducing T-cell infiltration and PD(L)-1 expression in the tumor microenvironment. - The ongoing Phase I/IIa study (NCT04725331) evaluates BT-001 as monotherapy and in combination with pembrolizumab, with the last Phase I patient enrolled in August 2024.
- Personalized cancer vaccines are emerging as a transformative approach in oncology, with BioNTech, Moderna, and myNEO Therapeutics leading development using mRNA technology refined during the COVID-19 pandemic. - The KEYNOTE-942 study demonstrated significant clinical benefit when combining Moderna's mRNA-4157 with Keytruda in melanoma patients, achieving a 74.8% recurrence-free survival rate at 2.5 years versus 55.6% for Keytruda alone. - Despite promising results, manufacturing challenges persist with production costs exceeding $100,000 per patient, though advancements in automation and AI-driven technologies are expected to reduce costs and increase accessibility.
- Transgene's TG4050 demonstrated a strong clinical proof of principle in adjuvant head and neck cancer, with all 16 patients remaining disease-free after 24.1 months. - The TG4050 vaccine induced specific immune responses against personalized antigen targets, showing strong immunogenicity and sustained immune responses over seven months. - BT-001, Transgene's oncolytic virus, induced tumor regression in patients unresponsive to prior anti-PD(L)-1 treatment, both as a monotherapy and in combination with pembrolizumab. - Transgene confirms financial visibility into Q4 2025, enabling continued progress and news flow on its immunotherapy portfolio.
- TG4050, an individualized immunotherapy, demonstrates 100% disease-free survival at 24.1 months in head and neck cancer patients after standard adjuvant therapy. - The neoantigen cancer vaccine induced immune responses targeting selected neoantigens in all treated patients, showing strong and sustained immunogenicity. - The ongoing Phase I/II trial is expanding internationally, with Phase II currently enrolling patients to further confirm these promising findings. - TG4050 combines Transgene's myvac platform with NEC's AI to personalize cancer treatment by stimulating the immune system against tumor-specific mutations.
- TG4050, an individualized immunotherapy, demonstrates a 100% disease-free rate in head and neck cancer patients after a median follow-up of 24.1 months. - The Phase I trial data highlights the vaccine's strong immunogenicity, with immune responses targeting selected neoantigens observed in all patients. - The ongoing trial has been expanded to a Phase I/II study to further evaluate TG4050's efficacy in preventing relapse in this high-risk patient population. - TG4050 leverages Transgene's myvac® platform and NEC's AI to optimize antigen selection, offering a personalized approach to cancer treatment.
