Transgene and BioInvent reported positive solid tumor results


Transgene, a biotech company designing and developing virus-based immunotherapies against cancer, and BioInvent International AB, a biotech company focused on the discovery and development of novel and first-class immune modulator antibodies for cancer immunotherapy, have announced positive phase Ia data on oncolytic viruses. BT-001 for the treatment of solid tumors.

Treatment with single agent BT-001 in 18 patients has now been completed with no reported safety issues. Patients had at least one accessible superficial lesion and were studied in three dose-increasing cohorts. BT-001 stabilized the injected lesion in a total of eleven patients: two of 106 pfu dose, five on 107 pfu and four hours 108 pfu. Objective antitumor activity, defined as a reduction in the size of the injected lesion by 50% or more, was observed in one patient in 106pfu cohort and one patient in 107 pfu group.

About the collaboration of Transgene and BioInvent

Transgene and BioInvent co-developed BT-001, an oncolytic virus developed using Transgene’s Invir.IO platform that encodes BioInvent’s anti-CTLA-4 antibody to elicit a robust and effective anti-tumor response. The drug is currently being evaluated in phase I/IIa clinical trials as a single agent and in combination with the PD-1 checkpoint inhibitor KEYTRUDA (pembrolizumab) against solid tumors.

The previously reported phase I data confirmed the mechanism of action of BT-001 as a single agent and showed the first signs of anti-tumor activity.

First patient enrolled

Based on these results, the independent Safety Review Committee (SRC) has now approved the start of the combination portion of the pembrolizumab trial. The first patients in phase I part B are expected to be enrolled in H2 2023.

“These data are a further positive indication of the efficacy of BT-001 against solid tumors. While this first advanced disease setting in a human trial does not allow long-term patient monitoring, the effect on injected lesions has the potential to translate into induction of systemic immune response, antitumor effects and ultimately clinical benefit in combination with pembrolizumab. No safety concerns and antitumor activity was observed even at the lowest doses. We look forward to further investigating BT-001 in combination with pembrolizumab,” said Martin Welschof, CEO of BioInvent and Alessandro Riva, chairman of Transgene.

In December, Transgene received clinical trial application (CTA) approval from the French National Agency for the Safety of Drugs and Health Products (ANSM) to proceed with phase I clinical trials of TG6050. TG6050 is a novel oncolytic virus (OV) that will be administered intravenously to patients with advanced non-small cell lung cancer.


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