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BioInvent International AB, a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, and Transgene, a biotech company that designs and develops virus-based immunotherapeutics against cancer, today announce positive Phase 1a data on the oncolytic virus BT-001 for the treatment of solid tumours.
Treatment with single agent BT-001 in 18 patients has now been completed with no safety concerns reported. Patients had at least one accessible superficial lesion and were studied in three dose-escalating cohorts. BT-001 stabilized the injected lesions in eleven patients in total: two at the 10^6 pfu dose (n=6), five at 10^7 pfu (n=6) and four at 10^8 pfu (n=6). Furthermore, objective antitumor activity, defined as decrease of injected lesion size of 50% or more, was observed in one patient in the 10^6 pfu cohort (n=6) and one patient in the 10^7 pfu cohort (n=6).
Transgene and BioInvent are co-developing BT-001, an oncolytic virus developed using Transgene’s Invir.IO platform encoding BioInvent’s anti-CTLA-4 antibody to elicit a strong and effective anti-tumoural response. The drug is currently being evaluated in a phase 1/2a clinical trial as a single agent and in combination with the PD-1 checkpoint inhibitor Keytruda (pembrolizumab) against solid tumours. Previously reported phase 1 data confirmed the mechanism of action of BT-001 as a single agent and demonstrated first signs of anti-tumour activity.
Based on these results, the independent Safety Review Committee has now approved initiation of the combination part of the trial with pembrolizumab. The first patient in this combination cohort is expected to be enrolled in H2 2023.
“These data are a further positive indication of the efficacy of BT-001 against solid tumours. While the advanced disease setting of this first in human trial did not allow long-term monitoring of patients, the effect on injected lesions has the potential to translate into the induction of a systemic immune response, antitumor effect and ultimately clinical benefit in combination with pembrolizumab. There were no safety concerns and antitumor activity was observed even at the lowest dose. We are looking forward to investigating BT-001 further in combination with pembrolizumab,” commented Martin Welschof, CEO of BioInvent and Dr. Alessandro Riva, chairman of Transgene.
The ongoing phase 1/2a (NCT04725331) study is a multicenter, open label, dose-escalation trial evaluating BT-001 as a single agent and in combination with pembrolizumab (anti-PD-1 treatment). Patient inclusions are ongoing in Europe (France, Belgium) and the trial has been authorized in the US.
This phase 1 is divided into two parts. In part A, patients with metastatic/advanced tumours receive single agent, intra-tumoural administrations of BT-001. Part B will explore the combination of intra-tumoural injections of BT-001 with pembrolizumab. In this part, Keytruda (pembrolizumab) will be provided to the trial by MSD (Merck & Co).
The phase 2a will evaluate the combination regimen in several patient cohorts with selected tumour types. These expansion cohorts will offer the possibility of exploring the activity of this approach to treat other malignancies not traditionally addressed with this type of treatment.
BT-001 is an oncolytic virus generated using Transgene’s Invir.IO platform and its patented large-capacity VVcopTK-RR- oncolytic virus, which has been engineered to encode both a Treg-depleting human recombinant anti-CTLA-4 antibody generated by BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms, and the human GM-CSF cytokine. By selectively targeting the tumour microenvironment, BT-001 is expected to elicit a much stronger and more effective antitumoural response. As a consequence, by reducing systemic exposure, the safety and tolerability profile of the anti-CTLA-4 antibody may be greatly improved.
BT-001 is being co-developed as part of a 50/50 collaboration on oncolytic viruses between Transgene and BioInvent.
BioInvent International AB is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently four drug candidates in five ongoing clinical programmes in phase 1/2 trials for the treatment of haematological cancer and solid tumours, respectively.
Transgene is a biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer.
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