First patient dosed in Transgene and BioInvent’s phase 1 trial
Transgene and BioInvent have announced that the first patient has been treated in the phase 1 part B clinical trial evaluating the combination of BT-001 and MSD’s anti-PD-1 therapy, Keytruda (pembrolizumab).
The phase 1 part B trial is intended to assess the repeated use of intra-tumoural injections of BT-001 in combination with intravenous infusions of Keytruda for the treatment of metastatic or advanced solid tumours, including melanoma. Endpoints of the trial include safety, efficacy and assessment of immune changes in tumour microenvironment.
The two companies are co-developing BT-001, an oncolytic virus designed with Trangene’s Invir.IO platform and using BioInvent’s differentiated anti-CTLA-4 antibody and human GM-CSF cytokine in order to trigger a strong and effective anti-tumoural response.
Dr Martin Welschof, CEO of BioInvent and Dr Alessandro Riva, chairman and CEO of Transgene, commented: “By combining BT-001 with pembrolizumab, we are building upon the promising data generated by BT-001 as a single agent. Targeting the PD1/PD-L1 pathway in addition to BT-001’s mechanism of action is expected to further stimulate and restore the patient’s immune system, which should result in improved antitumoral activity and patient outcome. We are thrilled to enter this new phase of the development of the novel oncolytic virus BT-001 and further demonstrate its potential in combination with a reference treatment.”
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