BioInvent makes a strong entrance at ESMO in Barcelona
BioInvent has released additional positive preliminary efficacy data from its ongoing phase IIa dose expansion study of BI-1808 as a monotherapy. Additionally, BioInvent and Transgene are set to present encouraging initial phase I/IIa data on BT-001 at ESMO 2024. BI-1910 will also be featured in a poster presentation at the same conference.
BioInvent has a clinical pipeline of five antibody candidates being tested in six different clinical programmes, both as monotherapy and in combination with current standard treatments for different types of cancer. The two lead drug candidates, BI-1206 and BI-1808, are being evaluated in phase I/IIa studies to treat non-Hodgkin’s lymphoma (NHL) and solid tumors.
Progress with BI-1808 as single agent
In May, BioInvent announced promising early signs of BI-1808 single-agent efficacy and a robust safety profile. The data, presented in a poster at the 2024 ASCO Annual Meeting ASCO 2024 in Chicago, showed one complete response (CR), one partial response (PR) and nine patients with stable disease (SD) out of 26 evaluable patients. Read more. BI-1808 is developed with support from the Leukemia & Lymphoma Society’s Therapy Acceleration Program.
Additional positive efficacy data
On September 9, BioInvent announced additional positive preliminary efficacy data from the ongoing phase IIa dose expansion study of BI-1808 as a single agent. In the Cutaneous T-cell Lymphoma (CTCL) cohort, three out of four evaluable patients who had progressed after standard therapy achieved a partial response (PR). The patients are still on treatment, reinforcing the data presented at ASCO in June.
In a press release, BioInvent’s CEO Martin Welschof said:
“We are thrilled by the observation of these partial responses in the CTCL cohort, which, together with the previously reported data, support the potential of BI-1808 to become a new class of immunomodulatory treatment option for patients with different kinds of cancers. We look forward to the emerging data from this trial from the CTCL cohorts as well as the ovarian cancer and additional cohorts.”
Presentations at ESMO
BioInvent has also announced promising initial phase I/IIa data with BT-001 which will be presented at the ESMO Annual Meeting in Barelona, 13-17 September. The clinical development of BT-001 is conducted in collaboration with Transgene, which is focused on developing BT-001 both as a single agent and in combination with MSD’s (Merck & Co) anti-PD-1 therapy KEYTRUDA (pembrolizumab).
The initial BT-001 monotherapy Phase I/II data showed stable disease and injected lesions shrinkage in advanced solid tumor patients. In the combination part of the study, the data showed promising efficacy data with partial responses in relapsed and refractory advanced melanoma and leiomyosarcoma patients. The safety profile for the compound is still favorable, with minimal adverse events and no dose-limiting toxicities.
Alessandro Riva, Chairman and CEO of Transgene, commented on the results:
“We are delighted to present these promising initial clinical results from part 1 of the ongoing Phase 1/2a trial of BT-001. BT-001 shows preliminary efficacy without dose-limiting toxicities both as monotherapy and in combination with pembrolizumab and by modulating the tumor microenvironment. We look forward to reporting further results as this study progresses.”
Stéphane Champiat, Medical Oncologist at Gustave Roussy and clinical investigator for the study, talked about the need for new treatments:
“Many cancer patients fail to respond to existing treatments, highlighting the significant need for new approaches. BT-001 is a very promising potential new immunotherapy shown to elicit a strong immune response that is further enhanced by the local expression of the immune checkpoint inhibitor and the cytokine. These promising data generated alone or in combination with pembrolizumab offer the chance to deliver better treatment outcomes with an improved safety profile for patients across multiple different cancer indications.”
In addition, an abstract for a trial-in-progress poster presentation on BI-1910, BioInvent’s second anti-TNFR2 program, has been published by the European Society for Medical Oncology. The poster will also be presented at the ESMO conference.
Continues to strengthen the upward trajectory
BI-1808 continues to be a cornerstone of the company’s portfolio, supported by the latest data. These findings indicate that the asset has potential for further development and represents a key driver for BioInvent in the future. Additionally, the latest BT-001 data further validates continued development in collaboration with Transgene.
BioInvent is also advancing its collaboration with AstraZeneca, announcing this week the enrollment of the first patient in the triple combination arm of a Phase IIa trial targeting non-Hodgkin’s lymphoma. In this study, Calquence is being added to the existing BI-1206 and rituximab regimen to explore the efficacy of the triplet combination.
BioInvent’s share continues to strengthen the solid momentum built up during the year. In one month, it has risen 10 per cent, and 124 per cent since the beginning of the year. Continuing to show relative strength vis-a-vis the rest of the market, despite an already solid gain, is a strong signal in itself.
