Using its antibody library n-CoDeR and screening platform FIRST, has BioInvent has developed five antibody candidates that are currently being evaluated in six different clinical programs. The candidates are being tested both as monotherapy and in combination with current standard treatments for various types of cancer.
The two leading drug candidates, BI-1808, an anti-TNFR2 antibody, and BI-1206, is being evaluated in Phase I/IIa studies. BI-1206 is being investigated in non-Hodgkin lymphoma (NHL) and solid tumors.
The portfolio also includes three early clinical programs; BI-1607, BI-1910 and BT-001, as potential treatments for several cancer types.
Promising data with BT-001
BT-001 is being developed as a monotherapy and in combination with MSD's (Merck & Co) anti-PD-1 treatment KEYTRUDA (pembrolizumab). Last week, BioInvent announced new promising initial Phase I/IIa data with BT 001 would be presented at the ESMO annual meeting in Barcelona, 13–17 September, together with the collaboration partner Transgene. . Read more here.
CMO comments
Initial Phase I/II data for BT-001 as monotherapy demonstrated stable disease and a reduction in injected lesions in patients with advanced solid tumors. The combination arm of the study showed promising efficacy data with partial responses in patients with relapsed and refractory advanced melanoma and leiomyosarcoma.
BioStock contacted BioInvent's CMO Andres McAllister, on site in Barcelona, to discuss the data presentation at ESMO.
Andres, BioInvent and Transgene presented promising phase I/IIa data on BT-001 at ESMO this weekend. Could you summarize the key findings you have made so far?
– BT-001 induced tumor regression in patients unresponsive to previous treatments with anti PD(L)-1, both as a monotherapy and in combination with MSD's KEYTRUDA (pembrolizumab).
– Preliminary data suggest that BT-001 replicates in the tumor, the payloads are expressed, and, importantly, with undetectable systemic exposure, which is, of course, the purpose as it will get rid of the toxicity observed when anti-CTLA4 is administered IV. The treatment was well tolerated and showed first signs of efficacy with clinical responses in 2 of 6 patients when given in combination with pembrolizumab. BT-001 treatment turned “cold” tumors to “hot” inducing T cell infiltration, a higher M1/M2 macrophage ratio, and a shift to PD(L)-1 positivity in the tumor microenvironment.
The European Society for Medical Oncology published an abstract for a BI-1910 trial-in-progress poster. What are the next steps for this program?
- Unfortunately, we could not disclose data given the restrictions imposed by the type of poster session. The study has progressed incredibly quickly given the adequate behavior of the drug, and we plan to present data from the phase I part before year-end and hope to be in phase II soon.
The phase IIa study of BI-1808 as a monotherapy has yielded preliminary positive efficacy data. How might this impact the future development?
- The results we are observing are important since single agent activity is rarely observed in this area of cancer immunotherapy. If this trajectory is confirmed, we have in our hands a very safe drug capable of treating a difficult to treat disease where few options exist, and those treatments approved come with a great deal of toxicity. Being a rare disease, it opens the way for facilitated regulatory pathways, that should accelerate the development and will significantly decrease the time to market.
The first patient has been enrolled in the triple combination study of BI-1206, rituximab, and Calquence for NHL. What are your expectations for this therapy?
– This approach will be very competitive given the ease of subcutaneous administration, the safe profile of the treatment and the potential to observe high response rates, similar to those observed with more complex agents where toxicity remains an issue for the treatment of indolent forms of disease.