BioInvent has a clinical pipeline that includes five antibody candidates that are being tested in six different clinical programs, both as monotherapy and in combination with current standard treatments for various types of cancer. The two lead drug candidates, BI-1206 and BI-1808, is being evaluated in Phase I/IIa studies to treat non-Hodgkin's lymphoma (NHL) and solid tumors.
Progress with BI-1808 as monotherapy
In May, BioInvent announced promising early signs of efficacy with BI-1808 as monotherapy and a robust safety profile. These data were presented as a poster at ASCOs annual meeting 2024 in Chicago, with one complete response (CR), one partial response (PR) and nine patients with stable disease (SD) out of 26 evaluable patients. Read the seaBI-1808 is being developed with support from 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 monotherapy. Three of four evaluable patients achieved partial responses in the cutaneous T-cell lymphoma (CTCL) patient cohort who had previously progressed on standard therapy. The patients are still on treatment, reinforcing the data presented at ASCO in June.
BioInvent CEO Martin Welschof comments on the results in a press release:
“We are very pleased to see these partial responses in the CTCL group, which, together with previously reported data, strengthen the potential for BI-1808 to become a new class of immunomodulatory treatment options for patients with various types of cancer. CTCL is an important indication where there is a great need for new, safe and effective solutions for patients, and we are now evaluating the next possible steps to accelerate the development of BI-1808 in this disease. We look forward to receiving more new data from the study, both from the CTCL and ovarian cancer groups, and from other cohorts.”
Presentations at ESMO
BioInvent has also published promising initial Phase I/IIa data with BT 001 which will be presented at the ESMO Annual Meeting in Barcelona from 13 to 17 September. The clinical development of BT-001 is being carried out in collaboration with Transgene. and focuses on developing BT-001 both as monotherapy and in combination with MSD's (Merck & Co) anti-PD-1 treatment KEYTRUDA (pembrolizumab).
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. The safety profile of the compound remains favorable, with minimal adverse events and no dose-limiting toxicities.
Alessandro Riva, Chairman of the Board and CEO of Transgene. , commented on the result:
“We are very pleased to present these promising initial clinical results from Part 1 of the ongoing Phase 1/2a study with BT-001. BT-001 shows preliminary efficacy without dose-limiting toxicity, both as monotherapy and in combination with pembrolizumab and by modulating the tumor microenvironment. We look forward to reporting additional results as this study progresses.”
Stéphane Champiat, medical oncologist at Gustave Roussy and clinical investigator for the study, spoke about the need for new treatments:
“Many cancer patients fail to respond to existing treatment, highlighting the great need for new approaches. BT-001 is a highly promising potential new immunotherapy that has been shown to elicit a strong immune response that is further enhanced by the local expression of the immune checkpoint inhibitor and cytokine. These promising data generated for monotherapy and in combination with pembrolizumab offer the opportunity to deliver better treatment outcomes with an improved safety profile for patients across multiple cancer indications.”
In addition, an abstract for the ongoing study with BI-1910, BioInvent's second anti-TNFR2 program, published by European Society for Medical OncologyThe poster will also be presented at the ESMO conference.
Continues to strengthen the upward trend
BI-1808 continues to be a cornerstone of the company's portfolio, supported by the latest data updates. The results indicate that the compound has potential for further development and constitute an important driver for BioInvent. In addition, the latest results for BT-001 validate the continued development in collaboration with Transgene.
BioInvent is also making progress in its collaboration with AstraZeneca. During the week it became clear that the first patient has been recruited to the triple combination arm in a phase IIa study targeting non-Hodgkin's lymphoma. In this study, the addition of Calquence to the existing BI-1206 and rituximab regimen to investigate the efficacy of the triple combination.
BioInvent's stock continues to build on the momentum it has built up over the year. It is up 10 percent in one month and 124 percent since the beginning of the year. Continuing to show relative strength against the rest of the market, despite an already solid uptrend, is a strong signal in itself.