BioInvent kicks off 2025 with positive clinical data
With multiple data readouts expected from its four clinical programs, BioInvent has started 2025 on a high note. The year’s first clinical data show encouraging initial efficacy in the triple-combination of BI-1206, rituximab, and Calquence for treating non-Hodgkin’s lymphoma. The company has also reported promising findings for BI-1910 as single agent in the phase I study targeting solid tumors. We reached out to Martin Welschof, CEO of BioInvent for a comment.
BioInvent focuses on the discovery and development of first-in-class immunomodulatory antibodies, aimed at advancing cancer treatment.
The company’s two lead candidates, BI-1808 and BI-1206, are being evaluated in ongoing phase I/IIa clinical trials. Additionally, BioInvent’s pipeline includes three early-stage clinical assets—BI-1607, BI-1910, and BT-001—that have the potential to address a range of cancer indications.
Promising clinical BI-1206 data
BioInvent aims to position BI-1206 as an essential component in the treatment of non-Hodgkin’s lymphoma. By using a triple combination of BI-1206, rituximab and AstraZeneca’s Calquence (acalabrutinib), the company believes it could result in a more efficacious treatment with higher response rates for patients.
This week, BioInvent announced that the first two patients enrolled in the phase IIa study triplet arm responded to treatment, with one complete response and one partial response and no safety or tolerability concerns.
”To date, we have not observed any enhancement of the toxicity of the other agents. In that context, it will mean adding another agent without accumulating additional adverse events or enhanced toxicity. Given the importance of the cocktail approach in oncology, this is a dream situation.” – Martin Welschof, CEO BioInvent
The study is now expanding to additional clinical sites, with patient enrolment on track and phase IIa results expected by mid-2025. Approximately 30 patients will be enrolled across Spain, Germany, the US, and Brazil. Meanwhile, the phase I/IIa trial of BI-1206 with MSD’s Keytruda in heavily pre-treated solid tumor patients is progressing, with an additional dose cohort added to refine dose-response and safety ahead of phase IIa.
BI-1910 in solid tumors is also moving forward
BioInvent also announced this week the first clinical data from its second anti-TNFR2 antibody, BI-1910. The candidate is being evaluated both as single agent (Part A) and in combination with Keytruda (Part B).
Part A has now been successfully completed without any notable adverse events, with half of the 12 currently evaluable patients displaying stable disease. A phase IIa studying BI-1910 as single agent is planned to start in H1 2025 and will be performed in several tumor types including HCC (hepatocellular cancer) patients. Meanwhile, the first patients have been enrolled in the phase I Part B study.
Comments from the CEO
To learn more about these news and BioInvent’s plans for 2025, we reached out to the CEO, Martin Welschof.
Martin, 2025 has kicked off with a strong start for BioInvent. What are the main takeaways from the initial data in the triple combination study?
– Still early days, but we can already foresee the triplet combination will very likely generate strong competitive efficacy data, along with a safe and convenient administration scheme. This will make a competitive approach for patients treated in the second+ line.
Can you elaborate on the significance of the complete and partial responses observed?
– A complete response indicates that the cancer is no longer detectable, which is a highly favorable outcome. Partial response means a significant reduction in the size of the tumor or extent of cancer in the body.
A patient with metastatic melanoma has an ongoing response for nearly two years. What does this suggest about the long-term efficacy of BI-1206?
– In our view, since this patient had received several previous lines of IO agents, it does indicate that BI-1206 is addressing the mechanism of resistance that led to progression of disease in the first instance. When we are able to incorporate BI-1206 as part of the maintenance along with anti-PD1 agents such as pembrolizumab, the response rates should increase, along with duration of response and other important parameters such as PFS and OS.
How important is the tolerability in a future marketing and regulatory perspective, given that the combination involves three drugs?
– To date, we have not observed any enhancement of the toxicity of the other agents. In that context, it will mean adding another agent without accumulating additional adverse events or enhanced toxicity. Given the importance of the cocktail approach in oncology, this is a dream situation.
Moving on to the new data with BI-1910. What are the key takeaways from the phase I study in solid tumors?
– We have observed several disease stabilizations in heavily pre-treated patients who had exhausted the standard of care options and had no further alternatives. In addition, the biomarker data is corroborating what we observed in preclinical models, that is, strong signs of immune activation. The innovative approach that we are taking for the phase 2a should indicate the best way to move forward.
Looking ahead, what do you expect in terms of data readouts and other important milestones during 2025?
– 2025 will be a catalyst rich year kicking off mid-year with expected additional Phase 2 data from both BI-1808 (anti-TNFR2) and BI-1206 (anti-FcyRIIB) programs. Second half of the year we expect the first Phase 1b data from the BI-1607 (anti-FcyRIIB) study in combination with ipilimumab and pembrolizumab, as well as further updates from the anti-TNFR2 platform.
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