During Q1 2025, BioInvent reported initial efficacy data from its ongoing phase IIa study evaluating the triple combination of BI-1206, rituximab, and Calquence (acalabrutinib) in non-Hodgkin’s lymphoma (NHL). The Q1 report states, “Among the first two patients treated, one complete response and one partial response were observed, with no safety concerns reported.” These findings suggest the potential for this regimen to provide a viable treatment option for NHL patients. Enrollment continues, with additional data expected by mid-2025.
Meanwhile, the phase I/IIa study of BI-1206 combined with Keytruda (pembrolizumab) in solid tumors is also advancing. The subcutaneous formulation of BI-1206 has demonstrated a favorable safety profile, with no reported safety concerns. Based on these results, BioInvent has initiated an additional dose cohort with increased frequency to explore the dose-response relationship and prepare for the planned phase IIa study.
BI-1910 prepares for phase IIa trial
During the first quarter, BioInvent also announced phase I results for BI-1910 monotherapy in solid tumors, with stable disease observed in 6 of 12 evaluable patients and no adverse events reported across tested doses.
– The results also showed favorable pharmacokinetics and robust target engagement, reinforcing confidence in the therapeutic mechanism, says CEO Martin Welschof in the Q1 report.
The company plans to initiate a phase IIa trial in the second half of 2025, targeting multiple tumor types.
Financial milestone from Takeda
On the partnering front, BioInvent received a 1 MUSD milestone payment from Takeda following the initiation of a phase III trial for mezagitamab (TAK-079), identified through the company’s n-CoDeR antibody library and validating BioInvent’s drug discovery platform. Read more here. Additionally, the company earned ISO 26000 verification, affirming its commitment to responsible business practices in environmental, social, and governance (ESG) areas.
As of March 31, Bioinvent’s liquid funds, current and long-term investments amounted to SEK 742.2 million. The cash flow for the Q1 period amounted to SEK -120.0 million.
BI-1808’s clinical and regulatory progress
In Q1 2025, BioInvent secured FDA Orphan Drug Designation for BI-1808 in T-cell lymphoma, supported by data latest presented at the 16th Annual T-Cell Lymphoma Forum in March 2025. On April 29, 2025, the FDA granted Fast Track Designation for BI-1808 in CTCL, a rare lymphoma affecting 3,000 U.S. patients annually. The Fast Track Designation will facilitate the development of BI-1808, with more frequent FDA interactions and potential accelerated approval pathways.
– It’s very encouraging that the FDA confirms that the presented BI-1808 data meet expectations to address this important unmet medical need. To date, BI-1808 demonstrated early clinical efficacy in heavily pretreated patients with an excellent safety and tolerability profile. We are committed to continue advancing the development of BI-1808 and look forward to providing an update from the ongoing phase IIa by mid-2025, says CEO Martin Welschof.
Phase IIa data from autumn 2024 showed three partial responses and one stable disease among four CTCL patients, aligning with ASCO 2024 solid tumor results (one complete response, one partial response, nine stable diseases).
Comments from the CEO
We reached out to Martin Welschof, CEO of BioInvent, for a comment on the Q1 performance and the Fast Track Designation for BI-1808.
In your opinion Martin, what stands out as the most important news during Q1?
– The Fast Track Designation granted by the FDA for BI-1808 in CTCL is undoubtedly the highlight of Q1. This milestone significantly boosts the potential for BI-1808’s development, allowing us to accelerate progress with more frequent FDA interactions and exploring expedited approval pathways. This designation is a testament to the promising clinical efficacy and safety profile BI-1808 has demonstrated thus far.
With the Fast Track Designation enabling more frequent FDA interactions, what strategies are you prioritising to expedite BI-1808’s development?
– We are committed to leveraging the benefits of Fast Track Designation to expedite BI-1808’s development and maintaining continuous dialogue with the FDA. Our efforts will focus on ensuring a robust clinical trial efficacy data package and maintaining the excellent safety profile observed so far.
How could the combined benefits of the Orphan Drug and Fast Track Designations attract potential strategic partners for BI-1808’s commercialisation in CTCL?
– The combined benefits of Orphan Drug and Fast Track Designations provide a compelling case for potential strategic partners. These designations not only highlight the critical unmet medical need BI-1808 addresses but also validate that the generated data meets the high standards laid out by the regulatory agencies.
Further phase IIa data for the triple combination of BI-1206 with rituximab and acalabrutinib are expected by mid-2025. What are your expectations for this release?
– Based on previous findings, we expect this triple combination therapy to show enhanced clinical efficacy, on par with currently available drugs like bi-specific antibodies and CAR-Ts, but with a much better safety and tolerability profile. This data will be crucial in validating our approach and guiding further development steps.
