In Q1 2025, reported BioInvent 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). In the Q1 report we can read: "In the first two patients treated, we observed a complete response and a partial response with no reported safety abnormalities." These results therefore suggest that the treatment has the potential to offer an effective option for patients with NHL. Patient recruitment is ongoing and additional data are expected in mid-2025.
At the same time, the phase I/IIa study with BI-1206 in combination with keytruda (pembrolizumab) in solid tumors. 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 is being prepared for phase IIa study
During the first quarter, BioInvent also announced Phase I results for BI-1910 as monotherapy in solid tumors, where data showed stable disease in 6 of 12 evaluable patients without side effects at any of the doses tested.
- The results also showed favorable pharmacokinetics and robust receptor coverage, strengthening confidence in the therapeutic mechanism., says CEO Martin Welschof in the Q1 report.
The company plans to initiate a Phase IIa study in the second half of 2025 targeting multiple tumor types.
Financial milestone from Takeda
On the partnering front, BioInvent received a milestone payment of 1 million USD from Takeda following the start of a Phase III study for mezagitamab (TAK-079), identified through the company's n-CoDeR antibody library, validating BioInvent's drug discovery platform. Read more hereIn addition, the company was awarded ISO 26000 verification, confirming its commitment to responsible business practices in the areas of environment, social responsibility and corporate governance (ESG).
As of March 31, Bioinvent's cash and cash equivalents, short-term and long-term investments amounted to SEK 742,2 million. Cash flow for the Q1 period amounted to SEK -120,0 million.
Clinical and regulatory progress for BI-1808
In Q1 2025, BioInvent secured orphan drug designation for BI-1808 in T-cell lymphoma, supported by data most recently 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 that affects 3 US patients annually. The Fast Track designation will facilitate the development of BI-000, with more frequent interactions with the FDA and potential accelerated approval pathways.
- It is very encouraging that the FDA confirms that the data presented for BI-1808 meet expectations to address this important medical need. To date, BI-1808 has shown early signs of clinical efficacy in heavily pretreated patients and with an excellent safety and tolerability profile. We are committed to continuing to advance the development of BI-1808 and look forward to providing an update from the ongoing Phase 2a study in mid-2025., says CEO Martin Welschof.
Phase IIa data from fall 2024 showed three partial responses and one stable disease in four CTCL patients, which is in line with the results in solid tumors from ASCO 2024 (one complete response, one partial response, nine stable disease).
CEO comment
We contacted Martin Welschof, CEO of BioInvent, for a comment on the Q1 results and Fast Track designation for BI-1808.
What were the most important milestones during Q1, in your opinion?
“The Fast Track Designation that the FDA has granted for BI-1808 in CTCL is undoubtedly the highlight. This milestone significantly increases the development potential of BI-1808, and allows us to accelerate the process with more frequent FDA interactions and explore the possibilities for accelerated approval. The designation is a testament to the promising clinical efficacy and safety profile that BI-1808 has demonstrated to date.”
Given that you have now received Fast Track Designation which allows for more frequent FDA interactions, what strategies are you prioritizing to accelerate the development of BI-1808?
“We are committed to leveraging the benefits of Fast Track Designation to accelerate the development of BI-1808 and have an ongoing dialogue with the FDA. We will focus on ensuring a robust clinical efficacy data package, as well as maintaining the excellent safety profile observed to date.”
How can the combined benefits of orphan drug and Fast Track status attract potential strategic partners for the commercialization of BI-1808 in CTCL?
“The combined benefits of orphan drug status and Fast Track status can be compelling arguments for potential strategic partners. These designations not only highlight the critical medical need that BI-1808 addresses, but also validate that our generated data meets the high standards set by regulatory authorities.”
Additional phase IIa data for the triple combination of BI-1206 with rituximab and acalabrutinib are expected in mid-2025. What are your expectations here?
– Based on previous results, we expect that this triple combination therapy will be able to demonstrate increased clinical efficacy, on par with currently available drugs such as bispecific antibodies and CAR-T, but with a much better safety and tolerability profile. These data will be crucial to validate our treatment and guide further development steps.
