BioInvent prepares for a data-rich 2025
BioInvent wrapped up 2024 with notable progress across its six clinical programs focusing on the developing antibodies for cancer therapy. With two phase II and four phase I trials ongoing BioInvent is heading for a milestone-rich 2025 with numerous data readouts expected.
BioInvent is dedicated to discovering and developing pioneering immunomodulatory antibodies, designed to transform cancer therapy. The company’s lead products, BI-1808 and BI-1206, are currently under evaluation in phase I/IIa clinical trials for different cancer types as both monotherapy and in combination with standard treatments. Additionally, BioInvent’s pipeline has a further three assets in earlier stages of development – BI-1607, BI-1910, and BT-001– each with the potential to target diverse cancer types.
The TNFR2 platform
Both BI-1808 and BI-1910 antibodies target TNFR2, but work via different mechanisms of action, providing optionality for treatment regimens. During 2024 BI-1808, advanced into a phase IIa trial as a single agent for solid tumors and cutaneous T-cell lymphoma (CTCL). Early data presented at ASCO in June, followed by additional efficacy results for CTCL later in the year, showed response levels comparable to Keytruda (pembrolizumab), a blockbuster drug that reached USD 29.5 billion in sales globally in 2024.
BI-1808’s performance in this group of heavily pre-treated CTCL patients, where unmet needs are significant, signals its potential as a standalone therapy. The drug’s ability to boost CD8+ tumor infiltration – associated with tumor regression – combined with a strong safety profile, has bolstered BioInvent’s confidence in the candidate’s frontline potential. Further data are expected for mid-2025.
More clinical progress in the company’s pipeline was made during the year with the company’s second TNFR2 candidate BI-1910, which hit a key milestone in its phase I trial by reaching a biologically active dose with reports of stable disease and no major adverse effects. This paved the way for a combination trial with Keytruda, launched in late 2024, with initial phase IIa and combination data expected in the second half of 2025. The company views BI-1910 as a key addition to its expanding oncology portfolio.
Unlocking new possibilities with FcγRIIB
BioInvent has two antibodies targeting FcγRIIB – BI-1206 and BI-1607, where the subcutaneous formulation of BI-1206 is being investigated in combination for its effects in enhancing the efficacy of existing standard of care cancer treatments such as rituximab and pembrolizumab. In the phase IIa triplet study with rituximab and Calquence for non-Hodgkin’s lymphoma (NHL), BioInvent reported promising early responses in January 2025. The treatment is also well tolerated , with no significant safety concerns. Additional data are anticipated by mid-2025.
In parallel, BioInvent’s phase I/IIa study of BI-1206 with Keytruda in solid tumors progressed smoothly, with subcutaneous administration proving well-tolerated. A complete response in a metastatic melanoma patient, first highlighted at ASCO 2024, has now held steady for over two years, which is encouraging. To optimize dosing, the company added a higher-frequency cohort, with results due in mid-2025.
Partnerships and financing
BioInvent underscored its ability to attract high-profile partners by signing three new collaborations with key industry players during 2024. Early in the year the company entered a supply agreement for Calquence for BI-1206 trials with AstraZeneca , followed later in the year by two separate agreements with MSD (providing Keytruda for BI-1910 and BI-1206 studies).
Sustaining momentum in moving BioInvent’s portfolio into later-stage clinical trials requires investment. The company’s 2024 results reflected this increased investment while also demonstrating it has the necessary funding to achieve its development goals for 2025.
The year-end figures reveal that cash flow from operating activities amounted to SEK -98.3 million, compared to SEK -72.4 million the prior year, reflecting increased investment in its expanding trials. Liquid funds, including current and long-term investments, stood at SEK 867.2 million as of December 31, 2024 (SEK 1,283 million in 2023).
Preparing for a data-rich 2025
BioInvent expects to report data from a number of clinical programs during 2025 including additional Phase 2 data from the two lead programs; single agent BI-1808 in CTCL and solid tumors, and the BI-1206 triplet combination in NHL. As the company gears up for this busy period, optimism runs high at the top. In the year-end report, CEO Martin Welschof shared his perspective on the year ahead:
– The growing body of clinical evidence from our programs reinforces our confidence in the potential of our platforms to transform cancer care. We look forward to another data-rich period to come with multiple potential value inflection points in 2025.
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