BioInvent anticipates a continued data-rich 2024
With cash reserves surpassing one billion SEK, providing significant operational flexibility, and anticipating results from several of its clinical programs, BioInvent is entering an eventful autumn. In the H1 interim report, CEO Martin Welschof conveys optimism about the company’s future developing novel cancer treatments.
– The second quarter was very busy and highly productive, and we will continue this momentum into the second half of the year.
BioInvent is at the forefront of developing novel immuno-modulatory antibodies aimed at enhancing cancer therapy. The goal is to boost the effectiveness of existing checkpoint inhibitors and activate anti-cancer immunity in patients who have not responded to other treatments. The company’s clinical portfolio is primarily focused on three key immunological targets: TNFR2, FcyRIIB, and CTLA-4.
The two lead drug candidates, BI-1808, an anti-TNFR2 antibody and BI-1206, an anti-FcyRIIB antibody, are being evaluated in phase I/IIa studies. BI-1206 is being explored in non-Hodgkin’s lymphoma (NHL) and solid tumours.
The portfolio also features three early clinical studies assets: BI-1607, BI-1910 and BT-001, as potential treatments for several cancer types. Additionally, five projects in clinical development are outlicensed to Mitsubishi Tanabe, Takeda, Abcentra, Daiichi-Sankyo and Hope Medicine/Bayer.
Showcasing clinical results at international hot-spots
At the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago in June, the company presented initial efficacy and safety data from the ongoing phase I/IIa study with BI-1808, both as a single agent and in combination with pembrolizumab (KEYTRUDA). The data revealed promising early signs of BI-1808 single agent efficacy, and a robust safety profile were announced. Data showed one complete response (CR), one partial response (PR) and nine patients with stable disease (SD) out of 26 evaluable patients. These findings reinforce the potential of BI-1808 as a new class of immunomodulatory agent with the ability to enhance cancer therapy effectiveness.
In a second presentation at ASCO, the company shared positive phase I data for BI-1206 in combination with pembrolizumab in heavily pre-treated patients with solid tumours. The results indicated clinical efficacy signals and good tolerability, with promising and durable responses in patients who had previously failed on anti-PD-1/L1 therapy. This suggests that blocking FcγRIIB may enhance the effectiveness of immune checkpoint inhibitors.
Furthermore, BioInvent attended the European Hematology Association (EHA) Congress 2024 in Madrid, presenting additional promising phase I/IIa data on BI-1206 combined with rituximab for relapsed/refractory NHL. The early efficacy results from subcutaneous dosing included 1 complete response (CR), 2 partial responses (PR), and 1 stable disease (SD) among 4 evaluable patients, suggesting BI-1206’s potential to overcome rituximab resistance.
Based on these encouraging results, BioInvent plans to initiate a phase IIa study arm, adding the BTK inhibitor acalabrutinib (Calquence) to the BI-1206 and rituximab regimen. Enrolment to this triplet combination is expected to begin soon, with first data anticipated by the end of 2024.
Further progress expected during H2
The company’s achievements during the first half of 2024 were also bolstered by two new collaborations with MSD, intellectual property advancements (a Notice of Allowance received from USPTO for the BI-1910 patent application).
In the interim report, CEO Martin Welschof concludes that the company plans to carry on with this momentum into the second half of the year, anticipating the release of additional clinical data from several programs by year-end, where additional data for BI-1808 as monotherapy and the first data for the triplet combination of BI-1206, rituximab and acalabrutnib are in focus.
The presentation of promising results from our two lead drug candidates at the ASCO Annual Meeting showcased their potential as first-in-class immunomodulatory agents and kicked off a data-rich period for BioInvent where we expect to report results from all six of our clinical programs.
Strong financial position
The company started 2024 with a robust financial position of SEK 1.358 million. By June 30 the cash reserves including placements stood at SEK 1.090 million, alongside a Q2 operating loss of SEK 148 million. With the current burn rate, BioInvent maintains a strong financial foundation, ensuring the company is well-equipped to sustain its operations through the second half of 2024 and beyond.
Taking a closer look at the company’s partnerships, one notable collaboration is the agreement with CASI Pharmaceuticals, signed in 2020 with an upfront payment of USD 12 million. This is particularly significant as it involves potential milestone payments totalling up to USD 83 million, structured around key developmental achievements and progress of BI-1206.
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