– The second quarter was very intense and productive and we expect to continue at the same pace in the second half of the year.
BioInvent is at the forefront of developing novel immunomodulatory antibodies aimed at improving cancer treatments. The goal is to increase the effectiveness of existing checkpoint inhibitors and activate antitumor immunity in patients who do not respond to other treatments. The company's clinical portfolio focuses primarily on three important immunological targets: TNFR2, FcγRIIB and CTLA-4.
The two leading drug candidates, the anti-TNFR2 antibody BI-1808 and the anti-FcγRIIB antibody BI-1206, is being evaluated in Phase I/IIa studies. BI-1206 is being investigated in both non-Hodgkin's lymphoma (NHL) and solid tumors.
The portfolio also includes three early clinical-stage assets: BI-1607, BI-1910 and BT 001, as potential treatments for several different types of cancer. In addition, five projects in clinical development have been licensed to Mitsubishi Tanabe, Takeda, Abcenter, Daiichi Sankyo and Hope Medicine/Bayer.
Clinical results presented internationally
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 monotherapy and in combination with pembrolizumab (KEYTRUDA). These data showed promising early signals of efficacy of BI-1808 as monotherapy and a robust safety profile was reported. The data showed one complete response (CR), one partial response (PR) and nine patients with stable disease (SD) out of 26 evaluable patients. These results strengthen the potential of BI-1808 as a new class of immunomodulatory drugs with the potential to enhance the efficacy of cancer therapies.
In a second presentation at ASCO, the company shared positive Phase I data for BI-1206 in combination with pembrolizumab in previously heavily pretreated patients with solid tumors. The results showed clinical efficacy signals and good tolerability, with promising and durable responses in patients who had previously failed anti-PD-1/L1 therapy. This suggests that blocking FcγRIIB may enhance the efficacy of immune checkpoint inhibitors.
BioInvent also participated in the European Hematology Association (AND HAS) Congress 2024 in Madrid, where further promising Phase I/IIa data were presented for BI-1206 in combination with rituximab for relapsed/refractory NHL. 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 the potential of BI-1206 to overcome resistance to rituximab.
Based on these encouraging results, BioInvent plans to initiate a Phase IIa study arm in which the BTK inhibitor Acalabrutinib (Calquence) is being added to the combination of BI-1206 and rituximab. Inclusion in this triple combination is expected to begin soon, with first data expected before the end of 2024.
Further progress expected in H2
The company's performance in the first half of 2024 was further strengthened by two new collaborations with MSD, progress in intellectual property rights (a Notice of Allowance obtained from USPTO for the patent application concerning BI-1910).
In the half-year report, the CEO states Martin Welschof that the company intends to continue at the same pace during the second half of the year, with expectations that additional important data from several of the clinical programs can be released before the end of the year, with additional data for BI-1808 as monotherapy and the first data from the triple combination of BI-1206, rituximab and acalabrutinib in focus.
The presentation of promising results for our two lead drug candidates at the ASCO annual cancer conference demonstrates their potential as first-in-class immunomodulatory drugs. This marks the beginning of an exciting period during which we expect to report results from all six of our clinical programs.
Strong financial position
The company started 2024 with a strong financial position of SEK 1,358 million. As of June 30, cash including investments amounted to SEK 1,090 million, along with an operating loss of SEK 148 million for Q2. With the current burn rate, BioInvent maintains its strong financial position, which ensures that the company is well equipped to continue operations with unabated momentum during the second half of 2024 and beyond.
If we take a closer look at the company's partnerships, a particularly notable collaboration is the agreement with CASI Pharmaceuticals which was signed in 2020 with an initial payment of USD 12 million. This is particularly significant as it involves potential milestone payments of up to USD 83 million, structured to be paid in connection with key development progress with BI-1206.