
BioInvent anticipates strong influx of clinical data
BioInvent achieved solid progress throughout the third quarter, and CEO Martin Welschof anticipates a data-rich conclusion to 2024 that will further strengthen the company.
– Looking ahead to next year, we expect BioInvent’s strong momentum to persist, with seven essential data readouts across four drug candidates in clinical development.
BioInvent is developing five antibody candidates currently being evaluated in six different clinical programs. These antibodies can be used as monotherapy or in combination with current standard treatments for various types of cancer. They enhance the efficacy of existing checkpoint inhibitors and activate antitumor immunity in patients who do not respond to treatment.
The two lead drug candidates, BI-1808 and BI-1206, are being evaluated in phase I/IIa studies. BI-1206 is being investigated in non-Hodgkin’s lymphoma (NHL) and solid tumors. The pipeline also includes three early-stage clinical assets: BI-1607, BI-1910, and BT-001 – potential treatments for several cancer types.
International spotlight
BioInvent had a solid first half of the year, as evident by the H1 interim report published at the end of August. During this period, the company showcased clinical results at international hot spots such as the American Society of Clinical Oncology (ASCO), the Annual Meeting in Chicago, and the European Hematology Association (EHA) Congress in Madrid.
At ASCO, 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. BioInvent also shared positive phase I data for BI-1206 in combination with pembrolizumab in heavily pre-treated patients with solid tumours.
At EHA, BioInvent presented additional promising phase I/IIa data on BI-1206 combined with rituximab for relapsed/refractory NHL. Recently, the company has announced two new collaborations with MSD and intellectual property advancements (a Notice of Allowance received from USPTO for the BI-1910 patent application).
The international presence was maintained during the third quarter. At the ESMO Annual Meeting in Barcelona, the company presented a status update for the ongoing phase I/IIa study with BI-1910 and results from the ongoing phase I/IIa study with BT-001. Read an interview with BioInvent’s CMO, Andres McAllister here, who attended the conference.
Clinical progress
During the third quarter, the company presented updated data from the phase I study of BI-1206 in a subcutaneous formulation for NHL treatment adding one complete response and one partial response to the earlier reported clinical responses, totaling two complete responses, three partial responses, and three cases of stable disease among nine evaluable patients.
BioInvent has also reported significant progress during Q3 across multiple other clinical trials. Preliminary data from the phase IIa dose-expansion study of BI-1808 as a monotherapy in patients with cutaneous T-cell lymphoma (CTCL) showed encouraging results, with three partial responses and one case of stable disease among four evaluable patients.
The first patient was also enrolled in a triple-combination arm of the phase I/IIa study using BI-1206 with rituximab and acalabrutinib for non-Hodgkin’s lymphoma (NHL).
Meanwhile, BioInvent has signed a clinical trial collaboration and supply agreement with MSD (Merck & Co.) to evaluate BI-1607 in combination with Keytruda and ipilimumab, potentially enhancing therapeutic efficacy.
Financial stability
With SEK 979 million in cash, cash equivalents, and investments, BioInvent has a solid financial position among comparable listed Swedish biotech companies. Cash flow from operating activities during the third quarter amounted to -97 million SEK by the end of the period (September 30th 2024).
The company is owned by a strong lineup of international funds, such as Redmile Group, Van Herk Investments (which recently increased its ownership to 13.7%), Forbion, HBM Healthcare Investments, Omega and the Swedish AP4. Recently, the Swedish specialist fund HealthInvest, part of Atle, also became a new owner.
Several expected milestones
So far this year, the company’s shares have surged by 134 per cent. It remains to be seen whether this upward trend can be sustained as more clinical data is released in the upcoming months.
Judging by the Q3 report, the company looks forward to a data-rich end to 2024 and an even more intense development next year. It expects to report additional data from both the phase IIa study with BI-1808 as monotherapy and the first phase I data for BI-1910 as monotherapy. BioInvent also expects to report the first phase IIa data for the triple combination BI-1206 in NHL by the end of the year, and further phase IIa results in mid-2025.
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