BioInvents The goal is to improve the efficacy of current checkpoint inhibitors and activate the immune system in patients who no longer respond to existing cancer treatment. The company combines a proprietary technology platform, FIRST, with the antibody library n-CoDeR, with the aim of developing potential drug candidates for cancer treatment. Currently, four candidates are in clinical evaluation: BI-1206, BI-1808, BT 001 and BI-1607. A fifth candidate, BI-1910, is planned to begin clinical development in H2 2023.
Clinical progress
During 2022, several advances were made with the four candidates in BioInvent's clinical pipeline, not least with BI-1206. In one phase I/II study with the candidate, the evaluation is taking place in non-Hodgkin's lymphoma (NHL) in combination with rituximab, the three complete responses observed in 2021 are still ongoing. Two have now lasted more than two years after completion of treatment. Additional data show four partial responses, one of which is still ongoing. At the end of the year, BioInvent also initiated a Phase I study with a subcutaneous version of BI-1206, which is expected to reduce the infusion-related reactions associated with the intravenous version.
BI-1206 was granted Orphan Drug Designation for the treatment of follicular lymphoma during the year. The candidate now has two ODDs – the second for the treatment of mantle cell lymphoma (MCL).
Other clinical successes include the positive progress and safety data from the ongoing Phase I/IIa study with the oncolytic virus BT-001, which BioInvent announced in June. The data also showed signs of anti-tumor activity in a difficult-to-treat patient population. In addition, the first patient was recruited into a Phase I/IIa study with the anti-FcγRIIB antibody BI-1607 in combination with anti-HER2 therapy.
The number of signed agreements is growing
In June, BioInvent announced that it had entered into an option and license agreement with the American biotechnology company Exelixis, which aims to identify and develop novel antibodies for use in immuno-oncology treatments. Exelixis also has a proven track record in developing and commercializing oncology drugs, making them a valuable partner for BioInvent.
Financially, the collaboration involved a payment from Exelixis of USD 25 million upfront, and success-based milestone payments tied to development and commercialization, as well as incremental royalty payments on annual net sales for each product commercialized within the framework of the collaboration.
The agreement is further proof of BioInvent's ability to enter into collaborations - the company already has a number of previously concluded agreements behind it. Read more about this here.
Strengthened organization
It was not only the company's business development that progressed in 2022. During the year, BioInvent's organization also grew by approximately 20 percent with a special focus on clinical development, manufacturing and research. The company also strengthened its management through two important appointments. Marie Moores was appointed Chief Operating Officer, and with her experience from the CRO field, she contributes to optimizing BioInvent's daily operations. The second addition consisted of Sylvie Ryckebusch who took over as Chief Business Officer. Ryckebusch has over 20 years of experience in the pharmaceutical industry and broad expertise in business development, corporate partnerships and strategic issues, making her a valuable asset to BioInvent.
Financial strength
Another test of strength was made when BioInvent in July, despite the current global financial situation, carried out a directed new share issue of approximately SEK 300 million in which both domestic and international investors participated. The result of the issue meant that the company's ownership base was further strengthened, and gave BioInvent the muscle to negotiate with potential partners.
For the full year 2022, BioInvent reports increased sales of SEK 326,1 million compared to SEK 19,1 million the following year. The company's Liquid assets amounted to SEK 1593,6 million (1365,0).
CEO tells more
BioStock contacted the CEO Martin Welschof, to learn more about what 2023 could mean for the company.
Martin, a number of clinical milestones are expected to be achieved during the year. Which one or which ones do you see as particularly value-driving, and why?
– If we look at the first half of the year, I'm particularly excited about the upcoming first results from the clinical trial with the subcutaneous formulation of BI-1206, to see if the promising data we've seen preclinically regarding the infusions-related reactions can be translated into the clinic. I also look forward to seeing further data from the BI-1808 single agent trial, where we have so far reported a good safety profile and some disease stabilizations.
How do you view the development of collaborations and partnerships in 2023?
– We have already concluded one partnership this year, with the Leukemia and Lymphoma Society where we received a strategic equity investment of USD 3 million and which will support clinical advancement of BI-1206 in Non-Hodgkin's Lymphoma and clinical development of BI-1808 in cutaneous T-cell lymphoma. Overall, we have an active partnership strategy meaning that we have ongoing discussions with a number of potential partners to update them on an ongoing basis about the progress that we do. When in time the next partnership will materialize, that is of course data-driven.
At the end of the year, BioInvent's cash consisted of approximately SEK 1.6 billion. How long do you estimate that these assets will finance the business?
– With the current plans, we have a cash runway well into 2025.
What challenges do you see in 2023 and how do you plan to deal with them?
- BioInvent is active in a very competitive field and manages these risks by applying competitive and market intelligence in the planning of our programs as well as careful portfolio management. Already in the discovery phase, BioInvent applies a stringent process in order to make sure that all of the company's drug candidates have a smart design and high commercial potential for successful partnering at the optimal time for each project. Furthermore, we have a diversified approach to drug candidates and mechanisms of action, and are targeting a very attractive space in the pharmaceutical landscape.