BioInvent’s CEO comments on the study success in China
BioInvent’s partner in China, CASI Pharmaceuticals, has announced preliminary encouraging efficacy data for BioInvent’s lead drug candidate BI-1206 in combination with rituximab in cancer patients with non-Hodgkin’s lymphoma. BioStock reached out to BioInvent’s CEO Martin Welschof, who expects that 2024 will be a break-out year for the company, with multiple data readouts expected during the second half of the year.
In 2020, BioInvent and CASI Pharmaceuticals, a Nasdaq-listed biopharmaceutical company with clinical development and commercial infrastructure in China, entered into an exclusive licensing agreement. The aim was to develop and commercialise BioInvent’s lead product BI-1206 – targeting both liquid and solid cancers – in mainland China, Taiwan, Hong Kong and Macau.
BioInvent received a USD 5 million upfront payment as a basis for the partnership. The company is also eligible to receive up to USD 83 million in development and commercial milestone payments, plus tiered royalties in the high-single to mid-double-digit range on net sales of BI-1206. CASI is responsible for the commercialisation in China and associated markets.
The new data reported last week by CASI confirms results from earlier studies carried out by BioInvent using BI-1206 to treat NHL, and supports the further development of BI-1206 as an important element in a potential new combination treatment for this type of blood cancer.
BI-1206 to overcome drug resistance
BI-1206 targets a pivotal mechanism of resistance to rituximab, a groundbreaking drug that transformed the therapy of B-cell lymphomas and stands as a cornerstone of contemporary cancer treatment protocols. Regrettably, resistance to rituximab develops gradually, leading to a diminishing sensitivity to the drug over time. The candidate drug is aimed at amplifying and restoring rituximab’s efficacy by addressing a crucial resistance mechanism: the tumour’s overexpression of FcgR2B, a receptor that modulates antibody activity.
Clinical studies in China
In 2021, China’s medical product regulator NMPA greenlit CASI’s Clinical Trial Application (CTA) to commence clinical trials of BI-1206 in patients with non-Hodgkin’s lymphoma (NHL). By 2022, the first patient received dosing in the phase I dose-escalation and expansion study of BI-1206, combined with rituximab. The study aims to evaluate the safety, tolerability, pharmacology, and clinical efficacy of BI-1206, administered via intravenous (IV) infusion.
“Impressive signs of clinical efficacy”
CASI recently announced preliminary efficacy data from the study. In a press release, the company concluded that the study showed impressive signs of clinical efficacy, with four partial responses (PR) and one complete response (CR) out of eight evaluable patients.
In a comment, Dr Wei-Wu He, CEO of CASI, said:
“These initial BI-1206 data showed promising response for patients with difficult-to-treat disease. The data are especially notable as they demonstrated strong and durable responses at lower dose levels. We believe these results represent important steps toward validating BI-1206 as a potential treatment as well as de-risk our plan for future development.”
Comments from BioInvent’s CEO
BioStock talked to BioInvent’s CEO Martin Welschof to delve into the implications of the news and for a comment on the anticipated clinical advancements across the seven ongoing studies.
Martin, the clinical efficacy results included a long-lasting complete response, all-in-all reinforcing previously reported data. What is your comment on the interim data?
– The data from CASI’s study is in line with the level of responses we saw in our previous studies with BI-1206, so the readout further validates our treatment approach. These data are important as Key Opinion Leaders (KOL) believe anti-CD20 therapy will remain the backbone treatment of NHL for the next 15-20 years, and BI-1206 is designed to re-establish the clinical efficacy of rituximab which is one of the leading anti-CD20 therapy used to treat NHL.
What are the overall potential implications of these findings, considering that BI-1206 is also being evaluated in solid tumours in combination with MSD’s (Merck & Co) blockbuster anticancer drug Keytruda?
– BI-1206 is developed to re-establish the clinical effect of existing cancer treatments such as pembrolizumab and rituximab, drugs with combined global sales of approximately USD 23 billion annually. The new data from CASI further validates data we have already reported showing that combining BI-1206 with these standard treatments can potentially improve efficacy.
Last month, BioInvent partnered up with AstraZeneca to support a triplet combination phase IIa trial where Calquence is added to the BI-1206 + rituximab mix. What are the objectives of this study?
– We aim to position BI-1206 as an essential component in the treatment of NHL. We believe using the triplet combination could result in an even more efficacious treatment with higher response rates for patients. We have completed the Phase 1 part of the Phase 1/2a trial testing BI-1206 together with rituximab, and seen impressive early signs of clinical efficacy with this combination. The Phase 2a IV dose expansion cohort testing the triplet combination with BI-1206 + rituximab + Calquence expect to recruit approximately 30 patients to be included in the cohort and to be relatively rapid, with sites in Sweden, Spain, the US, and Brazil.
With Calquence’s significant sales and potential indication expansion, what competitive advantages do you foresee for BI-1206 in this new combination therapy?
– The strong safety profile of BI-1206 compared to other agents in the field, such as the CAR-Ts and bispecific antibodies is a major advantage not to be underestimated when doctors and patients are searching for treatment options.
In the year-end report, you stated that 2024 will be a breakout year. Can you go into more detail regarding your positive outlook?
– With potential clinical results from six clinical programs across the year, we look forward to a news-rich year, kicking-off mid-year. We are particularly looking forward to the BI-1808 single-agent Phase 2a data expected towards the end of this year, as well as the first Phase 2 triplet data from the BI-1206 program in NHL, which we have just been discussing here and which could open up for significant additional business opportunities.
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