China licensing agreement further validates technology and strategy
"The exclusive licensing agreement with CASI Pharmaceuticals for BI-1206 in China is an important validation of BioInvent's technology, expertise and business model. It provides further impetus to our lead drug candidate and reinforces our financial position with $12 million upfront in cash and equity investment, plus potential future milestones and royalties."
Martin Welschof, CEO BioInvent
Comments from the CEO
BioInvent took a significant step forward with the signing of an exclusive licensing agreement with CASI Pharmaceuticals for the development and commercialization of our novel anti-FcγRIIB antibody, BI-1206, in mainland China, Taiwan, Hong Kong and Macau. It is an important validation of BioInvent's technology, expertise and business model and provides further impetus to our lead drug candidate.
This agreement will further accelerate the development and commercialization preparations for BI-1206, based on CASI's clinical and regulatory expertise and strong presence across this major market. Their established commercial infrastructure and medical marketing team, together with their wide access to a strong network of investigators across Greater China, make them an ideal partner to expand our global development footprint in this important region.
The agreement also further reinforces our financial position, as BioInvent receives $12 million upfront as a combination of cash and equity investment. We are eligible for up to $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.
In short this collaboration adds significant value to our overall BI-1206 program, through the leveraging of CASI's capabilities in this major market and the financial terms.
The clinical development of BI-1206 in both hematological cancers and solid tumors is progressing well. A Phase I/IIa trial of BI-1206 in combination with the anti-PD-1 therapy Keytruda[®] (pembrolizumab) in solid tumors is continuing as planned, as is the Phase I/IIa trial of BI-1206 in combination with rituximab for the treatment of non-Hodgkin lymphoma (NHL). With this exciting agreement with CASI now in place, we anticipate there could be further interest in similar partnerships for BI-1206 in other regional markets, or a license of the rest of the world.
Beyond BI-1206, BioInvent's pipeline is expanding further based on the productivity of our proprietary n-CoDeR[®]/F.I.R.S.T[TM] platforms and ability to generate antibodies to novel targets with potent anti-tumoral activity to address major unmet medical needs.
We have received regulatory authority approval of our clinical trial application in Denmark for a Phase I/IIa, first-in-human study of BI-1808, as monotherapy and in combination with the anti-PD-1 therapy Keytruda[®] (pembrolizumab) for the treatment of solid tumors and CTCL. BI-1808 will be the first anti-TNFR2 antibody to enter clinical development, and we believe this is a very promising approach for cancer therapy. We expect to enroll the first patient before the end of the year and to submit an investigational new drug (IND) application in the U.S. in the coming weeks. Together with our partner Transgene, we also continue to expect to initiate a Phase I clinical trial with the multifunctional oncolytic virus BT-001 before the end of 2020.
We continue our value-creating collaborations with various partners and most recently announced receipt of a €2 million milestone payment under our collaboration with Daiichi Sankyo, related to the initiation of a global Phase I clinical trial with a GARP directed antibody.
This all adds up to further substantial progress for BioInvent, across the pipeline, and I look forward to continuing to keep you up to date with further developments through the rest of 2020 and beyond.
As previously informed, BioInvent has taken necessary precautions with regards to the corona virus. Although we see an increase of cases, which is of course terrible for all those affected and their families, we still remain on track with our clinical trials and results. As the situation is still evolving, timelines are still subject to potential changes and we will provide updates as necessary.
With financing in place, a new partnering collaboration and the strong support of our investors, BioInvent is well positioned to continue to deliver on the promise of our pipeline.
Martin Welschof, CEO
Any questions regarding this report will be answered by Martin Welschof, CEO, +46 (0)46 286 85 50,
BioInvent International AB (publ)
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Forward looking information
This interim report contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as of the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual out-come may deviate significantly from the scenarios described in this press release.