BioInvent announces additional efficacy data from intravenous part of Phase 1/2 trial with BI-1206 in solid tumors
- One additional patient has developed a partial response (PR) and one patient has remained on stable disease for over 80 weeks
- These long-lasting responses in hard-to-treat metastatic diseases, in patients who had previously progressed after treatment with anti-PD1/PDL1 agents, strongly suggest that BI-1206 is enhancing and recovering the activity of pembrolizumab (an anti-PD1 agent)
Lund, Sweden – June 7, 2023 – BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announces six additional patients have been treated in the intravenous (IV) arm of its Phase 1/2 trial (NCT04219254; KEYNOTE-A04) of the novel anti-FcyRIIB antibody BI-1206 in combination with KEYTRUDA® (pembrolizumab), MSD’s (Merck & Co., Inc., Rahway, NJ., USA) anti-PD-1 therapy, in solid tumors.
The additional patients have been treated at a dose of 1 mg/kg. Previous observations had revealed that BI-1206 may enhance the activity of pembrolizumab in patients who have previously progressed on PD-1/PDL-1 targeting therapies.
In addition to the patients previously reported, (1 case of pseudo progression and 1 partial response (PR), new data now show one patient experiencing a long-lasting stable disease, with more than 80 weeks of treatment in the study, and another patient experiencing a PR. Both patients have melanoma, and both had previously been treated with immune checkpoint inhibitors. The latter had progressed after previous lines of those agents. The first PR observed is still responding and has been on treatment for more than 90 weeks. BioInvent will share additional updates from the IV arm of the trial during the second half of 2023.
The study is recruiting patients with advanced solid tumors who had progressed on prior treatments including PD-1/PD-L1 immune checkpoint inhibitors. Patients receive a three-week cycle of BI-1206 in combination with pembrolizumab for up to two years, or until disease progression. A second Phase 1/2 trial of BI-1206, in combination with rituximab in non-Hodgkin’s lymphoma (NHL), is also continuing.
“These new data further reinforce the promising profile of BI-1206, which we are now also investigating with a more flexible subcutaneous method of administration. We believe BI-1206 has the potential to significantly improve treatment and look forward to moving it towards market, along with the rest of our highly exciting clinical pipeline, to improve the lives of cancer patients,” said Martin Welschof, CEO of BioInvent.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
BioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently four drug candidates in five ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors, respectively. The Company's validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities.
The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at www.bioinvent.com. Follow on Twitter: @BioInvent.
For further information, please contact:
Cecilia Hofvander, Senior Director Investor Relations
Phone: +46 (0)46 286 85 50
Email: [email protected]
BioInvent International AB (publ)
Co. Reg. No. Org nr: 556537-7263
Visiting address: Ideongatan 1
Mailing address: 223 70 LUND
Phone: +46 (0)46 286 85 50
The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as 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 outcome may deviate significantly from the scenarios described in this press release.