BI-1206 in combination with pembrolizumab leads to responses in melanoma patients who previously failed on anti-PD1 therapy.
Lund, Sweden – May 23, 2024 – 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 announced promising Phase 1 data for BI-1206 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in heavily pre-treated patients with solid tumors. The data show promising and durable responses in patients who previously failed on anti-PD-1/L1 therapy. The combination was well-tolerated in this heavily pre-treated population of patients. The data will be presented in a poster at the 2024 ASCO Annual Meeting (ASCO 2024) held in Chicago, Illinois from May 31 to June 4, 2024.
“The number of targets available for antibody therapy is still limited and there is a high unmet medical need for new treatment options since the vast majority of patients do not respond or stop responding to current treatments. We believe that BI-1206 has the potential to be used in combination with CPIs to overcome immunotherapy drug resistance through its unique anti-FcyRIIB action,” said Martin Welschof, Chief Executive Officer of BioInvent.
BioInvent’s Chief Medical Officer Andres McAllister added, “The ability to induce responses in heavily pre-treated patients, including two durable responses and a stable disease lasting for more than 24 months, is encouraging and supports the importance of blocking FcyRIIB to enhance the activity of immune checkpoint inhibitors.”
The data announced today also show that the subcutaneous (SC) administration of BI-1206, being developed in parallel to the IV administration, was well tolerated with no notable injection reactions. SC administration led to extended target coverage and shows great promise to provide a further extended duration of receptor occupancy with increased tolerability. SC dose escalation is still ongoing.
Poster summary:
The Phase 1/2a trial is performed in previously treated patients with advanced solid tumors to assess the safety and tolerability of BI-1206 in combination with pembrolizumab at ascending intravenous (IV) and subcutaneous (SC) doses.
Safety and efficacy
An IV dose level (RP2D) has been selected for signal seeking in the subsequent Phase 2a study, while appropriate dose for use of SC in Phase 2a will be determined after completion of dose escalation. The Phase 2a part will include three expansion cohorts at the RP2D, each comprising a specific subset of subjects with advanced solid tumors (e.g., NSCLC, melanoma, and other tumors responsive to PD-1/PD-L1 inhibition).
Poster title: Phase 1/2a Clinical Trial of BI-1206, an Anti-CD32b (FcγRIIB) Antibody, in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors Previously Treated with Anti-PD-1/PD-L1
Abstract Number: 2593
Session: Developmental Therapeutics – Immunotherapy
Date: June 1, 2024
Time: 9:00 AM-12:00 PM CDT
The full poster will be posted to the company’s website https://www.bioinvent.com/en/our-science/scientific-publications shortly after the presentation.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About BioInvent
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 five drug candidates in six ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. 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 immune-modulatory 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 the social media platform X: @BioInvent.
For further information, please contact:
Cecilia Hofvander, Senior Director Investor Relations
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Email: cecilia.hofvander@bioinvent.com
BioInvent International AB (publ)
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www.bioinvent.com
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