drugset / Press release

BioInvent receives IND approval for Phase I/IIa trial of anti-TNFR2 antibody BI-1808

2021-04-07 · BioInvent International AB · original bioinvent.com ↗

Study explores potential in solid tumors and cutaneous T-cell lymphoma BI-1808 is one of three BioInvent drug candidates in clinical development Lund, Sweden - April 7, 2021 - BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) for the Phase I/IIa clinical study of the immuno-modulatory anti-TNFR2 antibody BI-1808. "FDA approval of the Phase I/IIa study of BI-1808 is another important milestone for BioInvent as we continue to broaden our exciting pipeline of anti-cancer antibodies. TNFR2 is increasingly attracting interest as revealed by the recent deals in the field. The development of BI-1808 is supported by an impressive set of preclinical data and is one of three BioInvent lead candidates in clinical development," said Martin Welschof, CEO of BioInvent. The Phase I/IIa study will evaluate the safety, tolerability, and potential signs of efficacy of BI-1808 as a single agent, and in combination with the anti-PD-1 therapy Keytruda ® in patients with ovarian cancer, non-small cell lung cancer and CTCL. It is planned to be carried out in the U.S., Denmark, Hungary, the United Kingdom and Russia and is already enrolling patients. The anti-TNFR2 antibody BI-1808 is a first-in-class drug candidate and is part of BioInvent's tumor-associated regulatory T cells (Treg)-targeting program. This has emerged from the F.I.R.S.T™ platform technology that simultaneously identifies new targets and high-quality antibodies, generating promising new drug candidates to target the tumor microenvironment (TME). TNFR2 is particularly upregulated on Tregs of the TME and has been shown to be important for tumor expansion and survival, representing a new and promising target for cancer immunotherapies. 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 three drug candidates in four ongoing clinical programs in Phase l/ll trials for the treatment of hematological cancer and solid tumors, respectively. The Company's validated, proprietary F.I.R.S.T™ technology platform simultaneously 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 or for additional licensing and partnering. 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 . For further information, please contact: Cecilia Hofvander Mary-Ann Chang, LifeSci Advisors Senior Director Investor Relations +44 7483 284853 +46 (0)46 286 85 50 [email protected] [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 www.bioinvent.com The information was submitted for publication at 08:30 a.m. CEST on April 7, 2021.

The release as fetched from its publisher. bioinvent.com ↗