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.
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
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 information was submitted for publication at 08:30 a.m. CEST on April 7, 2021.