BioNova Announces First Patient Dosed in a Phase 1/2 Study of BN301 for the Treatment of Hematologic Malignancies in China

Feb 13, 2023

SHANGHAI, China, February. 9, 2023 – BioNova Pharmaceuticals Limited (BioNova), a company dedicated to the discovery, development and commercialization of innovative medicines for the treatment of diseases with unmet medical needs, today announced that the first patient has been dosed in the phase 1 clinical study of BN301 (STRO-001) for the treatment of advanced B-cell Non-Hodgkin’s Lymphoma (NHL).

BN301 is a novel target, site-specific antibody drug conjugate (ADC) comprised of a human aglycosylated anti-CD74 IgG1 antibody and 2 non-cleavable maytansinoid drug-linkers. BN301/STRO-001 was granted Orphan Drug Designation by the US FDA for multiplemyeloma in October 2018. Through a licensing agreement with Sutro Biopharma, Inc. (Sutro, NASDAQ: STRO) in October 2021, BioNova gained the option to obtain exclusive rights to develop and commercialize BN301 in Greater China territory, includingmainland China, Hong Kong, Macau and Taiwan.

The multi-center Phase 1/2 clinical trial of BN301 is to evaluate BN301 in patients with B-cell NHL who have previously failed standard therapy or who are intolerant to standard therapy. This study is comprised of a Phase 1 dose escalation part and a Phase 2dose expansion part.

“We are very pleased with the Sutro collaboration and very excited about this important milestone for BN301 global development.” said Ye Hua, M.D., Founder and CEO of BioNova, “Patients with relapsed/refractory NHL have limited treatment options and their prognosis are usually poor. We are hopeful that this novel target ADC could provide those patients with a potential new treatment option. Together with Sutro colleagues, our development team is working diligently and efficiently to advance BN301 clinical development program in China.” 

About BioNova

BioNova Pharmaceuticals Limited is a privately held clinical-stage biopharmaceutical company dedicated to the development and commercialization of innovative medicines for cancer and other life-threatening diseases with high unmet medical needs. Headquartered in Shanghai, BioNova is a fast-growing company of which robust pipeline is built upon internal R&D programs,collaborations with and acquisitions from partners of cutting-edge technology. With a highly capable and experienced team in combination with substantial funding, BioNova is committed to delivering high-quality innovative medicines to patients in China and globally.

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