On October 12, 2021 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, and 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, reported an option agreement for BioNova to develop and commercialize STRO-001, a CD74-targeting Antibody-Drug Conjugate (ADC), for patients with hematologic cancers, in Greater China, including mainland China, Hong Kong, Macau and Taiwan (Press release, Sutro Biopharma, OCT 12, 2021, View Source [SID1234591100]).
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Under the terms of the agreement, BioNova has the option to obtain exclusive rights to develop and commercialize STRO-001 in Greater China. BioNova will pursue the clinical development, regulatory approval, and commercialization of STRO-001 in multiple indications, including non-Hodgkin’s lymphoma, multiple myeloma, and leukemia in the licensed territory. Sutro will retain development and commercial rights of STRO-001 globally outside of Greater China, including the United States. BioNova will pay to Sutro an initial licensing option payment of $4 million, with potential payments totaling up to $200 million related to option exercise, development, regulatory, and commercial milestones. Sutro will provide STRO-001 to BioNova under appropriate clinical and commercial supply service agreements. Upon commercialization, Sutro will receive tiered, double-digit royalties based on annual net sales of STRO-001 in Greater China.
"This strategic partnership of STRO-001 at this stage of its clinical development demonstrates the shared vision of Sutro and BioNova of the potential for this promising ADC," said Bill Newell, Chief Executive Officer of Sutro. "We believe BioNova is an ideal partner, having demonstrated success in business and clinical development and backed by marquee healthcare investors, to realize the potential for STRO-001 in multiple hematological cancers in Greater China, where there is a large unmet medical need."
"We are excited for the therapeutic potential of STRO-001 to be studied in new hematological cancers and in earlier disease settings," said Arturo Molina, Chief Medical Officer of Sutro. "In our clinical studies in the United States, we are exploring STRO-001 as a treatment for patients in later stages of multiple myeloma and non-Hodgkin’s lymphoma, including diffuse large B-cell lymphoma, mantle cell lymphoma, and follicular lymphoma. We are approaching optimized dose levels in our dose-escalation trial—5.0 mg/kg in the multiple myeloma cohort and 4.2mg/kg in the non-Hodgkin’s lymphoma cohort."
Ye Hua, MD, MPH, founder, Chairman and Chief Executive Officer of BioNova added, "We are excited to collaborate with Sutro, a leading ADC technology company with a proprietary protein synthesis platform, to develop and commercialize STRO-001 in Greater China. STRO-001 has shown encouraging early efficacy signals and good tolerability profile in relapsed/refractory hematologic malignancies in the Phase 1 dose-escalation study. Given our strength in drug development in Greater China, we are committed to expedite the development of STRO-001 into Phase 2 expansion in multiple hematologic malignancies to fully explore the therapeutic potential of this ADC. The partnership further strengthens BioNova’s position in hematology and brings synergistic potential to our existing pipeline."
About STRO-001
STRO-001 is a CD74-targeting ADC, based on Sutro’s integrated cell-free protein synthesis and site-specific conjugation platform, XpressCF+, currently being investigated in a Phase 1 clinical trial. Sutro is currently enrolling patients with multiple myeloma and non-Hodgkin’s lymphoma in a dose-escalation trial and the maximum tolerated dose has not yet been reached. STRO-001 was granted Orphan Drug Designation by the FDA for multiple myeloma in October 2018.