Sutro Biopharma and BioNova Pharmaceuticals Enter into Collaboration for STRO-001 in Greater China
SAN FRANCISCO and SHANGHAI, Oct. 12, 2021 /PRNewswire/ -- 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, today jointly announced 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.
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."
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.
About Sutro Biopharma
Sutro Biopharma, Inc., located in South San Francisco, is a clinical-stage drug discovery, development, and manufacturing company. Using precise protein engineering and rational design, Sutro is advancing next-generation oncology therapeutics.
Sutro's proprietary and integrated cell-free protein synthesis platform XpressCF® and site-specific conjugation platform XpressCF+™ led to the discovery of STRO-001 and STRO-002, Sutro's first two internally-developed ADCs. STRO-001 is a CD74-targeting ADC currently under investigation in a Phase 1 clinical trial for patients with advanced B-cell malignancies, and was granted Orphan Drug Designation by the FDA for multiple myeloma. STRO-002, a folate receptor alpha (FolRα)-targeting ADC, is currently being investigated in a Phase 1 clinical trial for patients with ovarian and endometrial cancers and was granted Fast Track designation by the FDA for ovarian cancer. A third product candidate, CC-99712, a BCMA-targeting ADC, which is part of Sutro's collaboration with Bristol Myers Squibb, formerly Celgene Corporation, is enrolling patients for its Phase 1 clinical trial of patients with multiple myeloma and has received Orphan Drug Designation from the FDA. A fourth product candidate, M1231, a MUC1-EGFR, first-in-class bispecific ADC, which is part of Sutro's collaboration with Merck KGaA, Darmstadt, Germany, known as EMD Serono in the U.S. and Canada (EMD Serono), is enrolling patients for its Phase 1 clinical trial of patients with metastatic solid tumors, non-small cell lung cancer (NSCLC) and esophageal squamous cell carcinoma. These four product candidates above being evaluated in clinical trials resulted from Sutro's XpressCF® and XpressCF+™ technology platforms. Bristol Myers Squibb and EMD Serono have worldwide development and commercialization rights for CC-99712 and M1231, respectively, for which Sutro is entitled to milestone or contingent payments and tiered royalties.
Sutro is dedicated to transforming the lives of cancer patients by creating medicines with improved therapeutic profiles for areas of unmet need. To date, Sutro's platform has led to ADCs, bispecific antibodies, cytokine-based immuno-oncology therapies, and vaccines directed at precedented targets in clinical indications where the current standard of care is suboptimal.
The platform allows it to accelerate discovery and development of potential first-in-class and best-in-class molecules through rapid and systematic evaluation of protein structure-activity relationships to create optimized homogeneous product candidates. In addition to developing its own oncology pipeline, Sutro is collaborating with select pharmaceutical and biotech companies to discover and develop novel, next-generation therapeutics.
Follow Sutro on Twitter, @Sutrobio, and at www.sutrobio.com to learn more about our passion for changing the future of oncology.
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. For further information, please refer to https://www.bionovapharma.com
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated development activities, potential benefits of the company's product candidates and platform, potential future milestone and royalty payments, and potential market opportunities for the company's product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although the company believes that the expectations reflected in such forward-looking statements are reasonable, the company cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause the company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company's ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, the impact of the COVID-19 pandemic on the Company's business, clinical trial sites, supply chain and manufacturing facilities, the Company's ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, the Company's ability to fund development activities and achieve development goals, the Company's ability to protect intellectual property, the value of the Company's holdings of Vaxcyte common stock, and the Company's commercial collaborations with third parties and other risks and uncertainties described under the heading "Risk Factors" in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
Annie J. Chang
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SOURCE Sutro Biopharma
Released October 12, 2021