SOUTH SAN FRANCISCO, CALIFORNIA, January 21, 2021 / PRNewswire / – Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development, and manufacture company that focuses today on the application of precise protein engineering and rational designs to the next-generation of cancer and autoimmune therapeutics Generation Focused announced the dosing of the first patient in the dose-expansion cohort of the Phase 1 STRO-002 study. STRO-002 is an in-house developed folate receptor alpha (FolRα) that targets the antibody-drug conjugate (ADC) for the potential treatment of ovarian cancer. The dose-expansion cohort evaluates the efficacy, safety and tolerability of STRO-002 at 4.3 and 5.2 mg / kg given every 3 weeks in patients with ovarian cancer. The dose expansion cohort for FolRα-selected endometrial cancer is planned for the end of this year.
“We are excited to advance the clinical development of STRO-002 in dose-escalation studies. The results of our STRO-002 dose escalation in a heavily pretreated ovarian cancer patient population showed improved results in RECIST response and duration of response,” he told DR. Arturo Molina, Chief Medical Officer of Sutro Biopharma. “Sutro plans to expand the study to approximately 35 clinical sites in the US and US Europe. We are confident that the dose-widening study will validate the preliminary signs of efficacy we saw in the dose escalation and provide valuable data on the treatment paradigm and patient population who will benefit from treatment, leading us to offer an important new one step brings closer possible treatment option for patients with ovarian cancer. “
DR. Lainie Martin, Head of the Gynecology / Oncology program at the hospital of University of Pennsylvania and a researcher on the STRO-002-GM1 study said, “STRO-002 continues to be well tolerated and we have seen encouraging preliminary activity in patients with advanced platinum-resistant and refractory ovarian cancer. We are excited to be a part of the STRO- 002-GM1 dose expansion study and the provision of additional clinical data to demonstrate the potential of this therapeutic for ovarian patients with limited treatment options. “
The dose-widening study includes two patient cohorts, advanced epithelial ovarian cancer and endometrial cancer. The ovarian cancer cohort currently enrolled includes patients with platinum-resistant disease who have previously received 1-3 or platinum-sensitive patients who have received 2-3 prior treatment regimens. Patients in the dose expansion cohort of the STRO-002-GM1 phase 1 study will be randomized 1: 1 and given IV or 5.2 mg / kg of STRO-002 every three weeks. Patients will not be pre-selected for FolRα expression and a fresh or archived tumor tissue sample is required for immunohistochemical (IHC) analysis of FolRα expression.
Further information on the study can be found at: https://clinicaltrials.gov/ct2/show/NCT03748186
About the phase 1 study of STRO-002 in ovarian cancer
STRO-002-GM1, the Phase 1 open-label, dose-escalation, multicenter dose escalation study of STRO-002, has completed registration. Follow-up is ongoing and will continue to evaluate the safety, tolerability and preliminary antitumor activity of STRO-002 in adults with advanced epithelial ovarian cancer, including fallopian tubes and primary peritoneal cancer. The study is registered under the ID NCT03748186 from clinicaltrials.gov. Sutro discovered, developed, and manufactured STRO-002 using its proprietary XpressCF® cell-free protein synthesis and XpressCF + ™ site-specific conjugation technologies.
About Sutro Biopharma
Sutro Biopharma, Inc. based in South San Franciscois a clinical-stage drug discovery, development and manufacturing company. With precise protein engineering and rational design, Sutro is driving the next generation of oncology therapeutics.
Sutro’s proprietary and integrated cell-free protein synthesis platform XpressCF® and the site-specific conjugation platform XpressCF + ™ led to the discovery of STRO-001 and STRO-002, Sutro’s first two in-house ADCs. STRO-001 is a CD74-targeted ADC currently in a Phase 1 clinical trial in patients with advanced B-cell cancers, including multiple myeloma and non-Hodgkin lymphoma. STRO-001 has been granted orphan drug designation for multiple myeloma by the FDA October 2018. STRO-002 is a folate receptor alpha (FolRα) target ADC currently in a Phase 1 clinical trial in patients with ovarian and endometrial cancer. This is the second product candidate to be evaluated in clinical trials based on Sutro’s XpressCF® and XpressCF + ™ technology platforms. A third program, CC-99712 (BCMA-Targeting ADC), which is part of Sutro’s collaboration with Bristol Myers Squibb (formerly Celgene Corporation), is enrolling patients in the Phase 1 clinical trial in patients with multiple myeloma. Sutro’s proprietary technology was responsible for the discovery and manufacture of CC-99712, which Bristol Myers Squibb holds worldwide development and marketing rights. Sutro is entitled to development and regulatory milestone payments and tiered royalties from Bristol Myers Squibb for this BCMA ADC. Sutro is committed to transforming the lives of cancer patients by developing drugs with improved therapeutic profiles for areas where there is no need.
To date, Sutro’s platform has resulted in cytokine-based immuno-oncology therapies, ADCs, vaccines and bispecific antibodies that target precedents in clinical indications where current standards of care are not optimal.
The platform makes it possible to accelerate the discovery and development of potential first-class and first-class molecules through rapid and systematic evaluation of the protein structure-activity relationships in order to create optimized homogeneous product candidates.
In addition to developing its own oncology pipeline, Sutro works with selected pharmaceutical and biotech companies to discover and develop novel next-generation therapeutics. As the pace of clinical development accelerates, Sutro and partners are developing therapeutics that can kill tumors more efficiently without harming healthy cells.
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, statements by the Company regarding anticipated preclinical and clinical development activities, as well as clinical development studies and announcements of clinical results, potential benefits of the company’s product candidates and platform, and potential market opportunities for the company’s product candidates. All statements other than statements of historical fact are statements that may be viewed as forward-looking statements. Although the company believes that the expectations contained in such forward-looking statements are reasonable, the company cannot guarantee future events, results, measures, levels of activity, performance or success, and the timing and results of developments in biotechnology and the potential regulatory approvals are inherently uncertain. Forward-looking statements are subject to risks and uncertainties that could cause the company’s actual activities or results to differ materially from those expressed in any forward-looking statements, including risks and uncertainties relating to the company’s ability to advance its product candidates, sustained and results Timing of potential regulatory names, approvals and commercialization of product candidates, impact of the COVID-19 pandemic on the company’s business, clinical trial locations, supply chain and manufacturing facilities, ability of the company to maintain and recognize the benefits of certain names received by Product candidates, timing and results of preclinical and clinical studies, the company’s ability to fund development activities and achieve development goals, the company’s ability to use intellectual property, e.g. u, and the Company’s commercial relationships with third parties; and other risks and uncertainties described under the heading, “Risk Factor ors” in documents the Company from time to time files 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 of this press release.
Annie j chang
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