Bill Newell, Chief Executive Officer of Sutro Biopharma, added, “Receiving Fast Track designation is an important recognition for STRO-002 as a potentially best-in-class FolRα ADC for women with ovarian cancer. We look forward to further collaboration with the FDA to bring this potentially important therapeutic option to women in advanced stages of their disease with limited treatment options.”
The Fast Track Designation
The FDA’s Fast Track designation intends to facilitate the development and review of drug candidates that treat serious conditions or life-threatening conditions and demonstrate the potential to address an unmet medical need. A drug candidate that receives Fast Track designation can expect more frequent interaction with the FDA to discuss the drug candidate’s development plan, the potential for accelerated approval, and the possibility of priority review, if relevant criteria are met at the time of submission of a Biologic Licensing Application (BLA).
STRO-002 Clinical Development
STRO-001-GM1 is a Phase 1 trial for STRO-002, assessing the safety, efficacy, and tolerability. for patients with advanced ovarian cancer that have progressed or relapsed after standard of care treatments. The dose-escalation cohort has been completed and the dose-expansion cohort has enrolled patients from sites in the U.S. and in Spain, with enrollment ongoing.
Patients are not pre-selected for FolRα expression but are required to provide a tissue sample for FolRα analysis prior to study treatment.
Patients are randomized 1:1 and treated with STRO-002 at either 4.3 or 5.2 mg/kg every three weeks.
About Sutro Biopharma Inc
Sutro Biopharma, Inc., is located in South San Francisco. It is clinical-stage drug discovery, development, and manufacturing company that uses precise protein engineering and rational design.
Sutro’s proprietary 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, a CD74-targeting ADC. This product is currently under investigation in a Phase 1 clinical trial for advanced B-cell malignancies. It was granted Orphan Drug Designation by the FDA for multiple myeloma.
STRO-002 is 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.
CC-99712, an ADC targeting BCMA, is part of Sutro’s collaboration with Bristol Myers Squibb, The trial is enrolling patients for its Phase 1 clinical trial for the treatment of multiple myeloma and has received Orphan Drug Designation from the FDA.
M1231 is a MUC1-EGFR, first-in-class bispecific ADC. It 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.
The aforementioned four product candidates are 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. Sutro is entitled to milestone or contingent payments and tiered royalties.
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 the firm to accelerate the 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.
It is obvious to us that Sutro Biopharma’s science is solid, the management is serious and responsible, and the products are unique and make sense, which is why the FDA saw a good possibility that STRO-002 can succeed where several other conventional treatments have failed, hence, granting the product a Fast Track designation.
Will Sutro Biopharma become part of the Prohost Portfolio?
The answer, and the reasons for it, will be in an upcoming comprehensive issue Prohost Letter.
Click here to read more about Sutro Biopharma.
The US FDA Granted Fast Track Designation for Sutro Biopharma Product STRO-002
Sutro Biopharma Inc Granted Fast Track Designation for STRO-002 by the US FDA
Sutro Biopharma Inc (STRO) announced that the U.S. FDA granted Fast Track designation for its STRO-002 – a folate receptor alpha (FolRα)-targeting antibody-drug conjugate (ADC), for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior lines of systemic therapy.
From the CMO & CEO of Sutro Biopharma Inc
Dr. Arturo Molina, Chief Medical Officer of Sutro Biopharma Inc expressed the firm’s pleasure with the FDA’s decision, as it opens the door to more frequent interactions with the agency.
Dr. Molina said, “We continue to be enthused by the potential of the STRO-002 program, which has shown encouraging preliminary activity and tolerability in our Phase 1 dose-escalation study in ovarian cancer, and plan to continue to work with the FDA to potentially accelerate our clinical and regulatory efforts.”