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Sutro (STRO) Ovarian Cancer Drug Gets FDA's Fast Track Tag
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Sutro Biopharma (STRO - Free Report) announced that the FDA has granted Fast Track designation to its drug STRO-002, a folate receptor (“FR”) alpha-targeting antibody-drug conjugate (“ADC”), to treat advanced ovarian cancer in patients who have received one to three prior lines of systemic therapy.
Fast Track is designed to facilitate the development, and speed up the review of drugs to treat serious conditions and fill an unmet medical need. STRO-002’s fast track designation has been granted based on the drug’s potential as a second-line to fourth-line treatment for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
In the year so far, Sutro’s stock has declined 14.5% against the industry’s 0.9% growth.
Image Source: Zacks Investment Research
STRO-002 is being evaluated in a phase I study — STRO-001-GM1 — to assess its efficacy, safety and tolerability for advanced ovarian cancer patients whose disease has relapsed after standard of care treatments. As part of the study, the candidate has completed a dose-escalation cohort and is currently enrolling patients for a dose-expansion cohort. The patients will be randomized in two equal groups and treated with STRO-002 at either 4.3 or 5.2 mg/kg every three weeks.
Apart from STRO-002, the company is also developing several pipeline candidates in early-stage studies. STRO-001, an ADC candidate, was granted Orphan Drug designation by the FDA for the treatment of multiple myeloma. The company is also collaborating with Bristol Myers Squibb (BMY - Free Report) to develop CC-99712, a BCMA-targeting ADC, which has also received Orphan Drug designation from the FDA to treat multiple myeloma.
Please note that Sutro’s pipeline candidates are developed using its proprietary and integrated cell-free protein synthesis platform, XpressCF, as well as site-specific conjugation platform, XpressCF+.
Immunogen is also developing its lead candidate, mirvetuximab soravtansine, in multiple late-stage clinical studies, both as a monotherapy for platinum-resistant ovarian cancer with FR alpha-high, and in combination regimens for both platinum-resistant and platinum-sensitive ovarian cancer.
Moderna’s earnings per share estimates for 2021 have increased from $25.19 to $29.04 in the past 30 days. The same for 2022 has risen from $17.71 to $22.26 over the same period. The stock has rallied 281.7% in the year so far.
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Sutro (STRO) Ovarian Cancer Drug Gets FDA's Fast Track Tag
Sutro Biopharma (STRO - Free Report) announced that the FDA has granted Fast Track designation to its drug STRO-002, a folate receptor (“FR”) alpha-targeting antibody-drug conjugate (“ADC”), to treat advanced ovarian cancer in patients who have received one to three prior lines of systemic therapy.
Fast Track is designed to facilitate the development, and speed up the review of drugs to treat serious conditions and fill an unmet medical need. STRO-002’s fast track designation has been granted based on the drug’s potential as a second-line to fourth-line treatment for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
In the year so far, Sutro’s stock has declined 14.5% against the industry’s 0.9% growth.
Image Source: Zacks Investment Research
STRO-002 is being evaluated in a phase I study — STRO-001-GM1 — to assess its efficacy, safety and tolerability for advanced ovarian cancer patients whose disease has relapsed after standard of care treatments. As part of the study, the candidate has completed a dose-escalation cohort and is currently enrolling patients for a dose-expansion cohort. The patients will be randomized in two equal groups and treated with STRO-002 at either 4.3 or 5.2 mg/kg every three weeks.
Apart from STRO-002, the company is also developing several pipeline candidates in early-stage studies. STRO-001, an ADC candidate, was granted Orphan Drug designation by the FDA for the treatment of multiple myeloma. The company is also collaborating with Bristol Myers Squibb (BMY - Free Report) to develop CC-99712, a BCMA-targeting ADC, which has also received Orphan Drug designation from the FDA to treat multiple myeloma.
Please note that Sutro’s pipeline candidates are developed using its proprietary and integrated cell-free protein synthesis platform, XpressCF, as well as site-specific conjugation platform, XpressCF+.
Immunogen is also developing its lead candidate, mirvetuximab soravtansine, in multiple late-stage clinical studies, both as a monotherapy for platinum-resistant ovarian cancer with FR alpha-high, and in combination regimens for both platinum-resistant and platinum-sensitive ovarian cancer.
Sutro Biopharma, Inc. Price
Sutro Biopharma, Inc. price | Sutro Biopharma, Inc. Quote
Zacks Rank & Stock to Consider
Sutro Biopharma currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the same sector is Moderna (MRNA - Free Report) , which holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Moderna’s earnings per share estimates for 2021 have increased from $25.19 to $29.04 in the past 30 days. The same for 2022 has risen from $17.71 to $22.26 over the same period. The stock has rallied 281.7% in the year so far.