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Sarcoma is not one of the many cancers that reaches top billing in the discussion of cancer research.
The cancer starts in tissues like bone, muscle or soft tissue and affects a relatively small, 12,000 Americans a year. That smaller sampling of cancer patients is precisely why TRACON Pharmaceuticals (NASDAQ: TCON) is currently focusing on the development of cancer therapeutics for Sarcoma.
TRACON, based in San Diego, California, is a clinical-stage biopharmaceutical company developing and commercializing novel targeted cancer therapeutics. So why is the company focused on Sarcoma, which affects relatively few Americans? According to company Chief Financial Officer Scott Brown, it’s about accelerating the approval process.
“We are on a fast track to market and win approval in a relatively small patient environment,” Brown said. “If you’re working in the lung and breast cancer realm, you need to recruit a ton of patients and FDA (U.S. Food and Drug Administration) approval could take forever.”
TRACON is working to revolutionize a subcutaneous injection during treatment, much like a flu shot but administered by the oncologist. TRACON believes the injections are quicker, safer and more patient friendly while lessening the chance of an infusion reaction. Reactions can develop during administration of a drug such as chemotherapy, and symptoms including pruritus, urticaria, fever, rigors/chills, diaphoresis, bronchospasms and cardiovascular collapse may occur.
The FDA granted Orphan Drug designation to envafolimab, a novel, single-domain antibody against PD-L1, for the treatment of patients with soft tissue sarcoma. The designation is granted by the FDA to drugs or biologics intended to treat a rare disease or condition, defined as one that affects fewer than 200,000 people in the United States. Programs that receive the status get a partial tax credit for clinical trial expenditures, waived user fees and 7-year eligibility for marketing exclusivity.
The Independent Data Monitoring Committee (IDMC) for the TRACON ENVASARC pivotal trial has recommended that the trial proceed as planned following a 12-week review of safety data from more than 20 patients enrolled in a May 2021 trial. The safety data reviewed included data from more than 10 patients enrolled into Cohort A of treatment with single-agent envafolimab and more than 10 patients enrolled into Cohort B of treatment with envafolimab and Yervoy (ipilimumab).
“Envafolimab continues to be well tolerated as a single agent and when combined with Yervoy in refractory sarcoma patients who are enrolled in the ENVASARC trial,” TRACON Chief Medical Officer Dr. James Freddo said. “We remain on track for the IDMC to review interim efficacy data in the 4th quarter of this year.”
Envafolimab is a novel, single-domain antibody against PD-L1, which is a protein that acts as a type of brake keeping immune responses under control. Envafolimab is the 1st subcutaneously injected PD-(L)1 inhibitor to be studied in pivotal trials and is also being studied in the ENVASARC Phase 2 pivotal trial in the U.S. sponsored by TRACON.
For more information on TRACON, go to www.traconpharma.com.
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