Drugs

Curis Gets FDA Go Ahead for Anti-Vista Antibody

FDA has approved a Curis IND application for CI-8993, which it describes as the first-in-class monoclonal anti-Vista antibody. A Phase 1a/1b study of CI-8993 is planned for the second half of the year. The multi-center, open-label dose escalation study will evaluate about 50 patients.

“When activated, Vista plays a critical role in suppressing T cell activity,” the company says. “Conversely, it has been shown in preclinical studies that blocking Vista reduces the suppression of T cells and reactivates anti-tumor immune function.” Certain cancers, such as mesothelioma, triple negative breast cancer, non-small cell lung cancer, and gynecologic malignancies, are known to be highly driven by Vista, Curis says, and these cancers may be amenable to monotherapy treatment with anti-Vista therapy. In other cancers, it speculates that anti-Vista therapy may be more effective as part of a combination approach.

“Vista is independent of, and complementary to, other immune checkpoints, including PD1 and CTLA4,” it says. “Published studies have shown that Vista expression increases up to five-fold as a compensatory mechanism following anti-CTLA4 or anti-PD1 treatment. Further preclinical studies have explored this relationship more deeply and support the potential of combining anti-Vista therapy with anti-PD1 or anti-CTLA4 therapies.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome