Drugs

Orphan Status for Pyxis Pancreatic Cancer Therapy

FDA has granted Pyxis Oncology an orphan drug designation for PYX-201 in pancreatic cancer. The company says subject dosing is already underway in a Phase 1 trial known as PYX-201-101. Preliminary data from the trial is expected in early 2024.

PYX-201 is described by Pyxis as a novel antibody-drug conjugate product licensed from Pfizer. It is designed to target extradomain-B (EDB) of fibronectin, a non-internalizing antigen, that is an integral component of the extracellular matrix in tumors. “EDB fibronectin is overexpressed in many solid tumors and minimally expressed in most normal adult tissues,” Pyxis says.

Once PYX-201 binds to EDB fibronectin, “a potent auristatin-derived payload is cleaved and diffuses across adjacent tumor cell membranes and surrounding supportive tumor infrastructures, including fibroblasts and tumor vasculature,” the company explains. PYX-201 also engages anti-tumor immunogenic activity “by promoting dendritic cell maturation and inducing immunogenic cell death, which could provide a rationale for the evaluation of combination-based approaches with immuno-oncology products, including checkpoint inhibitors,” it adds.

The Phase 1 trial is an open-label, multicenter, dose-escalation trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of PYX-201 and identify recommended doses for further study. “Patients with relapsed or refractory solid tumors, including non-small cell lung cancer, hormone receptor-positive breast cancer, ovarian cancer, thyroid cancer, pancreatic ductal adenocarcinoma, soft tissue sarcoma, hepatocellular carcinoma or kidney cancer are eligible to enroll,” the company says.

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