Pyxis Oncology Announces FDA Clearance of Two IND Applications
FDA grants IND clearances of PYX-201, a novel antibody-drug conjugate (ADC) product candidate, and PYX-106, an immunotherapy product candidate
Phase 1 clinical trials of PYX-201 and PYX-106 will evaluate the safety and anti-tumor activity in patients with select solid tumors
Dual IND clearances represent achievement of significant 2022 milestones and executional pipeline advancement
Cash runway extended into first half 2025
CAMBRIDGE, Mass., Dec. 01, 2022 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical stage company focused on developing next-generation therapeutics to target difficult-to-treat cancers, announced today that it has received clearance for its two Investigational New Drug (IND) applications from the U.S. Food and Drug Administration (FDA) to initiate Phase 1 clinical trials. PYX-201, a novel antibody-drug conjugate (ADC) product candidate, will be investigated for the potential treatment of several solid tumors, including breast, head and neck, lung, and thyroid cancer. PYX-106, an immunotherapy product candidate, will be investigated for the potential treatment of solid tumors, including bladder, cholangio-carcinoma, colorectal, and kidney cancer.
“We are thrilled to receive two nearly simultaneous IND clearances from the FDA, representing a major moment as we transition to a clinical stage company demonstrating the operational prowess of our team,” said Lara Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. “We are proud of both the substantial clinical IND execution capabilities of our organization and the recent expansion of exclusivity of our ADC technology toolkit with Pfizer, both of which solidify Pyxis Oncology as a leading emerging clinical company. We believe the combination of our veteran leadership team and our cash runway into the first half of 2025 positions us to advance these potentially important therapies for patients who desperately need new options.”
Jay Feingold, M.D., Ph.D., Chief Medical Officer of Pyxis Oncology, added, "We are excited to advance multiple programs to the clinic. Both product candidates could potentially be applied to a broad range of tumors and address a significant need in the community. PYX-201 represents a new potential class of ADCs with a multifaceted mechanism of action which targets a component of the tumor microenvironment that is highly expressed in a variety of solid tumors. In patient-derived xenograft (PDX) model studies of NSCLC and pancreatic cancer, the ADC delivered a highly potent payload that was shown to attack the tumor and associated cells directly in a dose-dependent manner. PYX-106 is a potential immunotherapy that has demonstrated strong activity in preclinical studies and binds to an immune-regulatory receptor, Siglec-15, that has been shown to have an immune suppressive function and shares little overlap with the most prominent IO targets, the PD-1/PDL-1 pathway. The antibody's strong activity and its target's unique expression suggest that PYX-106 could be valuable in both mono and combination treatment settings for a broad range of tumors. We look forward to beginning both clinical trials in early 2023."
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