On December 1, 2022 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical stage company focused on developing next-generation therapeutics to target difficult-to-treat cancers, reported 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 (Press release, Pyxis Oncology, DEC 1, 2022, View Source [SID1234624692]). PYX-106, an immunotherapy product candidate, will be investigated for the potential treatment of solid tumors, including bladder, cholangio-carcinoma, colorectal, and kidney cancer.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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."
About PYX-201-101
The first-in-human trial of PYX-201 will be a dose escalation trial to determine the recommended phase 2 dose. The study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in patients with solid tumors known to have significant expression of EDB of fibronectin.
About PYX-106-101
The first-in-human trial of PYX-106 will be a dose escalation trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in patients with tumors known to have significant infiltration of M2 macrophages and expression of Siglec-15 in order to determine the recommended phase 2 dose.
About PYX-201
PYX-201 is a non-internalizing ADC product candidate that binds to extradomain-B (EDB) fibronectin, an integral component of the extracellular matrix in the tumor that is overexpressed in many malignancies and is minimally expressed in most normal adult tissues. As shown in patient-derived xenograft (PDX) model studies of NSCLC and pancreatic cancer, its highly cell-permeable auristatin payload is enzymatically released after binding, which directly attacks cancer cells and other components that form the supportive tumor infrastructure. Auristatin elicits an antitumor immune response by inducing immunogenic cell death and dendritic cell maturation. While its effects are primarily due to its non-internalizing activity, a fraction of PYX-201 may also be internalized, further enhancing its antitumor activity.
About PYX-106
PYX-106 is an immunotherapy product candidate in development that blocks the activity of Siglec-15, an emerging immune suppressor expressed across a broad range of tumors. Siglec-15 expression does not overlap with one of the most common targets in immuno-oncology, PD-1, supporting its potential use alone and in combination with current immunotherapies. PYX-106 may benefit patients who do not respond to current standards of care. In preclinical studies, PYX-106 has demonstrated broad immune activation, strong binding affinity, and a 7-day half-life. Cumulatively, these advantages may translate to superior anticancer activity and more flexible dosing regimens.