Pyxis gets IND clearance from FDA for ADC and immunotherapy candidates

By Jane Byrne

- Last updated on GMT

© GettyImages/Andrew Brookes
© GettyImages/Andrew Brookes

Related tags Antibody drug conjugate Immunotherapy Cancer Clinical trials

Pyxis Oncology has received clearance for two IND applications from the US Food and Drug Administration (FDA) to initiate two Phase 1 clinical studies.

Those trials are set to begin early next year - they will evaluate the safety and anti-tumor activity of PYX-201, an antibody-drug conjugate (ADC) candidate, and PYX-106, an immunotherapy candidate.

PYX-201 will be investigated for the treatment of several solid tumors, including breast, head and neck, lung, and thyroid cancer, while PYX-106 will also be evaluated in relation to solid tumors linked to bladder, cholangio-carcinoma, colorectal, and kidney cancers.

This regulatory milestone marks Pyxis' transition to a clinical stage company and highlights the strength of the management team, who simultaneously advanced two programs to the clinic, said Dr Lara Sullivan, CEO, of the Cambridge, Massachusetts firm. “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.”

PYX-201 is based off intellectual property from Pfizer. In March 2021, Pyxis entered into a worldwide license agreement with that pharma giant for the development and commercialization of two ADC candidates and a license to Pfizer’s ADC technology platform. The Boston-based company recently expanded that licensing deal – it now has the flexibility to sublicense either the full platform or certain components only to third parties. And Pyxis confirmed it has concluded its first multi-target sublicensing deal under that new arrangement with a stealth ADC player.

“Our team believes in the potential of marrying internal and external development strategies to accelerate promising therapeutics for patients with difficult-to-treat cancers​,” said Dr Sullivan, in November. “In addition to strengthening our current partnerships, we see a significant opportunity to leverage our strong balance sheet and our team’s extensive industry networks to explore new avenues of scientific and therapeutic advancement.”

New class of ADCs

Jay Feingold, CMO at Pyxis, said 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 non-small cell lung cancer (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, which 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, he continued.

“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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