Clinical-stage Pyxis Oncology, a  company focused on developing antibody-drug conjugates (ADCs) and immune-oncology (IO) therapeutics to target difficult-to-treat cancers, is prioritizing the development of their investigational ADC, PYX-201,  a novel first-in-concept and first-in-class tumor stroma targeting ADC. Phase 1 trial progressing with fifth dose cohort at 3.6 mg/kg; data expected 1H 2024.

“We are excited to begin dosing in the fifth cohort of our Phase 1 trial of our lead asset PYX-201, a first-in-class and first-in-concept tumor stroma targeting ADC against EDB-fibronectin in tumor stroma. We believe the progress we are making through the dose escalation portion of our trial speaks to the potential safety profile of our ADC drug candidate,” said Lara S. Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology.

“Moreover, based on data from Pfizer’s HER2 ADC previously under development with the same linker and payload and our preclinical experiments, we believe that at 3.6 mg/kg and above, we are approaching biologically active dose levels,” said Lara S. Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology,” Sullivan added.

“In order to maximize PYX-201’s chances of success, as well as those of PYX-106, we are announcing a number of initiatives to extend our cash runway into 2026, which we believe is the responsible thing to do in the current funding environment. We believe the actions we are taking best position Pyxis Oncology for future success, with our current cash resources now taking us beyond important near-term 2024 readouts for our ongoing clinical trials,” she said.

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“In addition to the cost reductions, which include a 40% decrease in headcount, we are also seeking additional non-dilutive funding through the potential monetization of our acquired Apexigen royalty streams,” noted Pam Connealy, COO and CFO of Pyxis Oncology

“Additionally, we are evaluating partnerships of several assets that we have chosen not to move into the clinic and potential antibody and ADC platform technology collaborations. We believe this increased focus on our lead and secondary assets, in addition to the changes we are making to the PYX-106 program, gives us the best chance for success in bringing our novel ADC and IO candidates to the patients who need them. We appreciate the contributions from our dedicated team members that have enabled us to reach this point in our clinical programs,” Connealy added.

  • PYX-201: Fifth dose cohort open for enrollment in Phase 1 trial. To date, 15 subjects have been dosed with PYX-201 in the PYX-201-101 trial. The fifth dose cohort is expected to begin enrolling shortly and is planned to evaluate a 3.6 mg/kg dose administered once every three weeks. Management believes the efficient progression through dose escalation to date speaks to the potential safety profile of PYX-201, with preliminary Phase 1 data expected in 1H 2024.
  • PYX-106: Phase 1 trial now focusing on NSCLC and other tumor types. Following analyses of data from a competing anti-Siglec-15 clinical trial and a review of internally generated preclinical results, Pyxis Oncology has decided to focus on enrolling additional patients with specific tumor types, including non-small cell lung cancer, in its ongoing Phase 1 trial. Currently, dosing is ongoing in the second cohort at a dose of 1.0 mg/kg. As a result of this repositioning of the trial, preliminary data from the PYX-106-101 trial is now anticipated in 2H 2024. Importantly, the repositioning of the trial has not increased the cost of the study.

Clinical trials
Study of PYX-201 in Solid Tumors – NCT05720117
Study of PYX-106 in Solid Tumors – NCT05718557

[1] First Patient Dosed in Phase 1 Trial with Pyxis Oncology’s PYX-201 – ADC Review | J. Antibody-drug Conjugates; March 18, 2023 [Article]

Featured image Licensed under the Unsplash+ License.


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