Monomethyl auristatin

Pyxis Oncology Announces FDA Clearance of Two IND Applications

Retrieved on: 
Thursday, December 1, 2022

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.

Key Points: 
  • 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.
  • 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.
  • Pyxis Oncology, Inc. is a clinical stage company focused on defeating difficult-to-treat cancers.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. and Levena Biopharma, a Sorrento Company, are to Present Positive Clinical Progress of A166, an Anti-HER2 ADC, in Treating Locally Advanced or Metastatic HER2-Positive Breast Cancer Patients at the ASCO 20

Retrieved on: 
Wednesday, June 1, 2022

Of 23 patients treated at 4.8 mg/kg cohort, one had a confirmed and sustained complete response (CR) lasting 7+ months.

Key Points: 
  • Of 23 patients treated at 4.8 mg/kg cohort, one had a confirmed and sustained complete response (CR) lasting 7+ months.
  • At the upcoming 2022 ASCO meeting, Kelun-Biotech will report updated data from this Phase 1 trial (Abstract #1037 and Poster #415).
  • Of 23 patients treated in the 4.8 mg/kg cohort, one had a confirmed and sustained CR lasting 7+ months.
  • ZTlido is a registered trademark owned by Scilex Pharmaceuticals Inc.
    All other trademarks are the property of their respective owners.