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Oncolytics Biotech Inc T.ONC

Alternate Symbol(s):  ONCY

Oncolytics Biotech Inc. is a biotechnology company. The Company is focused on developing pelareorep, an intravenously delivered immunotherapeutic agent that activates the innate and adaptive immune systems and weakens tumor defense mechanisms. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype turning cold tumors hot through innate and adaptive immune responses to treat a variety of cancers. This improves the ability of the immune system to fight cancer, making tumors more susceptible to a broad range of oncology treatments. The Company’s primary focus is to advance its programs in hormone receptor-positive / human epidermal growth factor 2- negative (HR+/HER2-) metastatic breast cancer and advanced/metastatic pancreatic ductal adenocarcinoma to phase 3 licensure-enabling studies. In addition, it is exploring opportunities for registrational programs in other gastrointestinal cancers through its GOBLET platform study.


TSX:ONC - Post by User

Comment by Noteableon May 17, 2023 11:05am
104 Views
Post# 35452436

RE:FDA issues Complete Response Letter to ADC biotech developer

RE:FDA issues Complete Response Letter to ADC biotech developerRepost on FDA decision to suspend Byondis' anti-body drug conjugate (ADC) approvability. 

May 15, 2023 - According to the complete response letter, the FDA suspends the decision on the Byondis' antibody drug conjugate (ADC) approvability. 

Byondis sought approval for its anti-HER2 antibody-drug conjugate (ADC) in HER2-positive unresectable locally advanced or metastatic breast cancer (MBC), a disease with a high unmet medical need.

ADC's are the main focus of Pfizer's US$43 Billion aquisition of Seagen.
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