HIMALAYA THERAPEUTICS ANNOUNCES SUBMISSION IN MAINLAND CHINA OF IND APPLICATIONS FOR ITS CAB-AXL-ADC TO TREAT SARCOMAS AND NSCLC, ITS CAB-ROR2-ADC TO TREAT MELANOMA AND NSCLC
| October 4, 2021
SHANGHAI and SAN DIEGO, Oct. 4, 2021 /PRNewswire/ – Himalaya Therapeutics (“Himalaya”), a clinical-stage biopharmaceutical company focused on development and commercialization in Greater China, of a novel class of investigational antibody therapeutics for the treatment of solid tumor cancer, which are based on the Conditionally Active Biologics (“CAB”) technology platform, today announced that it has submitted four investigational new drug (IND) applications to the Center for Drug Evaluation (CDE) of the China National Medical Products Association (NMPA).
Himalaya submitted one IND for HTBA3011, its CAB-antibody drug conjugate (ADC) targeting AXL, a protein expressed on many tumor cells, for soft tissue and bone sarcomas, one for HTBA3011 for non-small cell lung cancer (NSCLC), one for HTBA3021, its CAB-ADC targeting ROR2, another protein expressed on many tumor cells, for melanoma, and one for HTBA3021 for NSCLC. AXL and ROR2 are both well-validated targets, where high expression has been correlated with aggressive disease in multiple cancer types and have both also been shown to be a common escape mechanism following PD-1, PD-L1, ALK and EGFR treatment.
“Although our Taiwan and Hong Kong sites are already part of the ongoing registrational global trials for these product candidates, adding Mainland China to our global trials as well will be a key milestone in our goal of providing treatment to patients in China for these deadly cancers for which availability of effective, novel treatments has been limited” said Brian Zhang, Himalaya’s CEO.
“This IND submission reflects our ability to operate quickly and efficiently in China by working closely with the regulatory authorities to advance its clinical candidates here” said Howe Li, Himalaya’s CMO. “This is an affirmation of the hard work, support and close coordination among not only our team members, but also our local and global partners, and BioAtla, our collaboration partner.”
About Himalaya Therapeutics
Himalaya is a global clinical-stage biotechnology company that is advancing its deep pipeline of novel monoclonal antibody and other protein therapeutic product candidates through clinical trials. These have been designed to have more selective targeting, greater safety and efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies. Its product candidates have been developed using CAB technology, which is protected by more than 500 issued and pending patents globally.