Himalaya Therapeutics Announces Interim Phase 2 Results for Mecbotamab vedotin (HTBA3011)

  • Preliminary observations in Non-Small Cell Lung Cancer ("NSCLC") support advancing to the registrational stage of the trial; anticipate full interim data set in 4Q'22
  • Undifferentiated Pleomorphic Sarcoma ("UPS") and osteosarcoma will advance to Phase 2, part 2 enrollment, which is anticipated to begin 4Q'22

SAN DIEGO, CA, USA and SHANGHAI, China I September 12, 2022 IHimalaya Therapeutics ("Himalaya"), a clinical-stage biopharmaceutical company focused on development and commercialization 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 interim topline data update from the HTBA3011 in NSCLC and certain sarcomas.

"This topline data is tremendously exciting, because it not only continues to validate the CAB platform," said Brian Zhang, PhD, Himalaya's CEO, "but also presents the possibility for treatment in patients with significant unmet needs.  We all know that sarcoma is a notoriously difficult cancer to treat, with no approved first-line antibody treatments, and the outlook is very poor for NSCLC patients who have failed multiple lines of therapy."

On August 9, Himalaya's collaboration partner, BioAtla (NASDAQ: BCAB) publicly announced operational updates on the ongoing global clinical trials for HTBA3011 in patients with AXL-positive NSCLC who have previously failed PD-1/L1, EGFR, or ALK inhibitor therapy. These trials included patients from Greater China, where Himalaya has regional rights for the product candidate, and where lung cancer is both the most frequent cancer, and the cancer with the highest mortality rate.  Of nine evaluable patients to date, two partial responses ("PR") and one complete response ("CR") were observed. All CR/PRs were observed in the non-squamous group, representing an objective response rate ("ORR") of 43% in the seven non-squamous patients.  HTBA3011 was generally safe and well-tolerated in both monotherapy and in combination with nivolumab, consistent with trials to date. 

Interim phase 2 analysis of HTBA3011 in certain sarcomas supports advancement of patients with undifferentiated pleomorphic sarcoma and osteosarcoma into part 2 of the phase 2 trial. In phase 1 and part 1 of the phase 2 trial, PRs were observed in four of eight UPS patients, or 50%. In phase 1 and part 1 of the phase 2 trial, PFS for osteosarcoma patients at three months was four of seven patients, or 57%. Development and advancement for other types of sarcoma also continues.

Himalaya's CMO, Howe Li, noted that "Himalaya is excited about its advancing pipeline, which includes three novel product candidates in clinical trials today, and expects to have a fourth, its first bispecific, in early 2024." 

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. 

SOURCE: Himalaya Therapeutics SEZC

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