- 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 and SHANGHAI,
Sept. 12,
2022 /PRNewswire/ -- Himalaya
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.
Investor Contact:
Nicholas
Desjardins
Himalaya Therapeutics
ndesjardins@himalayatherapeutics.com
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SOURCE Himalaya Therapeutics SEZC