Peregrine Pharmaceuticals, Inc. PPHM, a biopharmaceutical company developing first-in-class monoclonal antibodies focused on the treatment and diagnosis of cancer,
today highlighted data presented at the Annual Meeting of the American
Association for Cancer Research (AACR). Data was presented this week from
preclinical studies investigating the immune-stimulating mechanism of action
of Peregrine's lead phosphatidylserine (PS)-targeting oncology clinical
candidate bavituximab and the anti-tumor and imaging potential of other
PS-targeting molecules. Bavituximab is currently being evaluated in several
oncology clinical trials including the lead indication of second-line
non-small cell lung cancer (NSCLC), which is anticipated to advance into a
pivotal Phase III trial later this year.
"These studies yield important insights into the fundamental role that
exposed PS plays in tumor immune evasion, and further support our lead
clinical candidate bavituximab's ability to reactivate tumor immunity. This
is now clearly evidenced by several specific measurements of both the
immune-stimulating and anti-tumor mechanisms mediated by PS-targeting
antibodies as well as imaging studies demonstrating that tumor growth
inhibition is correlated with PS expression levels in tumors," said Jeff T.
Hutchins, Ph.D., vice president of preclinical research at Peregrine
Pharmaceuticals. "Included in these presentations was a compelling finding
of a pronounced antibody-mediated increase in tumor-fighting immune cells
that is independently correlated with an impressive survival benefit in
patients with NSCLC based on a published retrospective study of clinical
data(1) . When taken together, these results support PS as a promising
oncology drug target and provide additional rationale for the impressive
Phase II survival data we have seen in bavituximab's lead indication of
second-line NSCLC."
Data presented from imaging studies(2) demonstrate that the chemotherapeutic
drug docetaxel, a commonly prescribed second-line treatment for patients
with advanced NSCLC, increases the exposure of bavituximab's target
molecule, phosphatidylserine (PS), on tumor blood vessel cells and tumor
cells. Results also showed that PS exposure in tumors is correlated with
tumor burden and response to docetaxel treatment, supporting exposed PS as a
promising biomarker of cancer and response to therapy. Peregrine's
PS-targeting imaging agent I-124-PGN650 is currently being evaluated in a
clinical trial to assess its safety and potential to image multiple tumor
types in patients with cancer.
Additional data presented from a series of preclinical studies(3)
demonstrate that PS-targeting antibodies mediate immuno-stimulatory changes
in tumors resulting in an increase of tumor-fighting (M1) macrophages,
immune cells strongly associated with survival benefits in patients with
NSCLC(1) . Peregrine recently reported promising data from a randomized,
double-blind, placebo-controlled Phase II second-line NSCLC clinical trial
demonstrating a 60% improvement in median overall survival (OS) in patients
receiving 3 mg/kg bavituximab plus docetaxel compared to the control arm.
The company plans to meet with the U.S. Food and Drug Administration (FDA)
in the second quarter of calendar year 2013 with the goal of initiating a
Phase III trial by calendar year-end.
Researchers also presented details of new PS-binding constructs(4) . Termed
"betabodies," the molecules consist of the PS-binding domain of the serum
protein 2-glycoprotein I (2GPI), fused to the constant region of
an antibody. Betabodies bind to PS directly, are smaller in size and have a
longer serum half-life than natural antibodies. Early studies indicate that
betabodies hold potential as next-generation PS-binding agents that have the
potential to be used for a broad number of applications including
antibody-drug conjugates and next generation therapeutics for oncology and
infectious diseases.
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