TAIPEI and SAN DIEGO, Nov. 25,
2020 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492),
a clinical-stage biopharmaceutical company focused on
next-generation DNA Damage Response (DDR) therapeutics for the
treatment of cancer, today announced that it has submitted
multiple Investigational New Drug (IND) applications to
the U.S. Food and Drug Administration (FDA) and Health
Canada evaluating its investigational drug, CX-5461, for the
treatment of patients with solid tumors with BRCA2 or
PALB2 mutations.
"This IND submission is a key milestone in the clinical
development of CX-5461. In a phase I study conducted by Senhwa's
clinical partner, Canadian Cancer Trial Group (CCTG), CX-5461
demonstrated clinically meaningful and lasting benefits in patients
with specific tumor biomarkers that were resistant to platinum and
other chemotherapeutics. The US and Canada clinical trials are being designed to
further confirm the efficacy seen," said Dr. John Soong, Chief Medical Officer of Senhwa
Biosciences.
CX-5461 was recently named as a PCF-Pfizer Global Challenge
Award recipient. Specifically, it will be used in combination with
Pfizer's PARP inhibitor (PARPi), Talazoparib, to explore the
therapeutic potential in prostate cancer, which is the
second-leading cause of cancer death for men in
the United States. In 2016, a
recipient of the Stand Up to Cancer's Dream Team Grant selected
CX-5461 to study in their Phase I trial. This study's clinical
findings were featured in a spotlighted presentation at the 2019
annual San Antonio Breast Cancer Symposium (SABCS
2019). Due to the DNA repair defect, BRCA1/2 deficient
tumor cells are more sensitive to PARPi through the mechanism of
synthetic lethality. However, PARPi resistance is ubiquitous in
clinic. More than 40% of BRCA1/2-deficient patients fail to
respond to PARPi.
"CX-5461 is a first-in-class G-quadruplex stabilizer within a
novel class of therapy that accelerates dsDNA breaks and has proven
human efficacy across certain tumor types. We believe CX-5461 has
great potential as a therapeutic for patients who have developed
resistance to PAPRi or other chemotherapies. This continues to be
an unmet medical need in cancer treatment," said Dr. Tai-Sen Soong, CEO of Senhwa Biosciences.
About CX-5461
CX-5461 is designed to stabilize DNA G-quadruplexes of cancer
cells and leads to disruption of the cell's replication fork. While
acting in concert with Homologous Recombination (HR) pathway
deficiency, such as BRCA1/2 mutations, replication forks stall and
cause DNA breaks, resulting in cancer cell death. CX-5461 in
combination with Homologous Recombination Deficiency (HRD) tumors
may be exploited through a synthetic lethality approach, targeting
DNA repair defects in HRD tumors.
About Senhwa Bioscience
Senhwa Biosciences, Inc. is a leading clinical-stage company
focusing on developing first-in-class, next-generation DDR
therapeutics for patients with unmet medical needs in oncology.
Headquartered in Taiwan, with an
operational base in San Diego,
California, Senhwa is well-positioned to oversee the
development of its compounds.
Development is currently focused on two lead products
Silmitasertib (CX-4945) and Pidnarulex (CX-5461) with novel
mechanisms of action and for multiple indications. Clinical trials
are ongoing in Australia,
Canada, United States, Korea, and Taiwan, with more currently in
development.
Visit Senhwa Biosciences for more details:
www.senhwabio.com
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SOURCE Senhwa Biosciences, Inc.