TAIPEI and SAN
DIEGO, Sept. 17, 2024 /PRNewswire/ -- Senhwa
Biosciences, Inc. (TPEx: 6492), , a drug development company
focusing on first-in-class therapeutics for oncology, rare
diseases, and infectious diseases, today announced that an
Investigational New Drug (IND) application for Pidnarulex has been
submitted to the U.S. FDA by the NCI. Senhwa' investigational drug,
Pidnarulex (CX-5461), has been selected as an experimental drug in
the NExT (NCI Experimental Therapeutics) cancer program, sponsored
by the Division of Cancer Treatment and Diagnosis (DCTD), National
Cancer Institute (NCI), part of the U.S. National Institutes of
Health (NIH), for a five-year period. This drug will be used in a
pharmacodynamic (PD) pilot study involving patients with advanced
solid tumors.
In addition to this monotherapy trial, NCI is considering to
plan future clinical trials for Pidnarulex (CX-5461) in combination
with other therapies, including immunotherapy, antibody-drug
conjugates (ADC), and PARP inhibitors (Poly ADP-ribose Polymerase
inhibitors, PARPi). Should these trials be realized, they will be
led by the NCI, leveraging its medical team, scientific talent
network, and regulatory resources—capabilities that most biotech
companies would struggle to accomplish independently. This support
from the NCI is hoped to significantly accelerate the development
and expansion of indications for Pidnarulex (CX-5461), ultimately
benefiting patients with an earlier market launch.
This clinical trial, for which the IND application has been
submitted by NCI's Division of Cancer Treatment and Diagnosis
(DCTD), aims to explore the response of various biomarkers to
Pidnarulex (CX-5461) in patients with or without homologous
recombination deficiency (HRD).
Pidnarulex (CX-5461), developed by Senhwa, is a first-in-class
small-molecule designed to stabilize G-quadruplex (G4) structures,
which are frequently observed in promoters of oncogenes. By
stalling replication fork progression, Pidnarulex induces DNA
damage and promotes cancer cell death. Through this mechanism,
Pidnarulex holds great potential as a therapeutic agent for various
cancers.
In recent years, immunotherapy has become the fastest-growing
category in the cancer drug market, while the development of
antibody-drug conjugates (ADC) is undoubtedly an important trend in
biopharmaceuticals. Major pharmaceutical companies, including
Pfizer, AbbVie, AstraZeneca, and Merck, have invested billions of
dollars in acquiring or licensing related technologies. According
to a recent report from market research firm Evaluate, the ADC
market is expected to reach $30
billion by 2028, while the global cancer immunotherapy
market will surpass a staggering $224
billion by 2030. Given that only about 20% to 25% of
patients are effectively treated with immunotherapy, combining
immunotherapy with targeted drugs is becoming increasingly
important in cancer treatment. Combination therapies can address
multiple treatment pathways within the complex tumor
microenvironment and may enhance the efficacy of immunotherapy,
making it a hot research area for major pharmaceutical companies.
Therefore, Senhwa is confident and optimistic about the NCI's plans
to advance clinical trials of Pidnarulex (CX-5461) in combination
with immunotherapy and ADCs.
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SOURCE Senhwa Biosciences, Inc.