OnKure Announces FDA IND Regulatory Clearance to Start Phase 1 Trials for OKI-179

BOULDER, Colo.–(BUSINESS WIRE)–OnKure, Inc., the epigenetics-focused drug discovery and development
company that is advancing the first Largazole-derived, histone
deacetylase inhibitor into Phase 1 clinical trials, announced that its
lead drug, OKI-179, has cleared the FDA IND regulatory hurdle to start
Phase 1 trials.

OnKure’s platform is capable of transforming naturally occurring,
biologically active lead compounds into commercial drugs that address a
variety of diseases, with an emphasis on helping patients suffering from
cancer. At the heart of OnKure’s solution to Class 1 histone deacetylase
inhibition, OKI-179 is a drug with a potency and selectivity profile
that is reminiscent of Romidepsin, arguably the most potent Class 1
histone deacetylase inhibitor currently approved by the FDA. However,
while Romidepsin is administered by continuous infusion, OKI-179 is
delivered orally and has demonstrated an impressive safety profile in
preclinical studies.

“We are delighted that OKI-179 is poised to enter clinical development,”
said Tony Piscopio, co-founder, President and Chief Executive Officer of
OnKure. “We are excited to see how this potential best-in-class molecule
will perform in carefully selected patient populations.”

Collaborating with OnKure on the clinical investigation of OKI-179 will
be the University of Colorado, Anschutz Cancer Center, Aurora, CO and
the University of Texas, Austin Dell Medical School.

“We are very excited to begin our first in human studies with OKI-179,”
said S. Gail Eckhardt, M.D., FASCO, OnKure’s Chief Medical Officer and
Professor at UT Austin. She added, “Our preclinical data suggests that
OKI-179 may provide patients with a safer and more convenient
alternative to Romidepsin, both as a stand-alone agent and in rational
combinations with other targeted therapies.”

About OnKure

OnKure, Inc. is a biopharmaceutical company focused on the discovery and
development of targeted small molecule drugs to improve the outcomes of
patients afflicted with cancer. OnKure’s drug candidates aim to treat
patients by targeting malignant cells directly, by working in
combination with other small molecule therapies and by priming the tumor
microenvironment such that checkpoint inhibition is optimized. For more
information about OnKure and OKI-179, please visit www.onkuretherapeutics.com.


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