SAN
DIEGO, July 17, 2024 /PRNewswire/
-- Biotheryx, Inc., a biopharmaceutical company discovering
and developing a portfolio of first-in-class protein degraders with
a focus on validated targets in cancer and inflammatory diseases,
today announced that the first patient has been dosed in its Phase
1 clinical trial evaluating BTX-9341, an investigational oral and
bifunctional degrader of cyclin-dependent kinase 4 (CDK4) and
cyclin-dependent kinase 6 (CDK6), as a monotherapy and in
combination with fulvestrant for patients with advanced and/or
metastatic hormone receptor positive (HR+)/human epidermal growth
factor receptor 2 negative (HER2-) breast cancer who have
previously received CDK4/6 inhibitor therapy either in the adjuvant
or metastatic setting.
![(PRNewsfoto/BioTheryX, Inc.) (PRNewsfoto/BioTheryX, Inc.)](https://mma.prnewswire.com/media/1278619/BIOTHEREX_Logo.jpg)
"BTX-9341 is a potent and selective CDK4/6 degrader that has
shown significant anti-tumor activity in both CDK4/6 inhibitor
naïve and resistant preclinical models. We are optimistic that it
will meet a critical unmet medical need for patients with HR+/HER2-
breast cancer who have received prior CDK4/6 inhibitor therapy,"
said Leah Fung, Ph.D., CEO of
Biotheryx. "Dosing the first patient in this trial represents a
significant milestone for Biotheryx, the patients we aim to serve
and the scientists who have made this possible."
The Phase 1 clinical trial will begin with dose escalation of
BTX-9341 as a monotherapy, followed by a combination with
fulvestrant and will conclude with dose expansion of BTX-9341 in
combination with fulvestrant. The trial will assess safety,
tolerability, pharmacokinetic and pharmacodynamic activity of
BTX-9341 as a monotherapy and in combination with fulvestrant. Once
the recommended Phase 2 dose of the combination has been
determined, there will be a formal evaluation of efficacy in an
expansion cohort.
"We are thrilled to have dosed the first patient with BTX-9341
at The START Center for Cancer Research," stated START Co-Founder
and Co-Director of Clinical Research, Dr. Amita Patnaik, MD, FRCPC. "BTX-9341 is a highly
novel, first-in-class, potent and selective degrader of
CDK4/6, representing an innovative therapeutic approach. It has the
potential to transform the care of patients with advanced and/or
metastatic HR+/HER2- breast cancer, particularly those who have
received prior CDK4/6 inhibitor therapies. This milestone is
perfectly aligned with START's mission to accelerate drug
development and provide early access to cutting-edge anticancer
therapies, bringing hope to patients and their families."
In preclinical studies, orally administered BTX-9341
demonstrated in vivo CDK4/6 degradation and improved
anti-tumor activity as a monotherapy compared to current standard
of care treatment regimens. BTX-9341 also demonstrated synergies
with selective estrogen receptor degraders including fulvestrant,
elacestrant and camizestrant in CDK4/6 naïve and resistant
models.
About BTX-9341
BTX-9341 is a first-in-class, oral degrader of CDK4/6, important
targets for a range of cancers and clinically validated in
HR+/HER2- breast cancer. In preclinical breast cancer models,
BTX-9341 demonstrated superiority to CDK4/6 inhibitors through
potent and highly selective catalytic degradation of CDK4 and CDK6,
robust inhibition of Cyclin E and CDK2 transcription, cell cycle
arrest and ultimately superior in vivo efficacy in breast
cancer xenografts. Beyond this increased efficacy potential,
BTX-9341 is differentiated from CDK4/6 inhibitor approaches through
the ability to overcome key resistance mechanisms that limit the
impact of inhibitors in second line HR+/HER2- breast cancer.
About Biotheryx, Inc.
Biotheryx is a clinical-stage biopharmaceutical company
discovering and developing a portfolio of first-in-class protein
degraders, including bifunctional degraders and molecular glues.
Our focus is on deploying the differentiated potential of degraders
towards validated targets in cancer and inflammatory disease.
Members of our founding and scientific teams previously developed
the IMiDs, the first U.S. Food and Drug Administration (FDA)
approved modulators of Cereblon, the most widely validated E3
ligase involved in protein degradation, and we have applied our
expertise in Cereblon binding to build our proprietary PRODEGY
platform. Biotheryx's clinical program, BTX-9341, a bifunctional
degrader of CDK4 and CDK6, began a Phase 1 clinical trial in the
third quarter of 2024. Biotheryx's pipeline also includes
BTX-10908, a first-in-class degrader of SOS1 for pan-KRAS mutant
cancers and PDE4 degraders for inflammatory diseases. For more
information, please visit biotheryx.com and engage with
us on LinkedIn.
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SOURCE Biotheryx, Inc.