SAN
DIEGO, May 7, 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 disease, today
announced that the U.S. Food and Drug Administration (FDA) has
cleared the Company's Investigational New Drug (IND) application
for BTX-9341, a novel cyclin-dependent kinase 4/6 (CDK4/6)
bifunctional degrader. The Company plans to initiate the Phase 1
clinical trial in the second half of 2024 and intends to enroll
patients with HR+/HER2- breast cancer resistant to CDK4/6 inhibitor
therapies.
"Securing FDA clearance for our BTX-9341 IND application marks a
significant milestone for Biotheryx, affirming our commitment to
advancing innovative, orally bioavailable targeted protein
degraders. As we transition from promising preclinical data to
clinical trials, we are poised to explore the potential of BTX-9341
in offering tangible clinical benefits to patients battling breast
cancer," said Leah Fung, Ph.D., CEO
of Biotheryx.
The Phase 1 clinical trial includes dose escalation for the
initial monotherapy administration of BTX-9341 and combination dose
expansion combining BTX-9341 with fulvestrant. The initial clinical
evaluation will be focused on safety, biological activity and
preliminary efficacy.
About BTX-9341
BTX-9341 is a first-in-class, oral degrader of cyclin-dependent
kinase 4 (CDK4) and cyclin-dependent kinase 6 (CDK6), important
targets for a range of cancers and clinically validated in the
context of certain breast cancers. In preclinical breast cancer
models, BTX-9341 demonstrated superiority to CDK4/6 inhibitors
through potent and highly selective 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 potential ability to overcome key resistance mechanisms that
limit the impact of inhibitors (~20% of patients have intrinsic
resistance and up to 70% have acquired resistance to CDK4/6
inhibitors) and significantly enhanced penetration of the
blood-brain-barrier.
About Biotheryx, Inc.
Biotheryx is a biopharmaceutical company discovering and
developing a portfolio of first-in-class protein degraders,
including bifunctional degraders and molecular glues. Our initial
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. Our pipeline of bifunctional degraders includes BTX-9341
for HR+/HER2- breast cancer, the first ever bifunctional degrader
of CDK4 and CDK6 to receive IND approval from the FDA, as well as
first-in-class degraders of SOS1 for pan-KRAS mutant cancers, and
PDE4 for inflammatory diseases. For more information, please visit
www.biotheryx.com and engage with us on LinkedIn.
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SOURCE Biotheryx, Inc.