IDRx Announces $120 Million Series B Financing to Advance Potential Best-in-class New Treatment for Gastrointestinal Stromal Tumor (GIST)
07 Agosto 2024 - 6:00AM
Business Wire
- Financing led by RA Capital Management, Commodore Capital, and
Blackstone Multi-Asset Investing with participation from additional
new and existing investors
- Proceeds to support ongoing Phase 1/1b StrateGIST 1 study and
expected initiation of first pivotal study of IDRX-42 in
second-line GIST in 2025
- IDRX-42 recently granted Fast Track designation by U.S.
FDA
IDRx, Inc., a clinical-stage biopharmaceutical company dedicated
to transforming cancer treatment with purpose-built precision
therapies, today announced the completion of an oversubscribed $120
million Series B Preferred Stock financing. The financing was led
by RA Capital Management, Commodore Capital, and Blackstone
Multi-Asset Investing with additional new investors, including Rock
Springs Capital and a U.S.-based healthcare-focused fund. Existing
investors, including Andreessen Horowitz (a16z) Bio + Health,
Casdin Capital, Nextech Invest Ltd. (on behalf of one or more funds
managed by it), Forge Life Science Partners, co-founder Nick Lydon,
Ph.D., and strategic partner Merck KGaA, Darmstadt, Germany also
participated in the financing. Derek DiRocco, Ph.D., Partner at RA
Capital Management, has joined the IDRx Board of Directors.
IDRx plans to use the proceeds from the financing to support the
ongoing Phase 1/1b StrateGIST 1 study of its lead product candidate
IDRX-42, a potent, oral, highly selective KIT inhibitor targeting
all major categories of activating and resistance mutations in
patients with KIT-mutant GIST. Additionally, proceeds will be used
to fund the expected initiation of the first pivotal study for
IDRX-42 in patients with second-line GIST.
At the 2024 American Society of Clinical Oncology (ASCO) annual
meeting, IDRx presented preliminary Phase 1 data from the ongoing
Phase 1/1b StrateGIST 1 trial. The data support the best-in-class
potential of IDRX-42 in patients with GIST. This included a 23%
objective response rate (ORR) across all patients (median four
prior lines of therapy) and a 43% ORR in second-line patients,
including those with either or both ATP binding site and activation
loop mutations, with a favorable tolerability profile consistent
with use in front-line and second-line settings. IDRx is now
enrolling patients in the Phase 1b portion of the trial. In
addition, the U.S. Food and Drug Administration (FDA) has recently
granted Fast Track designation to IDRX-42 for the treatment of GIST
after disease progression on or intolerance to imatinib.
“We are thrilled to announce this financing, which includes
support from a top-tier syndicate of investors and positions us to
accelerate the development of IDRX-42 for a broad population of
patients with GIST, including in the second-line and front-line
settings, where patients haven’t seen a new treatment option in
over 15 years,” said Tim Clackson, Ph.D., Chief Executive Officer
of IDRx. “IDRX-42 was designed to overcome the twin challenges of
on-target treatment resistance and off-target driven adverse
events, which limit the clinical benefit of currently available
TKIs. We are extremely encouraged by the clinical data generated
with IDRX-42 to date and are focused on rapidly advancing this
potential new treatment option that could elevate the standard of
care for GIST patients.”
“RA Capital Management is excited to co-lead this round to
support the advancement of IDRX-42 as a differentiated new
treatment for GIST,” said Derek DiRocco, Ph.D., Partner of RA
Capital Management and board member of IDRx. “We have been
extremely impressed by what the IDRx team has accomplished in a
short time, and I look forward to contributing to IDRx’s future
growth and success as the company prepares to execute on its
late-stage clinical development activities for IDRX-42.”
About GIST
GIST is the most common subtype of soft tissue sarcoma.
Approximately 80% of cases arise from gain of function mutations in
the KIT receptor tyrosine kinase, driving the malignancy through
constitutive activation of aberrant signaling. Resistance mutations
in KIT emerge in ~90% of patients treated with imatinib, the
current standard of care for GIST. In unresectable or metastatic
GIST, clinical benefits from existing treatments can vary by
mutation type.
About the StrateGIST 1 Study
StrateGIST 1 is an ongoing, open-label, first-in-human Phase
1/1b study designed to evaluate the safety, tolerability,
pharmacokinetics, and preliminary antitumor activity of IDRX-42 in
patients with metastatic and/or surgically unresectable GIST after
failure of imatinib and other approved drugs. The study is
currently enrolling patients with documented pathogenic mutation in
KIT or any platelet-derived growth factor receptor alpha (PDGFRA)
mutation (other than PDGFRA exon 18) at sites in the U.S., United
Kingdom, Belgium, The Netherlands, France, Germany, Italy, Spain,
and South Korea. The Phase 1b portion has been initiated and
includes four expanded exploratory cohorts based on defined lines
of prior TKI therapy, including front line, second line, third line
+ (with standard approved TKIs only), and third line + (including
investigational TKIs).
About IDRX-42
IDRX-42 is a potent, oral, highly selective KIT inhibitor
targeting all major categories of activating and resistance
mutations in patients with KIT-mutant GIST (including variants in
exons 9, 11, 13 and 17). In preclinical studies, IDRX-42
demonstrated superior antitumor activity compared to imatinib, the
current first-line of therapy, in GIST human xenograft models
expressing mutations in KIT exons 9 and 11. In xenograft models
expressing secondary resistance mutations in KIT exon 13 or 17,
IDRX-42 treatment resulted in potent and dose-dependent antitumor
activity superior to the second-line standard of care agent,
sunitinib. IDRX-42 is currently being evaluated in StrateGIST 1, a
first-in-human Phase 1/1b study. IDRX-42 was granted Orphan Drug
designation by the FDA for the treatment of GIST.
About IDRx
IDRx is a clinical-stage biopharmaceutical company dedicated to
transforming cancer care with intelligently designed precision
therapies. IDRx aims to address the limitations of today’s
precision cancer medicines with highly potent and selective
targeted therapies to stop key tumor escape mechanisms and prolong
response to therapy. IDRx’s lead program is IDRX-42, designed to
inhibit key genetic drivers and drug-resistant mutations of KIT in
GIST. Founded in 2021, IDRx’s leadership team has extensive
experience in drug development and collectively has been involved
in the discovery, development, and commercialization of more than
10 approved medicines. To learn more, please visit www.idrx.com and
follow us on LinkedIn.
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