DARMSTADT, Germany - Thursday, 04. January 2024
First-in-class ompenaclid (RGX-202) currently in Phase II development for RAS-mutated advanced or metastatic colorectal cancer
Collaboration includes exclusive license outside the US with option to
co-develop and co-promote ompenaclid in the US, as well as global
co-development and co-commercialization rights for follow-on compounds
Strategic agreement builds on the heritage of ERBITUX® (cetuximab) and
complements the company’s expertise and ongoing development programs in
colorectal cancer
Not intended for UK-, US- or Canada-based media
(BUSINESS
WIRE) -- Merck, a leading science and technology company, today
announced a licensing agreement with Inspirna, Inc. (New York, NY) for
ompenaclid (RGX-202), a first-in-class oral inhibitor of the creatine
transport channel SLC6A8, and SLC6A8-targeting follow-on compounds.
Ompenaclid is currently being evaluated in a Phase II study for the
second-line treatment of RAS-mutated (RASmut) advanced or metastatic
colorectal cancer (mCRC).
“Over the past decade, the treatment
paradigm for patients with RAS-mutated CRC, accounting for approximately
45% of the second-line population, has not seen major innovation,” said
Victoria Zazulina, MD, Head, Development Unit, Oncology for the
Healthcare business sector of Merck. “With our expertise in the
treatment of CRC, and based on the encouraging early data for
ompenaclid, this agreement with Inspirna offers the opportunity to
advance a potential new first-in-class therapy that may improve outcomes
for patients.”
Ompenaclid is a first-in-class oral inhibitor of
the creatine transport channel SLC6A8. Data from the Phase Ib/II study
of ompenaclid in combination with FOLFIRI and bevacizumab showed
encouraging efficacy and safety for second-line treatment of RASmut
mCRC. Results presented at the 2023 European Society for Medical
Oncology (ESMO) Congress showed that, as of the September 18, 2023 data
cutoff, median progression-free survival was 10.2 months and median
overall survival was 19.1 months across all 41 patients with RASmut
mCRC. Of the 30 patients evaluable for response, the objective response
rate was 37%, with 11 partial responses. Ompenaclid was well-tolerated,
with no dose-limiting toxicities observed in the dose-escalation cohort
and combination safety profile comparable to FOLFIRI plus bevacizumab
backbone treatment. Inspirna has initiated a Phase II double-blind
randomized controlled trial in second-line RAS-mutant advanced or
metastatic CRC comparing ompenaclid versus placebo plus FOLFIRI and
bevacizumab.
The collaboration with Inspirna builds on Merck’s
long-standing commitment to the colorectal cancer community. 2024 marks
the 20th anniversary of the introduction of ERBITUX®, for which the
company has marketing rights outside the U.S. and Canada, as a backbone
treatment in mCRC; today, multiple active clinical trials continue to
evaluate ERBITUX® in this disease. The company is also developing M9140,
a CEACAM5-targeting antibody-drug conjugate with an exatecan payload
currently being evaluated in an ongoing Phase Ia/b study in patients
with mCRC.
“We are excited to partner with Merck, a leader in the
oncology field with global drug development and commercial expertise in
colorectal cancer specifically, to help bring our novel therapies to
more patients in need,” said Dr. Usman “Oz” Azam, MD, Chief Executive
Officer of Inspirna. “The data to date validates our belief in
ompenaclid as a potential first-in-class therapy for advanced colorectal
cancer and underscores the power of our proprietary target discovery
platform RNA-DRIVEr™. We look forward to working closely with Merck as
we continue to evaluate ompenaclid in the ongoing Phase II randomized
controlled trial.”
Under the terms of the license agreement,
Merck will receive an exclusive license to ompenaclid outside of the
United States and an option to co-develop and co-promote ompenaclid in
the US. Furthermore, the parties agreed to collaborate on Inspirna’s
SLC6A8 follow-on compounds for which Inspirna will retain US
co-development and co-commercialization rights. Inspirna will receive an
upfront payment of $45 million. Upon the achievement of certain
development and sales milestones for ompenaclid, Inspirna is eligible to
receive milestone payments with tiered royalty rates in the low teens
on net sales outside of the US. Inspirna is eligible to also receive
development, regulatory and sales milestone payments for each follow-on
compound targeting SLC6A8 along with up to double-digit royalties on net
sales outside of the US.
About ERBITUX® (cetuximab)
ERBITUX
is an IgG1 monoclonal antibody targeting the epidermal growth factor
receptor (EGFR). As a monoclonal antibody, the mode of action of ERBITUX
is distinct from standard non-selective chemotherapy treatments in that
it specifically targets and binds to the EGFR. This binding inhibits
the activation of the receptor and the subsequent signal-transduction
pathway, which results in reducing both the invasion of normal tissues
by tumor cells and the spread of tumors to new sites. It is also
believed to inhibit the ability of tumor cells to repair the damage
caused by chemotherapy and radiotherapy and to inhibit the formation of
new blood vessels inside tumors, which appears to lead to an overall
suppression of tumor growth. Based on in vitro evidence, ERBITUX also
targets cytotoxic immune effector cells towards EGFR-expressing tumor
cells (antibody-dependent cell-mediated cytotoxicity [ADCC]).
ERBITUX
has already obtained market authorization in over 100 countries
worldwide for the treatment of RAS wild-type metastatic colorectal
cancer and for the treatment of squamous cell carcinoma of the head and
neck. Merck licensed the right to market ERBITUX, a registered trademark
of ImClone LLC, outside the U.S. and Canada from ImClone LLC, a wholly
owned subsidiary of Eli Lilly and Company, in 1998.
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About Merck
Merck, a leading
science and technology company, operates across life science, healthcare
and electronics. More than 64,000 employees work to make a positive
difference to millions of people’s lives every day by creating more
joyful and sustainable ways to live. From providing products and
services that accelerate drug development and manufacturing as well as
discovering unique ways to treat the most challenging diseases to
enabling the intelligence of devices – the company is everywhere. In
2022, Merck generated sales of € 22.2 billion in 66 countries.
Scientific
exploration and responsible entrepreneurship have been key to Merck’s
technological and scientific advances. This is how Merck has thrived
since its founding in 1668. The founding family remains the majority
owner of the publicly listed company. Merck holds the global rights to
the Merck name and brand. The only exceptions are the United States and
Canada, where the business sectors of Merck operate as MilliporeSigma in
life science, EMD Serono in healthcare, and EMD Electronics in
electronics.
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