Cullinan Oncology and Taiho Pharmaceutical Complete Agreement for Strategic Collaboration to Jointly Develop and Commercialize CLN-081/TAS6417
June 23 2022 - 8:00AM
Cullinan Oncology, Inc. (Cullinan Oncology) (Nasdaq: CGEM) a
biopharmaceutical company focused on developing a diversified
pipeline of targeted therapies for patients with cancer, today
announced the completion of its agreement with Taiho Pharmaceutical
Co., Ltd. (Taiho) signed in May 2022. Per the terms of the
agreement, the companies will collaborate on the U.S. development
of CLN-081/TAS6417, a next generation, irreversible EGFR inhibitor
for the treatment of a genetically defined subset of patients with
non-small cell lung cancer (NSCLC).
Taiho has also completed its acquisition of
Cullinan Oncology’s subsidiary, Cullinan Pearl Corp. (Cullinan
Pearl) which has worldwide rights outside of Japan* to
CLN-081/TAS6417. Taiho has provided an upfront payment to Cullinan
Oncology of $275 million with the potential for an additional $130
million tied to EGFR exon20 NSCLC regulatory milestones.
In addition, the two companies have agreed to
co-develop and co-commercialize CLN-081/TAS6417. Cullinan Oncology
retains the option to co-commercialize CLN-081/TAS6417 in the
United States together with Taiho through its U.S. subsidiary,
Taiho Oncology, Inc. Taiho and Cullinan Oncology will equally
contribute to the future clinical development of CLN-081/TAS6417 in
the U.S., with each receiving 50% of the profits from potential
U.S. sales.
About CLN-081/TAS6417CLN-081/
TAS6417 is an orally available small molecule being developed in
collaboration with Taiho Pharmaceutical Co., Ltd. CLN-081/TAS6417
is designed as a next generation, irreversible EGFR inhibitor for
the treatment of a genetically defined subset of patients with
non-small cell lung cancer (NSCLC). CLN-081/TAS6417 is being
investigated in a Phase 1/2a dose escalation and expansion trial
evaluating oral, twice-daily administration of various doses in
patients with NSCLC harboring EGFRex20ins mutations who have had at
least one prior treatment with platinum-based chemotherapy or
another approved standard therapy. CLN-081/TAS6417 has received
Breakthrough Therapy Designation from the FDA.
About Cullinan OncologyCullinan
Oncology, Inc. (NASDAQ: CGEM) is a biopharmaceutical company
dedicated to creating new standards of care for patients with
cancer. We innovate without borders to find the most promising
clinic-ready cancer therapies, whether from our own discovery
efforts or through exceptional engagement with our academic and
industry partners. Anchored in a deep understanding of
immuno-oncology and translational cancer medicine, we leverage our
scientific excellence in small molecules and biologics to create
differentiated ideas, identify unique targets, and select the
optimal modality to develop transformative therapeutics across
cancer indications. Powered by our novel research model, we push
conventional boundaries from candidate selection to cancer
therapeutic, applying rigorous early experimentation to fast-track
only the most promising assets to the clinic and ultimately
commercialization. As a result, our diversified pipeline is
strategically built with assets that activate the immune system or
inhibit key oncogenic drivers across a wide range of modalities,
each with the potential to be the best or first in their class.
Our people possess deep scientific expertise, seek
innovation openly, and exercise creativity and urgency to deliver
on our promise to bring new therapeutic solutions to patients with
cancer. Learn more about our Company
at www.cullinanoncology.com, and follow us
on LinkedIn and Twitter.
Forward-Looking StatementsThis
press release contains forward-looking statements of Cullinan
Oncology, Inc. (Cullinan, we or our) within the meaning of the
Private Securities Litigation Reform Act of 1995. These
forward-looking statements include, but are not limited to, express
or implied statements regarding Cullinan’s beliefs and expectations
regarding its arrangements with Taiho, our preclinical and clinical
development plans, clinical trial designs, clinical and therapeutic
potential, and strategy of CLN-081/TAS6417, including but not
limited to our expectations and beliefs around its safety and
efficacy and plans for future CLN-081/TAS6417 studies. Any
forward-looking statements in this press release are based on
management's current expectations and beliefs of future events and
are subject to known and unknown risks and uncertainties that may
cause our actual results, performance or achievements to be
materially different from any expressed or implied by the
forward-looking statements. These risks include, but are not
limited to, the following: uncertainty regarding the timing and
results of regulatory submissions; success of our clinical trials
and preclinical studies; risks related to our ability to protect
and maintain our intellectual property position; risks related to
manufacturing, supply, and distribution of our therapeutic
candidates; risks related to the impact of COVID-19 affecting
countries or regions in which we have operations or do business,
including potential negative impacts on our employees, customers,
supply chain and production as well as global economies and
financial markets; the risk that any one or more of our product
candidates, including those that are co-developed, will not be
successfully developed and commercialized; the risk that the
results of preclinical studies or clinical studies will not be
predictive of future results in connection with future studies; and
success of any collaboration, partnership, license or similar
agreements. These and other important risks and uncertainties
discussed in our filings with the Securities and Exchange
Commission, or SEC, including under the caption “Risk Factors” in
our most recent Quarterly Report on Form 10-Q and subsequent
filings with the SEC, could cause actual results to differ
materially from those indicated by the forward-looking statements
made in this press release. Moreover, except as required by law,
neither Cullinan nor any other person assumes responsibility for
the accuracy and completeness of the forward-looking statements
included in this press release. Any forward-looking statement
included in this press release speaks only as of the date on which
it was made. We undertake no obligation to publicly update or
revise any forward-looking statement, whether as a result of new
information, future events or otherwise, except as required by
law.
Contacts:
Investor RelationsChad Messer+1
203.464.8900cmesser@cullinanoncology.com
MediaRose Weldon+1
215.801.7644rweldon@cullinanoncology.com
*Cullinan Pearl previously licensed the rights to
CLN-081/TAS6417 in Greater China to Zai Lab in 2020.
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