Cullinan Oncology, Inc. (Cullinan Oncology) (Nasdaq: CGEM) and
Taiho Pharmaceutical Co., Ltd. (Taiho) today announced an agreement
through which Taiho will acquire Cullinan Pearl Corp. (Cullinan
Pearl) and co-develop and co-commercialize Cullinan Oncology’s lead
program, CLN-081/TAS6417 (development code in Cullinan Oncology:
CLN-081, development code in Taiho: TAS6417), an orally available,
differentiated, irreversible EGFR inhibitor that selectively
targets cells expressing EGFR exon 20 insertion mutations while
sparing cells expressing wild-type EGFR. Subject to customary
closing conditions, including expiration or termination of the
waiting period under U.S. antitrust laws, the acquisition is
expected to close in the second quarter of 2022.
Under the agreement, Taiho will acquire Cullinan Oncology’s
subsidiary, Cullinan Pearl, which has worldwide rights outside of
Japan* to CLN-081/TAS6417, for an upfront payment to Cullinan
Oncology of $275 million and up to an additional $130 million tied
to EGFR exon20 non-small cell lung cancer (NSCLC) regulatory
milestones.
Cullinan Oncology will co-develop CLN-081/TAS6417 and will
retain the option to co-commercialize CLN-081/TAS6417 in the United
States together with Taiho Pharmaceutical through its U.S.
subsidiary, Taiho Oncology, Inc. Taiho will commercialize
CLN-081/TAS6417 in territories outside U.S. and China. 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. As a result of the
upfront cash payment and reduction in development and
pre-commercialization costs, Cullinan Oncology anticipates its cash
runway to extend through 2026 based on current operating plans.
This guidance does not include the potential regulatory milestone
cash payments or future U.S. profit share post-launch.
It is estimated that approximately 85%1 of all newly diagnosed
patients with lung cancer, or approximately 1.9 million people
worldwide have NSCLC. Among those patients with NSCLC,
approximately 2%2-3 or 38,000 patients have exon 20 insertions. In
the U.S., approximately 16% of NSCLC cases harbor EGFR mutations,
with insertions at exon 20 accounting for 12%(4) of those
mutations. Patients with EGFR exon 20 insertions are known to have
poorer outcomes than those with more common EGFR mutations, such as
exon 19 deletion. CLN-081/TAS6417 is currently in Phase I/IIa
development for treatment of patients with NSCLC having an exon 20
insertion mutation.
“We are pleased to bring CLN-081/TAS6417 back into our pipeline
and move it towards commercialization with Cullinan Oncology,” said
Masayuki Kobayashi, President and Representative Director of Taiho
Pharmaceutical Co., Ltd. “Cullinan Oncology has carried
CLN-081/TAS6417 from pre-IND to planned pivotal study in
approximately three years. Meanwhile the Food and Drug
Administration (FDA) has granted Breakthrough Designation status
for this novel molecule. Utilizing Cullinan Oncology’s unique
business model through this strategic collaboration, we aim to
hasten and maximize the development of CLN-081/TAS6417. Together
with Cullinan Oncology, the Taiho group will work to expeditiously
deliver this agent to patients as soon as possible.”
“We are excited to embark on this collaboration with Taiho.
Taiho is an ideal partner with whom to advance CLN-081/TAS6417 into
later stage development and commercialization, given their deep
understanding of the molecule and strategic focus on targeted
therapies, existing stake in Cullinan Pearl, and strong
oncology-focused commercial capabilities in the U.S.,” said Nadim
Ahmed, Chief Executive Officer of Cullinan Oncology. “Importantly,
the structure of the agreement provides the opportunity to
efficiently establish our own commercial infrastructure, which will
also be leveraged for our future programs. The transaction
payments, reduced development expense, and potential ongoing
revenue stream upon future commercialization will help us to devote
greater resources to advance our robust pipeline of assets across a
wide range of modalities, each with the potential to be the first
or best in their class, to deliver on our promise to bring new
therapeutic solutions to patients with cancer.”
Cullinan Oncology Conference Call
Information
Cullinan Oncology will host a conference call today, May 12, at
8 a.m. EDT during which company executives will provide an overview
of the collaboration. Investors and the general public are invited
to listen to a live webcast of the call. A link to join the call
and to find related materials will be available at:
https://investors.cullinanoncology.com/news-events/events
About CLN-081/TAS6417
CLN-081/TAS6417 is an orally available tyrosine kinase inhibitor
designed to target activating mutations in EGFR. The molecule was
engineered to inhibit EGFR variants with exon 20 insertion
mutations, while sparing wild-type EGFR. CLN-081/TAS6417 is a
clinical candidate for NSCLC driven by EGFR exon 20 insertion
mutations and is expected to be a novel therapeutic option for
patients with highly unmet medical needs. In 2019, Taiho granted
Cullinan Pearl, a company that Taiho and its subsidiaries and
Cullinan Oncology had established together, an exclusive global
license, excluding Japan, for the development and commercialization
of CLN-081/TAS6417. Following this agreement, Cullinan Pearl
rapidly advanced CLN-081/TAS6417, opening an Investigational New
Drug application and initiating a global Phase I/IIa study in NSCLC
patients harboring EGFR exon 20 mutations, which is currently
ongoing. Cullinan Oncology announced that the FDA granted
Breakthrough Therapy Designation for CLN-081/TAS6417 in early 2022.
Cullinan Oncology and Taiho expect to initiate a pivotal study in
the second half of 2022.
About Cullinan Oncology
Cullinan 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.
About Taiho
Taiho Pharmaceutical Co., Ltd., a subsidiary of Otsuka Holdings
Co., Ltd., is an R&D-driven specialty pharma company with a
focus on oncology. Taiho Pharmaceutical also has development
programs in allergy and immunology, urology and consumer healthcare
products. Our corporate philosophy is simple: “We strive to improve
human health and contribute to a society enriched by smiles.” For
more information about Taiho Pharmaceutical Co., Ltd., please
visit: https://www.taiho.co.jp/en/
Forward Looking Statements
This press release contains forward-looking statements 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 the milestone payments we may receive from
Taiho; the anticipated development and commercialization of
CLN-081/TAS6417; the development of our commercial infrastructure;
potential investments in our pipeline and the potential for such
product candidates; and our cash runway. The words “anticipate,”
“believe,” “continue,” “could,” “estimate,” “expect,” “hope,”
“intend,” “may,” “plan,” “potential,” “predict,” “project,”
“target,” “should,” “would,” and similar expressions are intended
to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. 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 product 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 performance
and results 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 (SEC), including under the caption “Risk Factors” in our
most recent Annual Report on Form 10-K 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. While we may elect to update such forward-looking
statements in the future, we disclaim any obligation to do so, even
if subsequent events cause our views to change, except to the
extent required by law. These forward-looking statements should not
be relied upon as representing our views as of any date subsequent
to the date of 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.
Contacts:
Investor Relations Chad Messer+1
203.464.8900cmesser@cullinanoncology.com
MediaRose Weldon+1 215.801.7644rweldon@cullinanoncology.com
1 American Cancer Society. What Is Non-Small Cell Cancer?.
https://www.cancer.org/cancer/lung-cancer/about/what-is.html2
Konduri et al. (Cancer Discov 2016 6 601)3 Riess et al. (WCLC2016)4
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6764748/
*Cullinan Pearl previously licensed the rights to
CLN-081/TAS6417 in Greater China to Zai Lab in 2020.
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