TOKYO, PRINCETON,
N.J. and CAMBRIDGE,
Mass., Jan. 28, 2025 /PRNewswire/ -- Taiho
Pharmaceutical Co., Ltd., Taiho Oncology, Inc., and Cullinan
Therapeutics, Inc., announced today the REZILIENT1 trial, a Phase
1/2 clinical trial of zipalertinib (development code:
CLN-081/TAS6417) monotherapy in patients with non-small cell lung
cancer (NSCLC) harboring the epidermal growth factor receptor
(EGFR) exon 20 insertion mutations who have received prior therapy,
met its primary endpoint of overall response rate. The safety
profile was generally consistent with previous data presentations.
These results are based on the Phase 2b part of this study.
Full results from REZILIENT1 will be submitted for presentation
at an upcoming international medical conference. Pending
discussions with the U.S. Food and Drug Administration (FDA), the
companies plan to submit for U.S. regulatory approval in the second
half of 2025.
About the REZILIENT1 Trial
REZILIENT1 is a Phase 1/2
clinical trial (NCT04036682) to evaluate efficacy and safety of
zipalertinib in patients with NSCLC harboring EGFR exon 20
insertion mutations who have received prior therapy. The topline
results obtained at this time are based on the Phase 2b part of this study. Preliminary results of
REZILIENT1 have been published in the Journal of Clinical
Oncology®.1
REZILIENT: Researching Zipalertinib In EGFR Non-Small Cell Lung
Cancer Tumors
About Zipalertinib
Zipalertinib (development
code: CLN-081/TAS6417) is an orally available small molecule
designed to target activating mutations in EGFR. The molecule was
selected because of its ability to inhibit EGFR variants with exon
20 insertion mutations, while sparing wild-type EGFR. Zipalertinib
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. Zipalertinib has received Breakthrough
Therapy Designation from the FDA.
Zipalertinib is being developed by Taiho Oncology, Inc., its
parent company, Taiho Pharmaceutical Co., Ltd., and in
collaboration with Cullinan Therapeutics, Inc. in the U.S.
About the EGFR exon 20 insertion mutations
NSCLC
is a common form of lung cancer and up to 4% of all cases have EGFR
exon 20 insertions, which makes them the third most common EGFR
mutation subtype.2 In the
United States, approximately 16% of patients with NSCLC
harbor EGFR mutations, with insertions at exon 20 accounting
for up to 12% of these mutations.2
About Taiho Pharmaceutical Co., Ltd. (Japan)
Taiho Pharmaceutical, a
subsidiary of Otsuka Holdings Co.,
Ltd. (https://www.otsuka.com/en/), is an R&D-driven
specialty pharma focusing on the fields of oncology and
immune-related diseases. Its corporate philosophy takes the form of
a pledge: "We strive to improve human health and contribute to a
society enriched by smiles." In the field of oncology, in
particular, Taiho Pharmaceutical is known as a leading company in
Japan for developing innovative
medicines for the treatment of cancer, a reputation that is rapidly
expanding through their extensive global R&D efforts. In areas
other than oncology, as well, the company creates and markets
quality products that effectively treat medical conditions and can
help improve people's quality of life. Always putting customers
first, Taiho Pharmaceutical also aims to offer consumer healthcare
products that support people's efforts to lead fulfilling and
rewarding lives. For more information about Taiho Pharmaceutical,
please visit https://www.taiho.co.jp/en.
About Taiho Oncology, Inc.
The mission of Taiho Oncology, Inc. is to improve the lives of
patients with cancer, their families and their caregivers. The
company specializes in the development and commercialization of
orally administered anti-cancer agents for various tumor types.
Taiho Oncology has a robust pipeline of small molecule clinical
candidates targeting solid tumor and hematological malignancies,
with additional candidates in pre-clinical development. Taiho
Oncology is a subsidiary of Taiho Pharmaceutical Co., Ltd. which is
part of Otsuka Holdings Co., Ltd. Taiho Oncology is headquartered
in Princeton, New Jersey and
oversees its parent company's European and Canadian operations,
which are located in Zug, Switzerland and Oakville, Ontario, Canada.
For more information, visit https://www.taihooncology.com/, and
follow us on LinkedIn and X.
About Cullinan Therapeutics
Cullinan
Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company
dedicated to creating new standards of care for patients. Cullinan
has strategically built a diversified portfolio of clinical-stage
assets that inhibit key drivers of disease or harness the immune
system to eliminate diseased cells in both autoimmune diseases and
cancer. Cullinan's portfolio encompasses a wide range of
modalities, each with the potential to be best and/or first in
class. Anchored in a deep understanding of oncology, immunology,
and translational medicine, we create differentiated ideas,
identify the most appropriate targets, and select the optimal
modality to develop transformative therapeutics across a wide
variety of autoimmune and cancer indications. We push conventional
boundaries from candidate selection to differentiated therapeutic,
applying rigorous go/no go criteria at each stage of development to
fast-track only the most promising molecules to the clinic and,
ultimately, commercialization. With deep scientific expertise, our
teams exercise creativity and urgency to deliver on our promise to
bring new therapeutic solutions to patients. Learn more about
Cullinan at https://cullinantherapeutics.com/, and follow us
on LinkedIn and X.
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 the company's beliefs and expectations
regarding our plans regarding future data presentations, the
clinical development plan and timeline of zipalertinib and other
statements that are not historical facts. The words "believe,"
"continue," "could," "estimate," "expect," "intends," "may,"
"plan," "potential," "project," "pursue," "will," 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 future results, performance or
achievements 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; the risk that any INDs or other global
regulatory submissions we may file with the United States Food and
Drug Administration or other global regulatory agencies are not
cleared on our expected timelines, or at all; the success of our
clinical trials and preclinical studies; the risks related to our
ability to protect and maintain our intellectual property position;
the risks related to manufacturing, supply, and distribution of our
product candidates; 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
the 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, 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 at some point 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 the company 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.
1 Piotrowska Z, Tan DS, Smit EF, et al. Safety, tolerability,
and antitumor activity of zipalertinib among patients with
non-small-cell lung cancer harboring epidermal growth factor
receptor exon 20 insertions. Journal of Clinical Oncology.
Available at: https://ascopubs.org/doi/full/10.1200/JCO.23.00152.
Last accessed: January 2025.
2 Burnett H, Emich H, Carroll C, et al. Epidemiological and
clinical burden of EGFR exon 20 insertion in advanced non-small
cell lung cancer: a systematic literature review. PLOS ONE.
2021;16(3):e0247620. Available at:
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0247620.
Last accessed: January 2025.
Contacts
Taiho Pharmaceutical Co.,
Ltd.
Junko Onishi
+81-80-1009-7683
junn-onishi@taiho.co.jp
Taiho Oncology
Leigh
Labrie
+ 609.664.9878
llabrie@taihooncology.com
Cullinan Therapeutics
Investors
Nick Smith
+1 401.241.3516
nsmith@cullinantx.com
Media
Rose Weldon
+1 215.801.7644
rweldon@cullinantx.com
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SOURCE Taiho Oncology
