Cullinan Oncology Announces U.S. FDA Clearance of Investigational New Drug Application for CLN-617, a Novel Fusion Protein Harnessing IL-2 and IL-12 Cytokines
March 27 2023 - 7:00AM
Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical
company focused on modality-agnostic targeted oncology therapies,
today announced the U.S. Food and Drug Administration (FDA)
has cleared its Investigational New Drug (IND) application for
CLN-617, a fusion protein comprised of two potent and synergistic
antitumor cytokines, IL-2 and IL-12, with a collagen binding domain
designed for retention in the tumor microenvironment (TME)
following intratumoral injection. Cullinan Oncology will initially
evaluate CLN-617 in a Phase 1 trial in patients with advanced solid
tumors.
”Both IL-2 and IL-12 play a powerful role in stimulating an
immune response to cancer, but previous attempts to harness these
potent cytokines have been limited by significant systemic
toxicities and a narrow therapeutic index” said Jeffrey Jones, MD,
MPH, MBA, Chief Medical Officer, Cullinan Oncology. “Preclinical
research shows that while CLN-617 is retained in the injected
tumor, it mediates a broad anti-tumor immune response that clears
both injected tumors and distant non-injected tumors and generates
immunological memory to prevent recurrence. We look forward to
working closely with investigators to initiate the Phase 1 trial
and are proud to advance this program, which will be our sixth
clinical-stage asset, to further our mission to create new
standards of care for patients with cancer.”
The first-in-human clinical study is a Phase 1, open-label,
dose-escalation and dose-expansion study designed to evaluate the
safety and efficacy of CLN-617 alone and in combination with
pembrolizumab in patients with advanced solid tumors.
About CLN-617
CLN-617 is a potential first-in-class cytokine therapy comprised
of two potent and synergistic antitumor cytokines, IL-2 and IL-12,
in a single molecule. The molecule is intended for intratumoral
injection and employs collagen-binding and size-enhancing domains
designed to retain the CLN-617 molecule inside the tumor and
thereby enhance efficacy and reduce toxicity. While CLN-617 is
injected and retained locally in the tumor, it directs a broad
immune response that may help eradicate not only the injected
tumor, but also attack distant tumor sites, as observed in
preclinical studies. Preclinical studies have also demonstrated the
potential for enhanced efficacy when CLN-617 is combined with
checkpoint inhibitor therapy. Cullinan plans to evaluate CLN-617 in
a Phase 1 clinical trial in patients with advanced solid
tumors.
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.
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 our preclinical and clinical development
plans and timelines, clinical trial designs, clinical and
therapeutic potential, and strategy of our product candidates,
including but not limited to our expectations and beliefs around
the safety and efficacy of CLN-617. 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 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
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.
InvestorsChad Messer+1
203.464.8900cmesser@cullinanoncology.com
Media Rose Weldon +1
215.801.7644 rweldon@cullinanoncology.com
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