Cullinan Oncology Announces First Patient Dosed in Phase 1 Trial Evaluating CLN-617, a Novel Fusion Protein Uniquely Harnessing Both IL-2 and IL-12 Cytokines
14 Dicembre 2023 - 10:30PM
Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical
company focused on modality-agnostic, targeted oncology therapies,
today announced that the first patient has been dosed with CLN-617
in a Phase 1 clinical trial. This is a first-in-human,
multi-center, open label study designed to evaluate the safety,
pharmacokinetics (PK), pharmacodynamics (PD), and preliminary
efficacy of CLN-617 alone and in combination with pembrolizumab, a
programmed death receptor-1 (PD-1) targeted checkpoint inhibitor,
in patients with advanced solid tumors.
“While checkpoint inhibitors have revolutionized
immuno-oncology, only a minority of patients respond, often due to
the tumors lacking appreciable numbers of cancer-specific T cells,
referred to as “cold” tumors. IL-2 and IL-12 are cytokines that
work together to stimulate an immune response to cancer cells,
potentially resulting in increased T cell infiltration, activation,
and proliferation and thereby turning the tumor ‘hot,’” said
Jeffrey Jones, MD, MPH, MBA, Chief Medical Officer, Cullinan
Oncology. “CLN-617 is a first-in-class cytokine therapy uniquely
combining human IL-2, IL-12, a collagen binding domain, and a
size-enhancing domain in a single molecule designed for
intratumoral injection. These unique characteristics are intended
to promote retention of the cytokines in the injected tumor and
potentially provide enhanced safety and efficacy. In pre-clinical
models, intratumoral administration of CLN-617 stimulated a broad
systemic immune response, resulting in the regression of
non-injected distal tumors and the generation of a memory T cell
response that enhanced long-term survival. We look forward to
working with investigators to explore the potential of CLN-617,
Cullinan Oncology’s sixth program in clinical development.”
About CLN-617CLN-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
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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;
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.
Contacts:Investor RelationsChad Messer+1
203.464.8900cmesser@cullinanoncology.com
MediaRose Weldon+1 215.801.7644rweldon@cullinanoncology.com
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