Cullinan Oncology Announces U.S. FDA Clearance of Investigational New Drug Application for CLN-978, a Novel T-Cell Engager for the Treatment of Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
January 24 2023 - 8:00AM
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-978, a CD19/CD3 T-cell engaging antibody construct with a human
serum albumin (HSA) binding domain to increase serum half-life.
Cullinan Oncology will initially evaluate CLN-978 in a Phase 1
trial for the treatment of relapsed/refractory B-cell non-Hodgkin
lymphoma (B-NHL).
“Despite advances for the treatment of B-cell malignancies,
substantial unmet need remains for effective treatments.
Preclinical evidence has demonstrated a differentiated profile for
CLN-978 as it binds with very high affinity to CD19-expressing
cells even at barely detectable levels of CD19.” said Jeffrey
Jones, MD, MPH, MBA, Chief Medical Officer, Cullinan Oncology.
“Consistent with our mission to create new standards of care for
patients with cancer, CLN-978 has the potential to become a
best-in-class treatment option for patients with B-cell
malignancies by offering a highly potent off-the-shelf treatment
that is delivered subcutaneously, resulting in more
patient-friendly administration and potentially reduced toxicity.
We are proud to advance this program, which came through our
internal discovery pipeline and is Cullinan Oncology’s fourth
clinical-stage asset, and we will be working diligently with
investigators to enroll patients in our study.”
The study is a Phase 1, open-label, dose-escalation and
dose-expansion study designed to evaluate the safety and efficacy
of CLN-978 in patients with relapsed/refractory B-NHL.
IND submission remains on track for CLN-617 (IL-2, IL-12 fusion
protein) in 1H 2023.
ABOUT CLN-978
CLN-978 is a novel, highly potent, half-life extended CD19/CD3
bispecific T-cell engaging antibody construct. CLN-978 contains two
single-chain variable fragments (scFv), one recognizing with high
affinity CD19 on malignant cells and the other targeting CD3 on
T-cells. While CLN-978 resembles the BiTE format, it also contains
a single-domain antibody (VHH) binding to human serum albumin
(HSA). CLN-978 redirects and activates T-cells to destroy cancer
cells via T-cell mediated cytotoxicity.
CLN-978 potentially offers a convenient, off-the-shelf
therapeutic option that may provide an alternative to CD19 CAR
T-cell therapies. High-affinity binding of CLN-978 to CD19 allows
for increased potency against tumor cells expressing very low
levels of CD19. An HSA-binding domain increases the serum half-life
of CLN-978 and, with subcutaneous delivery, permits more
patient-friendly dosing and potentially reduced toxicity.
CLN-978 has the potential to become a highly effective treatment
option for patients across a range of B-cell malignancies,
including those who have relapsed on other CD19-directed therapies
due to reduced CD19 target expression. CLN-978 is currently being
evaluated as a novel treatment for B-NHL, but with potential
applicability across the entire spectrum of B-cell mediated
diseases.
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-978. 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.
Investors
Chad Messer
+1 203.464.8900
cmesser@cullinanoncology.com
Media
Rose Weldon
+1 215.801.7644
rweldon@cullinanoncology.com
Cullinan Therapeutics (NASDAQ:CGEM)
Historical Stock Chart
From Jun 2024 to Jul 2024
Cullinan Therapeutics (NASDAQ:CGEM)
Historical Stock Chart
From Jul 2023 to Jul 2024