Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical
company focused on modality-agnostic targeted oncology therapies,
today announced first monotherapy clinical data from its Phase
1 study of CLN-619 in patients with advanced solid tumors. Findings
from the clinical trial will be shared at the 2023 American
Society of Clinical Oncology (ASCO) Annual Meeting as a poster
presentation during the “Developmental Therapeutics—Immunotherapy”
session (poster # 2532) on June 3, 2023 from 8:00 AM-11:00 AM
Central Time. CLN-619 is being studied in an ongoing Phase 1
clinical trial both as a monotherapy and in combination with
pembrolizumab in patients with advanced solid tumors.
Summary of Key Clinical Results from Monotherapy Arm of
Phase 1 Clinical Trial in Patients with Solid Tumors:
- Monotherapy dose escalation demonstrates acceptable safety
profile of CLN-619 across all doses assessed (0.1, 0.3, 1, 3, 6,
10mg/kg):
- No dose-limiting toxicities were observed
- Consistent with other monoclonal antibodies, infusion-related
reactions were limited to the first dose and all grade 1/2 in
patients receiving mandated pre-medication
- Data demonstrate monotherapy anti-tumor activity of CLN-619,
including objective tumor responses, across multiple tumor
types:
|
All Patients(n=37) |
Response Evaluable1at ≥1 mg/kg(n=22) |
Response Evaluable1GYN Malignancy2(n=10) |
Complete Response (CR) |
1 |
1 |
0 |
Partial Response (PR)3 |
2 |
2 |
2 |
Stable Disease (SD) |
7 |
7 |
5 |
CR + PR + SD |
10 |
10 |
7 |
Progressive Disease (PD) |
18 |
12 |
3 |
Not Evaluable (NE) |
9 |
NA |
NA |
1Patients who underwent at least one RECIST response assessment or
who had clinically assessed PD prior to first planned response
assessment2Endometrial, cervical, and ovarian3The observed partial
responses were unconfirmed but ongoing at time of data cut-off |
- One CR was observed in a patient with parotid gland cancer
whose cancer had progressed on prior checkpoint inhibitor
therapy
- Two PRs (pending confirmation) were observed in patients with
endometrial cancer, one whose cancer had progressed on prior
checkpoint inhibitor therapy
- Stable disease was observed in patients across multiple tumor
types, including cervical, ovarian, salivary gland, and breast
cancers
- Patients were heavily pre-treated with a median of 3 prior
systemic therapies (1 – 7), and 54% had received prior immune
checkpoint inhibitor therapy
- The trial continues to enroll in both the monotherapy and
combination arms.
"We are encouraged by the first clinical data for CLN-619
monotherapy, which demonstrates broad potential across a range of
tumor types. Objective responses and sustained stable disease were
observed, including in patients whose tumors had relapsed on or
were not amenable to checkpoint inhibitor therapy,” said Jeffrey
Jones, MD, MPH, MBA, Chief Medical Officer, Cullinan Oncology.
“Notably, clinical activity was observed in multiple gynecologic
cancer types of high unmet need. Based on these initial efficacy
observations, we will initiate expansion cohorts in endometrial and
cervical cancer and look to expand in additional tumor-specific
cohorts as the data matures. Additionally, the Phase 1 trial
continues to evaluate CLN-619 in combination with pembrolizumab,
and we look forward to sharing the results at a future medical
meeting.”
“These data demonstrate the potential of CLN-619 to treat a
range of solid tumors. Along with the monotherapy efficacy of
CLN-619, we also observed a favorable safety profile, with most
adverse events being grade 2 or lower,” said Judy Wang, MD, Florida
Cancer Specialists and Research Institute. “We need new ways to
help overcome immune evasion mechanisms, and CLN-619 is an antibody
that is designed to render cancer cells visible to the immune
system by binding to MICA and MICB, stress-induced ligands that
engage the activating receptor NKG2D present on both innate and
adaptive immune cells, representing a novel approach to enable
immune-mediated elimination of tumors.”
“Over 66,000 new cases of endometrial cancer are diagnosed every
year in the United States. The incidence has been rising for more
than a decade, particularly in the more aggressive subtypes, and
uterine cancer is projected to surpass colorectal cancer as the
fourth leading cause of cancer death among women by 2040.1,2
Despite recent advances in endometrial cancer therapeutics, this
patient population is often affected by other co-morbidities, so
safer and more effective treatment options are urgently needed to
address a growing unmet need” said Vicky Makker, MD, Section Head
of the Endometrial Cancer Program at Memorial Sloan Kettering
Cancer Center. “That need extends across gynecologic cancers. In
cervical cancer, treatment options remain limited, and even with
improvements in screening to reduce incidence rates, approximately
13,000 new cases of cervical cancer are diagnosed annually and
greater than 4,000 women die of this malignancy each year in the
U.S.3”
CLN-619 Further Development Plan
CLN-619 is being studied in an ongoing Phase 1 clinical trial
both as a monotherapy and in combination with pembrolizumab. The
study design allows dose level extensions as well as expansion in
tumor-specific cohorts. Consistent with prespecified criteria and
based on initial safety and efficacy observations, Cullinan will
initiate monotherapy expansion cohorts in endometrial cancer and
cervical cancer. Additional expansion cohorts may be initiated
based upon clinical activity observed in the current trial.
Virtual and Live Investor Event
Cullinan Oncology will host an Investor Event on Sunday, June 4,
2023, at 7:00 am Central Time, during which Dr. Jeff Jones, Chief
Medical Officer at Cullinan Oncology, will present an overview of
CLN-619 data shared at the 2023 ASCO Annual Meeting, and Dr. Vicky
Makker, MD, Section Head of the Endometrial Cancer Program at
Memorial Sloan Kettering Cancer Center, will share an overview of
the current treatment landscape for endometrial cancer. Investors
and analysts are invited to register to attend in-person by
emailing Chad Messer, VP Investor Relations
(cmesser@cullinanoncology.com). A live webcast will be available
via the events page of the Company’s investor relations website
at https://cullinanoncology.com/events-and-presentations/, and
a replay will be available shortly after the conclusion of
the live event.
About CLN-619CLN-619 is a potential
first-in-class humanized IgG1 monoclonal antibody that binds to the
stress induced ligands, MICA and MICB, which are expressed on a
wide variety of solid tumors and hematological malignancies.
Engagement of MICA/B by the activating receptor NKG2D, present on
both cytotoxic innate and adaptive immune cells, results in target
cell lysis. However, tumor cells can shed MICA/B via proteases they
release into the tumor microenvironment, resulting in evasion of
immune-mediated destruction. CLN-619 functions by restoring MICA/B
expression on the surface of tumor cells, enhancing the interaction
between MICA and NKG2D, and inducing antibody-dependent cellular
toxicity (ADCC), together promoting anti-tumor activity via
multiple immune-mediated mechanisms. CLN-619 is being studied in an
ongoing Phase 1 clinical trial both as a monotherapy and in
combination with pembrolizumab. The study design allows dose level
extensions as well as expansion in tumor-specific cohorts.
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 StatementsThis 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 potential benefits and therapeutic potential of
CLN-619; our clinical development plans and timelines; our plans
regarding future data presentations and other statements that are
not historical facts. 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.
Contacts:
Investor RelationsChad Messer+1
203.464.8900cmesser@cullinanoncology.com
MediaRose Weldon+1 215.801.7644rweldon@cullinanoncology.com
References:
- NCI/SEER Uterine Cancer Stat Facts
(https://seer.cancer.gov/statfacts/html/corp.html)
- Rahib L, Wehner MR, Matrisian LM, Nead
KT. Estimated projection of US cancer incidence and
death to 2040. JAMA Netw Open.
2021;4(4):e214708.
- Cervical Cancer Statistics | CDC
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