Cullinan Oncology, Inc. (Nasdaq: CGEM) and Harbour
BioMed (HKEX: 02142) today announced that Cullinan Oncology
has entered into an exclusive license with Harbour BioMed for the
development and commercial rights of HBM7008 (CLN-418) in the U.S.
CLN-418/HBM7008 is a B7H4 x 4-1BB bispecific immune activator
developed from next-gen heavy chain only antibody (HCAb)-based
multi-specific antibody discovery platform HBICE®, currently in a
Phase 1 clinical study being conducted at U.S. and Australian sites
in patients with advanced solid tumors.
“We are pleased to bring CLN-418, a potential first-in-class,
clinical-stage bispecific immune activator, into our diversified
portfolio. We believe the best approach to conditional activation
of 4-1BB is by targeting B7H4, a tumor associated antigen that is
highly expressed across multiple cancers and minimally overlaps
with PD-L1 expression. CLN-418 is a strong strategic fit for
Cullinan, building on our expertise with bispecifics, and placing
us at the forefront of bispecific antibody development in solid
tumors. Importantly, this transaction adds another clinical-stage
asset to our portfolio, and with it, we are on track to have
potentially six clinical stage assets in our pipeline by the end of
2023,” said Nadim Ahmed, Chief Executive Officer of Cullinan
Oncology. “This transaction is consistent with our goal to
strategically deploy capital to expand and advance our pipeline,
and the financial terms of the agreement allow us to maintain a
multi-year cash runway to fund our ongoing development efforts and
deliver data from multiple clinical programs. Harbour BioMed is a
global clinical-stage biotech company with experienced therapeutic
innovation capabilities and a network of partnerships, and we look
forward to realizing the full potential of this exciting
program.”
Under the agreement, Cullinan Oncology will pay Harbour BioMed
an upfront license fee of $25 million at closing for the exclusive
right to develop and commercialize CLN-418/HBM7008 in the U.S.
Harbour BioMed will be eligible to receive up to $148M in
development and regulatory milestones plus up to an additional
$415M in sales-based milestones as well as tiered royalties up to
high teens on potential U.S. commercial sales.
“This agreement is another validation from a leading global
biotech company on our technology platforms and innovation
capabilities. We believe that Cullinan Oncology is the ideal
partner to continue the development of CLN-418/HBM7008, which we
believe has first-in-class potential to treat a wide range of
solid-tumor cancers. They have a seasoned clinical development
team, strong capabilities in oncology drug development, and the
robust infrastructure necessary to move it forward,” said Dr.
Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. “We
look forward to working with Nadim and his team to advance this
program forward.”
Cullinan Oncology Conference Call
InformationCullinan Oncology will host a conference call
on Tuesday, February 14 at 8 a.m. ET. Investors and the general
public are invited to listen to a live webcast of the call. A link
to join the call and to find related materials will be available
at: investors.cullinanoncology.com/events
About CLN-418/HBM7008
CLN-418/HBM7008 is the only B7H4 x 4-1BB bispecific immune
activator in clinical studies. Both B7H4 and 4-1BB have been
targets of high interest and both have been evaluated clinically.
Their distinct biology and mechanisms of action provide strong
rationale to combine them as a bispecific antibody.
B7H4 is an attractive tumor associated antigen (TAA) highly
expressed on multiple tumor types, including triple negative breast
cancer, ovarian cancer, and lung cancer, while expression on normal
tissue is low. A coinhibitory immune checkpoint with PD-L1 in the
B7 family, B7H4 has minimal overlap with PD-L1 expression.
Targeting B7H4 has the potential to address tumor types for which
PD-L1-based immunotherapies have exhibited limited efficacy.
4-1BB is a key costimulatory molecule for both T- and NK-cell
engagement and is being studied in multiple clinical programs.
However, safety concerns such as hepatic toxicity remain despite
the biological validation of the 4-1BB pathway. Conditional
activation of 4-1BB in the tumor microenvironment that is dependent
on B7H4 expression presents a novel approach to harness the
potential of both targets. CLN-418/HBM7008, with strict TAA
crosslinking dependent T-cell activation, can potentially translate
to better safety and a more favorable therapeutic window.
The ongoing Phase 1 trial (NCT05306444) is an open-label,
multicenter study being conducted at U.S. and Australian sites
evaluating the safety, tolerability, pharmacokinetics and
anti-tumor activity of CLN-418/HBM7008 administered intravenously
in patients with advanced solid tumors. The study, which is
expected to enroll up to 108 subjects, aims to identify a maximum
tolerated dose and a recommended Phase 2 dose of CLN-418/HBM7008.
Initial clinical data from this study could be available in
2024.
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.
About Harbour BioMed
Harbour BioMed (HKEX: 02142) is a global biopharmaceutical
company committed to the discovery, development and
commercialization of novel antibody therapeutics focusing on
oncology and immunology. Harbour BioMed is building its robust
portfolio and differentiated pipeline through internal R&D
capability, collaborations with co-discovery and co-development
partners and select acquisitions. Harbour BioMed’s proprietary
antibody technology platforms Harbour Mice® generate fully
human monoclonal antibodies in two heavy and two light chain (H2L2)
format, as well as heavy chain only (HCAb) format. Building upon
the HCAb antibodies, the HCAb-based immune cell engagers (HBICE®)
are capable of delivering tumor killing effects unachievable by
traditional combination therapies. Integrating Harbour Mice®,
HBICE® with single B cell cloning platform, its antibody
discovery engine is highly unique and efficient for development of
next generation therapeutic antibodies. For more information,
please visit www.harbourbiomed.com, and follow as on LinkedIn.
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 of, and plans relating to, the
license agreement between Cullinan and Harbour BioMed, including
anticipated milestone payments under the license agreement; the
therapeutic potential of CLN-418; our expectations regarding our
use of capital; 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:
InvestorsCullinan Oncology:Chad Messer+1
203.464.8900cmesser@cullinanoncology.com |
Harbour BioMed:Richard Fu+86 18651850871ir@harbourbiomed.com |
Media Cullinan Oncology:Rose Weldon +1
215.801.7644 rweldon@cullinanoncology.com |
Harbour BioMed:Grace Heng+86 13775129195pr@harbourbiomed.com |
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