Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the
Company has entered into a definitive agreement to acquire Kolltan
Pharmaceuticals, Inc., a privately held clinical-stage company
focused on the discovery and development of novel, antibody-based
drugs targeting receptor tyrosine kinases (RTKs). Focused primarily
in oncology and backed by prominent thought leaders in RTK biology,
Kolltan has reported clinical and preclinical data that its drug
candidates can help overcome tumor resistance mechanisms associated
with current tyrosine kinase inhibitors and seen in patients who
have failed other cancer therapies. Celldex believes Kolltan’s
clinical candidates and preclinical platform are highly compatible
with the Company’s scientific approach and can be developed
independently and in combination with Celldex’s existing product
candidates.
“Celldex is committed to driving innovation in oncology to meet
the needs of patients and their families,” said Anthony Marucci,
Co-founder, President and Chief Executive Officer of Celldex
Therapeutics. “The acquisition of Kolltan provides Celldex with a
truly unique platform of antibodies targeting receptor tyrosine
kinases which we believe are highly compatible with our pipeline.
We believe this acquisition complements our leadership position in
immuno-oncology and enhances our ability to develop targeted
therapeutic regimens to dramatically improve patient outcomes.”
“Kolltan’s programs targeting KIT, ErbB3 and TAM receptors
potentially address major challenges surrounding tumor resistance
mechanisms in cancer biology,” said Gerald McMahon, Ph.D.,
President and Chief Executive Officer of Kolltan Pharmaceuticals.
“Celldex’s leadership and their scientific team played an
instrumental role in building the antibody field during their
tenure at Medarex and used this expertise to create a leading
pipeline in immuno-oncology at Celldex. We firmly believe Celldex
is uniquely positioned to advance our antibody portfolio targeting
RTKs to improve outcomes for patients and create optimal value for
our shareholders.”
Kolltan’s portfolio includes:
- KTN0158 – a humanized monoclonal antibody that is a potent
inhibitor of KIT activation in tumor cells and mast cells;
currently in a Phase 1 dose escalation study in refractory
gastrointestinal stromal tumors (GIST). KTN0158 prevents KIT
activation by blocking receptor dimerization. This mechanism may be
effective even in tumors harboring the most common resistant
mutations to Gleevec® and is unlikely to drive resistance.
Preclinical data demonstrate that KIT inhibition in certain immune
cells with KTN0158 enhances the activity of checkpoint blockade.
This mechanism may also be effective with other immunotherapies, in
particular with Celldex’s CD27 agonist, varlilumab.
- KTN3379 – a human monoclonal antibody designed to block the
activity of ErbB3 (HER3); clinical activity including meaningful
responses and stable disease has been observed in a Phase 1b study
in cetuximab (Erbitux®) refractory patients in head and neck
squamous cell carcinoma and in BRAF-mutant non-small cell lung
cancer (NSCLC). The proposed mechanism of action for KTN3379 sets
it apart from other drugs in development in this class due to its
ability to block both ligand-independent and ligand-dependent ErbB3
signaling by binding to a unique epitope. It also has a favorable
pharmacologic profile, including a longer half-life relative to
other drug candidates in this class. KTN3379 also has potential to
work well in combination with other targeted and cytotoxic
therapies to directly kill tumor cells. Tumor cell death and the
ensuing release of new tumor antigens could serve as a focus for
combination therapy with immuno-oncology approaches, even in
refractory patients.
- A multi-faceted TAM program – a broad antibody discovery effort
underway to generate antibodies that modulate the TAM family of
RTKs, comprised of Tyro3, AXL and MerTK, which are expressed on
tumor-infiltrating macrophages, dendritic cells and some tumors.
Research supports TAMs having broad application and potential
across immuno-oncology and immunology. In oncology, as with PD-1
and other checkpoints, TAMs regulate the immune response to cancer.
Modulation of TAM pathways may provide additional opportunities to
develop drugs to overcome resistance mechanisms, especially when
used in combination with either Celldex or external product
candidates or with existing approved therapies.
Upon closing of the acquisition of Kolltan, Celldex’s clinical
pipeline will include seven drug candidates including therapeutic
antibodies, antibody-drug conjugates (ADCs) and immune system
modulators, which are being tested in a range of difficult-to-treat
indications in oncology. This broad pipeline allows for novel
combination approaches, several of which are already under study.
In addition, Celldex would have two active preclinical
programs.
Transaction TermsUnder the terms of the
agreement, Celldex will acquire Kolltan in a stock-for-stock
transaction, in which the upfront payment represents an equity
value of approximately $62.5 million. In addition, Kolltan
shareholders are eligible to receive additional payments of up to
$172.5 million upon the completion of specific development,
regulatory and commercial milestones. The transaction, which is
subject to the receipt of Kolltan stockholder approval and other
customary closing conditions, is expected to be completed by
year-end. The Boards of Directors of both Celldex and Kolltan have
unanimously approved the transaction, and Kolltan’s Directors have
unanimously recommended that their stockholders approve the
transaction. Celldex was advised by Lowenstein Sandler, LLP.
Kolltan was advised by Guggenheim and Holland & Knight.
Conference Call DetailsCelldex will host a
conference call at 4:30 p.m. ET today to discuss the acquisition.
The conference call and presentation will be webcast live over the
internet and can be accessed by going to the "Events &
Presentations" page under the "Investors & Media" section of
the Celldex website at www.celldex.com. The call can also be
accessed by dialing (866) 743-9666 (within the United States) or
(760) 298-5103 (outside the United States). The passcode is
9492426.
A replay of the call will be available approximately two hours
after the call concludes through November 15, 2016. To access the
replay, dial (855) 859-2056 (within the United States) or (404)
537-3406 (outside the United States). The passcode is 9492426. The
webcast will also be archived on the Company’s website.
About Celldex Therapeutics, Inc.Celldex is
developing targeted therapeutics to address devastating diseases
for which available treatments are inadequate. Our pipeline is
built from a proprietary portfolio of antibodies and
immunomodulators used alone and in strategic combinations to create
novel, disease-specific therapies that induce, enhance or suppress
the body's immune response. Visit www.celldex.com for more info on
Celldex’s pipeline which includes:
- Glembatumumab vedotin, an antibody-drug conjugate (ADC) that
targets gpNMB, currently being evaluated in the pivotal METRIC
study in patients with metastatic triple-negative breast cancers
and in a broad range of additional indications, including
metastatic melanoma (in combination with varlilumab, after
checkpoint therapy), squamous cell lung cancer, osteosarcoma and
uveal melanoma
- Varlilumab, an agonist antibody that binds and activates CD27,
currently being evaluated in six indications in a broad Phase 1/2
clinical program which includes clinical trial collaborations with
Bristol-Myers Squibb and Roche
- CDX-1401, an NY-ESO-1-antibody fusion protein for
immunotherapy, which recently completed a Phase 2 study with
CDX-301 in metastatic melanoma; plans for additional combo studies
are underway
- CDX-301, a potent hematopoietic cytokine that uniquely expands
the number of dendritic cells to prime the immune system for more
robust immune responses to cancer antigens, currently in an
investigator sponsored Phase 1/2 study with Hiltonol® and low-dose
radiotherapy in patients with low-grade B-cell lymphomas
- CDX-014, an ADC targeting TIM-1, which recently entered Phase 1
clinical development in patients with clear cell and papillary
renal cell carcinoma
- A preclinical CD40 agonist program in which Celldex has
characterized a fully human antibody that has demonstrated potent
agonist activity. Importantly, Fc receptor interaction, which could
cause signal amplification and is required for some CD40 agonist
antibodies in development, was not required for agonist ability,
enabling controlled, sensitive activation of CD40.
About Kolltan PharmaceuticalsKolltan, a
privately held clinical-stage company, is focused on the discovery
and development of novel, antibody-based drugs targeting RTKs for
the treatment of cancer and other diseases with significant unmet
need. Kolltan is working in close collaboration with the laboratory
of Kolltan Co-Founder Dr. Joseph Schlessinger, as well as the Yale
University medical and scientific community. The Company has a
broad and novel oncology and immunology portfolio of therapeutic
biologics targeting multiple and different RTKs. KTN0158, targeting
the KIT receptor, and KTN3379, targeting the ErbB3 receptor, are
currently in Phase 1 clinical trials for the treatment of human
cancers. Kolltan also has active discovery efforts underway to
identify antibodies that can modulate the TAM family of RTKs
(Tyro3, AXL and MerTK).
Gleevec® is a registered trademark of Novartis AG. Erbitux® is a
registered trademark of Eli Lilly & Co. Hiltonol® is a
registered trademark of Oncovir, Inc.
Forward Looking StatementThis release contains
"forward-looking statements" made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of
1995. These statements are typically preceded by words such
as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,”
“should,” or similar expressions. These forward-looking statements
reflect management's current knowledge, assumptions, judgment and
expectations regarding future performance or events. Although
management believes that the expectations reflected in such
statements are reasonable, they give no assurance that such
expectations will prove to be correct or that those goals will be
achieved, and you should be aware that actual results could differ
materially from those contained in the forward-looking statements.
Forward-looking statements are subject to a number of risks and
uncertainties, including, but not limited to, the ability of
Kolltan and the Company to satisfy the closing conditions of the
acquisition, including the risk that Kolltan’s stockholders may not
approve the merger; our ability to successfully integrate the
business and programs of Kolltan with our business and programs;
our ability to successfully complete research and further
development and commercialization of glembatumumab vedotin and
other Company and Kolltan drug candidates; our ability to obtain
additional capital to meet our long-term liquidity needs on
acceptable terms, or at all, including the additional capital which
will be necessary to complete the clinical trials that we have
initiated or plan to initiate (or which Kolltan has initiated or
plans to initiate); the uncertainties inherent in clinical testing
and accruing patients for clinical trials; our limited experience
in bringing programs through Phase 3 clinical trials; our ability
to manage and successfully complete multiple clinical trials and
the research and development efforts for our multiple products at
varying stages of development; the availability, cost, delivery and
quality of clinical and commercial grade materials produced by our
own manufacturing facility or supplied by contract manufacturers,
who may be our sole source of supply; the timing, cost and
uncertainty of obtaining regulatory approvals; our ability to
maintain and derive benefit from the Fast Track designation for
glembatumumab vedotin which does not change the standards for
regulatory approval or guarantee regulatory approval on an
expedited basis, or at all; the failure of the market for the
Company's and Kolltan’s programs to continue to develop; our
ability to protect the Company's intellectual property; the loss of
any executive officers or key personnel or consultants;
competition; changes in the regulatory landscape or the imposition
of regulations that affect the Company's products; and other
factors listed under "Risk Factors" in our annual report on Form
10-K and quarterly reports on Form 10-Q.
All forward-looking statements are expressly qualified in their
entirety by this cautionary notice. You are cautioned not to place
undue reliance on any forward-looking statements, which speak only
as of the date of this release. We have no obligation, and
expressly disclaim any obligation, to update, revise or correct any
of the forward-looking statements, whether as a result of new
information, future events or otherwise.
Company Contact
Sarah Cavanaugh
Vice President of Investor Relations & Corp Communications
Celldex Therapeutics, Inc.
(781) 433-3161
scavanaugh@celldex.com
Charles Liles
Associate Director of Investor Relations & Corp Communications
Celldex Therapeutics, Inc.
(781) 433-3107
cliles@celldex.com
Media Inquiries
Dan Budwick
BrewLife
(973) 271-6085
dbudwick@brewlife.com
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