SEATTLE, WA and
HAMPTON, NJ, May 29, 2014 /PRNewswire/ - Oncothyreon Inc.
(NASDAQ: ONTY) and Celldex Therapeutics, Inc., (NASDAQ: CLDX) today
announced that they have agreed to collaborate on a combined
clinical trial of ONT-10 and varlilumab. ONT-10 is a therapeutic
vaccine targeting the tumor-associated antigen MUC1. Varlilumab is
a fully human monoclonal antibody that targets CD27, a critical
molecule in the activation pathway of lymphocytes.
The planned trial is an open-label Phase 1b
study of ONT-10 administered at the recommended single agent dose
in combination with varlilumab at two dose levels in up to 42
patients with advanced breast or ovarian cancer. The primary
objective of the trial is to determine the safety and tolerability
of the combined therapy. Additional objectives include evaluations
of the impact of combination treatment on MUC1-specific humoral and
cellular immune responses and anti-tumor effects.
"Recent advances in the immunotherapy of cancer
have created new opportunities for evaluating the effectiveness of
combination approaches," said Diana
Hausman, M.D., Chief Medical Officer at Oncothyreon. "We
believe the combination of a therapeutic vaccine with an agent
which activates T-cells has the potential to be particularly
exciting."
"The combination of an immunogenic
tumor-targeted vaccine such as ONT-10 and a broad immune
co-stimulator like varlilumab could create potent immunity that may
result in anticancer activity, either together or in combination
with a checkpoint inhibitor," said Tom
Davis, M.D., Senior Vice President and Chief Medical Officer
of Celldex. "We believe combination approaches represent the future
of immuno-oncology and look forward to starting this study and
gathering more information on the potential of varlilumab in
combination with this promising MUC1 vaccine and other potentially
complementary agents."
The collaboration agreement provides that
Oncothyreon will supply ONT-10 and Celldex will supply CDX-1127.
The Phase 1b trial will be conducted and funded by Oncothyreon,
which plans to submit a new Investigational New Drug (IND)
application for the combination trial. Oncothyreon and Celldex will
jointly own the data from the trial and will make any plans for
potential future development of the combination therapy together.
Under the agreement, neither company has granted the other a
license, or any other rights, to its product candidate.
About ONT-10
ONT-10 is a therapeutic vaccine targeting MUC1,
a tumor-associated antigen present on many types of human malignant
tumors, including lung, breast, colorectal, prostate and ovarian
cancer. ONT-10 contains a glycosylated antigen designed to mimic
the hypoglycosylated state of tumor-associated MUC1 and intended to
stimulate both the humoral and cellular arms of the immune
response. Additionally, ONT-10 contains the adjuvant PET-Lipid A, a
fully synthetic toll like receptor 4 (TLR4) agonist proprietary to
Oncothyreon. In an ongoing Phase 1 trial ONT-10 has been
well-tolerated, has led to a robust anti-MUC1 antibody response,
and has been associated with prolonged stable disease of greater
than six months in advanced stage patients. Oncothyreon currently
plans to expand the Phase 1 trial in two disease-specific cohorts
in patients with advanced breast or ovarian carcinoma.
About Varlilumab
Varlilumab is a fully human monoclonal antibody
that targets CD27, a critical molecule in the activation pathway of
lymphocytes. CD27 can be effectively manipulated with activating
antibodies to induce potent anti-tumor responses, and may result in
less toxicities due to its restricted expression and regulation.
Varlilumab is a potent anti-CD27 agonist that induces activation
and proliferation of human T cells when combined with T-cell
receptor stimulation. In lymphoid malignancies that express CD27 at
high levels, varlilumab has an additional mechanism through a
direct anti-tumor effect. In ongoing Phase 1 trials varlilumab has
shown an excellent safety profile and demonstrated clear biologic
activity and promising signs of clinical activity in an advanced,
refractory patient population.
About Oncothyreon
Oncothyreon is a biotechnology company
specializing in the development of innovative therapeutic products
for the treatment of cancer. Oncothyreon's goal is to develop and
commercialize novel synthetic vaccines and targeted small molecules
that have the potential to improve the lives and outcomes of cancer
patients. For more information, visit www.oncothyreon.com.
About Celldex
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.
Oncothyreon Forward-Looking
Statements
In order to provide Oncothyreon's investors
with an understanding of its current results and future prospects,
this release contains statements that are forward-looking. Any
statements contained in this press release that are not statements
of historical fact may be deemed to be forward-looking statements.
Words such as "believes," "anticipates," "plans," "expects,"
"will," "intends," "potential," "possible" and similar expressions
are intended to identify forward-looking statements. These
forward-looking statements include Oncothyreon's expectations
regarding clinical development activities and potential benefits of
its product candidates.
Forward-looking statements involve risks and
uncertainties related to Oncothyreon's business and the general
economic environment, many of which are beyond its control. These
risks, uncertainties and other factors could cause Oncothyreon's
actual results to differ materially from those projected in
forward-looking statements, including those predicting the timing,
duration and results of clinical trials, the timing and results of
regulatory reviews, the safety and efficacy of our product
candidates, and the indications for which our product candidates
might be developed. There can be no guarantee that the results of
preclinical studies or clinical trials will be predictive of either
safety or efficacy in future clinical trials. Although Oncothyreon
believes that the forward-looking statements contained herein are
reasonable, it can give no assurance that its expectations are
correct. All forward-looking statements are expressly qualified in
their entirety by this cautionary statement. For a detailed
description of Oncothyreon's risks and uncertainties, you are
encouraged to review the documents filed with the securities
regulators in the United States on
EDGAR and in Canada on SEDAR.
Oncothyreon does not undertake any obligation to publicly update
its forward-looking statements based on events or circumstances
after the date hereof.
Celldex Therapeutics Forward-Looking Statements
This release contains "forward-looking statements" made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, including those related to the
Company's strategic focus and the future development and
commercialization (by Celldex and others) of rindopepimut
(CDX-110), glembatumumab vedotin ("glemba"; CDX-011), varlilumab
(CDX-1127), CDX-1401, CDX-301 and other products and our goals for
2014. 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 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, our ability to
successfully complete research and further development and
commercialization of rindopepimut, glembatumumab vedotin and other
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; 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; the failure of the
market for the Company'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.
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.
Additional Information
Additional information relating to Oncothyreon can be found on
EDGAR at www.sec.gov and on SEDAR at www.sedar.com.
SOURCE Oncothyreon Inc.