--The conference call will take place today at 4:30 p.m. m., Eastern time--
| Fuente: Celldex Therapeutics, Inc.
HAMPTON, N.J., and NEW HAVEN, Conn., Nov. 1, 2016 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. , a private, clinical-stage company focused on the discovery and development of novel antibody-based drugs that are target receptor tyrosine kinases (RTKs). Primarily focused on oncology and endorsed by prominent thought leaders in RTK biology, Kolltan reported clinical and preclinical data that its drug candidates may help overcome tumor resistance mechanisms associated with current tyrosine kinase inhibitors and seen in patients who failed. with other cancer therapies. Celldex believes that Kolltan's preclinical platform and clinical candidates are highly compatible with the company's scientific approach and can be developed independently and in combination with existing Celldex 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 CEO of Celldex Therapeutics. “The Kolltan acquisition provides Celldex with a truly unique receptor tyrosine kinase antibody platform, which we believe is highly compatible with our product portfolio. 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 key challenges related to tumor resistance mechanisms in cancer biology," said Gerald McMahon, Ph.D., Chairman and CEO of Kolltan Pharmaceuticals. “Celldex's leadership and science team played a key role in building the antibody field during their tenure at Medarex and used that experience to build a leading immuno-oncology portfolio at Celldex. We strongly believe that Celldex is uniquely positioned to advance our RTK-targeted antibody portfolio to improve patient outcomes 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 (GISTs). KTN0158 prevents KIT activation by blocking receiver attenuation. This mechanism may be effective even in tumors harboring the most common Glivec-resistant mutations and resistance is unlikely to develop. Preclinical data demonstrate that inhibition of KIT in certain immune cells with KTN0158 increases checkpoint blockade activity. This mechanism may also be effective with other immunotherapies, particularly Celldex's CD27 agonist varlilumab.
- KTN3379: a human monoclonal antibody designed to block ErbB3 (HER3) activity; Clinical activity, including significant responses and stable disease, was observed in a phase 1b study in patients refractory to cetuximab (Erbitux®) in head and neck squamous cell carcinoma and in BRAF-mutated 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-dependent and independent ErbB3 signaling by binding to a single epitope. It also has a favorable pharmacological profile, including a longer half-life than other drug candidates in this class. KTN3379 also has the potential to work well in combination with other targeted and cytotoxic therapies to kill tumor cells directly. The death of tumor cells and the consequent release of new tumor antigens can serve as a focus for combination therapy with immuno-oncological approaches, even in refractory patients.
- A multifaceted TAM program: a large ongoing antibody discovery effort 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 with wide application and potential in 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 that overcome resistance mechanisms, especially when used in combination with Celldex or external candidate products or with existing approved therapies.
Following the close of the Kolltan acquisition, Celldex's clinical portfolio will include seven drug candidates, including therapeutic antibodies, antibody-drug conjugates (ADCs), and immune system modulators, which are being tested in a variety of difficult-to-treat indications in oncology. This broad portfolio allows for new combination approaches, several of which are already under study. In addition, Celldex would have two active preclinical programs.
terms of transaction
Under the terms of the agreement, Celldex will acquire Kolltan in a share-for-share transaction, with the initial payment representing 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 completing specific development, regulatory and business milestones. The transaction, which is subject to receipt of Kolltan shareholder approval and other customary closing conditions, is expected to close by the end of the year. The Celldex and Kolltan Boards of Directors unanimously approved the transaction, and the Kolltan Boards of Directors unanimously recommended to its shareholders to approve the transaction. Celldex was advised by Lowenstein Sandler, LLP. Kolltan was advised by Guggenheim and Holland & Knight.
conference call details
Celldex will hold a conference call at 4:30 p.m. m. ET today to discuss the acquisition. The conference call and presentation will be webcast live and can be accessed on the "Events and Presentations" page in the "Investors and Media" section of the Celldex website atwww.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 password is 9492426.
A replay of the conference call will be available approximately two hours after the conference call ends through November 15, 2016. To access the replay, dial (855) 859-2056 (within the US) or (404 ) 537-3406 (outside the US). USA). The password is 9492426. The webcast will also be archived on the company website.
Sobre Celldex Therapeutics, Inc.
Celldex is developing targeted therapies to treat devastating diseases for which available treatments are inadequate. Our portfolio is built from a proprietary portfolio of antibodies and immunomodulators that are used alone and in strategic combinations to create new disease-specific therapies that induce, enhance, or suppress the body's immune response. Visitwww.celldex.comfor more information on the Celldex pipeline, including:
- Glembatumumab vedotin, an antibody-drug conjugate (ADC) that targets gpNMB, is currently being evaluated in the pivotal METRIC study in patients with triple-negative metastatic breast cancer and 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 to and activates CD27, is currently being evaluated in six indications in a large Phase 1/2 clinical program that includes clinical trial collaborations with Bristol-Myers Squibb and Roche.
- CDX-1401, a NY-ESO-1 antibody fusion protein for immunotherapy, which recently completed a phase 2 study with CDX-301 in metastatic melanoma; plans for additional combined studies are underway
- CDX-301, a potent hematopoietic cytokine that uniquely expands the number of dendritic cells to prepare the immune system for stronger immune responses to cancer antigens, currently in an investigator-sponsored Phase 1/2 study with Hiltonol® and low-dose radiation therapy in patients with low-grade B-cell lymphomas
- CDX-014, a TIM-1-targeted ADC, which recently entered phase 1 clinical development in patients with papillary renal cell and clear cell carcinoma
- A preclinical CD40 agonist program in which Celldex characterized a fully human antibody that demonstrated potent agonist activity. Importantly, Fc receptor interaction, which can cause signal amplification and is required for the development of some CD40 agonist antibodies, was not required for agonist capacity, allowing for sensitive and controlled activation of CD40.
About Kolltan Pharmaceuticals
Kolltan, a private, clinical-stage company, is focused on the discovery and development of new antibody-based drugs that target RTKs for the treatment of cancer and other diseases with significant unmet need. Kolltan is working closely with the laboratory of Kolltan co-founder Dr. Joseph Schlessinger, as well as the medical and scientific community at Yale University. The company has a broad and innovative portfolio of therapeutic biologics for oncology and immunology targeting multiple different RTKs. KTN0158, which targets the KIT receptor, and KTN3379, which targets the ErbB3 receptor, are currently in Phase 1 clinical trials for the treatment of human cancers. Kolltan is also conducting active discovery efforts 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.
Forecast Statement
This release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are generally preceded by words such as "believes", "expects", "anticipates", "intends," "may," "could," "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 do not guarantee that such expectations are correct or that these objectives will be achieved, and should be aware that actual results may differ materially from those contained in forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, without limitation, the ability of Kolltan and the Company to meet the final terms of the acquisition, including the risk that Kolltan's shareholders will not approve the merger; our ability to successfully integrate Kolltan's businesses and programs with our businesses and programs; our ability to successfully complete the research, development and commercialization of glebatumumab vedotin and other Company and Kolltan drug candidates; our ability to raise additional capital to meet our long-term liquidity needs on acceptable terms, or at all, including additional capital that will be required to complete clinical trials that we have initiated or plan to initiate (or that Kolltan has initiated or plans to begin); the uncertainties inherent in clinical trials and the recruitment of patients for clinical trials; our limited experience in taking programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and research and development efforts for our various products at various stages of development; the availability, cost, delivery and quality of clinical and commercial grade materials produced by our own factory or supplied by contract manufacturers, which may be our sole source of supply; the time, cost and uncertainty of obtaining regulatory approvals; our ability to maintain and benefit from the Fast Track designation for glebatumumab vedotin, which does not change regulatory approval standards or guarantee regulatory approval on an accelerated basis or in any way; 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 or key personnel or consultants; competence; changes in the regulatory landscape or the imposition of regulations affecting 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 statement, which speaks only as of the date of this release. We are under no obligation, and we 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.
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