- 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.
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.
Company ContactSarah CavanaughVice President of Investor Relations & Corp CommunicationsCelldex Therapeutics, Inc.(781) firstname.lastname@example.orgCharles LilesAssociate Director of Investor Relations & Corp CommunicationsCelldex Therapeutics, Inc.(781) email@example.comMedia InquiriesDan BudwickBrewLife(973) firstname.lastname@example.org