Celldex Therapeutics was founded based on a fundamental scientific belief that harnessing the power of immune system would break significant barriers in drug development for a variety of devastating diseases. Our scientific philosophy is derived from longstanding roots in the antibody and immunotherapy field that have led to breakthrough technologies both at Celldex and in previous companies, including Medarex (now a subsidiary of the Bristol-Myers Squibb Company), from which Celldex was spun out in 2005.

Our pipeline is comprised of antibody-based therapies and other protein-based therapeutics that modulate the immune system or directly target tumors. We believe our programs have a higher probability of success because they target specific markers or pathways in the disease or in the immune response to the disease. And due to our specific target approach, we are able to develop companion diagnostics designed to help us best define patient populations most likely to benefit from therapy. Our programs are specifically aimed at patient populations with high unmet medical need—including many underserved or completely un-served orphan indications.

One of the important merits of immunotherapy has been the long term clinical benefit achieved in some patients. As we look to the future of immunotherapy, we believe the next great challenge for the field is to translate the greatest benefit to the largest population of patients possible. We believe this hurdle will be crossed successfully through the use of novel combination approaches that seek to leverage the power of the immune system across multiple levels. Many of our clinical programs seek to do so by combining therapeutic approaches to maximize their potential. Critical to this strategy is our ability to understand and exploit our own assets while also identifying promising external technologies that will complement it. Celldex draws upon a number of core technologies to design targeted therapeutic candidates that seek to leverage the power of the immune system to fight disease. Our programs encompass validated technologies such as fully human antibodies, important and proprietary disease related molecules and natural human proteins that can be exploited for specific therapeutic applications. Our comprehensive approach provides us with a unique capacity to tackle human diseases based on the newest scientific understanding and technologies.

Our key areas of focus include:


ACTIVE IMMUNOTHERAPY

Active immunotherapy and vaccination aim to drive specific immune attack against a patient’s disease. This can be achieved by training the immune system to attack a specific disease target, which is typically implemented through vaccination with the disease associated target. Protein-based vaccines can be improved through direct delivery of the targets to dendritic cells using our proprietary APC-Targeting Technology. An alternative approach to active immunotherapy is to modulate the immune system’s capacity to react to the disease targets already present in the patient. These agents include checkpoint inhibitors that release the immune systems natural brakes (e.g. antibodies that block the T cell inhibitory molecules CTLA-4 or PD-1), immune stimulatory agents that enhance immune responses by direct activation (e.g. antibodies that bind and activate immune enhancing molecules such as CD40, 4-1BB, OX40 and CD27) or indirectly by increasing the number of immune cells that can effectively activate immune responses (e.g. the dendritic cell growth factor, Flt3L). The immense promise of these approaches is based on sound advances in science, which is now being translated into a pipeline of clinical candidates for a variety of incurable diseases.

Celldex is currently developing the following active immunotherapy and vaccination technologies:

  • APC-Targeting Technology Programs and CDX-1401: Antibody-based dendritic cell-targeted protein vaccines for specific tumors and infectious disease targets
  • Varlilumab: Agonist CD27 human mAb for activating T cell immunity against tumors and other diseases
  • CDX-301: Recombinant human Flt3L, a potent growth factor for dendritic cells

For an in-depth scientific review of these programs, view our scientific publications and presentations.


DIRECT ANTI-TUMOR THERAPY

Monoclonal antibodies (mAbs) directed to targets on the surface of tumors cells can be exploited for therapeutic and diagnostic purposes, and this technology has led to a variety of successful products for the treatment of specific cancers. The success of mAb therapies is contributed to by several basic properties of these agents—the exquisite specificity of mAbs for a particular target, the ability to attach to the target molecules with very high affinity, a long half-life in patients, and their relative ease of manufacture. However, through decades of preclinical and clinical testing, we have learned that many other factors contribute to the effectiveness of anti-tumor mAbs.

MAbs can also be exploited as a means to deliver a toxic payload directly to cancer cells, which can reduce the systemic toxicity of highly cytotoxic agents. While this concept is straightforward, the development of antibody-drug conjugates (ADCs) has been challenging. Successful ADCs require the right combination of molecular target, antibody, toxin, and a linker that attaches the toxin to the antibody. Ideally the toxin is stably linked to the antibody in the bloodstream and only becomes released when internalized after binding to its target on the cancer cell. This concentrates the toxin within the tumor to provide a wider therapeutic window while decreasing toxic side effects that are associated with chemotherapy. Two recent approvals for ADCs (Adcetris®, Kadcyla) clearly indicate that this class of antibody-based therapy will be an important part of the cancer therapy landscape.

Celldex is currently developing the following Direct Anti-tumor Therapies:

  • Glembatumumab vedotin (CDX-011): Antibody-drug conjugate targeting gpNMB in breast cancer, melanoma, and selected other cancers
  • Varlilumab: Fully human anti-CD27 mAb that targets CD27-expressing cancers
  • CDX-014: Antibody-drug conjugate targeting TIM-1 in multiple cancers

For an in-depth scientific review of these programs, view our scientific publications and presentations.

Adcetris® is a registered trademark of Seattle Genetics; Kadcyla is a registered trademark of Genentech, Inc., a member of the Roche Group.