Monoclonal antibodies have proved to be highly effective therapeutics for treating cancer

Monoclonal antibodies are designed to mount a precise assault on a specific molecular target for a specific disease or infectious agent without harming normal cells. Often referred to as molecular guided missiles, these highly targeted therapeutics have the potential to treat many of diseases with minimal side effects.

The ability of monoclonal antibodies to distinguish cancer cells from normal cells has made them powerful tools in the search for new cancer therapeutics. Monoclonal antibodies work on cancer cells in the same way that natural antibodies work, by identifying and binding tightly to a specific target molecule, or antigen, that is usually found on the surface of the invading cells. In so doing, they can directly kill the cancer and/or identify the foreign cells for destruction by the host immune system. For cancer immunotherapy, the tactic is to create antibodies directed against a target antigen present on a specific type of tumor cell and to destroy only those tumor cells without damaging normal cells.

Advantages of Monoclonal Antibody-Based Therapeutics

Designed to look and act like the body's natural antibodies, monoclonal antibodies present a number of distinct advantages over other therapeutic approaches, including small inorganic molecules:

From the PATIENT CARE standpoint, anticancer monoclonal antibodies have the potential to:

• inhibit disease progression and improve survival time
• reduce side effects due to high specificity for the disease target
• decrease costs by eliminating the need for support care
• improve quality of life significantly
• promote greater patient compliance and higher efficacy due to favorable pharmacokinetics
• directly destroy or deliver toxic payloads to specific disease sites

From the DISCOVERY AND CLINICAL DEVELOPMENT standpoint, anticancer monoclonal antibodies:

• have an accelerated product development timeline
• present straightforward biology, i.e., the focus is on stopping a tumor by developing antibodies that either kill cancer cells outright or recruit the host's natural defenses
• provide drug developers access to patients for testing new compounds in the clinical trial setting due to the general lethality of cancers
• allow the use of survival, and/or established, well-defined clinical endpoints for efficacy, and in many cases, markers for monitoring response during treatment
• have a higher success rate than small-molecule drugs in clearing regulatory hurdles

From the THERAPEUTIC PRODUCT standpoint, anticancer monoclonal antibodies:

• are relevant therapeutics that address very large markets of unmet need
• have been validated as ideal cancer therapeutics through FDA approval of such products as Herceptin®, Rituxan®, Mylotarg®, and Campath®, with a number of other promising products nearing FDA approval

What Raven's Monoclonal Antibody Products May Do for Cancer

We expect our antibody products to lead to tumor elimination or shrinkage, resulting in improved cancer patient response, quality of life, and/or survival rates. We expect our monoclonal antibodies directed against antigens on the surface of tumor cells to be used either directly to mark and destroy these targets, or to potentiate standard treatments and thereby lead to reduced toxicity and fewer side effects. Some antibodies are well suited to be linked to a chemotherapeutic agent, radioactive substance, or other toxic substance to deliver a lethal payload directly to tumor cells.