From Vaccines To Monoclonal Antibodies: Creating Milestones In Cancer Theranostics

Most of the efforts until today, to combat cancer, have been markedly directed toward developing drugs that could yield therapeutic benefits characterized by a partial or complete remission. Despite colossal efforts and billions of dollars spent to develop cancer drugs, few cures, if any, have been realized for advanced cancers, and an unthinkable statistic revelation is that cancer still remains one of the biggest killers, plaguing the lives of millions of people worldwide.

Cancer can be best combated and survival of patients can be markedly increased by diagnosing it at an early, most treatable stage. However, early malignancy should be diagnosed, not conventionally, by a pathologist, but in fact, defined by a molecular marker, which would reside in a malignant cell, several months before the cell could even appear malignant. A cancer defined by a molecular marker, very early at its development history, would engender thus, a novel early diagnostic approach paving the way to execute effective therapies.

A significant breakthrough in cancer theranostics could be achieved, if the molecular marker defining the cancer is an immunogenic tumor protein that could be fished out by antibodies, and the same antibody could be employed as a double-edged tool to induce tumor apoptosis. Neogenix Oncology Inc., a research-focused biopharmaceutical firm, headquartered in Great Neck, NY, follows a similar approach to develop and commercialize innovative theranostics for several cancer indications. Its approach involves synthesizing a broad pipeline of monoclonal antibodies (mAbs), which identify cancer-specific immunogenic proteins (tumor associated antigens or TAAs) derived from specific tumor systems. These mAbs are of immense import as they are capable of defining the immunogenic tumor protein both as a diagnostic molecular maker and a therapeutic agent to induce tumor destruction.

Neogenix's mAbs were obtained from TAAs, which were originally isolated from a variety of pooled cancer patients' tumors, by Ariel Hollinshead, a pioneer scientist in tumor immunology at George Washington University Medical Center in Washington, DC, in the 1970s and 1980s. These TAAs are in fact vaccines, 80% to 90% pure, that were administered to cancer patients and tested in phase I to phase III clinical trials, approved by FDA at that time. The results of the clinical trial revealed antitumor responses and prolonged survival of cancer patients who had been vaccinated with these TAAs. These TAAs were also shown to be specific to the immunogenic proteins rather than a sugar or carbohydrate.

The FDA has certain stipulations today, with regard to vaccine production and does not allow synthesis of vaccines derived from allogenic sources. In addition, it necessitates that a vaccine produced is of good manufacturing practices (GMP) grade, manufactured in a GMP production facility. Consequently, the TAA vaccines generated 25 years back and tested in tumor patients could not be used for commercialization purposes. Neogenix, however, had overcome this commercialization roadblock by adopting a novel approach to produce its TAA vaccines. The company had used its TAAs as immunogens to develop mAbs, which represents Neogenix's cancer theranostics product portfolio today, targeting a wide range of cancer indications including colorectal, prostate, lung, ovarian, squamous, and others.

In addition to the unique diagnostic and therapeutic advantage, Neogenix's mAbs are highly specific to the immunogenic proteins in cancer cells, in contrast to the current FDA-approved mAbs that target the growth factors over-expressed in cancer cells, but also found in normal cells.

Neogenix has entered into a collaboration with Goodwin Biotechnology Inc. for process development and manufacturing of Neogenix's lead therapeutic product, NPC-1C. NPC-1C is a novel mAB derived from Hollinshead's TAAs, intended to treat advanced pancreatic cancer. On successful development, this product would enter phase I and phase II clinical trials, tentatively planned for the first half of 2008.


Myron Arlen MD

Chief Executive Officer

445 Northern Blvd

Great Neck, NY 11021

Phone: 516-487-9488

Direct Phone: 516-859-7670

Fax: 516-482-3848



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