Mining for melanoma

GSK, Abbott partner on molecular diagnostic test to select candidates for skin cancer immunotherapy

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DES PLAINES, Illinois—To prepare for the selection of patients who could benefit from a skin cancer treatment currently under development at GlaxoSmithKline PLC (GSK), the London-based pharma has selected Abbott to help develop a molecular diagnostic test to evaluate candidates for the study.

Under the agreement, announced in March, the companies will develop and commercialize a polymerase chain reaction (PCR) test for use on the Abbott m2000 automated molecular instrument system. The test will be designed to detect MAGE-A3, a tumor-specific antigen that is expressed in skin cancer and a wide variety of other cancers, but not in normal cells, in patients who will participate in clinical trials for GSK's MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) candidate. The candidate is currently being evaluated as an adjuvant treatment in melanoma biopsy specimens in the Phase III clinical study DERMA.

Financial terms of the partnership were not disclosed, but it's not the first time the companies have worked together on cancer-related research. In July 2009, they announced a similar collaboration and Phase III investigation for the MAGE-A3 marker in non-small-cell lung cancer, but this new agreement marks the company's first work together on a diagnostic test, notes Jamila Louahed, head of GSK's Biologicals R&D organization.

"We have a close relationship in R&D development, and this is one key factor for the obtaining success in the diagnostic area," Louahed says. "Both companies understand the development of this product, and Abbott fit our need for a diagnostic partner with reliability, expertise, regulatory experience and genotyping in the area of diagnostics."
There are currently no nucleic acid-based tests approved by the U.S. Food and Drug Administration for use in identifying patients who may derive treatment benefits from targeted skin cancer therapies. The companies will seek regulatory approval for the test in several markets, including the United States and Europe.

The potential commercial opportunity for the treatment that will eventually be developed is large. According to the American Cancer Society, melanoma, the most serious form of skin cancer, claimed 8,420 people in the U.S. alone in 2008. The number of new cases is estimated at more than 62,000, but if melanoma is detected and treated early, it is nearly 100 percent curable.

Abbott could not be reached by press time, but Stafford O'Kelly, head of Abbott's molecular diagnostics business, said in a statement that the company is excited about continuing its current collaboration with GSK.

"The agreement is indicative of our commitment to personalized medicine and our focus on developing innovative companion diagnostic tests that can be used to identify patients most likely to benefit from specific cancer therapies," O'Kelley stated.

GSK's ASCIs are designed to train the immune system to recognize and eliminate cancer cells in a highly specific manner. These candidate cancer immunotherapeutics combine tumor antigens, delivered as purified recombinant proteins, and GSK's proprietary immunostimulants, which are specific combinations of immunostimulating compounds selected to increase the anti-tumor immune response. ASCIs are being investigated in the clinic to support their use to reduce the risk of tumor recurrence following surgery, or to impact tumor growth in an early metastatic setting.

The highly specific mode of action of GSK's ASCIs is linked to the development of diagnostic tools to aid in selecting patients eligible for the treatment, depending on the expression of the tumor antigens. MAGE-A3 is a tumor-specific antigen that is expressed in a large variety of cancers, including melanoma, non-small cell lung cancer, liver and bladder cancer, with no expression in normal cells.

"We think things so far are going very well, and that this program will change the landscape of treatment for cancer patients," Louahed says.

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