Value Propositions – May 2015

May 2015, Vol 6, No 4 - Value Propositions

In This Article

New Genetic Tests for Breast Cancer on the Horizon, May Challenge Current Screening Strategy

Several genetic tests and new methods for assessing the risk for breast cancer associated with genetic mutations, which increase the risk for the disease, show promise and may soon change the way genetic screening is done for breast cancer.

Color Genomics, a biotechnology company, is developing an inexpensive genetic test for breast and ovarian cancer using a simple saliva sample.

In addition, the 2 major laboratories, Quest Diagnostics and LabCorp, are collaborating with French researchers to combine their data in an effort to enhance how BRCA1 and BRCA2 mutations are diagnosed; other companies and laboratories have been invited to join this venture, called “BRCA Share.”

Genetic screening has recently received much publicity by Angelina Jolie’s well-advertised decision to undergo a double mastectomy and recently also have her ovaries and fallopian tubes removed to reduce her risk for the disease because of her BRCA1-positive status.

Nevertheless, who should have genetic testing remains controversial. Color Genomics Chief Executive, Elad Gil, PhD, said he wanted to “democratize access to genetic testing,” a statement that has generated concern among some experts.

The company plans to charge $249 for its saliva test for BRCA1 and BRCA2 mutations, as well as 17 other genetic mutations. This price is a fraction of the cost of many other genetic tests currently provided by other companies. Dr Gil said his company’s test would be inexpensive enough for women to pay out of pocket to circumvent the need for insurance companies’ approval. He said the company was starting a program to provide free testing to women who cannot afford this test.

One of Color Genomics’s unpaid advisers is Mary-Claire King, PhD, the genetics expert from the University of Washington who was involved in the discovery of the BRCA gene. Last year, Dr King issued a call to offer genetic breast cancer testing to all US women aged ?30 years.

Other experts argue that the cost of genetic testing does not justify testing in the general population. “We have to be careful that we are not just increasing this group of worried-well who have incomplete information,” said Kenneth Offit, MD, Chief of Clinical Genetics Service, Memorial Sloan Kettering Cancer Center.

Furthermore, some experts question whether the saliva testing can be so inexpensive, considering that genetic sequencing is not the only cost involved; the expert interpretation of the results may increase the overall costs. Other companies charge ?$1500 for a complete multigene genetic analysis of the BRCA genes.

As for BRCA Share, Quest Diagnostics will provide money to improve the database and the interpretation process. “We are going to help them make it better,” said Charles M. Strom, MD, PhD, Vice President for Genomics and Genetics at Quest Diagnostics. Companies will pay for access to the data in the BRCA Share database based on their size, and some companies will have access without paying, if appropriate.

The New York Times; April 21, 2015

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Turbo-Charging the Immune System Potential Game-Changer in Killing Cancer

A protein that “turbo-charges” the immune system to enable it to fight off any cancer or virus has been discovered by researchers at the Imperial College in London, United Kingdom. This recent breakthrough has been described as a “game-changer” for the treatment of cancer, representing a new molecule that boosts the body’s ability to fight off chronic diseases, including cancer.

“This is exciting because we have found a completely different way to use the immune system to fight cancer,” said Professor Philip Ashton-Rickardt, Chair, Section of Immunobiology, Department of Medicine, Imperial College, who led the study that discovered that protein. He and his colleagues are now developing a gene therapy based on this protein, and hope to begin human trials in 3 years.

“It could be a game-changer for treating a number of different cancers and viruses,” Dr Ashton-Rickardt said. “This is a completely unknown protein. Nobody had ever seen it before or was even aware that it existed. It looks and acts like no other protein.”

The novel protein is called lymphocyte expansion molecule (LEM); it promotes the spread of cancer-killing T-cells by generating large amounts of energy not found in other proteins. When the immune system detects cancer cells, it normally overacts in the attempt to kill the cancer, which quickly depletes it of energy, and the process stops.

The LEM protein, however, provides a significant energy boost that generates a huge number of T-cells in quantities that the cancer cells are unable to destroy. The protein also increases the immune memory cells, which can recognize tumors and viruses they have encountered before, making it less likely that the cancer will recur.

The hope is to create a new type of immune therapy that will enhance the T-cells of patients with cancer with the protein, which will then be injected back into the body. If successful, this could revolutionize the approach to cancer therapy.

The London Telegraph; April 16, 2015

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New Immuno-oncology Collaboration to Promote CAR T-Cell Therapies

MaxCyte, a next-generation technology company dedicated to developing cell therapies using high-performance cell-transfection systems, announced the launch of its new strategic research collaboration with Johns Hopkins University to develop chimeric antigen receptor (CAR) T-cell therapies that harness patients’ immune systems to kill cancer cells.

MaxCyte’s approach to CAR-cell therapy targets solid tumors by enabling control over the on-target off-tumor toxicity that limits other CAR therapies to hematologic cancers. This is done by introducing the CAR construct as a transiently expressing mRNA that enables the control of the duration of expression and toxicity against target antigens in normal tissue. This unique approach also avoids the cell expansion step required for standard approaches, dramatically reducing manufacturing time and expense for CAR therapies from days or weeks to only hours.

The preclinical work by MaxCyte in collaboration with Johns Hopkins University will file an Investigational New Drug application for a CAR T-cell therapy that targets a broad range of solid tumors.

“We are truly excited to be collaborating with Johns Hopkins, one of the leading hospitals in the world, in the development of this next-generation CAR therapy,” said Doug Doerfler, MaxCyte’s President and Chief Executive Officer. “The combination of Johns Hopkins’ world renowned research and clinical development capabilities and MaxCyte’s unique product development capabilities will enable the rapidly advancing area of CAR therapies to move into the clinic in solid tumors in a platform that provides rapid cost-effective manufacture of Cellular Therapeutics.”

MaxCyte press release; April 21, 2015

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