Madison Vaccine to be Tested in Combination Prostate Cancer Treatment

Madison Vaccines, a Madison, WI-based startup developing immunotherapies for prostate cancer, will get a chance to see how well its lead vaccine can shrink tumors when teamed up with another drug. The Phase I trial will be led by Madison Vaccines co-founder Doug McNeel, an oncologist and professor of medicine at the University of Wisconsin-Madison. McNeel and a team of university researchers were awarded a $1.5 million grant to conduct the study. The Movember Foundation is providing the funding through the Movember-Prostate Cancer Foundation Challenge Award program.
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Attacking a Rare Disease at its Source with Gene Therapy

Treating the rare disease MPS I is a challenge. MPS I, caused by the deficiency of a key enzyme called IDUA, eventually leads to the abnormal accumulation of certain molecules and cell death. The two main treatments for MPS I are bone marrow transplantation and intravenous enzyme replacement therapy, but these are only marginally effective or clinically impractical, especially when the disease strikes the central nervous system (CNS). Using an animal model, a team from the Perelman School of Medicine at the University of Pennsylvania has proven the efficacy of a more elegant way to restore IDUA levels in the body through direct gene transfer. Their work was published this week online in Molecular Therapy.
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First Human Trials of Ebola Vaccine Start Next Week

e first human trials of a vaccine against the deadly Ebola virus will start next week in the U.S., officials announced Thursday, just as the World Health Organization predicted as many as 20,000 people could be infected in West Africa before the epidemic is brought under control. The National Institutes of Health will sponsor the first trial of the vaccine, one of several being developed against Ebola. It’s fast-tracked the testing because of the outbreak of Ebola that is ravaging three West African countries.
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After a String of Gene Therapy Licensing Deals, ReGenX Says it’s Time to Shine

ReGenX Biosciences is one of the most intriguing gene therapy biotechs you never heard of. And now the executive team in charge intends to start changing that. Today the Washington D.C.-based company is talking up an early stage but important inflection point for the company. It successfully concluded a proof-of-concept animal study for a gene therapy that addresses a rare lysosomal storage disorder. Now it is working on raising a new venture round that will allow the company to complete an IND and then jumping into the clinic with its own program in 2016.
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Allergy Immunotherapy: What Is the Evidence for Cost Saving?

Given the widespread prevalence of allergic disease, its substantially associated clinical and economic burden, the unique disease-modifying benefits of allergy immunotherapy (AIT), and increased availability of sublingual immunotherapy (SLIT), a critical update of the evidence for AIT-related cost savings [for both subcutaneous immunotherapy (SCIT) and SLIT] is particularly relevant and timely. The present article reviews the evidence for SCIT-related and SLIT-related cost savings derived from a systematic review of the published literature.

Examined were 24 publications pertaining to the health economics of AIT. Except for one early study comparing the costs of AIT to symptomatic drug treatment (SDT), the remainder provide compelling evidence for AIT cost savings (whether SCIT or SLIT) over SDT. Furthermore, of the six studies comparing cost outcomes of SLIT to SCIT, four reported cost savings favoring SLIT.
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Startup’s Antiviral Drug Combats HPV

San Diego startup Hera Therapeutics is developing a topical antiviral drug that attacks human papillomavirus - and early studies are showing it can successfully combat three strains, including two that cause 70 percent of all cervical cancer. The drug candidate, HTI-1968, blocked the replication of HPV-16, HPV-18 and HPV-11 cells, according to the NIAID-sponsored study. The work was conducted primarily by University of Alabama researchers Louise T. Chow and Thomas Broker. The drug could be effective against more, CEO Karl Hostetler said, but these are the only three HPV strains available for screening through the NIH.
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Exclusive: U.S. Approval of Merck Cancer Immunotherapy Expected Soon

U.S. regulators are likely to approve Merck & Co's highly anticipated immuno-oncology drug, pembrolizumab, as a treatment for melanoma well ahead of a late October deadline, according to three sources familiar with the situation. If approved by the Food and Drug Administration, the drug would be the first in a promising new class designed to help the body's own immune system fend off cancer by blocking a protein known as Programmed Death receptor (PD-1), or a related target known as PD-L1, used by tumors to evade disease-fighting cells. Companies including Bristol-Myers Squibb, Roche Holding AG and AstraZeneca Plc are racing to develop similar treatments for a variety of cancers. Some analysts expect the new class could generate more than $30 billion in annual sales worldwide by 2025.
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Speeding up the Fight Against Ebola, Other Diseases

For vaccines and treatments aimed at vanquishing infectious diseases, it’s a long, bumpy road from the laboratory to the doctor’s office, a journey that can take years and cost hundreds of millions of dollars — if it happens at all. Now, academic researchers, biotechnology specialists, and pharmaceutical leaders in Boston and elsewhere are offering tantalizing evidence that vaccines against Ebola and other killer diseases can be made faster and cheaper than previously believed. In a study accepted for publication in the journal Human Vaccines & Immunotherapeutics, a Boston research consortium, called VaxCelerate, details how it produced a vaccine ready for animal testing against lassa fever, a hemorrhagic disease similar to Ebola, for less than $1 million and in four months.
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Will Inovio’s Deal With Roche Lead To A Cancer Blockbuster?

Roche and Inovio had announced they would develop INO-5150, a vaccine for prostate cancer, back on September 10, 2013. The agreement, giving Roche exclusive rights, allowed for milestone payments of up to $412.5 million, including the initial payment of $10 million. "In addition, Inovio is entitled to receive up to double-digit tiered royalties on product sales." INO-5150 has only been tested so far in animal studies. It targets two antigens associated with prostate cancer, PSMA (prostate-specific membrane antigen) and PSA (prostate-specific antigen). The animal studies showed the vaccine invoked "strong and robust T-cell immune responses."
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Madison Vaccines Rides Immunotherapy Wave With Early-Stage Prostate Drug

Madison Vaccines (MVI) is working to develop a new treatment option for early-stage prostate cancer patients—after their prostates have been removed, but before the cancer has spread to the bones or other organs. The idea is to prevent, or at least delay, the onset of metastases and the need for castration by priming the immune system to recognize cancerous cells and kill them. Building on research from the lab of Douglas McNeel, an oncologist and professor of medicine at the University of Wisconsin-Madison, MVI is creating vaccines from tiny circular bits of DNA called plasmids. The company’s lead DNA vaccine, MVI-816, contains instructions for a protein named prostatic acid phosphatase (PAP), which is made by prostate cells. When injected into the skin, the DNA is taken up by the body’s cells (the company is still researching exactly which types of cells do the absorbing), which use the DNA to make copies of the PAP protein. That protein, in turn, acts as an antigen to stimulate an immune response against PAP, the company has shown in Phase I trials.
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