Local Biotech Company to Begin Human Testing for Ebola Vaccine

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Without any effective treatments for Ebola, health officials in West Africa are in desperate need of a vaccine to keep the virus from spreading. Stepping into that void, among others, is Inovio Pharmaceuticals of Plymouth Meeting, Pennsylvania. President and CEO of Inovio, Joseph Kim, said beginning early next year their DNA-based vaccine will be given to 30 volunteers. The phase I human trial will test for safety and preliminary signs of efficacy based on analysis of blood samples for the appropriate immune responses.

The Inovio vaccine contains bits of Ebola virus DNA that correspond to its surface sugar coating, or glycoprotein. Once delivered into cells, those sequences can trigger the body to make protective antibodies and T cells that can go on the attack in case of infection. The technology was pioneered by David Weiner, a researcher at the University of Pennsylvania, who currently serves on Inovio's scientific advisory board and also helped co-found a precursor to the company.
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Up to 18 Exposed to U.S. Ebola Patient, Including Children

Health experts were observing up to 18 people, including children, who had contact with the first person to be diagnosed with the deadly Ebola virus in the United States, officials said on Wednesday. Confirmation that a man who flew to Texas from Liberia later fell ill with the hemorrhagic fever prompted U.S. health officials to take steps to contain the virus, which has killed at least 3,338 people in Liberia, Sierra Leone and Guinea, the World Health Organization said.
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Press Release: Compugen Discloses New Results for Novel Target Candidate for Cancer Immunotherapy

Compugen Ltd. today disclosed results from recent studies further confirming CGEN-15049 as a promising target candidate for cancer immunotherapy. These recent studies evaluated the function of this Compugen-discovered immune checkpoint candidate on immune cells derived from the tumor environment of melanoma patients. Based on these and earlier experimental results, CGEN-15049, which is expressed on various cancers including lung, ovarian, breast, colorectal, gastric, prostate and liver, is further advancing in the Company’s Pipeline Program, with ongoing therapeutic antibody development activities against this novel target.
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Liver Gene Therapy Corrects Heart Symptoms in Model of Rare Enzyme Disorder

In the second of two papers outlining new gene-therapy approaches to treat a rare disease called MPS I, researchers from Perelman School of Medicine at the University of Pennsylvania examined systemic delivery of a vector to replace the enzyme IDUA, which is deficient in patients with this disorder. The second paper, which is published online in the Proceedings of the National Academy of Sciences this week, describes how an injection of a vector expressing the IDUA enzyme to the liver can prevent most of the systemic manifestations of the disease, including those found in the heart.
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Failed Cancer Vaccines Might Live Again with New Immune Drugs

Using vaccines to fight cancer is a field littered with failures but experts believe it is possible the approach could get a new lease of life if such shots are combined with a new class of drugs called checkpoint inhibitors. Unlike traditional preventative vaccines, therapeutic cancer vaccines are designed for people with established disease and are supposed to boost the patient's immune system to keep tumors at bay.

Unfortunately, the theory has not worked out in practice because, while the vaccines are successful at triggering a response from the "foot soldiers" of the immune system, cancer cells still manage to escape detection. The result has been a series of failures with high-profile experimental cancer vaccines such as Merck KGaA's Stimuvax and GlaxoSmithKline's MAGE-A3.
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GeoVax’s Chief Scientific Officer Featured as Lecturer at American Society for Microbiology Conference

GeoVax Labs, Inc., a biotechnology company developing HIV/AIDS vaccines, today announced that its Chief Scientific Officer, Harriet L. Robinson, Ph.D., presented a virtual lecture entitled "Working Towards an HIV Vaccine," on August 29, 2014 at the African Center for Integrated Laboratory Training in Sandringham, South Africa, sponsored by the American Society for Microbiology.

Dr. Robinson's lecture focused on the development of vaccines for control of the clade C pandemic in Africa and the clade B pandemic in the Americas. She reviewed clinical studies and vaccine responses that had correlated with control of infection in the first and only partially successful vaccine trial, conducted in Thailand. The lecture ended with a comparison of the distinctive features of the clade C vaccine advancing in human trials in Africa and the clade B vaccine that GeoVax is advancing in the Americas and the promise of these trials for success.
Dr. Robinson's lecture is available for viewing at www.geovax.com.
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Genzyme Collaborates on Gene Therapy for Rare Disease that Causes Childhood Blindness

Genzyme, a Sanofi company, today announced the establishment of a research collaboration with the University of Florida and the University of Pennsylvania to develop a gene therapy for the treatment of a rare genetic disease that causes childhood blindness. Leber congenital amaurosis type 1 (LCA-1) is usually diagnosed in children who are less than a year old, and patients remain severely visually impaired for the rest of their lives.

Genzyme is providing $900,000 in funding over three years to Dr. Shannon Boye, assistant professor of ophthalmology at the University of Florida, to fund her LCA-1 research. Dr. Boye’s research is focused on a gene called guanylate cyclase (GUCY2D) that is mutated in LCA-1 patients. The GUCY2D gene normally makes GC1, a protein expressed in photoreceptors, which are located in the retina of the eye and convert light into electrical signals that the brain interprets as vision. Genzyme’s funding supplements current funding from the Foundation Fighting Blindness. The majority of the early stage LCA-1 research is being conducted at the University of Florida, with Genzyme taking on increasingly more activities as the program advances toward clinical trials. Genzyme has the option to in-license the potential treatment before it enters clinical trials.
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Inovio, GeneOne to Advance Ebola Vaccine to Human Trials

Inovio Pharmaceuticals Inc. and GeneOne Life Science Inc. plan to advance Inovio's DNA vaccine for the Ebola virus into human trial next year, joining the ranks of other firms trying to fend off the rapidly spreading virus. The two companies are currently conducting pre-investigational-new-drug activities and plan to start a Phase 1 clinical trial in the first half of 2015, they said. Inovio and GeneOne, an international DNA vaccine manufacturer based in Seoul, said they would jointly seek additional third-party support and resources to further develop and commercialize this product upon successful completion of the Phase 1.

The companies' plans to co-develop the vaccine through clinical trial come as a number of pharmaceutical firms are speeding up their efforts to develop vaccines to prevent the deadly virus.
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PD-L1 Immunotherapy in Bladder Cancer

Initial excitement with PD-1 inhibitors was focused on renal cell carcinoma, lung cancer, and melanoma. However, a second wave of excitement has been generated by this approach in bladder cancer, explains Brian I. Rini, MD. Promising data from a phase I trial exploring the anti-PD-L1 therapy MPDL3280A were presented at the 2014 ASCO Annual Meeting, explains Rini. This study explored treatment with MPDL3280A in 67 patients with metastatic urothelial bladder cancer who received prior chemotherapy.

The objective response rate with MPDL3280A was 43% in PD-L1 positive patients (IHC 2/3). At the time of the data cut-off, 94% of patients had ongoing responses. This response rate is as high as chemotherapy with a promising safety profile, representing a potential "game-changer," Rini explains.
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Amgen One Step Closer To Immunotherapy Market

Amgen, Inc. (AMGN) has joined the list of big pharmaceuticals trying to enter the lucrative immunotherapy market. It submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) yesterday, for its novel cancer drug, blinatumomab. The drug is a bispecific T cell engager (BiTE) antibody construct, and is being evaluated for the indication of relapsed or refractory acute lymphoblastic leukemia (ALL). Immunotherapies are a class of cancer treatments that work by aiding the body’s own immune system to attack the cancer. This new market is expected to reach $35 billion in value over the next decade. If approved, Amgen will join the ranks of other pharmaceuticals, like Merck & Co., Inc. (MRK) and Bristol-Myers Squibb Co (BMY), which have already launched novel immunotherapies.
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