Gene Therapy Pharmaceutical Business News

Abeona Receives FDA Regenerative Medicine Advanced Therapy Designation for Gene Therapy in Epidermolysis Bullosa

Gene therapy developer, Abeona Therapeutics, announced that the FDA has granted Regenerative Medicine Advanced Therapy designation to EB-101, a gene-corrected autologous cell therapy product for patients with recessive dystrophic epidermolysis bullosa (RDEB). Abeona`s EB-101 product is an autologous, ex-vivo gene-corrected cell therapy in which the COL7A1 gene is inserted into a patient`s own skin cells (keratinocytes) for […]

Biotechnology cancer Cell Therapy Clinical Trials

Researchers repurpose immune-activating cytokine to fight breast cancer

The most lethal form of breast cancer could have a new treatment option, according to new research out of the Case Comprehensive Cancer Center at Case Western Reserve University School of Medicine. In the Proceedings of the National Academy of Sciences, researchers showed triple-negative breast cancer cells are highly vulnerable to interferon-β–a potent antimicrobial that […]

Biotechnology cancer Cancer Discovery Clinical Trials

Promising new treatment for rare pregnancy cancer leads to remission in patients

Three out of four patients with the cancerous forms of gestational trophoblastic disease (GTD) went into remission after receiving the immunotherapy drug pembrolizumab in a clinical trial carried out by researchers at Imperial College London. The trial, which took place at Charing Cross Hospital, part of Imperial College Healthcare NHS Trust, is the first to […]

Biotechnology Clinical Trials

No cardiovascular disease reduction with intensive blood pressure lowering treatment

Blood pressure lowering treatment does not reduce death or cardiovascular disease in healthy individuals with a systolic blood pressure below 140. This is shown in a systematic review and meta-analysis from Umeå University. The results, published in JAMA Internal Medicine, support current guidelines and contradict the findings from the Systolic Blood Pressure Intervention Trial (SPRINT). […]

Biotechnology cancer Clinical Trials Immunotherapies

For cancer patients with HIV, immunotherapy appears safe

A new category of immunotherapies called checkpoint inhibitors that has been highly effective against many different cancers appears safe to use in patients with both advanced malignancies and HIV, a population excluded from earlier trials of such therapies, according to an early-phase trial. Study Principal Investigator, Dr. Thomas Uldrick of the HIV & AIDS Malignancy […]

Biotechnology cancer Cell Therapy Clinical Trials

Cancer trial led by University of Minnesota Medical School’s Dr. Clark Chen shows promise

New data from a Phase I clinical trial led by Clark Chen, M.D., Ph.D., Lyle French Chair in Neurosurgery and Head of the University of Minnesota Medical School Department of Neurosurgery shows more than a quarter of patients with recurrent high-grade glioma, a form of brain cancer, were alive more than three years after treatment. […]

Biotechnology cancer Cell Therapy Clinical Trials Immunotherapies

Fred Hutch researchers engineer complex immunotherapy that may target relapsing leukemia

Researchers at Fred Hutchinson Cancer Research Center and the University of Washington have developed a novel way to genetically engineer T cells that may be effective for treating and preventing leukemia relapse. The findings, published online in the journal Blood, provide the basis for launching a first-in-human clinical trial of this new immunotherapy, which relies […]

cancer Clinical Trials Immunotherapies

KEYNOTE-040 evaluates pembrolizumab in head and neck cancer

Immunotherapy with the checkpoint inhibitor pembrolizumab may be a better option than standard treatments for patients whose head and neck cancer has spread, or recurred after an initial round of chemotherapy, according to results of the Keynote-040 trial presented at the ESMO 2017 Congress in Madrid. (1) Although the 19% improvement in overall survival among […]

Biotechnology cancer Cell Therapy Clinical Trials

A new HER2 mutation, a clinical trial and a promising diagnostic tool for metastatic breast cancer

There is a group of metastatic breast cancers that has the HER2 gene amplified – the cells have many copies of it – which leads to enhanced activity of the product enzyme, a tyrosine kinase. HER2 has been established as a therapeutic target in breast cancer, and breast cancers in which the HER2 gene is […]

Biotechnology Clinical Trials Pharmaceuticals

New combination of anti-obesity drugs may have beneficial effects

Research conducted in the Perelman School of Medicine at the University of Pennsylvania has revealed that a unique combination of hormone-based drugs can produce enhanced weight loss in laboratory tests with obese animals. The research is to be presented this week at the Annual Meeting of the Society for the Study of Ingestive Behavior (SSIB), […]

Biotechnology cancer Clinical Trials Immunotherapies

Genetically enhanced, cord-blood derived immune cells strike B-cell cancers

Immune cells with a general knack for recognizing and killing many types of infected or abnormal cells also can be engineered to hunt down cells with specific targets on them to treat cancer, researchers at The University of Texas MD Anderson Cancer Center report in the journal Leukemia. The team’s preclinical research shows that natural […]

Clinical Trials Gene Therapy

Altered virus may expand patient recruitment in human gene therapy trials

For many patients, participating in gene therapy clinical trials isn’t an option because their immune system recognizes and fights the helpful virus used for treatment. Now, University of Florida Health and University of North Carolina researchers have found a solution that may allow it to evade the body’s normal immune response. The discovery, published May […]

Biotechnology cancer Clinical Trials Prodrug

Clinical trial shows experimental drug’s ability to knock down pancreatic cancer’s defense

By adding an experimental drug to a standard chemotherapy regimen, a subset of patients with metastatic pancreatic cancer had a significantly longer period before the cancer progressed as compared with those who received the standard treatment, according to a Phase 2 clinical trial led by an investigator at Fred Hutchinson Cancer Research Center. The randomized, […]

Biotechnology cancer Vaccines

Immunotherapy with DNA vaccine shows promise for HPV-related head and neck cancer

A novel vaccine therapy can generate immune responses in patients with head and neck squamous cell carcinoma (HNSCCa), according to researchers at the Abramson Cancer Center of the University of Pennsylvania. The treatment specifically targets human papillomavirus (HPV), which is frequently associated with HNSCCa, to trigger the immune response. Researchers will present the results of […]

Pharmaceutical Business News

Forge Therapeutics Raises $15M Series A Financing to Develop First Novel Gram-Negative Antibiotic in Decades

Forge Therapeutics, Inc., a biotechnology company discovering first-in-class antibiotics using a breakthrough drug discovery platform, announced today the completion of a $15M Series A financing. The round is led by MagnaSci Ventures, with participation from Evotec AG, Alexandria Venture Investments, MP Healthcare Venture Management, Red Apple Group, and WS Investments. Forge has used its enabling […]

cancer Clinical Trials

AACR: Phase II Trial Shows Rice Bran Promotes Microbiome Diversity, Slows Growth of Colorectal Cancer Cells

Today at the American Association for Cancer Research (AACR) Annual Meeting 2017, University of Colorado Cancer Center researchers at Colorado State University present results of a phase II clinical trial of 29 people exploring the effects of adding rice bran or navy beans to the diets of colorectal cancer survivors. After the 4-week randomized-controlled trial […]

cancer Clinical Trials

First in Human’ Trial Defines Safe Dosage for Small Molecule Drug ONC201 for Solid Cancer Tumors

Research from Rutgers Cancer Institute of New Jersey examines oral drug that targets cancer cells and spares healthy tissue A ‘first in human’ clinical trial examining the small molecule drug ONC201 in cancer patients with advanced solid tumors shows that this investigational drug is well tolerated at the recommended phase II dose. That’s according to […]

Clinical Trials

Pivotal Trial Begins for Breast Fibroadenoma Using Focused Ultrasound

Patients with benign breast tumors may be eligible for a new focused ultrasound–based investigational treatment as part of a pivotal, multi-center clinical study. The trial began last month at the University of Virginia (UVA) Medical Center. David Brenin, MD, Associate Professor of Surgery and Chief of Breast Surgery at UVA, is the Principal Investigator for […]

Clinical Trials Pharmaceuticals

Georgetown Announces Phase II Clinical Trial of Nilotinib for Parkinson’s Disease

Georgetown University Medical Center (GUMC) today announces the launch of a phase II clinical trial to study the safety of the cancer drug nilotinib and its effects on clinical outcomes and biomarkers in people with Parkinson’s disease. GUMC is recruiting volunteers for the study in collaboration with its clinical partner, MedStar Georgetown University Hospital. The […]