| Over a week ago | ||||
Check out this morning's…
| ||||
Seraph Research… Seraph Research Institute, or SRI, and Enochian BioSciences announced that a 36-year old patient with recurrent glioblastoma achieved complete remission for a period of 15 months. The findings were published in the peer-reviewed American Journal of Case Reports. A complete remission response such as this is uncommon for this highly aggressive and deadly form of brain cancer. In compliance with FDA guidance, SRI treated the patient with natural killer, or NK, and dendritic cells, or DC, from a relative who had a partial genetic mismatch. The DCs were loaded with a component of cytomegalovirus that is known to be present in more than 90% of glioblastomas. Enochian BioSciences acquired the intellectual property for an approach that is similar to the one used for this clinical outcome. The novel, proprietary strategy includes genetic modification of DCs, potentially increasing the immune response and even more effectively attacking tumors. Enochian BioSciences is actively developing this enhanced immune technology, including proof-of-concept in vivo studies of the potential to clear tumors with a focus on pancreatic cancer. The company said the treatment strategy also could be applicable to several solid tumors. | ||||
| Over a quarter ago | ||||
Enochian BioSciences… Enochian BioSciences announced the formation of a Scientific Advisory Board for one of its promising pipelines. Effective immediately, the Hepatitis B Virus Cure SAB will include: Carol Brosgart, MD, Chairperson of the SAB and member of the Enochian BioSciences Board of Directors and Clinical Professor of Medicine, Biostatistics and Epidemiology, University of California, San Francisco; Peter Revill, PhD, Senior Medical Scientist, Victorian Diseases Reference Laboratory, Royal Melbourne Hospital, Peter Doherty Institute for Infection and Immunity, Melbourne, Australia; and Fabien Zoulim, MD, PhD, Clinical Professor of Medicine at Lyon University; Medical Director, Hepatology Department, Hospices Civils de Lyon; and Scientific Director, Department of Immunology and Virology, INSERM Unit 1052, France. | ||||
Enochian BioSciences… Enochian BioSciences announced the completion of an Initial Targeted Engagement for Regulatory Advice meeting with the U.S. Food and Drug Administration Center for Biologics Evaluation and Research Office of Tissues and Advanced Therapies. The meeting, which included management and scientists from Enochian BioSciences together with CBER OTAT staff, focused on the pathway forward for ENOB-HV-01. ENOB-HV-01 is a novel approach to autologous stem cell transplantation, with the potential to cure HIV by increasing engraftment of gene-modified cells that are resistant to HIV infection. Failure to achieve engraftment has limited the success of other attempts to cure HIV with autologous transplantation. "We considered the meeting to be very successful, with strong alignment between Enochian's approach to developing ENOB-HV-01 and the comments of the FDA reviewers," said Dr. Mark Dybul, Executive Vice-Chair of Enochian BioSciences. "I want to thank the reviewers from FDA CBER OTAT for their time and helpful insight during our meeting. We look forward to advancing our thoughtful and deliberate pre-clinical work during the remainder of this year and into early next, leading to a pre-IND submission in 2021." | ||||
Enochian Biosciences… Enochian Biosciences announces three scientific presentations given yesterday at the Annual Meeting of the American Society of Gene and Cell Therapy. All three abstracts submitted to the conference were accepted for presentation. More than 39 million people live with HIV worldwide. There were approximately 2 million deaths and 1 million new infections last year. Two presentations provide the first description of a novel approach to potentially cure HIV. Genetic modification of cells to overexpress an important enzyme protected them from dying when they were treated with low doses of a chemotherapeutic drug, cyclophosphamide. This innovative strategy resulted in a one hundred and sixty-four percent increase in engraftment of transplanted cells in a mouse model. Two people - the "London Patient" and the "Berlin Patient" have been cured of HIV following transplantation of cells with genetic mutations that prevent HIV infection. However, the transplanted cells were from another person, an approach that carries a high risk of death and significant illness. Attempts to genetically modify and transplant a patient's own cells, that have a much lower risk of serious side effects, have failed due to limited engraftment of the transplanted cells in the bone marrow. The substantial increase in engraftment of genetically modified and transplanted cells in the bone marrow of mice could lead to a clinical approach in humans to potentially cure HIV. Approximately 257 million or five percent of the people in the world are infected with HBV, and nearly 1 million people die per year. At the HEP DART meeting in December 2019, we showed that a novel approach killed up to 97 percent of cells infected with HBV in vitro. Today, we presented new data from several in vivo studies providing a further scientific foundation for the mechanism of action of that killing and further validation of the approach as a potential therapy to cure HBV. |