Cambridge, Mass. – March 23, 2020 – AlloVir, a late-clinical stage T-cell immunotherapy company, today announced the expansion of its research and development collaboration with Baylor College of Medicine to include the discovery and development of allogeneic, off-the-shelf, virus specific T-cell therapies to combat SARS-CoV-2, the virus that causes COVID-19. With AlloVir’s proprietary technology, in addition to targeting SARS-CoV-2, the investigational virus specific T-cell therapy may also address other coronavirus (CoV) strains including SARS-CoV, MERS-CoV, and also the endemic CoVs that commonly afflict immunocompromised patients. AlloVir aims to develop a therapy for CoVs that can be used as a stand-alone treatment or incorporated into the company’s multi-respiratory virus investigational therapy, ALVR106, which is designed to address other devastating and life-threatening community-acquired respiratory viruses.
“Given the worldwide coronavirus pandemic and risks to immunocompromised patients now and in the future, we believe it is our responsibility to leverage our scientific expertise and allocate resources for an allogeneic, off-the-shelf, coronavirus-specific T-cell program,” said Ann Leen, Ph.D., AlloVir Co-Founder, Chief Scientific Officer, and Professor of Pediatrics at Baylor College of Medicine. “Together with Baylor College of Medicine we have already advanced two highly innovative allogeneic, off-the-shelf, multi-virus specific T-cell investigational immunotherapies. We believe we can apply this same approach to develop a cell therapy to treat and prevent coronavirus infections and diseases in immunocompromised patients.”
“AlloVir and Baylor College of Medicine are leading the way in the clinical development of novel immunotherapies designed to restore natural T-cell immunity to fight off viral infections and diseases in immunocompromised patients, including recipients of stem cell and solid organ transplants,” said Michael Dilling, Executive Director of Baylor Licensing Group within Baylor College of Medicine Ventures. “Expanding upon this collaboration and technology platform to treat and possibly prevent other emerging life-threatening community-acquired virus infections and diseases is a natural extension of our partnership.”
About AlloVir’s Approach:
T cells are vital to the immune system’s ability to detect and kill virus-infected cells. In healthy individuals, virus-specific T cells form a critical component of the body’s natural defense system and provide protection against thousands of disease-causing viruses.However, these viruses can go unchecked in immunocompromised patients, such as those undergoing hematopoietic stem cell transplantation (HSCT), solid organ transplantation, and cancer treatment; in patients with HIV infection; and in the elderly. Typically, when viruses attack immunocompromised patients, standard of care therapies do not address the underlying problem of a weakened immune system and, therefore, many patients suffer with life-threatening outcomes such as multi-organ damage and failure, and even death. AlloVir uses natural immune stimulant proteins called cytokines combined with non-harmful fragments of the virus to activate and expand naturally occurring cells against target viruses. These cells are then provided to immunocompromised patients in order to restore natural T-cell immunity to prevent and/or treat associated viral infections and diseases. AlloVir has developed a proprietary manufacturing process that allows for a bank of virus-specific T cells to be developed from a small number of carefully chosen, healthy, virus-immune, third-party donors. AlloVir’s virus-specific T-cells therapies do not require exact immunological matching to patients, allowing hundreds of patients to be treated with virus-specific T-cells manufactured from a single donor. AlloVir’s therapies can be stored in a frozen state and thus supplied rapidly and globally as an off-the-shelf therapy for patients suffering from, or at risk for, one or more viral infections and diseases.
AlloVir, formerly ViraCyte, is an ElevateBio portfolio company that was founded in 2013 and is the leader in the development of novel cell therapies with a focus on restoring natural immunity against life-threatening viral diseases in patients with severely weakened immune systems. The company’s technology platforms deliver commercially scalable solutions by leveraging off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viral pathogens for immunocompromised patients under viral attack. AlloVir’s technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio.
AlloVir’s lead product Viralym-M (ALVR105) is in late-stage clinical development as an allogeneic, off-the-shelf, multi-virus specific T-cell therapy targeting six common viral pathogens in immunocompromised individuals: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6, and JC virus. In a positive Phase 2 proof-of-concept study, published in the Journal of Clinical Oncology (Tzannou, JCO, 2017), greater than 90% of patients who failed conventional treatment and received the company’s lead allogeneic T-cell therapy, Viralym-M, demonstrated a predefined criteria for a complete or partial clinical response, most with complete elimination of detectable virus in the blood and resolution of major clinical symptoms. The company plans to initiate pivotal and proof-of-concept studies with Viralym-M in 2020 for treatment and prevention of severe and life-threatening viral infections and diseases.
AlloVir’s second allogeneic, off-the-shelf, multi-virus specific T-cell therapy, ALVR106, targets four common and devastating community-acquired respiratory viruses: respiratory syncytial virus, influenza, parainfluenza virus, and human metapneumovirus (Vasileiou, Haematologica, 2019). The company anticipates initiating clinical studies with ALVR106 in 2020.
AlloVir’s investors include Fidelity Research and Management Company, Gilead Sciences, F2 Ventures, The Invus Group, Redmile Group, EcoR1, Samsara Biocapital, and Leerink Partners Co-investment Fund, LLC.
AlloVir is an ElevateBio portfolio company. More information can be found at allovir.com.
ElevateBio, LLC, is a Cambridge-based biotechnology company, established to create and operate a broad portfolio of cell and gene therapy companies with leading academic researchers, medical centers and entrepreneurs. ElevateBio builds companies by providing scientific founders with fully integrated bench-to-bedside capabilities including world-class scientists, manufacturing facilities, drug developers and commercial expertise. ElevateBio BaseCamp, a company-owned Cell and Gene Therapy Center of Innovation, will serve as the R&D, process development and manufacturing hub across the entire ElevateBio portfolio while also supporting selected strategic partners. For more information, visit www.elevate.bio
About Baylor College of Medicine
Baylor College of Medicine (www.bcm.edu) in Houston is recognized as a health sciences university and is known for excellence in education, research and patient care. It is the only private medical school in the greater southwest and is ranked 22nd among medical schools for research and 4th for primary care by U.S. News & World Report. Baylor is listed 20th among all U.S. medical schools for National Institutes of Health funding and No. 1 in Texas. Located in the Texas Medical Center, Baylor has affiliations with seven teaching hospitals and jointly owns and operates Baylor St. Luke’s Medical Center, part of CHI St. Luke’s Health. Currently, Baylor has more than 3,000 trainees in medical, graduate, nurse anesthesia, physician assistant, orthotics and genetic counseling as well as residents and postdoctoral fellows. Follow Baylor College of Medicine on Facebook (http://www.facebook.com/BaylorCollegeOfMedicine) and Twitter (http://twitter.com/BCMHouston).