Building a pipeline of allogeneic, off-the shelf, multi-virus specific T-cell therapies
At AlloVir (formerly ViraCyte) it’s our mission to develop and deliver transformative cell therapies for patients suffering from life-threatening virus-associated diseases. We are the leader in the clinical development of novel cell therapies designed to restore natural T-cell immunity against devastating virus-associated diseases in immunocompromised patients, including stem cell and organ transplant recipients. AlloVir has built an innovative technology platform developed by researchers at Baylor College of Medicine’s Center for Cell and Gene Therapy. Our proprietary technology platform delivers commercially scalable, “ready-to-administer” solutions by leveraging off-the-shelf, allogeneic, multi-virus specific T-cells, designed to treat or prevent multiple devastating virus-associated diseases. We are now planning and advancing mid- and late-stage clinical trials across our growing product pipeline.
Leveraging our innovative technology and manufacturing platform to develop and deliver solutions for patients
Innovating to restore the body’s natural immune defense
In healthy individuals virus-specific T-cells (VSTs) from the body’s natural defense system provide protection against thousands of disease-causing viruses. However, in patients with a weakened immune system these viruses can go unchecked. Virus-associated diseases are common, with potentially devastating and life-threatening consequences in immunocompromised patients. For example, 90% of patients reactivate at least one latent virus following an allogeneic stem cell transplant and two-thirds of these patients reactivate more than one virus, resulting in significant and prolonged morbidity and premature death. Typically, when viruses reactivate in immunocompromised patients, standard of care does 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.
Our solution: one off-the-shelf, allogeneic cell therapy for many virus-associated diseases
Through decades of innovative scientific research, AlloVir has developed a pipeline of investigational cell therapies designed to restore natural T-cell immunity for patients by administering a single cell therapy with multi-virus specific T-cells that recognize and attack specific pathogenic viruses.
We first isolate allogeneic (healthy donor) T-cells. These T-cells are activated by exposing them to non-harmful fragments of the target viruses in the presence of natural immune stimulant proteins called cytokines. These viral fragments are incapable of producing viruses but are capable of stimulating T-cells, causing them to go from a resting state to an activated state, turn on their virus specific immune functions and expand. We can develop these virus-specific T-cells to target multiple pathogenic viruses or one at a time. The virus-specific T-cells, once expanded, are cryopreserved, and are ready for administration to the immunocompromised patient when needed to treat or potentially prevent virus-associated diseases. This process is designed to mimic the body’s natural immune system, where exposure to viruses causes an activation and expansion of nature’s own virus specific T-cells, which are then able to ward off virus-associated diseases. In much the same way AlloVir’s virus-specific T-cells are designed to target and keep virus-associated diseases in check until the patient’s own immune system is restored – effectively creating a bridge immune system. In a Phase 2 proof-of-concept study, over 90% of patients who failed conventional therapy and received our lead allogeneic T-cell therapy, Viralym-M, demonstrated either a complete or partial clinical response, most with complete resolution of major clinical symptoms.
The benefit: An off-the-shelf cell therapy that does not need to be made specifically for an individual patient with the potential to treat, or prevent, multiple virus-associated diseases with a single cell therapy.
Robust, scalable manufacturing process, enables ready-to-administer cell therapies for patients
We know that developing meaningful new cell therapies is just one part of delivering medicines to patients. Manufacturing innovative therapies in an efficient way is just as important. AlloVir has developed a proprietary manufacturing process allowing hundreds of patients to be treated with virus-specific T-cells manufactured from a single donor. Our proprietary cell selection strategy enables us to match our bank of donor-derived cell lines to patients.
Our proprietary technology and manufacturing processes were developed by scientists at Baylor College of Medicine’s renowned Center for Cell and Gene Therapy who continue to serve in leadership and advisory roles at AlloVir.
Multiple mid- and late-stage clinical trials across our growing pipeline
Viralym-M Phase 3 studies planned for treatment of multiple life-threatening virus-associated diseases
Our lead therapy 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:
Human herpesvirus 6
In a Phase 2 study in drug-refractory patients, published in the Journal of Clinical Oncology (Tzannou, JCO, 2017), 93% of treated patients demonstrated a clinical response (or met clinical response criteria) following treatment with Viralym-M.
Our second therapy, ALVR106, is an allogeneic, off-the-shelf multi-virus specific T-cell therapy, that targets four common and devastating community-acquired respiratory viruses (Vasileiou, Haematologica, 2019):
Respiratory syncytial virus,