Data Presented at IDWeek™ 2021 Demonstrate that ALVR109, AlloVir’s Investigational SARS-CoV-2-Specific T Cell Therapy, Is Reactive Against a Broad Range of Variants, Including Delta
Early clinical data show expansion and persistence of cells and support the efficacy and safety profile of ALVR109 in transplant and non-transplant patients with COVID-19
Preclinical research from
“The preclinical data presented today underscore the power of AlloVir’s virus-specific T cell therapy platform, demonstrating the speed at which we can identify target antigens, advance these to our manufacturing process and generate highly potent VSTs that are effective against a broad range of SARS-CoV-2 variant strains, including the Delta variant,” said
When advanced into clinical study, ALVR109 was well tolerated and was associated with clinical improvement in the four enrolled transplant and non-transplant patients, with cells that expanded and persisted post-infusion. Given the profile of ALVR109 from these clinical and preclinical data and the unmet medical need in immunocompromised patients with COVID-19,
Beyond SARS-CoV-2, the early clinical data presented at IDWeek reinforce the potential for AlloVir’s VST therapies to address the major public health issue posed by ubiquitous respiratory viruses. The company plans to initiate a proof-of-concept study for its multi-respiratory virus-specific T cell therapy, ALVR106, targeting respiratory syncytial virus, influenza, parainfluenza and human metapneumovirus later this year.
About the Preclinical Data
Researchers screened peripheral blood mononuclear cells (PBMCs) from convalescent donors who had naturally controlled and cleared the SARS-CoV-2 virus to identify immunogenic and protective SARS-CoV-2 antigens. Of the proteins screened, a subset was identified as immunodominant and was advanced for VST manufacturing using AlloVir’s proprietary, clinically validated and commercially scalable manufacturing and cell culture process.
Though initially generated against the reference strain (
About the Clinical Data
A Phase 1b clinical trial enrolled adult, high-risk, hospitalized patients with at least two risk factors for poor outcomes, including age, history of malignancy, diabetes, hypertension and prior stem cell transplant. All four patients received standard of care and a single infusion of ALVR109, which was given at one of two dose levels. ALVR109 was well-tolerated, with only one serious adverse event of cytokine release syndrome 13 days after ALVR109 infusion; this event was transient and most likely attributable to COVID-19 disease progression. All four patients experienced clinical improvement after administration of ALVR109. One patient experienced clinical improvement after administration but subsequently experienced a late COVID-19 recurrence and died nearly four weeks following treatment with ALVR109. Three of the four patients experienced clinical improvement and remain well and virus-free.
Researchers also performed exploratory studies to examine the in vivo expansion and persistence of the ALVR109 infused cells. In all four patients, substantial increases in SARS-CoV-2 specific T cells following administration were observed, and ALVR109 VSTs were detected out to at least three months post-infusion in two of the four patients.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the potential for AlloVir’s VST therapies to address the major public health issue posed by ubiquitous respiratory viruses, the development and regulatory status of our product candidates, the planned conduct of its clinical trials and its prospects for success in those studies and trials, and its strategy, business plans and focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to AlloVir’s financial results, the timing for the initiation and successful completion of AlloVir’s clinical trials of its product candidates, whether and when, if at all, AlloVir’s product candidates will receive approval from the