Final Data from AlloVir’s Phase 2 Study of Posoleucel for Multi-Virus Prevention to be Highlighted in Oral Presentation at 64th American Society of Hematology Annual Meeting

Rhea-AI Summary

AlloVir, Inc. (NASDAQ: ALVR) announced that final data from its Phase 2 study of posoleucel to prevent clinically significant infections post-allo-HCT will be presented at the 64th American Society of Hematology Annual Meeting in New Orleans from December 10-13, 2022. Posoleucel is designed to combat multiple life-threatening viral infections in patients with weakened immune systems. Early results have prompted AlloVir to initiate a global Phase 3 study in multi-virus prevention, reflecting strong interest from leading transplant centers.

Positive

• Final data from Phase 2 study supports posoleucel's transformational potential.
• Initiation of a global Phase 3 multi-virus prevention study.
• Strong interest from leading transplant centers in participating in the trial.

Negative

• None.

WALTHAM, Mass.--(BUSINESS WIRE)-- AlloVir, Inc. (Nasdaq: ALVR), a late-clinical stage allogeneic T-cell immunotherapy company, today announced that final data from the Phase 2 study of posoleucel for the prevention of clinically significant infections or diseases by multiple viruses following allogeneic hematopoietic cell transplantation (allo-HCT) has been accepted as an oral presentation at the 64th American Society of Hematology (ASH) Annual Meeting to be held in New Orleans, Louisiana, December 10-13, 2022. The presentation will include final efficacy and safety results as well as posoleucel expansion and persistence data.

Posoleucel is AlloVir’s lead investigational virus-specific T cell (VST) therapy being developed as an off-the-shelf therapeutic for the treatment or prevention of up to six devastating viruses (adenovirus, BK virus, cytomegalovirus, Epstein-Barr virus, human herpesvirus-6 and JC virus) that have few to no effective treatment or prevention options and can be life-threatening for allo-HCT patients. These common viral infections present significant challenges in the management of allo-HCT patients, with the potential for prolonged hospitalization, increased risk for graft versus host disease (GVHD), end-organ damage and death. Preventing these viral infections and diseases – whether through the prophylaxis of patients at high risk for viral reactivation or through the preemptive treatment of patients with viral reactivation who have not yet developed clinically significant infections or disease – has the potential to fundamentally transform the treatment landscape for allo-HCT.

“We are excited to share the final data from our Phase 2 study of posoleucel for multi-virus prevention, which continue to support the transformational potential of posoleucel. Based on preliminary data from this study, AlloVir initiated a global Phase 3 multi-virus prevention study earlier this year. We are pleased with the enthusiasm we are seeing from leading transplant centers around the world participating in the trial,” said Diana Brainard, M.D., CEO, AlloVir.

Details of the presentation at ASH are as follows:

Final Clinical Outcomes from a Phase 2 Trial of Posoleucel, an Off-the-Shelf, Multivirus-Specific T-Cell Therapy, for the Prevention of Clinically Significant Viral Infections Post-HCT (Abstract 362)
Session 704: Cellular Immunotherapies: Early Phase and Investigational Therapies: CAR T in Multiple Myeloma and T-cell Therapies After Allo-HCT
Presentation Time: Saturday, December 10, 2022, 4:15 p.m. CT (5:15 p.m. ET)

About AlloVir

AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in pediatric and adult patients with weakened immune systems. The company’s innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, single- and multi-virus-specific T cells for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir’s technology and manufacturing process enable 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. For more information, visit www.allovir.com or follow us on Twitter or LinkedIn.

Forward-Looking Statements

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 AlloVir’s development and regulatory status of our product candidates, the planned conduct of its preclinical studies, and 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 U.S. Food and Drug Administration, or FDA, or other foreign regulatory authorities, competition from other biopharmaceutical companies, the impact of the COVID-19 pandemic on AlloVir’s product development plans, supply chain, and business operations and other risks identified in AlloVir’s SEC filings, including but not limited to the risks discussed in AlloVir's Annual Report on Form 10-K for the year ended December 31, 2021, and in our other filings with the SEC. AlloVir cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. AlloVir disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent AlloVir’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221102006217/en/

Media and Investor Contact:

Sonia Choi

AlloVir

schoi@allovir.com

Source: AlloVir, Inc.

FAQ

What were the final results of the Phase 2 study for posoleucel presented by AlloVir?

The final results for posoleucel were accepted for oral presentation at the ASH Annual Meeting, showcasing its efficacy in preventing viral infections post-allo-HCT.

When will AlloVir present the Phase 2 study results for posoleucel?

AlloVir will present the Phase 2 study results on December 10, 2022, at 4:15 p.m. CT during the ASH Annual Meeting.

What is the significance of posoleucel for allo-HCT patients?

Posoleucel aims to prevent multiple life-threatening viral infections, addressing significant challenges in managing allo-HCT patients.

What is AlloVir's next step following the Phase 2 study results?

AlloVir plans to proceed with a global Phase 3 multi-virus prevention study based on positive preliminary data from the Phase 2 study.

Which viruses does posoleucel target for prevention?

Posoleucel targets adenovirus, BK virus, cytomegalovirus, Epstein-Barr virus, human herpesvirus-6, and JC virus.