Human polyomavirus 2

AlloVir Provides Updates on Phase 3 Clinical Development Program for Posoleucel, an Allogeneic Virus-Specific T Cell Therapy

Retrieved on: 
Friday, December 22, 2023

WALTHAM, Mass., Dec. 22, 2023 (GLOBE NEWSWIRE) -- AlloVir, Inc. (Nasdaq: ALVR), an allogeneic T cell immunotherapy company, today provided an update on its three Phase 3 clinical trials with posoleucel, an investigational off-the-shelf multi-virus-specific T cell therapy, which targets six viral pathogens in immunocompromised individuals: adenovirus (AdV), BK virus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpesvirus-6 (HHV-6) and JC virus (JCV). The company will discontinue its three global Phase 3 posoleucel studies – for prevention of clinically significant infections or diseases by multiple viruses, treatment of virus-associated hemorrhagic cystitis (vHC), and treatment of adenovirus (AdV) – following allogeneic hematopoietic cell transplant (allo-HCT). The company made the determination following three pre-planned analyses by three independent Data Safety Monitoring Boards (DSMBs) each of which recommended stopping its respective trial for futility after a review of the data suggested that each study was unlikely to meet its primary endpoint. There were no observed safety concerns raised by any of the DSMBs.

Key Points: 
  • The company will discontinue its three global Phase 3 posoleucel studies – for prevention of clinically significant infections or diseases by multiple viruses, treatment of virus-associated hemorrhagic cystitis (vHC), and treatment of adenovirus (AdV) – following allogeneic hematopoietic cell transplant (allo-HCT).
  • AlloVir is in the process of notifying regulatory agencies and clinical trial investigators involved in these trials of the findings.
  • “In light of the DSMB recommendations, we will discontinue the prevention, vHC and AdV Phase 3 trials.
  • As of September 30, 2023, AlloVir had cash, cash equivalents and short-term investments of $213.3 million.

Discovery of Genetic Link to PML Honored by Largest MS Conference in the World

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Tuesday, October 17, 2023

NEWPORT BEACH, Calif., Oct. 17, 2023 /PRNewswire/ -- The discovery of rare genomic variants leading to cases of drug-induced PML shared Best of MSMilan2023 honors for the latest and most breakthrough results at the 9th Joint ECTRIMS-ACTRIMS Meeting.

Key Points: 
  • Two of the variants have a Positive Predictive Value of 100%, the strongest possible indication they are causative.
  • Progressive Multifocal Leukoencephalopathy (PML) is a rare but frequently fatal serious infection of the brain by the JC virus.
  • Out of 1,500 abstracts presented, Dr. Hatchwell's was one of eight highlighted as Best of MSMilan2023 in its content area.
  • Many MS medications currently carry a PML warning, including Tysabri, Ocrevus, and Rituxan, as well as Briumvi, Gilenya, Kesimpta, Mavenclad, Mayzent, Ponvory, and Tecfidera.

FDA Approves First Biosimilar to Treat Multiple Sclerosis

Retrieved on: 
Thursday, August 24, 2023

SILVER SPRING, Md., Aug. 24, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS).

Key Points: 
  • SILVER SPRING, Md., Aug. 24, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS).
  • "Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of multiple sclerosis," said Paul R. Lee, M.D., Ph.D., director of the Division of Neurology 2 in the FDA's Center for Drug Evaluation and Research.
  • This means patients can expect the same safety and effectiveness from the biosimilar as they would the reference product.
  • The FDA granted approval of Tyruko, the first biosimilar to Tysabri (natalizumab), to Sandoz Inc.

AlloVir Reports Second Quarter 2023 Financial Results

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Thursday, August 3, 2023

AlloVir, Inc. (Nasdaq: ALVR), a late-clinical stage allogeneic T cell immunotherapy company, today reported financial results from the second quarter ended June 30, 2023.

Key Points: 
  • AlloVir, Inc. (Nasdaq: ALVR), a late-clinical stage allogeneic T cell immunotherapy company, today reported financial results from the second quarter ended June 30, 2023.
  • General and administrative expenses were $12.5 million for the quarter ended June 30, 2023, compared with $13.2 million for the quarter ended June 30, 2022.
  • Stock-based compensation expense was $10.3 million and $11.0 million for the quarter ended June 30, 2023, and 2022, respectively.
  • For fiscal year 2023, AlloVir expects operating expenses to be in the range of $150 million to $170 million, excluding non-cash expenses.

AlloVir Reports First Quarter 2023 Financial Results

Retrieved on: 
Thursday, May 4, 2023

AlloVir (Nasdaq: ALVR), a late-clinical stage allogeneic T cell immunotherapy company, today reported financial results from the first quarter ended March 31, 2023.

Key Points: 
  • AlloVir (Nasdaq: ALVR), a late-clinical stage allogeneic T cell immunotherapy company, today reported financial results from the first quarter ended March 31, 2023.
  • Research and development expenses were $30.7 million for the quarter ended March 31, 2023, compared with $29.1 million for the quarter ended March 31, 2022.
  • General and administrative expenses were $12.5 million for the quarter ended March 31, 2023, compared with $14.1 million for the quarter ended March 31, 2022.
  • For fiscal year 2023, AlloVir expects operating expenses to be in the range of $150 million to $170 million, excluding non-cash expenses.

AlloVir Announces Positive Results Including Long-Term Mortality Data in Phase 2 Posoleucel Multi-Virus Prevention Study in Oral Presentation at EBMT 2023

Retrieved on: 
Wednesday, April 26, 2023

These data were highlighted today in an oral presentation (Abstract OS08-03) at the 49th annual meeting of the European Society for Blood and Marrow Transplantation (EBMT 2023).

Key Points: 
  • These data were highlighted today in an oral presentation (Abstract OS08-03) at the 49th annual meeting of the European Society for Blood and Marrow Transplantation (EBMT 2023).
  • “The data presented today provide further evidence supporting the potential benefits of using posoleucel to prevent viral infection in high-risk allo-HCT patients.
  • "Our global, registrational Phase 3 clinical trial further exploring the potential of posoleucel for multi-virus prevention is well underway and we anticipate data from this registrational study in 2024.
  • More information on the ongoing, global, registrational, Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial of posoleucel for multi-virus prevention can be found on clinicaltrials.gov under the study ID ( NCT05305040 ).

Leading MS/PML Experts Recommend Genetic Testing to Prevent Fatal Brain Infection

Retrieved on: 
Thursday, March 16, 2023

NEWPORT BEACH, Calif., March 16, 2023 /PRNewswire/ -- In an editorial in the journal Frontiers in Neurology, two leading multiple sclerosis (MS) experts are advocating for genetic testing to identify MS patients who are at higher risk of developing a devastating side effect from their medications. 

Key Points: 
  • People with MS are faced with the excruciating decision of whether they should take medications that are effective in slowing the progression of the disease, but may also trigger this potentially fatal complication, a rare brain infection called progressive multifocal leukoencephalopathy (PML).
  • The widespread use of such testing could potentially allow the physician to use alternative therapies that do not carry the same risk of PML."
  • PML is caused by the JC virus, which is very common but remains dormant in the vast majority of carriers.
  • And in 2022 alone, there were nearly 600 cases in the FDA's adverse event reporting system.

AlloVir Reports Full-Year 2022 Financial Results and 2023 Outlook

Retrieved on: 
Wednesday, February 15, 2023

AlloVir, Inc. (Nasdaq: ALVR), a late-clinical stage allogeneic T cell immunotherapy company, today reported full-year 2022 financial results for the period ended December 31, 2022.

Key Points: 
  • AlloVir, Inc. (Nasdaq: ALVR), a late-clinical stage allogeneic T cell immunotherapy company, today reported full-year 2022 financial results for the period ended December 31, 2022.
  • These results are important proof of concept for the use of posoleucel in the solid organ transplant setting.
  • For fiscal year 2023, AlloVir expects operating expenses to be in the range of $150 million to $170 million, excluding non-cash expenses.
  • A live audio webcast of the presentation will be available on the Investors & Press section of the AlloVir website at https://ir.allovir.com/events-and-presentations .

AlloVir Announces Plans to Complete Enrollment in Three Phase 3 Posoleucel Studies in 2023

Retrieved on: 
Monday, January 9, 2023

Global enrollment is ongoing in Phase 3 registrational studies of posoleucel for the treatment of vHC ( NCT04390113 ) and AdV infection ( NCT05179057 ), both in adult and pediatric allo-HCT patients.

Key Points: 
  • Global enrollment is ongoing in Phase 3 registrational studies of posoleucel for the treatment of vHC ( NCT04390113 ) and AdV infection ( NCT05179057 ), both in adult and pediatric allo-HCT patients.
  • Given the high proportion of sites participating in multiple posoleucel Phase 3 studies and the intentional prioritization of the multi-virus prevention trial, both the vHC and AdV studies are expected to complete enrollment by year-end 2023, with topline data anticipated in 2024.
  • The company expects to initiate clinical development of ALVR107 upon completion of the posoleucel Phase 3 registrational studies.
  • For fiscal year 2023, AlloVir expects operating expenses to be in the range of $150 million to $170 million, excluding non-cash stock compensation expenses.

AlloVir Announces Positive Final Results in Phase 2 Posoleucel Multi-Virus Prevention Study In Oral Presentation at the 64th ASH Annual Meeting and Exposition

Retrieved on: 
Saturday, December 10, 2022

Biomarker data demonstrated the persistence of posoleucel and association between expansion of functional virus-specific T cells (VSTs) and viral control.

Key Points: 
  • Biomarker data demonstrated the persistence of posoleucel and association between expansion of functional virus-specific T cells (VSTs) and viral control.
  • These data were highlighted in an oral presentation ( Abstract 362 ) at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition in New Orleans today.
  • Allogeneic hematopoietic cell transplant recipients are highly vulnerable to potentially devastating viral infections, particularly in the first 100-180 days post-transplant.
  • We are excited to see the durability of posoleucel efficacy and safety in this final data set from the Phase 2 multi-virus prevention study, which reinforces the preliminary data previously reported.