BK virus

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.

EQS-News: AiCuris´ AiCubator Program Opens New Application Round for Innovative Projects with Focus on Treatment Options for Viral Infections in Immunocompromised Patients

Retrieved on: 
Thursday, September 28, 2023

AiCuris’ AiCubator program provides first-hand support for early research projects of young start-ups and academic teams that work on innovative treatment options for viral infections in immunocompromised patients.

Key Points: 
  • AiCuris’ AiCubator program provides first-hand support for early research projects of young start-ups and academic teams that work on innovative treatment options for viral infections in immunocompromised patients.
  • The fourth AiCubator application round starts on October 1st and will end on December 31st, 2023.
  • AiCuris’ AiCubator provides first-hand support for early research projects with a focus on innovative treatment options for viral infections in immunocompromised patients.
  • Interested parties can apply to the AiCubator program by filling in the AiCubator standard application form , describing the project, its status and development plans.

Global Clinical Laboratory Molecular Diagnostic for Infectious Disease Research Report 2023: Multiplex Assays - The Game-Changer in Diagnosing and Treating Infectious Diseases - ResearchAndMarkets.com

Retrieved on: 
Wednesday, August 9, 2023

6.12 Siemens Healthineers to Develop Next-Gen, High-Throughput MDx Platform

Key Points: 

6.12 Siemens Healthineers to Develop Next-Gen, High-Throughput MDx Platform
6.13 Hologic Obtains CE Mark for MDx Epstein-Barr, BK Virus Assays
6.14 Pathogenomix Infectious Disease Platform Uses Cloud-Based Analytics, NGS

Orthogon Therapeutics Celebrates Major Technical Milestone and Secures Additional $6M Toward a Pioneering Drug for BK Virus

Retrieved on: 
Monday, July 24, 2023

Orthogon’s lead molecule has successfully completed acute toxicity studies, marking a pivotal technical milestone that has unlocked an additional $3M from its dedicated syndicate of healthcare investors.

Key Points: 
  • Orthogon’s lead molecule has successfully completed acute toxicity studies, marking a pivotal technical milestone that has unlocked an additional $3M from its dedicated syndicate of healthcare investors.
  • This wraps up a $6M financing over the past year and brings Orthogon's total raise to a formidable $18.5M.
  • "We're celebrating this scientific achievement as much as this new funding," said Dr. Ali H. Munawar, CEO of Orthogon Therapeutics.
  • This development serves as a major catalyst, propelling Orthogon’s pioneering drug candidate into pre-IND studies and moving it closer to the clinic.

EQS-News: AiCuris Announces Strategic Shift to Focus Development and Commercialization of Anti-infectives for Immunocompromised Patients

Retrieved on: 
Thursday, July 6, 2023

AiCuris to continue its transition into a fully integrated biopharmaceutical company leveraging its research, clinical development, and commercialization expertise.

Key Points: 
  • AiCuris to continue its transition into a fully integrated biopharmaceutical company leveraging its research, clinical development, and commercialization expertise.
  • With AiCuris’ enhanced focus on development and commercialization of anti-infectives for immunocompromised individuals, the Company will discontinue research activities outside of this strategic scope.
  • Larry Edwards, CEO of AiCuris Anti-infective Cures AG, said: “Immunocompromised patients develop severe, partially life-threatening disease from infections that are typically well controlled in immune competent individuals.
  • Highly prevalent latent virus infections such as CMV, HSV and BKV can cause severe complications in immunocompromised patients for example, after transplantations.

AlloVir Presents Positive Final Results From A Phase 2 Randomized, Placebo-Controlled Trial Evaluating Posoleucel Treatment of BK Infection in Kidney Transplant Recipients at the American Transplant Congress (ATC 2023)

Retrieved on: 
Monday, June 5, 2023

The findings, presented yesterday at the American Transplant Congress (ATC 2023) in San Diego, CA, during a late-breaking oral abstract session (LB001), support the safety and antiviral activity of posoleucel in adult kidney transplant recipients with BK virus (BKV) infection.

Key Points: 
  • The findings, presented yesterday at the American Transplant Congress (ATC 2023) in San Diego, CA, during a late-breaking oral abstract session (LB001), support the safety and antiviral activity of posoleucel in adult kidney transplant recipients with BK virus (BKV) infection.
  • Currently, there are no effective treatment options for BKV infection.
  • "The Phase 2 data presented at ATC continue to support the potential benefits of posoleucel use across transplant indications.
  • Approximately half of those will develop BKV-associated nephropathy (BKVAN)iii, which can lead to decreased kidney survival and a return to end-stage renal disease and dialysis.

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 ).

CareDx Presents Latest Advancements at 12th Congress of the International Pediatric Transplant Association

Retrieved on: 
Thursday, March 23, 2023

CareDx, Inc. (Nasdaq: CDNA), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced its gold-level sponsorship and participation at the 12th Congress of the International Pediatric Transplant Association (IPTA) taking place March 25-28, 2023, in Austin, Texas.

Key Points: 
  • CareDx, Inc. (Nasdaq: CDNA), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced its gold-level sponsorship and participation at the 12th Congress of the International Pediatric Transplant Association (IPTA) taking place March 25-28, 2023, in Austin, Texas.
  • “CareDx is 100% committed to driving transplant innovation and this is especially important for pediatric patients who require decades of graft function.
  • “We are very proud to once again be one of the lead sponsors for the 12th Congress of the IPTA – an organization at the forefront of advancing science and technology for pediatric patients.”
    CareDx will host a symposium highlighting the company’s latest developments in pediatric heart and kidney transplant patient care.
  • The symposium, “Paradigm Shifts in Pediatric Surveillance Testing: AlloSure and AlloMap in Action” will be held on Sunday, March 26, from 12:30 – 1:30pm CDT.

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 .