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AlloVir, Inc. (NASDAQ: ALVR) is a leading entity in the clinical-stage biotech sector, focusing on allogeneic T cell immunotherapy for viral diseases affecting immunocompromised patients. The company is dedicated to the research, development, and commercialization of innovative T-cell therapies designed to restore natural immunity against life-threatening viral diseases in pediatric and adult patients with weakened immune systems.
AlloVir is known for its proprietary technology platforms that produce off-the-shelf, multi-virus-specific T cells. These cells are used to address the urgent medical needs of patients suffering from viral-associated diseases. The company’s lead product candidate, posoleucel, has been in clinical trials for the prevention and treatment of infections caused by six common and devastating viruses, including adenovirus (AdV), BK virus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpesvirus-6 (HHV-6), and JC virus (JCV).
Despite the promise of posoleucel, AlloVir recently announced the discontinuation of its three global Phase 3 studies due to futility analyses that showed the studies were unlikely to meet their primary endpoints. However, the studies did not identify any safety concerns, maintaining the potential for further exploration of posoleucel in other contexts.
AlloVir’s pipeline also includes ALVR106, targeted at respiratory infections like respiratory syncytial virus (RSV), human metapneumovirus (hMPV), influenza, and parainfluenza virus (PIV), now completing Phase 1b/2a clinical trials. Additionally, ALVR107 aims to address chronic hepatitis B with preclinical studies supporting its potential efficacy.
Founded in 2013 and based in Waltham, Massachusetts, AlloVir continues to evaluate strategic options for its future, including mergers, sales, divestitures, or licensing opportunities. With substantial capital in reserves, AlloVir is positioned to explore and advance its mission to treat and prevent viral diseases.
For more detailed information, visit AlloVir's website or follow the company on LinkedIn and Twitter.
AlloVir, a late-stage allogeneic T-cell immunotherapy company, announced that CEO Diana Brainard will participate in a fireside chat at the Piper Sandler 34th Annual Healthcare Conference in New York on November 29, 2022, at 12:00 p.m. ET. Investors can access a live webcast and an archived replay through the company's website. AlloVir focuses on restoring immunity against viral diseases in patients with weakened immune systems, utilizing its proprietary technology for broader treatment and prevention of viral infections.
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.
AlloVir, Inc. (Nasdaq: ALVR) reported Q3 2022 financial results, highlighting ongoing Phase 3 trials of posoleucel for preventing life-threatening viral infections in patients post-allogeneic stem cell transplant. Research and development expenses decreased to $30 million from $33.1 million year-over-year, while general and administrative costs remained stable at $12.9 million. The company holds $264.1 million in cash and equivalents. AlloVir anticipates releasing final data from its Phase 2 multi-virus prevention study by year-end and plans a webcast on December 14.
AlloVir, Inc. (NASDAQ: ALVR), a late-stage allogeneic T-cell immunotherapy company, announced that CEO Diana Brainard will participate in a fireside chat at the Morgan Stanley 20th Annual Global Healthcare Conference in New York on Wednesday, September 14, 2022, at 12:20 p.m. ET. A live webcast and replay will be available on AlloVir’s website. The company focuses on restoring immunity against viral diseases in patients with weakened immune systems using innovative T-cell therapies. For more details, visit AlloVir's website.
AlloVir, Inc. (Nasdaq: ALVR) reported financial results for Q2 2022, highlighting ongoing Phase 3 trials for its lead candidate, posoleucel. The company raised $126.6 million through a direct offering to support these trials and global regulatory submissions. Preliminary Phase 2 data for posoleucel shows promise in preventing viral infections in transplant patients, enhancing its potential market impact. However, the company reported a net loss of $44.6 million for the quarter, and cash reserves decreased to $172.7 million, raising concerns about future financial sustainability.
AlloVir (ALVR) announced a registered direct offering to sell 27,458,095 shares at $4.61 each, raising approximately $126.6 million, expected to close around July 28, 2022. The proceeds will fund ongoing Phase 3 trials for posoleucel, aimed at treating severe infections in immunocompromised patients. AlloVir plans to use the funds for trial completion, regulatory submissions, and R&D. As of June 30, 2022, the company had $172.7 million in cash. The offering is made without an underwriter and involves participation from new and existing investors, including Kite (GILD).
AlloVir (ALVR) announced successful completion of Phase 2 study enrollment for posoleucel, a T-cell therapy aimed at treating BK viremia in kidney transplant patients. Importantly, posoleucel was well-tolerated, showing no graft rejection cases. Preliminary data indicated a significant decline in median BK viral load among patients after 12 weeks of dosing. The study is recognized as the largest of its kind in solid organ transplant patients. Unblinded results from all 61 participants are expected in Q1 2023.
AlloVir has initiated a registrational study for posoleucel to prevent six viral infections in high-risk allo-HCT patients, with enrollment ongoing in the U.S., Western Europe, and Asia. The FDA has granted RMAT designation for this indication, targeting a patient population of 40,000 annually. The company has also progressed three Phase 3 studies and a Phase 2 trial for ALVR106. Financially, for Q1 2022, AlloVir reported a net loss of $43.9 million and operating expenses of $43.2 million, while cash and equivalents stood at $201.4 million, down from $248.1 million at the end of 2021.
AlloVir has received its third Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for its lead product, posoleucel, aimed at preventing significant infections from six viruses in high-risk patients post-allogeneic hematopoietic cell transplant (allo-HCT). This designation acknowledges the therapy's potential to address unmet medical needs. Initial data from a Phase 2 study shows a favorable safety profile, with few clinically significant infections among participants. AlloVir anticipates final Phase 2 results by year-end.
AlloVir (Nasdaq: ALVR) appointed Shawn Tomasello to its Board of Directors, bringing over 35 years of experience in the life sciences sector, particularly in cell and gene therapy. Tomasello has a significant track record, including her role as Chief Commercial Officer at Kite Pharma. This strategic addition aims to drive AlloVir’s evolution into a commercial-stage company, enhancing its multi-virus specific T cell platform. Longstanding Board member John Wilson will retire following the 2022 annual meeting, marking a transition in the company’s leadership.
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