Benzinga | Dec 7, 2020 04:31PM EST

AlloVir Reports Phase 2 Proof-Of-Concept Data For Viralym-M, Burden Of Disease Data Presented At American Society Of Hematology Meeting

AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, today announced that results from the Phase 2, proof-of-concept CHARMS study demonstrated that an allogeneic, off-the-shelf, multi-virus specific T cell therapy, Viralym-M (ALVR105), achieved a 93% clinical response and was generally well-tolerated in allogeneic hematopoietic stem cell transplantation (allo-HSCT) patients with at least one drug refractory infection. The findings were highlighted during an oral presentation at the 62nd American Society of Hematology Annual Meeting (ASH). In a second oral presentation, a health outcomes analysis showed the high economic and clinical burden of virus-associated hemorrhagic cystitis (V-HC) in patients following allo-HSCT.

"There is an urgent need for new therapies that improve the treatment and prevention of viral infections which have significantly impacted immunocompromised patients as well as burdened the healthcare system," said Agustin Melian, MD, Chief Medical Officer and Head of Global Medical Sciences of AlloVir. "The data presented at ASH highlight the potential of Viralym-M in treating immunocompromised patients who are at a greater risk of viral infection."

Oral Presentation Treatment of Severe, Drug-Refractory Viral Infections with Allogeneic, Off-the-Shelf, Multi-virus Specific T Cell Therapy in Patients Following HSCT: Results from a Phase 2 Study

Presenter: Bilal Omer, MD, Center for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital, Houston Methodist Hospital, Houston, TX

Efficacy and safety data of Viralym-M in allo-HSCT recipients with at least one treatment-refractory infection (BKV, CMV, AdV, EBV, HHV-6, and/or JCV) were evaluated in the CHARMS study, a Phase 2 proof-of-concept clinical trial. Allo-HSCT patients who had either failed antiviral therapy or were unable to tolerate standard antivirals were enrolled and received a single infusion of Viralym-M. If a partial response was achieved, patients could receive up to four additional doses after four weeks, at two-week intervals.

Ninety-three percent (93%) of the patients achieved a complete (viral load returning to normal range and resolution of clinical signs/symptoms) or partial (a ?50% decrease in viral load and/or 50% improvement of clinical signs/symptoms) response by six weeks post-infusion. One hundred percent (100%) of patients who had two or more viral infections (11 of 11) responded to Viralym-M with 19 of the 23 viral infections across these 11 patients responding to treatment. Treatment with Viralym-M was generally well tolerated.

"Patients receiving an allogeneic hematopoietic stem cell transplant are at increased risk for multiple viral infections and diseases, which ultimately put them at risk for serious and life-threatening outcomes," said Bilal Omer, MD, Center for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital, Houston Methodist Hospital and presenting author. "Currently there is a lack of effective treatments and those that are available have significant toxicities. Data from the CHARMS study suggest that Viralym-M has the potential to safely and effectively treat the most common viral infections in patients following allogeneic HSCT and may address a critical unmet need in this patient population."

Oral Presentation: Economic and Clinical Burden of Virus-Associated Hemorrhagic Cystitis in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation

Presenter: Joseph P. McGuirk, DO, the University of Kansas Cancer Center, Westwood, KS

U.S. claims data were analyzed to compare health care reimbursement, health resource utilization, and clinical outcomes between allo-HSCT patients with virus-associated hemorrhagic cystitis (V-HC) to those without V-HC. The unadjusted mean reimbursement per patient group was $292,401 higher for patients with V-HC compared to patients without V-HC. Adjusted reimbursements were also significantly higher for V-HC patients with and without GVHD compared to patients without V-HC (p<.0001).

V-HC was associated with increased hospital length of stay and additional days in the intensive care unit. Readmission rates also increased for patients with V-HC compared to those without V-HC (p<.0001). The mean overall hospital LOS was prolonged by 27.1 days (p<0.0001), or 55% longer, for allo-HSCT patients with V-HC versus patients without V-HC.

In an adjusted analysis examining time to all-cause mortality, patients with V-HC had a 70% higher risk of mortality, even after adjusting for presence of GVHD as well as other baseline factors. V-HC was also associated with increased incidence for renal impairment in the follow-up period in patients with or without GVHD.

"Viral infections or disease including the viruses associated with hemorrhagic cystitis are a major complication in patients who have undergone allogeneic hematopoietic stem cell transplantation," said Joseph P. McGuirk, DO, the University of Kansas Cancer Center and presenting author. "These data show that virus associated hemorrhagic cystitis has a significant impact on patient outcomes including a greater risk of death and new renal impairment, while also placing a substantial burden on our healthcare system, highlighting the unmet clinical need for effective strategies to prevent and/or treat virus-associated hemorrhagic cystitis in allo-HSCT recipients."