Day 400 non-relapse mortality was 0%
Previously reported data from the 14-week
primary endpoint showed low rates of clinically significant viral
infections and diseases in this high-risk patient population
despite the expected high rates of viral reactivation
Global Phase 3 pivotal posoleucel trials
continue to progress with robust patient enrollment in the US,
Europe and Asia with data readouts on track for 2024
AlloVir, Inc. (Nasdaq: ALVR), a late-clinical stage allogeneic T
cell immunotherapy company, today announced the presentation of
positive long-term, follow-up data from the Phase 2 study of
posoleucel for the prevention of clinically significant infections
from six common and devastating viruses in allogeneic hematopoietic
cell transplant (allo-HCT) recipients. Posoleucel is the company’s
investigational, allogeneic, off-the-shelf, multi-virus specific T
cell therapy, designed to target adenovirus (AdV), BK virus (BKV),
cytomegalovirus (CMV), Epstein-Barr virus (EBV), human
herpesvirus-6 (HHV-6) and JC virus (JCV). These new findings
demonstrate that the high-risk allo-HCT patients who received
posoleucel experienced continued low rates of clinically
significant infections and end-organ disease and 0% non-relapse
mortality. 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. The non-relapse mortality
rate in patients receiving posoleucel was 0% through week 52 which
compares favorably with published non-relapse mortality rates among
allo-HCT patients ranging from 9 percent to over 15 percent," said
Diana Brainard, MD, CEO, AlloVir. "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. If successful, an option that
prevents viral infection, such as posoleucel, could transform the
care of allo-HCT patients."
"The majority of allo-HCT recipients reactivate one or more of
posoleucel's six target viruses post allo-HCT, which can lead to
clinically significant infections, prolonged morbidity,
hospitalization and premature death," said Sanjeet Singh Dadwal,
MD, Chief, Division of Infectious Diseases, and Professor of
Medicine, at City of Hope, one of the largest cancer research and
treatment organizations in the United States, and lead investigator
of the posoleucel multi-virus prevention Phase 2 study. "This
long-term 0% non-relapse mortality result builds upon the positive
data through week 26 post-HCT, which was reported at the end of
last year. These long-term follow-up data suggest that posoleucel
could significantly impact patient outcomes. When available, I look
forward to seeing the larger data set from the ongoing Phase 3
program."
Phase 2 Multi-Virus Prevention Study
This open-label Phase 2 study evaluated the efficacy and safety
of posoleucel for the prevention of clinically significant viral
infections and disease caused by six target viruses: AdV, BKV, CMV,
EBV, HHV-6 and JCV. The prevention study encompassed both the
prophylaxis of patients at high risk for viral reactivation and the
preemptive treatment of patients with viral reactivation who had
not yet developed clinically significant infections or disease.
Patients received up to seven biweekly posoleucel infusions and
were tested for viremia by polymerase chain reaction (PCR) on a
weekly basis against all six viruses over a period of 14 weeks.
After this dosing period, patients were followed through Week 26.
The primary study endpoint was the number of new onset clinically
significant infections or end-organ disease through Week 14.
Details from the Phase 2 study were reported in December 2022 and
can be found here.
The study also included a 52-week follow-up visit, data from
which were presented today at EBMT. These new data demonstrate
that, of the 26 patients dosed with posoleucel, the five deaths
were all related to relapse/progression of underlying disease; none
were due to infection or deemed treatment-related, resulting in 0%
non-relapse mortality.
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).
References: 1. Marty F, et al. N Engl J Med. 2017;377:2433-44.
2. McDonald GB, et al. Ann Intern Med. 2020;172:229-39. 3. Su Y, et
al. Clin Infect Dis. 2022;75:795-804.
About Posoleucel
AlloVir's lead product, posoleucel, is in late-stage clinical
development as an allogeneic, off-the-shelf, multi-virus-specific T
cell therapy targeting 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). In the positive Phase 2 proof-of-concept CHARMS study,
more than 90% of patients who failed conventional treatment and
received posoleucel demonstrated a complete or partial clinical
response based on predefined criteria, most with complete
elimination of detectable virus in the blood and resolution of
major clinical symptoms.
Based on the strength of the posoleucel Phase 2 data for both
treatment and prevention, the FDA has granted posoleucel
Regenerative Medicine Advanced Therapy (RMAT) designation for each
of the three indications being evaluated in Phase 3 clinical trials
– for the treatment of hemorrhagic cystitis (HC) caused by BKV, for
the treatment of AdV infection in adults and children following
allo-HCT, and for the prevention of clinically significant
infections and disease caused by posoleucel's six target viruses.
The FDA also granted posoleucel Orphan Drug Designation for the
treatment of virus-associated HC. The European Medicines Agency has
granted posoleucel PRIority MEdicines (PRIME) designation for the
treatment of serious infections with AdV, BKV, CMV, EBV and HHV-6,
and Orphan Medicinal Product designation as a potential treatment
of viral diseases and infections in patients undergoing HCT.
About AlloVir
AlloVir is a leading late clinical-stage allogeneic T cell
immunotherapy 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 the potential efficacy of posoleucel as a treatment for
the prevention of clinically significant infections or diseases
caused by AdV, BKV, CMV, EBV, HHV-6 and JCV and as a treatment to
prevent viral infection in high-risk allo-HCT patients, AlloVir's
development plans and the regulatory status of AlloVir's product
candidates, the planned conduct of its preclinical studies, and
clinical trials and its prospects for success in those studies and
trials, the planned enrollment of clinical trials, the anticipated
timing of data readouts and completion of its clinical 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
the potential of posoleucel as a treatment for the prevention of
clinically significant infection or diseases, the potential of
posoleucel as a treatment option to prevent viral infection in
high-risk allo-HCT patients, 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 (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, 2022, 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.
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