23 of 26 (88%) patients remained free of
clinically significant infections caused by any of six common
viruses that posoleucel targets through the Week 14 primary
endpoint
3 of 26 (12%) patients had clinically
significant infections despite 22 of 26 (85%) patients reactivating
one or more of six potentially devastating viruses
Biomarker data support the clinical results by
demonstrating expansion of functional virus-specific T cells
coincident with viral load declines
Enrollment progressing in Phase 3 posoleucel
multi-virus prevention registrational trial in the U.S., Europe and
Asia
Company to host investor webcast with external
KOLs on December 14, 2022, at 4:30 p.m. EST
AlloVir, Inc. (Nasdaq: ALVR), a late-clinical stage allogeneic
T-cell immunotherapy company, today announced final data from the
Phase 2 study of posoleucel, an investigational, allogeneic,
off-the-shelf, multi-virus specific T cell therapy, for the
prevention of clinically significant infections or diseases from
six common and devastating viruses in allogeneic hematopoietic cell
transplant (allo-HCT) recipients – adenovirus (AdV), BK virus
(BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human
herpesvirus-6 (HHV-6) and JC virus (JCV). These final data
demonstrated a substantial reduction in the expected rate of
clinically significant viral infections or diseases in this
high-risk patient population despite the expected high rates of
viral reactivation. Biomarker data demonstrated the persistence of
posoleucel and association between expansion of functional
virus-specific T cells (VSTs) and viral control. Repeat dosing of
posoleucel was generally well tolerated in the study. 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.
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. There are currently no
effective preventive therapies that can target these viruses
simultaneously to block the progression of viral reactivation to
clinically significant infections. When given as preventative
therapy, posoleucel is designed to serve as an immunologic bridge,
covering patients through the high-risk, post-transplant window
when patients’ own immune systems are rebuilding. Posoleucel
selectively expands in the presence of antigens from the six target
viruses, controls viral replication and contracts after viral
control and the reconstitution of patients’ own immune systems.
“Allogeneic hematopoietic cell transplant recipients are highly
vulnerable to potentially devastating viral infections,
particularly in the first 100-180 days post-transplant. The
downstream effects of these viral infections can be
life-threatening, and there are very few treatment options that can
control these infections and their sequelae,” said Sanjeet Singh
Dadwal, M.D., Chief, Division of Infectious Diseases, and Professor
of Medicine, City of Hope, and lead investigator of the posoleucel
multi-virus prevention Phase 2 study. “Preventing the progression
of viral reactivation into clinically significant infections or
disease and avoiding the devastating consequences of these
infections for patients, either through a prophylactic or
preemptive treatment approach with posoleucel, would be a
significant advance in the management of allo-HCT patients.”
“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. The additional biomarker data presented today on the
expansion of functional VSTs against all six target viruses provide
additional insight into the mechanism of action and role of
posoleucel in preventing the progression of these ubiquitous
viruses into clinically significant infections or end-organ
disease,” said Diana Brainard, M.D., CEO, AlloVir. “Multi-virus
prevention against six common, potentially devastating pathogens
represents a highly transformative use of posoleucel. We continue
to urgently enroll our ongoing global Phase 3 multi-virus
prevention study, with the goal of delivering this therapy to
patients as quickly as possible.”
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 or 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.
Following this dosing period, patients received follow-up through
Week 26. The primary study endpoint was the number of new onset
clinically significant infections or end-organ disease through Week
14.
The study enrolled 26 high-risk allo-HCT patients. Of these
patients, 12 (46%) received transplanted cells from haploidentical
donors, nine (35%) from mismatched unrelated donors, four (15%)
from matched unrelated donors with T cell depletion or with
lymphopenia, and one (4%) from umbilical cord blood.
Out of 26 high-risk allo-HCT patients who received posoleucel in
this open-label study, 22 (85%) patients experienced reactivation
of at least one of posoleucel’s target viruses. Despite these
expected high rates of viral reactivation, only three clinically
significant infections were observed through Week 14; two
asymptomatic patients initiated preemptive CMV treatment with
valganciclovir following withdrawal of letermovir, and one patient
started rituximab for EBV-associated post-transplant
lymphoproliferative disease in the setting of receiving high-dose
steroids.
Biomarker analyses demonstrated that viral control was
associated with expansion of functional VSTs. An increase in
frequency of functional VSTs, when evaluating change from baseline
(Pre) to peak response through the 14-week treatment period (Post),
was observed via ELISpot. This increased frequency of functional
VSTs was associated with a reduction in viremia during the same
timeframe. Cell persistence was evaluated with T cell receptor
sequencing, with the presence of posoleucel confirmed both during
the infusion period and up to 14 weeks after the last infusion.
Treatment of up to seven doses of posoleucel over 12 weeks was
generally well tolerated with no unanticipated safety signals.
Rates of GVHD (19%) were similar in frequency and severity to those
expected in this high-risk allo-HCT population. Three (12%)
treatment-related serious adverse events were reported. No episodes
of cytokine release syndrome were reported.
Based on preliminary data from this study released earlier this
year, AlloVir commenced a global, registrational Phase 3
multicenter, randomized, double-blind, placebo-controlled clinical
trial (NCT05305040) of posoleucel for multi-virus prevention. The
study is enrolling patients in the U.S., Europe and Asia.
Investor Webcast Details
The company will host an investor webcast on Wednesday, December
14, 2022, at 4:30 p.m. EST to discuss the unmet medical need for
and clinical value of a multi-virus prevention approach in the
management of allo-HCT patients. The webcast will feature remarks
from AlloVir CEO Diana Brainard; infectious disease specialist
Sanjeet Singh Dadwal, M.D., City of Hope; and
hematologist-oncologist and transplant specialist Joseph McGuirk,
D.O., University of Kansas Medical Center.
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. An archived replay
of the presentation will be available on the website for 30 days
following the event.
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 cell therapy 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,
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, 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 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, or 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, 2021 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221210005012/en/
Media and Investor Contact: Sonia Choi AlloVir
schoi@allovir.com
AlloVir (NASDAQ:ALVR)
Historical Stock Chart
From Mar 2024 to Apr 2024
AlloVir (NASDAQ:ALVR)
Historical Stock Chart
From Apr 2023 to Apr 2024