Of the 23 high-risk allogeneic hematopoietic
cell transplant patients in this analysis, no end-organ viral
disease was observed
Of the 13 patients who completed through the
Week 14 primary endpoint, 11 remained free of clinically
significant infection
Strength of these preliminary efficacy and
safety data support advancement of posoleucel into a Phase 3
registrational trial expected to initiate in 1H 2022
Company to host virtual investor event on
December 13
AlloVir (Nasdaq: ALVR), a late-clinical stage allogeneic T-cell
immunotherapy company, today announced preliminary data from the
ongoing open-label portion of a Phase 2 study assessing the safety
and efficacy of posoleucel (Viralym-M, ALVR105) for the prevention
of clinically significant infections and end-organ diseases from
six potentially life-threatening viruses in high-risk patients
following allogeneic hematopoietic cell transplantation (allo-HCT).
Out of 23 patients who received at least one dose of posoleucel in
the ongoing study, including those who completed, discontinued or
are continuing posoleucel, only three clinically significant
infections were observed through Week 14 and no patients developed
end-organ viral disease as of the data cut-off for this preliminary
analysis. Of the 13 patients who completed through the Week 14
primary endpoint, 11 remained free of clinically significant
infection. These initial results represent a substantial reduction
in the expected rate of clinically significant viral infections or
diseases in this high-risk patient population. Repeat dosing of
posoleucel was generally well-tolerated. These data were presented
today at the 63rd American Society of Hematology (ASH) Annual
Meeting and Exposition.
Based on preliminary data from this Phase 2 study, the U.S. Food
and Drug Administration (FDA) has agreed in principle with the
company’s plan to advance from this Phase 2 open-label study into a
Phase 3 registrational trial. The company plans to initiate this
study in the first half of 2022, following FDA review of the final
protocol.
Posoleucel, the company’s lead investigational product, is an
allogeneic, off-the-shelf, virus-specific T cell (VST) therapy
being evaluated for the prevention of six potentially
life-threatening viruses that commonly impact allo-HCT patients –
adenovirus (AdV), BK virus (BKV), cytomegalovirus (CMV),
Epstein-Barr virus (EBV), human herpesvirus-6 (HHV-6) and JC virus
(JCV). Nearly 90% of all allo-HCT patients will reactivate at least
one of these viruses following allo-HCT, and approximately two
thirds of these patients reactivate multiple viruses. Based on an
analysis of peer-reviewed published data and electronic medical
record reviews, approximately 70% of high-risk allo-HCT patients
develop clinically significant infection or end-organ disease from
one or more of these viruses following allo-HCT. There are
currently no effective preventive therapies that can target these
multiple viruses simultaneously, resulting in significant and
prolonged morbidity, hospitalization and premature death.
“Viral infections frequently occur after allogeneic
hematopoietic cell transplant and commonly lead to serious
complications that can be life-threatening and negatively impact
patient survival. Treatment is often complicated by adverse effects
of antiviral medications that do not address the underlying issue –
the immune-deficient state,” said Sanjeet Dadwal, M.D., Chief,
Division of Infectious Diseases, and Professor of Medicine, City of
Hope, and posoleucel study investigator. “Posoleucel has the
potential to address the underlying immune deficit that leaves
these patients vulnerable to viral infections and aims to work as a
bridge to eventual immune reconstitution of the patient. The
ability to prevent six serious viral infections or diseases in
high-risk situations, such as soon after allo-HCT, would be a
significant advancement, minimizing the downstream effects of these
viral infections.”
“We are encouraged and excited by these positive data that
support the potential for posoleucel to change the treatment
paradigm for allogeneic hematopoietic cell transplant recipients,
moving upstream to prevent viral infections or diseases before they
occur,” said Diana Brainard, M.D., Chief Executive Officer,
AlloVir. “Based on the strength of these data and the tremendous
unmet medical need, we look forward to working with urgency with
regulators and the transplant community to initiate a global Phase
3 multi-virus prevention study in the coming months which, in
combination with our other posoleucel Phase 3 treatment studies for
virus-associated hemorrhagic cystitis and adenovirus, present a
critically important opportunity to better serve allo-HCT
patients.”
Overview of the Multi-Virus Prevention Study Open-Label
Preliminary Data
This two-part multicenter, randomized, double-blind,
placebo-controlled study is evaluating the efficacy and safety of
posoleucel for the prevention of six viral infections – AdV, BKV,
CMV, EBV, HHV-6 and JCV. The Phase 2 open-label portion of this
study is enrolling 25 high-risk allo-HCT patients. Patients receive
up to seven biweekly posoleucel infusions and are 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 receive follow-up through Week 26.
At the time of the data cut-off for this preliminary analysis,
23 high-risk allo-HCT patients received at least a single dose of
posoleucel, including 13 patients who had completed through Week
14, one patient who discontinued the study and nine patients whose
evaluation for the primary endpoint is ongoing. Of these patients,
14 (61%) received cells from haploidentical donors, six (26%) from
mismatched unrelated donors, two (9%) from matched unrelated donors
with T cell depletion or with lymphopenia, and one (4%) from
umbilical cord blood.
In this preliminary analysis, high-risk allo-HCT patients
receiving posoleucel experienced no end-organ disease and had rates
of clinically significant viral infections substantially lower than
the expected rate estimated through an analysis of peer-reviewed
published data and electronic medical record reviews.
The primary study endpoint is the number of new onset clinically
significant infections or end-organ disease through Week 14. Among
the 23 patients who received at least a single dose of posoleucel,
only three of 138 possible clinically significant infections from
these six common and life-threatening viruses were observed through
14 weeks. Three out of 23 patients experienced one clinically
significant viral infection each. Specifically, two patients
initiated preemptive CMV treatment with valganciclovir following
withdrawal of letermovir, and one patient started rituximab for EBV
in the setting of receiving high-dose steroids.
Repeat posoleucel dosing has been generally well-tolerated, with
no unanticipated safety signals. The observed rates and severity of
graft versus host disease did not exceed those expected in this
high-risk allo-HCT patient population. Two (9%) treatment-related
serious adverse events were reported.
Virtual Investor Event Details
The company will host a virtual investor event on Monday,
December 13, 2021, at 8:00 a.m. EST. 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. FDA has granted posoleucel Regenerative
Medicine Advanced Therapy (RMAT) designation for the treatment of
hemorrhagic cystitis (HC) caused by BKV in adults and children
following allo-HCT, and 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 AlloVir’s development and regulatory status of our
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. 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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version on businesswire.com: https://www.businesswire.com/news/home/20211211005060/en/
Media and Investors: Sonia Choi AlloVir
schoi@allovir.com
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