Treatment of AdV infection is posoleucel’s
second potential indication to receive RMAT designation
Phase 3 registrational study of posoleucel for
AdV treatment is now open for enrollment
Proof-of-concept study of ALVR106 for the
treatment of multiple respiratory viral infections is also open for
enrollment
AlloVir, a late-clinical stage allogeneic T-cell immunotherapy
company, today announced that the U.S. Food and Drug Administration
(FDA) has granted its lead multi-virus specific T cell (VST)
therapy, posoleucel (Viralym-M, ALVR105), Regenerative Medicine
Advanced Therapy (RMAT) designation for the treatment of adenovirus
(AdV) infection following allogeneic hematopoietic stem cell
transplant (allo-HCT). The designation is based on positive results
from the Phase 2 CHARMS study.
RMAT designation recognizes the potential for posoleucel to
address the unmet medical need posed by AdV, a potentially
life-threatening condition with no approved treatment options. This
designation enables early interactions with the FDA to discuss
clinical trial design and other actions to expedite development and
review. The FDA previously granted RMAT designation to posoleucel
for the treatment of hemorrhagic cystitis (HC) caused by BK virus
in adults and children following allo-HCT.
“We are pleased that the FDA has granted posoleucel RMAT
designation for a second treatment-related indication,” said Ercem
Atillasoy, M.D., Chief Regulatory and Safety Officer, AlloVir. “The
two RMAT designations reinforce the potential of posoleucel in
areas of urgent patient need. We look forward to working closely
with FDA as we continue to advance posoleucel through late-stage
clinical development.”
A Phase 3 registrational study (NCT05179057) of posoleucel for
the treatment of AdV viremia is now open and enrolling pediatric
and adult patients following allo-HCT. This study is the second
Phase 3 registrational study of posoleucel, following the
initiation of the Phase 3 study for the treatment of
virus-associated HC last year.
Separately, the company also announced the initiation of a Phase
1/2 clinical trial (NCT04933968) of ALVR106, its investigational,
allogeneic, off-the-shelf, multi-VST therapy for the treatment of
infections caused by human metapneumovirus (hMPV), influenza,
parainfluenza virus (PIV) and respiratory syncytial virus (RSV).
This trial extends AlloVir’s VST platform to tackle respiratory
viruses that pose a considerable risk for autologous and allo-HCT
patients.
"The initiation of these posoleucel and ALVR106 studies
represents important progress in our effort to bring forward much
needed treatment options for immunocompromised patients,” said
Richard Riese, M.D., Ph.D., Senior Vice President, Clinical
Research, AlloVir. “These investigational multi-VST therapies aim
to restore immunity against viruses that, if left untreated, can
have devastating consequences. We look forward to working with
study investigators to enroll these studies and demonstrate the
potential for VST therapy in areas of urgent unmet need.”
About Adenovirus and the Posoleucel Phase 3 Study
AdV is a potentially life-threatening viral infection that has
no approved treatments. AdV viremia occurs in approximately one
third (32%) of pediatric allo-HCT patients and 6% of adult allo-HCT
patients. The spectrum of AdV-associated disease in HCT patients
ranges from mild gastroenteric or respiratory symptoms to
pneumonia, hepatitis, severe hemorrhagic enteritis or cystitis,
multi-organ failure or death. The current standard of care is
off-label use of an antiviral that has demonstrated limited
efficacy and significant toxicity.
The Phase 3 registrational trial (NCT05179057) of posoleucel is
a randomized, double-blind, placebo-controlled study assessing the
efficacy and safety of posoleucel for the treatment of AdV. The
study is enrolling 80 pediatric and adult allo-HCT patients with
high-level viremia (viral load ≥10,000 copies/mL) or with
consistently rising viral load and immune deficiency (viral load
≥1,000 copies/mL and <180 lymphocytes/mm3 or T cell depletion).
The primary efficacy endpoint is the reduction in viral load at
Week 4.
About Respiratory Viral Infections and the ALVR106 Phase 1/2
Study
Upper respiratory tract infections due to hMPV, influenza, PIV
and RSV are detected in up to 40% of allo-HCT patients. In
approximately half of these patients, these viral infections
progress to lower respiratory tract infections and present a 20-45%
mortality rate. There are no approved treatments or vaccines for
hMPV and PIV, and there is no vaccine for RSV; treatments for RSV
and influenza have limitations.
The ALVR106 Phase 1/2 proof-of-concept trial (NCT04933968) is a
double-blind, placebo-controlled study to assess the safety and
dose selection of ALVR106 in addition to standard of care for the
treatment of high-risk patients with respiratory viral infections
following HCT. The clinical trial consists of two parts. Part A
will evaluate multiple ascending doses of ALVR106 in up to 32
patients. Part B will expand the sample size of the selected Part A
dose cohort by enrolling an additional 45 high-risk patients. The
primary efficacy endpoint is the change in viral load at Week
4.
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 herpes virus-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.
A Phase 3 multicenter, double-blind, placebo-controlled trial of
posoleucel for the treatment of virus-associated HC is ongoing. A
Phase 2 trial to assess the safety and efficacy of posoleucel for
the prevention of infections and disease from the six target
viruses is also ongoing. Based on initial data from this Phase 2
multi-virus prevention study, the company plans to initiate a Phase
3 registrational trial for multi-virus prevention in the first half
of 2022, following FDA review of the final protocol. A Phase 2
proof-of-concept trial with posoleucel for the preemptive treatment
of BKV in adult kidney transplant recipients is also ongoing.
In addition to the RMAT designations for AdV and
virus-associated HC treatment, the FDA has 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 ALVR106
ALVR106 is an allogeneic, off-the-shelf, multi-virus specific
VST therapy candidate designed to target diseases caused by
respiratory syncytial virus (RSV), influenza, parainfluenza virus
(PIV) and human metapneumovirus (hMPV). In vitro data demonstrate
that ALVR106 reactive cells have antiviral activity against each of
the target viruses with minimal or no activity against
non-virus-infected cells.
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/20220105005344/en/
Media and Investor Contact: Sonia Choi AlloVir
schoi@allovir.com
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