Positive final posoleucel Phase 2 clinical data
presented at ASH 2022 underscore potential as multi-virus
prevention therapy and support ongoing global Phase 3 registration
trial
Completion of enrollment of all three
posoleucel Phase 3 registrational trials anticipated by the end of
2023 and data readouts in 2024
Topline results of posoleucel Phase 2 BKV
treatment study in kidney transplant patients expected in 1Q
2023
AlloVir, Inc. (Nasdaq: ALVR), a late-clinical stage, allogeneic
T-cell immunotherapy company, today announced the company’s 2023
priorities and anticipated future milestones across its pipeline of
virus-specific T cell therapies, including its lead investigational
therapy posoleucel. These updates will be the focus of a corporate
presentation by Chief Executive Officer Diana Brainard, M.D., at
the 41st Annual J.P. Morgan Healthcare Conference on Tuesday,
January 10, at 2:15 pm PT / 5:15 pm ET. A live webcast and archived
replay of the presentation will be available in the Investors &
Press section of the AlloVir website at https://ir.allovir.com.
“The positive posoleucel Phase 2 data we reported in 2022 and
the enthusiasm we are seeing from transplant centers give us
further confidence in our Phase 3 strategy for posoleucel and our
ability to execute on our trials in 2023,” said Dr. Brainard. “Our
Phase 2 multi-virus prevention study data underscore the potential
for posoleucel to be transformative for allo-HCT patients by
substantially reducing clinically significant infections from six
viruses that are devastating for this vulnerable population. Viral
infections are a leading cause of non-relapse mortality, generate
substantial healthcare expenditures, exact a significant emotional
burden on patients and their caregivers, and unfortunately most
viruses targeted by posoleucel currently have no preventive
therapies.”
Posoleucel is an investigational T cell therapy that targets
multiple viruses that commonly reactivate in patients who have
received allogeneic hematopoietic cell transplants (allo-HCTs) or
solid organ transplants. The therapy is being evaluated in three
Phase 3 registrational studies for three distinct indications — the
prevention of clinically significant infections or disease from
adenovirus (AdV), BK virus (BKV), cytomegalovirus (CMV),
Epstein-Barr virus (EBV), human herpesvirus-6 (HHV-6) and JC virus
(JCV), the treatment of virus-associated hemorrhagic cystitis
(vHC), and the treatment of AdV infection, all in allo-HCT
patients. These viral infections have limited to no approved
preventive therapies and treatment options, threatening patient
survival.
Posoleucel Multi-Virus Prevention
in Allo-HCT Patients Multi-virus prevention represents the
most transformational potential use of posoleucel, moving upstream
to prevent the progression of viral reactivations to clinically
significant infections and avoid the deleterious downstream effects
of these infections. Final data from the open-label, Phase 2
multi-virus prevention study of posoleucel were recently presented
at the 64th ASH Annual Meeting and Exposition. Results showed that
high-risk allo-HCT patients who received posoleucel had
substantially lower than expected rates of clinically significant
viral infections from posoleucel’s six target viruses, and that
repeat dosing was generally safe and well tolerated.
The posoleucel Phase 3 multi-virus prevention trial
(NCT05305040) is enrolling adult and pediatric patients in the
U.S., Europe, Asia, Australia and Canada. Enrollment is expected to
complete by year-end 2023, enabling topline data in mid-2024.
vHC and AdV Treatment in Allo-HCT
Patients Global enrollment is ongoing in Phase 3
registrational studies of posoleucel for the treatment of vHC
(NCT04390113) and AdV infection (NCT05179057), both in adult and
pediatric allo-HCT patients. Given the high proportion of sites
participating in multiple posoleucel Phase 3 studies and the
intentional prioritization of the multi-virus prevention trial,
both the vHC and AdV studies are expected to complete enrollment by
year-end 2023, with topline data anticipated in 2024.
BKV Treatment in Kidney Transplant
Patients Topline final data from the Phase 2 study
(NCT04605484) of posoleucel for the treatment of BK viremia in
kidney transplant patients are expected in the first quarter of
2023. These data will inform next steps for this potential
indication as well as our broader strategy in solid organ
transplant patients.
Earlier Stage Pipeline AlloVir’s early clinical and
preclinical VST therapy candidates provide portfolio expansion
opportunities, with pipeline advancement led by AlloVir or a
potential partner.
ALVR106 A Phase 1b/2
proof-of-concept clinical study (NCT04933968) of ALVR106 for the
treatment of respiratory syncytial virus (RSV), human
metapneumovirus, parainfluenza, and influenza, is enrolling auto-
and allo-HCT patients in the U.S. into the dose escalation part of
this two-part study.
ALVR107 Preclinical and
IND-enabling studies of ALVR107 for chronic HBV have been completed
and continue to support the potential for ALVR107 to achieve
functional HBV cure. The company expects to initiate clinical
development of ALVR107 upon completion of the posoleucel Phase 3
registrational studies.
ALVR109 The company continues to
make ALVR109 available to physicians in response to appropriate
compassionate use requests. Positive reports of ALVR109
compassionate use in immune-compromised patients have been
published and presented at the 2022 American Transplant Congress,
providing important insight into the potential utility of a
virus-specific T cell approach to treating respiratory viruses in
immunocompromised patients.
Financial Guidance As of December
31, 2022, the company’s cash balance was $234 million. For fiscal
year 2023, AlloVir expects operating expenses to be in the range of
$150 million to $170 million, excluding non-cash stock compensation
expenses. The cash balance amount is preliminary and subject to
revisions until the company reports its full financial results for
fiscal year 2022.
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 safety, efficacy and
regulatory and clinical progress of our product candidates,
including posoleucel, 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 Quarterly Report on
Form 10-Q for the quarter ended September 30, 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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version on businesswire.com: https://www.businesswire.com/news/home/20230109005224/en/
Media and Investor Contact: Sonia Choi AlloVir
schoi@allovir.com
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