Posoleucel demonstrated clinically meaningful
reductions in BK viral load as compared to placebo with the
greatest antiviral activity seen among patients with higher viral
loads and those who received more frequent posoleucel dosing
At Week 24, the percentage of patients with a
≥1-log viral load reduction in the biweekly dosing group was 50%
(10/20) vs. 28% (5/18) in the monthly dosing group and 14% (2/14)
in the placebo group
In the high viral load stratum (≥10,000
copies/mL), 69% (11/16) of patients who received posoleucel overall
and 75% (6/8) of patients in the biweekly dosing group, achieved a
≥1-log viral load reduction vs. 25% (1/4) of patients in the
placebo group
Biomarker data demonstrate that BK viral load
reductions coincided with substantial expansion of functional
BK-directed T cells specific for both posoleucel-targeted and
non-targeted antigens – indicating both direct and bystander T cell
benefit not observed in placebo patients
Repeat administration of posoleucel was
generally well tolerated, with balanced safety across posoleucel
dosing groups and placebo
AlloVir, Inc. (Nasdaq: ALVR), a late-clinical stage allogeneic T
cell immunotherapy company, today announced the presentation of
final results from a Phase 2 study of posoleucel, an
investigational, allogeneic, off-the-shelf, multi-virus-specific T
cell (VST) therapy, being studied for the treatment of BK viremia
in adult kidney transplant recipients. The findings, presented
yesterday at the American Transplant Congress (ATC 2023) in San
Diego, CA, during a late-breaking oral abstract session (LB001),
support the safety and antiviral activity of posoleucel in adult
kidney transplant recipients with BK virus (BKV) infection.
Currently, there are no effective treatment options for BKV
infection. Top line data were shared earlier this year.
"Our virus-specific T cell therapies have the potential to offer
new hope to immunocompromised patients by preventing or treating
devastating viral infections such as that caused by BKV," said
Diana Brainard, M.D., CEO, AlloVir. "The Phase 2 data presented at
ATC continue to support the potential benefits of posoleucel use
across transplant indications. The patients treated with posoleucel
had greater increases in BKV-specific T cells as compared to
placebo patients, and these cells persisted through week 24
post-dose, which reinforces posoleucel's mechanism of action.
Additionally, in posoleucel-infused patients we see bystander
benefit with endogenous BKV-specific T cell activation, increasing
the likelihood of durable benefit. As we continue enrollment in
three Phase 3 clinical studies exploring the potential of
posoleucel to prevent or treat infections in allo-HCT patients, we
are also consulting with key opinion leaders and preparing to meet
with the FDA to gain alignment on a Phase 3 clinical study design
to evaluate posoleucel’s treatment of BKV infection in kidney
transplant patients."
BKV infection poses a significant threat to kidney graft
survival. Over 90,000 kidney transplants are currently performed
each year globallyi, and the virus reactivates in up to 20% of
these patients.ii In patients who have reactivated BKV, a
substantial portion will develop high-level viremia. Approximately
half of those will develop BKV-associated nephropathy (BKVAN)iii,
which can lead to decreased kidney survival and a return to
end-stage renal disease and dialysis.
About the Phase 2 Study
The Phase 2 study evaluated the safety and efficacy of
posoleucel to treat BKV infection in adult kidney transplant
recipients with plasma BK viral load between 350-10,000,000
copies/mL (stratified by low (<10,000 copies/mL) or high
(≥10,000 copies/mL) viral load at study screening). Consensus
groups, including the American Society of Nephrology and the
American Society of Transplantation, consider BK viral load of
greater than or equal to 10,000 copies/mL to be presumptive BKVAN.
The primary endpoint of the study was the safety and tolerability
of posoleucel versus placebo, and the secondary endpoint of the
study was the change in BK viral load in patients receiving
posoleucel versus those receiving placebo. Top line results from
this study were shared earlier this year.
About BK Viremia in Kidney Transplant Recipients
Due to the long-term immunosuppression required to prevent graft
rejection, solid organ transplant recipients are at high risk for
reactivating common viruses that are typically controlled by the
body's natural immune system. Uncontrolled, these viruses can have
devastating consequences.
There are no approved or effective antiviral treatments for BKV
infection. The only approach to managing BKV infection is a
reduction in immunosuppression to allow the body's immune system to
fight the virus; this is typically triggered by a plasma BK viral
load that nears or exceeds 10,000 copies/mL. However, this
reduction in immunosuppression can also lead to graft rejection,
mediated by alloreactive T cells, and the development of
donor-specific antibodies, putting the success of the kidney
transplant at risk.
BK virus-specific T cells appear to play a key role in
protection against disease. Kidney transplant recipients who do not
develop BKVAN have been shown to have approximately 10-fold higher
BKV-specific T cell responses versus those with BKVAN. Kidney
transplant recipients with BK viremia who develop robust
BKV-specific T cell responses have also been shown to clear the
virus, while those who progressed to BKVAN required interventions
such as a reduction in immunosuppression. These data suggest that
VST therapy may help manage BKV infection and BKVAN.
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), BKV, cytomegalovirus (CMV),
Epstein-Barr virus (EBV), human herpesvirus-6 (HHV-6) and JC virus
(JCV). In a Phase 2 open-label study of posoleucel for the
prevention of clinically significant infections due to the six
viruses posoleucel targets, 88% of allo-HCT patients who received
posoleucel remained free of clinically significant infections
through week 14, the primary endpoint. Moreover, the non-relapse
mortality rate in patients who received posoleucel was 0% through
the 52-week follow-up visit. Additionally, in the positive Phase 2
proof-of-concept CHARMS treatment study which enrolled allo-HCT
recipients infected by one or more of the six viruses posoleucel
targets, more than 90% of patients who failed conventional
treatment and received posoleucel demonstrated a complete or
partial clinical response based on predefined criteria.
Based on the strength of the posoleucel Phase 2 data for both
prevention and treatment, 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
(EMA) 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 of posoleucel as a treatment of BKV in
kidney transplant recipients, the safety and antiviral activity of
posoleucel in adult kidney transplant recipients with BK infection,
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 the safety and efficacy of posoleucel
as a treatment of BKV in kidney transplant 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, 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.
i Kidney transplants worldwide by region 2021 | Statista
ii Gras J, Le Flécher A, Dupont A, et al. Characteristics, risk
factors and outcome of BKV nephropathy in kidney transplant
recipients: a case-control study. BMC Infect Dis. 2023;23:74.
iii Hirsch HH, Randhawa PS. BK polyomavirus in solid organ
transplantation-Guidelines from the American Society of
Transplantation Infectious Diseases Community of Practice. Clin
Transplant. 2019;33:e13528.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230605005273/en/
Media and Investor: ir@allovir.com
AlloVir (NASDAQ:ALVR)
Historical Stock Chart
From Jun 2024 to Jul 2024
AlloVir (NASDAQ:ALVR)
Historical Stock Chart
From Jul 2023 to Jul 2024