– Compelling early clinical response signals for VIR-5818 and
VIR-5500 in heavily pretreated patients with various solid
tumors
○ VIR-5818: In patients receiving doses ≥400
µg/kg, tumor shrinkage observed in 50% (10/20) of participants with
various HER2-expressing cancers; confirmed partial responses in 33%
(2/6) of participants with HER2-positive CRC
○ VIR-5500: PSA declines in 100% (12/12) and
PSA50 response confirmed in 58% (7/12) of mCRPC patients with first
step dose ≥120 µg/kg
– Promising safety profile with MTD not yet reached for VIR-5818
or VIR-5500 and no dose-limiting cytokine release syndrome (CRS)
observed; no CRS greater than grade 2 reported
– Initial clinical data demonstrate PRO-XTEN™ masking technology
may lead to minimal systemic unmasking and unlocks expanded
therapeutic index
– Investor conference call January 8, 2025, at 5:00 a.m. PT /
8:00 a.m. ET, available on https://investors.vir.bio
Vir Biotechnology, Inc. (Nasdaq: VIR) today is presenting
initial Phase 1 data from two of its dual-masked T-cell engagers
(TCEs): VIR-5818, targeting a variety of HER2-expressing solid
tumors; and VIR-5500, targeting PSMA in metastatic
castration-resistant prostate cancer (mCRPC). Data show encouraging
preliminary safety and efficacy profiles with no dose-limiting
cytokine release syndrome (CRS), maximum tolerated dose (MTD) not
yet reached as dose escalation continues, and early clinical
response signals observed in heavily pretreated participants. These
initial results provide clinical support for Vir Biotechnology’s
in-licensed PRO-XTEN™ masking technology, which is designed to
enable the selective activation of TCEs in the tumor
microenvironment, mitigating damage to healthy cells and reducing
toxicity.
“Overcoming the toxicity-driven limitations of traditional
T-cell engagers could address an important unmet medical need in
cancer care,” said Marianne De Backer, M.Sc., Ph.D., MBA, Chief
Executive Officer, Vir Biotechnology. “Preliminary safety and
efficacy data for our dual-masked T-cell engagers VIR-5818 and
VIR-5500 are compelling, and we will continue dose escalation with
an opportunity to expand the therapeutic window. We are encouraged
that our candidates may enable efficacious and well-tolerated
treatment regimens, potentially improving outcomes for people
living with a range of solid tumors.”
VIR-5818: PRO-XTEN™ Initial
Proof-of-Concept and Potential First-in-Class HER2
Immunotherapy
Despite availability of HER2-targeting therapies, there remains
a significant unmet need for treatments with novel mechanisms of
action to improve tolerability and extend survival. Currently, no
HER2-directed immunotherapies are approved for solid tumors. The
preliminary safety and efficacy data of VIR-5818 support the
tumor-specific activation of PRO-XTEN™ dual-masked TCEs and the
potential of this technology to broaden the therapeutic index of
TCEs.
VIR-5818 is being evaluated in a Phase 1 clinical trial
(NCT05356741) designed to study its safety and pharmacokinetics
alone, and in combination with pembrolizumab, in participants with
a variety of HER2-expressing cancers, including breast and
colorectal cancer (CRC). The study has enrolled 79 heterogeneous
and heavily pretreated participants in monotherapy cohorts.
Early efficacy data indicate that 50% (10/20) of participants
receiving VIR-5818 doses ≥400 µg/kg experienced dose-dependent
tumor shrinkage across multiple HER2-positive tumor types. This
includes participants who had received up to 9 prior lines of
therapy. Strong anti-tumor activity was observed in a subset of
participants with HER2-positive CRC who have exhausted standard of
care. In this subset, confirmed partial responses (cPRs) were seen
in 33% (2/6) of participants at early doses, and one patient
continued in cPR for more than 18 months as of the data
cut-off.
Preliminary safety data demonstrate that VIR-5818 is generally
well-tolerated, with minimal grade 1 or 2 CRS (20% and 10%,
respectively) and no grade 3 or greater CRS observed in any of the
79 participants across doses up to 1000 µg/kg. Most
treatment-emergent adverse events (TEAEs) were low grade,
reversible and manageable. The MTD has not yet been reached.
Preliminary pharmacokinetics and safety data indicate low systemic
unmasking of the TCE, suggesting tumor-specific activation. Dual
masking results in a half-life of approximately 6 days, which may
enable a less frequent dosing regimen. As a result, Vir
Biotechnology is currently evaluating a Q3W dosing regimen.
VIR-5500: First Dual-Masked
PSMA-Targeting TCE
Prostate cancer is the second most diagnosed cancer in men1.
Despite advancements, there is still a significant unmet need for
efficacious, well-tolerated treatments that can extend survival and
improve quality of life.
VIR-5500 is being evaluated in a Phase 1 clinical trial
(NCT05997615) designed to assess its safety, pharmacokinetics, and
preliminary efficacy in participants with mCRPC. The study has
enrolled 18 participants with significant disease burden who have
received 3 to 6 prior lines of therapy.
Early efficacy data show encouraging signs of prostate-specific
antigen (PSA) responses, and PSA reductions were observed in 100%
(12/12) of participants after an initial dose ≥120 µg/kg. PSA50
response was confirmed in 58% (7/12) of participants receiving a
first dose ≥120 µg/kg.
Preliminary data show a promising safety profile, with no
dose-limiting toxicities observed up to 1000 µg/kg without
prophylactic corticosteroids. Safety findings showed minimal grade
1 or 2 CRS (17% and 11%, respectively) and no grade 3 or greater
CRS at any dose. Most TEAEs were low grade. No hearing loss has
been reported, suggesting safety benefits of dual masking in
preventing on-target, off-tumor toxicities. Dose escalation is
ongoing, and the MTD for VIR-5500 has not yet been reached.
Preliminary pharmacokinetics and safety data indicate
tumor-specific activation with minimal unmasking outside the tumor.
The dual-masked TCE shows a desirable half-life of 8-10 days, which
is enabling Vir Biotechnology to evaluate a Q3W dosing regimen. The
safety and tolerability profile observed for VIR-5500 in ongoing
dose escalation, together with the observed signs of early
anti-tumor activity at low doses, may enable a wide therapeutic
index.
About VIR-5818, VIR-5500, VIR-5525
VIR-5818, VIR-5500, VIR-5525 are investigational, clinical
candidates currently being evaluated for the treatment of solid
tumors. These assets leverage the PRO-XTEN™ masking technology with
three different T-cell engagers (TCEs) targeting HER2, PSMA, and
EGFR, respectively.
TCEs are powerful anti-tumor agents that can direct the immune
system, specifically T-cells, to destroy cancer cells. The
PRO-XTEN™ masking technology is designed to keep the TCEs inactive
(or masked) until they reach the tumor microenvironment, where
tumor-specific proteases cleave off the mask and activate the TCEs,
leading to killing of cancer cells. By driving the activity
exclusively to the tumor microenvironment, we aim to circumvent the
traditionally high toxicity associated with TCEs and increase their
efficacy and tolerability. Additionally, the mask is designed to
help drug candidates stay in the bloodstream longer in their
inactive form, allowing them to better reach the site of action and
potentially allowing less frequent dosing regimens for patients and
clinicians.
References:
1 Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L,
Piñeros M, Znaor A, Soerjomataram I, Bray F (2024). Global Cancer
Observatory: Cancer Today. Lyon, France: International Agency for
Research on Cancer. Accessed December 31, 2024.
About Vir Biotechnology, Inc.
Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical
company focused on powering the immune system to transform lives by
discovering and developing medicines for serious infectious
diseases and cancer. Its clinical-stage portfolio includes
infectious disease programs for chronic hepatitis delta and chronic
hepatitis B infections and multiple dual-masked T-cell engagers
across validated targets in solid tumor indications. Vir
Biotechnology also has a preclinical portfolio of programs across a
range of infectious diseases and oncologic malignancies. Vir
Biotechnology routinely posts information that may be important to
investors on its website.
Vir Biotechnology has exclusive rights to the PRO-XTEN™ masking
platform for oncology and infectious disease. PRO-XTEN™ is a
trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as “should,” “could,” “may,” “might,” “will,”
“plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and
similar expressions (as well as other words or expressions
referencing future events, conditions or circumstances) are
intended to identify forward-looking statements. Forward-looking
statements contained in this press release include, but are not
limited to, statements regarding: the therapeutic potential of Vir
Biotechnology’s oncology solid tumor portfolio, preclinical
pipeline and PRO-XTEN™ masked TCE platform, including the
capability to overcome toxicity-driven limitations of traditional
TCEs and expand therapeutic index with efficacious and
well-tolerated TCE treatment regimens, which could improve outcomes
for people living with a range of solid tumors; Vir Biotechnology’s
clinical development plans and expectations for its TCE assets,
including with respect to potential dosing regimens; and any
assumptions underlying any of the foregoing. Many factors may cause
differences between current expectations and actual results,
including, without limitation: unexpected safety or efficacy data
or results observed during clinical studies or in data readouts,
including the occurrence of adverse safety events; risks of
unexpected costs, delays or other unexpected hurdles; the timing
and amount of Vir Biotechnology’s actual operating expenses, as
determined in accordance with U.S. Generally Accepted Accounting
Principles; difficulties in collaborating with other companies,
some of whom may be competitors of Vir Biotechnology or otherwise
have divergent interests, and uncertainty as to whether the
benefits of Vir Biotechnology’s various collaborations can
ultimately be achieved; challenges in accessing manufacturing
capacity; clinical site activation rates or clinical enrollment
rates that are lower than expected; the timing and outcome of Vir
Biotechnology’s planned interactions with regulatory authorities,
as well as general difficulties in obtaining any necessary
regulatory approvals; successful development and/or
commercialization of alternative product candidates by Vir
Biotechnology’s competitors, as well as changes in expected or
existing competition; Vir Biotechnology’s use of artificial
intelligence and machine learning in its efforts to engineer
next-generation proteins and in other research and development
efforts; geopolitical changes or other external factors; and
unexpected litigation or other disputes. In light of these risks
and uncertainties, the events or circumstances referred to in the
forward-looking statements may not occur. Drug development and
commercialization involve a high degree of risk, and only a small
number of research and development programs result in
commercialization of a product. Results in early-stage clinical
studies may not be indicative of full results or results from
later-stage or larger-scale clinical studies and do not ensure
regulatory approval. The actual results may vary from the
anticipated results, and the variations may be material. You are
cautioned not to place undue reliance on the scientific data
presented or these forward-looking statements, which are based on
Vir Biotechnology’s available information, expectations and
assumptions as of the date of this press release. Other factors
that may cause Vir Biotechnology’s actual results to differ from
those expressed or implied in the forward-looking statements in
this press release are discussed in Vir Biotechnology’s filings
with the U.S. Securities and Exchange Commission, including the
section titled “Risk Factors” contained therein. Except as required
by law, Vir Biotechnology assumes no obligation to update any
forward-looking statements, whether as a result of new information,
future events or otherwise.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250108263221/en/
Media Arran Attridge Senior Vice President, Corporate
Communications aattridge@vir.bio
Investors Richard Lepke Senior Director, Investor
Relations rlepke@vir.bio
Vir Biotechnology (NASDAQ:VIR)
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