- New Preclinical Data Show That ALG.APV-527 has Potential
for a Favorable Safety Profile
- Does Not Induce Systemic T-cell Activation at High Doses
Which Were Observed in a Urelumab Analogue in a Side-by-Side
Comparison
- ALG.APV-527 is a Novel Immunotherapeutic Bispecific
Candidate Designed to Treat Multiple Solid Tumors Expressing 5T4, a
Tumor-Restricted Antigen
SEATTLE and LUND,
Sweden, June 10, 2020 /PRNewswire/ -- Aptevo Therapeutics
Inc. (Nasdaq: APVO), a biotechnology company focused on developing
novel immuno-oncology therapeutics based on its proprietary
ADAPTIR™ bispecific technology platform, and Alligator Bioscience
AB (Nasdaq Stockholm: ATORX), a biotechnology company developing
antibody-based pharmaceuticals for tumor-directed immunotherapy,
today announced that new preclinical data for ALG.APV-527 are being
presented at the PEGS Virtual Interactive Global Summit, on
June 10, 2020 in an oral presentation
entitled, "ALG.APV-527: Tumor-directed T-cell
stimulation, in vivo tumor regression, and safety studies of a
4-1BB x 5T4 ADAPTIR™ bispecific antibody."
"Our latest preclinical data for ALG.APV-527 looks very
encouraging and shows that ALG.APV-527 may overcome many of the
limitations observed with other 4-1BB monoclonal antibody
therapeutics by improving the biodistribution, efficacy and
potential safety of this novel class of immunotherapies," said
Jane Gross, Ph.D., Chief Scientific
Officer for Aptevo. "Since ALG.APV-527 localizes at the tumor site,
immune activation depends on binding with 5T4 tumor antigen to
activate via 4-1BB, therefore limiting systemic activation seen
with other 4-1BB agonists. Most interestingly, our latest
preclinical data show the potential for a favorable safety profile
for ALG.-APV-527. In a head-to-head comparison with a urelumab
analogue in preclinical studies, ALG.APV-527 did not induce
systemic T-cell activity at high doses, a key differentiator from
other 4-1BB therapies."
ALG.APV-527 is a novel immunotherapeutic bispecific candidate
intended for the treatment of multiple solid tumors expressing 5T4,
a tumor-restricted antigen. 5T4 is an antigen that is highly
expressed in a large percentage of solid tumors, including,
non-small cell lung cancer (NSCLC), head and neck cancer and
mesothelioma. ALG.APV-527 is designed to activate anti-tumor
responses by inducing signaling through the co-stimulatory receptor
4-1BB (CD137), which is an immune receptor that is upregulated on
activated T cells and natural killer (NK) cells.
The preclinical data presented at the PEGS Virtual Interactive
Global Summit show that ALG.APV-527 may overcome many of the
limitations of competitor 4-1BB antibodies as it selectively
enhances the function of activated T cells and NK cells in the
presence of the tumor antigen 5T4, as shown in vitro, and
potently rejects tumors in an in vivo animal model.
In a high-dose toxicity human 4-1BB knock-in murine study
comparing ALG.APV-527 with a urelumab analogue, ALG.APV-527 was
well tolerated at high doses with no evidence of systemic T-cell
activation and no impact on body or spleen weight, whereas the
urelumab analogue induced weight loss, systemic activation of T
cells, and signs of ulcerative dermatitis.
In summary, the data presented at PEGS demonstrate that
ALG.APV-527:
- Enhances CD8+ T cell and NK function and
proliferation upon 5T4-mediated engagement
- Accumulates at 5T4-positive tumors in preclinical models
- In an in vivo human 4-1BB knock-in model:
-
- Induces rejection of established bladder cancer cells at low
doses
- Induces anti-tumor immunological memory
responses
- Does not induce systemic T-cell activation at high doses, which
were observed in a side-by side comparison with a urelumab
analogue
- Is well tolerated after repeated dosing in a GLP toxicology
study and displays an antibody-like half-life with a mean half-life
of 8 days
"Our data supports that ALG.APV-527 has the potential to induce
a strong anti-tumor immune response without systemic toxicity,
which is exactly what we hoped to see," commented Christina
Furebring, Ph.D., Vice President Projects at Alligator.
About ALG.APV-527
ALG.APV-527 is a bispecific antibody (4-1BB x 5T4) intended for
tumor-directed treatment of solid cancers. ALG.APV-527 was built
using Aptevo's ADAPTIR™ bispecific platform and combines binding
domains sourced from the ALLIGATOR-GOLD® human scFv library. The
ALG.APV-527 bispecific antibody consists of two moieties, one
moiety activating tumor-specific T cells through the co-stimulatory
receptor 4-1BB, the other moiety binding to the 5T4 protein
displayed on the surface of tumor cells. This enables
the immune-activating effect of ALG.APV-527 to be directed
specifically to the tumor and not against normal tissue.
About Aptevo Therapeutics Inc.
Aptevo Therapeutics Inc. is a clinical-stage biotechnology
company focused on developing novel immunotherapies for the
treatment of cancer. The Company's lead clinical candidate,
APVO436, and preclinical candidates, ALG.APV-527 and APVO603 were
developed based on the Company's versatile and robust ADAPTIR™
modular protein technology platform. The ADAPTIR platform is
capable of generating highly differentiated bispecific antibodies
with unique mechanisms of action for the treatment of different
types of cancer. For more information, please visit
www.aptevotherapeutics.com
Safe Harbor Statement
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Any statements, other than statements of historical fact,
including, without limitation, statements regarding potential
milestone payments, Aptevo's outlook, financial performance or
financial condition, estimated cash burn, Aptevo's technology and
related pipeline, collaboration and partnership
opportunities, milestones, and any other statements
containing the words "believes," "expects," "anticipates,"
"intends," "plans," "forecasts," "estimates," "will" and similar
expressions are forward-looking statements. These forward-looking
statements are based on Aptevo's current intentions, beliefs and
expectations regarding future events. Aptevo cannot guarantee that
any forward-looking statement will be accurate. Investors should
realize that if underlying assumptions prove inaccurate or unknown
risks or uncertainties materialize, actual results could differ
materially from Aptevo's expectations. Investors are, therefore,
cautioned not to place undue reliance on any forward-looking
statement. Any forward-looking statement speaks only as of the date
of this press release, and, except as required by law, Aptevo does
not undertake to update any forward-looking statement to reflect
new information, events or circumstances.
There are a number of important factors that could cause
Aptevo's actual results to differ materially from those indicated
by such forward-looking statements, including a deterioration in
Aptevo's business or prospects; adverse developments in research
and development; adverse developments in the U.S. or global capital
markets, credit markets or economies generally; and changes in
regulatory, social and political conditions. Additional risks and
factors that may affect results are set forth in Aptevo's filings
with the Securities and Exchange Commission, including its most
recent Annual Report on Form 10-K, as filed on March 25, 2020 and its subsequent reports on Form
10-Q and current reports on Form 8-K. The foregoing sets forth
many, but not all, of the factors that could cause actual results
to differ from Aptevo's expectations in any forward-looking
statement.
Source:
Aptevo Therapeutics
Stacey Jurchison
Senior Director
Investor Relations and Corporate Communications
+1-206-859-6628
JurchisonS@apvo.com
About Alligator Bioscience
Alligator Bioscience AB is a clinical-stage biotechnology
company developing tumor-directed immuno-oncology antibody drugs.
Alligator's pipeline includes five lead clinical and preclinical
drug candidates: Mitazalimab, ATOR-1015, ATOR-1017, ALG.APV-527
(co-developed with Aptevo Therapeutics Inc.) and AC101 (in clinical
development by Shanghai Henlius Biotech Inc.). Alligator's shares
are listed on Nasdaq Stockholm (ATORX). The Company is
headquartered in Lund, Sweden. For
more information, please visit www.alligatorbioscience.com.
The information was submitted for publication, through the
agency of the contact person set out above, at 3:00 p.m. CEST on June 10,
2020.
For Further Information:
Alligator Bioscience
Cecilia Hofvander
Director Investor Relations & Communications
Phone +46-46-540-82-06
E-mail:
cecilia.hofvander@alligatorbioscience.com.
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Aptevo Therapeutics
and Alligator Bioscience present new preclinical data
for ALG.APV-527 at the PEGS
Virtual Interactive Global Summit
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