Aptevo Therapeutics Inc. (Nasdaq: APVO), a biotechnology company
focused on developing novel immuno-oncology and hematology
therapeutics 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 Society
for Immunotherapy of Cancer's (SITC) 34th Annual Meeting at the
National Harbor, Maryland, November 6-10, 2019.
ALG.APV-527 is a novel immunotherapeutic
candidate intended for the treatment of a variety of 5T4-positive
solid tumors. It is designed to induce signaling through the
co-stimulatory receptor 4-1BB (CD137), which is present on
activated cytotoxic T cells and natural killer (NK) cells. Once
activated, it is designed to promote potent and selective
tumor-directed immune activation in the presence of the tumor
associated antigen, 5T4, which is present on many different types
of solid tumors.
The preclinical data presented at SITC show that
ALG.APV-527 selectively enhances T cell and NK cell responses in
the presence of 5T4 in vitro and displays potent and sustained
tumor suppression in vivo. The preclinical studies demonstrate that
ALG.APV-527
- Enhances CD8+ T cell and NK function and proliferation
preferentially over that of CD4+ T cells, upon 5T4-mediated
crosslinking
- In preliminary in vivo studies in a human 4-1BB knock in model,
induces rejection of established murine bladder cancer cells
expressing human 5T4 at doses of 20 µg in mice and induces
anti-tumor immunological memory responses
- Is well tolerated after repeated dosing in a GLP toxicology
study above the expected human dose and displays an antibody-like
half-life of up to 9.5 days
“We’re pleased that ALG.APV-527 continues to
show promising preclinical results,” said Jane Gross, Ph.D., Chief
Scientific Officer for Aptevo. “The ability of ALG.APV-527 to
induce potent anti-tumor T cell and NK cell activity suggests 4-1BB
is an attractive target for designing new immuno-oncology
therapeutics. Monospecific 4-1BB-directed antibodies have been
challenged by dose-limiting liver toxicities. As a novel bispecific
antibody ALG.APV-527 may circumvent these challenges and minimize
systemic toxicity by stimulating 4-1BB function only when
co-engaged with the tumor antigen, 5T4.”
“The presented preclinical data strongly support
a potent effect of ALG.APV-527 without compromising on safety. The
data further strengthens our CTA package and we are eagerly looking
forward to discussing this candidate with potential partners to
take this exciting asset further into clinical development,”
commented Christina Furebring, Ph.D., Vice President of Preclinical
Development at Alligator.
The Alligator/Aptevo poster presentation,
entitled “Potent Tumor-Directed T Cell Activation and Tumor
Inhibition Induced by a 4-1BB x 5T4 ADAPTIR™ Bispecific
Antibody” is being presented on Saturday, November 9, 2019
from 7:00 am – 8:30 pm ET.
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
parts, one part activating tumor-specific T cells through the
co-stimulatory receptor 4-1BB, the other part 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 oncology and
hematology therapeutics to meaningfully improve patients’ lives.
Aptevo has a commercial product, IXINITY® coagulation factor IX
(recombinant), approved and marketed in the United States for the
treatment of Hemophilia B, and a versatile core technology – the
ADAPTIR™ modular protein technology platform 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, Aptevo’s technology and related
pipeline, collaboration and partnership opportunities, commercial
portfolio, 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 18, 2019 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
JurchisonSenior Director, Investor Relations and Corporate
Communications+1 206-859-6628 JurchisonS@apvo.com
About Alligator
BioscienceAlligator Bioscience AB is a clinical-stage
biotechnology company developing tumor-directed immuno-oncology
antibody drugs. Alligator’s growing pipeline includes six lead
clinical and preclinical drug candidates: mitazalimab (ADC-1013),
ATOR-1015, ATOR-1017, ALG.APV-527 (co-developed with Aptevo
Therapeutics Inc.), ATOR-1144 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, and has approximately 55 employees. For more information,
please visit www.alligatorbioscience.com.
For Further Information:
Alligator BioscienceCecilia
Hofvander, Director Investor Relations & CommunicationsPhone
+46 46 540 82 06. E-mail:
cecilia.hofvander@alligatorbioscience.com.
The information was submitted for publication,
through the agency of the contact person set out above, at
3:00 pm CET on November 8, 2019.
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