- Preclinical Data Show that ALG.APV-527 is Well Tolerated
with Repeated Dosing
- Preliminary in vivo Data Show that ALG.APV-527 has
Potent Anti-tumor Activity and Induces an Immunological Memory
Response
SEATTLE and LUND, Sweden, Nov. 8,
2019 /PRNewswire/ -- Aptevo Therapeutics Inc. (Nasdaq:
APVO), a biotechnology company focused on developing novel
immuno-oncology and hematology therapeutics and Alligator
Bioscience (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
discuss this candidate with potential partners to take this
exciting asset further into clinical development," commented
Christina Furebring, Ph.D., Vice President 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:
ptevo 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 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 Bioscience
Cecilia Hofvander, Director Investor
Relations & Communications
Phone +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 p.m. CET on November
8, 2019.
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|
Aptevo Therapeutics
and Alligator Bioscience present new preclinical data
for ALG.APV-527 at the Society for Immunotherapy of Cancer
2019 Annual Meeting
|