LUND, Sweden and SEATTLE, Nov. 16,
2020 /PRNewswire/ -- Alligator Bioscience ("Alligator")
(Nasdaq Stockholm: ATORX), a biotechnology company developing
antibody-based pharmaceuticals for tumor-directed immunotherapy and
Aptevo Therapeutics Inc. ("Aptevo") (NASDAQ:APVO), a biotechnology
company focused on developing novel immuno-oncology therapeutics
based on its proprietary ADAPTIR™ bispecific technology platform,
today provided an update on ALG.APV-527, a novel immunotherapeutic
bispecific candidate intended for the treatment of multiple solid
tumors expressing 5T4, a tumor-restricted antigen.
Aptevo and Alligator are advancing ALG.APV-527 into Phase I
clinical development in a co-development 50/50 partnership. The
companies anticipate filing a Clinical Trial Authorization during
the first half of 2021 to initiate Phase I clinical development in
multiple sites in the European Union. Aptevo and Alligator
will continue to explore licensing opportunities as ALG.APV-527
moves into clinical development.
"We are very excited about
taking ALG.APV-527 into the clinic now, as
recent APVO436 complete remission data in two patients in cohort 6
of that Phase I clinical trial speaks to the potential of our
ADAPTIR platform. As a potential first-in-class molecule,
ALG.APV-527 showcases the versatility of our ADAPTIR platform in
generating bispecific antibodies with unique mechanisms of action
and a therapeutic profile that is more consistent with traditional
antibodies, including an extended half-life, desirable
antibody-like manufacturing characteristics and optimized for
potency and stability," said Mr. Marvin
White, President and CEO of Aptevo.
"Our collaboration with Alligator Bioscience continues to yield
encouraging data supporting the potential advantages of this novel
pathway for targeted immunotherapy of cancer. For these reasons,
and given recent improvements in our financial position, we are
excited to advance this asset into the clinic with the desire to
enable potential additional value creation for shareholders as we
develop the asset," concluded Mr. White.
"Aptevo's clinical candidate APVO436 is based on the same
ADAPTIR platform as ALG.APV-527. It is my belief that the
response data observed in the APVO436 Phase I trial validates the
bispecific format of ALG.APV-527, and strengthens our view that it
has the potential to become a successful cancer therapy," said Per
Norlén, CEO of Alligator Bioscience.
ALG.APV-527 is designed to simultaneously target 5T4 and the
co-stimulatory receptor 4-1BB (CD137) to promote potent,
tumor-directed immune T-cell activation. 5T4 is a well-defined
tumor antigen expressed on many different types of malignancies
including non-small cell lung, renal, pancreatic, prostate, breast,
colorectal, gastric, ovarian and cervical cancers and mesothelioma.
Conversely, 5T4 has limited expression on adult normal tissues,
making it an attractive target for cancer immunotherapy.
Presentation at the SITC 35th Annual Meeting
As announced on Monday, November
9, Aptevo is presenting two new posters at the Society for
Immunotherapy of Cancer's (SITC) 35th Virtual Annual
Meeting, including one on ALG.APV-527. The poster will present
preclinical data demonstrating that ALG.APV-527 has a potentially
favorable safety profile with no indication of systemic immune
activation or liver toxicity in NHP or murine models. ALG.APV-527
induces robust in vitro killing of tumors that is dependent
on 5T4 engagement. In vivo, ALG.APV-527 augmented anti-tumor
responses and promoted tumor-specific memory.
Details of the Poster Presentation are as follows:
ALG.APV-527: Potent tumor-directed T cell activation and
in vivo tumor inhibition induced by a 4-1BB x 5T4 ADAPTIR
bispecific antibody
The abstracts and the accompanying posters will be available in
the Virtual Poster Hall to registered attendees from 8:00 am EST on Monday, November 9, until the
Virtual Poster Hall closes on December 31,
2020 on the SITC abstract website
About ALG.APV-527
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.
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
About Alligator Bioscience
Alligator Bioscience AB is a clinical-stage biotechnology
company developing tumor-directed immuno-oncology antibody drugs.
Alligator's pipeline includes the two key assets ATOR-1017 and
mitazalimab. Furthermore, there are two partnered assets:
ALG.APV-527 in co-development with Aptevo Therapeutics Inc. and
AC101 in clinical development by Shanghai Henlius Biotech Inc.). In
addition, the company has developed a novel concept for more
patient-specific immunotherapy: Neo-X-Prime. Alligator's shares are
listed on Nasdaq Stockholm (ATORX). The Company is headquartered in
Lund, Sweden. 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 2:00 p.m. CET (8:00 a.m.
EST) on November 16,
2020.
Aptevo Therapeutics
Elif McDonald
Senior Director, Investor Relations and Corporate
Communications
Phone: 206.859.6616
E-mail: IR@apvo.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 our
expectations about the timing of the filing of a Clinical Trial
Authorization for ALG.APV-527, our intention to continue to explore
licensing opportunities for ALG.APV-527, our intention to advance
ALG.APV-527 into Phase I clinic development 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. For instance, actual
results may differ materially from those indicated by such
forward-looking statements as a result of various important
factors, including the uncertainties inherent in the initiation and
enrollment of future clinical trials, availability and timing of
data from ongoing clinical trials, expectations for the timing and
steps required in the regulatory review process, expectations for
regulatory approvals, the impact of competitive products, our
ability to enter into agreements with strategic partners and other
matters that could affect the availability or commercial potential
of the Company's product candidates, business or economic
disruptions due to catastrophes or other events, including natural
disasters or public health crises such as the novel coronavirus
(referred to as COVID-19). 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.
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Aptevo Therapeutics
and Alligator Bioscience advancing the bispecific 4-1BBx5T4
antibody ALG.APV-527 into Phase I clinical development
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