Aptevo Therapeutics Highlights Key Features of Its ADAPTIR™ Protein Therapeutic Platform at Two Industry Conferences
June 07 2017 - 9:02AM
Aptevo Therapeutics Inc. (Nasdaq:APVO), a biotechnology company
focused on developing novel immuno-oncology and hematology
therapeutics, announced today that aspects of its ADAPTIR™ protein
therapeutic platform were showcased recently at the Americas
Antibody Congress 2017 in San Diego, May 23-24, 2017, and at the
2017 Next Generation Protein Therapeutics Summit in San Diego, June
5-7, 2017.
In a presentation entitled, “From the Bench to
the Clinic: Developing Next Generation ADAPTIR molecules,” Dr.
David Bienvenue, Senior Director, Protein Sciences, presented an
overview of the key differentiating features of Aptevo’s ADAPTIR
technology. The presentation highlighted the activity,
stability and manufacturability of ADAPTIR bispecifics and included
recent data for a lead preclinical candidate, APVO436, which
targets CD123 and CD3. APVO436 has shown potent biological
activity in preclinical studies and is advancing towards
first-in-human clinical trials.
“Aptevo’s ADAPTIR therapeutic protein platform
offers important advantages over other bispecific antibody
formats,” remarked Dr. Bienvenue. “First, the flexible and
modular nature of the ADAPTIR structure provides the ability to
engineer protein therapeutics that can engage the immune system
through diverse mechanisms of action, including redirected T-cell
cytotoxicity, targeted cytokine delivery and receptor blockade,
among others. Second, the unique homodimeric structure
enables the easy assembly and screening of new drug candidates,
while avoiding the pitfalls encountered with heterodimeric
bispecific formats. Recent improvements to the ADAPTIR
scaffold and screening processes have led to candidates with
increased expression levels, stability, and improved serum
half-life (up to 12.5 days in rodents), while retaining traditional
antibody-like manufacturing characteristics. These enhanced
features enable the design and development of custom-engineered
protein therapeutics with novel mechanisms of action and highly
favorable supply economics. We believe this optimally
positions our ADAPTIR candidates vis-à-vis other immunotherapy
strategies.”
ADAPTIR Pipeline
Two first generation ADAPTIR molecules are
currently in clinical development: MOR209/ES414, which is being
investigated in a Phase 1, dose escalation, continuous infusion
study to evaluate safety and tolerability in patients with
metastatic castration resistant prostate cancer; and, otlertuzumab,
a monospecific antibody targeting CD37 under investigation for the
treatment of chronic lymphocytic leukemia. In addition,
Aptevo has several ADAPTIR candidates in preclinical development,
including: a next generation bispecific antibody candidate
targeting ROR1-expressing tumor cells, under development for the
treatment of hematological and solid tumors; and, APVO436 – an
optimized, next generation bispecific antibody candidate designed
to simultaneously target CD123 and CD3 and redirect T-cell
cytotoxicity for the treatment of acute myelogenous leukemia (AML),
a form of blood and bone marrow cancer.
Preclinical data presented by Dr. Bienvenue show
that APVO436 can potently and selectively induce tumor-specific
immune responses and T-cell mediated cytotoxicity in vitro and in
vivo through the dual targeting of CD123 (a cell surface receptor
highly expressed in several hematological malignancies) and CD3 (a
member of the T-cell receptor complex that promotes T-cell
activation and T-cell mediated cytotoxicity.) In these
studies, APVO436 dose-dependently inhibited tumor growth and
significantly prolonged survival compared to vehicle-treated
animals in a Xenograft tumor model of AML.
“We’re excited about the enhancements to our
next generation ADAPTIR platform and our ability to engineer novel
bispecific antibody therapeutics against a broad range of disease
targets,” said Dr. Bienvenue. “Aptevo is focusing its efforts
initially in immuno-oncology as we’ve seen encouraging in vitro and
in vivo data with our preclinical ADAPTIR candidates at low
concentrations showing potent and selective T-cell engagement and
tumor lysis (killing). We look forward to presenting
additional data from these programs later this year.”
ADAPTIR Technology Platform – Key
Differentiating Features
- Flexible, modular, adaptable structure promotes versatile
functionality
- Adaptable for production of T-cell engagers, targeted cytokine
delivery, targeted activation of immune cells, neutralization of
soluble factors, receptor blockade
- Candidate screening in bispecific format to rapidly identify
leads with the desired activity and stability
- A bispecific technology that retains monoclonal antibody-like
characteristics
- Bivalent binding to targets, leveraging avidity for tight
binding and potential for increased potency
- High expression levels using a single cell line production
process
- Standardized process, analytical and formulation development
that facilitate rapid advancement to the clinic
- Predictable and superior manufacturing attributes and highly
favorable supply side economics
- Extended serum half-life of up to 12.5 days in rodents
- Optimized stability (with an emphasis on enhanced functional,
conformational and colloidal properties)
- Fully human sequences with reduced potential for
immunogenicity
About Aptevo Therapeutics Inc.
Aptevo Therapeutics Inc. is a biotechnology
company focused on novel oncology and hematology therapeutics to
meaningfully improve patients’ lives. Our core technology is the
ADAPTIR modular protein technology platform. Aptevo has four
commercial products in the areas of hematology and infectious
diseases, as well as various investigational stage product
candidates in immuno-oncology.
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 Aptevo’s outlook, financial performance or financial
condition, our technology and related pipeline, collaboration and
partnership opportunities, commercial portfolio, Aptevo’s future
growth rates, Aptevo’s ability to timely manufacture its products,
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 our actual results to differ materially from those
indicated by such forward-looking statements, including possible
negative effects on our business operations, assets or financial
results as a result of the separation; a deterioration in our
business or prospects; the ability of our contractors and suppliers
to supply product and materials; our ability and the ability
of our contractors and suppliers to maintain compliance with cGMP
and other regulatory obligations; the results of regulatory
inspections; adverse developments in our customer-base or markets
and our ability to retain patients; 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 our filings with the Securities and Exchange
Commission, including Aptevo’s most recent Annual Report on Form
10-K, as filed on March 15, 2017, and our 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 our expectations in any forward-looking
statement.
Source:
Aptevo Therapeutics
Stacey Jurchison
Senior Director, Investor Relations and Corporate Communications
206-859-6628
JurchisonS@apvo.com
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