Aptevo Therapeutics Presents New Data on Enhanced Features of Its Next Generation ADAPTIR™ Bispecific Platform at the World...
October 02 2017 - 9:00AM
Aptevo Therapeutics Inc. (Nasdaq:APVO), a biotechnology company
focused on developing novel immuno-oncology and hematology
therapeutics, today announced that new information on the Company’s
proprietary next generation ADAPTIR™ protein therapeutic platform
was presented at the 8th Annual World Bispecific Summit in Boston,
MA, September 26-28, 2017.
In a presentation entitled, “ADAPTIR™ Platform:
Rapid Development of Novel Protein Therapeutics,” Dr. Peter Pavlik,
Principal Scientist at Aptevo, presented a comprehensive overview
of Aptevo’s next generation ADAPTIR platform, highlighting
improvements that have led to the development of new ADAPTIR
candidates with increased stability, superior manufacturability and
antibody expression levels, and an extended half-life of up to 12.5
days in rodents.
In his overview, Dr. Pavlik describes the
expansion of Aptevo’s ADAPTIR platform into several different
mechanisms of action, including, T-cell engagers targeting CD3; a
bispecific targeting the costimulatory receptor 41BB and a solid
tumor antigen; and a bispecific that targets a cytokine to specific
cells via an ADAPTIR platform. This evolution highlights the
flexible and versatile nature of the ADAPTIR platform and its
utility in generating multiple bispecific candidates.
These attributes have been demonstrated with
Aptevo’s next generation lead bispecific T-cell engager, APVO436,
which simultaneously targets CD123 (a cell surface receptor highly
expressed in several hematological malignancies) and CD3 (a T-cell
co-receptor that promotes cytotoxicity.) Data from
preclinical studies of APVO436 show that it:
- Potently and selectively induces tumor-specific immune
responses and T-cell mediated cytotoxicity in vitro and in
vivo
- Has an antibody-like serum half-life in mice of up to 12.5 days
– significantly longer than first generation ADAPTIR candidates and
other bispecific candidates in development
- Induces potent, dose-dependent T-cell mediated lysis (killing)
of CD123-expressing acute myelogenous leukemia (AML) cell lines,
accompanied by target-specific T-cell activation and
proliferation
- Possess low (nM) binding affinity; binds with high affinity to
human and cynomolgus CD123-expressing cells with EC50 values in the
low nanomolar range
- Dose-dependently inhibits tumor growth and significantly
prolongs survival compared to vehicle-treated animals in a
Xenograft tumor model of AML
“Our data on APVO436 confirm the important
advances we have made with our next generation ADAPTIR candidates,
specifically improved stability, half-life, activity and
manufacturability – all critical attributes for commercialization,”
said Jane Gross, Ph.D., Senior Vice President and Chief Scientific
Officer. “We have also reduced sequences that could lead to
immunogenicity in the clinic. Our next generation candidates,
like APVO436, are designed to be delivered by intravenous
dosing. With two ADAPTIR candidates currently in clinical
development, and a broad portfolio of bispecifics advancing in
preclinical development, Aptevo has a rich pipeline of assets in
the emerging field of targeted antibody therapeutics.”
ADAPTIR Bispecific Antibody Platform:
Differentiating Characteristics
- Unique Homodimer Structure - simplifies candidate generation;
facilitates rapid substitution of target binding domains to
evaluate numerous candidates simultaneously
- Bivalent for Both Binding Domains - increases the avidity and
potency of ADAPTIR candidates
- Unique IgG Fc ‘Backbone’ - extends the half-life of ADAPTIR
molecules (up to ~12.5 days in rodents)
- Antibody-like Production Processes – demonstrated capability to
produce up to 2.0g/L comparable to traditional antibody
manufacturing processes
- Improved Yield and Cost of Goods - use of a single gene and
ease of CHO cell line production enhances ADAPTIR bispecific
manufacturing productivity
ADAPTIR Clinical and Preclinical
Portfolio:
- APVO414 – a bispecific ADAPTIR candidate,
currently in Phase 1 development, targeting prostate specific
membrane antigen (PSMA), an enzyme that is expressed on the surface
of prostate cancer cells, and, CD3, a component of the T cell
receptor complex expressed on all T cells. APVO414 redirects
T cells to specifically kill PSMA expressing tumors and is being
developed for metastatic castration-resistant prostate cancer,
which is advanced prostate cancer that has spread to other organs
and no longer responds to hormone blocking therapies.
- Otlertuzumab – a monospecific ADAPTIR
candidate currently in Phase 2 development for the treatment of
chronic lymphocytic leukemia (CLL). Data from a Phase 2
clinical trial evaluating otlertuzumab in combination with
bendamustine, compared to bendamustine alone, demonstrated a
significant increase in median progression free survival for the
combination, from approximately 10 to 16 months.
- APVO436 – a bispecific ADAPTIR candidate
currently in preclinical development targeting CD123, a cell
surface receptor highly expressed on several hematological
malignancies and CD3, a component of the T-cell receptor. APVO436
engages T cells to kill tumor cells.
- ALG.APV-527 – a bispecific antibody candidate,
partnered with Alligator Bioscience, featuring a novel mechanism of
action designed to simultaneously target 4-1BB (CD137) and an
undisclosed tumor antigen. 4-1BB, a costimulatory receptor on
T cells, is known to enhance the immune response to cancer through
activation of tumor-specific T cells and is believed to be a
promising target for new immunotherapeutic approaches. ALG.APV-527
could potentially have utility in the treatment of a broad spectrum
of cancers over-expressing the tumor antigen, including breast,
cervical, non-small-cell-lung, prostate, renal, gastric, colorectal
and bladder cancers.
- APVO210 – a bispecific ADAPTIR preclinical
candidate with a novel mechanism of action based on targeted
cytokine delivery. APVO210 is composed of a humanized
anti-CD86 antibody fused with a modified form of IL-10 that
specifically induces IL-10 signaling on antigen presenting cells,
but not on lymphoid populations. APVO210 functions by suppressing
immune responses and inducing certain tolerogenic responses and
therefore may have potential benefit for the treatment of
autoimmune and inflammatory diseases.
- ROR1 Bispecific – a proof-of-concept
bispecific candidate targeting ROR1, an antigen found on several
solid tumors and hematologic, or blood-related malignancies.
Initial preclinical data demonstrate redirected T cell killing of
tumors expressing ROR1 in vitro and in vivo in animal models.
About Aptevo Therapeutics
Inc.
Aptevo Therapeutics Inc. is a clinical-stage
biotechnology company focused on novel oncology and hematology
therapeutics to meaningfully improve patients’ lives. Aptevo
has a commercial product, IXINITY®, 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 to treat cancer or autoimmune
diseases. Aptevo has two ADAPTIR antibody candidates
currently in clinical development and a broad pipeline of novel
investigational-stage bispecific antibody candidates focused in
immuno-oncology and autoimmune disease and inflammation. 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, 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 possible
negative effects on our business operations, assets or financial
results as a result of the closing of the transaction;; a
deterioration in Aptevo’s business or prospects; the parties may be
unable to achieve the anticipated benefits of the transaction;
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 31, 2017, 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.
For Further Information:
Aptevo Therapeutics Stacey JurchisonSenior Director, Investor
Relations and Corporate Communications206-859-6628
JurchisonS@apvo.com
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