Anticipates 2 IND Filings in 2018 for Novel
Bispecific Antibody Candidates
Aptevo Therapeutics Inc. (Nasdaq:APVO), a biotechnology company
focused on developing novel oncology and hematology therapeutics,
today announced recent developments related to the Company’s novel
ADAPTIR™ bispecific antibody platform, including the planned
commencement of a Phase 2 clinical evaluation of its monospecific
antibody candidate, otlertuzumab, in a new indication – peripheral
T-cell lymphoma (PTCL), scheduled to begin in the fourth quarter of
2017.
In addition, Aptevo announced that the Company
expects to file 2 Investigational New Drug (IND) applications in
2018 for 2 bispecific antibody candidates, APVO436, being developed
for the treatment of acute myeloid leukemia (AML), and APVO210,
being developed for the treatment of autoimmune and inflammatory
diseases.
“We continue to make solid progress advancing
our ADAPTIR portfolio with the expansion of our otlertuzumab
clinical development program to include a new indication in PTCL,
as well as planned IND filings for two new ADAPTIR candidates in
2018,” said Scott Stromatt, Chief Medical Officer. “Recently,
intriguing evidence has been reported on the overexpression of CD37
on T-cell malignancies, suggesting a potential role for
otlertuzumab in an attractive, orphan drug-eligible indication with
high unmet medical need. Based on these developments, Aptevo
has decided to expand its existing Phase 2 clinical protocol to
evaluate otlertuzumab in PTCL and discontinue enrollment in the
ongoing cohorts evaluating otlertuzumab in CLL with the intention
of continuing to explore partnership opportunities for Phase 3
development of otlertuzumab in CLL. With clinical proof-of-concept
data demonstrating the efficacy and tolerability of otlertuzumab in
previous combination studies, we believe that evidence of a
clinical effect in PTCL could open up a promising new market
opportunity for otlertuzumab in the treatment of T-cell
malignancies where there is a significant need for safe and
effective new treatments.”
“Aptevo is quickly establishing an impressive
portfolio of novel immunotherapeutics with a number of candidates
advancing, or poised to advance, into the clinic over the next 12
to18 months,” continued Dr. Stromatt. “We believe that
bispecifics represent the next frontier in antibody therapeutics
and are encouraged by Aptevo’s rapid progress in this field.
Importantly, the enhancements we have made to our next generation
ADAPTIR platform are differentiated from other bispecific
platforms, allowing us to assemble bispecific molecules that
possess desired antibody-like features, including: efficient
manufacturing properties, extended half-life, improved potency,
increased stability and the potential for reduced toxicity.
We look forward to data read-outs next year from our current
clinical candidates, APVO414 and otlertuzumab, and to further
expanding our portfolio of clinical candidates.”
About the Phase 2 Otlertuzumab
StudyThe Phase 2 study is an open-label, proof-of-concept
evaluation of the safety and efficacy of otlertuzumab in
combination with bendamustine in patients with relapsed or
refractory peripheral T-cell lymphomas (PTCL). Up to 24
patients will be enrolled in the study. The primary endpoint
is response rate, evaluable by the 2017 International Working Group
consensus response evaluation criteria in lymphoma (RECIL
2017).
About OtlertuzumabOtlertuzumab
is a monospecific antibody targeting CD37 that was built on
Aptevo’s ADAPTIR modular protein therapeutic platform. CD37
is a member of the tetraspanin superfamily of molecules and is
expressed on the surface of normal and transformed B cells, and
also recently discovered to be present on the surface of T-cell
lymphomas.
About PTCLAccording to the
Lymphoma Research Foundation, peripheral T-cell lymphoma (PTCL)
consists of a group of rare and typically aggressive Non-Hodgkin
lymphomas (NHLs) that develop from mature T-cells. Most
T-cell lymphomas (a type of blood cancer) are classified as PTCLs.
Treatment options for relapsed and refractory PTCL are
limited, with only two approved drugs on the market, FOLOTYN and
ISTODAX, with worldwide sales of approximately $50 million and $80
million, respectively.
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
peripheral T-cell lymphoma (PTCL). A previous Phase 2
clinical study evaluating otlertuzumab for the treatment of chronic
lymphocytic leukemia (CLL) have shown that 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 initiate killing of 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 5T4, a
tumor antigen widely overexpressed in a number of different types
of cancer. 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® 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 to treat cancer and 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 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 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.
Source:
Aptevo Therapeutics Stacey JurchisonSenior Director, Investor
Relations and Corporate Communications206-859-6628
JurchisonS@apvo.com
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