Aptevo Therapeutics Begins Patient Dosing in Phase 2 Clinical Trial of Otlertuzumab in Peripheral T-Cell Lymphoma
January 08 2018 - 9:00AM
Aptevo Therapeutics Inc. (Nasdaq:APVO), a biotechnology company
focused on developing novel oncology and hematology therapeutics,
today announced that it has commenced patient dosing in a Phase 2
clinical evaluation of otlertuzumab in a new indication –
peripheral T-cell lymphoma (PTCL). Otlertuzumab is a
monospecific antibody targeting CD37 that was built on Aptevo’s
ADAPTIR™ modular protein therapeutic platform.
“Clinical proof-of-concept data from a
randomized Phase 2 study demonstrated the efficacy and tolerability
of otlertuzumab with bendamustine in relapsed chronic lymphocytic
lymphoma (CLL). In this study there was a significant
increase in median progression free survival, from approximately 10
to 16 months in patients receiving the combination of otlertuzumab
and bendamustine,” said Scott Stromatt, M.D., Senior Vice President
and Chief Medical Officer for Aptevo. “We were intrigued by
recent reports in the literature showing that CD37 appears to be
overexpressed in various T-cell lymphomas, suggesting a potential
role for otlertuzumab in the treatment of T-cell
malignancies. If the proof-of-concept clinical data in CLL
translate to PTCL, this 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.”
The 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). Otlertuzumab has been
studied in over 250 patients with CLL or indolent NHL. A
previous Phase 2 clinical study evaluating otlertuzumab for the
treatment of relapsed 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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