Affimed Enters into Collaboration with Merck to Evaluate AFM13 in Combination with KEYTRUDA(R) (pembrolizumab) for Patients w...
25 January 2016 - 9:00PM
Affimed N.V. (Nasdaq:AFMD), a clinical stage biopharmaceutical
company focused on discovering and developing highly targeted
cancer immunotherapies, announced today that it has entered into a
clinical research collaboration in immuno-oncology with Merck
(NYSE:MRK), known as MSD outside the United States and Canada.
Under the terms of the agreement, Affimed will fund and conduct a
Phase 1b clinical trial to investigate the combination of Merck's
anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), with Affimed's
proprietary drug candidate AFM13 for the treatment of patients with
Hodgkin lymphoma whose disease has relapsed or is refractory to
chemotherapy, including treatment with the marketed
antibody-drug-conjugate AdcetrisTM (brentuximab vedotin). Merck
will supply Affimed with KEYTRUDA for the clinical trial. The
purpose of the study is to establish a dosing regimen for this
combination therapy and assess its safety and efficacy. Affimed is
on track to initiate the study in the first half of 2016.
AFM13 is a bispecific antibody targeting CD30, an antigen
specifically expressed in a variety of T- and B-cell lymphomas and
targeting CD16A, an antigen expressed on natural killer (NK-)
cells, which are important for the activation of the innate immune
system and the subsequent killing of tumor cells. KEYTRUDA is a
humanized monoclonal antibody that works by increasing the ability
of the body's immune system to help detect and fight tumor cells.
KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1
and PD-L2, thereby activating T lymphocytes, which may affect both
tumor cells and healthy cells.
In patient-derived xenograft models, AFM13, in combination with
an anti-PD-1 antibody, demonstrated impressive synergy, with up to
90 percent of the tumor eradicated. In this preclinical work,
conducted at Stanford University, it was also shown that both NK-
and T-cells infiltrated the tumors and that cytokine levels,
including notably interferon-gamma, were elevated.
"Our development strategy is to combine our NK-cell engagers
with other immunotherapies that could enhance their efficacy
through the uptake of both NK-cells and T-cells, and the
collaboration with Merck is an important step in executing this
strategy," said Dr. Adi Hoess, CEO of Affimed. "AFM13, a
first-in-class NK-cell engager, has shown an acceptable safety
profile and preliminary antitumor activity in the first-in-human
Phase 1 study. Additionally, preclinical studies indicate that a
combination with an anti PD-1 therapy could act synergistically and
represent an additional future treatment option for patients."
"Evaluating the potential for innovative combination therapies
through strategic collaborations in difficult-to-treat tumor types
continues to be an important part of our clinical development
program for KEYTRUDA," said Dr. Eric Rubin, vice president and
therapeutic area head, oncology early-stage development, Merck
Research Laboratories. "In partnering with companies such as
Affimed, we continue our efforts to bring forward new scientific
breakthroughs for patients with Hodgkin lymphoma and the field of
immuno-oncology overall."
The agreement is between Affimed and Merck, through a
subsidiary. The collaboration agreement includes a provision for
the potential expansion of the collaboration to include a
subsequent Phase 3 clinical trial. Additional details were not
disclosed.
About AFM13
AFM13 is a first-in-class bispecific NK-cell TandAb®, which
binds NK-cells (natural killer cells) specifically via CD16A and
has a second binding domain for CD30, a cancer-specific target.
CD16A is expressed on NK-cells, highly potent cytotoxic effector
cells of the innate immune system, enabling AFM13 to selectively
bind these effector cells. AFM13 redirects the NK-cells to CD30
expressing cancer cells and binds both targets with high affinity,
establishing a bridge, whereby the NK-cells are activated and
redirected to kill the cancer cells. AFM13 is designed to treat
CD30-positive malignancies including Hodgkin lymphoma (HL) and
T-cell lymphoma (TCL) and it is currently in Phase 2 studies in HL
patients. Like all TandAbs®, AFM13 is a stable, off-the-shelf,
targeted immunotherapeutic which does not require continuous
infusion due to a favorable half-life in a patient's bloodstream,
yet is tunable by dosing adjustment when required. This highly
specific NK-cell antibody and the related bispecific platform are
unique to Affimed.
About Affimed N.V.
Affimed (Nasdaq:AFMD) is a clinical-stage biopharmaceutical
company focused on discovering and developing highly targeted
cancer immunotherapies. Affimed's product candidates are being
developed in the field of immuno-oncology, which represents an
innovative approach to cancer treatment that seeks to harness the
body's own immune defenses to fight tumor cells. The most potent
cells of the human defense arsenal are types of white blood cells
called natural killer cells, or NK-cells, and T-cells. Affimed's
proprietary, next-generation bispecific antibodies, called TandAbs
for their tandem antibody structure, are designed to direct and
establish a bridge between either NK-cells or T-cells and cancer
cells, triggering a signal cascade that leads to the destruction of
cancer cells. Affimed has focused its research and development
efforts on three proprietary TandAb programs for which it retains
global commercial rights. For more information, please visit
www.affimed.com.
Forward-Looking Statements of Affimed N.V.
This press release contains forward-looking statements within
the meaning of the safe harbor provisions of the United States
Private Securities Litigation Reform Act of 1995. All statements
other than statements of historical fact are forward-looking
statements, which are often indicated by terms such as
"anticipate," "believe," "could," "estimate," "expect," "goal,"
"intend," "look forward to", "may," "plan," "potential," "predict,"
"project," "should," "will," "would" and similar expressions.
Forward-looking statements are based on management's beliefs and
assumptions and on information available to management only as of
the date of this press release. These forward-looking statements
include, but are not limited to, statements regarding the risk of
cessation or delay of any of our ongoing or planned clinical
studies and/or development of our product candidates, as well as
statements regarding our collaborations and development of our
products in combination with other therapies. Our actual results
could differ materially from those anticipated in these
forward-looking statements for many reasons, including, without
limitation, risks associated with our clinical development
activities, regulatory oversight, product commercialization,
collaborations, intellectual property claims, and the risks,
uncertainties and other factors described under the heading "Risk
Factors" in Affimed's filings with the Securities and Exchange
Commission. Given these risks, uncertainties and other factors, you
should not place undue reliance on these forward-looking
statements, and we assume no obligation to update these
forward-looking statements, even if new information becomes
available in the future.
CONTACT: Affimed N.V.
Caroline Stewart, Head IR & Communication
Phone: +1 347394 6793
E-Mail: IR@affimed.com or c.stewart@affimed.com
Media requests:
Stephanie May or Gretchen Schweitzer
MacDougall Biomedical Communications
Phone: +49 89 2424 3494 or
+49 172 861 8540
E-Mail: smay@macbiocom.com
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