Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a
clinical-stage immuno-oncology company committed to giving patients
back their innate ability to fight cancer, today announced two
upcoming data presentations at the American Society of Hematology
(ASH) 2022 Annual Meeting.
Dr. Yago Nieto, M.D., Ph.D., Professor of Stem
Cell Transplantation and Cellular Therapy at The University of
Texas MD Anderson Cancer Center and principal investigator of the
study, will provide a clinical update from the ongoing phase 1/2
trial with Affimed’s lead innate cell engager (ICE®) AFM13
precomplexed with cord blood-derived natural killer (cbNK) cells
followed by three weekly infusions of AFM13 in patients with
CD30-positive relapsed or refractory Hodgkin and non-Hodgkin
lymphomas in an oral presentation, on Saturday, December 10 at 1:15
p.m. CST.
Since the last study update in April 2022 until
the end of July, an additional 11 patients were enrolled, resulting
in 24 patients treated at the recommended phase 2 dose (RP2D) with
up to 4 cycles; a total of 30 patients have now been enrolled in
the study. The combination treatment continues to show a 100%
overall response rate (ORR) at the highest dose level and a further
improvement in the complete response (CR) rate, from the previously
reported 62% to 70.8%.
Affimed will also present updated preclinical
data from its AFM28 program in a poster on December 12 from 6:00 -
8:00 p.m. CST, demonstrating the highly potent and selective
killing of CD123-positive leukemic cells as well as leukemic stem
cells and progenitor cells, supporting AFM28’s potential to achieve
durable responses in relapsed or refractory Acute Myeloid Leukemia
patients.
“Our ICE® possess very high affinity to CD16A on
NK cells and are considered highly efficient in redirecting such
cells, both allogeneic and autologous, to attack tumor cells,” said
Dr. Andreas Harstrick, Chief Medical Officer at Affimed. “The
extremely high efficacy seen with AFM13 in combination with NK
cells is the basis of taking forward our other ICE®, such as AFM24
and AFM28, to develop therapies that can serve the high unmet needs
of cancer patients.”
Details of AFM13 Oral Presentation and
Abstract
Title: Innate Cell Engager AFM13 Combined with
Preactivated and Expanded Cord Blood-Derived NK Cells for Patients
with Double Refractory CD30+ LymphomaSession:
Cellular Immunotherapies: Early Phase and Investigational
Therapies: LymphomaPresentation Date & Time:
Saturday, December 10, 2022, 1:15 p.m. CST
Location: Ernest N. Morial Convention Center, La
Nouvelle Orleans Ballroom AB
The AFM13-104 study is evaluating a combination of the ICE®
AFM13 with cbNK in late-stage patients with relapsed or refractory
CD30+ Hodgkin and non-Hodgkin lymphoma. As of the abstract data
cut-off on July 31, the study had enrolled 30 patients across three
different dose levels DL1 (106 NK/kg), DL2 (107NK/kg) and DL3 (108
NK/kg); a total of 24 patients had been treated at DL3 (108 NK/kg)
which was established as the RP2D. Each cycle of treatment consists
of a lymphodepletion, followed by single dose of AFM13 precomplexed
with cbNK cells and three subsequent infusions of AFM13
monotherapy. Two cycles of therapy were administered to patients 1
– 19 and up to four cycles were administered starting with patient
20.
At the data-cut-off, across all dose cohorts, the ORR was 97%
with a CR rate of 63%. At the RP2D, the study continued to
demonstrate a 100% ORR in all 24 patients treated, with 17 patients
achieving a CR (70.8%).
Across all dose levels at median follow-up of 8 months (range
1-23 months), an event-free survival (EFS) rate of 57% and an
overall survival (OS) rate of 83% was observed. Five patients had a
response consolidated with a stem cell transplant. Analyses of
patient serum from day one after infusion with AFM13 precomplexed
with cbNK cells suggest that no sensitization effects in patients
occur.
Overall, the treatment continues to show a manageable safety
profile. There were no infusion-related reactions (IRR) after
infusing AFM13-NK and 11 IRR in 182 infusions of AFM13 alone (6%)
(1 grade 3, 10 grade 2). In addition, no cases of cytokine release
syndrome (CRS), immune effector cell-associated neurotoxicity
syndrome (ICANS) or graft versus host disease (GVHD) of any
grade.
A more in-depth analysis of the data will be presented in Dr.
Nieto’s oral presentation at ASH and through a company press
release.
Details of AFM28 Poster Presentation and
Abstract
Title: The Novel Bispecific Innate Cell Engager
(ICE®) AFM28 Efficiently Directs Allogeneic NK Cells to
CD123-positive leukemic cells Session: Molecular
Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster
IIIPresentation Date & Time: Monday, December
12, 2022, 6:00 p.m. - 8:00 p.m. CSTLocation:
Ernest N. Morial Convention Center, Hall D
Innate Cell Engager (ICE®) AFM28 aims to direct a patient’s own
or allogeneic NK cells towards CD123-positive AML blasts and
leukemic stem cells (LSC) providing a promising approach to
achieving long-term remissions. Data from a collaboration between
Affimed and the Department of Hematology and Oncology, Medical
Faculty Mannheim, Heidelberg University will be presented at the
ASH conference. The study evaluated the efficacy of AFM28 in
preclinical AML models. In a panel of AML cell lines, AFM28
successfully engaged allogeneic NK cells to destroy CD123-positive
tumor cells through antibody-dependent cytotoxicity (ADCC). ADCC
induced by AFM28 was independent of leukemic cell mutational
profiles and was also effective in targeting cells with low levels
of CD123 surface expression.
Residual leukemic stem cells are a frequent cause for relapse
and associated with poor prognosis. Patient-derived AML cell
cultures incubated with AFM28 and allogeneic NK cells showed
significantly reduced numbers of outgrowing colonies compared to
controls. That indicates that LSCs and progenitor cells were
eliminated. These results were confirmed in an AML mouse model
demonstrating complete inhibition of tumor growth throughout a
42-day treatment period in comparison to untreated control mice who
all developed systemic disease.
AFM28 is currently being prepared for a first-in-human clinical
investigation as monotherapy and in combination with allogeneic NK
cells.
The full abstracts for both presentations are available on the
ASH conference website via the following link: 64th ASH Annual
Meeting & Exposition - Hematology.org
About the AFM13-104 Phase 1/2 Study
The University of Texas MD Anderson Cancer Center is studying
AFM13 in an investigator-sponsored phase 1/2 trial in combination
with cord blood-derived allogeneic NK cells in patients with
recurrent or refractory CD30-positive lymphomas. The study is a
dose-escalation trial of precomplexed NK cells, followed by an
expansion phase, recruiting up to 40 patients with r/r CD30
positive lymphomas, treated with the RP2D (1×108 NK cells/kg
followed by three weekly doses of 200 mg AFM13 monotherapy).
MD Anderson has an institutional financial conflict of interest
with Affimed related to this research and has therefore implemented
an Institutional Conflict of Interest Management and Monitoring
Plan. Additional information about the study can be found at
www.clinicaltrials.gov (NCT04074746).
About AFM13
AFM13 is a first-in-class innate cell engager
(ICE®) that uniquely activates the innate immune system to destroy
CD30-positive hematologic tumors. AFM13 induces specific and
selective killing of CD30-positive tumor cells, leveraging the
power of the innate immune system by engaging and activating
natural killer (NK) cells and macrophages. AFM13 is Affimed’s most
advanced ICE® clinical program and is currently being evaluated as
monotherapy in a registration-directed trial in patients with
relapsed/refractory peripheral T-cell lymphoma (REDIRECT).
Additional details can be found at www.clinicaltrials.gov
(NCT04101331).
About AFM28
AFM28, a tetravalent, bispecific CD123- and
CD16A-binding ICE® developed on Affimed’s ROCK® platform, is
designed to bring a new immunotherapeutic treatment to patients
with CD123-positive myeloid malignancies, including acute myeloid
leukemia (AML) and myelodysplastic syndrome (MDS). It engages NK
cells to initiate tumor cell killing via antibody-dependent
cellular cytotoxicity (ADCC), even at low CD123 expression levels.
Clinical development is planned as both monotherapy and in
combination with allogeneic NK cells in patients with
relapsed/refractory CD123-positive leukemias.
About Affimed N.V.
Affimed N.V. (Nasdaq: AFMD) is a clinical-stage
immuno-oncology company committed to giving patients back their
innate ability to fight cancer by actualizing the untapped
potential of the innate immune system. The company’s proprietary
ROCK® platform enables a tumor-targeted approach to recognize and
kill a range of hematologic and solid tumors, enabling a broad
pipeline of wholly-owned and partnered single agent and combination
therapy programs. The ROCK® platform predictably generates
customized innate cell engager (ICE®) molecules, which use
patients’ immune cells to destroy tumor cells. This innovative
approach enabled Affimed to become the first company with a
clinical-stage ICE®. Headquartered in Heidelberg, Germany, with
offices in New York, NY, Affimed is led by an experienced team of
biotechnology and pharmaceutical leaders united by a bold vision to
stop cancer from ever derailing patients’ lives. For more about the
company’s people, pipeline and partners, please visit:
www.affimed.com.
Forward-Looking Statements
This press release contains forward-looking statements. 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 appear in a number of places throughout
this release and include statements regarding our intentions,
beliefs, projections, outlook, analyses and current expectations
concerning, among other things, the potential of AFM13, AFM24,
AFM28 and our other product candidates, the value of our ROCK®
platform, our ongoing and planned preclinical development and
clinical trials, our collaborations and development of our products
in combination with other therapies, the timing of and our ability
to make regulatory filings and obtain and maintain regulatory
approvals for our product candidates, our intellectual property
position, our collaboration activities, our ability to develop
commercial functions, clinical trial data, our results of
operations, cash needs, financial condition, liquidity, prospects,
future transactions, growth and strategies, the industry in which
we operate, the trends that may affect the industry or us, impacts
of the COVID-19 pandemic, the benefits to Affimed of orphan drug
designation, the impact on our business by political events, war,
terrorism, business interruptions and other geopolitical events and
uncertainties, such as the Russia-Ukraine conflict and the risks,
uncertainties and other factors described under the heading “Risk
Factors” in Affimed’s filings with the SEC. 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.
Investor Relations ContactAlexander
FudukidisDirector, Investor RelationsE-Mail:
a.fudukidis@affimed.com Tel.: +1 (917) 436-8102
Media ContactMary Beth Sandin Vice President,
Marketing and CommunicationsE-Mail: m.sandin@affimed.com Tel: +1
(484) 888-8195
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