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 that two
abstracts have been accepted for presentation at the 17th
International Conference on Malignant Lymphoma (17-ICML) taking
place in Lugano, Switzerland on June 13-17, 2023. A poster
presentation will share a preclinical data set of Affimed’s innate
cell engager (ICE®) AFM13 in combination with Artiva
Biotherapeutics Inc.’s (“Artiva”) off-the-shelf NK cell AB-101. An
additional encore oral presentation will show the final results of
the phase 2 REDIRECT study with AFM13 monotherapy in a r/r PTCL
patient population.
The preclinical data set shows that AFM13 binds homogenously to
thawed AB-101, directs the NK cells to CD30-positive tumor cells
and enhances the cytotoxic activity of AB-101 against the tumor
cells. Associated with the AFM13-induced cytotoxic activity was an
increased functional activation status of AB-101 demonstrated
through degranulation and IFN-γ production. Importantly, in a mouse
xenograft model, adoptive transfer of AB-101 in combination with
AFM13 conferred tumor growth control.
The data of AFM13 in combination with the allogeneic,
cryopreserved, off-the-shelf, cord blood-derived AB-101 NK cells
demonstrate synergistic anti-tumor activity in vivo. Building on
the unprecedented efficacy results of the phase 1 study with AFM13
in combination with fresh cord blood-derived NK cells
(NCT04074746), as reported at ASH 2022, the Company recently
received Food and Drug Administration (FDA) IND clearance and is
expecting to initiate a phase 2 study, LuminICE-203, with AFM13 and
AB-101 in patients with r/r classical Hodgkin lymphoma in Q3 2023.
The study will also include a cohort of 20 PTCL patients.
“These preclinical data of AFM13 + AB-101 as well as the
clinical data from the phase 1 combination study demonstrate that
AFM13 plus NK cells can achieve remarkable cytotoxicity against
CD30-positive cancers,” said Dr. Arndt Schottelius, Chief
Scientific Officer at Affimed. “As a next step we want to bring
this therapeutic approach to more patients in need and we look
forward to initiate the LuminICE-203 study.”
Details of the AFM13 + AB-101 poster presentation are as
follows:
Title: AFM13 enhances the anti-tumor activity
of AB-101 towards CD30+ tumors, conferring tumor growth control in
vivo
Presenting Author: Jens Pahl
Poster Presentation Time: Thursday, 15 June
2023, 12:30 - 13:00 CET
Poster and Abstract Book Code: 419
In addition, an encore presentation of the final results of the
phase 2 REDIRECT study will be given by Dr. Won Seog Kim, Professor
of Hematology-Oncology at Samsung Medical Center in Seoul and a
principal investigator of the study. AFM13 monotherapy exhibited
clinical efficacy in a heavily pre-treated CD30-positive r/r PTCL
population and a well-managed safety profile.
Details of the REDIRECT oral presentation are as follows:
Title: AFM13 in patients with CD30-positive
relapsed or refractory (R/R) peripheral T cell lymphoma (PTCL):
Results from the Phase 2 REDIRECT study
Presenting Author: Won Seog Kim
Session: Focus on… Session: T-Cell
Lymphomas
Presentation Time: Thursday, 15 June 2023,
17:00 - 18:00 CET
Poster and Abstract Book Code: 126
More details about the 17-ICML conference are available online
at Home - ICML
About AFM13
AFM13 is a first-in-class tetravalent bispecific 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 was evaluated as monotherapy in
a phase 2 trial in patients with relapsed/refractory peripheral
T-cell lymphoma (REDIRECT, NCT04101331). In addition, The
University of Texas MD Anderson Cancer Center is studying AFM13 in
an investigator-sponsored Phase 1 trial in combination with cord
blood-derived allogeneic NK cells in patients with recurrent or
refractory CD30-positive lymphomas (NCT04074746). The company
reported data from this study at ASH 2022 annual meeting. To find
out more about AFM13 and the studies, please visit:
www.affimed.com.
About AB-101
AB-101 is Artiva’s non-genetically modified, cord blood-derived,
allogeneic, cryopreserved, ADCC-enhancing NK cell therapy candidate
for use in combination with monoclonal antibodies or innate-cell
engagers in the out-patient setting. Artiva selects cord blood
units with the high affinity variant of the receptor CD16 and a
KIR-B haplotype for enhanced product activity. Using Artiva’s
AlloNK® platform, Artiva can generate thousands of doses of pure,
cryopreserved, infusion-ready NK cells from a single umbilical cord
blood unit while retaining high and consistent expression of CD16
and other tumor-engaging receptors, without the need for
engineering.
Artiva is conducting a Phase 1/2 multicenter clinical trial
(ClinicalTrials.gov Identifier: NCT04673617) to assess the safety
and clinical activity of AB-101 alone and in combination with the
anti-CD20 monoclonal antibody, rituximab, in patients with relapsed
or refractory B-cell-non-Hodgkin lymphoma (B-NHL) who have
progressed beyond two or more prior lines of therapy. This study is
progressing at multiple clinical sites across the U.S., and AB-101
is administered weekly in the out-patient setting over one-month
cycles and with up to four cycles to assess therapeutic efficacy
and durability. Artiva presented data from the first-in-human phase
1/2 clinical trial of AB-101 in combination with rituximab in R/R
non-Hodgkin lymphoma at the 2023 ASCO Annual Meeting.
About Affimed N.V.
Affimed (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 the Company’s
intentions, beliefs, projections, outlook, analyses and current
expectations concerning, among other things, the potential of
AFM13, AFM24, AFM28 and the Company’s other product candidates, the
value of its ROCK® platform, its ongoing and planned preclinical
development and clinical trials, its collaborations and development
of its products in combination with other therapies, the timing of
and its ability to make regulatory filings and obtain and maintain
regulatory approvals for its product candidates, its intellectual
property position, its collaboration activities, its ability to
develop commercial functions, clinical trial data, its results of
operations, cash needs, financial condition, liquidity, prospects,
future transactions, growth and strategies, the industry in which
it operates, the macroeconomic trends that may affect the industry
or the Company, such as the instability in the banking sector
experienced in the first quarter of 2023, impacts of the COVID-19
pandemic, the benefits to Affimed of orphan drug designation, the
impact on its business by political events, war, terrorism,
business interruptions and other geopolitical events and
uncertainties, such as the Russia-Ukraine conflict, the fact that
the current clinical data of AFM13 in combination with NK cell
therapy is based on AFM13 precomplexed with fresh allogeneic cord
blood-derived NK cells from The University of Texas MD Anderson
Cancer Center, as opposed to Artiva’s AB-101 and other
uncertainties and 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 the Company
assumes no obligation to update these forward-looking statements,
even if new information becomes available in the future.
Investor Relations Contact
Alexander FudukidisDirector, Investor
RelationsE-Mail: a.fudukidis@affimed.comTel.: +1 (917) 436-8102
Media Contact
Mary Beth Sandin Vice President, Marketing and
CommunicationsE-Mail: m.sandin@affimed.com
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