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, announced updated data
on its lead innate cell engager (ICE®) acimtamig. Data from the
investigator-initiated trial is being presented today at the
American Society of Hematology (ASH) 2023 Annual Meeting by 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. Affimed will host a
webcast following the presentation to review the data and provide a
strategic update on acimtamig’s future development.
A total of 42 patients were enrolled in the study with 36
patients treated at the RP2D. 32 of the 36 patients treated at the
RP2D were HL patients. All 32 HL patients were heavily pretreated
with multiple lines of chemotherapy, all had previously received
CPIs and BV, and were refractory to their most recent line of
therapy with active progressive disease at the time of enrollment.
Across all dose levels, the treatment regimen achieved an ORR of
93% with a CR rate of 67%; among the 32 HL patients treated at the
RP2D the treatment regimen achieved an ORR of 97% and a CR rate of
78%. In addition, the treatment regimen demonstrated a good safety
and tolerability profile with no cases of CRS, ICANS or GvHD of any
grade. Mild to moderate infusion related reactions (IRRs) were seen
in 7.7% of the acimtamig infusions.
Across all dose levels, median event free survival (EFS) was 8.8
months and median overall survival (OS) was not reached. For the HL
patients treated at the RP2D, median EFS was 9.8 months - with 84%
patients alive at 12 months. The median DoR was 8.8 months and 72%
CR assessed at 6 months for HL patients treated at the RP2D; 30% of
patients with complete response remained in CR beyond 12
months.
“When we conduct studies in a patient population that has failed
their previous line of therapy, demonstrating even a modest
response is encouraging. To see this magnitude of responses in
terms of ORR (97%) and CR (78%) is remarkable and fuels our
commitment to bring this therapy to more patients,” said Dr.
Andreas Harstrick, Chief Medical Officer at Affimed. “Building on
these results, we are well underway with our Phase 2 LuminICE-203
study. We have enrolled and dosed patients in the first two cohorts
and we look forward to sharing data in the first half of 2024.”
The Company will host a call today at 1:30 p.m. PST / 4:30 p.m.
EST / 22:30 CET to discuss the data presented at ASH and provide a
strategic update. The conference call will be available via phone
and webcast. The live audio webcast of the call will be available
in the “Webcasts” section on the “Investors” page of the Affimed
website
at https://www.affimed.com/investors/webcasts-and-corporate-presentation/.
To access the call by phone, please use the link:
https://register.vevent.com/register/BIb2258d6c5f5a474cad74869a7b7b1bb5,
and you will be provided with dial-in details and a pin number.
Note: To avoid delays, we
encourage participants to dial into the conference call 15 minutes
ahead of the scheduled start time. A replay of the webcast will be
accessible at the same link for 30 days following the call.
About the AFM13-104 Phase 1/2 Study
The University of Texas MD Anderson Cancer Center is studying
acimtamig (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 that recruited 36 patients with r/r CD30 positive
lymphomas, treated with the RP2D of 1×108 NK cells/kg followed
by three weekly doses of 200 mg acimtamig monotherapy. Each
treatment cycle consists of lymphodepleting chemotherapy with
fludarabine (30 mg/m² per day) and cyclophosphamide (300 mg/m² per
day) followed two days later by a single infusion of
cytokine-preactivated and expanded cord blood-derived NK cells that
are pre-complexed with acimtamig. Three weekly infusions of
acimtamig (200 mg) monotherapy are subsequently administered and
responses are assessed by the investigator on day 28 by
FDG-PET.
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 Acimtamig
Acimtamig (AFM13) is a first-in-class innate
cell engager (ICE®) that uniquely activates the innate immune
system to destroy CD30-positive hematologic tumors. Acimtamig
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. Acimtamig
is a tetravalent bispecific innate cell engager designed to act as
a bridge between the innate immune cells and the tumor creating the
necessary proximity for the innate immune cells to specifically
destroy the tumor cells.
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 Mannheim, 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.
About AlloNK® and Artiva
Artiva is an immunotherapy company with the ability to produce
off-the-shelf, allogeneic NK cell therapies at a massive scale.
Artiva’s mission is to develop effective, safe and accessible cell
therapies for patients with devastating autoimmune diseases and
cancers. Artiva’s lead program, AlloNK® (also known as AB-101), is
an allogenic, non-genetically modified NK cell therapy candidate
designed to enhance the antibody-dependent cellular cytotoxicity
(ADCC) effect of monoclonal antibodies or NK cell engagers. AlloNK
is a cryopreserved, off-the-shelf therapy with the potential to be
administered in the community setting. Using the company’s cell
therapy manufacturing platform, Artiva can generate thousands of
doses of cryopreserved, infusion-ready AlloNK cells from a single
umbilical cord blood unit while retaining high and consistent
expression of CD16 and other activating NK receptors. Artiva is
headquartered in San Diego. For more information,
visit www.artivabio.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
acimtamig, 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 acimtamig in combination with NK cell
therapy is based on acimtamig precomplexed with fresh allogeneic
cord blood-derived NK cells from The University of Texas MD
Anderson Cancer Center, as opposed to Artiva’s AlloNK® 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.
Affimed Investor Relations
Contact
Alexander FudukidisDirector, Investor
RelationsE-Mail: a.fudukidis@affimed.comTel.: +1 (917) 436-8102
Affimed Media Contact
Mary Beth Sandin Vice President, Marketing and
CommunicationsE-Mail: m.sandin@affimed.com
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