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 provided a data
update from the ongoing phase 1/2 study of the Company’s lead
innate cell engager (ICE®) AFM13 precomplexed with cord
blood-derived natural killer (cbNK) cells in patients with
CD30-positive relapsed or refractory Hodgkin and Non-Hodgkin
lymphomas. The results are being presented today at the 64th
American Society of Hematology (ASH) Annual Meeting by principal
investigator Yago Nieto, M.D., Ph.D., Professor of Stem Cell
Transplantation and Cellular Therapy at The University of Texas MD
Anderson Cancer Center. Results from the study continue to
demonstrate high objective and complete response rates with a
well-tolerated safety profile.
In 31 patients with Hodgkin lymphoma treated at
the RP2D, an ORR of 97% and a CR rate of 77% were observed. In four
non-Hodgkin lymphoma patients treated at the RP2D, three objective
responses, including one CR in a patient with peripheral T-cell
lymphoma, were observed. Across all 35 patients treated at the
RP2D, a 94% ORR and a CR rate of 71% were observed.
“It’s impressive that we continue to see these
response rates in a patient population that has exhausted all other
treatment options. As a physician, when I consider that all
patients in this study did not respond to their previous line of
treatment, these results are especially meaningful,” said Dr.
Andreas Harstrick, Chief Medical Officer at Affimed.
Duration of response (DOR) continues to be
monitored, and key observations as of the cutoff date include:
- 63% of patients with at least 6 months follow-up after initial
infusion (n=24) remain in CR for at least 6 months
- 18 of 33 responders at the RP2D remain in response as of the
cutoff date, including 17 of 25 patients with a CR
- Five patients treated at the RP2D had their response
consolidated with a stem cell transplant
The treatment continues to be well tolerated in
the larger patient population, with minimal side effects beyond the
expected myelosuppression from the preceding lymphodepleting
chemotherapy. No instances of cytokine release syndrome, immune
effector cell-associated neurotoxicity syndrome, or graft versus
host disease were observed. There were 20 infusion-related
reactions in 294 infusions (6.8%) of AFM13 alone and one
infusion-related reaction in 99 infusions (1%) of the cord
blood-derived NK cells precomplexed with AFM13. No dose-limiting
toxicities were encountered.
“These data further confirm that combining our
AFM13 innate cell engager with cord blood-derived natural killer
cells has the potential to provide a truly transformative treatment
for patients with limited therapeutic options,” commented Dr. Adi
Hoess, Chief Executive Officer at Affimed. “Our focus and
commitment together with our new partner Artiva is expected to
bring AFM13 in combination with NK cells to the market as quickly
as possible for the benefit of patients with CD30-positive
lymphomas.”
AFM13, a bispecific tetravalent ICE® molecule,
is designed for high affinity binding, both to CD16A on NK cells
and macrophages, and to CD30 on lymphoma cells.
Oral Presentation Details
Title: Innate Cell Engager
AFM13 Combined with Preactivated and Expanded Cord Blood-Derived NK
Cells for Patients with Double Refractory CD30+ Lymphoma
Session: Cellular Immunotherapies: Early Phase and
Investigational Therapies: Lymphoma Presentation Date &
Time: Saturday, December 10, 2022, 1:15 p.m. CST
Location: Ernest N. Morial Convention Center, La
Nouvelle Orleans Ballroom AB
Investor Event, Conference Call and
Webcast Information
Affimed will host an investor event to review
AFM13 clinical data and development plans in CD30-expressing
malignancies. The investor event will take place in-person and
virtually and a webcast of the event will be available in the
“Webcasts” section on the “Investors” page of Affimed’s website
at https://www.affimed.com/investors/webcasts-and-corporate-presentation/.
To access the event via phone, please dial +1 (929) 205-6099 for
U.S. callers, or +44 (203) 481-5240 for international callers, and
reference meeting ID 847 4106 6227 approximately 15 minutes prior
to the call. To reserve your place in the live event, please
contact Alex Fudukidis via e-mail at a.fudukidis@affimed.com.
A replay of the webcast/call will be archived on Affimed’s website
for 30 days after the call.
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 at the RP2D of 1×108 NK cells/kg. 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
AFM13. Three weekly infusions of AFM13 (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). As of
the cut-off date, 41 patients with relapsed or refractory
CD30-positive Hodgkin and Non-Hodgkin lymphoma were treated in the
study, all of whom were evaluable for response. The patients
treated in the study have received a median of seven prior lines of
therapy. After the first 13 patients treated at the RP2D, the
protocol was amended to allow patients to receive up to 4 cycles,
whereas previously patients were only eligible for 2 cycles.
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
a 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 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 trends that may affect the industry or
the Company, 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 Fudukidis Director, Investor Relations E-Mail:
a.fudukidis@affimed.com Tel.: +1 (917) 436-8102
Media Contact Mary Beth Sandin
Vice President, Marketing and Communications E-Mail:
m.sandin@affimed.com Tel: +1 (484) 888-8195
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