- All four patients
experienced significant disease reduction, with two complete
responses and two partial responses as assessed by the
investigator, with an objective response rate of 100%
- There were no
observed events of cytokine release syndrome, neurotoxicity
syndrome or graft-versus-host disease
- Study is continuing
enrollment of the second dose cohort
- Company to host
conference call/webcast on April 14 at 4:05 p.m. EDT
Heidelberg, Germany, April 9, 2021
– Affimed N.V. (Nasdaq: AFMD), a clinical-stage
immuno-oncology company committed to giving patients back their
innate ability to fight cancer, announced today positive initial
clinical data from an investigator-sponsored study at The
University of Texas MD Anderson Cancer Center evaluating cord
blood-derived natural killer (cbNK) cells pre-complexed with
Affimed’s innate cell engager (ICE®) AFM13
(CD16A/CD30).
This approach was developed in the laboratory of Katy Rezvani,
M.D., Ph.D., Professor of Stem Cell Transplantation and Cellular
Therapy at MD Anderson, who is presenting the data as part of
the Major Symposia and Advances sessions at the virtual American
Association for Cancer Research (AACR) Annual Meeting. The
presentation is available for viewing by registered participants
through June 21, 2021. Dr. Rezvani will take part in a live panel
discussion as part of the presentation on April 13, 2021 at 1:30
p.m. EDT.
“We are encouraged by the initial safety and efficacy data from
this groundbreaking first in-human study. The finding of an
objective response rate of 100% amongst our first four patients
enrolled is impressive,” said Andreas Harstrick, M.D., Chief
Medical Officer of Affimed. “These initial results indicate AFM13
may have the potential to help NK cells target and destroy cancer
cells. We plan to continue to develop and customize approaches that
leverage the unique and differentiating features of our ICE®
molecules in combination with adoptive NK cell transfer to provide
options for treating a variety of hematologic and solid
tumors.”
The open-label, non-randomized, single-center, dose-escalation
trial is evaluating the pre-complexing of AFM13 with cbNK cells
followed by three weekly infusions of AFM13 monotherapy in adult
patients with recurrent/refractory CD30-positive lymphomas. The
trial is led by Yago Nieto, M.D., Ph.D., Professor of Stem Cell
Transplantation and Cellular Therapy at MD Anderson.
“There remains a high unmet need for effective treatments in
relapsed/refractory (R/R) CD30+ lymphomas. We are encouraged by the
data generated from the first patients treated with cbNK cells
pre-complexed with AFM13,” said Dr. Rezvani. “The results suggest
this combination is facilitating clinical responses with minimal
toxicity, warranting further study as we continue to explore novel
cell therapies for our patients.”
As of March 31, 2021, three patients have been dosed with two
cycles of therapy in dose cohort 1 (1x106 AFM13-cbNK/kg) and one
patient has received a single cycle of therapy in dose cohort 2
(1x107 AFM13-cbNK/kg). The study is currently enrolling patients in
the second dose cohort of NK cells, and further updates are
expected later in 2021. Results from the first cycle of the first
dose cohort are being presented by Dr. Rezvani at AACR, and Affimed
is supplementing the data with best responses as of March 31, 2021,
as summarized below.
Patient number |
cbNK Cell Dose |
Patient |
Cancer Type |
Prior Treatment |
CRS/ Neurotoxicity/ GVHD |
Best Response |
Cohort 1 – completed |
#1 |
1x106 / kg |
43-year-old-male |
Hodgkin lymphoma |
4 lines of therapy (ABVD, ICE, brentuximab vedotin, nivolumab +
ruxolitinib) |
None |
Partial response |
#2 |
1x106 / kg |
31-year-old-male |
Hodgkin lymphoma |
14 lines of therapy (ABVD, brentuximab vedotin, HDACi/P13Ki,
pembrolizumab, nivolumab, allo-HSCT, hypercytoxan, ibrutinib,
niraparib, bendamustine, everolimus) |
None |
Partial response |
#3 |
1x106 / kg |
53-year-old-female |
Hodgkin lymphoma |
5 lines of therapy (ABVD, ICE, brentuximab vedotin, nivolumab,
GemOx) |
None |
Complete response after cycle 2 |
Cohort 2 – ongoing (1 of 3 patients enrolled) |
#4 |
1x107 / kg |
26-year-old-male |
Hodgkin lymphoma |
9 lines of therapy (ABVD, ICE + brentuximab vedotin, radiation,
nivolumab, CD30-CART, TTI-622, brentuximab vedotin + bendamustine,
allo-HSCT, brentuximab vedotin + bendamustine with brentuximab
vedotin maintenance) |
None |
Complete response |
ABVD = Adriamycin (doxorubicin), Bleomycin, Vinblastine,
Dacarbazine (DTIC)ICE = chemotherapy combination includes the
drugs: ifosfamide, carboplatin, & etoposide phosphateGemOx=
gemcitabine, oxaliplatin
There were no observed events of cytokine release syndrome,
neurotoxicity syndrome or graft-versus-host disease.
Response evaluation followed the Lymphoma Response to
Immunomodulatory Therapy Criteria (LYRIC). All four patients
had relapsed/refractory Hodgkin Lymphoma and were heavily
pretreated, with between 4 and 14 previous lines of therapy which
in all cases included brentuximab vedotin (Adcetris®) and anti-PD1
antibodies. Of note, patient #4 had also previously received a
CD30-CAR-T.
Conference Call/Webcast DetailsAffimed will
host a conference call and webcast on April 14, 2021, at 4:05 p.m.
EDT to discuss the initial study findings. The conference call will
be available via phone and webcast. To access the call, please dial
+1 (646) 741-3167 for U.S. callers, or +44 (0) 2071 928338 for
international callers, and reference passcode 1788338 approximately
15 minutes prior to the call.A live audio webcast of the conference
call will be available in the “Webcasts” section on the “Investors”
page of the Affimed website at
https://www.affimed.com/investors/webcasts_cp/. A replay of the
webcast will be accessible at the same link for 30 days following
the call.
About the Phase 1 StudyThe 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. The study is a dose-escalation
trial of pre-complexed NK cells, with patients receiving 1x106 NK
cells/kg in Cohort 1; 1x107 NK cells/kg in Cohort 2; and, 1x108 NK
cells/kg in Cohort 3. The trial is designed to explore safety and
activity and determine the recommended Phase 2 dose. In each
cohort, the dose of the pre-complexed NK cells with AFM13 is to be
followed by weekly doses of 200 mg AFM13 monotherapy for three
weeks, with each patient evaluated for dose-limiting toxicities and
responses on day 28. Additional information about the study can be
found at www.clinicaltrials.gov (NCT04074746).
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.
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 or
transformed mycosis fungoides (REDIRECT). The study is actively
recruiting, and 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, New York, 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
STATEMENTSThis 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, including with cbNK cells, 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, 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.
Investor Relations ContactAlexander
FudukidisHead of Investor Relationsa.fudukidis@affimed.comTel.: +1
(917) 436-8102
Media ContactMary Beth SandinHead of Marketing
and Communicationsm.sandin@affimed.comTel.: +1 (484) 888-8195
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