Affimed N.V. (Nasdaq: AFMD) (“Affimed”), and Artiva Biotherapeutics
Inc. (“Artiva”), both immuno-oncology companies focused on
developing and commercializing therapies utilizing the innate
immune system, today announced a new strategic partnership to
jointly develop, manufacture, and commercialize a combination
therapy comprised of Affimed’s Innate Cell Engager (ICE®) AFM13 and
Artiva’s cord blood-derived, cryopreserved off-the-shelf allogeneic
NK cell product candidate, AB-101.
Affimed submitted a pre-IND meeting request for the AFM13 and
AB-101 co-administered combination therapy to the FDA requesting
feedback on the clinical trial design in relapsed/refractory (r/r)
Hodgkin lymphoma (HL) with an exploratory arm evaluating the
combination in r/r CD30-positive peripheral T-cell lymphoma (PTCL)
and potential path to registration. FDA responded to this request
and guided to providing feedback by Q1 2023.
This clinical agreement follows the parties’ existing two-year
preclinical collaboration to assess combining elements of the
companies’ respective platforms in the generation of targeted,
off-the-shelf allogeneic NK cell therapies. As part of the
collaboration, the companies evaluated the combination of AFM13 and
AB-101 in various preclinical models and generated data that
supports development of a co-administered combination therapy.
“Based on the compelling clinical data we have generated for
AFM13 in combination with NK cells, we are committed to finding the
fastest path to bringing this potentially life-changing treatment
to lymphoma patients,” said Dr. Adi Hoess, CEO of Affimed. “The
allogeneic NK field is still at a nascent stage, and we selected
Artiva because of their commercially-viable production process that
can support a multicenter clinical trial and potentially enable a
path to registration.”
"We are developing AB-101 as a universal ADCC enhancer when
combined with monoclonal antibodies and NK cell engagers,” said Dr.
Fred Aslan, CEO of Artiva. “The data Affimed has generated to date
with AFM13 in combination with cord blood-derived NK cells in a
patient population with great unmet need is very compelling, and we
are excited to partner with Affimed on what could become one of the
first approvals for an allogeneic NK cell therapy-based
regimen.”
AFM13 is currently being investigated in combination with
allogeneic cord blood-derived NK cells (cbNK) from The University
of Texas MD Anderson Cancer Center. In this investigator sponsored
study, data published earlier today for presentation at the 64th
ASH Annual Meeting and Exposition demonstrated that all 24 patients
in the recommended Phase 2 dose cohort responded (overall response
rate of 100%) and showed a complete response rate of 70.8%. The
combination was well tolerated with few infusion-related reactions
and without cytokine release syndrome, immune effector
cell-associated neurotoxicity syndrome, or graft versus host
disease.
The Affimed-Artiva partnership aims to expedite further
development of the combination therapy in CD30-positive lymphoma
patients who have exhausted other treatment options. AB-101 has
already completed a monotherapy safety cohort in an initial Phase 1
trial and is currently being assessed in combination with the
anti-CD20 monoclonal antibody, rituximab, in patients with relapsed
or refractory non-Hodgkin lymphoma (NHL). Preclinical results
investigating the combination of AFM13 and AB-101 have further
demonstrated enhanced anti-tumor activity. The companies plan to
file an IND for the program in relapsed/refractory CD30-positive
lymphoma patients during the first half of 2023.
Under the terms of the agreement, Affimed and Artiva will pursue
the development of the AFM13/AB-101 combination treatment in the
United States on a co-exclusive basis. Affimed will lead regulatory
activities through Phase 2 and any confirmatory studies. Affimed
will be responsible for funding clinical study costs through Phase
2, while Artiva will be responsible for the costs of supplying
AB-101 and IL-2 for such studies. If accelerated approval is
obtained, the companies will share confirmatory study costs on a
50/50 basis.
Both companies will retain commercialization and distribution
rights and book sales for their respective products. Affimed will
be responsible for promotional activities and expenses of the
combination therapy. Pursuant to the agreement, revenues from the
combination will be shared, with Affimed receiving 67% of the
combination therapy revenue and Artiva receiving 33%.
Conference call and webcast informationAffimed and
Artiva will host a conference call and webcast on November 3, 2022,
at 10:30 a.m. EDT / 15:30 CET to discuss this partnership and next
steps in the development of AFM13 in combination with AB-101. The
conference call will be available via phone and webcast. 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-and-corporate-presentation/.
To access the call by phone, please use link
https://register.vevent.com/register/BIca92c598dd7a41319b8a09f5f7ce08bf,
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 AFM13AFM13 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 <sup>®</sup> 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 AB-101
AB-101 is a cord blood-derived, allogeneic, cryopreserved,
ADCC-enhancing NK cell therapy candidate for use in combination
with monoclonal antibodies or innate-cell engagers. Artiva selects
cord blood units with the high affinity variant of the receptor
CD16 and a KIR-B haplotype for enhanced product activity. Artiva
can generate thousands of doses of pure, cryopreserved,
infusion-ready NK cells from a single umbilical cord blood unit
while retaining the high and consistent expression of CD16 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 (NHL) who have progressed beyond two or
more prior lines of therapy.
About Affimed N.V.
Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology
company committed to give 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.
About Artiva
Artiva’s mission is to deliver highly effective, off-the-shelf,
allogeneic NK cell-based therapies utilizing our
Manufacturing-First approach, that are safe and accessible to
cancer patients. Artiva’s pipeline includes AB-101, an ADCC
enhancer NK-cell therapy candidate for use in combination with
monoclonal antibodies or innate-cell engagers. Artiva is currently
advancing a Phase 1/2 clinical trial of AB-101 in combination with
rituximab for the treatment of relapsed or refractory B-cell
lymphomas. Artiva’s pipeline also includes AB-201, an anti-HER2
CAR-NK cell therapy candidate for the treatment of
HER2-overexpressing tumors, such as breast, gastric, and bladder
cancers, and for which an IND has been allowed by FDA, and a
pipeline of CAR-NK candidates targeting both solid and
hematopoietic cancers. Artiva has entered into therapeutic NK cell
collaborations with Merck Sharp & Dohme Corp. and with Affimed
GmbH. Artiva’s AlloNK™ platform incorporates cell expansion,
activation, and engineering technology developed by Artiva’s
strategic partner, GC Cell Corporation, a member of the GC family
of companies, a leading healthcare company in Korea. Artiva is
headquartered in San Diego. For more information, please 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 our intentions,
beliefs, projections, outlook, analyses and current expectations
concerning, among other things, the potential of AFM13 and AB-101
and the Affimed-Artiva partnership, the value of our ROCK®
platform, our ongoing and planned preclinical development and
clinical trials, potential development pathways and commercial
results. Actual results may differ for various reasons, including
the risks, uncertainties and other factors described under the
heading “Risk Factors” in Affimed’s filings with the SEC, as well
as the fact that the current clinical data of AFM13 in combination
with NK cell therapy is based on AFM13 in combination with
allogeneic cord blood-derived NK cells from The University of Texas
MD Anderson Cancer Center, as opposed to AB-101, the timing and
content of FDA guidance with respect to the AFM13/AB-101
combination, the clinical and commercial viability of AB-101 and
the potential for commercial revenue from the collaboration. 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.
Affimed Investor Relations Contact
Alexander FudukidisDirector, Investor RelationsE-Mail:
a.fudukidis@affimed.com Tel.: +1 (917) 436-8102
Affimed Media Contact
Mary Beth Sandin Vice President, Marketing and
CommunicationsE-Mail: m.sandin@affimed.com Tel.: +1 (484)
888-8195
Artiva Investor ContactMichael E. FaermChief
Financial OfficerArtiva BiotherapeuticsE-mail: ir@artivabio.com
Artiva Media ContactJessica Yingling,
Ph.D.Little Dog Communications Inc. E-mail: jessica@litldog.comTel.
+1.858.344.8091
Affimed NV (NASDAQ:AFMD)
Historical Stock Chart
From Mar 2024 to Apr 2024
Affimed NV (NASDAQ:AFMD)
Historical Stock Chart
From Apr 2023 to Apr 2024