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 the
U.S. Food and Drug Administration (FDA) has issued a written
response to the Company’s pre-IND meeting request for the AFM13 and
Artiva Biotherapeutics, Inc. (“Artiva”)’s AB-101 co-administered
combination therapy in relapsed/refractory (r/r) Hodgkin lymphoma
(HL) and the exploratory arm evaluating the combination in r/r
CD30-positive peripheral T-cell lymphoma (PTCL). Based on the
written response, Affimed remains on track to submit an IND in the
first half of 2023 and, subject to FDA clearance of the IND, to
initiate a clinical study during 2023.
“We remain excited about the clinical and
commercial potential of the AFM13/AB-101 combination therapy for
CD30-positive HL and PTCL patients and look forward to initiating
clinical development during 2023,” said Dr. Adi Hoess, CEO of
Affimed. “We believe there is significant unmet need to help
patients in these difficult cancer indications with limited
treatment options and continue to make progress across our
pipeline. We are looking forward to sharing key clinical milestones
in 2023 and beyond.”
In November 2022, Affimed announced that it had
entered into a 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, to accelerate clinical development and
address the high unmet need of CD30-positive lymphoma patients.
Other Clinical Stage Program Updates
AFM24 (EGFR/CD16A)
- Affimed expects
to report data from all three ongoing AFM24 studies at scientific
conferences in Q2/Q3 2023.
- AFM24-101:
Affimed continues to enroll patients in the expansion phase of the
AFM24 monotherapy study at the RP2D. The expansion cohorts include
patients with renal cell carcinoma (clear cell), non-small cell
lung cancer (EGFR mutant) and colorectal cancer.
- AFM24-102:
Enrollment is completed in the 480 mg dose escalation cohort of the
phase 1/2a combination study of AFM24 with the anti-PD-L1
checkpoint inhibitor atezolizumab (Tecentriq®) in patients with
advanced epidermal growth factor receptor-expressing solid tumors.
AFM24-102 includes patients with non-small cell lung cancer (EGFR
wildtype), gastric and gastroesophageal junction adenocarcinoma and
pancreatic/hepatocellular/biliary tract cancer. No dose-limiting
toxicities (DLTs) have been observed thus far in the dose
escalation. Expansion cohorts are expected to begin enrollment in
Q1 2023.Data from the first cohort (4 patients at 160 mg dose) of
the phase 1 dose escalation study presented at the annual meeting
of the Society for Immunotherapy of Cancer (SITC) in November 2022
showed that clinical activity was observed in two patients. A
patient with gastric cancer and skin metastases who had rapidly
progressed following four prior lines of therapy, including a PD-1
inhibitor, achieved a partial response. A second patient with
pancreatic adenocarcinoma showed stable disease beyond four months.
Patients being enrolled in the study are required to have
progressed or relapsed on standard of care therapies.
- AFM24-103: In
the phase 1/2a combination study of AFM24 with SNK01, NKGen
Biotech’s ex vivo expanded and activated autologous NK cell
therapy, enrollment has been completed in the dose cohort of 480 mg
AFM24 weekly, with no DLTs observed to date.AFM24-103 is focused on
the treatment of patients with non-small cell lung cancer (NSCLC,
EGFR-wildtype), squamous cell carcinoma of the head and neck, and
colorectal cancer.
AFM28 (CD123/CD16A)
Affimed’s AFM28 ICE® targets CD16A on NK cells
and macrophages, and CD123 on leukemic blasts and leukemic stem
cells that are prevalent in acute myeloid leukemia (AML).
In December 2022, CTAs were cleared in France
and Spain, and the Company expects to initiate a phase 1 clinical
study in Q2 2023.
Financial Update
As of December 31, 2022, preliminary unaudited
cash and cash equivalents were approximately €190 million, with an
anticipated cash runway into 2025.
Partnerships and
Collaborations
Partnered programs with Genentech and Affivant
(a Roivant company) continue to progress. Affimed is eligible for
additional proceeds including pre-clinical milestones as well as
milestones based on early regulatory achievements. Affivant expects
to file an IND for AFVT-2101 (formerly AFM32) in the first half of
2023.
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.
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 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 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
FudukidisDirector, Investor RelationsE-Mail:
a.fudukidis@affimed.comTel.: +1 (917) 436-8102
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