Molecular Partners to Present Initial Data from Ongoing Phase 1/2a Trial of MP0533 for Patients with Relapsed/Refractory AML and AML/MDS at the 65th ASH Annual Meeting and Exposition
02 Noviembre 2023 - 12:00AM
Ad hoc announcement pursuant to Art. 53 LR
Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage
biotech company developing a new class of custom-built protein
drugs known as DARPin therapeutics, will present preliminary data
from its ongoing Phase 1/2a trial of MP0533, a novel tetra-specific
T cell engager at the 65th American Society of Hematology (ASH)
Annual Meeting and Exposition being held from December 9–12 in San
Diego, California. MP0533 is in development for the treatment of
patients with relapsed/refractory acute myeloid leukemia (r/r AML)
and myelodysplastic syndrome (AML/MDS).
As of data cut-off (20 July 2023) of the abstract published
today, five patients across three dosing regimens had been treated.
The preliminary data reported indicate an acceptable safety
profile, with no dose-limiting toxicity or Grade ≥3 adverse
reactions. Grade 1/2 events considered related to MP0533 included
infusion-related reactions and cytokine release syndromes. One of
the two patients evaluable for MP0533 antitumor activity in the
third treatment cohort achieved a response. The study is currently
enrolling its fifth cohort with up to seven dose-escalating cohorts
planned and a total enrollment of up to 45 patients. The Company
anticipates to present data including from the fourth dose cohort
at the ASH Annual Meeting and Exposition in December this year.
“The data from the ASH abstract represent the beginning of an
exciting and encouraging clinical journey for the MP0533 program.
We are now able to show initial clinical activity of the first
tetra-specific, non-antibody-based T cell engager, MP0533, in
patients with r/r AML and MDS/AML,” said Patrick Amstutz, Ph.D.,
Molecular Partners’ CEO. “We see both an acceptable tolerability
profile at initial doses, as well as the emergence of single-agent
anti-tumor activity at relatively low dose levels and we look
forward to presenting additional data on MP0533’s potential to
treat this particularly intractable blood cancer at the ASH Annual
Meeting in December.”
The clonal heterogeneity and lack of single AML-specific target
antigens represent major challenges for the development of targeted
immune therapies for AML. To overcome these hurdles, Molecular
Partners designed MP0533, a novel tetra-specific T cell-engaging,
half-life extended DARPin, which simultaneously targets CD33,
CD123 and CD70, as well as CD3 on T cells. This unique mode of
action is designed to enable avidity-driven, T cell-mediated
killing of leukemic stem cells and malignant blast cells, which
commonly co-express at least two of the three target antigens,
while preserving a therapeutic window that minimizes damage to
healthy cells.
The ongoing single-arm, open-label, multicenter Phase 1/2a study
of MP0533 is designed to evaluate the safety, tolerability,
pharmacokinetics, and pharmacodynamics, as well as assess
preliminary antileukemic activity of MP0533 as a monotherapy for
patients with r/r AML and AML/MDS.
The presentation details are as follows:
Session Name: 616. Acute Myeloid Leukemias:
Investigational Therapies, Excluding Transplantation and Cellular
Immunotherapies: Poster 2 Publication Number:
2921Title: MP0533, a CD3-Engaging DARPin Targeting
CD33, CD123, and CD70 in Patients with Relapsed/Refractory AML or
MDS/AML: Preliminary Results of a Phase 1/2a Study Session
Location & Date: San Diego Convention Center, Halls
G-H; Sunday, December 10, 2023 Presentation Time:
6:00–8:00 pm PT
The abstract will become available today on the ASH website at
9:00 am ET.
About DARPin TherapeuticsDARPin therapeutics
are a new class of custom-built protein therapeutics based on
natural binding proteins that open a new dimension of
multi-functionality and multi-target specificity in drug design. A
single DARPin candidate can engage more than five targets, and its
flexible architecture and small size offer benefits over other
currently available protein therapeutics. DARPin therapeutics have
been clinically validated through to registration via the
development of abicipar, a DARPin drug candidate for ophthalmologic
indications. The DARPin platform is a fast and cost-effective drug
discovery engine, producing drug candidates with optimized
properties for development and very high production yields.
About Molecular Partners AG Molecular
Partners AG is a clinical-stage biotech company developing DARPin
therapeutics, a new class of custom-built protein drugs designed to
address challenges current modalities cannot. The Company has
formed partnerships with leading pharmaceutical companies to
advance DARPin therapeutics in the areas of oncology and infectious
disease and has compounds in various stages of clinical and
preclinical development across multiple therapeutic areas.
www.molecularpartners.com; Find us on LinkedIn and X -
@MolecularPrtnrs
For further details, please contact:Seth Lewis,
SVP Investor Relations & StrategyConcord, Massachusetts,
U.S.seth.lewis@molecularpartners.comTel: +1 781 420 2361
Laura Jeanbart, PhD, Head of Portfolio Management &
Communications Zurich-Schlieren,
Switzerlandlaura.jeanbart@molecularpartners.com Tel: +41 44 575 19
35
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