On November 5, 2024 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, reported the presentation of data from its MP0533 and MP0621 programs at the upcoming Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in San Diego, running December 7–10, 2024 (Press release, Molecular Partners, NOV 5, 2024, View Source [SID1234655799]).
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The poster presentation details are as follows:
Session Name: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster II
Publication Number: 2881
Title: MP0533 (CD33 x CD123 x CD70 x CD3), a Tetra-Specific CD3-Engaging Darpin for the Treatment of Patients with Relapsed/Refractory AML or MDS/AML: Results of an Ongoing Phase 1/2a Study
Session Location: San Diego Convention Center, Halls G-H
Presentation Date & Time: Sunday, December 8, 2024, 6:00–8:00 pm PT
Session Name: 701. Experimental Transplantation: Basic and Translational: Poster III
Publication Number: 4775
Title: MP0621 (cKit x CD16a x CD47), a Multi-Specific Switch-Darpin with Conditional Blockade of CD47 Targeting Hematopoietic Stem Cells: Preclinical Evaluation of a Next-Generation Conditioning Agent for Stem Cell Transplantation
Session Location: San Diego Convention Center, Halls G-H
Presentation Date & Time: Monday, December 9, 2024, 6:00–8:00 pm PT
The full abstracts will be available on the ASH (Free ASH Whitepaper) website from 9:00 am ET on November 5, 2024.
About MP0533 (CD33 x CD123 x CD70 x CD3)
MP0533 is a novel tetraspecific T cell engaging DARPin which simultaneously targets the three tumor-associated antigens (TAAs) CD33, CD123 and CD70, as well as CD3 on T cells. The mechanism of action of MP0533 is designed to preferentially kill AML cells that express any combination of these three TAAs while sparing healthy cells, which express only one or none of these targets. The immune activation against the malignant cells is achieved through CD3-mediated T cell-engagement.
The poster to be presented at ASH (Free ASH Whitepaper) 2024 will provide a clinical update of the ongoing first-in-human dose-escalation phase 1/2a study of MP0533 in patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)/AML. MP0533 showed an acceptable safety profile in the first 7 dose cohorts, with the majority of adverse events reported being infusion-related reactions and cytokine release syndrome.
Based on this observed tolerability profile and initial antitumor and pharmacodynamic activity data, Molecular Partners is amending the protocol to further optimize the dosing schedule and improve the exposure profile of MP0533.
About MP0621 (cKit x CD16a x CD47)
MP0621 is a Switch-DARPin candidate designed to induce killing of hematopoietic stem cells (HSCs) as a next-generation conditioning regimen for HSC transplantation (HSCT). The Switch-DARPin platform provides a logic-gated "on/off" function (the "Switch") to multispecific DARPin candidates leading to target activation only in the presence of defined antigens. In MP0621, the Switch-DARPin binds to either cellular cKit or to the anti-CD47 DARPin binder. Upon MP0621 binding to cKit on HSCs, the Switch-DARPin will unmask the anti-CD47 DARPin, which in turn will bind CD47 and block the "don’t-eat-me" signal, leveraging the power of CD47 inhibition without its associated toxicity to healthy cells.
The poster to be presented at ASH (Free ASH Whitepaper) 2024 builds on the data presented earlier this year at the European Haematology Association 2024 Congress and provides further preclinical in vivo proof-of-mechanism data, demonstrating that MP0621 could be an efficient next-generation conditioning regimen for autologous HSCT.
At present non-human primate data do not indicate that MP0621 would serve as a treatment for AML, as was previously hypothesized, in addition to HSCT. As Molecular Partners’ portfolio strategy prioritizes therapeutic candidates for oncology, MP0621 is being evaluated for partnering.
About DARPin Therapeutics
DARPin (Designed Ankyrin Repeat Protein) therapeutics are a new class of custom-built protein drugs based on natural binding proteins that open new dimensions of multi-functionality and multi-target specificity in drug design. The flexible architecture, intrinsic potential for high affinity and specificity, small size and high stability of DARPins offer benefits to drug design over other currently available protein-based therapeutics. DARPin candidates can be radically simple, with a single DARPin unit acting as the delivery vector to a specific target; or multispecific, with the possibility of engaging more than five targets, and combining multiple and conditional functionalities in a unique DARPin drug candidate. The DARPin platform is designed to be a rapid and cost-effective drug discovery engine, producing drug candidates with optimized properties and high production yields. DARPin therapeutics have been clinically validated across several therapeutic areas and developed through to the registrational stage.