Molecular Partners announces upcoming poster presentations at the ASH | 65th Annual Meeting and Exhibition 05.11.24

Clinical update from the ongoing MP0533 phase 1/2a dose escalation study confirms the overall acceptable safety profile and initial antileukemic and pharmacodynamic activity observed to date

Switch-DARPin MP0621 demonstrates cKit+ cell killing while reducing off-target effects seen with systemic anti-CD47 blockade

ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., Nov. 5, 2024 (GLOBE NEWSWIRE) — Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of tailor-made protein medicines announced as DARPin therapies, today announced the presentation of data from its MP0533 and MP0621 programs at the upcoming American Society of Hematology (ASH) annual meeting in San Diego, December 7-10, 2024.

The details of the poster presentation are as follows:

Session name: 616. Acute Myeloid Leukemias: Investigational Drugs 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 from an ongoing phase 1/2a study
Session Location: San Diego Convention Center, Halls GH
Date and time of presentation: Sunday, December 8, 2024, 6:00 PM – 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 multispecific 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 GH
Date and time of presentation: Monday, December 9, 2024, 6:00 PM – 8:00 PM PT

The full summaries will be available on the ASH website beginning at 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 that 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 a combination of these three TAAs, while sparing healthy cells that 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 2024 will provide a clinical update of the ongoing first-in-human Phase 1/2a dose-escalation study of MP0533 in patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)/AML. MP0533 demonstrated 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 data on antitumor and pharmacodynamic activity, Molecular Partners is modifying the protocol to further optimize the dosing regimen 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” feature (the “Switch”) for multi-specific DARPin candidates, leading to target activation only in the presence of defined antigens. In MP0621, the Switch-DARPin binds to cellular cKit or to the anti-CD47 DARPin binder. When MP0621 binds 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”, harnessing the power of CD47 inhibition without associated toxicity. to healthy cells.

The poster to be presented at ASH 2024 builds on data presented earlier this year at the European Hematology 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.

ACurrent data in non-human primates do not indicate that MP0621 could serve as a treatment for AML, as previously hypothesized, in addition to HSCT. As Molecular Partners’ portfolio strategy prioritizes therapeutic candidates for oncology, MP0621 is being evaluated for collaboration.

About DARPin Therapeutics
DARPin (Designed Ankyrin Repeat Protein) therapies are a new class of tailor-made protein medicines, based on natural binding proteins, that open new dimensions of multifunctionality 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 advantages for drug design over other currently available protein-based therapies. DARPin candidates can be radically simple, with a single DARPin unit acting as the delivery vector for a specific target; or multispecific, with the ability to achieve more than five targets, and combine multiple and conditional functionalities into a unique DARPin drug candidate. The DARPin platform is designed as a fast and cost-effective drug discovery engine, producing drug candidates with optimized properties and high production yields. DARPin therapies have been clinically validated in several therapeutic areas and developed through to the registration phase.

About Moleculair Partners AG
Molecular Partners AG is a clinical-stage biotech company pioneering the design and development of DARPin therapies for medical challenges that other drug modalities cannot easily address. The company has programs in various stages of preclinical and clinical development, with oncology as its primary focus. Molecular Partners leverages the benefits of DARPins to provide unique solutions to patients through its proprietary programs and through partnerships with leading pharmaceutical companies. Molecular Partners was founded in 2004 and has offices in Zurich, Switzerland and Concord, MA, USA. For more information, visit www.molecularpartners.com and find us on LinkedIn and Twitter/X @MolecularPrtnrs

For more information please contact:
Seth Lewis, SVP Investor Relations & Strategy
Concord, Massachusetts, USA
[email protected]
Tel: +1 781 420 2361

Laura Jeanbart, PhD, Head of Portfolio Management & Communications
Zurich-Schlieren, Switzerland
[email protected]
Tel: +41 44 575 19 35

Cautionary Statement Regarding Forward-Looking Statements
Any statements in this press release that are not statements of historical fact may be forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, including but not limited to: implied and express statements regarding the clinical development of Molecular Partners’ current or future product candidates; expectations regarding the timing for reporting data from ongoing clinical trials or the initiation of future clinical trials; the potential therapeutic and clinical benefits of Molecular Partners’ product candidates and its RDT and Switch-DARPin platforms; the selection and development of future programs; Molecular Partners’ collaboration with Orano Med, including the benefits and results that can be achieved through the collaboration; and Molecular Partners’ expected business and financial prospects, including expected 2024 costs and cash usage and current cash runway expectations. These statements may be identified by words such as “goal,” “expect,” “guidance,” “intend,” “outlook,” “plan,” “potential,” “will” and similar expressions and are based on Molecular Partners’ current beliefs and expectations. These statements involve risks and uncertainties that could cause actual results to differ materially from those expressed in such statements. Some of the key factors that could cause actual results to differ from Molecular Partners’ expectations include its plans to develop and potentially commercialize its product candidates; Molecular Partners’ dependence on external partners and employees over which it may not always have full control; Molecular Partners’ ongoing and planned clinical trials and preclinical studies for its product candidates, including the timing of such trials and studies; the risk that results from preclinical studies and clinical trials may not be predictive of future results associated with future clinical trials; the timing of and ability of Molecular Partners to obtain and maintain regulatory approvals for its product candidates; the extent of clinical trials that may be required for Molecular Partners’ product candidates; the clinical utility and ability to achieve market acceptance of Molecular Partners’ product candidates; the potential that Molecular Partners’ product candidates may exhibit serious adverse, unwanted or unacceptable side effects; the impact of a health pandemic, macroeconomic factors and other global events on Molecular Partners’ preclinical studies, clinical trials or operations, or the operations of third parties on which it depends; Molecular Partners’ plans and development of any new indications for its product candidates; Molecular Partners’ commercialization, marketing and manufacturing capabilities and strategy; Molecular Partners’ intellectual property position; Molecular Partners’ ability to identify and in-license additional product candidates; unexpected factors in addition to the foregoing that may impact Molecular Partners’ financial and business projections and guidance; and other risks and uncertainties described in the Risk Factors section of Molecular Partners’ Annual Report on Form 20-F for the fiscal year ended December 31, 2023 filed with the Securities and Exchange Commission (SEC) on March 14, 2024 and other filings that Molecular Partners files with the SEC. These documents are available on the Investors page of Molecular Partners’ website at www.molecularpartners.com. In addition, this press release contains information relating to interim data as of the relevant data cut-off date, the results of which may differ from topline results that may be obtained in the future. Any forward-looking statements speak only as of the date of this press release and are based on information available to Molecular Partners as of the date of this press release. Molecular Partners assumes no obligation to update any forward-looking statements and does not intend to do so. forward-looking statements, whether as a result of new information, future events or otherwise.