Core Insights - Molecular Partners AG is presenting updated data from a Phase 1/2a trial of its T-cell engager MP0533 for treating acute myeloid leukemia (AML) at the 67th ASH Annual Meeting [1][2] Group 1: Trial Results - The multicenter, open-label study shows that densified dosing of MP0533 is tolerable and leads to improved serum exposure with preliminary antitumor activity [2][4] - As of September 1, 2025, 54 patients have been treated with MP0533, with 8 out of 48 evaluable patients achieving a response, including 5 reaching composite complete responses [4] - Six of the eight responders had less than 20% bone marrow blasts at baseline, indicating that patients with low disease burden are likely to benefit the most from MP0533 [4][7] Group 2: Expert Commentary - Prof. Courtney DiNardo expressed optimism about the clinical benefits of MP0533 in mutation-agnostic R/R AML patients, particularly those with lower disease burden, supporting further investigation in a Phase 2 setting [3][5] Group 3: Drug Mechanism and Design - MP0533 is a novel tetra-specific T cell-engaging DARPin that targets three tumor-associated antigens (CD33, CD123, CD70) on AML cells and the immune activator CD3 on T cells, designed to preferentially kill AML cells while minimizing damage to healthy cells [6][9] Group 4: Future Development - The trial is progressing well, with the densified dosing regimen showing feasibility and an acceptable safety profile, prompting interest from several consortia for further studies in both R/R and front-line AML settings [5][9]

Core Insights - Molecular Partners AG presented new data on MP0712, a Radio-DARPin targeting DLL3, at the Targeted Radiopharmaceuticals Summit Europe, showcasing promising human imaging results and supporting mechanism of action data [1][2][3] Clinical Development - MP0712 is being developed in collaboration with Orano Med for treating small cell lung cancer (SCLC) and other neuroendocrine cancers, with a Phase 1 trial expected to start by the end of 2025 [1][7] - The Phase 1 Investigational New Drug (IND) application has been filed, and ongoing discussions with the FDA are taking place [7][8] Imaging and Efficacy - Initial imaging results indicate targeted delivery of MP0712 into tumors with minimal exposure to healthy organs, suggesting its potential effectiveness in a clinical setting [2][3] - A case study showed specific uptake in tumor lesions at 24 hours, sustained over four days, with limited accumulation in healthy organs [3][5] Mechanism of Action - MP0712 is engineered for half-life optimization to maintain drug levels in the blood, supporting its intended mechanism of action [3][6] - The data suggests that MP0712 can achieve high tumor uptake even with low DLL3 expression levels, leveraging internalization and optimal binding properties [6] Future Outlook - The company anticipates initial clinical data from the Phase 1/2a study in 2026, which will assess safety and determine a recommended phase 2 dose for MP0712 [7][8] - Molecular Partners is also advancing additional Radio-DARPin programs in 2026 [2][8] Technology and Innovation - The Radio-DARPin platform combines the targeting capabilities of DARPins with the therapeutic potential of 212Pb, aiming to improve the delivery of radioactive payloads to solid tumors [11] - DARPins are designed to offer high specificity and affinity, making them suitable for efficient delivery of therapeutic radionuclides [12]

Core Insights - Molecular Partners AG presented new data on MP0712, a Radio-DARPin targeting DLL3, at the Targeted Radiopharmaceuticals Summit Europe, showcasing promising human imaging results and supporting mechanism of action data [1][2][3] Group 1: Clinical Development - MP0712 is being developed in collaboration with Orano Med for treating small cell lung cancer (SCLC) and other neuroendocrine cancers [1][2] - The Phase 1 Investigational New Drug (IND) application for MP0712 has been filed, with the trial expected to start by the end of 2025, pending regulatory clearance [7][8] - Initial clinical data from the Phase 1/2a study is anticipated in 2026 [7][8] Group 2: Imaging and Mechanism of Action - The imaging data indicates targeted delivery of MP0712 into tumors with minimal exposure to healthy organs, suggesting its potential effectiveness in a clinical setting [2][3] - A case study showed specific uptake of Pb-MP0712 in tumor lesions at 24 hours, sustained over 4 days, with limited accumulation in healthy organs [3][5] - MP0712 is engineered for half-life optimization to maintain sufficient drug levels in the blood, supporting its intended mechanism of action [3][6] Group 3: Technology and Innovation - The Radio-DARPin platform combines the targeting capabilities of DARPins with the therapeutic potential of lead isotopes, aiming to improve delivery of radioactive payloads to tumors [11][12] - DARPins offer advantages in drug design, including high specificity, small size, and stability, which can enhance therapeutic efficacy [12][13]

Core Insights - Molecular Partners AG is presenting updated data from a Phase 1/2a trial of MP0533, a novel T cell engager for acute myeloid leukemia (AML) patients, at the upcoming ASH Annual Meeting [1][2] Group 1: Clinical Trial Details - The trial is a first-in-human, multicenter, open-label study evaluating MP0533 in relapsed/refractory AML and myelodysplastic syndrome (MDS)/AML patients [2] - MP0533 demonstrates an acceptable safety profile across dosing regimens DR 1–9, with preliminary signs of antitumor activity being encouraging [2] - The study is currently administering doses to patients in DR 10 [2] Group 2: Mechanism of Action - MP0533 is a tetra-specific T cell-engaging DARPin that targets three tumor-associated antigens (CD33, CD123, CD70) on AML cells and the immune activator CD3 on T cells [3] - The design allows MP0533 to preferentially bind to AML cells over healthy cells, enhancing T cell-mediated killing while minimizing damage to healthy cells [3] Group 3: Presentation Details - The presentation will occur on December 7, 2025, during the session focused on investigational drugs and cellular therapies for acute myeloid leukemias [4] - The full abstracts will be available on the ASH website starting November 3, 2025 [4] Group 4: About DARPin Therapeutics - DARPin therapeutics represent a new class of custom-built protein drugs that offer multi-functionality and multi-target specificity [5] - The platform is designed for rapid and cost-effective drug discovery, producing candidates with optimized properties and high production yields [5] Group 5: About Molecular Partners AG - Molecular Partners AG is a clinical-stage biotech company focused on developing DARPin therapeutics, primarily in oncology [6] - The company has various programs in different stages of development and collaborates with leading pharmaceutical companies [6]

Core Insights - Molecular Partners AG is advancing its logic-gated CD3 Switch-DARPin T cell engager (TCE) designed for targeted immune activation in solid tumors, particularly ovarian cancer, by presenting new preclinical data at the SITC 2025 meeting [1][4] Group 1: Product Development - The Switch-DARPin TCE utilizes an AND-gate mechanism to activate T cells only when both mesothelin (MSLN) and epithelial cell adhesion molecule (EpCAM) are present, addressing limitations of systemic toxicity and efficacy in TCEs for solid tumors [2][4] - Preclinical data indicate that the Switch-DARPin shows selective T cell cytotoxicity against cells co-expressing MSLN and EpCAM, while exhibiting reduced activity against healthy tissues [3][6] - The T cells exposed to the CD2/CD3 Switch-DARPin demonstrated improved activation and proliferation compared to CD3 engagement alone, suggesting potential to mitigate T cell exhaustion [3][4] Group 2: Safety and Efficacy - Significant tumor regression was observed in a xenograft mouse model expressing MSLN and EpCAM, without systemic cytokine release, indicating a favorable safety profile for the Switch-DARPin [3][6] - The logic-gated approach allows for conditional immune activation, enhancing both efficacy and safety compared to traditional therapies targeting a single tumor antigen [4][6] Group 3: Company Overview - Molecular Partners AG is a clinical-stage biotech company focused on developing DARPin therapeutics, which offer advantages in multi-target specificity and high stability over existing protein-based drugs [5][8] - The company has a diverse pipeline with programs in various stages of development, primarily targeting oncology [8]

Core Insights - Molecular Partners AG is advancing its clinical-stage pipeline, focusing on DARPin therapeutics, with significant developments in its Radio-DARPin programs and T-cell engagers [1][2][3] Research & Development Highlights - The IND application for MP0712, a Radio-DARPin targeting DLL3 for small cell lung cancer, has been filed, with a Phase 1 trial expected to start by the end of 2025 [3][7] - Initial clinical imaging data for MP0712 will be presented in November, showcasing its application in compassionate care in South Africa [2][5] - MP0533, a multispecific T-cell engager for acute myeloid leukemia (AML), has shown promising results, with over 30% of evaluable patients achieving a clinical response [10][12] - The company is exploring further dosing strategies for MP0533 to enhance patient outcomes and is planning to present updated data at the ASH Annual Meeting in December [11][12] - MP0317, a tumor-localized agonist, is undergoing an investigator-initiated trial for advanced cholangiocarcinoma, with a focus on progression-free survival [13][14] Corporate Governance Highlights - Martin Steegmaier, Ph.D., has been appointed as Chief Scientific Officer, bringing extensive oncology drug development experience [17] Financial and Business Outlook - For 2025, the company anticipates total operating expenses of CHF 55-60 million, with sufficient cash reserves of CHF 105 million to fund operations until 2028 [18][19]

Core Insights - Molecular Partners AG is making significant progress in its clinical programs, particularly with MP0712 and MP0533, with key milestones expected in the near future [2][6] - The company has appointed Martin Steegmaier, Ph.D., as Chief Scientific Officer, enhancing its leadership team [2][15] - Financially, the company is in a strong position with cash reserves projected to last until 2028 [2][19] Research & Development Highlights - MP0533 is in a Phase 1/2a trial for acute myeloid leukemia, showing promising results with over 30% of evaluable patients achieving a clinical response [3][4] - The dosing regimen for MP0533 has been optimized to enhance patient responses, with initial data from cohort 9 expected in Q4 2025 [5][6] - MP0712, a Radio-DARPin therapy for small cell lung cancer, is preparing for an IND filing, with initial clinical data anticipated in H1 2026 [8][9] Corporate Governance Highlights - The appointment of Martin Steegmaier, Ph.D., as CSO is aimed at strengthening the company's focus on oncology drug development [15] - A strategic review led to a planned reduction of up to 40 positions, which is expected to improve operational efficiency and extend the cash runway into 2028 [16] Financial and Business Outlook - For 2025, the company expects total operating expenses between CHF 55-65 million, with a significant portion being non-cash costs [18] - As of June 30, 2025, cash and cash equivalents totaled CHF 114 million, sufficient to fund operations into 2028 [19]

Core Viewpoint - Molecular Partners AG has appointed Martin Steegmaier, Ph.D., as Chief Scientific Officer (CSO), effective October 1, 2025, to enhance its oncology drug development efforts, particularly in DARPin therapeutics [1][2]. Company Overview - Molecular Partners AG is a clinical-stage biotech company focused on developing DARPin therapeutics, which are custom-built protein drugs aimed at addressing medical challenges that other drug modalities cannot effectively tackle [6]. - The company has a pipeline that includes various programs in pre-clinical and clinical development, with a primary focus on oncology [6]. Leadership Appointment - Martin Steegmaier brings extensive experience in oncology drug development from previous roles at Roche, MorphoSys, Boehringer Ingelheim, and SOTIO Biotech, where he led the development of a broad pipeline of oncology programs [1][3][2]. - The CEO of Molecular Partners, Patrick Amstutz, expressed confidence that Steegmaier's expertise will significantly contribute to the company's research organization and the advancement of its targeted DARPin therapeutics [2]. Educational Background - Martin Steegmaier holds a Ph.D. in biochemistry from the University of Basel and an MBA from the Edinburgh Business School, which complements his extensive experience in the biotech and pharmaceutical sectors [4]. Future Directions - The company aims to innovate and advance its pipeline of targeted DARPin therapeutics, including Radio-DARPins and Switch-DARPins, which are designed for logic-gated immune cell activation [2][5].

Core Insights - Molecular Partners AG is undergoing a strategic review to enhance operational efficiency and focus on advancing its clinical assets, resulting in a workforce reduction of up to 40 positions, approximately 24% of total staff [1][2][4] Group 1: Strategic Review and Workforce Reduction - The company has initiated a strategic review aimed at increasing efficiency and sharpening focus on clinical assets, leading to a potential reduction of up to 40 positions [1][4] - The decision to reduce workforce is part of a plan to extend the company's cash runway into 2028, beyond the previous guidance of 2027 [4][7] - A consultation process with employees has begun in accordance with Swiss employment law, and support will be provided to affected employees, including severance packages and job-seeking assistance [3][4] Group 2: Clinical Development Focus - The company is prioritizing the development of clinical assets MP0533 and MP0712, which are expected to provide significant value for patients and shareholders [2][4] - Clinical data from both MP0533 and MP0712 is anticipated in the second half of 2025, maintaining previously announced timelines [4][7] - The strategic review identified redundancies primarily in research and associated functions, allowing for a more focused approach to clinical development [4] Group 3: Financial Outlook - The workforce reduction is expected to lead to cost savings that will become fully effective by early 2026 [3][4] - The company plans to report its half-year financials on August 25, 2025, which will provide further insights into its financial health and operational adjustments [4]

Core Insights - Molecular Partners AG is a clinical-stage biotech company focused on developing DARPin therapeutics, which are custom-built protein drugs designed to address medical challenges that other drug modalities cannot effectively tackle [4] Group 1: Upcoming Events - The management team of Molecular Partners will participate in two investor conferences: the H.C. Wainwright 3rd Annual BioConnect Investor Conference on May 20, 2025, and the TD Cowen's 6th Annual Oncology Innovation Summit on May 28, 2025 [2][3] - Both events will be webcast and accessible on the Molecular Partners website under the investors tab [3] Group 2: Company Overview - Molecular Partners was founded in 2004 and has its offices in Zurich, Switzerland, and Concord, Massachusetts, USA [4] - The company is primarily focused on oncology and has various programs in different stages of pre-clinical and clinical development [4] - Molecular Partners collaborates with leading pharmaceutical companies to leverage the advantages of DARPins for unique patient solutions [4]