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Molecular Partners AG (MOLN) is a clinical-stage biotech company whose news flow is closely tied to the progress of its DARPin-based oncology pipeline. The company regularly issues updates on its clinical trials, preclinical data presentations and strategic collaborations, giving investors and observers insight into how its programs are advancing through development.
News about Molecular Partners often highlights milestones for its Radio-DARPin platform, including MP0712, a 212Pb-based candidate targeting DLL3 in small cell lung cancer and other neuroendocrine cancers, and MP0726, which targets mesothelin in cancers with high unmet need. Press releases describe regulatory steps such as Investigational New Drug applications, initiation of Phase 1/2a studies, and early human imaging data from compassionate care programs, as well as the role of its collaboration with Orano Med in radiotherapeutics.
Another major source of updates is the companys multispecific T cell engager MP0533, in Phase 1/2a for relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome/AML. Molecular Partners reports interim clinical data, dosing refinements and response patterns, particularly in patients with lower disease burden, through conference presentations and ad hoc announcements. News items also cover MP0317, a tumor-localized CD40 agonist in an investigator-initiated Phase 2 trial in cholangiocarcinoma, and preclinical Switch-DARPin programs that use logic-gated immune activation.
Corporate communications further include quarterly and half-year financial results, cash runway commentary, and management changes such as the appointment of a Chief Scientific Officer. For readers following MOLN stock, this news page provides a centralized view of regulatory disclosures, scientific conference presentations and pipeline progress updates related to Molecular Partners DARPin therapeutics.
Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN) and Orano Med presented positive preclinical data for their Radio-DARPin Therapeutic (RDT) candidate MP0712 at the EANM Congress 2024. MP0712, targeting delta-like ligand 3 (DLL3), showed:
- Dose-dependent efficacy with a favorable safety profile
- Attractive tumor to kidney ratios in biodistribution studies
- Picomolar affinity and high specificity for DLL3
The companies plan to initiate first-in-human studies in 2025, pending regulatory clearance. MP0712 demonstrated strong tumor uptake in models with clinically relevant DLL3 expression levels, while maintaining low kidney exposure. The treatment was well-tolerated at clinically relevant dosages and showed strong efficacy compared to a radiolabelled anti-DLL3 antibody.
DLL3 is expressed in >85% of small cell lung cancer tumors and other aggressive neuroendocrine tumors, making it a highly relevant target for radiopharmaceutical therapy.
Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN) has strengthened its co-development agreement with Orano Med for 212Pb-based Radio-DARPin Therapeutics. The revised agreement now includes four Radio-DARPin programs, with each company holding commercialization rights to two programs. Molecular Partners retains rights to the first program, MP0712 targeting DLL3, and gains rights to the second nominated Radio-DARPin Candidate.
The companies plan to initiate first-in-human studies for MP0712 in 2025, pending regulatory clearance. Molecular Partners expects no immediate impact on its 2024 financial forecast and maintains its funding guidance into 2027. The company's estimated cash and cash equivalents as of September 30, 2024, are approximately CHF 140 million (unaudited).
Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN) has announced upcoming poster presentations at the 2024 SITC Annual Meeting. The company will introduce proof-of-concept data for its new CD3 Switch-DARPin, designed to overcome challenges in T cell engagers for solid tumors. Additionally, they will present further analyses from the Phase 1 study of MP0317 in patients with advanced solid tumors.
Two poster presentations are scheduled:
- Title: "Unlocking precision: a next generation multi-specific CD3 Switch-DARPin with enhanced function to tackle the current limitations of T cell engagers in ovarian cancer" (Abstract & Poster Number: 842)
- Title: "Comprehensive biomarker analyses from a Phase 1 study reveals marked tumor microenvironment modulation in patients with advanced solid tumors treated with MP0317, a FAP-localized CD40 agonistic DARPin" (Abstract & Poster Number: 612)
The presentations will take place on November 9, 2024, from 9 am to 8:30 pm CT in Exhibit Halls AB. The posters will be available on Molecular Partners' website after the conference.
Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN) announced an upcoming presentation on MP0712, a ²¹²Pb-labeled Radio-DARPin Therapeutic (RDT) targeting DLL3 for Small Cell Lung Cancer, at the European Association of Nuclear Medicine (EANM) Congress in Hamburg, Germany, October 19-23, 2024. The presentation, titled "Preclinical Assessment of Lead-212 (²¹²Pb) Radio-DARPin Therapeutic (RDT) Targeting Delta-like Ligand 3 (DLL3) in Small Cell Lung Cancer (SCLC)," will be held on October 22, 2024.
MP0712, co-developed with Orano Med, is Molecular Partners' first RDT candidate. It shows low kidney accumulation and high tumor uptake in preclinical models, leading to strong tumor growth inhibition with a good safety profile in vivo. DLL3 is expressed in >85% of SCLC tumors and other aggressive neuroendocrine tumors, making it a priority target for radiopharmaceutical therapy.
Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN) reported corporate highlights and financials for H1 2024. Key developments include:
- Nomination of MP0712, the first Radio-DARPin Therapy (RDT) candidate targeting DLL3
- Strategic collaboration with Orano Med to co-develop 212Pb-based RDT candidates
- Progression of MP0533 phase 1 dose escalation for AML treatment
- Presentation of preclinical data for Switch-DARPin platform and MP0621
- Positive Phase 1 data for MP0317 presented at ASCO
Financial highlights: CHF 159.1 million cash position as of June 30, 2024, funding operations into 2027. Total operating expenses expected to be CHF 65-75 million in 2024. The company reported an operating loss of CHF 31.8 million and a net loss of CHF 26.4 million for H1 2024.
Molecular Partners (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech firm specializing in DARPin therapeutics, will participate in the 2nd TD Cowen Radiopharmaceutical Innovation Summit on June 17, 2024. Michael Stumpp, Ph.D., EVP and co-founder, will represent the company in a fireside chat at 10:40 a.m. ET (4:40 p.m. CET). The event will be webcast live on Molecular Partners' website and archived for one year.
Molecular Partners has revealed promising preclinical data for MP0621, their first Switch-DARPin candidate, at the European Hematology Association 2024. MP0621 targets cKit-positive cells and conditionally blocks CD47 to facilitate hematopoietic stem cell transplantation (HSCT) in acute myeloid leukemia (AML) patients. The candidate showed selective cell killing and minimal systemic side effects in vivo, validating the Switch-DARPin concept. Preclinical studies demonstrated effective cKit+ cell depletion and a pharmacokinetic profile suitable for HSCT therapy. Phase 1 clinical trials for MP0621 are scheduled for 2025.
Molecular Partners and Orano Med have presented promising preclinical data for their Radio-DARPin Therapy (RDT) candidate, MP0712. Targeting DLL3, MP0712 features 212Pb as a potent therapeutic payload and demonstrates a strong tumor to kidney ratio, favorable biodistribution, antitumor activity, and a good safety profile in preclinical trials.
Presented at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2024 Annual Meeting, MP0712 aims to treat small-cell lung cancer (SCLC) and other DLL3+ neuroendocrine tumors. A first-in-human study is planned with initial data expected in 2025.
Molecular Partners' RDT platform is expanding to include additional targets, leveraging DARPins' unique properties like high affinity, selectivity, and small size. These advancements address historical challenges in radiopharmaceutical therapeutics, including kidney accumulation and suboptimal tumor uptake.
Molecular Partners has presented the final data from its Phase 1 trial of MP0317, a CD40 agonist, at the ASCO 2024 Annual Meeting. The study included 46 patients with advanced solid tumors and showcased favorable safety and promising efficacy. MP0317 was shown to localize within the tumor microenvironment (TME), activating immune cells without systemic toxicities. The drug's safety profile was manageable, with common side effects being mild fatigue and infusion reactions. One patient exhibited an unconfirmed partial response, while 14 had stable disease. The findings encourage further clinical trials, particularly in combination therapies.
Molecular Partners (MOLN) reported its Q1 2024 results, highlighting advancements in its clinical pipeline.
Key updates include the ongoing Phase 1 trial of MP0533, with dose escalation progressing smoothly and showing promising safety and anti-tumor activity. The Radio-DARPin Therapy platform is advancing with IND-enabling studies set for 2024, and preclinical data to be presented at upcoming conferences.
The company also provided updates on its Switch-DARPin Platform and MP0317 program, both showing progress towards key milestones.
Financially, Molecular Partners has CHF 174.1 million in cash, with no debt, funding into 2026. Operating expenses are expected to be CHF 70-80 million for 2024.
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