MP0712 / Orano, Molecular Partners - LARVOL DELTA

Molecular Partners Highlights Favorable MP0712 DLL3 Radiotherapeutic Imaging, U.S. Phase I/II Ready (Yahoo Finance) - "The U.S. phase I/II trial is open and ready for screening with initial patients expected soon; Molecular Partners is collaborating with Orano Med using Lead-203 for imaging and Lead-212 for therapy (with Actinium-225 discussed as a potential future option) and plans safety updates in H1 and early activity readouts in H2 2026."

P1/2 data • Gastrointestinal Neuroendocrine Carcinoma • Large Cell Neuroendocrine Carcinoma • Lung Neuroendocrine Carcinoma • Small Cell Lung Cancer

Study of [212Pb]Pb-DOTAM-MAM279 ([212Pb]Pb-MP0712) in Patients With Small Cell Lung Cancer and Other DLL3 Expressing Solid Tumors (clinicaltrials.gov) - P1/2 | N=138 | Recruiting | Sponsor: Molecular Partners AG | Not yet recruiting ➔ Recruiting | Trial completion date: Sep 2030 ➔ Sep 2032

Enrollment open • Trial completion date • Endocrine Cancer • Large Cell Carcinoma • Lung Cancer • Neuroendocrine Carcinoma • Oncology • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor • DLL3

Study of [212Pb]Pb-DOTAM-MAM279 in Patients With Small Cell Lung Cancer and Other DLL3 Expressing Solid Tumors (clinicaltrials.gov) - P1/2 | N=138 | Not yet recruiting | Sponsor: Molecular Partners AG

New P1/2 trial • Endocrine Cancer • Large Cell Carcinoma • Lung Cancer • Neuroendocrine Carcinoma • Oncology • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor

The Phase 1 Investigational New Drug (IND) application for MP0712…for the treatment of small cell lung cancer (SCLC) and other DLL3-expressing neuroendocrine cancers, has been filed (GlobeNewswire) - "Dialogue with the FDA is ongoing and, pending regulatory clearance, the Phase 1 trial is expected to initiate before the end of 2025."

IND • New P1 trial • Neuroendocrine Carcinoma • Small Cell Lung Cancer

MP0712, the first anti-DLL3 212Pb radio-DARPin (RDT) candidate for targeted radiotherapy of small cell lung cancer (SCLC) (AACR 2025) - "In NCI-H82 tumors, median survival duration increased up to 3-fold with MP0317 compared with the buffer control. MP0712 also showed a favorable safety profile in vivo up to 30µCi. These preclinical results support our 212Pb-based RDT against DLL3 as a promising treatment option for SCLC, with encouraging in vivo antitumor activity and a good safety profile for our first DLL3-targeting 212Pb-RDT candidate for further development into the clinic."

Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • DLL3

Molecular Partners presents new preclinical data on Radio-DARPin and Switch-DARPin programs at AACR 2025 (GlobeNewswire) - "Preclinical data presented on MP0712, a DLL3-targeting and 212Pb-labeled Radio-DARPin, show a high tumor uptake and a favorable safety profile for MP0712, with good efficacy and tumor reduction in mouse models matching clinically relevant DLL3 expression levels. With these data, the IND-enabling package is complete; IND filing and initial first-in-human clinical data are expected in 2025. DLL3 is a promising target for radioligand therapy as it is highly upregulated in small cell lung cancer and other high-grade neuroendocrine tumors, while not expressed in healthy tissues."

IND • Preclinical • Neuroendocrine Carcinoma • Small Cell Lung Cancer

Molecular Partners Outlines Clinical Expansion Plans and Strengthens Radiopharma Strategic Focus for 2025 at 43rd Annual J.P. Morgan Healthcare Conference (GlobeNewswire) - "Dialogue with the U.S. Food and Drug Administration (FDA) is ongoing and Molecular Partners and Orano Med anticipate submitting the IND application for MP0712 in H1 2025, with the first-in-human study to start following regulatory clearance....Molecular Partners has submitted an amendment to the study protocol to improve the exposure profile of MP0533 and to further deepen and expand responses being observed in cohort 8. Data on the amended dosing scheme are expected in 2025."

Clinical protocol • IND • Acute Myelogenous Leukemia • Myelodysplastic Syndrome • Small Cell Lung Cancer

Molecular Partners and Orano Med Present Additional Positive Preclinical Data Supporting DLL3 Targeting Radio-DARPin Therapeutic Candidate MP0712 at EANM 2024 (GlobeNewswire) - "Molecular Partners and Orano Med anticipate initiating first-in-human studies, pending regulatory clearance, in 2025. Initial clinical data of MP0712 is also anticipated in 2025....Dose-range finding studies in mice confirmed that treatment at a clinically relevant dosage was well tolerated, supporting a favorable safety profile. Finally, MP0712 led to strong and dose-dependent efficacy in mice bearing established tumors with clinically-relevant levels of DLL3 expression and at a clinically-relevant dose, as compared to a positive control of a radiolabelled anti-DLL3 antibody rovalpituzumab (Rova)."

Preclinical • Small Cell Lung Cancer

Molecular Partners Announces Upcoming Top-Rated Oral Presentation on MP0712, a ²¹²Pb-labeled Radio-DARPin Therapeutic targeting DLL3 for Small Cell Lung Cancer co-developed with Orano Med, at EANM 2024 (Molecular Partners Press Release) - "Molecular Partners AG...announced that the Company will present on its lead-212 (212Pb)-labeled Radio-DARPin Therapeutic (RDT) targeting delta-like ligand 3 (DLL3) co-developed with Orano Med, at the European Assocation of Nuclear Medicine (EANM) Congress....At EANM 2024, Molecular Partners will present their preclinical results supporting MP0712 as a promising treatment candidate for SCLC, with an attractive biodistribution profile, potent antitumor activity and a good safety profile."

Preclinical • Small Cell Lung Cancer

Molecular Partners Reports H1 2024 Corporate Highlights and Financials (Molecular Partners Press Release) - "MP0712: Molecular Partners will present additional data in an oral presentation at the 2024 Congress of the European Association of Nuclear Medicine (EANM) in October 2024, and plans to initiate a first-in-human clinical trial of MP0712 in 2025; MP0533: MP0533...is currently being evaluated in a Phase 1/2a clinical trial for patients with relapsed/refractory acute myeloid leukemia (r/r AML) and myelodysplastic syndrome/AML...Molecular Partners plans to present a clinical update on the program in H2 2024, and on the amended dosing scheme for MP0533 in 2025."

Clinical • New P1 trial • Preclinical • Acute Myelogenous Leukemia • Myelodysplastic Syndrome • Oncology