Core Viewpoint - Aktis Oncology, Inc. has received Fast Track designation from the U.S. FDA for its drug AKY-1189, aimed at treating adult patients with locally advanced or metastatic urothelial cancer who have progressed after prior systemic therapies [1][7] Group 1: Fast Track Designation - Fast Track designation is intended to expedite the development and review of drugs for serious conditions, allowing for more frequent interactions with the FDA and the possibility of rolling submissions for Biologics License Applications [2] - The designation provides Aktis Oncology a unique opportunity to collaborate closely with the FDA to expedite the development of AKY-1189, addressing an unmet medical need in urothelial cancer treatment [3] Group 2: Clinical Trials and Development - Aktis is conducting a multi-site Phase 1b clinical trial (NCT07020117) for AKY-1189, which includes patients with locally advanced or metastatic urothelial cancer and other Nectin-4 expressing tumors [3] - Preliminary results from Part 1 of the trial are expected to be presented in the first quarter of 2027 [3] Group 3: Technology and Pipeline - Aktis has developed a proprietary miniprotein radioconjugate platform that selectively delivers radioisotopes to targeted tumors, maximizing anti-cancer activity while minimizing exposure to normal tissues [4] - The company’s pipeline includes AKY-1189 targeting Nectin-4 and AKY-2519 targeting B7-H3, with potential applications across various tumor types [5]

Core Insights - Molecular Partners AG has presented promising first patient imaging and dosimetry data for its DLL3-targeted Radio-DARPin candidate MP0712 at the 8th Theranostics World Congress, indicating strong potential for treating small cell lung cancer and other DLL3-expressing neuroendocrine cancers [1][2][4] Clinical Development - The data from five evaluable patients show favorable tumor uptake of MP0712 with limited uptake in healthy tissues, supporting its therapeutic potential [2][3] - The biodistribution and dosimetry data validate the ongoing U.S. Phase 1/2a study of MP0712, which aims to assess safety and determine a recommended phase 2 dose [4][5] Presentation Details - Two posters and an oral presentation were made at the congress, highlighting the specific tumor accumulation and dosimetry data that support the clinical development of MP0712 [5][7] - The oral presentation titled "From DARPins to Radio-DARPin Therapeutics" was scheduled for January 31, 2026, focusing on the progress of MP0712 [7] Future Outlook - Initial clinical data from the Phase 1/2a study of MP0712 is expected in 2026, with the company planning to share safety and activity data as the study progresses [4][5] - The company aims to establish itself as a leader in alpha-targeted therapies for small cell lung cancer and neuroendocrine malignancies [4]

Core Insights - Molecular Partners AG has presented promising first patient imaging and dosimetry data for its DLL3-targeted Radio-DARPin candidate MP0712 at the 8th Theranostics World Congress, indicating strong potential for treating small cell lung cancer and other DLL3-expressing neuroendocrine cancers [1][2][4] Group 1: Clinical Development - The data from five evaluable patients support the clinical development plans for MP0712, which utilizes the therapeutic isotope 212Pb [2][4] - The biodistribution of MP0712 shows specific tumor uptake with limited accumulation in healthy tissues, reinforcing its therapeutic potential [3][4] - The ongoing Phase 1/2a study in the U.S. aims to assess safety and determine a recommended phase 2 dose for MP0712, with initial clinical data expected in 2026 [4][5] Group 2: Presentation Details - The data was presented through two posters and an oral presentation at the Theranostics World Congress, highlighting the favorable distribution profile and dosimetry data of MP0712 [2][5] - An oral presentation titled "From DARPins to Radio-DARPin Therapeutics" was conducted, showcasing the progress of MP0712 [7] Group 3: Company Strategy and Future Outlook - The CEO of Molecular Partners expressed optimism about the data, emphasizing the company's ambition to lead in alpha-targeted therapies for small cell lung cancer and neuroendocrine malignancies [4] - The company plans to share initial Phase 1 safety and activity data in 2026 as it advances its Radio-DARPin platform [4][5] - Molecular Partners' Radio-DARPins are designed to address limitations of traditional radioligand therapy, enhancing tumor uptake while minimizing toxicity [9][10]