LY4170156 / Eli Lilly - LARVOL DELTA

Initial results from a first-in-human phase 1 study of LY4170156, an ADC targeting folate receptor alpha (FRα), in advanced ovarian cancer and other solid tumors. (ASCO 2025) - P1 | "Pts with prior ADCs targeting FRα with payloads other than topo-I (including mirvetuximab soravtansine-gynx [mirv]) were allowed... LY4170156 was well-tolerated with encouraging clinical activity among HGSOC pts, including those with FRα expression < 75% and those with prior mirv. Randomized dose optimization is ongoing and updated data will be presented."

Metastases • P1 data • Anemia • Fatigue • Febrile Neutropenia • High Grade Serous Ovarian Cancer • Neutropenia • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

Lilly presents first clinical data for its investigational, next-generation FRα targeting ADC in platinum-resistant ovarian cancer at the 2025 ASCO Annual Meeting (Eli Lilly Press Release) - P1a/1b | N=360 | NCT06400472 | Sponsor: Eli Lilly and Company | "Eli Lilly and Company...announced new Phase 1 data showing that its folate receptor alpha (FRα) antibody-drug conjugate (ADC) (LY4170156) demonstrated an encouraging safety profile and anti-tumor activity across dose and FRα expression levels in women with heavily pre-treated platinum-resistant ovarian cancer, including patients previously treated with mirvetuximab soravtansine. A preliminary overall objective response rate (ORR) of 55% was observed at the potential recommended Phase 2 dose of 4 mg/kg...These data will be presented today in a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting...As of the March 9, 2025 data cutoff, the study enrolled 95 participants with high-grade serous ovarian cancer across four dose levels (2 - 6 mg/kg)....At the potential recommended Phase 2 dose of 4 mg/kg, the ORR was 55% (11/20 patients)."

P1 data • Platinum resistant • Ovarian Cancer

Lilly announces details of presentations at 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (PRNewswire) - "Presentation Highlights:...(i) LY4170156 (investigational ADC targeting FRα): In a poster presentation, Lilly will report initial results from the multicenter, open-label, first-in-human Phase 1a/1b study of LY4170156 in patients with platinum-resistant ovarian cancer (PROC). LY4170156 is an Fc-silent, FRα specific humanized monoclonal antibody linked to exatecan, a topoisomerase I inhibitor, via a proprietary cleavable polysarcosine linker. The submitted abstract utilized a November 27, 2024 data cut-off date, and the poster will utilize a March 9, 2025 data cut-off date."

P1 data • Platinum resistant • Ovarian Cancer

LOXO-FRA-24001: A Study of LY4170156 in Participants with Selected Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=360 | Recruiting | Sponsor: Eli Lilly and Company | N=220 ➔ 360

Enrollment change • Breast Cancer • Cervical Cancer • Colorectal Cancer • Endometrial Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • Uterine Cancer

A First-In-Human Phase 1 Study Of LY4170156, An Antibody-Drug Conjugate Targeting Folate Receptor a (FRa)-Expressing Advanced Solid Tumors (Trial In Progress) (ESGO 2025) - P1 | "Mirvetuximab soravtansine-gynx, an FRα antibody-drug conjugate (ADC) with a DM4 payload, is approved for the treatment of platinum resistant ovarian cancer (PROC) with high FRα expression representing ~30% of PROC patients (pts). Key secondary objectives are to evaluate the pharmacokinetic profile and antitumor activity of LY4170156 per RECIST v1.1. The study is currently enrolling pts.Results NAConclusion NA"

Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • FOLR1 • PROC

A first-in-human phase I study of LY4170156, an antibody-drug conjugate targeting folate receptor α (FRα)-expressing advanced solid tumors (ESMO 2024) - P1 | "Mirvetuximab soravtansine-gynx, an FRα antibody-drug conjugate (ADC) with a DM4 payload, is approved for the treatment of platinum resistant ovarian cancer (PROC) with high FRα expression representing ∼30% of PROC patients (pts). Primary objectives are to determine the RP2D and assess the safety of LY4170156. Key secondary objectives are to evaluate the pharmacokinetic profile and antitumor activity of LY4170156 per RECIST v1.1."

Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • FOLR1 • PROC

A Study of LY4170156 in Participants With Selected Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=220 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Tumor cell • Breast Cancer • Cervical Cancer • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • Uterine Cancer

A Study of LY4170156 in Participants With Selected Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=220 | Not yet recruiting | Sponsor: Eli Lilly and Company

Metastases • New P1 trial • Tumor cell • Breast Cancer • Cervical Cancer • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • Uterine Cancer

MBK-103, a potent novel conjugation platform-based antibody-drug conjugate, changing therapeutic options in folate receptor alpha positive cancer patients (AACR 2023) - "The compound was also very well tolerated in cynomolgus monkeys with HNSTD at 50 mg/kg and even when administered repeatedly. High conjugation yields along with 100% homogeneity are major drivers of the successful ongoing manufacturing process with planned IND submission in Q4/2023."

Clinical • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • FOLR1

Mablink Bioscience to Present Promising Preclinical Data for Lead ADC Candidate MBK-103 at the AACR Annual Meeting 2023 (GlobeNewswire) - "Mablink Bioscience...announced that preclinical efficacy and safety data on its lead ADC candidate, MBK-103, will be presented at the American Association for Cancer Research ('AACR') Meeting 2023 on April 17, 2023, in Orlando, Florida....The compound was also well tolerated in cynomolgus monkeys at the highest non-severely toxic dose (HNSTD) of 50 mg/kg administered repeatedly. These promising data are a significant differentiator in the ADC’s landscape."

Preclinical • Oncology • Solid Tumor

Mablink Bioscience Announces a €31 Million Series A Funding Round Led by Sofinnova Partners and Mérieux Equity Partners (Issuer Direct) - "Mablink Bioscience...announced today that it has raised a €31 million Series A funding round to advance its lead candidate to the clinic and to build a pipeline of ADCs using its proprietary platform technology....The proceeds of this financing round will enable Mablink to become a clinical-stage biotech by bringing its lead candidate, MBK-103, into clinical development for the treatment of solid tumors, notably ovarian cancer."

Financing • Oncology • Solid Tumor