IM-1021 / Immunome, Zentalis Pharma - LARVOL DELTA

Immunome Doses First Patient in Phase 1 Trial of IM-1021, a ROR1-Targeted ADC (Businesswire) - "Immunome, Inc...announced that the first patient has been dosed in the Phase 1, first-in-human trial of IM-1021, a ROR1-targeted ADC....The Phase 1 trial is an open-label, multicenter dose escalation and expansion study designed to determine the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of IM-1021. The study is expected to include participants with advanced B-cell lymphomas and advanced solid tumors."

Trial status • B Cell Lymphoma • Solid Tumor

A Phase 1 Study of IM-1021 in Participants with Advanced Cancer (clinicaltrials.gov) - P1 | N=117 | Recruiting | Sponsor: Immunome, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor

A Phase 1 Study of IM-1021 in Participants with Advanced Cancer (clinicaltrials.gov) - P1 | N=117 | Not yet recruiting | Sponsor: Immunome, Inc.

New P1 trial • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor

Immunome Provides Pipeline Update in Advance of Presentation at the 43rd Annual J.P. Morgan Healthcare Conference (Businesswire) - "The presentation will cover Immunome’s pipeline of targeted therapeutics, including varegacestat (formerly known as AL102), a once-daily oral gamma secretase inhibitor in the Phase 3 RINGSIDE clinical trial for the treatment of desmoid tumors. Immunome expects to report topline data in the second half of 2025....Immunome also announced the FDA clearance of its IND submission for IM-1021, a ROR1-targeted ADC. Immunome anticipates submitting an IND for IM-3050, its FAP-targeted radioligand therapy, by the end of the first quarter of 2025."

IND • P3 data: top line • Desmoid Tumors

Preclinical evaluation of IM-1021, a ROR1-targeted antibody-drug conjugate with a novel topoisomerase I linker payload (EORTC-NCI-AACR 2024) - "The efficacy of IM-1021 was evaluated across several mouse xenograft models and was also compared to zilovertamab vedotin (ZV). IM-1021 was more active than ZV at the same dose and schedule in cell-derived xenograft models of mantle cell lymphoma and triple negative breast cancer, and also induced significant regressions in patient-derived lung cancer xenografts with low ROR1 expression. ConclusionsWe have developed a novel ADC candidate with best-in-class potential for ROR1-expressing tumors using a proprietary and differentiated topoisomerase I linker payload technology."

Preclinical • Breast Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Mantle Cell Lymphoma • Oncology • Solid Tumor • Triple Negative Breast Cancer • ROR1 • TOP1

Immunome Reports Third Quarter 2024 Financial Results and Provides Business Update (Businesswire) - "Immunome expects to report topline data for RINGSIDE Part B in the second half of 2025. In parallel, Immunome is performing additional manufacturing and pharmacology work required to support a new drug application filing for AL102. Immunome also anticipates submitting INDs for IM-1021 and IM-3050 in the first quarter of 2025, as previously disclosed."

IND • P3 data • Desmoid Tumors

Immunome Presents Compelling Preclinical Data Demonstrating Robust Anti-Tumor Activity for IM-1021 (Businesswire) - "The poster included preclinical results for IM-1021 in both liquid and solid tumors while also highlighting the enhanced ADME properties of HC74: IM-1021 showed superior efficacy compared to zilovertamab vedotin in both the Jeko-1 mantle cell lymphoma model and the MDA-MB-468 triple negative breast cancer model. In the MDA-MB-468 study, 5 out of 8 animals achieved complete responses after three 5 mg/kg doses. HC74 demonstrated superior potency (IC50=5nM) compared to deruxtecan (IC50=20nM) in a panel of 89 cancer cell lines. HC74 showed faster hepatocyte clearance, higher permeability, and lower efflux than deruxtecan."

Preclinical • Mantle Cell Lymphoma • Triple Negative Breast Cancer

Immunome to Present Poster Highlighting Preclinical Evaluation of IM-1021, a ROR1-Targeted Antibody Drug Conjugate, at the 36th EORTC-NCI-AACR Symposium (Businesswire) - "Immunome, Inc...announced that it will present a poster highlighting preclinical evaluation of IM-1021, a ROR1-targeted antibody drug conjugate (ADC), at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona on October 24, 2024....Immunome expects to submit an IND for the IM-1021 program to the FDA in the first quarter of 2025."

IND • Preclinical • Oncology

Immunome Reports Second Quarter 2024 Financial Results and Provides Business Update (Businesswire) - "...Immunome continues to expect to report topline data for RINGSIDE Part B in the second half of 2025. In parallel, Immunome is performing additional manufacturing and pharmacology work required to support a new drug application filing for AL102. Immunome also anticipates submitting INDs for IM-1021 and IM-3050 in the first quarter of 2025, as previously disclosed."

Commercial • IND • P3 data • Desmoid Tumors

Immunome Reports First Quarter 2024 Financial Results and Provides Business Update (Businesswire) - "Immunome expects to report topline data for RINGSIDE Part B in the second half of 2025...Immunome anticipates submitting INDs for two preclinical candidates in the first quarter of 2025: IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted RLT....In-process research and development expenses for the quarter ended March 31, 2024 were $112.0 million. These expenses were related to Immunome’s acquisition of AL101 and AL102 from Ayala Pharmaceuticals, Inc. and the exclusive license of IM-1021 and related ADC platform technology from Zentalis Pharmaceuticals, Inc., both of which closed in the quarter ended March 31, 2024."

Commercial • IND • P2/3 data • Desmoid Tumors • Oncology • Solid Tumor

Immunome Reports Full Year 2023 Financial Results and Provides Update on Recently Acquired Assets (Businesswire) - "Topline data for Phase 3 RINGSIDE trial of AL102 expected in first quarter of 2025; IM-1021 and IM-3050 IND filings expected in first quarter of 2025; Current cash expected to fund activities into 2026."

IND • P3 data: top line • Desmoid Tumors • Oncology • Solid Tumor

Immunome Exclusively Licenses Zentalis ROR1 Antibody-Drug Conjugate and Proprietary Technology Platform (Businesswire) - "Immunome, Inc...and Zentalis^® Pharmaceuticals, Inc...announced that they have entered into an exclusive, worldwide license agreement under which Immunome has licensed from Zentalis ZPC-21, a preclinical ROR1 antibody-drug conjugate (ADC) with best-in-class potential on track for IND submission in 1Q 2025, and Zentalis’ proprietary ADC platform technology....Under the terms of the deal, Zentalis will receive an up-front payment of $35 million in cash and Immunome common stock. Zentalis will be eligible to receive up to $275 million of milestone payments for ZPC-21 and the platform technology in addition to mid-to-high single-digit royalties."

IND • Licensing / partnership • Oncology • Solid Tumor