varegacestat (AL102) / Immunome - LARVOL DELTA

Change in T2-weighted signal intensity, change in tumor volume, and exposure-response analysis in the RINGSIDE phase 2 study of varegacestat in patients with desmoid tumors. (ASCO 2025) - P2/3 | "Substantial early and rapid reductions in T2W and TV on MRI preceded eventual RECIST responses in adults with DT treated with varegacestat. These data add to a growing body of work showing T2W and TV may play a role in evaluating treatment response in DT. Future research should evaluate the prognostic or predictive value of these imaging techniques in DT and standardization to allow for use in clinical management of DT patients."

Clinical • P2 data • Desmoid Tumors • Oncology • Pain • Sarcoma

Subgroup analysis of the phase 2 part of the RINGSIDE phase 2/3 trial of varegacestat for treatment of desmoid tumors. (ASCO 2025) - P2/3 | "Comparable, objective tumor responses to oral varegacestat therapy were shown in all subgroups examined. These findings support continued evaluation of all desmoid tumor patients independent of subgroups in the ongoing, double-blind, randomized, placebo-controlled Phase 3 study of varegacestat (RINGSIDE NCT04871282). Varegacestat response in subgroups."

P2/3 data • Addiction (Opioid and Alcohol) • Desmoid Tumors • Oncology • Pain • Sarcoma • CTNNB1

Immunome Reports First Quarter 2025 Financial Results and Provides Business Update (Yahoo Finance) - "Pipeline Highlights: (i) Varegacestat:...Immunome expects to report topline data for RINGSIDE Part B in the second half of 2025...; (ii) IM-3050: Immunome received IND clearance for IM-3050 in April 2025 and expects to initiate a Phase 1 clinical trial in the second half of 2025."

IND • New P1 trial • P3 data: top line • Desmoid Tumors • Solid Tumor

A Phase 1 Study to Examine the Effects of Itraconazole After Single Dose Administration of Varegacestat (AL102) to Healthy Participants (clinicaltrials.gov) - P1 | N=22 | Completed | Sponsor: Immunome, Inc. | Active, not recruiting ➔ Completed

Trial completion

A Cardiac Liability Study of Varegacestat in Healthy Participants (clinicaltrials.gov) - P1 | N=32 | Active, not recruiting | Sponsor: Immunome, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed

A Phase 1 Mass Balance Study of Varegacestat (clinicaltrials.gov) - P1 | N=6 | Active, not recruiting | Sponsor: Immunome, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed

Immunome Reports Full Year 2024 Financial Results and Provides Business Update (Businesswire) - "Pipeline Highlights: Varegacestat: Full enrollment for the Phase 3 RINGSIDE Part B study of varegacestat for the treatment of desmoid tumors was completed in February 2024, and Immunome expects to report topline data for RINGSIDE Part B in the second half of 2025."

Enrollment closed • P3 data: top line • Desmoid Tumors

A Varegacestat Hepatic Impairment Study (clinicaltrials.gov) - P1 | N=44 | Recruiting | Sponsor: Immunome, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology

A Cardiac Liability Study of Varegacestat in Healthy Participants (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Immunome, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

A Cardiac Liability Study of Varegacestat in Healthy Participants (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Immunome, Inc.

New P1 trial

A Phase 1 Study to Examine the Effects of Itraconazole After Single Dose Administration of Varegacestat (AL102) to Healthy Participants (clinicaltrials.gov) - P1 | N=22 | Active, not recruiting | Sponsor: Immunome, Inc. | Trial completion date: Jan 2025 ➔ Apr 2025

Trial completion date

A Phase 1 Mass Balance Study of Varegacestat (clinicaltrials.gov) - P1 | N=6 | Recruiting | Sponsor: Immunome, Inc.

New P1 trial

A Phase 1 Varegacestat Hepatic Impairment Study (clinicaltrials.gov) - P1 | N=44 | Not yet recruiting | Sponsor: Immunome, Inc.

New P1 trial • Hepatology

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

A Phase 1 Study to Examine the Effects of Itraconazole After Single Dose Administration of Varegacestat (AL102) to Healthy Participants (clinicaltrials.gov) - P1 | N=22 | Active, not recruiting | Sponsor: Immunome, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed

A Phase 1 Study to Examine the Effects of Itraconazole After Single Dose Administration of Varegacestat (AL102) to Healthy Participants (clinicaltrials.gov) - P1 | N=22 | Recruiting | Sponsor: Immunome, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

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

A Phase 1 Study to Examine the Effects of Itraconazole After Single Dose Administration of Varegacestat (AL102) to Healthy Participants (clinicaltrials.gov) - P1 | N=22 | Not yet recruiting | Sponsor: Immunome, Inc.

New P1 trial

Gamma-Secretase Inhibitor-Associated Hypophosphatemia in Patients with Desmoid Tumors (KIDNEY WEEK 2024) - "The objective of the study was to elucidate the mechanism of GSI-HP. We used our institute's electronic medical record system to conduct a retrospective cohort analysis of the subjects in the DeFi trial, the RINGSIDE trial (an ongoing trial of AL102, another GSI), and those on compassionate use of nirogacestat at a single large cancer center. We conclude that the primary mechanism of GSI-HP is gastrointestinal loss due to diarrhea. High urine FePO4 may also contribute to GSI-HP in some patients, but FGF23 does not mediate it. This is the first study to describe the mechanism of GSI-HP."

Clinical • Desmoid Tumors • Gastrointestinal Disorder • Oncology • Renal Disease • Sarcoma • FGF23

RINGSIDE: A Study of AL102 in Patients With Progressing Desmoid Tumors (clinicaltrials.gov) - P2/3 | N=192 | Active, not recruiting | Sponsor: Immunome, Inc. | Trial completion date: Feb 2025 ➔ Oct 2026 | Trial primary completion date: Jan 2025 ➔ Oct 2025

Trial completion date • Trial primary completion date • Desmoid Tumors • Oncology • Sarcoma

Updated results of the RINGSIDE phase II trial and open-label extension of AL102 for treatment of desmoid tumors (ESMO 2024) - P2/3 | "AL102 was well tolerated with a safety profile consistent with previously reported GSI toxicities. Efficacy of the 1.2 mg QD dose was demonstrated early and continued to improve with longer time on treatment. Enrollment in the RINGSIDE phase III randomized, controlled trial of 1.2 mg QD is complete, and the study is ongoing."

Clinical • P2 data • Desmoid Tumors • Oncology • Sarcoma

Immunome to Present Updated Results for RINGSIDE Phase 2 Trial of AL102 for the Treatment of Desmoid Tumors at the European Society for Medical Oncology (ESMO) Congress 2024 (Businesswire) - "Immunome, Inc...announced that it will present a poster with updated results from the RINGSIDE Phase 2 clinical trial of AL102 for the treatment of desmoid tumors at the European Society of Medical Oncology (ESMO) Congress, being held in Barcelona from 13-17 September 2024. Enrollment in the Phase 3 portion of RINGSIDE was completed in February 2024, and Immunome expects to report topline data from that trial in the second half of 2025."

P2 data • P3 data: top line • Desmoid Tumors • Oncology • Solid Tumor

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