Biotechnology company Immunome (Nasdaq: IMNM) announced today that it has dosed the first patient in its Phase 1, first-in-human clinical trial of IM-1021, a ROR1-targeted antibody-drug conjugate (ADC). This milestone marks an important step forward in the company's development of targeted cancer therapies.
"Immunome is developing differentiated ADCs that we believe can greatly benefit cancer patients," said Bob Lechleider, M.D., Chief Medical Officer at Immunome. "The dosing of our first patient with IM-1021 advances that mission, as we work to establish safety and explore efficacy of IM-1021 in patients with high unmet need in B-cell lymphomas and solid tumors."
Trial Design and Target Population
The Phase 1 trial is designed as an open-label, multicenter dose escalation and expansion study. Its primary objectives are to determine the safety, tolerability, and pharmacokinetics of IM-1021, while also assessing preliminary anti-tumor activity. The study will enroll participants with advanced B-cell lymphomas and advanced solid tumors, populations that often have limited treatment options after progression on standard therapies.
IM-1021 represents a novel approach in targeted cancer therapy, incorporating Immunome's proprietary TOP1 inhibitor, HC74, with a ROR1-targeted antibody. ROR1 (receptor tyrosine kinase-like orphan receptor 1) is an oncofetal protein that is highly expressed in various malignancies but has minimal expression in normal adult tissues, making it an attractive target for cancer therapy.
Expanding Pipeline of Targeted Therapies
This trial adds to Immunome's growing portfolio of targeted oncology therapeutics. The company's most advanced pipeline programs include:
- Varegacestat (formerly AL102), a gamma secretase inhibitor currently in Phase 3 trials for desmoid tumors
- IM-1021, the ROR1-targeted ADC now in Phase 1 trials
- IM-3050, a FAP-targeted radioligand with an IND submission expected in Q1 2025
- Several preclinical ADCs (IM-1617, IM-1335, and IM-1340) targeting undisclosed molecules expressed in multiple solid tumors
The Promise of ADC Technology
Antibody-drug conjugates represent a significant advancement in precision oncology, combining the targeting ability of monoclonal antibodies with potent cytotoxic payloads. This approach aims to deliver therapeutic agents directly to cancer cells while minimizing damage to healthy tissues.
The development of IM-1021 builds on Immunome's expertise in this field, with leadership that previously played key roles in the design, development, and commercialization of other cutting-edge targeted cancer therapies, including ADCs.
Market Context and Unmet Need
The advancement of IM-1021 into clinical trials comes at a time of growing interest in ADC technology across the oncology landscape. Several ADCs have demonstrated remarkable clinical efficacy in recent years, leading to multiple FDA approvals and increased investment in this therapeutic approach.
For patients with relapsed or refractory B-cell lymphomas and advanced solid tumors, new treatment options are urgently needed. Current therapies often provide limited durability of response, and many patients eventually develop resistance to available treatments.
As Immunome progresses its clinical development program for IM-1021, the company will be working to establish whether this novel ADC can address these significant unmet needs and potentially provide new hope for patients with limited treatment options.
The company has not disclosed a timeline for when initial data from this Phase 1 trial might be available, but typical dose-escalation studies in oncology often generate preliminary safety findings within 12-18 months of initiation.
