Immunic and I-Mab recently provided corporate updates and reported financial results, highlighting progress in their respective clinical pipelines. Immunic's lead asset, vidofludimus calcium (IMU-838), is advancing through phase 3 trials for relapsing multiple sclerosis (RMS) and phase 2 trials for progressive multiple sclerosis (PMS), while I-Mab is focused on developing differentiated immunotherapies for cancer treatment.
Immunic's Vidofludimus Calcium Shows Promise in Multiple Sclerosis
Immunic's twin phase 3 ENSURE trials evaluating vidofludimus calcium in RMS are proceeding as planned after an interim futility analysis by an Independent Data Monitoring Committee (IDMC) confirmed that the trials should continue without any sample size increase. The company expects to complete the ENSURE-1 trial in the second quarter of 2026 and the ENSURE-2 trial in the second half of 2026.
"We continue to believe that, if approved, vidofludimus calcium, with its combined neuroprotective, anti-inflammatory and anti-viral effects, would represent a unique new treatment option targeted to the complex pathophysiology of MS," said Daniel Vitt, Ph.D., Chief Executive Officer of Immunic.
Vidofludimus calcium is an orally available, small molecule activator of nuclear receptor related 1 (Nurr1). It combines neuroprotective effects with anti-inflammatory and anti-viral properties by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH).
The company anticipates top-line data from the phase 2 CALLIPER trial of vidofludimus calcium in PMS in April 2025. Interim data from the CALLIPER trial supported the potential effectiveness of vidofludimus calcium in slowing disease progression in PMS and further substantiated its neuroprotective capabilities through the activation of Nurr1.
I-Mab Advances Immunotherapy Pipeline
I-Mab is making strides in advancing its pipeline of immunotherapies. Uliledlimab (TJ004309), an antibody targeting CD73, is set to begin a randomized phase 2 combination study in first-line metastatic non-small cell lung cancer (mNSCLC) in the first half of 2025. Phase 1 data presented at the 2024 World Conference on Lung Cancer (WCLC 2024) showed that uliledlimab achieved full target engagement with a positive correlation between the overall response rate (ORR) in patients with mNSCLC and uliledlimab exposure.
Givastomig (TJ033721 / ABL111), a bispecific antibody targeting Claudin 18.2 (CLDN 18.2)-positive tumor cells, is currently in a phase 1b escalation and expansion study in combination with nivolumab plus chemotherapy in first-line metastatic gastric cancer. Topline phase 1 monotherapy data presented at the European Society for Medical Oncology (ESMO 2024) showed promising objective responses in patients with gastric cancers expressing CLDN 18.2 across low and high levels.
The study showed an ORR of 16.3% (7/43), including seven partial responses (PR) at doses between 5 mg/kg and 18 mg/kg, with five of the seven patients (71%) having received prior checkpoint inhibitor therapy. Stable disease (SD) was reported in 14 patients, with a disease control rate (DCR) of 48.8% (21/43 patients). The safety profile was favorable, with mainly grade 1 or 2 treatment-related adverse events (TRAEs) and no observations of dose-limiting toxicities (DLTs) or identification of a maximum tolerated dose (MTD).
I-Mab also presented a poster highlighting phase 1 pharmacokinetic modeling data for optimizing dose estimation of givastomig at the Society for Immunotherapy of Cancer (SITC 2024) on November 9, 2024, based on three clinical studies and additional nonclinical data. The studies demonstrated a dose-response relationship for givastomig and supported 8-12 mg/kg administered every two weeks (Q2W) as the optimal monotherapy dose range for gastric cancer patients.
Ragistomig (TJ-L14B / ABL503), a bispecific antibody designed to provide anti-PD-L1 activity and conditional 4-1BB-driven T-cell activation, is in phase 1 dose escalation and dose expansion in advanced and/or PD-L1 positive, solid tumors. In October, the United States Patent and Trademark Office (USPTO) issued a composition of matter patent for ragistomig, providing coverage through February 2039 before consideration of any potential patent term extensions.
"I-Mab is making excellent progress in advancing the development of our pipeline projects, supported by our strong cash balance, streamlined operating model, and a focused in-licensing strategy," said Dr. Sean Fu, CEO and Board Member of I-Mab.
