IGI, a Clinical-Stage Oncology Biotech, Reveals Initial Results from Groundbreaking Trispecific TREAT Antibody Study
Based in New York, Ichnos Glenmark Innovation (IGI), a prominent clinical-stage biotech company known for its multispecific developments in the oncology sector, has revealed the initial clinical data from the early dose-escalation phase of its groundbreaking phase 1 trial of ISB 2001. This investigational study focuses on relapsed or refractory multiple myeloma (RRMM).
About ISB 2001:
ISB 2001, the experimental trispecific TREAT antibody, targets BCMA and CD38 on multiple myeloma cells as well as CD3 on T cells. Early results from 20 participants treated as of October 1, 2024, indicated a 75% overall response rate (ORR) across doses ranging from 0.005 to 1.2 mg/kg, with stringent complete remission (sCR) and complete remission (CR) rates at 20%. For the 18 patients treated at active doses (0.05 mg/kg and above), the ORR was 83%, including a 22% sCR/CR rate. This safety profile was mild and tolerable, outperforming previous-generation 1+1 bispecifics.
Presentation and Experts’ Commentary:
These findings were shared at the renowned 66th American Society of Hematology (ASH) Annual Meeting in San Diego, California.
“Today’s presentation on ISB 2001 emphasizes its astounding efficacy as an innovative trispecific-antibody engager for T cells. These results are exceptionally remarkable for this patient demographic. ISB 2001 holds enormous potential to transform treatment paradigms for multiple myeloma patients who have exhausted approved therapies,” expressed Professor Hang Quach, M.D., from the University of Melbourne and St Vincent’s Hospital Melbourne.
Design and Development of ISB 2001:
ISB 2001 is crafted to enhance binding affinity with dual binders targeting specific myeloma-linked antigens, even at minimal expression levels, ensuring enhanced safety over earlier bispecific antibodies. IGI focuses on ISB 2001 to address pressing needs of RRMM patients, often post T-cell therapy, such as CAR-T cells and bispecifics.
“The preliminary data involving merely 20 participants are promising. ISB 2001 has demonstrated significant clinical outcomes in a heavily pretreated patient base. Coupled with a favorable safety and tolerance profile, these outcomes suggest that ISB 2001 might become a pivotal asset for RRMM treatment,” highlighted Lida Pacaud, M.D., IGI’s Chief Medical Officer.
Pacaud further mentioned, “We are thrilled to progress with ISB 2001, completing dose-escalation and eagerly moving into the dose-expansion phase to determine the recommended phase 2 dosage and ideal dosing routine.”
Study Overview and Implications:
The phase 1, first-in-human, open-label investigation scrutinizes ISB 2001’s safety and anti-myeloma efficacy in RRMM sufferers (NCT05862012). It targets patients who have undergone immunomodulatory regimes, proteasome inhibitors, and anti-CD38 monoclonal antibodies, yet remain resistant to or intolerant of established beneficial therapies. Suitable candidates include those with prior CAR-T cell experiences, bispecific uses, and/or former BCMA-targeted treatments.
Divided into two phases: dose-escalation and dose-expansion. Current data hails from initial dose-escalation within six US and Australian premises.
ISB 2001 displays a promising safety metric in extensively pretreated RRMM subjects, with no dose-limiting adverse effects or treatment halts for adverse reactions.
Of the 20 extensively pretreated patients, a 75% overall response rate was observed across all dose dimensions.
ISB 2001 was conceptualized via IGI’s proprietary BEAT protein platform, blending TCR interface-focused heavy chain pairing with universal light chain tech to architect multispecific antibodies. This inventive layout can bolster tumor cell adhesion while minimizing untargeted effects and/or enhance immune attacks against tumors by leveraging multiple signaling pathways.
Cyril Konto, M.D., President, and CEO of IGI, stated:
“Despite notable progress in treating relapsed/refractory multiple myeloma, many individuals still relapse. IGI crafted ISB 2001 to present a therapeutic solution to those who’ve previously pursued T-cell guided treatments, varying from initial bispecifics to CAR-T cells.”
Konto also remarked, “These findings affirm IGI’s BEAT technology, effectively addressing stability and engineering challenges that previously obstructed large-scale multipurpose antibody production.”
Partnered under Ichnos Glenmark Innovation (IGI), Ichnos Sciences Inc., and Glenmark Pharmaceuticals Ltd. (Glenmark) fuel efforts to accelerate innovative cancer treatment discoveries.