Ichnos Glenmark presents data from Phase 1 study of ISB 2001 in multiple myeloma
In a presentation at the 66th American Society of Hematology Annual Meeting, Ichnos Glenmark Innovation (IGI) unveiled promising results from its Phase 1 clinical trial of ISB 2001, a trispecific antibody developed for the treatment of relapsed or refractory multiple myeloma. The study showed an impressive overall response rate (ORR) and revealed ISB 2001’s potential to revolutionize how heavily pretreated patients with multiple myeloma are managed. This marks a significant milestone in cancer research, with the trispecific antibody demonstrating both efficacy and a favorable safety profile.
Phase 1 Clinical Data: Key Findings
The Phase 1 trial of ISB 2001 was designed to assess its safety and anti-myeloma activity. Initial results from the first 20 heavily pretreated patients indicate a robust ORR of 75%, with an ORR of 83% among those receiving active doses (0.05 mg/kg or higher). The data suggests that ISB 2001, a trispecific antibody targeting BCMA, CD38, and CD3, offers significant clinical benefits even in patients who have already undergone multiple treatment regimens, including CAR-T therapies and bispecific antibodies.
Patients exhibited durable responses, with a stringent complete remission (sCR) and complete remission (CR) rate of 20%. The median time to the first objective response was 36 days, and 80% of patients remained on treatment at the time of data cutoff. These findings suggest that ISB 2001 could become a game-changing option for multiple myeloma patients who have exhausted current therapies.
Safety Profile and Tolerability
The safety profile of ISB 2001 further underscores its potential. No dose-limiting toxicities were observed up to the highest tested dose of 1.2 mg/kg. Cytokine Release Syndrome (CRS) was mild in most cases, with no neurotoxicity or treatment discontinuations due to adverse events. Grade 1 CRS was reported in 65% of patients, and the median duration was just two days. These findings indicate that ISB 2001 has a manageable safety profile, especially in comparison to first-generation bispecific antibodies.
Expert Opinion on ISB 2001’s Potential
Professor Hang Quach, a leading hematologist at the University of Melbourne, expressed enthusiasm over the results, stating that the clinical data demonstrated by ISB 2001 were among the most impressive he had seen in this patient population. He emphasized that the trispecific antibody could potentially revolutionize the treatment landscape for multiple myeloma, offering a new, highly effective option for patients who have exhausted available therapies.
Dr. Lida Pacaud, Chief Medical Officer at IGI, also highlighted the promising data, noting that ISB 2001 showed encouraging clinical responses, especially in a heavily pretreated population. She stressed that the drug’s favorable safety and tolerability, combined with its effectiveness, could lead to its role as a significant advancement in treating multiple myeloma in the future.
The Future of ISB 2001 and IGI’s BEAT Platform
ISB 2001 was developed using IGI’s proprietary BEAT protein platform, designed to create multispecific antibodies that enhance tumor cell binding while minimizing off-tumor side effects. Dr. Cyril Konto, President and CEO of IGI, underscored the role of this innovative platform in overcoming engineering challenges that have previously hindered the large-scale production of bispecific antibodies. He expressed confidence that the promising results from ISB 2001 will drive further development and provide new hope for patients battling relapsed/refractory multiple myeloma.
The Phase 1 clinical data on ISB 2001 marks a critical advancement in the field of oncology, particularly for patients with relapsed or refractory multiple myeloma. The trispecific antibody has demonstrated an encouraging overall response rate, favorable safety profile, and durable responses, setting the stage for further trials and potential approval. As the study progresses into its dose-expansion phase, ISB 2001 could soon provide a new therapeutic avenue for patients who have limited options, representing a potential breakthrough in the fight against multiple myeloma.
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