Ichnos Glenmark to Present Phase I Study Data for Myeloma Drug Candidate ISB 830
Ichnos Glenmark, a subsidiary of Glenmark Pharmaceuticals focused on discovering and developing novel immuno-oncology therapies, has announced that it will present new data from its Phase I clinical trial evaluating its drug candidate, ISB 830, in patients with multiple myeloma. The data will be shared at an upcoming scientific conference, marking a significant milestone in the development of the drug, which is designed to target the immune checkpoint receptor LAG-3 to enhance immune response against cancer cells.
The Phase I study, which was initiated to evaluate the safety, tolerability, and preliminary efficacy of ISB 830, has shown promising early results, according to a statement from the company. The trial primarily aimed to determine the maximum tolerated dose (MTD) of the drug, along with its pharmacokinetics (how the drug is absorbed, distributed, metabolized, and excreted in the body), and potential early signs of antitumor activity in patients with relapsed or refractory multiple myeloma (RRMM).
Targeting LAG-3 in Multiple Myeloma
Multiple myeloma is a type of blood cancer characterized by the uncontrolled growth of plasma cells in the bone marrow. Despite significant advances in treatment, including immunomodulatory drugs (IMiDs), proteasome inhibitors, and monoclonal antibodies, many patients eventually develop resistance to therapy, leading to relapse and disease progression. The identification of new therapeutic targets is therefore crucial in improving outcomes for patients with this aggressive malignancy.
ISB 830 is an investigational monoclonal antibody designed to block Lymphocyte-Activation Gene 3 (LAG-3), a protein that plays a key role in suppressing the immune system. LAG-3 is found on the surface of immune cells such as T-cells, where it acts as an immune checkpoint, preventing T-cells from attacking tumor cells effectively. By inhibiting LAG-3, ISB 830 aims to restore immune system function and enhance the body’s ability to recognize and destroy cancer cells, potentially leading to improved treatment outcomes in cancers like multiple myeloma.
The Phase I trial is part of a broader development program for ISB 830, which is being studied as both a monotherapy and in combination with other therapeutic agents to assess its potential in a variety of malignancies. The encouraging early-phase data from the myeloma trial offer hope for improved outcomes for patients who have few treatment options left.
Phase I Study Design and Results
The Phase I study enrolled patients with relapsed or refractory multiple myeloma who had failed at least one prior therapy. Patients were treated with escalating doses of ISB 830 to determine the maximum tolerated dose (MTD) and to assess the safety profile of the drug. In addition to safety, early efficacy signals were also evaluated, with the primary endpoint being the assessment of adverse events (AEs) and the secondary endpoint focusing on response rates, including overall response rate (ORR) and progression-free survival (PFS).
Initial results presented by Ichnos indicate that the drug was well-tolerated in the patient population, with no unexpected safety signals. The most common adverse events were mild to moderate in nature and primarily consisted of infusion-related reactions, which are typical for monoclonal antibody therapies. Notably, a subset of patients demonstrated early evidence of clinical activity, including reductions in tumor burden and signs of durable responses, suggesting the potential of ISB 830 as a viable treatment option for those with refractory disease.
Dr. Jorge P. Bianchi, Chief Medical Officer at Ichnos Sciences, commented, “The early results from this Phase I trial are promising and support the continued development of ISB 830 as a potential therapeutic option for patients with multiple myeloma. Blocking LAG-3 represents an exciting new approach to immuno-oncology, and we are encouraged by the safety and early efficacy data seen thus far. We look forward to further exploring the potential of ISB 830 in combination with other therapies in future clinical trials.”
Next Steps and Future Outlook
Following the encouraging Phase I results, Ichnos plans to expand the study to include additional patients and explore combination therapy regimens with other immune checkpoint inhibitors and standard treatments for multiple myeloma. A Phase II study is expected to begin in the near future to further evaluate the efficacy of ISB 830, as well as its long-term safety profile in a larger cohort of patients.
Ichnos Glenmark’s innovative approach to targeting LAG-3 is part of an increasing trend of developing next-generation immunotherapies aimed at overcoming resistance mechanisms and providing more durable responses in cancers like multiple myeloma. With the data from the Phase I trial in hand, the company is optimistic about the potential for ISB 830 to become an important treatment option for patients suffering from this challenging and often refractory cancer.
As the field of immuno-oncology continues to evolve, therapies like ISB 830 hold promise for transforming the treatment landscape for multiple myeloma and other malignancies, offering renewed hope for patients and clinicians alike.
