New Delhi: In a significant development, pharmaceutical major Novartis has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III clinical trial of anticancer drug Ianalumab (VAY736).
However, this approval is subject to the condition that the applicant submit safety data on 45 global subjects (including 8 subjects from the country) for review by the committee, and once the data is reviewed by the committee, the trial might be continued in the country.
This came after the drug major Novartis presented the Phase III clinical trial protocol no. CVAY736O12301, version 02 dated 29-09-2022 before the committee.
Ianalumab (VAY736) is a monoclonal antibody that is being investigated for autoimmune hepatitis, multiple sclerosis, pemphigus vulgaris, rheumatoid arthritis, Sjögren syndrome, and systemic lupus erythematosus. This drug is being developed by Novartis. As of 2021, ianalumab is undergoing Phase II/III trials.
Ianalumab (VAY736) was designed to target the BAFF receptor and competitively inhibit the binding of BAFF ligand and thereby block BAFF receptor-mediated signaling and the downstream survival pathway in B cells. In addition, it was engineered (by defucosylating carbohydrate modifications on the Fc chain) to enhance antibody-dependent cellular cytotoxicity (ADCC) so as to maximally deplete circulating B cells. Pro-B and pre-B cells are BAFF receptor negative, so they are not directly affected by ianalumab. Ianalumab targets the receptor, which is in contrast to other BAFF agents that target the ligand (e.g., the approved antibodies belimumab, tibulizumab, and tabalumab, and the BAFF ligand-sequestering peptides blisibimod and atacicept).
At the recent SEC meeting for oncology and hematology held on March 14, 2023, the expert panel reviewed the Phase III clinical trial protocol no CVAY736O12301, Version 02, dated 29-09-2022 presented by drug major Novartis.
The committee noted that the applicant has not conducted a Phase II clinical trial with the proposed indication; however, two Phase III clinical trials on other indications are ongoing in India.
In addition, the expert panel found that the present trial will be conducted in patients with warm autoimmune hemolytic anemia and proposed for 16 subjects out of 90 subjects globally in the trial.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial with the condition that the applicant should submit safety data of 45 global subjects (including 08 subjects from the country) for review by the committee, and once the data is reviewed by the committee, the trial might be continued in the country.