Date: 2015-08-06
Type of information: Clinical trial autorization
phase: 1
Announcement: clinical trial authorization
Company: Valor Biotherapeutics (USA - TX)
Product: IGN002
Action
mechanism: antibody drug conjugate. IGN002, comprises an anti-CD20 monoclonal antibody attached to IFN through stable peptide linker system. IGN002 has the potential to improve treatment outcomes for indolent non-Hodgkin lymphoma (NHL) patients, for whom there are currently few effective therapies. NHL is a diverse group of blood cancers that impact the lymphatic system, part of the body\'s immune system. In the U.S., indolent subtypes of NHL make up about 30 percent of the approximately 585,000 people living with or in remission from NHL. IGN002 was created under the support of a research grant by The Leukemia & Lymphoma Society (LLS).
Disease: non-Hodgkin lymphoma (NHL)
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On August 6, 2015, Valor Biotherapeutics and The Leukemia & Lymphoma Society (LLS) announced that the FDA has approved an investigational new drug (IND) application for Valor\'s lead product candidate, IGN002. The approved IND is a key step in allowing Valor—a joint venture between ImmunGene and Caliber Biotherapeutics—to begin a phase 1 clinical study of IGN002 in patients with non-Hodgkin lymphoma (NHL). Through its Therapy Acceleration Program (TAP), a strategic initiative to partner with biotechnology companies and speed the development of new therapies, LLS previously committed approximately $6 million to co-fund the pre-clinical development, manufacturing, and a Phase 1 clinical study of IGN002. Valor, ImmunGene, and LLS staff have collaborated over the past two years to complete the pre-clinical development and manufacturing of IGN002 for the IND filing.
