NovalGen doses first patient in Phase I study in Chronic Lymphocytic Leukemia & Mantle Cell Lymphoma

NovalGen doses first patient in Phase I study in Chronic Lymphocytic Leukemia & Mantle Cell Lymphoma

–  NVG-111 is the first-in-class T-cell engager that simultaneously binds CD3 on T-cell and ROR1 on tumor cells –

London, United Kingdom, June 9, 2021 – NovalGen Ltd (“NovalGen”), a clinical stage biopharmaceutical company developing breakthrough cancer therapies today announced that it has dosed the first patient in a Phase I/2 open label study of a first-in-class bispecific antibody T-cell engager, NVG-111, which simultaneously binds CD3 on T-cells and Receptor Tyrosine Kinase Like Orphan Receptor 1 (ROR1) on tumor cells in patients with Chronic Lymphocytic Leukemia (CLL) & Mantle Cell Lymphoma (MCL).

The study, an open-label, multi-centre Phase I/2 trial evaluating the safety, tolerability and clinical efficacy of NVG-111 in patients with CLL and MCL is expected to recruit approximately 90 patients and report initial data in 2021/2022. Recruitment is ongoing in the UK. Link to Study.

“The dosing of our first patient marks a significant milestone for NovalGen. NVG-111, is our first clinical program for patients with Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma,” said Professor Amit Nathwani, CEO of NovalGen. “We are developing bispecific therapies that can safely harness the immune system to treat both hematologic malignancies and solid tumors and have an exciting pipeline of products in development.”

Dr Townsend, Consultant Haematologist at UCLH and Principal Investigator at NIHR UCLH Clinical Research Facility said, “I am very excited to personally treat the first patient in this study which I hope will bring benefit to many of our patients by allowing more patients to achieve durable clinical remission, thus raising the prospects of a potential cure.”

Dr Parag Jasani, Consultant Haematologist at Royal Free London and at UCLH and Chief Investigator on the study added, “NVG-111 holds great promise for patients with Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma, which are both currently incurable conditions. Patients typically endure multiple rounds of therapy and ultimately their cancer develops resistance or transforms into an aggressive, unresponsive form.”

NVG-111 redirects endogenous T-cells to sites of tumors and, upon engagement with the ROR1 antigen on cancer cells, promotes the formation of immunological synapses, selectively killing the tumor independently of major histocompatibility complex, costimulatory molecules and antigen presentation. It is designed to be highly effective in the killing of cancer cells without affecting healthy immune cells or tissues and may potentially target cancer-initiating stem cells, a subpopulation of cancer cells that are resistant to standard cancer therapies. In preclinical studies, NVG-111 showed efficacy in a range of hard-to-treat blood cancers as well as solid tumors. The initial clinical focus with NVG-111 is in previously treated CLL and MCL patients to establish the drug’s safety and efficacy profile, followed by clinical expansion to target other ROR1-expressing cancers. The Company’s proprietary ROR1 and CD3-targeting bispecific molecule has been engineered for optimal tumor targeting and T-cell activation, respectively, for the efficient killing of cancer cells without excessive release of cytokines.