Researchers at the NIHR UCLH Clinical Research Facility will lead the trial of the drug, called NVG-111, which was conceived and developed by Amit Nathwani, a Professor of Immunology at UCL Institute of Immunity & Transplantation.

The drug will be trialled on patients with NHL subtypes, including relapsed/refractory chronic lymphocytic leukaemia (CLL) / small lymphocytic lymphoma (SLL) and mantle cell lymphoma (MCL).

This multi-centre trial, sponsored and funded by NovalGen Limited, a UCL spinout company, will be taking place at various centres in the UK including UCLH.

Professor Nathwani, who is also founder and Chief Executive of NovalGen, said: “The dosing of our first patient marks a significant milestone for NovalGen.

“NVG-111 is our first clinical programme for patients with chronic lymphocytic leukemia and mantle cell lymphoma.

“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.”

NHL usually originates in lymphoid tissues (cells and organs important in the immune response, including bone marrow, thymus, and lymph nodes) and the incidence increases with age. Options for chemotherapy-resistant patients currently remain limited and new therapies are needed.

NVG-111 is a first-in-class bispecific antibody T-cell engager which is designed to be effective in the killing of cancer cells without affecting healthy immune cells. In preclinical studies, NVG-111 showed efficacy in a range of hard-to-treat blood cancers as well as solid tumours.

The trial will be conducted in two parts: In Part A, sequential doses will be tested to identify ‘dose limiting toxicities’ (DLTs) and used to decide dose - to be studied; Part B will include one cohort of patients with CLL/SLL and one with MCL to further assess the efficacy and safety profile of NVG-111.

The maximum duration of participation for each patient is up to 32 months. This includes up to a four week screening period, a treatment period of up to six cycles, and a safety follow-up conducted four weeks after the last dose as well as up to 24 months long term follow-up.

At University College London Hospitals NHS Foundation Trust (UCLH), the trial will be led by Principal Investigator Dr William Townsend, a consultant haematologist who leads a comprehensive portfolio of early phase trials in lymphoproliferative disorders.

“I am very excited to be helping to bring this novel therapy to the CRF for the benefit of our patients. It is particularly gratifying as this drug was developed through the UCL laboratories and helps to deliver on the UCL/UCLH bench-to-bedside research vision,” he said.

The study’s Chief Investigator Dr Parag Jasani, a Consultant Haematologist at UCLH and clinical lead for CLL, said: “NVG-111 holds great promise for patients with chronic lymphocytic leukaemia 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.”

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‘Magnification micrograph of mantle cell lymphoma of the terminal ileum’, Credit: Nephron via Wikimedia Commons [CC BY-SA 3.0]

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