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NovalGen receives CTA approval to start a Phase 1/2 first in human study to evaluate the safety, pharmacokinetics and efficacy of NVG-111 in Chronic Lymphocytic Leukemia & Mantle Cell Lymphoma

7 April 2021

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

NovalGen Ltd (“NovalGen”), a biopharmaceutical company developing breakthrough cancer therapies, announced that its Clinical Trial Application (“CTA”) has been accepted by the UK Medicines and Healthcare products Regulatory Agency (“MHRA”), and that University College London Hospital (“UCLH”) has been activated as NovalGen’s first UK clinical site. The Company is now ready to conduct a Phase 1/2 first in human study evaluating the safety and efficacy of its lead product, NVG-111. The study will include patients with both Chronic Lymphocytic Leukemia (“CLL”) & Mantle Cell Lymphoma (“MCL”), and the Company expects to dose the first patient in Q2 2021. NVG-111 is a first-in-class bispecific antibody T-cell engager which simultaneously binds CD3 on T-cells and Receptor Tyrosine Kinase Like Orphan Receptor 1 (“ROR1”) on tumour cells.

“Approval to start our first clinical study represents an important validation of our approach and is a significant milestone for NovalGen only 2 years following the company’s formation” said Professor Amit Nathwani, CEO of NovalGen. “We are developing bispecific therapies that can safely harness the immune system to treat both hematological malignancies and solid tumours, and we are excited to imminently bring our first antibody forward to patients with CLL and MCL in this study.”

NVG-111 redirects endogenous T-cells to sites of tumours and, upon engagement with the ROR1 antigen on cancer cells, promotes the formation of immunological synapses, selectively killing the tumour 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 tumours. 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 tumour targeting and T-cell activation, respectively, for the efficient killing of cancer cells without excessive release of cytokines.

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Further information

JW Communications
Julia Wilson
Tel. +44 (0) 7818 430877
Email: juliawilsonuk@gmail.com

About NovalGen

NovalGen is a privately held immuno-oncology company developing breakthrough bispecific therapies that can safely harness the immune system to fight cancer, with the aim of creating life-saving enhancing new treatments for people with cancer. Our dedicated team of experienced scientists, physicians and professionals are passionate about building a pipeline of disruptive and differentiated bispecific antibody products tailored to the needs of the patient.

The company’s lead program, NVG-111, is a ROR1-targeting bispecific antibody T-cell engager for the treatment of both hematologic malignancies and solid tumors using our breakthrough bispecifics technology.

About Chronic Lymphocytic Leukemia & Mantle Cell Lymphoma

CLL is the most common form of leukemia in the Western world and is a type of cancer that begins in the bone marrow. The disease occurs due to a mutation in B lymphocytes, a type of immune cell that fights infection. CLL cells do not fight infection like normal lymphocytes and, over time, the uncontrolled growth of CLL cells in the marrow leads to an increase in the number of CLL cells in the blood.

MCL is a cancer of the lymphatic system and is an often-aggressive type of non-Hodgkin lymphoma beginning in the B lymphocytes within the lymph node mantle zone. These B lymphocytes are ineffective in fighting infection and progress to build up in the lymph nodes. If left undiagnosed or uncontrolled over time, the cells can spread to and build up in other parts of the body such as bone marrow and spleen.