NovalGen receives CTA approval to start a Phase 1/2 first in human study

NovalGen receives CTA approval to start a Phase 1/2 first in human study.

London, United Kingdom, 7 April 2021 – 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 tumor 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 tumors, 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 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.

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