Sep 17, 2021

NovalGen announces data presentation at the Upcoming XIX International Workshop on Chronic Lymphocytic Leukemia

- Poster presentation for NVG-111, a first in human Phase 1/2 study for novel ROR1xCD3 bispecific antibody for non-Hodgkin lymphoma

London, United Kingdom, September 17 2021 – NovalGen Ltd (“NovalGen”), a biopharmaceutical company developing breakthrough cancer therapies, announced that the company will give a poster presentation at the XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL) virtual meeting 2021, taking place September 17-20, 2021.

NovalGen has developed an ROR1xCD3 bispecific antibody T cell engager, NVG-111, that is currently in Phase 1/2 development for patients with non-Hodgkin lymphoma; initially focused on Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic Leukemia (CLL), but with the potential to target >20 different hard-to-treat solid and liquid cancers. To date 3 patients have been dosed in the study and are being analysed for safety and efficacy. NVG-111 is a first in class bispecific antibody T cell engager targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1). ROR1 is a tumor-associated antigen that is overexpressed in a broad range of cancers, but has negligible expression in healthy adult tissues, making it an ideal candidate for novel, targeted cancer therapies.

"The data being presented at iwCLL shares details of an innovative Phase 1/2, first in human study for NVG-111," said Professor Amit Nathwani, CEO of NovalGen. "The key design features of the study, including intra-patient dose escalation at low doses, has allowed us to progress the study expeditiously, with 3 patients having been dosed and another 6 sites ready to enrol patients. Our goal is to advance the scientific understanding of the potential of NVG-111 in a range of difficult-to-treat cancers.”

Dr Parag Jasani, Consultant Haematologist with NHS practice at Royal Free London NHS Trust and University College London Hospitals and Chief Investigator on the study added, “NVG-111 represents an important, novel treatment opportunity for patients with CLL and other low-grade lymphomas who have advanced disease. Success with patients with CLL will enable broader use in other malignancies.”

Poster Presentation Details:

Abstract Number for Publication: 1082736
Abstract Title:  A First-in-human, Phase 1/2 Study of NVG-111, a Novel ROR1xCD3 Bispecific Antibody, in Patients with Debulked, Relapsed/Refractory Chronic Lymphocytic Leukaemia (CLL), Small Lymphocytic Lymphoma (SLL) and Mantle Cell Lymphoma (MCL)

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Further information

JW Communications

Julia Wilson
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About NovalGen
NovalGen is a privately held clinical stage immuno-oncology company developing breakthrough bispecific therapies that can safely harness the immune system to fight cancer, with the aim of creating life-saving 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 an 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 (CLL)
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.

About Mantle Cell Lymphoma (MCL)
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.