– First clinical data for NVG-111, a novel ROR1xCD3 bispecific antibody in patients with relapsed / refractory CLL and MCL

– Early data demonstrates promising efficacy with a predictable and manageable safety profile

LONDON, UK I May 26, 2022 I NovalGen Ltd (“NovalGen”), a biopharmaceutical company developing breakthrough cancer therapies, announces first clinical data from the ongoing Phase 1/2 study of NVG-111, a novel ROR1 targeting bispecific antibody T cell engager, in patients with relapsed and refractory Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL), in a poster presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting McCormick Place, Chicago, IL, June 3 to 7, 2022. The Company will also be presenting additional clinical data at the conference.

As of the January 31, 2022 data cut-off date, 6 patients had been enrolled to the study; three into each of the accelerated dose titration (ADT) cohorts and the remaining into a 30 µg/day flat dosing cohort. Early signs of efficacy and evidence of response was observed in all patients from Cohort 2 onwards. Amongst these, 2 patients had undetectable MRD in the blood with one being MRD negative in the bone marrow and the remaining patients achieved partial responses. NVG-111 was well tolerated with the most common adverse event being transient, Grade 1 lethargy, headaches, nausea, vomiting and thrombocytopenia. Dose escalation is ongoing, including exploration of step-up dosing.

“The safety and selectivity of NVG-111 observed in the pre-clinical studies have translated into the preliminary data in this on-going Phase I/II study,” said Professor Amit Nathwani, Founder and CEO of NovalGen. “We are encouraged by these early clinical data, demonstrating a predictable and manageable safety profile, alongside promising efficacy and it underscores NovalGen’s commitment to bring transformational therapies to patients”.

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 MCL as well as many other hematological malignancies. The data in this heavily treated patient population are encouraging and warrants further investigation, with the potential to broaden its use into other malignancies.”

Poster Presentation Details:

Abstract Title: First-in-Human Phase I Study of a ROR1 targeting bispecific T cell engager (NVG-111) shows evidence of efficacy in patients with relapsed refractory CLL and MCL (ClinicalTrials.gov identifier: NCT04763083).

Lead Author: Dr Parag Jasani

Session Date/Time: Saturday, June 4, 2022, 8:00 AM-11:00 AM CDT

Abstract Number: 7535

In addition to releasing preliminary clinical data, NovalGen is also publishing 4 other abstracts encompassing NVG-111 pharmacokinetic, manufacturing and our next generation pipeline assets including ROR1 Extended Half Life and inducible armoured CAR-T.

Abstract Title: A sensitive and robust bioanalytical assay for pharmacokinetic analysis of ROR1xCD3 bispecific T cell engager (NVG-111) in a first-in-human study.

Abstract Title: The use of a transient transfected expression system to deliver high quality bispecific T cell engager drug product, NVG-111, to the clinic for a fraction of the cost and time associated with the development and use of a producer cell line.

Abstract Title: Activity and biophysical properties related to clinical evaluation of a first-in-class EHL ROR1xCD3 T Cell Engager.

Abstract Title: A Next Generation Inducible Armored CAR to Overcome the Immunosuppressive Tumour Microenvironment and Enhance the Cytotoxicity of CAR-T and TILs.

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.

SOURCE: Novalgen