Nov 02, 2023

NovalGen announces one oral and one poster presentation at the 65th American Society of Hematology Annual Meeting

- Updated clinical data for ROR1xCD3 targeting TCE NVG-111 in hematological malignancies focussed on relapsed / refractory CLL and MCL-

- Pre-clinical data for NVG-222, a first-in-class half-life extended Autoregulated T Cell engager targeting ROR-1-

London, United Kingdom, November 2, 2023 – NovalGen Ltd (“NovalGen”), a biopharmaceutical company developing breakthrough immunotherapies, alongside an Autoregulation platform, today announces the online publication of two abstracts submitted to the American Society of Hematology Annual meeting, to be held December 9-12, 2023 in San Diego, USA.

“We are pleased to announce our forthcoming oral presentation on the hematological arm of the NVG-111-01 Phase I clinical study (NCT04763083). Our comprehensive findings reveal highly favorable safety and efficacy outcomes among patients with relapsed/refractory Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL), with patients demonstrating encouraging activity in both monotherapy and combination therapy groups. Building upon these achievements, we are advancing the development of NVG-111 into solid tumor indications,” said Professor Amit Nathwani, Founder and CEO of NovalGen. “We are also presenting a poster detailing the development of NVG-222, our next-generation T cell engager that will enter clinic in 2024 and carries our proprietary Autoregulation or ‘AR’ platform. NVG-222 unlocks the potential of AR in clinic with its ability to automatically deactivate when there is risk of toxicity at the site of action. This mitigates adverse events but also facilitates the administration of higher doses over extended durations, thereby expanding the therapeutic index. We firmly believe AR can be a paradigm-shifting development for a range of immunotherapies.”

Oral Presentation:

Abstract Title: Time Limited Exposure to a ROR1 Targeting Bispecific T cell Engager (NVG-111) Leads to Durable Response in Subjects with Relapsed Refractory Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL)

Link to abstract

Session Title: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: New Inhibitors and Cellular Therapies for Treatment of Relapsed CLL
Session Date: Saturday, December 9, 2023
Presentation Time: 4:00 PM - 5:30 pm PT
Location: Manchester Grand Hyatt San Diego, Grand Hall D
Publication Number: 329
Presenting Author: Dr Parag Jasani

Summary: Between May 2021 and July 2023 12 subjects (10 males and 2 females, median age 60 years) completed a maximum of 6 cycles of NVG-111 treatment, with all evaluable for toxicity and 11 evaluable for efficacy. Grade 1 or 2 CRS occurred in 58% of subjects, mainly in week 1 cycle 1. Objective clinical responses were observed in 55% of subjects, including two with clear evidence of single agent activity. Amongst these, three CLL subjects were rendered MRD negative in peripheral blood and one MCL subject achieved complete metabolic response by the Lugano criteria. These data provide clinical proof of concept for objective antitumor activity by ROR1 targeting TCE NVG-111, even in CLL patients known to have defective T cell function, with a safety profile consistent with the mechanism of action. Further evaluation of this promising molecule is now progressing into solid tumors.

Poster Presentation:

Abstract Title: NVG-222: A First-in-Class Autoregulating Half-Life Extended ROR1xCD3 T Cell Engager Heralding a New Class of Safer Drugs

Link to abstract

Session Title: 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster II
Session Date: Sunday, December 10, 2023
Presentation Time: 6:00 PM - 8:00 pm PTLocation: San Diego Convention Center, Halls G-H
Publication Number: 2820
Presenting Author: Dr Vincent Muczynski

 Summary: Building on the success of lead clinical programme of NVG-111, NovalGen’s proprietary Autoregulation (AR) platform has been applied to next-generation half-life extended T cell engager NVG-222. This groundbreaking technology aims to improve the safety profile and extend the therapeutic window to improve patient outcomes. NovalGen have shown that applying AR to TCEs does not affect the potency, but significantly reduces toxicity in pre-clinical models. Furthermore, modelling from preclinical PK suggests NVG-222 will support dosing once every two weeks in clinic, and is due to enter trials in 2024.

About NovalGen

NovalGen is a privately held clinical stage immunology company developing breakthrough bispecific therapies, with the aim of creating life-saving new treatments for people with immunologically driven diseases. Our Autoregulation (AR) platform can be applied to multiple drug modalities for a wide range of indications in oncology, hematology, inflammation and other areas in the immunology space.

Our dedicated team of experienced scientists, physicians and professionals are passionate about building a pipeline of disruptive and differentiated 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 hematological malignancies and solid tumors using our breakthrough bispecifics technology. Our lead AR programme, NVG-222, builds on the success of NVG-111 and is primed for entry into the clinic in 2024.

About Autoregulation (AR)

AR is NovalGen’s proprietary platform for next-generation therapeutics that has the potential to transform the treatment paradigm across multiple indications. AR therapies harness a response-mediated negative-feedback loop that detects when there is the risk of severe toxicities arising from the drug’s mechanism of action. When this occurs, the drug is deactivated at the site of action to prevent serious side effects. As the risk of toxicity reduces the drug is replenished from circulating active drug and treatment continues. AR enables the potential for therapies to be safely given at higher doses and for longer, widening the therapeutic index and resulting in better outcomes for patients.

About Chronic Lymphocytic Leukemia (CLL)

CLL is the most common form of leukemia in the Western world and is a type of cancer that affects a specific type of white blood cell called B-lymphocytes. These abnormal lymphocytes accumulate in the blood, bone marrow, lymph nodes, spleen and other tissues. Common symptoms of CLL can include fatigue, enlarged lymph nodes, and susceptibility to infections. However, not everyone with CLL will experience these symptoms. Treatment options for CLL can vary and may include watchful waiting, chemotherapy, immunotherapy, targeted therapy, or stem cell transplantation, depending on the individual's specific situation and stage of the disease.

About Mantle Cell Lymphoma (MCL)

MCL is an aggressive but rare cancer that affects white blood cell called B-lymphocytes located in the mantle zone the body's lymphatic system. Typical symptoms include swollen lymph nodes, fatigue, and digestive problems. It can be treated with different therapies, including chemotherapy, targeted drugs, and stem cell transplantation depending on the stage of disease and individual factors.