NovalGen announces one oral and two poster presentations at

NovalGen announces one oral and two poster presentations at

Updated Clinical Data for NVG-111, a New ROR1xCD3 Bispecific Antibody in Patients with Relapsed/Refractory CLL and MCL –
– Preclinical data for a first-in-class, extended half-life T-cell activator targeting ROR-1-

– NovalGen’s autoregulatory platform expanded to non-oncology indications – in hematology with preclinical data for Hemophilia A in an oral presentation –

LONDON, Nov. 3, 2022 (GLOBE NEWSWIRE) — NovalGen Ltd (“NovalGen”), a biopharmaceutical company developing innovative cancer therapies, coupled with a self-regulatory platform, today announces the online publication of three abstracts sent to the American Society of Hematology Annual Meeting, to be held December 10-13, 2022.

“We are delighted to present encouraging clinical data in poster presentations from our flagship program for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL), as well as important preclinical data for our first program in Enchadorador. class half-life extended T-cell assay targeting ROR-1 that demonstrates the inherent value in both our pipeline and technology base,” said Professor Amit Nathwani, Founder and CEO of NovalGen. “We are still focusing on bispecific antibodies for oncology indications, but we can produce safer existing drugs, including a bispecific antibody that mimics factor VIII with a built-in regulatory off switch designed to improve safety without compromising efficacy for hemophilia patients.” A, to be delivered as an oral presentation at the conference.”

Abstracts to present:

1. Abstract title: The first human phase I study of a bispecific T-cell receptor targeting ROR1 (NVG-111) shows evidence of efficacy in patients with relapsed refractory CLL and MCL ( identifier: NCT04763083).
Session title: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster I
Date and time of the session: Saturday, December 10, 2022
Presentation time: 5:30 p.m. – 7:30 p.m. Eastern Time
Session room: Ernest N. Morial Convention Center, Room D
Publication number: 1810
Author Presentation: parag jasani

As of July 31, 2022, the data cutoff date, 10 patients (8 men and 2 women, median age 60 years) had been enrolled in the study; 3 in single-subject ATD cohorts, 3 in 30 μg/day flat-dosing cohorts (cohort 4), and 4 in cohorts 4b that involved incremental dosing of NVG-111 only in cycle 1; (first week cycle 1: 3 μg/day, second week, cycle 1: 10 μg/day and week 3, cycle 1: 30 μg/day dose). Eight subjects had FLC and 2 MCL. NVG-111 was well tolerated. Adverse events (AEs) were largely confined to Week 1 of Cycle 1 and all were reversible. The most common AEs were grade 1 or 2 nausea (70%), headaches (60%), and fatigue (50%), and thrombocytopenia (30%). Grade 1/2 cytokine release syndrome (CRS) was observed in (40%) of the subjects. Grade 3 dose-limiting toxicities occurred in two subjects consisting of immune effector cell-associated neurotoxicity syndrome (ICANS)-like symptoms in one (cohort 4) and elevated ALT and AST (cohort 4b) in the other. Both subjects recovered upon stopping NVG-111. Evidence of T cell activation was observed in all evaluable subjects (9/10). Objective clinical responses were observed in 66% of subjects and included 2 MRD4 negative clinical remissions (CRs). These two subjects remained MRD4-negative CRs at 6 months after completing treatment. In conclusion, early data shows that NVG-111 is generally well tolerated with a predictable and manageable safety profile. Promising evidence of efficacy that appears to be durable was observed in two MRD4-negative CR subjects. Dose escalation is ongoing in combination or as monotherapy to determine the maximum tolerated dose/recommended Phase II dose.

2. Abstract title: Preclinical development of a first-of-its-kind long-lived extended T-cell Engager targeting ROR-1.
Session Title: 802. Chemical Biology and Experimental Therapeutics: Poster II
Date and time of the session: Sunday, December 11, 2022, 6-8pm
Session room: Ernest N. Morial Convention Center, Room D
Publication number: 3478
Author Presentation: david granger

Based on safety and efficacy data emerging from the Phase I/II trial of NVG-111, NovalGen seeks to develop an extended half-life ROR1xCD3 T-Cell Activator (TCE) with a more convenient once-a-day dosing regimen. week, without compromising the safety, efficacy, and chemical, manufacturing, and control (CMC) attributes of NVG-111. Several formats were designed and evaluated, and the company successfully generated a first-in-class TCE-targeted ROR1 with extended half-life that maintains the functional and biophysical properties of clinically promising NVG-111. Systematic evaluation suggests careful selection of humans leukocyte elastase (HLE) is essential for the development of a molecule with good performance, biophysical characteristics and potency. The selected ROR1 HLE-TCE supports weekly dosing while maintaining potency at subnanomolar concentrations, properties that differentiate it from other TCEs in development. Investigational New Drug (IND) habilitation studies with NovalGen’s first ROR1 targeting HLE-TCE will conclude in 2023, supporting the initiation of a Phase I clinical trial in ROR1 hematologic malignancies.

3. Abstract title: A bispecific FVIII mimetic antibody with a built-in autoregulatory mechanism reduces the risk of prothrombotic events for the treatment of hemophilia A.
Session Title: 802. Chemical Biology and Experimental Therapeutics I
Date and time of the session: Saturday, December 10, 2022; 14:00 – 15:30
Presentation time: 14:45
Session room: Ernest N. Morial Convention Center, 353-355
Publication number: 274
Author Presentation: Vincent Muczynski

The commercial approval of emicizumab, a factor VIII (FVIII) mimetic bispecific antibody (bsAb) that simultaneously binds coagulation factor IX (FIX) and factor X (FX), has significantly changed the treatment paradigm for patients with hemophilia A. Unlike FVIII, emicizumab is constitutively active and cannot be “turned off” by the natural feedback loop of the activated protein C (APC)-mediated coagulation cascade and therefore remains in a permanent procoagulant state. Consequently, emicizumab is associated with a high incidence of thromboembolic events and thrombotic microangiopathies, particularly when combined with activated prothrombin complex concentrates. NovalGen has developed a next-generation FVIII mimetic antibody equipped with a physiological autoregulatory mechanism that can inactivate the bsAb when sufficient coagulation has occurred to maintain a stable clot and prevent progression of thrombotic events, thus it may serve as an option safer therapy. for patients with hemophilia A. This study heralds a new class of hemophilia A therapies with an autoregulatory switch designed to improve safety without compromising efficacy.

More information
JW Communications
Julia Wilson
phone +44 (0) 7818 430877

About NovalGen
NovalGen is a private, clinical-stage immuno-oncology company developing innovative bispecific therapies that can safely harness the immune system to fight cancer, with the goal of creating new life-saving treatments for people with cancer. Alongside this, we are developing our autoregulatory platform that can be applied to other medicines for indications outside of oncology, such as hematology, as well as other immunotherapy indications, including cell-based therapies such as chimeric antigen receptors (CAR-T) . .
Our dedicated team of experienced scientists, clinicians, and professionals are passionate about building a line of differentiated, disruptive products tailored to patient needs.
The company’s lead program, NVG-111, is a bispecific antibody T-cell activator targeting ROR1 for the treatment of hematologic malignancies and solid tumors using our innovative bispecific 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 causes 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’s lymphoma that begins in B cells within the mantle zone of lymph nodes. These B lymphocytes are ineffective at fighting infection and progress to accumulate in the lymph nodes. If left undiagnosed or unchecked over time, the cells can spread and accumulate in other parts of the body, such as the bone marrow and spleen.

About hemophilia A
Hemophilia A is an inherited bleeding disorder in which the blood does not clot normally. People with hemophilia A will bleed more than normal after an injury, surgery, or dental procedure. This disorder can be severe, moderate or mild. In severe cases, heavy bleeding occurs after a minor injury or even when there is no injury (spontaneous bleeding). Bleeding into the joints, muscles, brain, or organs can cause pain and other serious complications. In milder forms, there is no spontaneous bleeding, and the disorder may only be diagnosed after surgery or serious injury. Hemophilia A is caused by low levels of a protein called factor VIII. Factor VIII is needed to form blood clots. The disorder is inherited in an X-linked recessive manner and is caused by changes in the F8 gene.

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