NVG-222 / Novalgen - LARVOL DELTA

NVG-222: A First-in-Class Autoregulating Half-Life Extended ROR1xCD3 T Cell Engager Heralding a New Class of Safer Drugs (ASH 2023) - P1 | "Results Selected AR peptides were exposed to a range of proteases present in circulation or in the tumour microenvironment and showed a specific and threshold-dependent sensitivity to granzyme B. A first prototype of an AR TCE was engineered from NVG-111, a ROR1xCD3 TCE in clinical development (NCT04763083), and showed uncompromised cytotoxic potency in vitro with an EC50 in the pM range. Conclusion Our AR platform technology has the potential to improve the therapeutic index of immunotherapies leading to improved safety and efficacy outcomes. This technology has been applied to our next generation ROR1-targeting TCE NVG-222, which is in IND-enabling studies with the aim of beginning clinical development for hematological and solid malignancies in 2024."

Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • Solid Tumor • Targeted Protein Degradation • GZMB • ROR1

NovalGen to Begin World’s First Clinical Trial for a Self-Regulating Immunotherapy (GlobeNewswire) - "...Following confirmation of Clinical Trial Authorisation (CTA) by the MHRA, it is set to begin clinical evaluation later this year. The Phase I/II adaptive basket study will be sponsored and managed by Cancer Research UK’s Centre for Drug Development (CDD) and will enrol patients across the UK with a range of ROR1-positive haematological malignancies. First patient dosing is expected in Q4 2025."

New P1/2 trial • Hematological Malignancies

NovalGen presents NVG-111 clinical data in hematological malignancies in an oral session and preclinical data for next-generation AR T cell engager NVG-222 at the 65th American Society of Hematology Annual Meeting (GlobeNewswire) - "NovalGen is also introducing their proprietary Autoregulation (AR) technology platform. This innovative platform is showcased in the development of NVG-222, a next-generation T cell engager targeting ROR1 but can be applied to a range of immunotherapies including CAR-T cells to improve the therapeutic index....'NVG-222 has the potential to extend the therapeutic window and set a new standard for patient care for ROR1 positive hematologic malignancies as well as solid tumors'....Autoregulation (AR) platform displays significant protective effects from T cell engager toxicity and will enter the clinic with NVG-222 in 2024."

New trial • Preclinical • Hematological Malignancies • Solid Tumor

NovalGen announces one oral and one poster presentation at the 65th American Society of Hematology Annual Meeting - P1 | N=90 | NCT04763083 | Sponsor: NovalGen Ltd. | "NovalGen Ltd...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....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....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."

New trial • P1 data • Preclinical • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology