NVG-111 News - LARVOL Sigma

|||||||||| NVG-222 / Novalgen
NVG-222: A First-in-Class Autoregulating Half-Life Extended ROR1xCD3 T Cell Engager Heralding a New Class of Safer Drugs (Halls G-H (San Diego Convention Center)) - Nov 3, 2023 - Abstract #ASH2023ASH_3768;
P1
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.

|||||||||| Imbruvica (ibrutinib) / AbbVie, J&J
Time Limited Exposure to a ROR1 Targeting Bispecific T Cell Engager (NVG-111) Leads to Durable Responses in Subjects with Relapsed Refractory Chronic Lymphocytic Leukemia (CLL) and Mantle Ce... (Grand Hyatt - Grand Hall D) - Nov 3, 2023 - Abstract #ASH2023ASH_1380;
P1
The safety profile was consistent with the mechanism of action. Further evaluation of this promising molecule is ongoing.

|||||||||| MODULE 5: Promising Investigational Agents and Strategies (Omni San Diego, Grand Ballroom (Level 2), 4) - Sep 23, 2023 - Abstract #ASH2023ASH_267;
Supported by educational grants from AstraZeneca Pharmaceuticals LP, BeiGene Ltd, Bristol Myers Squibb, and Lilly. Biological rationale for the investigation of CD19-directed chimeric antigen receptor T-cell therapy for patients with CLL Published and emerging findings with lisocabtagene maraleucel (liso-cel) monotherapy in the Phase I/II TRANSCEND CLL 004 trial; rates of complete response compared to historical controls Early findings with liso-cel in combination with ibrutinib for heavily pretreated CLL Mechanism of action of nemtabrutinib; early efficacy and safety data with nemtabrutinib for R/R CLL and ongoing Phase III evaluation for treatment-na

||||||||||  NVG-111 / Novalgen
Phase classification:  NVG111-101: First in Human Study of NVG-111 in Relapsed/Refractory ROR1+ Malignancies (clinicaltrials.gov) -  Jul 7, 2023
P1, N=90, Recruiting,  Sponsor: NovalGen Ltd.
Biological rationale for the investigation of CD19-directed chimeric antigen receptor T-cell therapy for patients with CLL Published and emerging findings with lisocabtagene maraleucel (liso-cel) monotherapy in the Phase I/II TRANSCEND CLL 004 trial; rates of complete response compared to historical controls Early findings with liso-cel in combination with ibrutinib for heavily pretreated CLL Mechanism of action of nemtabrutinib; early efficacy and safety data with nemtabrutinib for R/R CLL and ongoing Phase III evaluation for treatment-na Phase classification: P1/2 --> P1

|||||||||| NVG-111 / Novalgen
Pre-Clinical Development of a First in Class Half-Life Extended T Cell Engager Targeting ROR-1 (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_4868;
Our systematic evaluation suggests that careful selection of HLE format is critical for the development of a molecule with good yield, biophysical characteristics and potency. The selected ROR1 HLE-TCE supports weekly administration whilst maintaining potency at sub-nanomolar concentrations, properties which differentiate it from other TCEs in development.

|||||||||| NVG-111 / Novalgen
First-in-Human Phase I Trial of a ROR1 Targeting Bispecific T Cell Engager (NVG-111) in Combination with Ibrutinib or As Monotherapy in Subjects with Relapsed Refractory Chronic Lymphocytic Leukaemia (CLL) and Mantle Cell Lymphoma (MCL) (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_2673;
Promising evidence of efficacy was observed which appears to be durable in two subjects with MRD4 negative CR. Dose escalation is ongoing in combination or as monotherapy to determine the MTD/RP2D.

|||||||||| NVG-111 / Novalgen
A sensitive and robust bioanalytical assay for pharmacokinetic analysis of ROR1xCD3 bispecific T cell engager (NVG-111) in a first-in-human study. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_2744;
Dose escalation is ongoing in combination or as monotherapy to determine the MTD/RP2D. Development, custom optimization and validation of a highly sensitive MSD-ECLA PK assay has enabled GCLP-compliant measurement of circulating NVG-111 in CLL or MCL patients treated with at least 10µg/day cIV NVG-111.

|||||||||| Actemra IV (tocilizumab) / Roche, JW Pharma
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. (Available On Demand; 188) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2641;
P1/2
Five patients had CLL, and one had MCL, with all subjects remaining on ibrutinib whilst receiving NVG-111...This did not require tocilizumab or dose interruption except in one patient who developed transient, grade 3 immune effector cell–associated neurotoxicity syndrome-like symptoms (ICANS)... Early data with NVG-111 shows promising efficacy with a predictable and manageable safety profile.

|||||||||| NVG-111 / Novalgen
Activity and biophysical properties related to clinical evaluation of a first-in-class EHL ROR1xCD3 T Cell Engager. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_1813;
This format maintains functional activity, is stable, and expresses well with a favorable aggregation profile. Further molecular refinements are being actively evaluated in readiness for IND enabling studies.

|||||||||| NVG-111 / Novalgen
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. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_1771;
P1/2
The process costed less than the more conventional manufacturing approach of using a producer cell line. The strategy offers a rapid, and very efficient way of reaching a first in human study without a trade-off between time, quality and cost.

||||||||||  NVG-111 / Novalgen
Enrollment open:  NVG111-101: First in Human Study of NVG-111 in Relapsed/Refractory ROR1+ Malignancies (clinicaltrials.gov) -  May 17, 2021
P1/2, N=90, Recruiting,  Sponsor: NovalGen Ltd.
The strategy offers a rapid, and very efficient way of reaching a first in human study without a trade-off between time, quality and cost. Not yet recruiting --> Recruiting

|||||||||| NVG-111 / Novalgen
[VIRTUAL] NVG-111, a novel ROR1xCD3 bispecific antibody for non-Hodgkin lymphoma. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2286;
NVG-111 shows potent T-cell mediated lymphoma cell cytotoxicity in vitro at concentrations well below those associated with extensive cytokine release . NVG-111 is in an ongoing Phase 1/2 study and may present a novel option for adoptive immunotherapy in patients with non-Hodgkin lymphoma and potentially other cancers.

||||||||||  NVG-111 / Novalgen
New P1/2 trial:  NVG111-101: First in Human Study of NVG-111 in Relapsed/Refractory ROR1+ Malignancies (clinicaltrials.gov) -  Feb 20, 2021
P1/2, N=90, Not yet recruiting,  Sponsor: NovalGen Ltd.



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