NVG-111

NVG-111 was administered in combination (N=8) with ibrutinib to subjects who had achieved a partial response to >1 year of ibrutinib therapy, or as monotherapy in subjects that progressed after covalent BTKi/B-cell lymphoma 2 inhibitor (BCL2i) (N=4). These data provide clinical proof of concept for selective targeting of ROR1 with a TCE leading to objective evidence of antitumor activity with encouraging response durability even in CLL patients known to have defective T cell function. The safety profile was consistent with the mechanism of action. Further evaluation of this promising molecule is ongoing.

P1, N=90, Recruiting, NovalGen Ltd. | Phase classification: P1/2 --> P1

We have generated a first in class ROR1 targeting half-life extended TCE that maintains the functional and biophysical properties of the clinically promising NVG-111. 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.

Early data shows that NVG-111 is generally well tolerated with a predictable and manageable safety profile. 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.

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.

P1/2, N=90, Recruiting, NovalGen Ltd. | Not yet recruiting --> Recruiting

P1/2, N=90, Not yet recruiting, NovalGen Ltd.