Arvinas Advances ARV-6723 Into Phase 1/2 Trial In Advanced Solid Tumors
(RTTNews) - Arvinas Inc. (ARVN) announced that the first participant has been dosed in the Phase 1/2 clinical trial of ARV-6723, the company's first clinical candidate in immuno-oncology.
ARV-6723 is an investigational oral PROTAC designed to selectively degrade hematopoietic progenitor kinase 1 (HPK1) in patients with advanced solid tumors.
The ARV-6723-101 Phase 1/2 trial is a global, multicenter study designed to evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of ARV-6723 as a monotherapy and in combination with pembrolizumab, an anti-PD-1 therapy.
The first-in-human study will initially evaluate ARV-6723 as a monotherapy before progressing to combination treatment.
The initial monotherapy cohort is enrolling patients with advanced solid tumors who have previously received an immune checkpoint inhibitor and have no suitable standard treatment options.
ARV-6723 targets HPK1, a negative regulator of immune activation that is expressed across multiple immune cell types, including T cells, B cells, natural killer cells and dendritic cells.
The therapy is designed to remove the HPK1 protein and its signaling scaffolding, potentially addressing both kinase-dependent and kinase-independent functions of the target.
In preclinical studies, ARV-6723 demonstrated potent and selective HPK1 degradation, enhanced immune activity and antitumor effects as a single agent and in combination with an immune checkpoint inhibitor.
The program also showed activity across tumor models with different levels of immune responsiveness, including models resistant to anti-PD-1 therapy.
Arvinas said that in seven preclinical models, ARV-6723 demonstrated meaningful single-agent activity in settings where neither an HPK1 inhibitor nor anti-PD-1 therapy showed benefit.
These findings support the clinical evaluation of ARV-6723 both as monotherapy and in combination with an anti-PD-1 therapy.
ARV-6723 is the first HPK1 PROTAC degrader to enter clinical development in the United States and represents Arvinas' expansion of its targeted protein degradation platform into immuno-oncology.
The company is developing ARV-6723 alongside other investigational programs, including ARV-393 targeting BCL6 in relapsed/refractory non-Hodgkin lymphoma, ARV-102 targeting LRRK2 in neurodegenerative disorders, ARV-027 targeting polyglutamine-expanded androgen receptor in spinal-bulbar muscular atrophy, and ARV-806 targeting KRAS G12D in solid tumors.
ARVN has traded between $6.97 and $14.51 over the last year.
The stock closed Monday's trade at $7.59, down 2.57%. In the pre-market trading, the stock is trading at $7.60, up 0.13%.
