On June 17, 2022 Kineta, Inc. ("Kineta" or the "Company"), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology, reported that it presented the Phase 1/2 clinical trial design and new preclinical data supporting KVA12.1 as a potential treatment for cancer patients with advanced solid tumors at the Tumor Myeloid-Directed Therapies Summit held on June 14-16 in Boston, MA (Press release, Kineta, JUN 17, 2022, View Source;utm_medium=rss&utm_campaign=kineta-presents-new-preclinical-data-and-phase-1-2-clinical-trial-design-of-kva12-1-at-the-tumor-myeloid-directed-therapies-summit [SID1234616067]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Shaarwari Sridhar, Scientist at Kineta, presented a poster outlining the first-in-human clinical trial design and study objectives evaluating KVA12.1 as a monotherapy and in combination with an anti-PD1 immunotherapy. New preclinical and toxicology data supporting advancing KVA12.1 into clinical development were also presented. KVA12.1 is a potential best-in-class VISTA blocking immunotherapy that was discovered through the Company’s proprietary immuno-oncology PiiONEER platform. The Phase 1/2 study will be a multicenter, open label, dose escalation and dose expansion study of intravenous infusion of KVA12.1 as a monotherapy and in combination with a fixed dose of an anti-PD1 antibody in patients with advanced solid tumors. Kineta plans to initiate the Phase 1/2 clinical study in Q4 2022.
"We are very encouraged by the preclinical data and are excited for KVA12.1 to enter the clinic later this year," said Thierry Guillaudeux, PhD, EVP Research and Development at Kineta. "KVA12.1 was developed through Kineta’s PiiONEER platform as an engineered IgG1 monoclonal antibody that binds to a unique epitope at physiologic and acidic Ph levels. It is highly differentiated as it has demonstrated efficacy as a single agent and in combination with PD-1 in multiple tumor models with no CRS-associated cytokine secretion seen in preclinical tox studies."
Phase 1/2 clinical study objectives detailed in the poster presentation include:
Clinical
Safety measurements and DLTs as single agent and in combination with anti-PD1
Overall Response Rate and durability of response using RECISTv1.1
Determined MTD and R2PD
Pharmacologic and Biomarker
PK
Receptor Occupancy
Cytokine and Chemokine profiles in plasma samples
Flow Cytometry for PD marker on Immune cells
Tumor biopsies : multiparameter analysis to evaluate tumor cells as well as Immune infiltrating cells. Characterized expression of immune checkpoint and exhausted markers.
Presentation Details:
Title: KVA12.1 a novel fully human anti-VISTA antibody to treat cancer patients with advanced solid tumors
Date Presented: June 15-16, 2022
Presenter: Shaarwari Sridhar
For further details, please view the poster presentation on Kineta’s website here.