On November 29, 2021 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, reported a presentation describing the Phase 1/2 trial design supporting KVA12.1 for the potential treatment of difficult-to-treat solid tumors at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Anniversary Annual Meeting (Press release, Kineta, NOV 29, 2021, View Source;utm_medium=rss&utm_campaign=kineta-presents-clinical-trial-design-of-kva12-at-sitc [SID1234596193]). Thierry Guillaudeux, PhD, Senior Vice President Immuno-oncology at Kineta, presented a poster outlining the first-in-human clinical trial design KVA 12.1, a novel fully human anti-VISTA antibody, in monotherapy and in combination with an anti-PD1 antibody.
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"Our fully human anti-VISTA antibody, KVA12.1, which binds to a unique epitope has been optimized to reduce the potential risks of severe inflammation . It demonstrates excellent clinical characteristics including an extended pharmacokinetic (PK) profile" said Thierry Guillaudeux, PhD, Senior Vice President Immuno-oncology at Kineta. "We are encouraged by the exceptional preclinical results of KVA12.1 and are eager to enter the clinic with KVA12.1 in the third quarter of 2022."
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 refractory or metastatic solid tumors.
Study objectives detailed from the SITC (Free SITC Whitepaper) poster presentation:
Primary objective: Evaluate the safety, tolerability, Dose Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and Identify the Recommended Phase 2 Dose (RP2D) of VISTA-Mab when administered alone and in combination with an anti-PD1 antibody.
Secondary objectives: Further describe i) the PK of KVA12.1; ii) VISTA-Receptor Occupancy; and iii) the anti-tumor activity of KVA12.1 (alone and in combination).
Presentation Details:
Title: KVA 12.1 a novel fully human anti-VISTA antibody clinical trial design in monotherapy and in combination with an anti-PD1 antibody
Date Presented: November 12-13, 2021
Presenter: Thierry Guillaudeux, PhD
Poster: Click on the link below to view the poster:
VISTA Publications – Poster Presentation at SITC (Free SITC Whitepaper) 2021
KVA12.1 is a fully human, optimized IgG1 monoclonal antibody (mAb) that was designed to bind to VISTA through a unique epitope. KVA12.1 drives strong antitumor immune cell activation:
Increases inflammatory monocyte differentiation and activation
Increases HLA-dependent T cell activation
Reduces MDSC-mediated T cell suppression
In preclinical models, KVA12.1 demonstrates strong single agent efficacy in poorly immunogenic "cold tumors" and complementary efficacy when dosed in combination with immune checkpoint inhibitors (ICIs) like PD-1 or CTLA-4. It is well-tolerated with no change in IL6 or TNFα levels, which are responsible for cytokine release syndrome (CRS), in toxicology studies. KVA12.1 is being developed as an intravenous infusion.
KVA12.1 may be an effective immunotherapy for many types of cancer patients including non-small cell lung cancer (NSCLC), colorectal (CRC), renal cell carcinoma (RCC), head and neck squamous cell carcinoma (HNSCC), and ovarian (OC) cancers.