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Kineta Presents New Preclinical Data and Phase 1/2 Clinical Trial Design of KVA12.1

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Kineta, Inc., a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology, announced today 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.

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:

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
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.

Kineta is a clinical-stage biotechnology company with a mission to develop next generation immunotherapies that transform patients’ lives. Kineta has leveraged its expertise in innate immunity with an intent to develop first or best-in-class immunotherapies that address the major challenges with current cancer therapy. For more information on Kineta please visit www.kinetabio.com, and follow Kineta on Twitter, LinkedIn and Facebook.

PiiONEER™ Platform is focused on developing fully human monoclonal antibodies that target novel innate immune pathways. It was designed for the discovery and development of first or best-in-class immunotherapies that address the major challenges with cancer immune resistance to current therapies. Utilization of the PiiONEER™ Platform results in novel, well-characterized lead antibody therapeutics that can be efficiently advanced into formal IND enabling and clinical studies.

KVA12.1 is a potential best-in-class VISTA blocking immunotherapy to address the problem of immunosuppression in the tumor microenvironment. It is a fully human engineered IgG1 monoclonal antibody that was designed to bind to VISTA through a unique epitope. KVA12.1 may be an effective immunotherapy for many types of cancer including NSCLC (lung), colorectal, renal cell carcinoma, head and neck, and ovarian. These initial target indications represent a significant unmet medical need with a large worldwide commercial opportunity for KVA12.1.

Anti-CD27 mAb program: Kineta has developed a diverse set of anti-CD27 agonist antibodies. They are fully human monoclonal antibodies (mAbs) that demonstrate low nanomolar (nM) binding affinity to CD27 in humans. In preclinical studies, Kineta’s selected lead anti-CD27 agonist mAbs induce T cell proliferation and secretion of cytokines involved in T cell priming and recruitment, demonstrating the ability to potentiate new anti-tumor responses. Kineta is in the final stage of lead selection and plans to nominate a clinical candidate in Q2 2022.

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