Kineta Unveils Positive New Data from VISTA-101 Clinical Trial of KVA12123 at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting
Favorable Clinical Safety and Tolerability Profile Observed with No Evidence of CRS-associated Cytokines
Achieved Greater Than Dose-Proportional Pharmacokinetics
Biomarker Results Demonstrate Robust VISTA Target Engagement
Additional Monotherapy and Combination Therapy Clinical Data Anticipated in Q2 2024
SEATTLE, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, announced today the presentation of new positive data from its ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123, the company’s VISTA blocking immunotherapy, in patients with advanced solid tumors at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting. Thierry Guillaudeux, Ph.D., Chief Scientific Officer of Kineta, presented the company’s poster unveiling the new clinical data.
“We are excited to unveil these promising findings from our ongoing VISTA-101 clinical trial. VISTA blocking immunotherapy KVA12123 has performed remarkably well in demonstrating excellent safety and tolerability in the clinic. Notably, the pharmacokinetic data and biomarker assessments demonstrate the drug's potential efficacy and confirm its mechanism of action,” said Shawn Iadonato, Ph.D., Chief Executive Officer of Kineta. “We continue to advance KVA12123 to the higher monotherapy dose levels, as well as evaluate it in combination with pembrolizumab, where we recently announced the first patient dosed. Kineta is committed to advancing KVA12123 as a potential new immunotherapy for cancer patients in need of new treatment options.”
The Phase 1/2 VISTA-101 trial (NCT05708950) enrolled 11 patients with advanced solid tumors in the first three monotherapy dose-escalation cohorts, where subjects received either 3, 10 or 30 mg of KVA12123 by intravenous (IV) infusion every two weeks. Primary objectives of the Phase 1/2 study are to evaluate the safety and tolerability of KVA12123 and to determine the recommended Phase 2 dose (RP2D). Patients enrolled in the study were heavily pretreated with multiple prior lines of therapy including chemotherapy, radiation and immunotherapy. Additional monotherapy and initial combination therapy data are anticipated in the second quarter of 2024.
Key highlights from the poster presentation:
Eleven patients were dosed and cleared the first three monotherapy cohorts. KVA12123 was well tolerated at all doses and no dose limiting toxicities (DLT) were observed. All KVA12123 treatment emergent adverse events were grades 1-2. Furthermore, no evidence of cytokine release syndrome (CRS) or associated cytokines including IL-6, TNFα & IL-10 were detected at any of the dose levels.
Pharmacokinetics and VISTA Receptor Occupancy (RO)
KVA12123 exhibited a greater than dose-proportional pharmacokinetic profile in drug exposure across all evaluated doses, consistent with target-mediated drug disposition at lower doses. To guide the RP2D decision, Kineta developed a proprietary assay to evaluate VISTA RO on immune cells from patients treated with KVA12123. KVA12123 achieved a greater than 90% VISTA RO at the 30 mg dose indicating that KVA12123 may be approaching an optimal clinical dose.
KVA12123 demonstrated dose-proportional on-target biomarker immune responses involved in anti-tumor activity. KVA12123 demonstrated significant efficacy-related cytokine induction of CXCL10, MCP1, MIP1α and MIP1β, which are involved in immune cell activation and recruitment to the tumor microenvironment. Additionally, increases in anti-tumor immune cell subpopulations including nonclassical monocytes, NK cells, CD4+ T cells and CD8+ T cells were observed during treatment. Changes in these key biomarkers and immune cell populations are indicative of the anti-tumor effects of blocking VISTA.
SITC Presentation Details:
Title: VISTA-101 – A phase 1/2 clinical trial of KVA12123, an engineered IgG1 targeting VISTA, alone and in combination with pembrolizumab in advanced solid tumors
Abstract Number: 780
Date / Time: Saturday, November 4 at 9:00 A.M. – 7:00 P.M. Pacific Time
Location: Exhibit Halls A and B1 - San Diego Convention Center
Kineta is advancing the VISTA-101 trial to higher monotherapy dose levels and recently initiated Part B of the study evaluating KVA12123 in combination with pembrolizumab. Additional monotherapy safety and efficacy data and combination therapy clinical data are anticipated in the second quarter of 2024.
Kineta (Nasdaq: KA) 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 and is focused on discovering and developing potentially differentiated immunotherapies that address the major challenges with current cancer therapy. The company’s immuno-oncology pipeline includes KVA12123, a novel VISTA blocking immunotherapy currently in a Phase 1/2 clinical trial in patients with advanced solid tumors, and a preclinical monoclonal antibody targeting CD27. For more information on Kineta, please visit www.kinetabio.com, and follow Kineta on Twitter, LinkedIn and Facebook.
KVA12123 is a VISTA blocking immunotherapy in development as a twice weekly infusion. The drug is being evaluated in a Phase 1/2 clinical trial for patients with advanced solid tumors. Competitive therapies targeting VISTA have demonstrated either poor monotherapy anti-tumor activity in preclinical models or induction of cytokine release syndrome (CRS) in human clinical trials. Through the combination of unique epitope binding and an optimized IgG1 Fc region, KVA12123 demonstrates strong monotherapy tumor growth inhibition in preclinical models without evidence of CRS in clinical trial participants. KVA12123 effectively de-risks the VISTA target and provides a novel approach to address immune suppression in the tumor microenvironment (TME) with a mechanism of action that is differentiated and complementary to T cell focused therapies. KVA12123 may be an effective immunotherapy for many types of cancer including non-small cell lung (NSCLC), colorectal, renal cell carcinoma, head and neck, and ovarian cancer.
VISTA (V-domain Ig suppressor of T cell activation) is a negative immune checkpoint that suppresses T cell function in a variety of solid tumors. High VISTA expression in tumor correlates with poor survival in cancer patients and has been associated with a lack of response to other immune checkpoint inhibitors. Blocking VISTA induces an efficient polyfunctional immune response to address immunosuppression and drives anti-tumor responses.
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Source: Kineta, Inc.