Kineta Reports Initial Clinical Response Data at AACR 2024 of its Ongoing Phase 1/2 VISTA-101 Clinical Trial

Partial response and stable disease reported in combination cohort, and durable stable disease observed in monotherapy cohorts

Favorable clinical safety and tolerability profile observed with no dose limiting toxicities and no evidence of CRS-associated cytokines observed at any dose level

Cleared fifth of six monotherapy cohorts and second of four combination cohorts

SEATTLE, April 08, 2024 (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 at the American Association for Cancer Research (AACR) in San Diego, CA an update on its ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123, an anti-VISTA monoclonal antibody, as monotherapy and in combination with Merck’s anti-PD1 therapy, KEYTRUDA^® (pembrolizumab), in patients with advanced solid tumors.

KVA12123 cleared the fifth of six monotherapy dose levels and the second of four cohorts in combination with pembrolizumab. KVA12123 was well tolerated with no dose limiting toxicities (DLT) or cytokine related adverse events at any dose level.

The poster presentation #CT068: “Interim results of the ongoing phase 1/2 clinical trial of KVA12123, an engineered IgG1 targeting VISTA, alone and in combination with pembrolizumab in advanced solid tumors” was presented Monday, April 8, 2024 and reported the following findings (the data cutoff date was February 28, 2024):

Monotherapy Dose Escalation (3–300 mg KVA12123 Q2W)

• Of 21 patients enrolled, 12 received at least one baseline and one follow-up scan
• Best overall response (BOR) in 9 of 12 patients with at least one follow-up scan is stable disease with a mean duration of 15 weeks
• One patient with non-small cell lung cancer that failed 6 prior lines of therapy, including checkpoint inhibitor (CPI) therapy, has experienced stable disease lasting 28 weeks
• Nine patients remain on-treatment

Combination Therapy Dose Escalation (30-100 mg KVA12123 Q2W, 400 mg pembrolizumab Q6W)

• Of 9 patients enrolled, 3 received at least one baseline and one follow-up scan
• BOR in 2 of 3 patients with at least one follow up scan is:
  • Partial Response in 1 mucoepidermoid carcinoma patient with a 54% reduction in target lesions and a complete response in non-target lesions
  • Stable disease in 1 renal cell carcinoma patient that had progressed on prior CPI therapy with a 24% reduction in target lesions
• Eight patients remain on-treatment
  

Biomarkers

• Dose-dependent induction of on-target pro-inflammatory cytokines and chemokines
• Dose-dependent increases in activated non-classical monocytes, CD4+ and CD8+ T cells, and NK cells

Safety

• No DLTs observed in any patient at any dose level
• No evidence of cytokine release syndrome in any patient at any dose level

“We are pleased to present our progress on the VISTA-101 clinical trial at AACR this year, with the initial clinical response data and the durability of patient benefit emerging from the study. The safety profile of KVA12123 to date has been remarkable in the monotherapy as well as combotherapy cohorts, supporting advancement to the final monotherapy dosing cohort of KVA12123 and reaching the estimated optimal therapeutic dose,” said Thierry Guillaudeux, Ph.D., Chief Scientific Officer of Kineta. “Initial read-outs demonstrated that KVA12123 is not only safe but exhibits potential clinical benefit for some patients as either monotherapy or combotherapy and may offer patients a novel approach to address immunosuppression in the tumor microenvironment and better manage solid tumor cancers.” In February 2024, the company announced that it is pursuing strategic alternatives to maximize shareholder value due to certain investors indicating they will not fulfill their April 2024 funding obligation in the previously disclosed private placement financing. As a result, the company has suspended new patient enrollment into the Phase 1/2 VISTA-101 trial and will not be recruiting patients into either the sixth cohort in the monotherapy arm or the third cohort in the combination therapy arm. Patients currently enrolled in the trial will be permitted to continue to participate.

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About Kineta

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 X (Twitter) and LinkedIn.

KVA12123 is a VISTA blocking immunotherapy in development as a twice weekly monoclonal antibody infusion drug 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 has been shown to de-risk the VISTA target and provides a novel approach to address immune suppression in the TME with a mechanism of action that is differentiated and complementary with 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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