• VISTA Blocking KVA12123 Monoclonal Antibody (mAb) Engineered to Provide Strong Single Agent Anti-Tumor Activity While Minimizing Cytokine Related Adverse Events
• KVA12123 recognizes a unique VISTA epitope and binds at neutral and acidic pH
• Data Supports KVA12123’s Potential as a Therapy Against Poorly Immunogenic Tumors

SEATTLE, Dec. 13, 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 peer-reviewed publication in Frontiers in Immunology of preclinical data highlighting the potential of KVA12123 as a new immunotherapy against poorly immunogenic tumors. The publication titled “A Highly Potent Anti-VISTA Antibody KVA12123 - A New Immune Checkpoint Inhibitor and a Promising Therapy Against Poorly Immunogenic Tumors”, reports on the development of KVA12123.

“This scientific article summarizes the extensive characterization and selection of our clinical candidate KVA12123 that targets VISTA, a strong driver of immune suppression in the tumor microenvironment,” said Thierry Guillaudeux, Ph.D., Chief Scientific Officer of Kineta. “These data demonstrate that our engineered IgG1 anti-VISTA antibody binds to a unique epitope at neutral and acidic pH and has significant potential to address immuno-resistance in cancer patients.”

Key results from the publication include:

• High affinity binding to VISTA through a unique epitope that is distinct from other clinical-stage anti-VISTA mAbs
• High specificity against VISTA with no cross-reactivity against other members of the B7 family
• Blockade of VISTA binding to all four of its respective ligands
• Ability to reverse T cell suppression by myeloid-derived suppressor cells, one of the main drivers of immune suppression in the tumor microenvironment
• Ability to induce T cell and NK-mediated monocyte activation
• Strong single-agent antitumor activity in several syngeneic tumor models and enhanced efficacy in combination with anti-PD-1
• On-target induction of cytokines/chemokines associated with VISTA blockade
• Well tolerated in preclinical toxicology studies without antibody-dependent cellular cytotoxicity or induction of CRS-related cytokines

“We are excited to share the discovery, characterization and preclinical development of KVA12123 in Frontiers in Immunology, a well-known journal in the field,” said Shawn Iadonato, Ph.D., Chief Executive Officer of Kineta. “The publication highlights the differentiating potency and safety characteristics of KVA12123 that guided its advancement into clinical development. Our Phase 1/2 trial with KVA12123 as a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors is on track, demonstrating early promising safety and biomarker results in the clinic.”

KVA12123 is currently being evaluated in a Phase 1/2 VISTA-101 open-label clinical trial as a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors (NCT05708950). Additional clinical efficacy data in the monotherapy arm and initial combination data with pembrolizumab are anticipated in Q2 2024.

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 Twitter, LinkedIn and Facebook.

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.

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.

Cautionary Statements Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The use of words such as, but not limited to, “believe,” “expect,” “estimate,” “project,” “intend,” “future,” “potential,” “continue,” “may,” “might,” “plan,” “will,” “should,” “seek,” “anticipate,” or “could” and other similar words or expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Kineta’s current beliefs, expectations and assumptions regarding the future of Kineta’s business, future plans and strategies, clinical results and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Such forward-looking statements are subject to a number of material risks and uncertainties including, but not limited to: the adequacy of Kineta’s capital to support its future operations (including its ability to complete the second tranche of the previously disclosed contemplated private placement) and its ability to successfully initiate and complete clinical trials; the difficulty in predicting the time and cost of development of Kineta’s product candidates; Kineta’s plans to research, develop and commercialize its current and future product candidates, including, but not limited to, KVA12123; the timing and anticipated results of Kineta’s planned pre-clinical studies and clinical trials and the risk that the results of Kineta’s pre-clinical studies and clinical trials may not be predictive of future results in connection with future studies or clinical trials; the timing of the availability of data from Kineta’s clinical trials; the timing of any planned investigational new drug application or new drug application; the risk of cessation or delay of any ongoing or planned clinical trials of Kineta or its collaborators; the clinical utility, potential benefits and market acceptance of Kineta’s product candidates; Kineta’s commercialization, marketing and manufacturing capabilities and strategy; developments and projections relating to Kineta’s competitors and its industry; the impact of government laws and regulations; the timing and outcome of Kineta’s planned interactions with regulatory authorities; Kineta’s ability to protect its intellectual property position; Kineta’s estimates regarding future revenue, expenses, capital requirements and need for additional financing; the intended use of proceeds from the registered direct offerings completed in April 2023 and October 2023; and those risks set forth under the caption “Risk Factors” in the company’s most recent Annual Report on Form 10-K filed with the SEC on March 31, 2023, and Quarterly Reports on Form 10-Q filed with the SEC on May 11, 2023, August 11, 2023 and November 3, 2023, as well as discussions of potential risks, uncertainties and other important factors in Kineta’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Except as required by law, Kineta undertakes no obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Kineta, Inc. :
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Investor Relations:
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LifeSci Advisors, LLC
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