KVA12123 is a rationally targeted, anti-VISTA antibody checkpoint inhibitor to reverse VISTA immune suppression and remodel the tumor microenvironment (TME) to overcome acquired resistance to immunotherapies
KVA12123 is currently in a Phase 1/Phase 2 clinical study as a monotherapy and in combination with Merck's anti-PD1 therapy, KEYTRUDA® (pembrolizumab), in patients with advanced solid tumors
To date, KVA12123 has demonstrated a favorable clinical safety and tolerability profile observed with no dose limiting toxicities and no evidence of Cytokine Release Syndrome (CRS) associated toxicities at doses examined
Concurrent $5 million investment from existing TuHURA shareholder preserves TuHURA's strong balance sheet for advancing its IFx-2.0 Phase 3 accelerated approval trial and novel bi-functional ADCs
TAMPA, Fla. and SAN DIEGO, July 8, 2024 /PRNewswire/ -- TuHURA Biosciences, Inc. ("TuHURA"), a Phase 3 registration-stage immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, and Kintara Therapeutics, Inc. (NASDAQ:KTRA) ("Kintara"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced TuHURA has entered into an Exclusivity and Right of First Offer Agreement (the "Agreement") with Kineta, Inc. (NASDAQ:KA) ("Kineta") for the potential acquisition of Kineta's KVA12123 anti-VISTA antibody and related rights and assets associated with and derived from the asset.
"KVA12123 has multiple synergies with both of our IFx and Delta receptor technologies and could be a promising addition to our pipeline, bringing in a potential Phase 2 ready, novel checkpoint inhibitor," commented Dr. James Bianco, Chief Executive Officer of TuHURA. "Unlike other checkpoint inhibitors which work on activated T-cells, KVA12123 focuses on VISTA, which is the only known checkpoint on quiescent T-cells preventing their activation and represents a promising new target in cancer immunotherapy. VISTA is highly overexpressed on tumors known not to respond to currently marketed checkpoint inhibitors most notably gynecologic cancers like ovarian cancer. They are also expressed on myeloid cells including tumor associated myeloid-derived suppressor cells ("MDSCs"), which, like VISTA, are also implicated in TME immunosuppression. Our novel bi-functional Antibody Drug Conjugates ("ADCs") are intended to target and block the delta receptor on MDSCs."
Under the terms of the Agreement, TuHURA will pay Kineta $5.0 million, with $2.5 million paid at signing and, subject to certain provisions, an additional $2.5 million to be paid by July 15, 2024. In conjunction with the Agreement, TuHURA sold $5.0 million of shares of its common stock in a private offering to an existing shareholder. The exclusivity period under the Agreement lasts for 90 days (until October 1, 2024), subject to extension for an additional 20 days.
About KVA12123
KVA12123 is a VISTA blocking immunotherapy in development as a twice weekly monoclonal antibody infusion drug completing two clinical trials both as a monotherapy and in combination with Merck's anti-PD1 therapy, KEYTRUDA® (pembrolizumab), in patients with advanced treatment refractory, 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 and represents the introduction of a new class of checkpoint inhibitors.
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.
"TuHURA Biosciences is well positioned to advance KVA12123," said Craig W. Philips, President of Kineta. "TuHURA has significant expertise and deep experience in the field. We believe they will make an excellent partner for this program and in advancing this novel drug program which could provide an important new treatment option for cancer patients."
As previously announced, TuHURA entered into a definitive agreement for an all-stock transaction with Kintara to form a company combining expertise and resources to advance a risk diversified late-stage oncology pipeline. The combined company will focus on advancing TuHURA's personalized cancer vaccine(s) and first-in-class bi-functional ADCs, two technologies that seek to overcome the major obstacles that limit the effectiveness of current immunotherapies in treating cancer. The combined company is expected to operate under the name "TuHURA Biosciences, Inc." and to trade on The Nasdaq Capital Market under the ticker "HURA". The transaction is subject to customary closing conditions, including stockholder approval of both companies, and is expected to close in the third quarter of 2024.
About Kineta, Inc.
Kineta (NASDAQ:KA) is ...