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TAMPA, FL and SAN DIEGO, CA - Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company, has reopened enrollment for its VISTA-101 Phase 1/2 clinical trial, which is evaluating KVA12123, a VISTA blocking antibody. This development follows an Exclusivity and Right of First Offer Agreement with TuHURA Biosciences, Inc., which is currently evaluating the potential acquisition of KVA12123.
The trial, which includes both monotherapy and combination therapy with Merck's KEYTRUDA® (pembrolizumab), has enrolled 30 out of an anticipated 39 patients. KVA12123 has successfully completed the fifth of six monotherapy dose levels and two of the four combination cohorts. Initial results have shown partial responses and stable disease in combination cohorts, and durable stable disease in monotherapy cohorts, with no dose-limiting toxicities or evidence of cytokine release syndrome (CRS) at any dose level.
Dr. James Bianco, CEO of TuHURA, expressed optimism about the potential of KVA12123 as a new treatment for cancer patients, highlighting its synergies with TuHURA's technologies. Thierry Guillaudeux, Chief Scientific Officer of Kineta, noted the trial's progress and the drug's favorable safety profile. The trial's enrollment is expected to be completed by the end of 2024.
KVA12123 is being developed as an infusion dosed every two weeks for patients with advanced treatment-refractory solid tumors. It aims to differentiate from other VISTA-targeting therapies by avoiding CRS and demonstrating strong tumor growth inhibition in preclinical models.
TuHURA Biosciences, a Phase 3 registration-stage immuno-oncology company, is also preparing to initiate a Phase 3 trial of its personalized cancer vaccine candidate, IFx-2.0, in combination with KEYTRUDA® for advanced or metastatic Merkel Cell Carcinoma. Additionally, TuHURA is advancing bi-functional ADCs targeting Myeloid Derived Suppressor Cells to inhibit immune suppression in the tumor microenvironment.
The collaboration between Kineta and TuHURA is part of a broader strategy, as TuHURA has entered a definitive agreement for an all-stock transaction with Kintara Therapeutics, Inc. (Nasdaq: KTRA). The resulting company will focus on advancing a risk diversified late-stage oncology pipeline and is expected to trade on The Nasdaq Capital Market under the ticker "HURA" upon completion of the transaction, subject to customary closing conditions.
This article is based on a press release statement.
InvestingPro Insights
As Kineta, Inc. (Nasdaq: KA) continues to progress in its clinical trials, recent market data reflects several financial challenges the company is facing. According to InvestingPro data, Kineta has a market capitalization of just $6.92 million, demonstrating a relatively small size within the biotech industry. The company's stock price has experienced significant volatility, with a 1-week total return of -7.54% and a 1-month total return of -17.8%. However, it's worth noting that the stock has shown a strong return over the last three months, with a 24.78% increase.
InvestingPro Tips highlight that Kineta has been grappling with weak gross profit margins and that the company's short-term obligations currently exceed its liquid assets. Additionally, analysts do not anticipate Kineta will be profitable this year, which is further evidenced by a negative P/E Ratio of -0.35. These financial metrics suggest that investors should exercise caution and conduct thorough due diligence. For those interested in a deeper analysis, InvestingPro offers 11 additional tips on Kineta, which can be accessed at the dedicated InvestingPro page for Kineta.
Despite these financial headwinds, Kineta's clinical developments, such as the VISTA-101 Phase 1/2 clinical trial and the potential acquisition of KVA12123 by TuHURA Biosciences, Inc., could prove to be pivotal for the company's future. The strategic collaboration with TuHURA and the all-stock transaction with Kintara Therapeutics, Inc. (Nasdaq: KTRA) may also have significant implications for Kineta's market performance and operational capabilities in the long term.
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