Kineta Reopens Enrollment for the VISTA-101 Clinical Trial Evaluating KVA12123 in Patients with Advanced Solid Tumor Cancer
Kineta (Nasdaq: KA) has reopened enrollment for its VISTA-101 Phase 1/2 clinical trial evaluating KVA12123 in patients with advanced solid tumor cancer. The trial includes a monotherapy arm and a combination arm with Merck's KEYTRUDA®. To date, 30 patients have been enrolled, and Kineta expects full enrollment by end of 2024. Initial results showed partial response and stable disease in combination cohorts and durable stable disease in monotherapy cohorts. KVA12123 demonstrated a favorable safety profile with no dose-limiting toxicities or cytokine release syndrome.
Kineta recently entered an exclusivity agreement with TuHURA Biosciences, receiving a $5 million payment. TuHURA has an exclusive right to acquire Kineta's KVA12123-related assets until October 1, 2024, subject to extension.
Kineta (Nasdaq: KA) ha riaperto le iscrizioni per il suo studio clinico VISTA-101 di fase 1/2 che valuta il KVA12123 in pazienti con tumori solidi avanzati. Lo studio comprende un braccio di monoterapia e un braccio di combinazione con KEYTRUDA® di Merck. Fino ad oggi, 30 pazienti sono stati arruolati, e Kineta prevede di completare l'arruolamento entro la fine del 2024. I risultati iniziali hanno mostrato risposte parziali e malattia stabile nei gruppi di combinazione e malattia stabile duratura nei gruppi di monoterapia. Il KVA12123 ha dimostrato un profilo di sicurezza favorevole senza tossicità limitanti per la dose o sindrome da rilascio di citochine.
Recentemente, Kineta ha firmato un contratto di esclusività con TuHURA Biosciences, ricevendo un pagamento di 5 milioni di dollari. TuHURA ha il diritto esclusivo di acquisire gli asset relativi al KVA12123 di Kineta fino al 1° ottobre 2024, con possibilità di estensione.
Kineta (Nasdaq: KA) ha reabierto las inscripciones para su ensayo clínico VISTA-101 de fase 1/2 que evalúa el KVA12123 en pacientes con cáncer de tumores sólidos avanzados. El ensayo incluye un brazos de monoterapia y un brazos de combinación con KEYTRUDA® de Merck. Hasta la fecha, 30 pacientes han sido inscritos, y Kineta espera completar la inscripción para finales de 2024. Los resultados iniciales mostraron respuesta parcial y enfermedad estable en los grupos de combinación y enfermedad estable duradera en los grupos de monoterapia. El KVA12123 demostró un perfil de seguridad favorable sin toxicidades limitantes de dosis ni síndrome de liberación de citoquinas.
Recientemente, Kineta firmó un acuerdo de exclusividad con TuHURA Biosciences, recibiendo un pago de 5 millones de dólares. TuHURA tiene el derecho exclusivo de adquirir los activos relacionados con el KVA12123 de Kineta hasta el 1 de octubre de 2024, sujeto a extensión.
키네타(Kineta) (나스닥: KA)는 VISTA-101 1/2상 임상 시험에 대한 참여를 재개했습니다, 이는 고급 고형 종양 암 환자에서 KVA12123를 평가합니다. 이 시험에는 머크의 KEYTRUDA®와의 단일 요법 그룹과 병용 요법 그룹이 포함됩니다. 현재까지 30명의 환자가 등록되었으며, 키네타는 2024년 말까지 전체 등록을 완료할 것으로 예상하고 있습니다. 초기 결과는 병용 요법 그룹에서 부분 반응 및 안정 병변을 보여주었고, 단일 요법 그룹에서는 지속적으로 안정된 병변을 보였습니다. KVA12123는 유리한 안전성 프로필을 보여주었으며, 용량 제한 독성이 없거나 사이토카인 방출 증후군이 나타나지 않았습니다.
최근 키네타는 TuHURA 생명과학과 독점 계약을 체결하며 500만 달러의 지급을 받았습니다. TuHURA는 2024년 10월 1일까지 키네타의 KVA12123 관련 자산을 인수할 수 있는 독점 권리를 보유하고 있으며, 연장의 가능성이 있습니다.
Kineta (Nasdaq: KA) a réouvert ses inscriptions pour son essai clinique VISTA-101 de phase 1/2 évaluant le KVA12123 chez des patients atteints de cancer avancé à tumeurs solides. L'essai comprend un bras de monothérapie et un bras de combinaison avec le KEYTRUDA® de Merck. À ce jour, 30 patients ont été inclus, et Kineta s'attend à une inscription complète d'ici la fin de 2024. Les résultats initiaux ont montré une réponse partielle et une maladie stable dans les cohortes de combinaison et une maladie stable durable dans les cohorts de monothérapie. Le KVA12123 a démontré un profil de sécurité favorable sans toxicités limitantes de dose ni syndrome de libération de cytokines.
Récemment, Kineta a conclu un accord d'exclusivité avec TuHURA Biosciences, recevant un paiement de 5 millions de dollars. TuHURA a le droit exclusif d'acquérir les actifs liés au KVA12123 de Kineta jusqu'au 1er octobre 2024, sous réserve d'extension.
Kineta (Nasdaq: KA) hat die Teilnahme an ihrem klinischen Studien VISTA-101 der Phase 1/2 zur Evaluation von KVA12123 bei Patienten mit fortgeschrittenem soliden Tumorkrebs wiedereröffnet. Die Studie umfasst einen Monotherapie-Arm und einen Kombinations-Arm mit Mercks KEYTRUDA®. Bisher sind 30 Patienten eingeschrieben, und Kineta erwartet, die vollständige Einschreibung bis Ende 2024 abzuschließen. Erste Ergebnisse zeigten partielle Reaktionen und stabile Erkrankung in den Kombinationsteilen und dauerhafte stabile Erkrankung in den Monotherapie-Teilen. KVA12123 hat ein günstiges Sicherheitsprofil gezeigt, ohne dosislimitierende Toxizitäten oder das Zytokinfreisetzungssyndrom.
Kineta hat kürzlich eine Exklusivitätsvereinbarung mit TuHURA Biosciences unterzeichnet, die eine Zahlung von 5 Millionen Dollar umfasst. TuHURA hat das exklusive Recht, die mit KVA12123 verbundenen Vermögenswerte von Kineta bis zum 1. Oktober 2024 zu erwerben, mit der Möglichkeit einer Verlängerung.
- Reopening of enrollment for VISTA-101 Phase 1/2 clinical trial
- Initial results show partial response and stable disease in combination cohorts
- Durable stable disease observed in monotherapy cohorts
- Favorable safety profile with no dose-limiting toxicities or cytokine release syndrome
- $5 million non-refundable payment received from TuHURA Biosciences
- Exclusive agreement with TuHURA potentially leading to acquisition of KVA12123 assets
- Previous suspension of patient enrollment due to funding issues
- Full enrollment not expected until end of 2024
- Potential acquisition of KVA12123 assets by TuHURA may impact Kineta's future development plans
Insights
The reopening of enrollment for Kineta's VISTA-101 clinical trial is a significant development in the oncology field. With 30 patients already enrolled and the trial expected to be fully enrolled by end of 2024, this study could provide important data on KVA12123's efficacy. The initial results showing partial response and stable disease in combination cohorts and durable stable disease in monotherapy are promising. The favorable safety profile without dose-limiting toxicities or cytokine release syndrome is particularly noteworthy, as it could potentially differentiate KVA12123 from other immunotherapies. This trial's progress could have substantial implications for advanced solid tumor cancer treatment, especially if the combination with Keytruda shows synergistic effects.
The resumption of the VISTA-101 trial is a positive financial indicator for Kineta. The
Kineta's VISTA-101 trial represents a novel approach in immuno-oncology. The VISTA (V-domain Ig suppressor of T cell activation) pathway is a relatively unexplored target compared to PD-1/PD-L1, potentially offering a new mechanism to overcome cancer immune resistance. The combination arm with Keytruda is particularly intriguing, as it could reveal synergistic effects that enhance efficacy beyond current standards of care. The involvement of TuHURA, a Phase 3 company, suggests strong interest in this technology platform. If successful, KVA12123 could become a valuable asset in the competitive immuno-oncology landscape, potentially rivaling established checkpoint inhibitors. However, the trial's previous suspension highlights the challenges small biotechs face in bringing novel therapies to market.
Effective immediately, clinical sites in the VISTA-101 Phase 1/ Phase 2 clinical trial can resume screening of patients for enrollment in the clinical study
30 patients have been enrolled in the clinical trial to date, including a monotherapy arm with KVA12123 and a combination arm utilizing KVA12123 together with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab)
Kineta anticipates the trial to be fully enrolled by the end of 2024
SEATTLE, Aug. 19, 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 that enrollment has resumed for the Company’s ongoing VISTA-101 Phase 1/2 clinical trial, effective immediately. As previously announced on March 12, 2024, patient enrollment in the clinical trial was suspended due to certain investors indicating that they would not fulfill their funding obligation due in April 2024 pursuant to the previously disclosed private placement financing.
To date, KVA12123 has cleared the fifth of six monotherapy dose levels and two of the four cohorts in combination with pembrolizumab. Initial results demonstrating partial response and stable disease in the combination cohorts and durable stable disease in the monotherapy cohorts were reported earlier this year at the American Association of Cancer Research (AACR) Annual Meeting 2024. Additionally, the initial results of KVA12123 showed a favorable clinical safety and tolerability profile with no dose limiting toxicities and no evidence of CRS-associated cytokines at any dose level.
“We are very pleased to resume enrollment for VISTA-101. KVA12123 has been well tolerated with no dose limiting toxicities and no cytokine release syndrome and we continue to be encouraged by the initial data demonstrated. With enrollment now recommenced, we are focused on successful execution and working towards completing enrollment which we expect to do by the end of 2024,” said Thierry Guillaudeux, Chief Scientific Officer of Kineta.
On July 8, Kineta announced that it had entered into an exclusivity and right of first offer agreement (the “Agreement”) with TuHURA Biosciences, Inc. (“TuHURA”), a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy. As part of the Agreement, Kineta received a concurrent
“KVA12123 is a novel, differentiated new treatment alternative for patients with cancer. The completion of the enrollment in the Phase 1 portion of the trial this year is an important milestone for this exciting development program and we are pleased to work closely with the Kineta team to resume enrollment,” said James A. Bianco, Chief Executive Officer of TuHURA.
Pursuant to the Agreement, among other things, Kineta has granted TuHURA an exclusive right to acquire Kineta’s worldwide patents, patent rights, patent applications, product and development program assets, technical and business information, and other rights and assets associated with and derived from its development program related to KVA12123, Kineta’s VISTA blocking immunotherapy. This exclusive right shall continue through the first to occur of (a) the execution of any definitive agreement with respect to a potential transaction by TuHURA or one or more of its affiliates and (b) 11:59 PM Eastern Time on October 1, 2024, subject to extension.
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 (formerly Twitter) and LinkedIn.
Through the combination of unique epitope binding and an optimized IgG1 Fc region, KVA12123 has demonstrated strong tumor growth inhibition as both a monotherapy or in combination with other checkpoint inhibitors in preclinical models. KVA12123 provides a novel approach to address immune suppression in the tumor microenvironment 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.
In February 2024, Kineta announced a significant corporate restructuring to substantially reduce expenses and preserve cash. The restructuring included a significant workforce reduction and the suspension of enrollment of new patients in its ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123 in patients with advanced solid tumors. At that time, Kineta also announced that it was exploring strategic alternatives to maximize stockholder value.
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. These forward-looking statements include, without limitation, statements relating to the anticipated benefits of the Agreement and statements relating to Kineta’s exploration of strategic alternatives and reinitiation of the VISTA-101 Phase 1/2 clinical trial. 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: Kineta’s 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, Kineta’s reinitiation of the VISTA-101 Phase 1/2 clinical trial for 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 ability to prevail in litigation against investors who failed to close an anticipated private placement; risks relating to volatility and uncertainty in the capital markets for biotechnology companies; availability of suitable third parties with which to conduct contemplated strategic transactions; whether Kineta will be able to pursue a strategic transaction, or whether any transaction, if pursued, will be completed on attractive terms or at all; whether Kineta’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital requirements; and those risks set forth under the caption “Risk Factors” in Kineta’s most recent Annual Report on Form 10-K filed with the SEC on March 21, 2024 and Quarterly Reports on Form 10-Q filed with the SEC on May 15, 2024 and August 8, 2024, 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:
Investor Relations:
info@kineta.us
Source: Kineta, Inc.
FAQ
What is the current status of Kineta's VISTA-101 clinical trial for KVA12123?
How many patients have been enrolled in Kineta's VISTA-101 trial as of August 2024?
What are the initial results of Kineta's KVA12123 trial?
What is the significance of Kineta's agreement with TuHURA Biosciences?
