Kineta Announces Completion of Enrollment in the Monotherapy Arm of the VISTA-101 Phase 1 Clinical Study in Advanced Solid Tumors
Kineta announced the completion of enrollment in the monotherapy cohorts of its Phase 1 VISTA-101 clinical trial evaluating KVA12123, a novel VISTA blocking immunotherapy, in patients with advanced solid tumors. The trial enrolled patients in 6-dose cohorts ranging from 3mg to 1000mg every two weeks, with no dose limiting toxicities or cytokine related adverse events observed.
The study is now enrolling patients into cohorts evaluating KVA12123 in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). Initial results reported earlier this year showed partial response and stable disease in combination cohorts and durable stable disease in monotherapy cohorts. Kineta aims to complete full enrollment before year-end and will present additional scientific data in 2024 at an upcoming scientific meeting.
Kineta ha annunciato il completamento dell'arruolamento nei gruppi di monoterapia del suo studio clinico di Fase 1 VISTA-101 che valuta KVA12123, una nuova immunoterapia che blocca VISTA, in pazienti con tumori solidi avanzati. Lo studio ha arruolato pazienti in gruppi con dosi che vanno da 3mg a 1000mg ogni due settimane, senza limitazioni di dose o eventi avversi correlati a citochine osservati.
Lo studio sta ora arruolando pazienti in gruppi che valutano KVA12123 in combinazione con la terapia anti-PD-1 di Merck, KEYTRUDA® (pembrolizumab). I risultati iniziali riportati all'inizio di quest'anno hanno mostrato una risposta parziale e una malattia stabile nei gruppi in combinazione e una malattia stabile durevole nei gruppi di monoterapia. Kineta punta a completare l'arruolamento completo entro la fine dell'anno e presenterà ulteriori dati scientifici nel 2024 in un prossimo incontro scientifico.
Kineta anunció la finalización de la inscripción en los grupos de monoterapia de su ensayo clínico de Fase 1 VISTA-101 que evalúa KVA12123, una nueva inmunoterapia bloqueadora de VISTA, en pacientes con tumores sólidos avanzados. El ensayo inscribió pacientes en grupos de dosis que van de 3mg a 1000mg cada dos semanas, con sin limitaciones de dosis ni eventos adversos relacionados con citoquinas observados.
El estudio ahora está inscribiendo pacientes en grupos que evalúan KVA12123 en combinación con la terapia anti-PD-1 de Merck, KEYTRUDA® (pembrolizumab). Los resultados iniciales reportados a principios de este año mostraron una respuesta parcial y enfermedad estable en los grupos de combinación y enfermedad estable duradera en los grupos de monoterapia. Kineta tiene como objetivo completar la inscripción total antes de fin de año y presentará datos científicos adicionales en 2024 en una próxima reunión científica.
키네타는 VISTA-101 임상 시험의 단독 치료 Cohorts에 대한 등록이 완료되었다고 발표했습니다. 이 시험은 진행성 고형 종양 환자에서 새로운 VISTA 차단 면역 요법인 KVA12123를 평가합니다. 이 시험은 3mg에서 1000mg까지의 용량 Cohorts에서 환자를 등록했으며, 두 주마다 용량 제한 독성이나 사이토카인 관련 부작용은 관찰되지 않았습니다.
이 연구는 이제 Merck의 항-PD-1 요법인 KEYTRUDA®(펨브롤리주맙)와 KVA12123의 시험에 환자를 등록하고 있습니다. 올해 초 보고된 초기 결과는 부분 반응과 안정적인 병을 보였으며, 단독 치료 Cohorts에서는 지속 가능한 안정적인 병을 보였습니다. 키네타는 연말 이전에 전체 등록을 완료할 계획이며, 2024년 다가오는 과학 회의에서 추가적인 과학 데이터를 발표할 것입니다.
Kineta a annoncé l'achèvement de l'inscription dans les cohortes de monothérapie de son essai clinique de phase 1 VISTA-101 évaluant KVA12123, une nouvelle immunothérapie bloquant VISTA, chez des patients atteints de tumeurs solides avancées. L'essai a recruté des patients dans 6 cohortes de dosage allant de 3 mg à 1000 mg toutes les deux semaines, avec aucune toxicité liée à la dose ou événements indésirables liés aux cytokines observés.
Une étude recrute maintenant des patients dans des cohortes évaluant KVA12123 en combinaison avec la thérapie anti-PD-1 de Merck, KEYTRUDA® (pembrolizumab). Les premiers résultats rapportés plus tôt cette année ont montré une réponse partielle et une maladie stable dans les cohortes combinées et une maladie stable durable dans les cohortes de monothérapie. Kineta vise à compléter l'inscription complète avant la fin de l'année et présentera des données scientifiques supplémentaires en 2024 lors d'une prochaine réunion scientifique.
Kineta gab die Fertigstellung der Registrierung in den Monotherapie-Kohorten seiner Phase-1 VISTA-101-Studie bekannt, die KVA12123 evaluiert, eine neuartige VISTA-blockierende Immuntherapie für Patienten mit fortgeschrittenen soliden Tumoren. Die Studie hat Patienten in 6-Dosis-Kohorten mit Dosen von 3mg bis 1000mg alle zwei Wochen rekrutiert, ohne dass dosierungsbedingte Toxizitäten oder cytokinebedingte unerwünschte Ereignisse beobachtet wurden.
Die Studie rekrutiert jetzt Patienten in Kohorten, die KVA12123 in Kombination mit Mercks Anti-PD-1-Therapie KEYTRUDA® (Pembrolizumab) evaluieren. Erste Ergebnisse, die Anfang dieses Jahres berichtet wurden, zeigten teilweise Antworten und stabile Erkrankungen in den Kombinationskohorten und dauerhaft stabile Erkrankungen in den Monotherapie-Kohorten. Kineta plant, die vollständige Registrierung vor Jahresende abzuschließen und wird 2024 auf einer bevorstehenden wissenschaftlichen Konferenz zusätzliche wissenschaftliche Daten präsentieren.
- Completion of enrollment in monotherapy arm of Phase 1 VISTA-101 clinical trial
- No dose limiting toxicities or cytokine related adverse events observed in monotherapy cohorts
- Initial results show partial response and stable disease in combination cohorts
- Durable stable disease observed in monotherapy cohorts
- Received $5 million nonrefundable payment from TuHURA Biosciences in July 2024
- TuHURA exercised right to extend exclusivity and right of first offer agreement
- None.
Insights
The completion of enrollment in the monotherapy arm of Kineta's VISTA-101 Phase 1 clinical trial for KVA12123 is a significant milestone. Key points include:
- No dose-limiting toxicities or cytokine-related adverse events observed across 6 dose cohorts (3mg to 1000mg)
- Ongoing enrollment in combination therapy cohorts with KEYTRUDA®
- Previous data showed partial responses and stable disease in combination therapy and durable stable disease in monotherapy
- Favorable safety and tolerability profile reported earlier
The collaboration with TuHURA Biosciences, including a
This clinical progress represents a positive development for Kineta (OTC Pink: KANT), a small-cap biotech with a market cap of about
- The
$5 million non-refundable payment from TuHURA in July 2024 significantly bolsters Kineta's cash position - Ongoing collaboration with TuHURA potentially reduces R&D costs and risks
- Extended exclusivity agreement suggests potential for future licensing or acquisition deals
- Advancement to combination therapy stage could increase the asset's value
However, investors should consider that as an early-stage biotech, Kineta likely has high cash burn rates. The company's OTC Pink listing also indicates less stringent reporting requirements, which may limit transparency. Future capital needs and potential dilution remain key concerns. The stock's valuation will heavily depend on forthcoming clinical data and any developments in the TuHURA partnership.
Kineta has completed enrollment in the monotherapy cohorts of the Phase 1 VISTA-101 clinical trial.
The ongoing Phase 1 study is now enrolling patients into cohorts evaluating KVA12123 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab).
The company will present additional scientific data in 2024 at an upcoming scientific meeting.
SEATTLE, Oct. 08, 2024 (GLOBE NEWSWIRE) -- Kineta, Inc. (OTC Pink: KANT) (“Kineta” or the “Company”), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, announced today that it has completed the enrollment of new patients into the monotherapy arm of the VISTA-101 phase 1 clinical trial evaluating KVA12123, Kineta’s novel VISTA blocking immunotherapy, in patients with advanced solid tumors. The monotherapy portion of the trial enrolled patients in 6-dose cohorts ranging from 3mg to 1000mg every two weeks and no dose limiting toxicities or cytokine related adverse events have been observed in the study. The Company is continuing to enroll patients into cohorts evaluating KVA12123 in combination with Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab).
Initial results demonstrating partial response and stable disease in the cohorts evaluating KVA12123 in combination with pembrolizumab 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 pleased to successfully complete patient enrollment in the monotherapy arm, and we remain on target for completing full enrollment into this study before year end,” said Craig W. Philips, President of Kineta.
On July 8, 2024, 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
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About Kineta
Kineta 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.
Through the combination of unique epitope binding and an optimized IgG1 Fc region, KVA12123 has demonstrated strong tumor growth inhibition as both a monotherapy and 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
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