Kazia Therapeutics Announces Presentation of EVT801 Clinical Data at 15th Biennial Ovarian Cancer Research Symposium
Kazia Therapeutics (NASDAQ: KZIA) presented promising clinical data for EVT801 in high grade serous (HGS) Ovarian Cancer at the 15th Biennial Ovarian Cancer Research Symposium. The Phase 1 first-in-human trial met its primary objectives, identifying the maximal tolerated dose at 500mg twice a day (BID) and the recommended Phase 2 dose at 400mg BID. Key findings include:
- 26 patients treated across 6 dosing cohorts
- 46% of HGS ovarian cancer patients showed stable disease for at least three cycles
- One patient had a partial response (-39% decrease) after 2 cycles
- EVT801 was well-tolerated with mostly mild to moderate, transient toxicities
Dr. John Friend, CEO of Kazia Therapeutics, expressed optimism about EVT801's potential as a first-in-class VEGFR-3 inhibitor for ovarian cancer treatment.
Kazia Therapeutics (NASDAQ: KZIA) ha presentato dati clinici promettenti per EVT801 nel carcinoma ovarico sieroso di alto grado (HGS) al 15° Simposio Biennale sulla Ricerca del Cancro Ovarico. Lo studio di Fase 1, primo nel suo genere sugli esseri umani, ha raggiunto i suoi obiettivi primari, identificando la dose massima tollerata a 500mg due volte al giorno (BID) e la dose raccomandata per la Fase 2 a 400mg BID. Tra i risultati chiave si evidenziano:
- 26 pazienti trattati in 6 coorti di dosaggio
- Il 46% dei pazienti con cancro ovarico HGS ha mostrato malattia stabile per almeno tre cicli
- Un paziente ha registrato una risposta parziale (-39% di riduzione) dopo 2 cicli
- EVT801 è stato ben tollerato con per lo più tossicità transitorie lievi a moderate
Il Dr. John Friend, CEO di Kazia Therapeutics, ha espresso ottimismo riguardo al potenziale di EVT801 come inibitore di classe prima del VEGFR-3 per il trattamento del cancro ovarico.
Kazia Therapeutics (NASDAQ: KZIA) presentó datos clínicos prometedores para EVT801 en cáncer de ovario seroso de alto grado (HGS) en el 15° Simposio Bienal de Investigación sobre Cáncer de Ovario. El ensayo de Fase 1, el primero en humanos, cumplió con sus objetivos primarios, identificando la dosis máxima tolerada en 500mg dos veces al día (BID) y la dosis recomendada para la Fase 2 en 400mg BID. Los hallazgos clave incluyen:
- 26 pacientes tratados en 6 cohortes de dosificación
- El 46% de los pacientes con cáncer de ovario HGS mostró enfermedad estable durante al menos tres ciclos
- Un paciente tuvo una respuesta parcial (-39% de disminución) después de 2 ciclos
- EVT801 fue bien tolerado, con toxicidades transitorias mayormente leves a moderadas
El Dr. John Friend, CEO de Kazia Therapeutics, expresó optimismo sobre el potencial de EVT801 como un inhibidor de VEGFR-3 de primera clase para el tratamiento del cáncer de ovario.
Kazia Therapeutics (NASDAQ: KZIA)는 제15회 양성자궁암 연구 심포지엄에서 고등급 세러스(HGS) 난소암에 대한 EVT801의 유망한 임상 데이터를 발표했습니다. 1상 최초 인간 시험은 주요 목표를 달성하여 최대 내약 용량을 500mg 하루 두 번 (BID)로, 권장 2상 용량을 400mg BID로 확인했습니다. 주요 발견은 다음과 같습니다:
- 6개 용량 집단에서 26명의 환자 치료
- HGS 난소암 환자의 46%가 최소 3회 사이클 동안 안정된 질환을 보임
- 1명의 환자가 2회 사이클 후 부분 반응(-39% 감소)을 보임
- EVT801은 대부분 경미하고 일시적인 독성이 나타나며 잘 견딜 수 있었습니다
Kazia Therapeutics의 CEO인 Dr. John Friend는 EVT801이 난소암 치료를 위한 첫 번째 VEGFR-3 억제제로서의 잠재력에 대해 낙관적인 입장을 밝혔습니다.
Kazia Therapeutics (NASDAQ: KZIA) a présenté des données cliniques prometteuses concernant EVT801 pour le cancer de l'ovaire séreux de haut grade (HGS) lors du 15ème Symposium Biennal de Recherche sur le Cancer de l'Ovaira. L'essai de Phase 1, premier de son genre sur l'homme, a atteint ses objectifs principaux, identifiant la dose maximale tolérée à 500mg deux fois par jour (BID) et la dose recommandée pour la Phase 2 à 400mg BID. Les principaux résultats incluent :
- 26 patients traités dans 6 cohortes de dosage
- 46% des patients atteints de cancer de l'ovaire HGS ont montré une maladie stable pendant au moins trois cycles
- Un patient a eu une réponse partielle (-39% de diminution) après 2 cycles
- EVT801 a été bien toléré avec principalement des toxicités légères à modérées et transitoires
Dr John Friend, PDG de Kazia Therapeutics, a exprimé un optimisme quant au potentiel d'EVT801 en tant qu'inhibiteur VEGFR-3 de première classe pour le traitement du cancer de l'ovaire.
Kazia Therapeutics (NASDAQ: KZIA) präsentierte vielversprechende klinische Daten zu EVT801 bei hochgradigem serösem (HGS) Eierstockkrebs auf dem 15. Biennalen Symposium zur Krebsforschung bei Eierstöcken. Die Phase-1-Studie, die erste ihrer Art am Menschen, erreichte ihre primären Ziele und identifizierte die maximal tolerierte Dosis bei 500mg zweimal täglich (BID) sowie die empfohlene Dosis für Phase 2 bei 400mg BID. Zu den wichtigsten Ergebnissen gehören:
- 26 Patienten wurden in 6 Dosierungsgruppen behandelt
- 46% der HGS-Eierstockkrebspatienten zeigten über mindestens drei Zyklen eine stabile Erkrankung
- Ein Patient hatte nach 2 Zyklen eine partielle Reaktion (-39% Rückgang)
- EVT801 wurde gut vertragen, mit überwiegend milden bis moderaten, vorübergehenden Nebenwirkungen
Dr. John Friend, CEO von Kazia Therapeutics, äußerte Optimismus hinsichtlich des Potenzials von EVT801 als ein erstes VEGFR-3-Inhibitor für die Behandlung von Eierstockkrebs.
- Phase 1 trial met primary objectives, identifying maximal tolerated dose and recommended Phase 2 dose
- 46% of HGS ovarian cancer patients showed stable disease for at least three cycles
- One patient had a partial response (-39% decrease) after 2 cycles of EVT801 therapy
- EVT801 was well-tolerated across all doses with mostly mild to moderate toxicities
- None.
Dr. John Friend, CEO Kazia Therapeutics presented preliminary data from a Phase 1 first-in-human clinical trial evaluating the safety and tolerability of EVT801, a highly selective small molecule VEGFR3 inhibitor targeting tumour angiogenesis. The Phase 1 study met its primary objectives, with the maximal tolerated dose identified at 500mg twice a day (BID). The Phase 1 study also identified the recommended Phase 2 dose starting at 400mg BID. It was observed that EVT801 was tolerated across all doses, with the majority of toxicities being mild to moderate and transient in nature.
Key points of the presentation included:
- A total of 26 patients were treated across 6 dosing cohorts ranging from 50mg once daily (QD) to 500mg twice daily (BID)
- Patients with eleven different cancer types (ex. colon, renal cell, pancreatic) were enrolled in the study, with heavily pretreated advanced ovarian cancer being the most prevalent indication (11 patients)
- Biomarkers have shown strong VEGFR3 expression in multiple indications, including ovarian cancer
- Encouraging clinical activity in High Grade Serous ovarian cancer patients with forty-six percent (
46% ) having stable disease or for at least three cycles, including two patients who received 9 cycles - One patient had a partial response (-
39% decrease) after 2 cycles of EVT801 therapy
Dr John Friend, CEO of Kazia Therapeutics, commented: "I was honored to participate at the Ovarian Cancer Research Symposium and present our findings to fellow clinicians and ovarian cancer researchers from around the globe. Ovarian cancer is often diagnosed at late stages with poor patient prognosis, so the data from the Phase 1 study is extremely encouraging and gives us confidence that we could potentially have a first-in-class VEGFR-3 inhibitor with EVT801."
Abstract: Phase I study of EVT801, a VEGFR-3 inhibitor, shows promising clinical activity in HGS ovarian cancer
https://www.xcdsystem.com/rivkin/program/ZR7NvO4/index.cfm?pgid=1697
September 21, 2024 – 11:30am-1:30pm
About Kazia Therapeutics Limited
Kazia Therapeutics Limited (NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney,
Our lead program is paxalisib, an investigational brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of brain cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in this disease. A completed Phase 2 study in glioblastoma reported early signals of clinical activity in 2021, and a pivotal study in glioblastoma, GBM AGILE, has been completed with presentation of paxalisib arm data expected later in 2024 at a major medical conference. Other clinical trials involving paxalisib are ongoing in brain metastases, diffuse midline gliomas, and primary CNS lymphoma, with several of these trials having reported encouraging interim data.
Paxalisib was granted Orphan Drug Designation for glioblastoma by the FDA in February 2018, and Fast Track Designation (FTD) for glioblastoma by the FDA in August 2020. Paxalisib was also granted FTD in July 2023 for the treatment of solid tumour brain metastases harboring PI3K pathway mutations in combination with radiation therapy. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA for diffuse intrinsic pontine glioma in August 2020, and for atypical teratoid / rhabdoid tumours in June 2022 and July 2022, respectively.
Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to be active against a broad range of tumour types and has provided evidence of synergy with immuno-oncology agents. A Phase I study has been completed and preliminary data was presented at 15th Biennial Ovarian Cancer Research Symposium in September 2024.
For more information, please visit www.kaziatherapeutics.com or follow us on X @KaziaTx.
Forward-Looking Statements
This announcement may contain forward-looking statements, which can generally be identified as such by the use of words such as "may," "will," "estimate," "future," "forward," "anticipate," or other similar words. Any statement describing Kazia's future plans, strategies, intentions, expectations, objectives, goals or prospects, and other statements that are not historical facts, are also forward-looking statements, including, but not limited to, statements regarding: the timing for results and data related to Kazia's clinical and preclinical trials, Kazia's strategy and plans with respect to its programs, including paxalisib and EVT801, the potential benefits of EVT801 as a VEGFR3 inhibitor and the potential market opportunity for EVT801. Such statements are based on Kazia's current expectations and projections about future events and future trends affecting its business and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, including risks and uncertainties: associated with clinical and preclinical trials and product development, related to regulatory approvals, and related to the impact of global economic conditions. These and other risks and uncertainties are described more fully in Kazia's Annual Report, filed on form 20-F with the SEC, and in subsequent filings with the United States Securities and Exchange Commission. Kazia undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this announcement.
This announcement was authorized for release by Dr John Friend, CEO.
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SOURCE Kazia Therapeutics Limited
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