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Details:
GDC-0084 (paxalisib) is an oral PI3K/mTOR dual inhibitor, which is being evaluated for the treatment of patients with PI3K pathway mutation brain metastases.
Lead Product(s): Paxalisib
Therapeutic Area: Oncology Product Name: GDC-0084
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 21, 2024
Details:
GDC-0084 (paxalisib) is a brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of brain cancer.
Lead Product(s): Paxalisib
Therapeutic Area: Oncology Product Name: GDC-0084
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2023
Details:
GDC-0084 (paxalisib), a brain-penetrant inhibitor of the PI3K/Akt/mTOR pathway, is being developed to treat multiple forms of brain cancer. The direct anti-cancer effects of PI3K inhibitors are well demonstrated, and five therapies have been approved by the US FDA.
Lead Product(s): Paxalisib
Therapeutic Area: Oncology Product Name: GDC-0084
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: QIMR Berghofer Medical Research Institute
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration December 15, 2022
Details:
The safety profile of paxalisib in combination was broadly consistent with monotherapy experience in other clinical trials, and a maximum tolerated dose (MTD) of 45mg daily in combination with radiotherapy was confirmed.
Lead Product(s): Paxalisib
Therapeutic Area: Oncology Product Name: GDC-0084
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 05, 2022
Details:
GDC-0084 (paxalisib), a brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat glioblastoma, the most common and most aggressive form of primary brain cancer in adults.
Lead Product(s): Paxalisib
Therapeutic Area: Oncology Product Name: GDC-0084
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Global Coalition for Adaptive Research
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 01, 2022
Details:
INT230-6 (Paxalisib), a brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, the safety profile of drug was highly consistent with previous clinical studies: hyperglycaemia, oral mucositis, and skin rash were among the most common drug-related toxicities.
Lead Product(s): Paxalisib
Therapeutic Area: Oncology Product Name: GDC-0084
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2022
Details:
At the outset, all patients will be treated with ONC201, combined with either paxalisib or panobinostat. The study employs an adaptive design, in which different arms will be opened and closed based on emerging preclinical and clinical data.
Lead Product(s): ONC201,Paxalisib
Therapeutic Area: Oncology Product Name: ONC201
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pacific Pediatric Neuro-Oncology Consortium
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 11, 2021
Details:
Kazia's lead program, paxalisib, is currently in a pivotal study for glioblastoma, the most common and most aggressive form of brain cancer. If successful, paxalisib has the potential to become the first new drug treatment for newly diagnosed patients in almost twenty years.
Lead Product(s): Paxalisib
Therapeutic Area: Oncology Product Name: GDC-0084
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 10, 2021
Details:
Conclusion of the paxalisib phase II study, initial data readouts from a number of the paxalisib investigator-initiated studies in other forms of brain cancer, and commencement of the first-in-human phase I study of EVT801.
Lead Product(s): Paxalisib
Therapeutic Area: Oncology Product Name: GDC-0084
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2021
Details:
Paxalisib is the only PI3K inhibitor in mainstream development with the ability to penetrate the blood-brain barrier, and as such has a unique rationale for development in PCNSL.
Lead Product(s): Paxalisib
Therapeutic Area: Oncology Product Name: GDC-0084
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 07, 2021
Details:
Kazia Therapeutics has executed a Letter of Intent with the Pacific Pediatric Neuro-Oncology Consortium to launch a clinical trial of multiple therapies, including Kazia's investigational, paxalisib, in diffuse midline gliomas including diffuse intrinsic pontine glioma.
Lead Product(s): ONC201,Paxalisib
Therapeutic Area: Oncology Product Name: ONC-201
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kazia Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration December 10, 2020
Details:
The new interim analysis of paxalisib phase II study in glioblastoma is highly consistent with prior data. Median progression-free survival (PFS) of 8.4 months reported on this analysis (versus 5.3 months for temozolomide, the existing standard of care).
Lead Product(s): Paxalisib
Therapeutic Area: Oncology Product Name: GDC-0084
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Genentech
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2020
Details:
Cash outflows are likely to increase as the Company proceeds with the GBM Agile trial, he pivotal study for registration of paxalisib in glioblastoma.
Lead Product(s): Paxalisib
Therapeutic Area: Oncology Product Name: GDC-0084
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $25.2 million Upfront Cash: Undisclosed
Deal Type: Public Offering October 23, 2020
Details:
The study will open a new arm with Kazia's investigational new drug, paxalisib (formerly GDC-0084), and will now move into an operational phase with recruitment of patients to the paxalisib arm expected to begin in Q1 CY2021.
Lead Product(s): Paxalisib
Therapeutic Area: Oncology Product Name: GDC-0084
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kazia Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 16, 2020
Details:
The collaboration aims at investigating the use of Kazia’s new drug, paxalisib (formerly GDC-0084), in primary central nervous system (CNS) lymphoma, a potential new indication for the drug. DFCI will initiate an open-label phase II clinical trial of paxalisib in PCNSL.
Lead Product(s): Paxalisib
Therapeutic Area: Oncology Product Name: GDC-0084
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kazia Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration September 22, 2020
Details:
Food and Drug Administration has granted Orphan Drug Designation to Kazia’s paxalisib (formerly GDC-0084) for the treatment of malignant glioma, which includes Diffuse Intrinsic Pontine Glioma (DIPG), a rare and highly aggressive childhood brain cancer.
Lead Product(s): Paxalisib,Radiation therapy
Therapeutic Area: Oncology Product Name: GDC-0084
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2020
Details:
With RPDD granted, Kazia may now be eligible to receive a ‘rare pediatric disease priority review voucher’ (PRV) if paxalisib is approved for DIPG.
Lead Product(s): Paxalisib,Radiation therapy
Therapeutic Area: Oncology Product Name: GDC-0084
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 07, 2020
Details:
Previous paxalisib data presented at ASCO was based on Stage 1 (n=9) of the ongoing phase II study in glioblastoma. This interim analysis at AACR includes all patients in the study (n=30), and therefore provides a more robust and substantial data set.
Lead Product(s): Paxalisib
Therapeutic Area: Oncology Product Name: GDC-0084
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2020
Details:
Analysis of Stage 1 of the study (n=9) shows median overall survival (OS) of 17.7 months. This compares very favourably with temozolomide, the existing standard of care, which has a reported median OS of 12.7 months in this patient population.
Lead Product(s): Paxalisib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2020
Details:
Interim analysis of Part showed median overall survival of 17.7 months, representing a clinically meaningful extension of life when compared to the 12.7 months of temozolomide.
Lead Product(s): Paxalisib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2020
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