Australia

Kazia Therapeutics

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US FDA Awards Orphan Drug Designation (ODD) To Paxalisib For Malignant Glioma, Including DIPG

Lead Product(s): Paxalisib,Radiation therapy

Therapeutic Area: Oncology Product Name: GDC-0084

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 24, 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.

Kazia Therapeutics

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US FDA Grants Rare Pediatric Disease Designation (RPDD) to Paxalisib for DIPG

Lead Product(s): Paxalisib,Radiation therapy

Therapeutic Area: Oncology Product Name: GDC-0084

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 07, 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.

Noxopharm

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Noxopharm Reports Veyonda’s Potential in Late-Stage Cancer at ASCO 2020

Lead Product(s): Idronoxil

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 04, 2020

Details:

The posters addressed how NOX66 may improve treatment responses in men with mCRPC and also its contribution to restoring sensitivity to apoptosis and potentially modulating the immune microenvironment of nasopharyngeal carcinoma (NPC).

Immutep

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Immutep Completes Enrollment for the INSIGHT-004 Study

Lead Product(s): Eftilagimod Alpha,Avelumab

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 21, 2020

Details:

Last patient has been enrolled and safely dosed for the second cohort of the INSIGHT-004 Phase I clinical trial evaluating combination of eftilagimod alpha with a standard dose of avelumab.

Immutep

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Immutep’s Partner, EOC Pharma, Reports Completion of Recruitment of Phase I Study of Efti

Lead Product(s): Eftilagimod Alpha,Paclitaxel

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 19, 2020

Details:

Last patient enrolled and safely dosed, completing patient recruitment for EOC Pharma’s phase I study in metastatic breast cancer (MBC).

Noxopharm

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Noxopharm Alliance With GenesisCare

Lead Product(s): Idronoxil

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: GenesisCare

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement February 18, 2020

Details:

The alliance formalises a program under which Noxopharm has been making Veyonda® available through GenesisCare as an adjunctive therapy with 177Lu-PSMA therapy for mCRPC patientsin Australia.

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Kazia Therapeutics

US FDA Awards Orphan Drug Designation (ODD) To Paxalisib For Malignant Glioma, Including DIPG

Kazia Therapeutics

US FDA Grants Rare Pediatric Disease Designation (RPDD) to Paxalisib for DIPG

Noxopharm

Noxopharm Reports Veyonda’s Potential in Late-Stage Cancer at ASCO 2020

Immutep

Immutep Completes Enrollment for the INSIGHT-004 Study

Immutep

Immutep’s Partner, EOC Pharma, Reports Completion of Recruitment of Phase I Study of Efti

Noxopharm

Noxopharm Alliance With GenesisCare