• Neuren gets US FDA approval to start Phase 2 of NNZ-2591 
  • Imugene will commence Phase 1 trial of VAXINIA 
  • RadioPharm prepares for Phase 1 trial in Australia targeting lung cancer

Neuren gets US FDA approval to start Phase 2 trial

Neuren Pharma (ASX:NEU) has received approval from the US FDA) to proceed with the Phase 2 trial of NNZ-2591 in Phelan- McDermid syndrome (PMS).

The Phase 2 trial will be conducted at four hospitals in the United States, enrolling up to 20 children aged 3 to 12 years who suffer from PMS.

The trial will examine the safety, tolerability, pharmacokinetics and efficacy over 13 weeks of treatment with NNZ-2591.

Neuren is also moving its other pipelines forward, with the Phase 2 trials in PMS, Angelman syndrome and Pitt Hopkins syndrome to commence.

Work is also underway to prepare for Phase 3 development of NNZ-2591 across multiple indications.

All six programs have been granted “orphan drug” designation in the US, which provides financial incentives to encourage development of therapies for rare and serious diseases.

Neuren share price today:



Imugene to start Phase 1 trial

Clinical stage immuno-oncology company, Imugene (ASX:IMU) raced 8% higher today after announcing an approval to commence a Phase I clinical trial of its oncolytic virotherapy candidate, VAXINIA.

VAXINIA (or CF33-hNIS, HOV2) will be tested as a treatment in multiple solid tumours in patients.

The US component of the Phase I trial will be conducted under the FDA investigational new drug (IND) process, following the clearance in December 2021.

Site activation and patient recruitment will proceed immediately at the City of Hope, a world-renowned independent cancer research and treatment centre near Los Angeles.

The trial is anticipated to run for 24 months and is funded from existing budgets and resources.

Imugene CEO Leslie Chong said, “The start of our USA VAXINIA study is a significant milestone for Imugene and clinicians treating Americans faced with the challenge of metastatic advanced solid tumours.”

The company has been releasing a series of positive news flow lately.

Just last week, Imugene announced a new clinical trial collaboration and supply agreement with MSD, a tradename of global player Merck & Co.

That deal enables the commencement of Imugene’s HER-Vaxx trial, which will study the impact it has on HER-2 positive gastric cancer. when combined with anti-PD-1 therapy, pembrolizumab.


Imugene share price today:



Radiopharm to start first Phase 1 trial in Ausrtralia

Radiopharm Theranostics (ASX:RAD) has agreed on a Letter of Intent (LOI) with global oncology provider GenesisCare to start its first Phase 1 trial in Australia.

The phase 1 therapeutic trial will involve Radiopharm’s proprietary nanobody from its Nano-mAbs platform, which targets lung cancer.

The drug will specifically target the PDL1 expression in non-small cell lung cancer, which is the most common type of lung cancer.

“This is currently an area of high unmet need, and we are hopeful of bringing a first in class treatment to the market that will greatly improve patient outcomes,” said Radiopharm CEO, Riccardo Canevari.


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