• Invex gets green light from UK regulator for Phase 3 trial
  • Chimeric extends deal with U-Penn for viral vectors
  • Nyrada encounters trial delays due to China lockdowns

Invex gets UK approval

Invex Therapeutics (ASX:IXC) surged by 11% this morning after receiving an approval from the UK’s MHRA to commence its IIH EVOLVE Phase 3 clinical trial in the country.

The trial will study patients with Idiopathic Intracranial Hypertension (IIH) treated with Presendin versus placebo once weekly over 24 weeks.

In addition, Invex has also received a favourable ethical opinion from a Research Ethics Committee (REC), which was also a requirement prior to commencing the trial.

Invex now intends to open a number of clinical sites across the UK and another 40 sites globally, and will rapidly progress institutional contracts to facilitate the commencement of patient recruitment.

The primary endpoint of the trial is the “change in intracranial pressure from baseline”, with key secondary endpoints related to “vision and headache outcome measures”.

“In my clinic in Birmingham, I routinely observe the devastating effects of IIH on patients, their caregivers, and the associated healthcare costs to manage their disease, where standard drug therapies are lacking,” said Invex chief scientific officer, Professor Alex Sinclair.

“Our research group has modelled the economic cost of IIH for England to be almost £500 million by 2030.

“In Scotland for example, the incidence of IIH has also materially increased to approximately 40 per 100,000 in obese females aged 15–44, which is a direct consequence of the increasing levels of obesity,” he added.

Presendin has been progressed into a single Phase 3 trial in IIH following a successful Phase 2 clinical trial in May 2020.


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Chimeric extends deal with U-Penn

Chimeric Therapeutics (ASX:CHM) was up 7% this morning after announcing that it has expanded its licence agreement with the University of Pennsylvania (Penn) related to CDH17 chimeric antigen receptor (CAR) therapies.

Under the amended deal, Chimeric has acquired a non-exclusive know-how licence to use Penn’s third-generation lentiviral vector plasmid system for the development and commercialisation of CHM 2101 (CDH17 CAR T).

Viral vector is a critical component used in the manufacturing of CAR T cells, and third-generation lentiviral vectors offer improved safety over earlier generations.

The amended licence will enable Chimeric to manufacture clinical-grade lentiviral vector for use in its planned Phase 1 study of CDH17 CAR-T for gastrointestinal cancers.


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Nyrada delays start of Phase 1 trial

Nyrada (ASX:NYR) plunged 13% this morning after announcing a delay in its Phase I first-in-human study for its Cholesterol-Lowering Program.

The company said drug manufacturing delays caused by COVID-related lockdowns in Shanghai were the main reason for the trial delay.

The main driver was the inability of employees of the contract manufacturing organisation (CMO) engaged by Nyrada to access laboratory sites in China while the extended lockdown remained in place.

The required preclinical safety and toxicology studies are however still expected to commence in Q3 of 2022.

The primary objective of the Phase I study is to evaluate Nyrada’s drug candidate for safety and tolerability. A secondary endpoint will assess blood cholesterol levels in cohorts treated for 14 days with Nyrada’s drug candidate.


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