The Institute of Cancer Research (ICR), London, UK, and Nuvectis Pharma have announced plans to commence a Phase I clinical trial of a new experimental drug, NXP800, in advanced cancer patients.

Discovered by the researchers at the Cancer Research UK Cancer Therapeutics Unit at ICR, NXP800 is an oral drug that potentially hinders the heat shock factor-1 (HSF1) pathway.

The HSF1 pathway plays a key role in the regulation of vital pathways associated with cancer cell growth, metastasis and survival across various malignancies.

‘Transcription factors’ such as HSF1 are hard to target directly with treatments.

Utilising cellular ‘phenotypic screening’, ICR scientists discovered a small molecule that can hinder HSF1’s gene activation programme in live cancer cells in culture.

Sponsored by Nuvectis Pharma, the first-in-human Phase I trial of NXP800 will begin in the fourth quarter of this year in cancer patients from The Royal Marsden.

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Specialist teams in pharmacodynamics and pharmacokinetics at ICR will oversee the capture of data on the body’s management of the drug and its biological effects.

This will offer biomarkers that could become a ‘pharmacological audit trail’ of NXP800’s behaviour, ICR noted.

In pre-clinical studies, the drug was demonstrated to effectively hinder human cancer cell growth in culture as well as induce regression of tumours in mice.

Furthermore, ovarian clear cell carcinoma (OCCC) and endometroid ovarian cancer, both serious conditions of unmet medical need were most sensitive to the therapy.

The Institute of Cancer Research, London Drug Development Deputy Director professor Udai Banerji said: “NXP800 is an innovative first-in-class drug and we are excited to be nearing the stage of the drug development pathway when patients will start receiving it.

“This Phase I trial will aim to establish a safe dose and dosing schedule for NXP800, as well as provide initial evidence of its clinical activity in a range of cancer types, and we hope that it will lead on to late-stage clinical development.”

Nuvectis licensed global development and marketing rights to NXP800 from the CRT Pioneer Fund (CPF) managed by Sixth Element Capital.

The company has also raised Series A Preferred Stock funds worth $15m with institutional, as well as private investors.