• Immutep gets US FDA clearance to start Phase 1 study
  • Noxopharm says its Sofra platform is effective against inflammatory skin disease
  • Epsilon Healthcare announced a new CEO


US FDA approves Imugene’s Phase 1

Immuno-oncology biotech Imugene (ASX:IMU) jumped 9% this morning after receiving a US FDA Investigational New Drug (IND) clearance to initiate a Phase 1 clinical study of its oncolytic virotherapy candidate, onCARlytics.

The clearance allows Imugene to start patient recruitment and dosing of CARlytics (CF33-CD19) combined with blinatumomab in patients with advanced or metastatic solid tumors.

Previous studies have shown that Imugene’s CF33-CD19 oncolytic virus, when combined with blinatumomab (sold under brand name Blincyto and developed by US-based Amgem) has the potential to eradicate solid tumours that otherwise cannot be treated with Blincyto therapy alone.

Imugene CEO Leslie Chong said that starting this study is a significant milestone for clinicians treating patients with solid tumour cancers, which to date have been untreatable with CD19-targeting biological drugs.


Noxopharm says it can fight inflammatory skin disease

Oncology biotech Noxopharm (ASX:NOX) said that a new preclinical product candidate from its Sofra technology platform has shown effectiveness against inflammatory skin disease.

The results were conducted with the Hudson Institute of Medical Research, which have now been presented at the 15th International Congress on Systemic Lupus Erythematosus currently being held in Seoul.

In the presentation, Noxopharm reported that its novel drug, known as SOF-XX, is a promising new class of therapeutics for the treatment of autoimmune diseases such as psoriasis and lupus.

The number of individuals suffering from autoimmune diseases in the US alone are around 14 to 24 million cases, while in Australia, an estimated 20,000 patients have lupus.

Noxopharm explained that some autoimmune diseases, including lupus and psoriasis, involve the overactivation of an immune sensor known as Toll-like receptor 7 (TLR7).

When Noxopharm’s SOF-XX was applied topically via a gel to a mouse model with skin inflammation, it blocked TLR7 activity and thereby significantly protected the mice from the development of skin scaling and redness.


Epsilon announces new CEO

Cannabis company Epsilon Healthcare (ASX:EPN) jumped 17% after announcing that Peter Giannopoulos has been appointed to the role of CEO, effective on 23 May.

Giannopoulos brings to Epsilon more than 25 years experience across the Australian healthcare ecosystems, including proven success with an ASX-listed company.

Most recently, he was CEO of Cell Therapie, an Australian-based company with a specialisation in cell and gene therapies and cellular immunotherapy products.

Prior to Cell Therapies, Giannopoulos led the diversification of Australia’s largest private hospital provider, Ramsay Healthcare (ASX: RHC) as the CEO of the Ramsay Pharmacy Group over a 12-year period.

Under his leadership, the Ramsay’s pharmacy group operations expanded exponentially to become a multi-site operation (90 sites) generating revenues of more than $400m.


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