US FDA approves Clarity Pharma’s IND application

Radiopharma-focused biotech, Clarity Pharmaceuticals (ASX: CU6), has announced the approval of its Investigational New Drug (IND) application by the US FDA.

The approval was received for Clarity’s SAR-Bombesin product, an imaging agent that will enable its Phase 2 “SABRE” imaging trial on prostate cancer to progress.

The SABRE study will enrol up to 50 PSMA-negative prostate cancer patients in the US.

Approximately 20% of prostate cancer patients with biochemical recurrence are PSMA-PET (Prostate-Specific Membrane Antigen) negative, which means they are unsuitable for the currently approved agents in the market.

The primary objectives of the SABRE trial are to investigate the safety and tolerability of 64Cu SAR-Bombesin, as well as its ability to correctly detect the recurrence of prostate cancer.

The trial builds upon the promising clinical data from the pilot trial of 64Cu SAR-Bombesin in breast cancer, led by Prof Louise Emmett of St Vincent’s Hospital Sydney.

“We look forward to further progressing the development of SAR-Bombesin and hope it will provide a new and effective diagnostic option for prostate cancer patients,” said Clarity’s executive chairman, Dr Alan Taylor.

“Combined with the clinical, environmental and logistical benefits enabled by the copper isotope pairing, SAR-Bombesin has potential to provide this large patient population with accurate and precise detection and treatment of prostate cancer.”

“We anticipate the SABRE trial to commence shortly and the theranostic trial to commence in 2023,” Dr Taylor added.


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Nyrada unveils target for brain injury program

Nyrada (ASX:NYR) has unveiled a target for its brain injury program.

The biotech says it wants to target a class of proteins known as the “Canonical” Transient Receptor Potential, or TRPC ion channels.

Following brain injury, these channels are constantly activated, allowing sustained calcium entry into the cells which in turn causes cell death.

Nyrada’s brain injury drug candidate NYR-BI02 is a potential blocker of three subtypes of the channel – TRPC3, TRPC6 and TRPC7.

According to animal studies and previously published literature, these three TRPC channel subtypes facilitate a secondary injury pathway, leading to an undesirable larger injury following a traumatic brain injury or stroke.

This larger injury is responsible for outcomes such as increased disability, along with reduced patient survival and quality of life.

Nyrada says its NYR-BI02 drug is able to cross the blood-brain barrier, meaning that it can reach the injured brain at a therapeutic level.

As part of its active intellectual property protection program, Nyrada has filed a provisional patent covering a library of molecules that block these channels.

It is anticipated that the patent will have coverage firstly in Australia, followed by the UK and US.


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Immutep presents data at ASCO 2022

Immune-oncology biotech Immutep (ASX:IMM) will present its TACTI-002 Phase 2 trial results data at the ASCO 2022 event later today (US time).

The trial has demonstrated that its lead drug candidate, Efti, when combined with pembrolizumab (Keytruda), produced favourable anti-tumor activity in first-line non-small cell lung cancer (NSCLC) patients.

The results showed an improved Overall Response Rate (ORR) by local read of 38.6% (intent to treat, 44/114 patients), and 42.7% (evaluable patients, 44/103), compared with data reported at ASCO 2021 (N=36).

Overall, Immutep says TACTI-002 has met its primary objective, is safe, and well tolerated.

The safety profile is also consistent with that observed in previously reported studies for pembrolizumab monotherapy.


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