Check Up: The TGA is 100pc cool with the world’s first faecal transplant, oral delivery being studied

• The TGA has made a landmark approval on faecal transplant therapy
• South Australian BiomeBank has managed to cultivate a ‘faecal bank’ donated from healthy people
• We take a look at the performance of ASX biotechs over the past month

Here’s some exciting news.

The Australian Therapeutic Goods Administration (TGA) has just approved a faecal transplant therapy designed to target a serious bacterial infection.

This approval marks the first time ever any regulatory body in the world has formally authorised this kind of microbiome therapy.

A faecal transplant (also called faecal microbiota transplantation or FMT) is a procedure to collect faeces, also called stools, excrement, poopy doo-doos or naughty fudge, from a healthy donor and introduce them into a patient’s gastrointestinal tract.

The procedure is supposed to control an infection called Clostridium difficile, or C. diff, by adding healthy bacteria into the recipient’s intestines.

Previous research has shown that faecal transplant can restore healthy bacteria in the lower intestine, which can help control C. diff and keep it from coming back.

In some cases, FMT can be more effective than antibiotics for keeping C. diff in check, but the problem has always been that no one consistent source of poo can be generated from hundreds of donors.
 

Enter Aussie biotech, BiomeBank

So how do we standardise faecal transplants and dish out large volumes to patients like we do with conventional medicine?

Even the US FDA has stayed away from giving a formal regulatory approval, preferring instead to allow patients to supply their own source of faecal matter.

Well.. enter BiomeBank, an unlisted South Australian biotech with a mission to treat and prevent disease by restoring gut microbial ecology.

Founded in 2018, BiomeBank has managed to cultivate a ‘faecal bank’ donated from healthy people who attend the company’s facility to donate their faecal samples in custom-designed toilets.

BiomeBank collects these samples and processes them into syringes, then freezes and delivers them to clinical facilities for administration into patients via either colonoscopy or enema.

The company says oral delivery capsules will be made available in the near future.

Currently, the TGA approval given to BiomeBank is only for the treatment of recurrent C diff, but BiomeBank believes that microbiome-based therapies are set to transform the treatment of many diseases.

“This approval is a landmark for BiomeBank and an important advance for microbiome therapeutics globally,” says BiomeBank co-founder and CEO, Dr Sam Costello.

“It’s an exciting time for the microbiome field and we are pleased to be pioneering new solutions to treat these diseases.”

And now, not before time, to the ASX…

Best and worst performing ASX biotechs over the past month

Clarity Pharma (ASX:CU6)

Clarity jumped over 50% in the past month after reporting that patient recruitment into its Phase II diagnostic 64Cu SAR-Bombesin trial (BOP) for patients with prostate cancer has reached the 50% recruitment milestone.

BOP is a Phase II investigator-initiated trial (IIT) in up to 30 patients led by Prof Louise Emmett at St Vincent’s Hospital, Sydney.

The BOP trial is assessing the safety of 64Cu-SAR-Bombesin as well as looking at the diagnostic potential across two different groups of men with prostate cancer.

“We believe SAR-Bombesin will play a role in the identification of disease that is not observed with conventional imaging or PSMA-PET,” said Prof Emmett.

“This could ultimately lead to more effective treatments for this large patient population where unfortunately, very few treatment options are available at present.”
 

Singular Health (ASX:SHG)

Medtech company Singular Health also rose 50% in the month after announcing its preparations to enter the US market.

The company announced the appointment of Kelyniam Global, a US-based patient-specific medical device manufacturer, as its US-based agent.

This is a key appointment and an important pre-requisite to satisfy the final regulatory requirement, prior to Singular Health making sales in the US.

Singular believes that Kelyniam is very well positioned to both provide continual feedback on the 3Dicom Surgical software and AI cranial implant tool

The 3Dicom Viewer was developed as a cross-platform application which allows end-users to interact with standard 2D medical images such as MRI and CT scans in 3D.
 

Impedimed (ASX:IPD)

Impedimed rose on the back of its contract extension with global biotech AstraZeneca.

Impedimed will continue to play a part in AstraZeneca’s Phase IIb trial, which utilises the 210 SOZO devices to measure fluid volume in patients with chronic kidney disease, for an additional eight months.

The extension of the trial will generate over $1 million of additional revenue, which will be recognised over the remainder of the 2023 financial year.

In total, over $6.7 million in contract value has been signed under the various AstraZeneca trial agreements.

Separately, Impedimed also said that it has reached a milestone of 500,000 patient tests performed with the SOZO Digital Health Platform.
 

Resonance Health (ASX:RHT)

Resonance rose over 30% in the month after revealing that it has been contracted to provide services for two new pharma customers in their clinical trials.

Value of the new contracts is up to $1.5m (€1m), payable over the 28-month duration of each trial.

Under the deals, Resonance Health will provide its FerriScan and Cardiac-T2 iron-overload analysis and related services.

The agreements increased the total clinical trials currently under contract and being serviced by Resonance Health to 12.
 

Telix Pharma (ASX:TLX)

Telix also raced ahead in the last 30 days after reporting positive top line results from its ZIRCON Phase III study of imaging agent TLX250-CDx in clear cell renal cell carcinoma (ccRCC).

Telix reported that all of its primary and secondary endpoints have been met.

The company says these “ground-breaking results” indicate that TLX250-CDx has the potential to become a new clinical standard in the diagnosis of ccRCC and deliver an unmet medical need for a non-invasive diagnostic tool in this disease setting.

“TLX250-CDx could optimise surgical intervention – particularly in the incidence of very small renal masses,” Telix chief medical officer Dr Colin Hayward said.

Earlier this week, Telix also announced that it will acquire Optimal Tracers, a US-based radiochemistry development business providing radiochemistry process development services and research tracers for use in clinical trials.

This acquisition is expected to bolster Telix’s in-house radiochemistry development capability, by adding a highly skilled team to Telix and establishing a US-based laboratory and production footprint for clinical trial doses.