Australian biotech company Prescient Therapeutics has successfully finished a round of safety testing on its PTX-100 drug in a basket trial of patients with solid and blood cancers, revealing an “excellent” safety profile.

On Tuesday, Prescient Therapeutics announced it had completed Phase 1b trials of its novel PTX-100 cancer treatment, with none of the ten patients in the study suffering serious adverse effects linked to the medication.

Additionally the study found PTX-100 was well tolerated by patients even at the highest administered dosage of 2,000 mg/m2.

Steven Yatomi-Clarke, Prescient Therapeutics’ Chief Executive, said he was “pleased” with the results, and noted there were other reasons for the company to celebrate.

Phase 1b testing was primarily designed to test for PTX-100’s safety profile, however clinical benefits were also observed in two of the study’s patients who have previously failed other treatments.

One of these patients had endured five failed treatments before joining the study, and each time was only able to control the disease for a few months before it advanced again.

Following the administration of PTX-100, the patient saw a reduction in their cancer burden and the disease has not progressed for 17 months.

The patient has undergone 24 treatment cycles with PTX-100 and is still taking the drug.

Another patient with cutaneous T cell lymphoma (CTCL) with K-Ras mutation also had aggressive disease and had failed three prior treatments.  This patient had a partial response on the study, with reduced cancerous lesions and symptomatic relief.  The patient was on therapy for 12 months, receiving 19 cycles of therapy.

“We are encouraged by the biological activity demonstrated by PTX-100 in certain patients on the basket trial with T cell lymphomas,” Mr Yatomi-Clarke said.

“Whilst numbers are small, the observation is encouraging in that it indicates activity of PTX-100 as a monotherapy in patients where other therapies have failed.” 

“We look forward to exploring this in the expansion cohort study as we pursue the quickest route to market for PTX-100 in areas of unmet clinical need.”

Positive results in OmniCAR testing

Earlier in July, separate immunogenicity testing on Prescient Therapeutics’ OmniCAR universal CAR-T platform provided similarly positive safety results.

The in-silico tests (meaning they were conducted by complex computer algorithms) found two binding components used in OmniCAR treatments, SpyTag and SpyCatcher, are unlikely to trigger adverse immune responses in patients.

However, Prescient Therapeutics did acknowledge that due to limitations with modern algorithms, in silico testing can often be over-predictive.

Even so, the results substantially de-risk the platform’s development and Mr Yatomi-Clarke said the results leave him confident patients’ immune systems won’t react dangerously to treatments.

OmniCAR is a next-generation CAR-T platform, designed to give medical practitioners greater control over traditional CAR-T treatments – which genetically re-engineer a patients’ own immune system to identify and attack cancerous cells.

The platform is also designed to make treatment safer for patients.

Join Prescient Therapeutics CEO Steven Yatomi-Clarke for a special investor briefing this Friday, 30th July at 11am (AEST), where he will discuss the results of this study in further detail and provide a company update. Click here to book in.

To stay up-to-date on Prescient’s news and announcements, register your details on the Investor Centre.

Reach Markets have been engaged by PTX to help manage their investor communications.

Sources:

• Prescient Therapeutics, PTX-100 Trial Progresses to Exansion Cohort Following Successful Phase 1b
• Prescient Therapeutics, Prescient Achieves Key Milestone By Demonstraing OmniCAR’s Key Compenents Show Minimal Immunogenicity In Silco
• Prescient Therapeutics, Technology