• Patry receives positive toxicology reports on PAT-DX1
  • Immutep says triple combination trial of Efti shows it is well tolerated
  • Clarity Pharma is now advancing to cohort 2


Patrys receives positive report

Therapeutic antibody development biotech, Patrys (ASX: PAB), surged 20% this morning after receiving favourable draft reports for its two recently completed toxicology studies testing of PAT-DX1 in animals.

The reports say there were no safety or tolerability issues associated with PAT-DX1 in rats and non-human primate species that are likely to impede a human clinical trial.

This result is consistent with the favourable safety profile we’ve seen in previous toxicology studies for PAT-DX1.

Two additional draft reports are expected by the end of July, which will provide further toxic characterisations of  PAT-DX1.

Patrys expects to receive the final report towards the end of the year. This report will be used to initiate a clinical trial of PAT-DX1.

CEO Dr James Campbell said that while today’s reports are still draft in nature, they typically would identify any major issues or areas of concern.

“So we do not expect the findings presented in the final report to differ materially.

“In the meantime, we believe that we will be able to restart manufacturing for the PAT-DX1 material for the clinical trial in Q3, 2023,” said Campbell.

Immutep’s Efti continues to progress

Immutep (ASX:IMM) climbed 5% after announcing promising new clinical data from its Triple Combination Therapy in INSIGHT-003 Trial.

The trial is studying the efficacy of Efti, Immutep’s lead drug, combined with standard-of-care anti-PD-1 therapy and doublet chemotherapy, in first line non-small cell lung cancer patients.

Results show that the triple combination is well tolerated, and continue to show promising initial signals of efficacy.

The therapy has achieved a 67% response rate and 91% disease control rate in the 21 patients enrolled, despite 81% of patients having low or negative PD-L1 expression.

Apart from this trial, Efti is currently under evaluation for a variety of other solid tumours including neck squamous cell carcinoma (HNSCC) and metastatic breast cancer.

The drug’s favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy.


Clarity to move to Cohort 2

Clarity Pharmaceuticals’ (ASX:CU6)  theranostic prostate cancer trial is now advancing to cohort 2 after the completion of cohort 1 dosing.

Cohort 1 was completed in six participants with metastatic castrate-resistant prostate cancer (mCRPC), who received therapy with 67Cu SAR-bisPSMA at the lowest dose level of 4GBq.

No dose-limiting toxicities were reported in cohort 1.

The Safety Review Committee has now recommended that the trial continues to cohort 2, where patients will be given a dose level of 8GBq.


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