ASX Health Stocks: PYC on the same page with FDA, Cleo's cancer test peer-reviewed

PYC to take ADOA drug to human clinical trials
Imugene provides update of its Phase 1 MAST (Metastatic Advanced Solid Tumours) trial
Cleo’s CleoDX Triage Test was published in ‘Cancer’ journal

PYC to commence human trials in 2024 after FDA meeting

PYC Therapeutics (ASX:PYC) announced that it has aligned with the US Food and Drug Administration (FDA) on the proposed path for its investigational drug candidate for ADOA (Autosomal Dominant Optic Atrophy).

Following pre-IND meeting with the FDA, PYC now anticipates progressing the drug candidate to human trials in the first half of calendar year 2024.

Successful progression into human studies will mark the second first-in-class drug program that PYC has advanced into the clinic.

PYC says it remains on track to realise its objective of progressing a third drug with disease-modifying potential into human studies before the end of 2024.

Meanwhile, ADOA is a progressive and irreversible blinding eye disease and affects approximately 1 in every 35,000 people, representing a market size of ~$2 billion per annum.

ADOA is caused by a mutation in one copy of the OPA1 gene and in ~85% of patients. This leads to insufficient levels of OPA1 gene expression to support normal cellular function in the retinal ganglion cells of the eye.

The abnormal function of the affected cells due to the OPA1 deficiency causes cell stress and ultimately cell death.

Imugene advances Phase 1 clinical trial

Imugene (ASX:IMU) surged 15% this morning after providing a clinical trial update of its Phase 1 MAST (Metastatic Advanced Solid Tumours) trial evaluating its novel cancer-killing virus, CF33-hNIS (VAXINIA).

In the last announcement last week, Imugene reported that it has cleared cohort 4 of the intravenous (IV) arm of the monotherapy dose escalation study, as well as IV cohort 2 of the combination study where VAXINIA is administered with checkpoint inhibitor drug, pembrolizumab (KEYTRUDA).

Imugene announced today that Cohort 5 of the IV arm for the monotherapy dose escalation is now open, as is IV cohort 3 of the combination study.

Twenty-five patients were evaluable (received at least their first scan at day 42) and seven patients have their first scan still pending.

Of the evaluable patients the BOR (best overall response) were: one Complete Response (CR), one Partial Response (PR), 16 Stable Disease (SD), showing patients had control and stability of their cancer, and eight progressive disease (PD).

Importantly, early results from six patients with gastrointestinal cancers who received CF33-hNIS alone including two colorectal cancer, two bile duct, one pancreatic and one liver cancer showed positive treatment effects, with a disease control rate of 75%.

Trial expansion is now planned for 10 patients with bile duct cancers.

Cleo’s cancer test peer reviewed

Results from Cleo Diagnostics’ (ASX:COV) first clinical validation study of the CleoDX Triage Test, performed in a 334 patient cohort, have been published in the peer-reviewed journal “Cancers”.

The article, entitled ‘A novel predictive multi-marker test for the pre-surgical identification of ovarian cancer’, provides a detailed overview of the high performance of Cleo’s ovarian cancer diagnostics test.

The article concluded that Cleo’s ovarian cancer test was highly accurate with 95% sensitivity and 95% specificity.

The test also correctly discriminated malignant from benign samples, and was superior to current clinical methods.

Cleo says peer review provides important validation of Cleo’s technology and commercial strategy, which is targeting the surgical triage market where accurate and sensitive identification of malignant tumours is essential.