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Last close As at 09/06/2023
USD1.32
▲ 0.04 (3.13%)
Market capitalisation
USD22m
Kazia Therapeutics has announced the expansion of the PNOC022 (NCT05009992) trial to two new sites in Australia. The Phase II trial is investigating the combination of ONC201 (a dopamine D2 receptor antagonist) and paxalisib (Kazia’s brain penetrant PI3K inhibitor) in the treatment of diffuse midline glioma (DMG) and diffuse intrinsic pontine glioma (DIPG). Importantly, the PNOC022 trial, which is sponsored by the Pacific Pediatric Neuro-Oncology Consortium, uses an adaptive platform design, meaning new arms of the trial can be opened or closed based on the data gathered. Considering this, we see the expansion of PNOC022 as encouraging support for the paxalisib/ONC201 combination; however, we will wait to see initial clinical data (expected in CY23) before drawing more material conclusions.
Kazia Therapeutics |
PNOC022 trial expanded |
Clinical trial expansion |
Pharma and biotech |
10 October 2022 |
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Kazia Therapeutics is a research client of Edison Investment Research Limited |
Kazia Therapeutics has announced the expansion of the PNOC022 (NCT05009992) trial to two new sites in Australia. The Phase II trial is investigating the combination of ONC201 (a dopamine D2 receptor antagonist) and paxalisib (Kazia’s brain penetrant PI3K inhibitor) in the treatment of diffuse midline glioma (DMG) and diffuse intrinsic pontine glioma (DIPG). Importantly, the PNOC022 trial, which is sponsored by the Pacific Pediatric Neuro-Oncology Consortium, uses an adaptive platform design, meaning new arms of the trial can be opened or closed based on the data gathered. Considering this, we see the expansion of PNOC022 as encouraging support for the paxalisib/ONC201 combination; however, we will wait to see initial clinical data (expected in CY23) before drawing more material conclusions.
Year end |
Revenue (US$m) |
PTP* |
EPADR* |
DPADR |
P/E |
Gross yield |
06/21 |
10.5 |
(3.1) |
(0.25) |
0.0 |
N/A |
N/A |
06/22 |
0.0 |
(14.6) |
(1.08) |
0.0 |
N/A |
N/A |
06/23e |
0.0 |
(18.6) |
(1.23) |
0.0 |
N/A |
N/A |
06/24e |
10.6 |
(16.8) |
(1.11) |
0.0 |
N/A |
N/A |
Note: *Converted at A$1.45/US$. Dividend yield excludes withholding tax. Investors should consult their tax advisor regarding the application of any domestic and foreign tax laws.
As a reminder, DIPG and DMG are particularly aggressive and invasive high-grade (Grade IV) glioma that mostly affect young children. DIPG is predominantly diagnosed in children aged five to 10 and rarely occurs in the adult population. While the incidence of DIPG is low (one to two per 100,000 in the United States, ~300 new pediatric cases per year), most patients will survive less than one year after diagnosis (median overall survival rate 9–11 months). Paxalisib has previously demonstrated, in our view, encouraging clinical and preclinical effects in these indications (for more detail see our Deep dive into childhood brain cancer).
The PNOC022 trial is enrolling children and young adults with DMGs (including DIPG) and will include newly diagnosed and pretreated (with radiotherapy) patients. The adaptive platform design will see all patients administered a combination of paxalisib and ONC201. As such, the newly announced Australian sites will see the first clinical trial of paxalisib in this region. Kazia has communicated that recruitment for the trial has been robust, hence initial primary endpoint data (six-month progression-free survival and overall survival at seven months) is expected to be reported in CY23.
We value Kazia Therapeutics at US$146.6m or US$9.79 per basic ADR.
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ReNeuron Group, a stem cell-derived exosome technology company, has presented encouraging preclinical data highlighting the enhanced drug delivery capability of its customisable exosome platform (CustomEx) over conventional human embryonic kidney-derived (HEK) exosomes. The company’s CustomEx exosomes displayed a minimum 10-fold increase in cellular uptake across three cell types (endothelial, neural and epithelial) compared to HEK-derived exosomes, with an 18-fold increase observed in endothelial cells. Additionally, when loaded with a therapeutic payload (small interfering RNA, siRNA), a 600% improvement in delivery to the target cell was recorded versus HEK exosomes. The most advanced exosome technologies that have entered clinical development, to date, are HEK-derived exosomes. We believe these results therefore not only provide encouraging signs for the clinical progression of ReNeuron’s exosomes, but may also provide a distinct competitive advantage against HEK competitors. Our estimates are currently under review.
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