Kazia Therapeutics Ltd (ASX:KZA) has had its valuation updated to A$137 million or A$2.20 a share by Edison Investment Research Limited, which maintains its base case scenario of a 2024 launch for Kazia's brain cancer drug GDC-0084.
The report also suggests an alternative delayed scenario of a 2026 launch with an adjusted value of A$86 million or A$1.38 a share.
It estimated about A$15-20 million will be needed to fund the GDC-0084 phase-2b and phase-three studies that could start in 2020 and progression of ovarian cancer treatment Cantrixil is assumed to require a partner.
Edison says that initial data of the current GDC-0084 phase-two study, if positive, could trigger a phase-2b randomised study and potential partnering by 2023.
The following is an extract from the report:
Efficacy indications for GDC-0084 by late 2019
Kazia is recruiting a 20-patient expansion cohort in its current GDC-0084 phase II study at a 60 milligram dose – higher than the 45 milligram used by Genentech.
GDC-0084 has a provisionally assigned official name, paxalisib, subject to final confirmation.
The initial data may be available by Q419. If positive, this could trigger a phase-2b randomised study and potential partnering by 2023.
We assume as our base case scenario that this might be adequate for approval in 2024 as patients resistant to the current standard therapy, temozolomide, have no other therapies available.
New metastatic trial for GDC-0084 with radiotherapy
Memorial Sloan Kettering Cancer Center (MSK) in New York supported by Kazia will lead a phase-one trial of GDC-0084 combined with radiotherapy to treat solid brain metastases with a genetic alteration.
This has a dose ranging phase followed by cohort expansion. It may report data in H221.
The PI3K pathway inhibited by GDC-0084 enables cells damaged by radiation to survive rather than enter apoptosis (cell death) so blocking PI3K might boost the efficacy of radiotherapy.
Cantrixil efficacy indications possible by late 2019
Cantrixil is also in a cohort expansion stage with 12 patients recruited and data due in Q4.
Initial data in April was very promising, with one partial responder and five stable disease patients treated.
Cantrixil, an intra-peritoneal injection of a novel cytotoxic agent, could become a standard treatment for third-line ovarian cancer patients who now have few therapy alternatives and very poor prognosis.