Kazia all in on GBM AGILE, but eyes on brain mets

All in on GBM AGILE, but eyes on brain mets

AU$2.10 per share valuation
Nathan Calloway - Edi son analyst, states he is very conservative with the Kazia valuation assumptions, other than that he sees imminent data readouts.
His paxalisib analysis highlights, other than the GBM AGILE study :-.

Brain met readouts might determine the drug’s future
Although we do not expect major news from the GBM AGILE study in the near term, there are multiple other ongoing clinical studies utilising paxalisib that are providing readouts very soon and could potentially shape the direction of this program. In particular, we are interested in the upcoming readouts for three clinical studies investigating the product for the treatment of BMs. BMs are a major cause of mortality in metastatic cancer patients because the blood brain barrier limits the effectiveness of many treatments that work at other metastasis sites. Therefore, paxalisib is well positioned to provide a benefit to these patients as a targeted cancer treatment designed to cross the blood brain barrier. In addition to these BM studies, there are also investigator-sponsored studies for primary central nervous system lymphoma (PCNSL) and diffuse intrinsic pontine glioma (DIPG) that are expected to begin recruiting patients shortly in Q1 CY21

All three ongoing investigator-sponsored studies of BMs are expected to provide readouts in the very near term. The company is hoping to have results in H1 CY21 for each study, but this is subject to the internal timelines of the independent investigators, which is subject to change.

The earliest stage program is a Phase I study at Memorial Sloan-Kettering investigating paxalisib in combination with radiotherapy for any primary tumour type as long as it has PI3K pathway mutations. This study has targeted enrolment of 36, and we expect the main readout to be on the safety of the combination treatment. Another program in Phase II sponsored by the NIH is also investigating BMs from any primary solid tumour. This program is also investigating the CDK4/6 inhibitor Verzenio (abemaciclib, Eli Lilly) and the TRK inhibitor Vitrakvi (entrectinib).

Finally, we are expecting an imminent readout from the Phase II BCBM study being performed at Dana-Farber any day. The company is currently guiding toward the program providing data in H121 (albeit with the above caveats regarding investigator timelines), but previous guidance was for Q420, so the readout is overdue, in our view. This study is investigating the drug in combination with Herceptin (trastuzumab) in HER2+ breast cancer patients. We expect results of this study to be potentially the most informative of the three investigator-sponsored BM programs because we consider the BCBM market the clearest future potential indication for the product outside of primary brain tumours. One retrospective study of patients in Belgium found that among HER2+ breast cancer patients, 10.8% had BMs at their initial screening and 41.7% developed BMs within their lifetime.1 Survival of these patients was significantly reduced, from 46.7 months for those with no central nervous system involvement to 20.8 months for those with BMs.

https://www.edisongroup.com/publication/all-in-on-gbm-agile-but-eyes-on-brain-mets/28944/

Regards.