reports
- Sean Conroy
Kazia Therapeutics - Multiple paxalisib data points expected in Q4
Kazia expects to release multiple data points from its paxalisib program in Q4 CY21. These include final data from the 30-patient Phase II trial in newly diagnosed glioblastoma multiforme (GBM) patients, as well as initial data for paxalisib in the treatment of brain metastases (BMs). Additionally, the Phase I for EVT801 is expected to begin enrolment by year-end.
- Sean Conroy
Kazia Therapeutics - Multiple paxalisib data points expected in Q4
Kazia expects to release multiple data points from its paxalisib program in Q4 CY21. These include final data from the 30-patient Phase II trial in newly diagnosed glioblastoma multiforme (GBM) patients, as well as initial data for paxalisib in the treatment of brain metastases (BMs). Additionally, the Phase I for EVT801 is expected to begin enrolment by year-end.
- Sean Conroy
Kazia Therapeutics - Multiple paxalisib data points expected in Q4
Kazia expects to release multiple data points from its paxalisib programme in Q4 CY21. These include final data from the 30-patient Phase II trial in newly diagnosed glioblastoma multiforme (GBM) patients, as well as initial data for paxalisib in the treatment of brain metastases (BMs). Additionally, the Phase I for EVT801 is expected to begin enrolment by year-end.
- Sean Conroy
Kazia Therapeutics - Multiple paxalisib data points expected in Q4
Kazia expects to release multiple data points from its paxalisib programme in Q4 CY21. These include final data from the 30-patient Phase II trial in newly diagnosed glioblastoma multiforme (GBM) patients, as well as initial data for paxalisib in the treatment of brain metastases (BMs). Additionally, the Phase I for EVT801 is expected to begin enrolment by year-end.
- Sean Conroy
Kazia Therapeutics - New asset to target tumor lymphangiogenesis
Kazia announced that it is expanding its pipeline to include EVT801, a novel small molecule inhibitor of VEGFR3. The drug is being licensed from Evotec for €1m upfront, €308m in milestones and tiered single-digit royalties. EVT801 was developed as part of a collaboration between Evotec and Sanofi. Kazia will be responsible for development, but will collaborate with and have access to Evotec resources to support development. The product is currently in preclinical development, but Kazia believes ...
- Sean Conroy
Kazia Therapeutics - New asset to target tumor lymphangiogenesis
Kazia announced that it is expanding its pipeline to include EVT801, a novel small molecule inhibitor of VEGFR3. The drug is being licensed from Evotec for €1m upfront, €308m in milestones and tiered single-digit royalties. EVT801 was developed as part of a collaboration between Evotec and Sanofi. Kazia will be responsible for development, but will collaborate with and have access to Evotec resources to support development. The product is currently in preclinical development, but Kazia believes ...
- Sean Conroy
Kazia Therapeutics - Paxalisib Chinese rights licensed
Kazia has announced it has signed an agreement for the Greater China rights to paxalisib with Simcere Pharmaceuticals. The deal includes an US$11m upfront (US$7m in cash, and US$4m in an equity investment), up to US$281m in milestone payments and royalties in the mid-teens. This is a key development for Kazia because not only does this payment help alleviate the near-term financing needs of the company, but the deal illustrates the potential value of this asset to partners.
- Sean Conroy
Kazia Therapeutics - Paxalisib Chinese rights licensed
Kazia has announced it has signed an agreement for the Greater China rights to paxalisib with Simcere Pharmaceuticals. The deal includes an US$11m upfront (US$7m in cash, and US$4m in an equity investment), up to US$281m in milestone payments and royalties in the mid-teens. This is a key development for Kazia because not only does this payment help alleviate the near-term financing needs of the company, but the deal illustrates the potential value of this asset to partners.
- Sean Conroy
Kazia Therapeutics - All in on GBM AGILE, but eyes on brain mets
Patients have officially begun to receive doses of paxalisib as part of the pivotal GBM AGILE study that Kazia is participating in. The Phase II/III study is active in at least 31 sites in the US and Canada currently and is expanding to Europe and China in H121. Given the study design, it is unlikely to report clinical data in 2021, so the near-term focus will be on clinical results from ongoing investigator-sponsored studies, particularly in brain metastases (from other cancer types), which we ...
- Sean Conroy
Kazia Therapeutics - All in on GBM AGILE, but eyes on brain mets
Patients have officially begun to receive doses of paxalisib as part of the pivotal GBM AGILE study that Kazia is participating in. The Phase II/III study is active in at least 31 sites in the US and Canada currently and is expanding to Europe and China in H121. Given the study design, it is unlikely to report clinical data in 2021, so the near-term focus will be on clinical results from ongoing investigator-sponsored studies, particularly in brain metastases (from other cancer types), which we ...
- Sean Conroy
Kazia Therapeutics - Cantrixil final Phase I data reported
Kazia Therapeutics announced the final data from both parts of the Phase I dosing study of cantrixil for the treatment of metastatic ovarian cancer. Of the 16 patients evaluable for efficacy, one had a complete response (CR) and two had a partial response (PR). This response rate data has not changed significantly since the dosing portion of the study was completed in 2018. The company will seek partners for the further development of the product, while it focuses its efforts on paxalisib.
- Sean Conroy
Kazia Therapeutics - Cantrixil final Phase I data reported
Kazia Therapeutics announced the final data from both parts of the Phase I dosing study of cantrixil for the treatment of metastatic ovarian cancer. Of the 16 patients evaluable for efficacy, one had a complete response (CR) and two had a partial response (PR). This response rate data has not changed significantly since the dosing portion of the study was completed in 2018. The company will seek partners for the further development of the product, while it focuses its efforts on paxalisib.
- Sean Conroy
Kazia Therapeutics - Phase IIa shows good safety, consistent efficacy
Kazia presented the results from a new interim data analysis of its ongoing Phase IIa study of paxalisib in glioblastoma multiforme (GBM). The data were consistent with previous data and showed progression-free survival (PFS) of 8.4 months and overall survival (OS) of 17.5 months. Importantly, Kazia also published some of the first safety data at the full 60mg dose, which show an attractive profile compared to other members of this class.
- Sean Conroy
Kazia Therapeutics - Phase IIa shows good safety, consistent efficacy
Kazia presented the results from a new interim data analysis of its ongoing Phase IIa study of paxalisib in glioblastoma multiforme (GBM). The data were consistent with previous data and showed progression-free survival (PFS) of 8.4 months and overall survival (OS) of 17.5 months. Importantly, Kazia also published some of the first safety data at the full 60mg dose, which show an attractive profile compared to other members of this class.
- Sean Conroy
Kazia Therapeutics - Bringing a vetted drug class to the brain
We are reinitiating on Kazia Therapeutics, which is entering late-stage trials for its lead product, paxalisib, for glioblastoma multiforme (GBM). The product is a PI3K inhibitor originally developed by Genentech to cross the blood-brain barrier. The drug is scheduled to be included in the ongoing GBM AGILE study, an innovative investigator-sponsored study testing multiple candidates against the disease, with the first paxalisib patients being enrolled by the end of 2020. We are reinitiating wit...
- Sean Conroy
Kazia Therapeutics - Paxalisib trial still on track for H220 start
In the current viral pandemic, it is worth recalling that brain cancers will arise during and after the epidemic. The core business case for Kazia remains strong as it is developing the only brain penetrating PI3K inhibitor agent in trials to treat glioblastoma. In the current Phase II, the 21-patient expansion cohort was fully recruited in February. No hospitalisation is needed to continue with this study; it is oral dosing. The potentially pivotal Phase III using the AGILE trial network is on ...
- Sean Conroy
Kazia Therapeutics - An agile pivot
Kazia Therapeutics has announced that GDC-0084, its promising glioblastoma drug, will join (subject to definitive agreement) the pivotal GBM AGILE trial. AGILE is a clinician-led trial that currently enables fast access to 11 US glioblastoma centers. GDC-0084 could be dosed from Q2/Q3 CY20. Data from the 20-patient stage of the GDC-0084 Phase II should be available during 2020. Our indicative value remains at $93m.
- Sean Conroy
Kazia Therapeutics - An agile pivot
Kazia Therapeutics has announced that GDC-0084, its promising glioblastoma drug, will join (subject to definitive agreement) the pivotal GBM AGILE trial. AGILE is a clinician-led trial that currently enables fast access to 11 US glioblastoma centres. GDC-0084 could be dosed from Q2/Q3 CY20. Data from the 20-patient stage of the GDC-0084 Phase II should be available during 2020. Our indicative value remains at A$137m.
- Sean Conroy
Kazia Therapeutics - GDC-0084 – encouraging initial efficacy
Kazia Therapeutics has presented very encouraging initial efficacy data from the dose-ranging stage of its current Phase II trial. The data are sufficient to give Kazia confidence that it can run a large, and potentially pivotal, study starting by mid-CY20. Promising Cantrixil interim data were released in September. FY19 results showed cash of $4.1m now boosted by a $2.9m net placing. Our indicative value remains at c $104m or about US$13/ADR post placing.
- Sean Conroy
Kazia Therapeutics - Executive Interview
Kazia Therapeutics has presented very encouraging initial efficacy data from the dose-ranging stage of its current Phase II trial. The data are sufficient to give Kazia confidence that it can run a large, and potentially pivotal, study starting by mid-CY20. In this video, Kazia’s CEO, Dr James Garner, explains the background to GDC-0084, which has a novel brain penetrating action which potentially could give it a unique role in the chronic treatment of glioblastoma. He discusses the latest t...
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