Kazia Presents Further Paxalisib and Cantrixil Data at AACR, Reinforcing Positive Efficacy Signals for both Drugs

SYDNEY,June 22,2020 -- Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA),an Australian oncology-focused biotechnology company,is pleased to share poster presentations of interim data from the ongoing phase II study of paxalisib (formerly GDC-0084) in glioblastoma,the most common and most aggressive form of primary brain cancer,and from the phase I study of Cantrixil in ovarian cancer.

Key Points

Previous paxalisib data presented at ASCO was based on Stage 1 (n=9) of the ongoing phase II study in glioblastoma. This interim analysis at AACR includes all patients in the study (n=30),and therefore provides a more robust and substantial data set

Progression-free survival (PFS) for paxalisib is 8.5 months,versus 8.4 months in the previous analysis

Paxalisib overall survival (OS) remains at 17.7 months,in line with ASCO data

A separate poster on the investigator-initiated study of paxalisib in combination with radiotherapy is presented by clinicians at Memorial Sloan Kettering Cancer Center in New York. It noted a 'robust response' in the first treated patient

Cantrixil data shows one complete response (CR) to treatment,meaning no measurable disease,and two partial responses (PR),for an overall response rate of 19% (3 / 16 evaluable patients)

Summary of Paxalisib Data in Comparison to Temozolomide (existing standard of care)

Temozolomide[1]

(FDA-approved treatment)

Paxalisib

(interim phase II data)

Progression-Free Survival (PFS)

5.3 months

8.5 months

Overall Survival (OS)

12.7 months

17.7 months

Kazia CEO,Dr James Garner,commented,"The data summarized in these posters help to strengthen our confidence in both our clinical programs. As paxalisib moves towards commencement of the GBM AGILE pivotal study in the second half of calendar 2020,these findings will be used to support set-up activities. In the meantime,the fact that the PFS has remained robust as the analysis is extended out to the full data set gives us a great deal of additional confidence in the efficacy signal it provides. For Cantrixil,the emergence of one complete responder (CR) to treatment is very positive,and these new results will help us to explore partnering opportunities over the second half of the year."

AACR Annual Meeting

The American Association of Cancer Research (AACR) Annual Meeting is one of the leading global academic conferences for oncology research. It is typically attended by more than 20,000 clinicians,researchers,industry executives,and investors,representing over 140 countries. The conference is being conducted through a virtual format this year and has been broken into two sections. AACR Virtual Meeting I took place 27-28 April 2020,and AACR Virtual Meeting II is being held 22-24 June 2020.

The paxalisib poster is found under number CT205 (NCT03522298),and the Cantrixil poster under CT166 (NCT02903771). Registration to the virtual meeting is free and interested parties may register via the AACR website. The posters can be viewed on our website:

https://kza.irmau.com/irm/PDF/42fa1764-4329-42d8-9fbc-c9e2433b3ecc/PaxalisibposterpresentedatAACRvirtualmeeting

https://kza.irmau.com/irm/PDF/e55c6c96-c2c8-4aa1-ad7f-369d771857ca/CantrixilposterpresentedatAACRvirtualmeeting

Initial Data from Memorial Sloan-Kettering Study of Paxalisib with Radiotherapy

Dr Jonathan Yang and team at Memorial Sloan Kettering Cancer Center in New York,NY,also presented a poster (number CT252) on their ongoing phase I study of paxalisib in combination with radiotherapy (NCT04192981). The poster principally reported the design of their study,but also noted a 'robust response' in the first patient treated. Further data is expected as the study progresses

Next Steps

The paxalisb phase II study remains ongoing with a number of patients in follow-up and approximately half of the total enrolled patient population still receiving drug at the time of analysis. Kazia expects to complete the study in 1H CY2021.

Set-up work is well underway for paxalisib's planned entry into the GBM AGILE pivotal study,and it is expected that the first patient will be enrolled in the second half of calendar 2020.

The Cantrixil phase I study is now complete and analysis is underway,with final data expected in the second half of calendar 2020.

[1]ME Hegi,A-C Desirens,T Gorlia,et al. N Engl J Med (2005); 352:997-1003

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