Kazia Therapeutics Ltd (KZIA)

[trendzone]

Another one,Mr big shot, average price $1.05 sold at $0.98 ohhhh so painful of a loss Mr bashbag,gee what happen Mr know it all with that pump and dump $FRGT at the time $0.85, about to go over a buck, now at $0.37, how's that working out for you,still holding that heavy bag, lol.

[TrendTrade2016]

u sound angry....nice pick...lol

[trendzone]

What they really need to do is get their heads out of their toxic azzes.

[Pt3]

I'm in let. Goo positive

[crudeoil24]

KAZIA'S PAXALISIB DEMONSTRATES POSITIVE MONOTHERAPY EFFICACY SIGNALS IN PRECLINICAL MODELS OF MELANOMA
7:00 am ET October 27, 2022 (PR Newswire) Print
Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, is pleased to announce the presentation of new data from an ongoing research collaboration with the Huntsman Cancer Institute at the University of Utah in Salt Lake City, UT.

https://mma.prnewswire.com/media/1872892/Kazia_Logo.jpg

A poster presentation by Dr Gennie Parkman and colleagues, working in the laboratory of Professor Sheri Holmen, has shown paxalisib to be active in vitro and in vivo against a range of preclinical models of metastatic melanoma, the most aggressive form of skin cancer. Dr Parkman's data suggested substantial activity for paxalisib as monotherapy, and greater activity in combination with MEK and BRAF inhibitors, two classes of drugs that are commonly used for a substantial proportion of melanoma patients.

"This is among the most promising single agent data that we have seen in our research," commented Professor Sheri Holmen, lead investigator on the project. "Despite the widespread adoption of immunotherapy in recent years, there remains substantial unmet need in melanoma, particularly in those patients who develop brain metastases. We look forward to exploring the potential of paxalisib further in our research, and hopefully seeing the drug transition to a clinical trial in the near future."

[Xrouter]

They really need management like Dr. Kelly to come back and fix it before it goes lower

[Cuppy]

What's the consensus on this one now? I have been watching for a couple years now (no position). It seems dirt cheap IF it still has a chance for approvals.

[Roadtojourney]

Wow dump on news?? Makes no sense.

[doogdilinger]

Yessir brotha you're on FIRE>>>$$$$$$$$$$$$$$$$$$$$$$$$$$$

[subslover]

Did you see that plow up for $3.37? Like a runaway spacecraft. :)

[doogdilinger]

KABOOM;)

[subslover]

Interim data from the first stage of the study reports that all 9 evaluable patients experienced complete or partial response, representing an overall response rate (ORR) of 100%. For comparison, a typical ORR associated with whole brain radiotherapy alone can commonly range from 20-45% in published studies, of which some representative examples are indicated below.

The data has been accepted for an oral presentation at the upcoming 2022 Annual Conference on CNS Clinical Trials and Brain Metastases, jointly organised by the Society for Neuro-Oncology (SNO) and the American Society for Clinical Oncology (ASCO), and held in Toronto, Canada from 12-13 August 2022.

Key Points

Approximately 200,000 cancer patients develop brain metastases in the United States each year. Brain metastases are typically very challenging to treat and are associated with poor prognosis. Radiotherapy remains a mainstay of clinical management.

Dr. Jonathan Yang, Director, Metastatic Disease, Department of Radiation Oncology at Memorial Sloan Kettering Cancer Center is the Principal Investigator of this clinical trial that is examining the combination of paxalisib with whole brain radiotherapy for patients with brain metastases (NCT04192981). The trial is designed in two stages: an initial exploratory stage and a confirmatory expansion stage.

9 of 12 patients in the initial stage were evaluable for efficacy. All 9 patients exhibited complete or partial response, according to RANO-BM criteria, representing an ORR of 100%.

The patients comprised a range of primary tumours, with breast cancer the most common, representing one third of patients.

The safety profile of paxalisib in combination was broadly consistent with monotherapy experience in other clinical trials, and a maximum tolerated dose (MTD) of 45mg daily in combination with radiotherapy was confirmed.

Recruitment to the expansion stage has already commenced, with the objective of recruiting an additional 12 patients.
Kazia CEO, Dr. James Garner, commented, "We are encouraged by this data and by the potential benefit it may indicate to this substantial and high-need group of patients. Radiotherapy is a ubiquitous component of the treatment paradigm for brain metastases, but resistance is common. Dr. Yang's study has shown a very promising signal that paxalisib may help to potentiate the effect of radiotherapy. We also learned recently that the ongoing Alliance study in brain metastases had graduated to an expansion stage in the breast cancer cohort, so this now represents the second positive signal for paxalisib in brain metastases, which we increasingly believe represents a very promising opportunity for the product candidate."

Brain Metastases

It is estimated that as many as 20% of all patients with cancer will develop brain metastases (secondary tumours in the central nervous system). The most common primary tumours that spread to the brain include lung, breast, colorectal, melanoma, and renal cell carcinoma. Median overall survival for patients diagnosed with brain metastases ranges from 2.3 to 7.7 months.[1] It is estimated that approximately 200,000 patients are diagnosed with brain metastases each year in the United States alone.[2]

Radiotherapy is the mainstay of treatment for brain metastases, and generally consists in either stereotactic radiosurgery (SRS) or whole brain radiotherapy (WBRT) or some combination thereof. The efficacy of WBRT differs according to the type of tumour and the number and volume of brain metastases, but several recent publications cite overall response rates of 20-45%.



Publication

Setting

ORR

Arrietta et al. (2020)

NSCLC

47.1 %

Zhou et al. (2021)

NSCLC (meta-analysis)

20.4% - 27.4%

Kim et al. (2020)

HER2+ breast cancer

42 %



Clinical Study Rationale and Design

Research by Dr. Yang and others has shown that activation of the PI3K pathway is common in brain metastases, even in some cases where it is not present in the primary tumour. Moreover, PI3K pathway activation appears to be induced by radiotherapy, and to confer upon the tumour resistance to radiotherapy. These observations provide a strong rationale for testing the combination of a brain-penetrant PI3K inhibitor with radiotherapy.

This phase I study is a single-arm prospective trial comprising patients with brain metastases or leptomeningeal metastases from any primary tumour. The primary objective is safety and tolerability. All patients have PI3K pathway mutations at baseline. The first stage of the study is intended to establish the MTD of paxalisib in combination with WBRT and to characterise safety and tolerability. The second stage is intended to elicit confirmatory signals of efficacy, with the intent to recruit a further 12 patients.

Next Steps

Enrolment to the second stage of the study is already underway and we currently estimate preliminary data from the second part of the phase I clinical trial in CY2023.

Kazia expects to discuss emerging data from this study, along with other research in brain metastases, with its scientific advisors and regulatory consultants in due course, with potential FDA consultation at a future date.

Summary of Abstract

Session 2: Multimodality Approaches to Primary and Secondary Brain Tumors - Invited
Speakers and Oral Abstracts
Friday, 12 August 2022
11am – 1pm

Abstract MMAP-05 - Phase I study of concurrent paxalisib and radiation therapy in patients with solid tumor brain metastases or leptomeningeal metastases harboring PI3K pathway mutations: results from the dose-escalation cohort (NCT04192981)
Lead Author: T Jonathan Yang, MD, PhD
Institution: Memorial Sloan Kettering Cancer Center, New York, NY

For More Information, Please Contact:-

In the United States:

Joe Green

Edison Investor Relations

[e-mail]

Phone: [phone]

In Australia:

Jane Lowe

IR Department

[e-mail]

Phone: [phone]



About Kazia Therapeutics Limited

Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA) is an oncology-focused drug development company, based in Sydney, Australia.

Our lead program is paxalisib, a brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat glioblastoma, the most common and most aggressive form of primary brain cancer in adults. Licensed from Genentech in late 2016, paxalisib commenced recruitment to GBM AGILE, a pivotal study in glioblastoma, in January 2021. Seven additional studies are active in various forms of brain cancer. Paxalisib was granted Orphan Drug Designation for glioblastoma by the US FDA in February 2018, and Fast Track Designation for glioblastoma by the US FDA in August 2020. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Designation by the US FDA for DIPG in August 2020, and for AT/RT in June 2022.

Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to be active against a broad range of tumour types and has provided compelling evidence of synergy with immuno-oncology agents. A phase I study commenced recruitment in November 2021.

For more information, please visit www.kaziatherapeutics.com or follow us on Twitter @KaziaTx.

Forward-Looking Statements

This announcement may contain forward-looking statements, which can generally be identified as such by the use of words such as "may," "intend," "potential," "prospective," or other similar words, and may include statements regarding the therapeutic potential of Kazia's product candidates and anticipated results from clinical trials. Kazia's product candidates may include paxalisib, EVT801, or other molecules, administered alone or in combination with other therapies for any disease. Any statement describing Kazia's future plans, strategies, intentions,

[subslover]

Kazia gains on FDA’s rare pediatric disease designation for childhood cancer therapy
Jul. 06, 2022 6:44 AM ETKazia Therapeutics Limited (KZIA)By: Dulan Lokuwithana, SA News Editor1 Comment
https://seekingalpha.com/news/3854493-kzia-stock-gains-on-fdas-rare-pediatric-designation-for-cancer-therapy

[Pt3]

My ask 10 where

[weedtrader420]

WOOHOOOOOO

[weedtrader420]

KZIA$

[Cuppy]

Absolutely!

[aussiekevin]

Bad timing. Looks like an easy 10 bagger from here.

[ipo_dude]

Patience is king. Im Out!!! Glad i held on and didn’t sell @ loss.

[aussiekevin]

Yes, the news was very negative so this is not surprising.

[ipo_dude]

This is getting crushed

[whatarush12]

congrats!

[ipo_dude]

Do it??

[Oger]

Check back with me Friday morning and ask me how I’m doing....

[whatarush12]

How's it going? I'd SELL this turd!!! OUCH! Losing more and more $$$

https://www.otcmarkets.com/stock/KZIA/financials

[Oger]

Opens $12 or more on Monday...

[Cuppy]

FDA Awards Orphan Drug Designation (ODD) To Paxalisib For Malignant Glioma, Including DIPG

9:14 pm ET August 23, 2020
Kazia Therapeutics Limited (NASDAQ: KZIA) is pleased to announce that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Kazia's paxalisib (formerly GDC-0084) for the treatment of malignant glioma, which includes Diffuse Intrinsic Pontine Glioma (DIPG), a rare and highly aggressive childhood brain cancer.

Key Points

Orphan Drug Designation (ODD) is a special status accorded to drugs which are considered promising potential treatments for rare ('orphan') diseases, generally defined as those which affect less than 200,000 cases per annum in the United States
ODD can provide drug developers with up to seven years of Orphan Drug Exclusivity (ODE), extending the effective life of a commercial product. It also provides opportunities for grant funding, protocol assistance, and financial benefits, such as a waiver of New Drug Application fees, and tax credits
Receipt of ODD follows award of Rare Pediatric Disease Designation (RPDD) for DIPG on 7 August 2020
Kazia CEO, Dr James Garner, commented, "Taken together, RPDD and ODD provide a powerful suite of incentives, opportunities, and protections for the development of paxalisib in DIPG. We look forward to seeing initial data from the ongoing phase I study in DIPG at St Jude Children's Research Hospital during the second half of calendar 2020. In parallel, we are working closely with collaborators, advisors, and researchers to determine the best path forward for paxalisib in this devastating disease."

He added, "This award of ODD concludes a program of regulatory optimisation that Kazia has initiated for paxalisib over the past six months. As we orient paxalisib towards commercialization, these special designations from FDA will allow us to move forward in the swiftest and most effective way possible."

[ClayTrader]

* * $KZIA Video Chart 08-20-2020 * *

Link to Video - click here to watch the technical chart video

[Nfixus]

The next year has a lot in the pipeline since FDA awards FTD today.
https://pennystocks.news/kazia-jumps-after-lead-drug-is-awarded-by-the-fda-kzia/

[ClayTrader]

* * $KZIA Video Chart 08-07-2020 * *

Link to Video - click here to watch the technical chart video

[ClayTrader]

* * $KZIA Video Chart 11-25-2019 * *

Link to Video - click here to watch the technical chart video

[sanderburwil]

KZIA Data PFS 8.4 months vs Temozolomide, Temodar (US) the only FDA approved drug to 5.3 months. Results are spectacular

[sanderburwil]

?$KZIA Kazia Therapeutics press release. Positive interim efficiency data from GDC-0084 Phase II Study in Glioblastoma released from SNO Conference. PFS) calculated at 8.4 months vs 5.3 Temozolomide?

[sanderburwil]

Kazia Therapeutics- $KZIA - Data-2019 SNO Conference OUT PFS 8.4 Months!!!!Expecting a $KRTX like move.
Temozolomide, Temodar (US) is the only FDA approved drug which extends patient lives from 4.4 months to 5.3 months. Kazia 8.4 is a huge success

We’re talking multi billion dollar market space here !!


CEO link on recent webcast suggest successful data here and co should be valued between 200-$500 million at this point of data is positive
Conservatively this is $45-$60 company given its potential and how easy and quick this will be FDA approved. They’re funded and they expect a “LARGER PHARMA” to bring GDC-0084 to fruition.


Dana Farber - Harvard Medical - MD Anderson - UCLA - Stephenson Cancer - John Theurer - Genetech

Poster Presenting Author(s)

Patrick Wen
Director, Center For Neuro-Oncology

ACTR-64 - Phase 2 study to evaluate the safety, pharmacokinetics and clinical activity of PI3K/mTOR inhibitor GDC-0084 in GBM patients with unmethylated O6-methylguanine-methyltransferase (MGMT) promoter status

[sanderburwil]

Kazia Therapeutics- $KZIA - Data presented this weekend -2019 SNO Conference . Halt lifted Monday morning. Expecting a $KRTX like move. CEO link on recent webcast suggest successful data here and co should be valued between 200-$500 million at this point of data is positive
Conservatively this is $45-$60 company given its potential and how easy and quick this will be FDA approved. They’re funded and they expect a “LARGER PHARMA” to bring GDC-0084 to fruition.


For GDC 0084 to work this well as a monotherapy it will CERTAINLY raise eyebrows of the worlds best experts over the weekend. Look who is presenting the data non other than Prof Wen!!!!




Dana Farber - Harvard Medical - MD Anderson - UCLA - Stephenson Cancer - John Theurer - Genetech

Poster Presenting Author(s)

Patrick Wen
Director, Center For Neuro-Oncology

ACTR-64 - Phase 2 study to evaluate the safety, pharmacokinetics and clinical activity of PI3K/mTOR inhibitor GDC-0084 in GBM patients with unmethylated O6-methylguanine-methyltransferase (MGMT) promoter status