KZIA

Kazia Therapeutics licenses paxalisib to Sovargen for intractable seizures in rare central nervous system diseases

Retrieved on: 
Thursday, March 21, 2024
TSC, PI3K, TSC1, Epilepsy, Brain, FCD, Central nervous system, Patient, CNS, Seizure, KZIA, TSC2, Pharmaceutical industry

Paxalisib is an oral dual inhibitor targeting both PI3K and mTOR within this pathway, and it is distinguished by its ability to penetrate the brain.

Key Points: 
  • Paxalisib is an oral dual inhibitor targeting both PI3K and mTOR within this pathway, and it is distinguished by its ability to penetrate the brain.
  • Although FCD T2 and TSC are rare orphan diseases, they represent a high medical unmet need with significant market opportunity.
  • The licensing agreement includes all countries worldwide, excluding mainland China, Hong Kong, Macao and Taiwan, which Kazia retains.
  • Our license with Sovargen provides us the ability to explore the impact of paxalisib outside of our area of expertise where there is substantial patient need and market opportunity.

Kazia announces presentation of new data at AACR Annual Meeting

Retrieved on: 
Wednesday, March 13, 2024
PNOC, Patient, MD, Outline, AACR, KZIA, Therapy, Medical imaging

SYDNEY, March 13, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a biotechnology company specialising in oncology, is pleased to announce the presentation of new data for both its pipeline molecules, paxalisib and EVT801, at the upcoming Annual Meeting of the American Association of Cancer Research (AACR) in San Diego, California, from 5-10 April 2024.

Key Points: 
  • SYDNEY, March 13, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a biotechnology company specialising in oncology, is pleased to announce the presentation of new data for both its pipeline molecules, paxalisib and EVT801, at the upcoming Annual Meeting of the American Association of Cancer Research (AACR) in San Diego, California, from 5-10 April 2024.
  • There will be three presentations in total at AACR, including data from the phase 1 study of EVT801 in advanced solid cancers.
  • The data being presented will outline initial clinical data from the phase 1 study and provides support and direction for the next stage of the study.
  • In addition, data will be presented on the results of the combination therapy of paxalisib and gemcitabine for patients with relapsed/recurrent atypical teratoid/rhabdoid tumors AT/RT.

Kazia Therapeutics Reports Early Conclusion of Clinical Trial After Reaching Primary Endpoint

Retrieved on: 
Wednesday, February 21, 2024
Cancer, Neoplasm, Incidence, FDA, MTD, Food, Part, Fast track (FDA), Radiation therapy, WBRT, Conference, Society, FTD, Safety, University, Brain, Patient, PI3K, Metastasis, SRS, KZIA, Research, Radiation, Medical imaging

SYDNEY, Feb. 21, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a biotechnology company specializing in oncology, today announced the early conclusion based on positive safety and promising clinical response findings observed to date of an important two-part Phase I trial. This investigator-initiated trial evaluated the use of paxalisib (an oral PI3K/mTOR dual inhibitor) with radiation therapy for the treatment of patients with PI3K pathway mutation brain metastases from solid tumors.

Key Points: 
  • SYDNEY, Feb. 21, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a biotechnology company specializing in oncology, today announced the early conclusion based on positive safety and promising clinical response findings observed to date of an important two-part Phase I trial.
  • After reviewing the Part II patient data generated to date, the three lead investigators have determined that the primary endpoint of the study has been reached.
  • In addition, the investigators continued to observe encouraging signs of clinical response in patients in the expansion cohort.
  • The increasing incidence of brain metastasis and the low response rates to existing treatments underscores the need for new treatment options.

KAZIA CONTINUES BOARD RENEWAL WITH TWO NEW APPOINTMENTS

Retrieved on: 
Thursday, January 18, 2024
Corporation, Executive Committee, Temple University, Antares, Lilly, Eli Lilly and Company, KZIA, Eli Lilly, Acquisition, Carmine, Finance, Marketing, Growth, Management

Mr. Apple also served on the Board of Directors at Antares from 2016 until May 2022.

Key Points: 
  • Mr. Apple also served on the Board of Directors at Antares from 2016 until May 2022.
  • He previously served on the Boards of Directors of InKine Pharmaceutical, PaxMedica Inc., and Kerathin Inc.
  • In a further renewal of the Board, Non-Executive Director Mr. Bryce Carmine has been appointed Chairman.
  • Commenting on the Board appointments, Kazia's CEO Dr. John Friend said: "We are delighted that Bryce has accepted the role of Chairman and that Bob has agreed to join the Board.

Kazia Therapeutics Announces Closing of $2 Million Registered Direct Offering

Retrieved on: 
Tuesday, December 5, 2023
Sale, The Act, Regulation D, Security (finance), Kazia Pelka, Form, SEC filing, KZIA, ADS, American depositary receipt, 3rd Floor

The Company also issued in a concurrent private placement unregistered warrants to purchase up to an aggregate of 4,444,445 ADSs.

Key Points: 
  • The Company also issued in a concurrent private placement unregistered warrants to purchase up to an aggregate of 4,444,445 ADSs.
  • The gross proceeds to the Company from the offering were approximately $2 million, before deducting the placement agent's fees and other offering expenses payable by the Company.
  • The offering of such securities in the registered direct offering was made only by means of a prospectus supplement that forms a part of the effective registration statement.
  • A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering were filed with the SEC and are available on the SEC's website at www.sec.gov .

KAZIA ANNOUNCES NON-BINDING LETTER OF INTENT FOR THE PROPOSED GRANTING OF RIGHTS TO DEVELOP AND COMMERCIALIZE PAXALISIB OUTSIDE OF ONCOLOGY

Retrieved on: 
Wednesday, November 29, 2023
Negotiation, Patient, KZIA, Cancer, Pharmaceutical industry, Hong Kong

The LOI sets out the proposed terms and preliminary conditions of the agreement as well as a 90-day exclusivity period.

Key Points: 
  • The LOI sets out the proposed terms and preliminary conditions of the agreement as well as a 90-day exclusivity period.
  • The proposed terms include an upfront payment, and potential for clinical and regulatory milestone payments, as well as commercial sales-based royalties and milestones.
  • "As we continue to pursue the potential benefits of paxalisib in patients with cancer, this strategic alliance would assist to develop paxalisib to address a significant unmet medical need outside of oncology," said Kazia CEO Dr. John Friend.
  • "This alliance would leverage our strengths as well as those of our partner to benefit patients, families and our stakeholders.

KAZIA PROVIDES OVERVIEW OF PAXALISIB RELATED PRESENTATIONS FROM THE SOCIETY OF NEURO-ONCOLOGY 2023 ANNUAL MEETING

Retrieved on: 
Tuesday, November 21, 2023
CNS, DNA, Neoplasm, Metformin, PIK3CA, PI3K, Patient, KZIA, Radiation, Standard of care, MD, Diagnosis, DMG, Survival, ONC201, Female, DIPG, Society, DMG interpersonal, Pharmaceutical industry, Medical imaging

SYDNEY, Nov. 21, 2023 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, is pleased to provide key highlights of the clinical and preclinical paxalisib related presentations given by key thought leaders at the Society of Neuro-Oncology 2023 Annual Meeting.

Key Points: 
  • SYDNEY, Nov. 21, 2023 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, is pleased to provide key highlights of the clinical and preclinical paxalisib related presentations given by key thought leaders at the Society of Neuro-Oncology 2023 Annual Meeting.
  • "The 2023 SNO Annual Meeting was another successful event with the latest advances in clinical trials, diagnosis and treatment of pediatric and adult patients with CNS malignancies," stated Dr. John Friend, CEO Kazia.
  • "We are highly encouraged with the preliminary overall survival data from the PNOC022 clinical study that we believe will provide an alternative to the current therapies considered as standard of care."
  • Key paxalisib highlights from the meeting:
    Specifically, the authors observed how ONC201 over activates the PI3K-AKT pathway, which is the target pathway for paxalisib
    Two patient case studies were discussed; each receiving the combination of paxalisib and ONC201 through compassionate access
    Six-year old female with DIPG who received the combination of paxalisib and ONC201 after upfront radiation therapy.

KAZIA ANNOUNCES RECEIPT OF NASDAQ MINIMUM BID NOTIFICATION

Retrieved on: 
Monday, November 20, 2023
American depositary receipt, Failure, KZIA, Calendar, Notice, Cryptocurrency

SYDNEY, Nov. 20, 2023 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA) (Kazia or the company) received a deficiency notification from the Listing Qualifications Staff of the Nasdaq Stock Market LLC (Nasdaq), dated November 20, 2023, notifying the company that it is not in compliance with the minimum bid price requirement set forth in the Nasdaq Capital Market's rules for continued listing (the Notice).

Key Points: 
  • SYDNEY, Nov. 20, 2023 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA) (Kazia or the company) received a deficiency notification from the Listing Qualifications Staff of the Nasdaq Stock Market LLC (Nasdaq), dated November 20, 2023, notifying the company that it is not in compliance with the minimum bid price requirement set forth in the Nasdaq Capital Market's rules for continued listing (the Notice).
  • The deficiency notification has no immediate impact on the company's operations or listing.
  • Kazia's securities will continue to trade as normal on Nasdaq Capital Market (Nasdaq C-M) under the ticker KZIA.
  • If at any time before May 20, 2024, the bid price of the company's ADSs closes at or above US$ 1.00 per share for a minimum of 10 consecutive business days, the company will regain compliance with the minimum bid requirement.

KAZIA ANNOUNCES THE RELEASE OF PNOC022 CLINICAL STUDY ABSTRACT HIGHLIGHTING PAXALISIB IN DIFFUSE MIDLINE GLIOMA PATIENTS AHEAD OF THE SOCIETY OF NEURO-ONCOLOGY 2023 ANNUAL MEETING

Retrieved on: 
Wednesday, November 15, 2023
DRD2, Annual general meeting, Therapy, Eosinophilia, Disulfiram-like drug, Lymphocyte, Patient, KZIA, PNOC, Colitis, Mucositis, MD, Trial of the century, Diagnosis, DMG, Hyperglycemia, ONC201, Physician, OS, Society, Hypokalemia, DMG interpersonal, Pharmaceutical industry

The preliminary results from a single cohort in this Pacific Pediatric Neuro-Oncology Consortium (PNOC) sponsored cooperative group clinical study will be presented on Sunday, 19 November 2023 in Vancouver, Canada.

Key Points: 
  • The preliminary results from a single cohort in this Pacific Pediatric Neuro-Oncology Consortium (PNOC) sponsored cooperative group clinical study will be presented on Sunday, 19 November 2023 in Vancouver, Canada.
  • Sixty-eight children and young adults with DMG who completed standard of care radiation treatment received paxalisib (an investigational PI3K-mTOR dual inhibitor) and ONC201 (an investigational dopamine receptor D2 (DRD2) and ClpP agonist).
  • The abstract reported that median overall survival (OS) from time of diagnosis was 16.5 months.
  • "The PNOC022 study has exceeded expectations in terms of enrolment rates and has partnered with 29 leading children's cancer centers and physicians across the globe."

KAZIA THERAPEUTICS ANNOUNCES CLINICAL DATA AT ESMO 2023 FROM ONGOING PHASE 1 EVT801 STUDY

Retrieved on: 
Monday, October 23, 2023
Data analysis, Metastasis, AACR, Ovarian cancer, ESMO, Prevalence, Cell, CD8, Immunity, Recurrence, Neoplasm, Oncology, KZIA, European Society for Medical Oncology, Patient, VEGFR3, Hypoxia, Medical imaging, Vaccine, Kazia Pelka

SYDNEY, Oct. 23, 2023 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, announces that selected clinical data from the company's ongoing Phase 1 clinical trial evaluating EVT801 in patients with advanced solid tumours was presented at the European Society of Medical Oncology Congress 2023 (ESMO 2023) on Saturday, 21 October 2023.

Key Points: 
  • SYDNEY, Oct. 23, 2023 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, announces that selected clinical data from the company's ongoing Phase 1 clinical trial evaluating EVT801 in patients with advanced solid tumours was presented at the European Society of Medical Oncology Congress 2023 (ESMO 2023) on Saturday, 21 October 2023.
  • Professor Carlos A Gomez-Roca, (IUCT-Oncopole, Toulouse France) presented data from a correlation analysis of tumour biopsies from six (6) enrolled patients with high grade serous ovarian cancer (HGS-OC).
  • To date, twenty (20) patients with advanced solid tumors have been dosed in in the ongoing Phase 1 clinical trial, and the trial has advanced to dose escalation cohort 6.
  • "We look forward to completing dose escalation in stage 1 of the ongoing study and progressing to stage 2 of the Phase 1 Study ."