REM-001 therapy / Kintara Therap - LARVOL DELTA

Kintara Therapeutics Announces Fiscal 2024 Financial Results and Provides Corporate Update (PRNewswire) - "As of October 7, 2024, four patients have been dosed in Kintara's open label 15-patient REM-001 study (the 'REM-001 Study') in cutaneous metastatic breast cancer (CMBC)."

Trial status • Breast Cancer

Kintara Therapeutics Provides Update on Corporate Developments and REM-001 Clinical Study (PRNewswire) - "As of September 10, 2024, the REM-001 study in patients with cutaneous metastatic breast cancer (CMBC) has enrolled four of the 10 patients needed to reach the minimum patient enrollment to assess safety and appropriate Phase 3 dose with several other patients identified as study candidates at Kintara's clinical sites, the Memorial Sloan Kettering Cancer Center and the Montefiore Medical Center, the University Hospital for Albert Einstein College of Medicine. Consistent with REM-001's safety profile, no treatment-related safety issues have been identified to-date, and assessment of the appropriate Phase 3 dose is ongoing....The majority of the cost associated with the REM-001 study is being covered by a $2.0 million Small Business Innovation Research (SBIR) grant Kintara was awarded previously from the National Institutes of Health."

Enrollment status • Financing • Breast Cancer • Oncology

Kintara Therapeutics and TuHURA Biosciences Provide Update on Recent Corporate and Clinical Advancements and Outline Near Term Milestones (PRNewswire) - "Recent Clinical Advancements...Advanced enrollment, dosing and clinical site expansion in Kintara's open label 15-patient REM-001 study in cutaneous metastatic breast cancer (CMBC); As of June 26, 2024, four patients have been dosed in the open label 15-patient REM-001 study in CMBC; In addition to Memorial Sloan Kettering Cancer Center, Montefiore Medical Center, the University Hospital for Albert Einstein College of Medicine, will soon begin screening patients...Expected Near-term Milestones....Q4 2024: Complete enrollment and 8 week follow-up of 10 patients in the REM-001 study; 2H 2024: Commence TuHURA's Phase 3 trial for IFx-2.0 personalized cancer vaccine for advanced Merkel cell carcinoma under FDA's accelerated approval pathway."

Enrollment status • New P3 trial • Trial status • Breast Cancer • Merkel Cell Carcinoma • Oncology • Skin Cancer • Solid Tumor

Kintara Therapeutics Announces Fiscal 2024 Third Quarter Financial Results (PRNewswire) - "Announced that Kintara had entered into a definitive merger agreement (the 'Merger Agreement') with TuHURA Biosciences...and Kayak Mergeco, Inc., Kintara's wholly-owned subsidiary, whereby Kayak Mergeco will merge with and into TuHURA with TuHURA surviving the merger and becoming Kintara's direct, wholly-owned subsidiary(the 'Merger'). Pursuant to the terms of the Merger, stockholders of TuHURA will receive shares of Kintara common stock. Kintara's existing stockholders will receive contingent value rights ('CVR'), entitling them to receive shares of common stock upon achievement of enrollment of a minimum of 10 patients in the REM-001 study, with such patients each completing 8 weeks of follow-up on or before December 31, 2025."

M&A • Solid Tumor

Kintara Therapeutics Announces Expansion of REM-001 Clinical Study to Include Patients on Pembrolizumab (PRNewswire) - "Kintara Therapeutics...announced the expansion of the inclusion criteria in the open label 15- patient REM-001 study in cutaneous metastatic breast cancer (CMBC) to include patients receiving pembrolizumab (KEYTRUDA) for at least three months at screening. CMBC patients are being screened and dosed in the 15-patient study which is evaluating REM-001, a second-generation photodynamic therapy (PDT) photosensitizer agent, and is designed to test the 0.8 mg dose as well as optimize the study design in advance of a Phase 3 trial initiation."

Clinical protocol • Breast Cancer

Efficacy and Safety Study of REM-001 Photodynamic Therapy for Treatment of Cutaneous Metastatic Breast Cancer (CMBC) (clinicaltrials.gov) - P2 | N=15 | Recruiting | Sponsor: Kintara Therapeutics, Inc. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Sep 2024 ➔ Dec 2024

Enrollment open • Metastases • Surgery • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Kintara Therapeutics Announces Initiation of REM-001 Clinical Trial for the Treatment of Cutaneous Metastatic Breast Cancer (PRNewswire) - "Kintara Therapeutics, Inc...today announced the initiation of a REM-001 15-patient clinical trial (NCT05374915) in cutaneous metastatic breast cancer (CMBC) patients...This open label 15-patient study in CMBC patients is evaluating REM-001, a second-generation photodynamic therapy (PDT) photosensitizer agent, and is designed to test the 0.8 mg dose as well as optimize the study design in advance of a Phase 3 trial initiation."

Trial status • Breast Cancer • Oncology • Solid Tumor

Kintara Therapeutics Announces Preliminary Topline Results From GBM AGILE Study (PRNewswire) - "'As we shift priorities, we look forward to enrolling our first patient in our 15-patient study of REM-001 in cutaneous metastatic breast cancer'...Kintara expects to enroll the first subject in a 15-patient CMBC study around the end of calendar year 2023....The Company was recently awarded a $2 million grant from the National Institutes of Health (NIH) which is expected to cover the majority of the cost to run the CMBC study."

Financing • New P2 trial • Breast Cancer

Kintara Therapeutics Awarded $2.0 Million National Institutes of Health SBIR Grant to Support the Clinical Development of REM-001 (PRNewswire) - "Kintara Therapeutics...announced that the Company has been awarded a $2.0 million Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to support the clinical development of REM-001, a second-generation photodynamic therapy photosensitizer agent for the treatment of cutaneous metastatic breast cancer (CMBC)."

Financing • Breast Cancer • Oncology • Solid Tumor

Efficacy and Safety Study of REM-001 Photodynamic Therapy for Treatment of Cutaneous Metastatic Breast Cancer (CMBC) (clinicaltrials.gov) - P2 | N=15 | Not yet recruiting | Sponsor: Kintara Therapeutics, Inc. | Trial completion date: Dec 2023 ➔ Dec 2024 | Initiation date: Sep 2022 ➔ Jul 2023 | Trial primary completion date: Aug 2023 ➔ Jul 2024

Trial completion date • Trial initiation date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Kintara Therapeutics Granted Fast Track Designation from FDA for REM-001 for Cutaneous Metastatic Breast Cancer (PRNewswire) - "Kintara Therapeutics, Inc...announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Kintara's REM-001 Therapy for the treatment of patients with cutaneous metastatic breast cancer (CMBC)."

Fast track designation • Breast Cancer • Oncology

Kintara Therapeutics Pauses REM-001 Program to Conserve Funds to Support VAL-083 International Registrational Study (PRNewswire) - "Kintara Therapeutics, Inc....announced today that the REM-001 program in Cutaneous Metastatic Breast Cancer (CMBC) was paused to conserve cash which will be used to support the funding of the Company's ongoing international registrational study for VAL-083 in glioblastoma (GBM). By pausing the REM-001 program, the Company expects to save approximately $3.0 million through 2023....'We continue to look forward to announcing top-line data for VAL-083 in GBM from the international registrational GBM AGILE study around the end of calendar year 2023.'"

P2/3 data • Trial status • Brain Cancer • Breast Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Kintara Therapeutics Announces Fiscal 2022 Financial Results and Provides Corporate Update (PRNewswire) - "'Moving our REM-001 CMBC program back into the clinic is also an important step for us to deliver on our mission of serving cancer patients where there is a clear unmet medical need. We believe we remain on track to start enrolling patients in the CMBC study around the end of September 2022'."

Enrollment status • Breast Cancer • Oncology • Solid Tumor

Efficacy and Safety Study of REM-001 Photodynamic Therapy for Treatment of Cutaneous Metastatic Breast Cancer (CMBC) (clinicaltrials.gov) - P2 | N=15 | Not yet recruiting | Sponsor: Kintara Therapeutics, Inc. | Initiation date: Jun 2022 ➔ Sep 2022

Trial initiation date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Kintara Therapeutics Receives Study May Proceed Letter from the FDA for REM-001 for Cutaneous Metastatic Breast Cancer (PRNewswire) - "Kintara Therapeutics, Inc...announced that it has received a Study May Proceed letter from the United States Food and Drug Administration (FDA) to begin its 15 patient study evaluating REM-001 Photodynamic Therapy (PDT) for the treatment of Cutaneous Metastatic Breast Cancer (CMBC). This study is intended to aid in the design of a planned phase 3 registrational study....The planned clinical study is expected to enroll 15 patients with CMBC that is refractory or not eligible for radiotherapy or surgery. The study will evaluate cutaneous tumor response using standardized and calibrated 3D digital photography."

IND • New P3 trial • Breast Cancer • Oncology • Solid Tumor

Kintara Therapeutics Enters Into Equity Purchase Agreement for Up to $20 Million with Lincoln Park Capital (PRNewswire) - "Kintara Therapeutics, Inc...announced it has entered into an equity purchase agreement for up to $20 million with Lincoln Park Capital Fund, LLC (LPC), a Chicago-based institutional investor....The Company expects this commitment from LPC will provide financial flexibility and is aligned with Kintara's long-term strategy for value creation. Kintara intends to use any net proceeds from the sale of its common stock to LPC for working capital and general corporate purposes, including development expenses for VAL-083 and REM-001."

Financing • Brain Cancer • Breast Cancer • Glioblastoma • Oncology

Efficacy and Safety Study of REM-001 Photodynamic Therapy for Treatment of Cutaneous Metastatic Breast Cancer (CMBC) (clinicaltrials.gov) - P2 | N=15 | Not yet recruiting | Sponsor: Kintara Therapeutics, Inc.

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Kintara Therapeutics Announces Fiscal 2022 Second Quarter Financial Results and Provides Corporate Update (PRNewswire) - "...'Our 15-patient confirmatory study of REM-001 for cutaneous metastatic breast cancer remains on track to start enrolling patients in the second quarter of calendar year 2022'."

Enrollment status • Breast Cancer • Oncology • Solid Tumor

Kintara Therapeutics Announces Fiscal 2022 First Quarter Financial Results and Provides Corporate Update (PRNewswire) - "Continued to advance development of REM-001 for the treatment of Cutaneous Metastatic Breast Cancer (CMBC), including taking critical steps toward manufacturing sufficient quantity of drug to allow for initiation and completion of the 15-patient confirmatory study. Enrollment of first patient is expected in the second quarter of calendar 2022."

New trial • Breast Cancer • Oncology

Kintara Therapeutics Appoints Dr. Mario Lacouture to Scientific Advisory Board for Cutaneous Metastatic Breast Cancer (PRNewswire) - "Kintara Therapeutics, Inc...announced the appointment of Mario Lacouture, M.D. to the REM-001 Scientific Advisory Board with the initial focus in Cutaneous Metastatic Breast Cancer....'We are pleased to welcome Dr. Lacouture to our CMBC focused Scientific Advisory Board as we prepare REM-001, our photodynamic therapy platform, for late-stage pivotal testing in this debilitating oncology indication'"

Clinical • Breast Cancer • Oncology

Kintara Therapeutics Announces First Fiscal Quarter 2021 Financial Results and Recent Corporate Updates (PRNewswire) - "'In conjunction with this transformational milestone, we strengthened our balance sheet with a $25 million private placement to enable us to execute a timely advance of our key programs including the clinical stage of the GCAR GBM AGILE registrational study for VAL-083 and the confirmatory cutaneous metastatic breast cancer study for REM-001.'"

Clinical • Brain Cancer • Breast Cancer • Glioblastoma • Oncology

Adgero Biopharmaceuticals granted FDA Orphan Drug Designation of REM-001 therapy for the treatment of basal cell carcinoma nevus syndrome (GlobeNewswire) - P1/2, N=14, "Adgero Biopharmaceuticals Holdings, Inc....announced today that the U.S. Food and Drug Administration ("FDA") has granted Orphan Drug Designation to REM-001, for the treatment of Basal Cell Carcinoma Nevus Syndrome ("BCCNS"), a rare genetic condition."

Orphan drug