On November 19, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported positive results from ReoGlio, an investigator-sponsored, phase 1b trial evaluating the combination of pelareorep and granulocyte-macrophage colony-stimulating factor (GM-CSF) alongside standard chemoradiotherapy and adjuvant temozolomide for the treatment of glioblastoma multiforme (GBM) (Press release, Oncolytics Biotech, NOV 19, 2020, View Source [SID1234571435]). The results, which were featured in a podium presentation at the 2020 Society of Neuro-Oncology Annual Meeting, show a compelling signal of efficacy and demonstrate the safety and tolerability of the pelareorep-based combination therapy in newly diagnosed GBM patients.

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"The ReoGlio trial results add to a robust set of clinical data supporting the safety, tolerability, and efficacy of pelareorep in a broad range of indications," said Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics. "The median progression-free survival (PFS) of approximately eight months is encouraging in this challenging indication, particularly considering the improved median PFS correlated with the dose of pelareorep administered. Together, these results drive momentum to develop pelareorep across a spectrum of cancer indications."

The podium presentation, Pelareorep and granulocyte-macrophage colony-stimulating factor (GM-CSF) with standard chemoradiotherapy/adjuvant temozolomide for glioblastoma multiforme (GBM) patients: ReoGlio phase I trial results, was given by Susan Short, M.R.C.P., Ph.D., Professor of Clinical Oncology and Neuro-Oncology at the University of Leeds. Key data and conclusions from the presentation include:

Evaluable patients treated at pelareorep dose level-2 (3×1010 TCID50) had an estimated median PFS of 9.4 months (n=6; 95% CI: 4.2-10.6)
Evaluable patients treated at pelareorep dose level-1 (1×1010 TCID50) had an estimated median PFS of 6.1 months (n=6; 95% CI: 4.9-9.2)
The estimated median PFS of all evaluable patients, regardless of pelareorep dose level, was 7.8 months (n=12; 95% CI: 4.9-9.7)
Pelareorep, in addition to GM-CSF, standard chemoradiotherapy, and adjuvant temozolomide, was safe and well-tolerated
Oncolytics remains focused on the clinical advancement of pelareorep and will continue evaluating new commercial opportunities for pelareorep, while prioritizing the current programs and achieving the expected milestones for those in breast, gastrointestinal, and hematological malignancies. Oncolytics thanks the University of Leeds, Cancer Research UK, and The Brain Tumor Charity for designing, managing, and funding the ReoGlio trial.

About ReoGlio

The ReoGlio trial was an investigator-sponsored phase 1b, open-label trial evaluating the combination of pelareorep and GM-CSF, alongside standard chemoradiotherapy and adjuvant temozolomide, for the treatment of newly diagnosed GBM. Fifteen patients were treated in the trial, twelve of which were evaluable for efficacy analyses. The primary objective of the study was to determine the maximum tolerated dose of pelareorep and GM-CSF with standard chemoradiotherapy. Secondary objectives were to gain a preliminary assessment of the activity of the pelareorep-GM-CSF combination and to assess treatment compliance. The trial was designed and managed by the University of Leeds and funded through grants provided by Cancer Research UK and The Brain Tumor Charity.

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On November 19, 2020 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported that its Chief Executive Officer, Steven Engle, will present a company overview at the Piper Sandler 32nd Annual Healthcare Conference, being held virtually on December 1 – 3, 2020 (Press release, CohBar, NOV 19, 2020, View Source [SID1234571434]). This presentation will be available on demand for registered attendees.

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On November 19, 2020 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported interim data on its two Phase 2 trials of VAL-083, the Company’s lead compound for the treatment of glioblastoma multiforme (GBM) (Press release, Kintara Therapeutics, NOV 19, 2020, View Source [SID1234571433]). The data are to be presented in two posters at the 25th Annual Scientific Meeting of the Society for Neuro-Oncology (SNO) which will be held virtually due to the Covid-19 pandemic on November 19-21, 2020.

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"I’m extremely pleased with the continual progress being achieved by both of these ongoing Phase 2 clinical studies evaluating VAL-083, as the results garnered thus far are an indicator of the compound’s potential to be an important therapeutic option for GBM patients in the recurrent, newly-diagnosed first-line, and newly-diagnosed adjuvant treatment settings," commented Saiid Zarrabian, Kintara’s Chief Executive Officer. "It is a pleasure to present the data updates at the Society for Neuro-Oncology’s Annual Meeting, as these studies have provided valuable insight in initiating the VAL-083 arm of the Global Coalition for Adaptive Research GBM AGILE registrational study which is expected to occur later this year."

Dr. John de Groot, professor, Department of Neuro-Oncology at The University of Texas MD Andersen Cancer Center and also a founding member of Kintara’s Scientific Advisory Board stated, "These data continue to confirm VAL-083’s compelling potential as a potent DNA targeting cytotoxic agent for the treatment of GBM. I’m particularly encouraged by VAL-083’s continued ability to demonstrate a favorable progression-free survival trend as compared to TMZ historical data in newly-diagnosed GBM, and improvement in overall survival compared to lomustine historical data in the recurrent setting."

At the SNO Annual Meeting, Kintara is to present posters updating two Phase 2 clinical trials evaluating VAL-083 in patients with MGMT-unmethylated GBM as follows:

Newly-Diagnosed and Recurrent GBM

The first poster outlined interim data from two groups of patients receiving VAL-083 in the open-label, Phase 2 study in recurrent and adjuvant unmethylated GBM settings being conducted at the MD Anderson Cancer Center in Houston.

In newly-diagnosed patients receiving VAL-083 as adjuvant therapy following treatment with radiation and TMZ, for the 27 efficacy evaluable patients (of a planned up to 36 patients) as of the data cut-off of October 23, 2020, median progression-free survival (PFS) is currently 10.0 months (confidence interval: CI 7.6-10.8). While not a head-to-head study, this PFS data compares favorably to historical TMZ control of 5.3 months* and 6.9 months**, respectively.

For patients in the recurrent group receiving second-line therapy with VAL-083 following first-line TMZ failure, 84 patients have been enrolled as of the data cut-off of October 23, 2020 with 35 patients (34 efficacy evaluable) having received an initial dose of 40 mg/m2/day and 49 (43 efficacy evaluable) having received the planned Phase 3 initial dose of 30 mg/m2/day (on days 1, 2 and 3 of a 21-day cycle). Median overall survival (mOS) for the 77 efficacy evaluable patients who have completed at least once cycle of treatment was 7.6 months (CI 6.4-10.6 months). Additionally, for the 43 efficacy evaluable patients initially receiving the planned Phase 3 initial dose of 30 mg/m2/day, mOS is currently 8.5 months (CI 6.8-13.7 months). While this is not a head-to-head trial, historically, lomustine, which is the most commonly used chemotherapy for these patients, has demonstrated mOS of 7.2 months***.

Consistent with prior studies, myelosuppression is the most common adverse event with VAL-083 in both the recurrent GBM and adjuvant treatment setting. In the 30 mg/m2/day starting dose cohort (the planned dose for the GBM AGILE pivotal study) three subjects have experienced a serious adverse event (SAE) possibly related to VAL-083 in the recurrent group and one patient has experienced a possibly drug-related SAE in the adjuvant group as of the relevant data cut-off dates.

First-Line GBM

The second poster outlined the open-label, Phase 2 study of VAL-083 as a first-line treatment in newly-diagnosed, unmethylated GBM patients being conducted at Sun Yat-sen University Cancer Center in China. For the 29 patients who had completed at least their first efficacy assessment as of the October 21, 2020 cut-off date, median PFS with VAL-083 is currently 9.3 months (95% CI 6.4-12.0 months). Additionally, for the 25 patients initially receiving the treatment dose that will be carried forward in the GBM AGILE pivotal Phase 3 study of 30 mg/m2/day on days 1, 2 and 3 of a 21-day cycle, median PFS was reported to be 8.7 months (CI 6.4-12.5 months). While not a head-to-head study, this PFS data compares favorably to historical TMZ control of 5.3 months* and 6.9 months**, respectively. Multiple treatment cycles of VAL-083 at the 30 mg/m2/day dose in combination with standard radiation treatment (2 Gy/day, 5 days/week) was shown to be generally safe and well-tolerated.

On November 19, 2020 Imago BioSciences, Inc. ("Imago") a clinical-stage biopharmaceutical company developing innovative treatments for myeloproliferative neoplasms reported the close of an $80 million Series C financing round (Press release, Imago BioSciences, NOV 19, 2020, View Source [SID1234571432]). Farallon Capital Management, LLC led the round, with participation from new investors including funds and accounts advised by T. Rowe Price Associates, Inc., funds and accounts managed by Blackrock Advisors, LLC., Surveyor Capital (a Citadel company), Irving Investors and Kingdon Capital Management. Existing investors also participating in the financing include a fund managed by Blackstone Life Sciences, Frazier Healthcare Partners, Omega Funds, Amgen Ventures, MRL Ventures Fund, HighLight Capital, Pharmaron Investments Ltd., Greenspring Associates and Xeraya Capital.

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Imago will use the proceeds to complete a Phase 3 study of bomedemstat for the treatment of myeloproliferative neoplasms. Bomedemstat (IMG-7289) is an orally available small molecule that inhibits lysine-specific demethylase 1 (LSD1), an enzyme shown to be vital in self-renewal of cancer stem cells and hematopoiesis. Bomedemstat is being investigated in a Phase 2b clinical trial for the treatment of myelofibrosis, and a Phase 2b clinical trial for the treatment of essential thrombocythemia. The FDA has granted Fast Track Designation and Orphan Drug Designation to bomedemstat in both indications and the EMA has given bomedemstat PRIME designation for the treatment of myelofibrosis.

"The support of this group of elite health care investors enables us to pursue our bold vision of developing transformative medicines to treat people living with devastating cancer of the bone marrow with our first efforts focused on bone marrow neoplasms including the myeloproliferative diseases," said Hugh Young Rienhoff, Jr. M.D., CEO at Imago BioSciences. "This financing allows us to take bomedemstat through the next set of late stage clinical trials in multiple indications."

About Bomedemstat

Bomedemstat is being evaluated in open-label Phase 2 clinical trials for the treatment of advanced myelofibrosis (MF), essential thrombocythemia (ET), and polycythemia vera, bone marrow cancers that alter the production of blood cells. MF patients who are resistant to, intolerant of, or ineligible for a Janus Kinase (JAK) inhibitor are eligible for the study of bomedemstat as monotherapy. Interim data will be presented in an oral session at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Congress on December 5, 2020.

Bomedemstat is an orally available small molecule discovered and developed by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme shown to be vital in cancer stem/progenitor cells, particularly neoplastic bone marrow cells. In non-clinical studies, bomedemstat demonstrated robust in vivo anti-tumor efficacy across a range of myeloid malignancies as a single agent and in combination with other chemotherapeutic agents. Bomedemstat is an investigational agent currently being evaluated in multiple ongoing clinical trials (ClinicalTrials.gov Identifier: NCT03136185, NCT04262141, NCT04254978 and NCT04081220). Bomedemstat has U.S. FDA Orphan Drug and Fast Track Designation for the treatment of myelofibrosis and essential thrombocythemia, Orphan Drug Designation for treatment of acute myeloid leukemia and PRIME designation by the European Medicines Agency for the treatment of MF.

On November 19, 2020 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that its chief executive officer, Dr. Gerrit Dispersyn, will present at the upcoming 3rd Annual Evercore ISI HealthCONx Conference, which is being held virtually this year from December 1-3, 2020 (Press release, Phio Pharmaceuticals, NOV 19, 2020, View Source [SID1234571431]).

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Dr. Dispersyn is scheduled to participate in a fireside chat on Thursday, December 3rd, at 3:05 p.m. ET. Interested parties may access a live webcast of the presentation at View Source

An archived version of the webcast will be made available on the "Investors – Events and Presentations" section of the Company’s website after the live event.