On May 19, 2020 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that management will participate in a fireside chat at the 2020 RBC Capital Markets Global Healthcare Virtual Conference on Wednesday, May 20, 2020, at 11:30 a.m. ET (Press release, Athenex, MAY 19, 2020, View Source [SID1234573877]).

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A live audio webcast of the presentation can be accessed through the Events & Presentations section of the Company’s website at ir.athenex.com. An archived replay of the webcast will be available on the Company’s website following the live presentation.

On May 19, 2020 iCo Therapeutics Inc. (TSXV: ICO) (OTCQB: ICOTF) ("iCo" or "the Company"), reported financial results for the year ended December 31, 2019. Amounts, unless specified otherwise, are expressed in Canadian dollars and presented under International Financial Reporting Standards ("IFRS") (Press release, iCo Therapeutics, MAY 19, 2020, View Source [SID1234562020]).

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Stated William Jarosz, President and CEO of iCo Therapeutics Inc., "2019 represented a year of significant advances as we entered into a Phase 1b clinical trial for Oral Amphotericin B and we welcomed a new partner, Alexion Pharmaceuticals Inc., who are developing our iCo-008 (also known as bertilimumab). While COVID-19 has disrupted our business as with many other companies, we remain encouraged by our progress in 2019."

2019 Operational and Financial Highlights

Oral Amp B Delivery System

On December 9, 2019, we initiated a second study using oral Amphotericin B (Phase 1b) exploring safety and pharmacokinetics of multiple ascending drug doses (MAD) in healthy subjects. On February 25, 2020 we announced that that this study was successfully completed with no serious adverse events. On April 15, 2020, we announced the pharmacokinetic data from this study which showed a doubling in the AUC (0-inf), a measure of drug accumulation, after 10 days dosing compared to day 1 dosing.

iCo-008

On October 21, 2019, the US Court approved a sales order which assigned IMMUNE’s rights and obligations under the IMMUNE License Agreement to Alexion Pharmaceuticals Inc. This approval was followed by the Israeli court’s approval of the US driven sales order. Under the terms of the sales order, Alexion was required to pay US$6 million into the Court in the settlement of IMMUNE’s creditor claims in exchange for IMMUNE’s rights under the IMMUNE License Agreement.

Corporate

During the year, we completed two private placements for net proceeds of approximate $3 million.

Financial Results for Year End 2019

We incurred a total comprehensive loss of $1,932,202 for the year ended December 31, 2019 compared to a total comprehensive loss of $1,712,724 for the year ended December 31, 2018, representing an increased loss of $219,478. The increase in the loss is primarily the result of higher general and administrative expenses and lower research and development tax credits offset by lower research and development expenses recognized during 2019.

Research and development expenses were $917,475 for the year ended December 31, 2019 compared to $1,420,457 for the year ended December 31, 2018, representing a decrease of $502,982. The decrease related to lower contract research expenses because there were no clinical trials conducted on the Oral Amp B program until December 2019. In the prior year, research and development expenses related to the manufacture of clinical drug supplies and the initiation and successful conclusion of its Phase 1a clinical study in Australia.

For the year ended December 31, 2019 general and administrative expenses were $1,288,198 compared to $781,282 for the year ended December 31, 2018, representing an increase of $506,916. The increase reflects higher professional fees and management consulting fees during the period due to the Company’s participation in the IMMUNE bankruptcy process.

Liquidity and Outstanding Share Capital

As at December 31, 2019, we had cash and cash equivalents of $989,937 compared to $10,140 as at December 31, 2018.

As at May 15th, 2020, we had an unlimited number of authorized common shares with 153,747,713 common shares issued and outstanding.

For complete financial results, please see our filings at www.sedar.com.

On May 19, 2020 Hoag Family Cancer Institute and Pickup Family Neurosciences Institute at Hoag, in collaboration with Nascent Biotech, Inc reported a first in the nation clinical trial for a novel immunotherapy treatment that holds considerable promise for glioblastoma (GBM), the deadliest form of brain cancer (Press release, Nascent Biotech, MAY 19, 2020, View Source [SID1234558391]).

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Pritumumab is a unique monoclonal antibody that attacks cancers originating in the cells lining an organ – referred to as epithelial cells. These include cancers of the brain, breast, colon and pancreas, as well as melanoma. Prior Phase I and II clinical trials in Japan focused on the treatment of high-grade gliomas including GBM.

This Phase I clinical trial leverages the Hoag Family Cancer Institute and Pickup Family Neurosciences Institute’s assets in their collaboration when treating all aspects of brain tumors. With more than 20,000 new cases of GBM diagnosed in the U.S. every year, Hoag’s infrastructure in its Center for Research Education, as well as Hoag’s neurosciences and cancer expertise and reputation appealed to Nascent Biotech as they chose a national site.

The study will be conducted by Hoag’s Neuro-Oncology Clinic that helps guide the entire continuum of comprehensive care for patients with brain tumors.

"The trial is a natural fit for Hoag, which is devoted to compassionate patient-centric care, creative innovation, and clinical excellence," said Jose Carrillo, M.D., Hoag neuro-oncologist and principal investigator on the trial. "By offering our patients access to targeted immunotherapy, we expand our toolkit to include a treatment option that has the potential to turn the tables on brain cancer."

"Targeted immunotherapy, unlike chemotherapy, fights only the cancer cells, without damaging healthy cells. This has the potential to improve outcomes and help our patients beat cancer while minimizing the debilitating side effects normally associated with cancer treatment," added Dr. Carrillo.

Pritumumab works by targeting ectodomain vimentin, a protein expressed on the surface of epithelial cancers. Because vimentin is found in a variety of cancers, the clinical trial at Hoag could have implications for more common cancers, such as breast or lung. In fact, the Hoag trial will employ a unique Phase I design that can ultimately treat a variety of brain cancers from gliomas and other primary brain tumors to brain metastases and leptomeningeal cancers arising from breast, lung and other solid tumors.

"There are significant unmet medical needs in a variety of cancers," said Sean Carrick, CEO of Nascent Biotech, makers of the immunotherapy treatment. "Nascent is committed to changing patient expectations and outcomes in one of the world’s most debilitating cancers and Hoag is a natural partner towards achieving this goal. We’re highly encouraged by the potential of Pritumumab to deliver an innovative, first-in-class treatment option, and we are delighted to be working closely with Hoag in this study."

Hoag’s Phase I clinical trials and many aspects of its cancer research are significantly supported by philanthropy.

For more information on the research studies and clinical trials at Hoag, visit www.hoag.org/clinicaltrials.

On May 19, 2020 Oncoceutics, Inc. reported that the latest research findings with ONC201 and its novel class of imipridones will be presented at the 2020 annual meeting of the American Association of Cancer Research (AACR) (Free AACR Whitepaper) on June 22-24, 2020 (Press release, Oncoceutics, MAY 19, 2020, View Source [SID1234558312]).

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The research presented at AACR (Free AACR Whitepaper) highlights the antitumor and cancer prevention activity of ONC201 in tumor types with dysregulation of its two binding targets DRD2 and ClpP: H3 K27M-mutant diffuse midline glioma, endometrial cancer, medullary thyroid cancer, small cell lung cancer, and colon cancer. The presentations further highlight novel ONC201 biomarkers that help to further inform the clinical efficacy profile of ONC201 and newly discovered synergistic combinations of ONC201 with chemotherapies and several targeted therapies that suggest new approaches to treat patients with advanced cancers.

Additional research features the preclinical efficacy of ONC206 and ONC212 as single agents and in combination in a broad set of tumor types, including endometrial cancer, brain tumors and pancreatic cancer. Research led by Varun Prabhu, Vice President R&D at Oncoceutics, and several collaborators summarize the unique mechanism of action of ONC206, which will be featured in an oral presentation on June 24.

Please see below for a complete list of AACR (Free AACR Whitepaper) presentations:

ONC201 Chemoprevention

14. TRAIL-Inducing Small Molecule ONC201 Prevents Intestinal Tumors in FAP Mouse Model.
June 22, 2020, 9:00AM

ONC201 Combinatorial Activity:

1836. ONC201 Shows Synergistic Effect with the Androgen Receptor (AR) Inhibitor Darotulamide in Prostate Cancer Model.
June 22, 2020, 9:00AM

4808. ONC201 Decreases Protein Chaperone ClpX to Unleash Mitochondrial Protease ClpP Activity, Integrated Stress Response and Tumor Cell Death.
June 22, 2020, 9:00AM

3012. Novel Small Molecule ONC201 Induces Apoptosis in Gastric Adenocarcinoma and Exhibits Synergy with rhTRAIL.
June 22, 2020, 9:00AM

5407. Novel Imipridone Combination Therapies Targeting Oncohistone H3 K27M-Mutant Diffuse Midline Glioma (DMG).
June 22, 2020, 9:00AM

4042. Potent Synergistic Tumor Cell Suppression from Combination of ONC201 and Epigenetic Modulators EZH2 or HDAC Inhibitors Provides a Novel Treatment Strategy for Solid Tumors.
June 22, 2020, 9:00AM

3902. Novel Therapeutic Targeting of Epigenetic Aberrations in Pediatric Sarcomas through Combination of ONC201 and HDAC Inhibitors.
June 22, 2020, 9:00AM

5260. Preclinical Studies with ONC201 in Combination with Clinically Approved Chemotherapy as a Novel Treatment Strategy Against Small Cell Lung Cancer (SCLC).
June 22, 2020, 9:00AM

3904. The Novel Combination of PAC-1 and ONC201 Circumvent H3K27M-Driven Pro-Survival Gene Expression to Induce DIPG Cell Death.
June 22, 2020, 9:00AM

ONC201 Clinical Translation:

TBD. Immuno-modulatory Activity of Selective DRD2 Antagonist ONC201, an Imipridone, in Metastatic Endometrial Cancer (mEC).
Date and time TBD

ONC201 Mechanism and Biomarkers:

3173. Predictive Biomarker Evaluation for the Anti-Cancer Imipridone ONC201.
June 22, 2020, 9:00AM.

4794. Mitochondrial Matrix Protease ClpP Agonists Inhibit Cell Growth and Cancer Stem Cell Function in Breast Cancer Cells.
June 22, 2020, 9:00AM

ONC206

5688. IND-Enabling Characterization of ONC206 as the Next Bitopic DRD2 Antagonist for Neuro-oncology.
June 24, 2020, 9:00AM

5314. A Novel Dopamine Receptor D2 Antagonist (ONC206) Potentiates the Effects of Olaparib in Endometrial Cancer Cells through Inhibition of Cell Proliferation and Modulation of the mTOR Pathway.
June 22, 2020, 9:00AM

3797. Investigating the Anti-Cancer Effects of Novel Dopamine Receptor D2 Antagonists in a Panel of Human Cancer Cell Lines.
June 22, 2020, 9:00AM

5321. Novel Imipridone ONC206 Inhibits Cell Proliferation and Induces Apoptosis in Uterine Serous Cancer through Altering MAPK/AKT Signaling Network and Metabolic Reprogramming
June 22, 2020, 9:00AM

5336. Olaparib Potentiates the Anti-Proliferative and Anti-Metastatic Effects of ONC206 in Ovarian Cancer Cells.
June 22, 2020, 9:00AM

2958. ONC206, an Imipridone Derivative, Induces Cell Death through Activation of the Integrated Stress Response in Serous Endometrial Cancer In Vitro.
June 22, 2020, 9:00AM

ONC212

6225. Addition of TRAIL Receptor Antagonists after Treatment with ONC201 or ONC212 Converts Pancreatic Cancer Cells from Anti-Proliferative to Apoptotic In Vitro.
June 22, 2020, 9:00AM

612. ONC212 Affects ClpXP Complex, Impairs Mitochondrial Bioenergetics and Synergizes with Glycolysis Inhibition in Pancreatic Cancer.
June 22, 2020, 9:00AM

On May 19, 2020 Invivoscribe reported that LeukoStrat CDx FLT3 Mutation Assay as an FDA approved kit with analysis software (Press release, Invivoscribe Technologies, MAY 19, 2020, View Source [SID1234558302]).

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In 2017, Invivoscribe’s LeukoStrat CDx FLT3 Mutation Assay became the first FDA approved FLT3 test and launched as a testing service at LabPMM, Invivoscribe’s clinical laboratory in San Diego. This PMA supplement approval by the FDA provides customers a choice to purchase the IVD-labeled LeukoStrat CDx FLT3 Mutation Assay kits for in-house testing. The ability to perform efficient, accurate, and objective FLT3 testing at regional laboratories, cancer treatment centers, and hospitals is expected to improve the management of patients diagnosed with acute myelogenous leukemia (AML).

As the companion diagnostic to midostaurin (US, EU, Switzerland, Australia), gilteritinib fumarate (US, JP, EU), and quizartinib hydrochloride (JP), the LeukoStrat CDx is the only globally standardized FLT3 mutation test validated to meet international regulatory standards for detection of genetic mutations in the FLT3 gene, which is one of the most important driver mutations in AML. The LeukoStrat CDx FLT3 Mutation Assay may be used as an aid in assessment of AML patients for treatment with approved FLT3 targeted therapies.

"The release of the IVD-labeled kit will benefit patients afflicted with AML and is a critical tool for healthcare providers to identify the most appropriate treatment for newly diagnosed or relapsed/refractory FLT3mut+ AML patients," said Jeffrey Miller, Invivoscribe CSO and CEO.

US Intended Use
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML).

The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom RYDAPT (midostaurin) treatment is being considered.

The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom XOSPATA (gilteritinib) treatment is being considered.

The test is for use on the 3500xL Dx Genetic Analyzer.