Qualigen Therapeutics Receives U.S. Patent Notice of Allowance for its STARS™ Technology

On June 4, 2020 Qualigen Therapeutics, Inc. (NASDAQ: QLGN) (Qualigen or the Company) reported that the United States Patent and Trademark Office has issued a Notice of Allowance for a U.S. patent, which will be issued to the Company, titled "Devices and Methods for On-Line Whole Blood Treatment" regarding the Company’s Selective Target Antigen Removal System (STARS) technology (Press release, Qualigen, JUN 4, 2020, View Source [SID1234560856]). STARS is a DNA/RNA-based treatment for the removal of viral and tumor-produced compounds from a patient’s blood. The STARS technology utilizes a filtration cartridge designed for use in a standard dialysis machine, and contains aptamer-coated microparticles that bind to specific agents in circulating blood for targeted removal.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"When issued, this new U.S. patent will further protect our proprietary STARS technology and enhance our overall intellectual property portfolio," said Michael Poirier, President, Chief Executive Officer and Chairman of Qualigen. "Qualigen’s strategy to fighting disease is to ‘Detect, Destroy, Remove’. Supporting the Remove component, the STARS development program utilizes technology and expertise from our FastPack point-of-care diagnostic system, which has been in use worldwide for nearly 20 years for the detection of cancer and other diseases. We look forward to advancing STARS as a target and removal therapy for multiple diseases and other health conditions."

The Company plans to develop STARS for cancer applications to remove inflammatory factors and inhibitory checkpoints from blood, thus reducing pain and helping the body’s immune system fight the disease, as well as for infectious diseases to remove viruses and other foreign agents. STARS technology and key components utilize membranes coated with target capture reagents. STARS is in the early stages of development and has demonstrated promising proof-of-concept results in the Company’s in vitro studies.

Bristol Myers Squibb to Take Part in 41st Annual Goldman Sachs Global Healthcare Conference

On June 4, 2020 Bristol Myers Squibb (NYSE: BMY) reported that it will take part in a fireside chat at the 41st Annual Goldman Sachs Global Healthcare Conference, which will be webcast on June 11, 2020. Chris Boerner, EVP and Chief Commercialization Officer and Nadim Ahmed, EVP and President, Hematology will answer questions about the company at 3 p.m. E.T (Press release, Bristol-Myers Squibb, JUN 4, 2020, View Source [SID1234560823]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Investors and the general public are invited to listen to a live webcast of the session at View Source An archived edition of the session will be available later that day.

Oragenics, Inc. to Present at the June 2020 Virtual Summer Investor Summit

On June 4, 2020 Oragenics, Inc. (NYSE American: OGEN), reported that Alan Joslyn, Ph.D., President and CEO of Oragenics, Inc., will give a virtual corporate presentation at the June 2020 Virtual Summer Investor Summit taking place online from June 9th to 12th, 2020 (Press release, Oragenics, JUN 4, 2020, View Source [SID1234560840]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The presentation will be held on Wednesday, June 10, 2020 at 2:10 pm ET, followed by a live Q&A session with registered investors and other conference attendees. A live webcast of the presentation will be available here View Source Dr.. Joslyn will be available for one-on-one meetings online as well. Interested investors may request a meeting time by emailing: [email protected].

Taiho Oncology To Present Data on Futibatinib (TAS-120) at the AACR Annual Meeting 2020

On June 4, 2020 Taiho Oncology, Inc. reported that preclinical data for futibatinib (TAS-120) will be presented online during the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II 2020 from June 22-24 (Press release, Taiho, JUN 4, 2020, View Source [SID1234560857]). Key presentations include:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Futibatinib (TAS-120) plus chemotherapy demonstrated a synergistic effect across various FGFR-deregulated cancer cell lines and xenograft models (Abstract 564). Results will be shared online as a poster presentation on June 22, 2020. The abstract for this presentation is available on the AACR (Free AACR Whitepaper) website: View Source!/9045/presentation/2469
Synergistic antitumor activity of futibatinib (TAS-120), a FGFR1-4 inhibitor, and PI3K pathway inhibitors (Abstract 659). Results will be shared online as a poster presentation on June 22, 2020. The abstract for this presentation is available on the AACR (Free AACR Whitepaper) website: View Source!/9045/presentation/1864
Synergistic antitumor activity of futibatinib, an FGFR1-4 inhibitor, and TAS-117, a selective AKT inhibitor, in FGFR-deregulated cancer models (Abstract 661). Results will be shared online as a poster presentation on June 22, 2020. The abstract for this presentation is available on the AACR (Free AACR Whitepaper) website: View Source!/9045/presentation/1873
"We are pleased to present these pre-clinical data for futibatinib, in combination with chemotherapy or targeted agents," said Martin J. Birkhofer, MD, Senior Vice President and Chief Medical Officer, Taiho Oncology, Inc. "These data advance our research of novel combination regimens as potential options to be tested in clinical trials."

In May 2018, the U.S. Food and Drug Administration Office of Orphan Drug Development granted futibatinib orphan drug status for the treatment of cholangiocarcinoma.

About Futibatinib (TAS-120)
Futibatinib (TAS-120) is an investigational, oral, potent, selective, and irreversible small-molecule inhibitor of FGFR1, 2, 3, and 4 being studied as a potential treatment for patients with advanced solid tumors, with FGFR1-4 genetic aberrations, including cholangiocarcinoma, who were previously treated with chemotherapy or other therapies. Futibatinib selectively and irreversibly binds to the ATP binding pocket of FGFR1-4 resulting in the inhibition of FGFR-mediated signal transduction pathways, reduced tumor cell proliferation and increased tumor cell death in tumors with FGFR1-4 genetic aberrations.

Can-Fite Concludes Successful Meeting with European Medicines Agency (EMA) Regarding Phase III Trial and Registration Plan for Namodenoson in the Treatment of Liver Cancer

On June 4, 2020 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported it has successfully concluded a meeting with the Scientific Advice Working Party (SAWP) of the European Medicines Agency (EMA) regarding Phase III development of its drug candidate Namodenoson in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer (Press release, Can-Fite BioPharma, JUN 4, 2020, View Source [SID1234560824]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Namodenoson is Can-Fite’s adenosine A3 receptor (A3AR) agonist which has recently been shown to prolong median overall survival (OS) in a selected patient population with HCC in a Phase II clinical trial. Can-Fite sought scientific advice from the EMA to complement previous input from the U.S. Food and Drug Administration (FDA) in its recent End-of-Phase II meeting regarding plans for a Phase III registration trial of Namodenoson in patients with HCC and Child Pugh Class B7 (CPB7) cirrhosis. Having completed its meeting with the SAWP, Can-Fite now has sufficient regulatory input to conduct a registration trial in accordance with the requirements of both the U.S. and the European Union.

The planned trial, a randomized, double blind, placebo controlled trial, will enroll approximately 450 patients with HCC and underlying CPB7 cirrhosis at multiple centers worldwide. Patients will be randomized to oral treatment with either Namodenoson 25 mg or matching placebo given twice daily. The primary efficacy endpoint of the trial is overall survival (OS), based on the favorable OS response seen in the Phase II trial in patients with HCC and CPB7 cirrhosis. Other oncology trial efficacy outcomes, such as tumor radiographic response rates and median progression-free survival, as well as standard safety parameters, will be assessed.

"We appreciate the EMA’s advice which, combined with the input we received last October from the U.S. FDA along with recommendations from our academic key opinion leaders, gives us excellent guidance for conducting a successful Phase III clinical and registration program," stated Can-Fite CEO Dr. Pnina Fishman.

According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year. HCC is commonly aggressive with poor survival rates. As new drugs that effectively and safely treat HCC are developed and approved, the market for HCC treatments is estimated by Delveinsight to reach $3.8 billion by 2027 for the G8 countries.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated as a second line treatment for hepatocellular carcinoma, with a recently completed Phase II trial and planned Phase III trial in this indication. The drug recently concluded a Phase II trial which successfully achieved efficacy and safety endpoints in the treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.