On June 4, 2020 Alpha Tau Medical, the developer of breakthrough alpha-radiation cancer therapy Alpha DaRT, reported the closing of a Series B equity financing of $26 million (Press release, Alpha Tau Medical, JUN 4, 2020, View Source [SID1234560859]). Investors in the round included a mix of existing investors from previous rounds, such as Shavit Capital, Medison Ventures, and OurCrowd, who continue to demonstrate support for the clinical development of Alpha DaRT, as well as a number of new private and family office investors primarily from Israel and North America.

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During the last year, Alpha Tau successfully completed its first-in-human clinical trial of Alpha DaRT with squamous cell carcinoma patients from Italy and Israel. The impressive results from this study, published in the prestigious International Journal of Radiation Oncology, Biology, Physics (known as the "Red Journal") were subsequently applauded in this recent editorial in the same journal.

The Company is now conducting clinical trials in multiple clinical indications across the world, including its first US trial at Memorial Sloan Kettering Cancer Center in New York, a pancreatic cancer trial at CHUM in Montreal, and trials at three academic institutions in Japan. The Company is also establishing new global manufacturing facilities in Israel and elsewhere, and is in the middle of a process for CE marking for its first indication. These activities and others will be supported by the proceeds of this financing.

CEO Uzi Sofer commented, "We are humbled by the groundswell of continued support we’ve seen from both existing and new investors. This will enable us to push forward our mission to help cancer patients across the world, even during these challenging times in which COVID-19 is the focus of everyone’s health concerns."

CFO Raphi Levy added, "We have been very fortunate to continue our progress at full speed across all fronts, including R&D, clinical and operations, and now financing as well, even during a period of global turmoil. As concerns associated with systemic cancer therapies that affect the immune system have become more salient, we see strong interest in our trials from clinicians, patients, and investors who recognize the advantages of a focused and highly potent cancer therapy."

About AlphaDaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) enables highly potent and conformal alpha-irradiation of solid tumors. The treatment is delivered by intratumoral insertion of radium-224 impregnated seeds. When the radium decays, its short-lived daughters are released from the seed, and disperse while emitting high-energy alpha particles that destroy the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT mainly affects the tumor, sparing the healthy tissue around it.

On June 4, 2020 Protagonist Therapeutics, Inc. (Nasdaq:PTGX) reported that the company will present data from its Phase 2 trial of PTG-300 for the treatment of beta-thalassemia at the 25th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, which will take place in a virtual format June 11-14, 2020 (Press release, Protagonist, JUN 4, 2020, View Source [SID1234560858]). Details of the oral presentation are as follows:

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Presentation Title: A hepcidin mimetic, PTG-300, demonstrates pharmacodynamic effects indicating reduced iron availability in transfusion-dependent beta-thalassemia subjects
Session: New therapeutic approaches for thalassemia
Abstract: S298
Date and Time: Available on the on-demand Virtual Congress platform on Friday, June 12, 2020, at 8:30 a.m. CEST

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:

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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.

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.

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"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.

On June 4, 2020 Genelux Corporation, a privately-held, clinical-stage immuno-oncology company, reported that it has formed a Clinical Advisory Board (CAB) on gynecologic cancers that will guide clinical development of its lead clinical-stage candidate, Olvi-Vec (olvimulogene nanivacirepvec) (Press release, Genelux, JUN 4, 2020, View Source [SID1234560855]). Genelux has completed enrollment of VIRO-15, a multi-center, open-label, Phase 2 study (NCT02759588) testing Olvi-Vec in platinum-resistant/refractory ovarian cancer and is in the follow up phase of the trial.

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"We are honored and extremely fortunate to have assembled this team of gynecologic oncology experts, all of whom are preeminent clinicians, extensively-published authors and renowned lecturers, as well as leaders of gynecologic cancer societies and prestigious editorial boards," said Thomas Zindrick, President and CEO of Genelux. "Following our recently-announced productive Type C meeting with the FDA, the appointment of our CAB members comes at a pivotal time in our Company’s evolution, and we look forward to their insight and expertise in helping the company advance our promising Olvi-Vec program into Phase 3."

Abbreviated biographies of Genelux’s inaugural CAB members are as follows:

Chair: Robert W. Holloway, MD – Medical Director, Gynecologic Oncology, AdventHealth Cancer Institute, Orlando, Florida

Dr. Holloway is the principal investigator for VIRO-15 and has served on several committees of the Society of Gynecologic Oncology (SGO), including its Board of Directors. He is a Fellow of the American College of Surgeons and founding member of the Global Robotics Institute at AdventHealth, Orlando. Dr. Holloway has authored or coauthored more than 100 peer-reviewed articles. Dr. Holloway completed medical school at Vanderbilt University Medical Center, residency at University of Alabama, Birmingham, and fellowship at Georgetown University Hospital.
Robert L. Coleman, MD – Gynecologic Oncology, Chief Scientific Officer, US Oncology Research, The Woodlands, Texas

Dr. Coleman currently serves on the Board of Directors of Gynecologic Oncology Group and is a Director of GOG-Partners. In addition, he has served as President of SGO and as a Council member and Secretary Treasurer for the International Gynecologic Cancer Society, for which he is President-Elect (2020-2022). Dr. Coleman has authored or coauthored more than 300 peer-reviewed articles. Dr. Coleman completed medical school at Creighton University School of Medicine, residency at Northwestern University Medical Center, and gynecologic oncology fellowship at the University of Texas MD Anderson Cancer Center. He served as Professor and Ann Rife Chair in Gynecology at University of Texas, M.D. Anderson Cancer Center and Executive Director, M.D. Anderson Cancer Network Research until April 2020.
Thomas J. Herzog, MD – Deputy Director of the University of Cincinnati Cancer Institute and Vice-Chair of Quality and Safety for Obstetrics and Gynecology, University of Cincinnati College of Medicine Cincinnati, Ohio

Dr. Herzog is Secretary Treasurer and Associate Director of the GOG Foundation. In addition, he has served on the leadership board or council of SGO, the Foundation for Women’s Cancer, Board of Governors for the American College of Surgeons, American Board of Obstetrics and Gynecology, and International Gynecologic Cancer Society. Dr. Herzog has authored/co-authored 290+ peer-reviewed articles. Dr. Herzog graduated from the University of Cincinnati College of Medicine and completed his residency at Good Samaritan Hospital in Cincinnati and a fellowship in gynecologic oncology at the Washington University School of Medicine, St. Louis, MO.
Alberto A. Mendivil, MD – Co-Director, Gynecologic Oncology, Hoag Memorial Hospital Presbyterian, Newport Beach, California

Dr. Mendivil, site principal investigator for VIRO-15, serves as Co-Director, Gynecologic Oncology and Complex Pelvic Surgery, Hoag Hospital. He has authored or coauthored more than 40 peer-reviewed publications and has been the principal investigator or site sub-investigator on 20+ clinical trials. Dr. Mendivil received his medical degree from the University of Utah School of Medicine and completed internship and residency training in Obstetrics and Gynecology at the University of California, Irvine, and fellowship training in gynecologic oncology at the University of North Carolina, Chapel Hill.
David M. O’Malley, MD – Professor and Division Director, Ohio State University Comprehensive Cancer Center – James Cancer Hospital & Solove Research Institute, Columbus, Ohio

Dr. O’Malley is the clinical trial advisor/lead for ovarian cancer within GOG Partners, a committee member for the NCI Gynecologic Cancer Steering Committee’s Ovarian Task Force and the NRG Oncology (Ovarian Cancer and Developmental Therapeutics Groups), and a panel member of the national Comprehensive Cancer Network Guidelines for Ovarian Cancer. He has authored 130+ peer-reviewed publications. Dr. O’Malley received his medical degree from the Wayne State University School of Medicine, and completed his residency at Case Western Reserve University (MetroHealth) and the Cleveland Clinic Foundation, and gynecologic oncology fellowship at Yale University.
About Olvimulogene Nanivacirepvec (Olvi-Vec)
Olvi-Vec is a proprietary, non-pathogenic oncolytic vaccinia virus, modified to increase its safety, tumor selectivity and anti-tumor activity. Virus-mediated oncolysis results in immunogenic cell death and triggers immune activation and memory for long-term immunotherapy against cancer. Clinical results in more than 150 subjects have shown Olvi-Vec is well tolerated with documented clinical benefits.