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.

On June 4, 2020 Amyris, Inc. (Nasdaq: AMRS), a leading synthetic biotechnology company in Clean Health and Beauty markets through its consumer brands and a top supplier of sustainable and natural ingredients, reported that it has successfully executed a binding funding agreement with leading institutional investors to raise $200 million at $3.00 per common share through a private investment in public equity (PIPE) in the Company (Press release, Amyris Biotechnologies, JUN 4, 2020, View Source [SID1234560854]). The offering includes 49% of common stock and 51% of preferred stock, convertible into common stock following stockholder approval. The private investment is subject to customary closing conditions.

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The investment is being made by a consortium of high quality institutional and accredited investors and mutual funds with expertise in health care, biotechnology or a consumer orientation consisting of approximately 70% new investors and 30% existing investors.

Following closing of the investment, the Company expects to use the proceeds from the offering for general corporate purposes and to repay certain outstanding indebtedness by approximately $61 million to lower total debt to about $162 million. Of this reduction, $24 million is from conversions to equity and, thus, not from using proceeds from the transaction. The reduced debt results in significantly lower future debt servicing expense.

"We are very excited to have obtained funding that will enable us to execute our strategic priorities, support business growth, further reduce debt and simplify our balance sheet and help us attain positive cash flow from operations," said Han Kieftenbeld, Chief Financial Officer.

"We believe that this financing positions us very well for continued industry leading revenue growth with our consumer brands and ingredients portfolio, toward our goal of profit and positive cash generation. We are committed to strong value generation for shareholders while making our planet healthier," commented John Melo, President and Chief Executive Officer.

Jefferies LLC and Cowen and Company LLC served as joint lead placement agents for the financing. Oppenheimer & Co. Inc. served as co-placement agent.

The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended, or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the "SEC") registering the resale of the shares of common stock sold in the private placement and the shares of common stock issuable upon exercise of the preferred stock.

On June 4, 2020 TVAX Biomedical reported that receipt of Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the use of its vaccine-enhanced adoptive T cell therapy (VACT) for treatment of glioblastoma multiforme, a deadly form of brain cancer (Press release, TVAX Biomedical, JUN 4, 2020, View Source [SID1234560853]).

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"We are very pleased to receive Fast Track Designation by the FDA for glioblastoma multiforme (GBM)," stated Dr. Wayne Carter, Chief Executive Officer. "Glioblastoma is a devastating disease for which there are limited treatment options."

FDA Fast Track Designation is designed to accelerate marketing approval of therapies aimed at treating serious and life-threatening diseases. The Designation creates an opportunity for close and regular communication between TVAX Biomedical and the FDA in order to improve the efficiency of product development. Additionally, it provides a pathway for accelerated approval and rolling review of completed Biological Licensing Application sections by the FDA.

TVAX Biomedical has completed Phase 1 and 2a studies in multiple cancers, including GBM. Significant benefit was demonstrated in GBM patients using TVAX’s patented VACT in those studies. TVAX’s currently planned studies will evaluate VACT in newly diagnosed GBM patients who have healthy immune systems and minimal disease at a time when VACT would be anticipated to generate maximal efficacy.