Cellectis Wins Patent Challenge in Europe for a Method Using CRISPR-Cas9 for Gene Editing in T-Cells

On November 20, 2019 Cellectis (Euronext Growth: ALCLS; Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported that European Patent EP3004337, which claims a method of preparing T-cells for immunotherapy using the CRISPR-Cas9 system, initially granted on August 2, 2017, has been upheld by the European Patent Office (EPO) following an opposition procedure initiated in May 2018 (Press release, Cellectis, NOV 20, 2019, View Source [SID1234551531]).

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European Patent EP3004337 claims a method of genetically modifying T-cells by introduction into the cells and/or expression in the cells of an RNA-guided endonuclease, and a specific guide RNA that directs an endonuclease to at least one targeted locus in the T-cell genome, where it is expressed from transfected mRNA and guide RNA is expressed in the cells as a transcript from a DNA vector. The patent also covers the expansion phase of the resulting cells in vitro.

The inventors of this patent are Dr. André Choulika, Chairman and CEO, Cellectis, Dr. Philippe Duchateau, Chief Scientific Officer, Cellectis and Dr. Laurent Poirot, VP, Immunology Department, Cellectis.

Q BioMed Announces FDA Approval

On November 20, 2019 BioMed Inc. (OTCQB: QBIO), reported FDA approval of its contract manufacturer IsoTherapeutics Group LLC (ITG) (Press release, Q BioMed, NOV 20, 2019, View Source [SID1234551547]). ITG is now cleared to manufacture the Company’s FDA approved non-opioid cancer bone pain drug Strontium-89 Chloride USP.

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The long-awaited approval of the facility means that this important oncologic pain drug will soon be available to patients in the US and the rest of the world. Q BioMed is now the only FDA-approved source for this drug in the western world. The Company is activating its planned commercial operations to support marketing, sales, and distribution in the US and, soon, in the rest of the world.

Strontium-89 is an FDA-approved non-opioid radiopharmaceutical indicated for the treatment of painful skeletal metastases caused by cancer. The product is administered intravenously once every three months as an alternative to opioid analgesics and plays a critical role in the treatment of metastatic bone pain. The product has a long history of providing well-documented and significant pain relief for patients suffering from the excruciating pain associated with primary cancers that have spread to the bone, including breast, prostate, lung and others. This is the ideal time to be launching Strontium-89 given the current concerns with the over-use of opioid drugs. In addition, as more therapies come to market for the treatment of primary cancers, more people are living longer with metastatic disease. It is estimated that approximately two million patients experience debilitating bone pain from metastatic disease. The opportunity to provide significant pain relief to this group is substantial.

QBioMed CEO Denis Corin said, "We have been anticipating this critical regulatory step for a long time, certainly longer than we hoped, but we are thrilled that we can now move forward with certainty. This is the start of a new chapter in the evolution of our company, and we are looking forward to serving the needs of thousands of patients suffering from metastatic bone pain, providing them the chance to minimize their pain and positively impact life with metastatic disease. With millions of potential patients around the world, this is a major market opportunity for our company. In addition, we are investigating and planning expansion trials to provide additional indications for the drug and entry into an even larger therapeutic market."

Announcement of Series A2 financing

On November 20, 2019 Thyas reported that it has raised JPY 240 million in Series A2 financing on November 20, with participation from Kyoto University Innovation Capital Co., Ltd., Chushin Venture Capital Co., Ltd., and Future Venture Capital Co., Ltd. (Press release, Thyas , NOV 20, 2019, View Source [SID1234629210]).

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The funds will be used for accelerating the research and development including preclinical studies of iPS cell-derived T cell therapy for the treatment of solid cancers.

Phio Pharmaceuticals Announces Closing of Public Offering of Common Stock

On November 20, 2019 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 the closing of its previously announced public offering of 10,000,000 shares of its common stock at a public offering price of $0.10 per share (Press release, Phio Pharmaceuticals, NOV 20, 2019, View Source [SID1234551532]). The Company’s Chairman, Robert Bitterman; board director, Geert Cauwenbergh; board director, Robert L. Ferrara; President & CEO, Gerrit Dispersyn; VP of Business Operations, James Cardia and VP of Finance & Administration, Caitlin Kontulis, each purchased shares in the offering. The gross proceeds from the offering, before deducting placement agent fees and other offering expenses, are approximately $1.0 million.

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H.C. Wainwright & Co. acted as exclusive placement agent for the offering.

Phio intends to use the net proceeds from the offering to fund the development of its immuno-oncology programs, for other research and development activities and for general working capital needs.

The shares of common stock described above were offered by Phio pursuant to a shelf registration statement on Form S-3 (File No. 333-224031) filed with the Securities and Exchange Commission (the "SEC") on March 29, 2018 and declared effective by the SEC on April 6, 2018. The final terms of the offering were disclosed in a prospectus supplement filed with the SEC on November 18, 2019. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, via e-mail at [email protected] or via telephone at (646) 975-6996.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

CNS Pharmaceuticals Announces Attendance at the 24th Annual Meeting of the Society of Neuro-Oncology

On November 20, 2019 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, reported Chief Executive Officer of CNS Pharmaceuticals, John M. Climaco, along with founder, Waldemar Priebe, PhD, and members of management, including, Chief Medical Officer, Sandra Silberman, MD, PhD, Chief Scientific Officer, Donald Picker, PhD, and scientific advisory board member, Sigmund Hsu, MD, PhD, will be attending the 24th Annual Meeting of the Society of Neuro-Oncology ("SNO") (Press release, CNS Pharmaceuticals, NOV 20, 2019, View Source [SID1234551548]). The event will take place November 20-24, 2019 at the JW Marriott Desert Ridge Resort in Phoenix, Arizona.

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"Following our recent IPO, we are looking forward to connecting with the scientific community at the world’s largest neuro-oncology conference," stated John Climaco. "We remain committed to further pursuing the advancement of our novel anthracycline, Berubicin, and to developing therapies for the treatment of glioblastoma."

About Berubicin
Berubicin is an anthracycline, a class of drugs among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to damage the DNA of targeted cancer cells by interfering with the action of the topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin was developed at the MD Anderson Cancer Center (MDACC), the world’s largest cancer research facility. Berubicin appeared to demonstrate one Durable Complete Response in a Phase I human clinical trial conducted by a prior developer.