Qualigen Therapeutics Announces Issuance of U.S. Patent for Expanded Applications of ALAN Anticancer Platform Technology

On December 15, 2020 Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, reported that the United States Patent and Trademark Office has issued a patent entitled "Anti-Nucleolin Agent-Conjugated Nanoparticles as Radio-Sensitizers and/or MRI Contrast Agents" regarding the Company’s ALAN (Aptamer-Linked Anti-Nucleolin) technology (Press release, Qualigen, DEC 15, 2020, View Source [SID1234572894]). This patent issued to the University of Louisville (UofL) protects the ALAN technology for use with cancer radiation therapy and for imaging tumors utilizing magnetic resonance imaging (MRI). The novel ALAN technology has several other potential applications, including its use as a monotherapy for the treatment of cancer and as a vehicle to deliver other anticancer compounds directly to tumors. In 2018, Qualigen obtained exclusive worldwide rights from the UofL for the use of the ALAN technology.

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The gold nanoparticle component of ALAN is believed to enhance radiation therapy by "magnifying" the effects of radiation on the targeted tumor cells with the potential to justify lower radiation exposure and, in turn, decrease side effects. ALAN may also potentially be used in combination with MRIs to provide higher-resolution images of solid tumors and tumor cells as special imaging dyes attach to the gold nanoparticle compound.

"With the issuance of this patent, we continue to build our intellectual property portfolio as a key component to protect our technologies under development," stated Michael Poirier, Qualigen’s Chairman, Chief Executive Officer and President. "ALAN is a valuable therapeutic platform technology that may be applied in numerous indications. Currently, we are evaluating strategic options on how to develop and monetize these additional applications while we continue to advance ALAN in our development pipeline against acute myeloid leukemia."

ALAN is a DNA aptamer-based anticancer drug candidate that combines the DNA aptamer AS1411 with a gold nanoparticle to dramatically increase its potency. This drug candidate has the potential to target and destroy tumor cells in a wide variety of cancer types with minimal side effects. The Company plans to commence Phase 1 human trials with ALAN in 2021 in patients with acute myeloid leukemia, its lead indication.

"The issuance of this patent for ALAN further protects this technology’s potential broad applicability as a treatment for cancer," added Paula Bates, PhD, Professor of Medicine at UofL. "We look forward to our continued collaboration with Qualigen as we plan to enter this drug candidate into clinical trials as a therapeutic next year. We believe ALAN has the potential to be more targeted than available cancer treatments with the ability not to harm normal healthy cells resulting in less side effects for the patient."

Qualigen currently has 58 issued and pending patents and has in-licensed rights to a further 42 issued and pending patents.

Singlera Genomics raises $150 million in Series B financing to promote the development and commercialization of early cancer screening products

On December 15, 2020 Singlera Genomics Inc. reported that it raised $150 million in Series B financing (Press release, Singlera Genomics, DEC 15, 2020, View Source [SID1234572893]). This round of financing was led by the CICC Kai Tak Innovative Biomedicine Fund, and co-led by Detong Capital and Furong Investment. The new group of investors also include Huamei International, Linden Asset Group, Wuxi Capital, FutureX Skyline Capital, Shanghai Free Trade Zone Fund, and initial investors from the Series A round such as Greenpine Capital, Prosperico Ventures, and Proxima Ventures joined with follow-on investment. Singlera will utilize this round of financing mainly to expand the company’s early cancer screening product research and development pipeline and focus on promoting product registration and commercialization, as well as expanding prospective studies into pan-cancer early screening.

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Singlera was established in 2014 with a commitment to develop the next generation of genetic testing and molecular diagnostic technologies. By focusing on the development and application of non-invasive early screening and diagnosis technology, the company developed a patented methylation detection platform for early tumor diagnostics and prevention. The series B round of financing demonstrates Singlera’s strong scientific technology research and development strength and broad commercial development prospects.

In July 2020, Singlera and Fudan University published groundbreaking scientific research results, which used Singlera’s circulating tumor DNA (ctDNA) methylation multi-cancer screening technology PanSeer to validate early cancer detection in a large population cohort. After this round of financing, Singlera Genomics will continue to carry out large-scale pan-cancer early screening prospective studies.

Mr. Johny Zhang, co-founder and CEO of Singlera, said in a statement "we thank investors for their trust and support. I am honored that the innovative R&D, clinical transformation, and commercialization capabilities of Singlera have been recognized by top investors. This round of financing will help us further expand our product system and strengthen our strategic advantages and marketing capabilities in the field of early tumor screening and liquid biopsy. Cancer has been a major disease that impacts the entire world. Since its establishment 6 years ago, Singlera has been aiming to overcome early cancer screening and diagnosis. It has made a series of major breakthroughs in cancer early screening and early diagnostic technology. The next priority is to accelerate the commercialization of products so that these innovations can be applied to cancer prevention and treatment for hundreds of millions of people."

"Singlera has been committed to building an open and diversified ‘industry-university-research-medicine’ collaborative innovation ecosystem. In the past few years, we have cooperated with dozens of domestic and international scientific research institutes, hospitals and Pharmaceutical companies have carried out extensive cooperation, which has laid a huge advantage for us in basic research and application results transformation of early tumor screening and liquid biopsy," Professor Yuan Gao, co-founder and scientific advisor of Singlera, said in a statement. "We have developed early cancer screening and diagnostic technologies and products covering a variety of cancer types including lung, colorectal, liver, stomach, esophageal, pancreatic, and thyroid. This round of financing will help us carry out large-scale prospective studies and clinical trials".

Clarity Pharmaceuticals closes $25m capital raising

On December 15, 2020 Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported that it has completed a capital raising of $25,000,410 (Press release, Clarity Pharmaceuticals, DEC 15, 2020, View Source [SID1234572891]).

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Dr Alan Taylor, Executive Chairman of Clarity Pharmaceuticals, commented, "It has been a pivotal year for Clarity with numerous critical milestones achieved in the development of our main products, advancement of our platform, as well as accelerated corporate and strategic activities despite facing an unprecedented global environment.

"The money raised will enable us to keep the momentum from 2020 going and provide financial resources to progress the following important initiatives:

– SARTATE

Progress the Cu-64/Cu-67 SARTATE Neuroblastoma trial at the Memorial Sloan Kettering Cancer Center in children with neuroblastoma;
Expand the Cu-64/Cu-67 SARTATE Neuroblastoma trial to additional clinical sites across the US with the ultimate goal of developing better treatment options for children with cancer; and
Commence patient recruitment in Phase II Cu-64 SARTATE Neuroendocrine trial.
– SAR-Bombesin

Progress and expand the Cu-64 BOmbesin in Breast CAncer Trial (C-BOBCAT) led by A/Prof Louise Emmett, Director of Theranostics and Nuclear Medicine, at St Vincent’s Hospital in Sydney with an aim of developing better treatment options to women with metastatic breast cancer, an area currently with a high unmet need;
Expand the C-BOBCAT trial to include prostate cancer patients; and
Seek US Food and Drug Administration’s (FDA) approval for an Investigational New Drug (IND) Application.
– SAR-bisPSMA

Commence a clinical trial in the US for Cu-64/Cu-67 SAR-bisPSMA (theranostic) and in Australia for Cu-64 SAR-bisPSMA (diagnostic) to build on the promising pre-clinical data with the help of an internationally recognised team of key opinion leaders in the prostate cancer field; and
Seek US FDA approval for an IND Application.
– Develop new targeted theranostic products for a broad range of cancer types, utilising Clarity’s SAR Technology Platform and the Cu-64/Cu-67 pairing."

Dr Taylor continued, "Clarity has a strong focus on getting its lead product SARTATE to market, supported by the US FDA granting both Cu-67 SARTATE and Cu-64 SARTATE Orphan Drug Designations and Rare Paediatric Disease Designations for the treatment and clinical management of neuroblastoma, as well as developing the copper platform in large and unmet clinical indications."

"It has been a very exciting year for Clarity" Dr Taylor added. "We would like to sincerely thank our long-term shareholders for their continued support of Clarity, as well as welcome and thank a broad range of new shareholders including institutions, family offices, high net-worth individuals and others who wanted to be part of the Clarity story. We would also like to thank Blue Ocean Equities for their contribution in assisting us with the capital raise."

Nevro to Present at 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021

On December 15, 2020 Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, reported that D. Keith Grossman, Nevro’s Chairman, CEO and President, will present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021, at 4:30 pm Eastern Time / 1:30 pm Pacific Time (Press release, Nevro, DEC 15, 2020, View Source [SID1234572890]).

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A live webcast of this event, as well as an archived recording, will be available in the Investors section of Nevro’s website at www.nevro.com.

Internet Posting of Information

Nevro routinely posts information that may be important to investors in the "Investor Relations" section of its website at www.nevro.com. The company encourages investors and potential investors to consult the Nevro website regularly for important information about Nevro.

Protagonist Therapeutics, Inc. Announces Closing of $115 Million Public Offering of Common Stock and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On December 15, 2020 Protagonist Therapeutics, Inc. (Nasdaq: PTGX), a clinical stage biopharmaceutical company, reported the closing of its previously announced underwritten public offering of 5,476,189 shares of its common stock, including 714,285 shares sold pursuant to the underwriters’ exercise in full of their "green shoe" option to purchase additional shares, at a price to the public of $21.00 per share (Press release, Protagonist, DEC 15, 2020, View Source [SID1234572889]). Aggregate gross proceeds to Protagonist from the offering were approximately $115.0 million, before deducting underwriting discounts and commissions and offering expenses.

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J.P. Morgan Securities LLC, SVB Leerink LLC, Piper Sandler & Co. and BMO Capital Markets Corp. are acting as joint book-running managers for the offering.

A shelf registration statement relating to the offered shares of common stock was filed with the Securities and Exchange Commission (SEC) on December 10, 2020. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and is available on the SEC’s website, located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus related to the offering may be obtained, when available, from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected]; from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132 or by email at [email protected]; from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at [email protected]; or from BMO Capital Markets Corp., Attention: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036, by telephone at (800) 414-3627 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities 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.