On June 16, 2022 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the closing of its upsized underwritten public offering of 17,899,698 shares of its common stock, and to certain investors in lieu thereof, pre-funded warrants to purchase 3,030,302 shares of its common stock at an exercise price of $0.01 per share (Press release, Cogent Biosciences, JUN 16, 2022, View Source [SID1234616061]). The shares of common stock sold include 2,730,000 shares pursuant to the option to purchase additional shares granted by Cogent to the underwriters, which option was exercised in full. The public offering price of each share of common stock was $8.25 and the public offering price of each pre-funded warrant was $8.24. The aggregate gross proceeds to Cogent from this offering were approximately $172.6 million, before deducting underwriting discounts and commissions and other estimated offering expenses.

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The net proceeds from the offering will be used for development, regulatory and commercial preparation activities relating to bezuclastinib and other product candidates, as well as for working capital and general corporate purposes.

Jefferies, Piper Sandler & Co. and Guggenheim Securities, LLC acted as joint book-running managers for the offering. LifeSci Capital also acted as lead manager for the offering.

The securities described above were offered pursuant to a shelf registration statement (File No. 333-264773) filed with the Securities and Exchange Commission (SEC), which became effective on May 24, 2022. A copy of the final prospectus supplement and accompanying prospectus relating to and describing the terms of the offering has been filed with the SEC and may be obtained from the SEC’s website at www.sec.gov, or by request to Jefferies LLC (Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022; telephone: 877-821-7388; email: [email protected]); or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, or by telephone at (800) 747-3924, or by email at [email protected]; or Guggenheim Securities, LLC: Attention: Equity Syndicate Department, 330 Madison, New York, New York 10017, by telephone at 212-518-9544, or by email at [email protected].

This press release does not constitute an offer to sell or the 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 that state or jurisdiction.

On June 16, 2022 Nammi Therapeutics, Inc. (Nammi), a Los Angeles based immunotherapy company, reported that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its lead program, QXL138AM, for the treatment of Pancreatic Cancer (Press release, Nammi Therapeutics, JUN 16, 2022, View Source [SID1234616055]). Nammi has previously received ODD for QXL138AM for treatment of multiple myeloma.

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QXL138AM is a Masked Immunocytokine (MIC) that targets a masked interferon alpha (IFNα) to the CD138 protein on the surface of the tumor cells. Once bound to the tumor cell, proteases on the tumor cell surface cleave the mask off the IFNα allowing it to bind its receptor. Activation of the IFNAR complex induces direct killing of Pancreatic tumor cells as well as activating innate and adaptive anti-tumor immunity.

Pancreatic Cancer is a relatively rare form of cancer, with the American Cancer Society estimating over 62,210 new cases and 49,830 deaths from Pancreatic Cancer this year. Surgical removal is the only potentially curative treatment known and 80% of patients present with advanced disease that do not benefit from surgery. IFNα based therapeutics have demonstrated anti-tumor activity in clinical studies but are infrequently used due to significant toxicities. QXL138AM directly addresses this toxicity issue by targeting the IFNα to the tumor cells with an anti-CD138 antibody and by masking the IFNα activity until it gets to the tumor.

About QXL138AM
QXL138AM is a first in class MIC comprised of a CD138-targeted antibody fused with Interferon alpha (IFNα) that is masked with a tumor-selectively releasable peptide. CD138 is expressed in multiple myeloma as well as many different solid tumor indications including pancreatic, breast, colon, hepatic, ovarian, urothelial, and head and neck cancers. Nammi Therapeutics is expecting to file an Investigational New Drug (IND) application with the FDA to allow initiation of clinical studies this year.

On June 16, 2022 Global Cord Blood Corporation (NYSE: CO) ("GCBC" or the "Company"), China’s leading provider of cord blood collection, laboratory testing, hematopoietic stem cell processing and stem cell storage services, reported that Cellenkos, Inc. ("CLNK") recently announced that the U.S. Food and Drug Administration ("FDA") has cleared its Investigational New Drug ("IND") application to initiate a Phase 1b, open-label study of CK0804 as an add on therapy to ruxolitinib in patients with myelofibrosis who experience a suboptimal response to ruxolitinib (Press release, Global Cord Blood, JUN 16, 2022, View Source [SID1234616053]). Details related to this news can be found via the following Cellenkos news announcement:

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Cellenkos Receives FDA Clearance of Investigational New Drug (IND) Application for CK0804 as Add on Therapy to Ruxolitinib for the Treatment of Myelofibrosis (prnewswire.com)

Ms. Ting Zheng, Chief Executive Officer and Chairperson of GCBC commented, "The Global Cord Blood team is encouraged by the above news announced by CLNK which highlights a potentially transformative treatment for myelofibrosis patients. We congratulate CLNK team on this development."

On June 16, 2022 Nonagen Bioscience, a cancer diagnostics company, reported CE marking for its Oncuria immunoassay for bladder cancer (Press release, Nonagen Bioscience, JUN 16, 2022, View Source [SID1234616052]).

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Oncuria is the first-of-its-kind multiplex urine test for the quantitative detection of 10 biomarkers in urine that are associated with the presence of bladder cancer. Bladder cancer is the tenth most diagnosed cancer in the world, with approximately 573,000 newly diagnosed cases worldwide each year.1 Bladder cancer is also highly recurrent. In fact, up to 77% of early-stage bladder tumors treated with current approaches (tumor resection and/or intravesical bacillus Calmette-Guérin [BCG] or chemotherapy) will recur.2

Nonagen Bioscience now has CE marking for its Oncuria bladder cancer immunoassay, setting the stage for European sales.

Oncuria now bears the CE marking and is registered under the EU In Vitro Diagnostic Directive (IVDD), EU Directive 98/79/EC, which allows Nonagen to sell the diagnostic in the European market.

"The CE mark demonstrates the quality of the Oncuria test, which reflects years of rigorous clinical development by an exceptional team," said Charles J. Rosser, MD, MBA, chief executive officer and chief medical officer at Nonagen Bioscience. "This is a significant first step on the path to the global commercialization of Oncuria."

Nonagen Bioscience is targeting a United States launch of Oncuria in the last quarter of 2022, followed soon after by a European launch of Oncuria as an IVDD. Pending US Food and Drug Administration approval, Nonagen Bioscience intends to make Oncuria available as an in vitro diagnostic.

About Oncuria
Oncuria has been developed for the early detection of bladder cancer in patients presenting with hematuria (blood in the urine) or with a history of bladder cancer on disease surveillance. The test is performed using Luminex xMAP technology. It is designed to detect the concentration of 10 proteins that are associated with bladder cancer in urine samples. The data are entered into a proprietary algorithm for providing diagnostic results for bladder cancer, which can be used in conjunction with (not in lieu of) current standard diagnostic procedures. In clinical studies, Oncuria was shown to have 93% sensitivity and 93% specificity for detecting bladder cancer.3 www.nonagen.com/products

On June 16, 2022 RefleXion Medical, a therapeutic oncology company pioneering the use of biology-guided radiotherapy (BgRT)* for all stages of cancer, reported its first symposium focused on the power of using cancer biology to direct treatment planning and delivery for personalized radiotherapy (Press release, RefleXion Medical, JUN 16, 2022, View Source [SID1234616051]). The symposium is the inaugural event at the company’s newly dedicated Sanjiv "Sam" Gambhir Memorial Learning Center, to be held on Thursday, June 16.

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"We have assembled a group of top-tier radiation oncologists and medical physicists to present their unique approaches to radiotherapy that unleash the power of cancer cell biology to dictate the treatment plan," said Todd Powell, CEO and president at RefleXion Medical. "These novel treatment paradigms dovetail incredibly well with our breakthrough biology-guided radiotherapy and may one day become the new standards of care."

More than 65 cancer care professionals from 30 leading cancer programs are expected to attend the symposium to hear keynote speakers, as well as take part in panel presentations and tour the RefleXion manufacturing facility on its Hayward campus.

The event will commence with a dedication of the Sam Gambhir Memorial Learning Center, named after Sanjiv "Sam" Gambhir, M.D., Ph.D., to honor his pioneering contributions to early cancer detection. Dr. Gambhir was a world-renowned physician-scientist, often referred to as the father of molecular imaging. For decades before his death from cancer in 2020, Dr. Gambhir dedicated his career to advancing technologies to catch tumors in their earliest possible stage. He was an advisor and early supporter of RefleXion’s BgRT.

BgRT is the first and only technology designed to use emissions generated by cancer cells in response to an injected radiotracer to guide the delivery of radiotherapy. RefleXion’s BgRT received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for use in lung tumors because of its potential to detect and then immediately treat moving targets. The company aims to one day scale BgRT to treat all visible cancer sites to create a new treatment option for patients with metastatic disease.