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, Sutro Biopharma, Inc. (the "Company") presented the corporate presentation (Presentation, Sutro Biopharma, JUN 16, 2022, View Source [SID1234616035]).

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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 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 Vaxart, Inc. (Nasdaq: VXRT) reported that it will host a question-and-answer webcast with investors and analysts on Wednesday, June 22, 2022, at 1:00 p.m. Eastern Time (Press release, Aviragen Therapeutics, JUN 16, 2022, View Source [SID1234616038]). During the webcast, Andrei Floroiu, President and Chief Executive Officer, Dr. Sean Tucker, SVP and Chief Scientific Officer, and Dr. James Cummings, Chief Medical Officer, will provide an overview of the Company’s oral vaccine programs.

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The Company will take written questions from investors and analysts. Please visit the webcast link to RSVP and submit written questions. Questions may also be submitted in advance to [email protected].

A replay of the webcast will be available on the Investors page of the Company’s website at www.vaxart.com approximately two hours following the conclusion of the event.

As previously announced, Vaxart’s 2022 annual meeting of stockholders has been adjourned to Wednesday, July 6, 2022, at 12:30 p.m. Eastern Time. Vaxart encourages all stockholders of record on April 11, 2022, to vote their shares or change their votes in favor of all the proposals being submitted at the annual meeting by 11:59 p.m. Eastern Time on July 5, 2022.