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.

On June 16, 2022 Boundless Bio, a next-generation precision oncology company developing innovative therapeutics directed against extrachromosomal DNA (ecDNA) in oncogene amplified cancers, reported to share the news that a global team of ecDNA experts comprised of several Boundless Bio scientific co-founders and led by Boundless Bio principal founder, Paul Mischel, M.D. has been awarded $25 million in funding by the National Cancer Institute (NCI*) and Cancer Research UK (CRUK) through Cancer Grand Challenges to deepen the understanding of the role of ecDNA in cancer pathogenesis (Press release, Boundless Bio, JUN 16, 2022, View Source [SID1234616050]). Cancer Grand Challenges is a unique global funding initiative founded by CRUK and the NCI, who have set ambitious challenges to assemble global teams to think creatively and make a profound difference in the fight against cancer.

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The global ecDNA research team, also known as "the Cancer Grand Challenges eDyNAmiC team", is led by Dr. Mischel, who has been at the forefront of research into the importance of ecDNA in gene amplified cancers such as EGFR amplified glioblastoma. Dr. Mischel and his team will use the funding to answer key scientific questions to further understand the biological mechanisms of ecDNA generation and function, as well as potential therapeutic strategies to help improve cancer outcomes. The multi-disciplinary research team includes the following scientific experts that are also members of Boundless Bio’s Scientific Advisory Board:

Paul Mischel, M.D., Institute Scholar, ChEM-H; Professor and Vice Chair of Research for the Department of Pathology, Stanford University
Vineet Bafna, Ph.D., Professor of Computer Science & Engineering, University of California San Diego
Howard Chang, M.D., Ph.D., Virginia and D.K. Ludwig Professor of Cancer Genomics and Genetics, Stanford University
Ben Cravatt, Ph.D., Professor and Gilula Chair of Chemical Biology, The Scripps Research Institute
Roel Verhaak, Professor and Associate Director of Computational Biology, The Florine Deschenes Roux Chair for Genomics and Computational Biology, The Jackson Laboratories
"We congratulate Paul and the eDyNAmiC team for receiving the prestigious Cancer Grand Challenges award to progress innovative research in the expanding field of ecDNA," said Zachary Hornby, President and Chief Executive Officer of Boundless Bio. "This award further underscores the importance of ecDNA biology in cancer and our goal to bring the first ecDNA-directed therapeutics (ecDTx) into clinical trials for patients with oncogene amplified cancer. We at Boundless continue to be inspired by Dr. Mischel and the eDyNAmiC scientific team’s commitment to advancing the scientific understanding of ecDNA."

"We are thrilled to receive the NCI and CRUK award, an acknowledgement of the critical role ecDNA play in the biology of cancer," said Dr. Mischel, Professor and Vice Chair of Research for the Department of Pathology, Stanford University. "It is amazing to reflect on how rapidly the ecDNA field has come of age. With this recognition and dedicated funding for ecDNA research, we have the opportunity to further explore the pathogenesis of ecDNA in cancer with the goal of developing innovative new treatments that benefit patients with oncogene amplified cancers driven by ecDNA."

For more information on Cancer Grand Challenges, please visit: www.cancergrandchallenges.org/new-teams-2022

For more information on the eDyNAmiC team, please visit: www.cancergrandchallenges.org/teams/eDyNAmic

*The National Cancer Institute is part of the National Institutes of Health.

About ecDNA

Extrachromosomal DNA ("ecDNA") are circular units of nuclear DNA that are physically distinct from chromosomes and are found within cancer cells. ecDNA encode full length genes, including oncogenes and regulatory regions, are highly transcriptionally active, and lack centromeres. ecDNA replicate and express within cancer cells and, due to their lack of centromeres, can be asymmetrically passed to daughter cells during cell division, leading to focal gene amplification and copy number heterogeneity in cancer. By leveraging the plasticity afforded by ecDNA, cancer cells have the ability to increase or decrease copy number of select oncogenes located on ecDNA to enable survival under selective pressures, including targeted therapy, immunotherapy, chemotherapy, or radiation, thereby making ecDNA one of cancer cells’ primary mechanisms of growth, recurrence, and treatment resistance. ecDNA are not found in healthy cells but are present in many solid tumor cancers. They are a key driver of the most aggressive and difficult-to-treat cancers, specifically those characterized by high copy number amplification of oncogenes.