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.

On June 16, 2022 Pionyr Immunotherapeutics, Inc., a company developing first-in-class Myeloid Tuning antibody therapeutics that enhance the body’s anti-tumor immunity by altering, or "tuning," immune cells within the tumor microenvironment, reported that Chief Medical Officer Leonard Reyno, M.D., will lead a discussion on myeloid cell targeting to reprogram the tumor microenvironment, modulate innate immune activity, and enhance anti-tumor immunity (Press release, Pionyr Immunotherapeutics, JUN 16, 2022, View Source [SID1234616049]). The presentation will highlight preclinical and early clinical research on Pionyr’s first in class TREM1-targeting monoclonal antibody called PY159. The presentation titled, "Reprogramming TREM1+ Myeloid Cells to Overcome Immunotherapy Resistance in Solid Tumors," takes place at the 2nd Tumor Myeloid Directed Therapies Summit on June 16, 2022.

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"Pionyr was built on the premise that the myeloid compartment is a source of provocative, untapped anti-tumor drug targets that can be harnessed to modulate the innate immunity and our natural defenses against cancer cells," said Leonard Reyno, M.D., Chief Medical Officer at Pionyr. "With first-in-class drug candidates in clinical development targeting TREM1 and TREM2 associated myeloid cells, and a preclinical program targeting MARCO, our approach demonstrates the incredible potential to improve innate immunity, overcome the limitations of checkpoint inhibitors, and illustrate a foundational approach to transforming immuno-oncology."

As part of the presentation, Pionyr will highlight the PY159 development program. PY159 is a humanized monoclonal antibody that specifically binds triggering receptor expressed on myeloid cells 1 (TREM1). The presentation will highlight:

Preclinical research demonstrating expression of TREM1 to be higher in cancerous tissues vs normal tissues
Preclinical evidence showing TREM1 as a promising therapeutic opportunity for patients with checkpoint inhibitor (CPI)-hypo-responsive or resistant tumors as the receptor is expressed on the three myeloid immuno-suppressive cell populations
In vivo model data demonstrating administration of PY159 alone or in combination with CPIs resulted in complete regressions of tumors
First in human clinical experience administering PY159 both alone and in combination with pembrolizumab including identification of target archival tumor specimens from participating patients
Outline clinical plans for further study in patients with advanced refractory solid tumors
The Tumor Myeloid-Directed Therapies Summit is the only industry-focused meeting dedicated to unlocking novel therapeutic potential of the myeloid compartment where experts come together to identify, validate and clinically progress myeloid targets to expand the oncologist’s toolkit and realize better responses by engaging myeloid anti-tumor function. It is designed for experts working directly in myeloid-directed therapies, and those in adjacent immune-oncology fields, from cell therapy to checkpoint inhibitor development.

About Myeloid Tuning

Pionyr has developed a therapeutic platform called Myeloid Tuning, a process that rebalances the tumor microenvironment (TME) to promote anti-tumor immunity. Myeloid cells are a type of immune cell and are part of a family of cell types that play an important role in both the activation and suppression of the immune response to cancer.

One such critical type of myeloid cell, tumor-associated macrophages (TAM), are a key component of the TME. TAMs are generally categorized into two functionally contrasting subtypes called M1-like and M2-like macrophages: M1-like typically exerts anti-tumor functions, including directly mediating antibody-dependent cell-mediated cytotoxicity (ADCC) to kill tumor cells; M2-like macrophages can promote the occurrence and metastasis of tumor cells, inhibit T cell-mediated anti-tumor immune response, promote tumor angiogenesis and lead to tumor progression.

Myeloid Tuning effectively describes the mechanism of introducing agents that shift the balance of inhibitory myeloid cells – including M2-like TAMs – towards more inflammatory M1-like TAMs to promote anti-tumor immune responses in the TME and destroy solid tumors.

On June 16, 2022 Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a late-stage clinical biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ reported it entered into an agreement with PCI Pharma Services (PCI), a leading integrated global contract development manufacturing organization (CDMO), to provide importation, release and commercialization services in the United Kingdom (UK) for lenzilumab (Press release, Humanigen, JUN 16, 2022, View Source [SID1234616048]). Under the agreement, PCI will purchase lenzilumab for resale and distribution in the event a Conditional Marketing Authorization is received in the UK for use in patients hospitalized with COVID-19.

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"We continue our commercial preparation in the UK and in parallel are working closely with the Medicines and Healthcare products Regulatory Agency (MHRA) to address regulatory requirements for a potential Conditional Marketing Authorization. With its global reach, PCI will provide a critical function in the supply chain, by directly purchasing lenzilumab for further distribution in the UK and facilitating this key process for Humanigen," said Edward Jordan, Chief Commercial Officer. "It is anticipated that we will complete our response to MHRA soon after the top-line results from the ACTIV-5/BET-B clinical trial with lenzilumab are received."

If authorized, lenzilumab will offer an important treatment option to patients hospitalized with COVID-19. Hospitalizations from COVID-19 continue in the United Kingdom with more than 235,000 admitted year-to-date and with ~5,000 currently hospitalized.1 In addition, Humanigen believes that treatment with lenzilumab may deliver economic value to the healthcare system. Previously published research has demonstrated that treatment with lenzilumab may save the National Health Service over £10,000 per patient.2

Lenzilumab is an investigational product and is not approved or authorized in any country.

About Lenzilumab

Lenzilumab is a proprietary Humaneered first-in-class monoclonal antibody that has been proven to neutralize GM-CSF, a cytokine of critical importance in the hyperinflammatory cascade, sometimes referred to as cytokine release syndrome, or cytokine storm, associated with COVID-19 and other indications. Lenzilumab binds to and neutralizes GM-CSF, potentially improving outcomes for patients hospitalized with COVID-19. Humanigen believes that GM-CSF neutralization with lenzilumab also has the potential to reduce the hyperinflammatory cascade known as cytokine release syndrome common to chimeric antigen receptor T-cell (CAR-T) therapy and acute Graft versus Host Disease (aGvHD).

In CAR-T, lenzilumab successfully achieved the pre-specified primary endpoint at the recommended dose in a Phase 1b study with Yescarta in which the overall response rate was 100% and no patient experienced severe cytokine release syndrome or severe neurotoxicity. Based on these results, Humanigen plans to test lenzilumab in a randomized, multicenter, potentially registrational, Phase 3 study ("SHIELD") to evaluate its efficacy and safety when combined with Yescarta and Tecartus CAR-T therapies in non-Hodgkin lymphoma. Lenzilumab will also be tested to assess its ability to prevent and/or treat aGvHD in patients undergoing allogeneic hematopoietic stem cell transplantation.

A study of lenzilumab is also underway for patients with chronic myelomonocytic leukemia (CMML) exhibiting RAS pathway mutations. This study builds on evidence from a Phase 1 study, conducted by Humanigen, that showed RAS mutations are associated with hyper-proliferative features, which may be sensitive to GM-CSF neutralization.