On June 10, 2020 bioAffinity Technologies, a privately held biotech company, reported its test validation trial for CyPath Lung resulted in specificity of 88% and sensitivity of 82%, similar to far more invasive procedures commonly used to diagnose lung cancer (Press release, BioAffinity Technologies, JUN 10, 2020, View Source [SID1234560979]). Overall accuracy of CyPath Lung was 87%.

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"It is important to note that our clinical trial compared two very similar and therefore difficult to distinguish cohorts – those at high risk with and without cancer – in contrast to the trials of some other lung cancer diagnostics that compare healthy individuals to cancer patients," said bioAffinity President and Chief Executive Officer Maria Zannes. "In an earlier study using our porphyrin marker to label sputum on microscope slides, we saw 100% accuracy in distinguishing sputum from healthy patients from those diagnosed with lung cancer. While impressive, the true test of a lung cancer diagnostic is its ability to distinguish those at high risk with and without cancer, which CyPath Lung has shown it can do. We are extremely pleased with our trial results."

CyPath Lung is a flow cytometric test to aid in the diagnosis of lung cancer. Patients collect sputum samples non-invasively at home, a particular benefit during the COVID-19 pandemic. The sample is shipped overnight to the laboratory for processing. Sample data is acquired by flow cytometry, a technique that can count, sort and profile individual cells with remarkable speed. Using an automated analysis with pre-set parameters, CyPath Lung profiles the lung environment including the presence of cancer-associated cells. Data acquisition and physician reports can be generated in minutes.

"We successfully tested our automated analysis program and found it to be fast and very robust in predicting what is cancer and what is high risk," Zannes said. "Physician reports can be generated immediately after flow cytometry acquires sample data in approximately 20 minutes per sample. Looking beyond lung cancer, we believe our automated platform can be successfully applied to cancer diagnostic tests for several other cancers, which will improve overall survival rates for patients through early diagnosis and treatment."

CyPath Lung’s automated flow cytometry analysis reveals four distinct predictors that distinguish the sputum collected from high-risk individuals from samples collected from patients with lung cancer. The Company’s proprietary porphyrin compound preferentially binds to cancer and cancer-related cells. Confirming results of an earlier clinical trial, the test validation trial found cells labeled by the porphyrin molecule are a significant predictor in the test’s automated analysis for lung cancer.

"CyPath Lung reveals the lung environment by profiling cell populations in sputum, meaning that the test analyzes whole cells and cell populations to find predictors of lung cancer in a sample that comes directly from the lung," explained Executive Vice President and Chief Medical and Science Officer Vivienne Rebel, MD, PhD. "Our technology has advantages over genomic approaches to diagnosing earlier stage lung cancers that search for circulating tumor cells or cell fragments in a much more dilutive blood sample."

The test validation trial compared sputum samples collected from individuals at high risk for lung cancer with sputum samples collected from lung cancer patients. Individuals at high risk for lung cancer have smoked the equivalent of one pack of cigarettes a day for 30 years or more, have not quit smoking in the past 15 years and are 55-80 years of age. Trial participants who had lung cancer collected their sputum sample prior to tissue biopsy that confirmed the cancer diagnosis. Trial results are based on analysis of 150 samples, including samples from 122 high-risk individuals and 28 people diagnosed with lung cancer.

The U.S. Preventive Services Task Force recommends that smokers and former smokers at high risk for lung cancer undergo annual screening by low dose computed tomography (LDCT). Screening by LDCT has been proven to detect lung cancer at earlier stages when it can be more successfully treated. The National Lung Cancer Screening Trial (NLCST) of more than 53,000 participants resulted in a 20% decrease in lung cancer–specific mortality when LDCT screening is performed in high-risk patients. However, screening by LDCT had a low 3.8% positive predictive value (PPV) which raises the risk of unnecessary, invasive, and costly procedures for those who test positive. In the NLCST, for every 100 people who received a positive LDCT, less than four of those individuals actually had lung cancer.

In the CyPath Lung validation trial, the non-invasive test showed a positive predictive value (PPV) of 62% and a 95% negative predictive value (NPV). Using CyPath Lung after a positive LDCT screen has the potential to significantly improve PPV compared to LDCT alone in the high-risk population. Early diagnosis of lung cancer followed by treatment can significantly increase survival. Studies have shown early diagnosis of lung cancer can increase the 10-year survival rate of the disease to 88% from the present overall 5-year survival rate of 19%.

"CyPath Lung proves to be a highly accurate test for the early detection of lung cancer," Zannes said. "Our test for lung cancer has high specificity and sensitivity, in contrast to other tests that claim high sensitivity and very low specificity, or vice versa."

CyPath Lung has been licensed by Precision Pathology Services, a CAP/CLIA laboratory in San Antonio, TX. Precision Pathology Services anticipates certification and sale of CyPath Lung in 2020 as a Laboratory Developed Test (LDT). Following its certification as an LDT, physicians will order CyPath Lung for their patients at high risk for lung cancer and who receive a positive screening result or otherwise are suspected of having the disease.

On June 10, 2020 Genetron Holdings Limited ("Genetron Health"), a China-based precision oncology company that covers full-cycle cancer care, reported that it has entered into a strategic partnership agreement with Thermo Fisher Scientific ("Thermo Fisher") (Press release, Genetron Health Technologies, JUN 10, 2020, View Source [SID1234560978]). With plans to build on the sequencer Genetron S5 (Registration Number 20193220820), the partnership aims to enhance innovation, commercialization and promotion of next-generation sequencing (NGS) platforms in the field of molecular cancer diagnosis in China’s public hospitals.

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The partnership will introduce the Company’s medium-throughput NGS system Genetron S5 to public hospitals across China, promoting the application and development of Genetron S5 in more fields, such as reproductive health, genetic disease, pathological microorganism testing, and other independent clinical lab testing and scientific research.

"Genetron Health is committed to leading and empowering the cancer diagnostics and treatment industry," said Wang Sizhen, Co-Founder and CEO of Genetron Health. "We have been working with Thermo Fisher, one of our world-class partners, to create open, flexible, convenient and accurate molecular diagnostic products, and to offer a comprehensive one-stop solution. Our products and solutions are designed to empower medical institutions continuously improve their diagnostic and treatment capabilities, bringing more accurate and speedy services to the public."

" Thermo Fisher’s memorandum of understanding with Genetron in this field will help further our companies’ work together to develop IVD solutions for the fast-growing Chinese market," said Tony Acciarito, president of Thermo Fisher Scientific China "We look forward to generating significant customer value and promoting precision medicine to improve public health throughout China."

Genetron Health has received National Medical Products Administration (NMPA) approval for clinical application of seven IVD products, which cover three major technology platforms: the NGS, dPCR and qPCR. The NGS platform, in particular, provides flexible combinations of products with low, medium and high-throughput. Genetron Health also offers overall R&D and commercialization solutions for in vitro diagnostic technologies available on multiple technology platforms and in various application scenarios, by fully exploring and tapping into the unique strength of each technology platform.

About Genetron S5

Genetron S5 platform approved by NMPA on November 1, 2019, is a medium-throughput NGS system that enables simple targeted sequencing workflows at an affordable price, without compromising on performance or reliability. Genetron S5 platform offers several throughput options, which provide the flexibility to scale from small to large projects, enabling multiple targeted sequencing applications on a single system. Based on the design, Genetron S5 is particularly suitable for hospitals as it offers more practical solutions and greater scalability.

On June 10, 2020 Menarini Group, a privately held Italian pharmaceutical and diagnostics company, reported that is has successfully completed the acquisition of Stemline Therapeutics Inc., a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics (Nasdaq: STML), for an aggregate cash consideration up to $677 million on a fully diluted basis (Press release, Menarini, JUN 10, 2020, View Source [SID1234560977]).

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The transaction, which was announced on 4 May 2020, strengthens Menarini’s oncology portfolio with the addition of both commercial and clinical-stage assets. Menarini acquired Stemline for an upfront payment of $11.50 per share in cash and one non-tradeable Contingent Value Right (CVR) that will entitle each holder to an additional $1.00 per share in cash upon completion of the first sale of ELZONRIS in any EU5 country after European Commission approval.

Stemline launched ELZONRIS for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adult and pediatric patients, two years or older, following the approval by the United States Food and Drug Administration in December 2018. ELZONRIS is a novel targeted therapy directed to the interleukin-3 (IL-3) receptor-α (CD123), a target present on a wide range of malignancies. In parallel, Stemline has been evaluating ELZONRIS in clinical trials in additional indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), acute myeloid leukemia (AML), and others. Stemline’s additional pipeline candidates include felezonexor (SL-801) (XPO1 inhibitor; Phase 1 in advanced solid tumor patients ongoing) and SL-1001 (RET kinase inhibitor, IND-enabling studies ongoing).

Elcin Barker Ergun, CEO of Menarini Group, commented, "We are very excited to complete the acquisition of Stemline and to welcome their accomplished team to Menarini. The addition of ELZONRIS, which has potential to treat many other malignancies, as well as the other attractive pipeline assets augments our research and development capabilities and will accelerate our efforts to deliver novel oncology therapeutics to patients in need."

About ELZONRIS

ELZONRIS (tagraxofusp), a targeted therapy directed to CD123, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with BPDCN. For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA).

ELZONRIS is also being evaluated in additional clinical trials in other CD123+ indications, including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), acute myeloid leukemia (AML), and others are planned including a CD123+ all-comers trial.

About CD123

CD123 is a cell surface target expressed on a wide range of malignancies including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123+ cells have been detected in the tumor microenvironment of several solid tumors as well as in certain autoimmune disorders including cutaneous lupus and scleroderma.

About BPDCN

BPDCN, formerly blastic NK-cell lymphoma, is an aggressive hematologic malignancy, often with cutaneous manifestations, with historically poor outcomes. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. The World Health Organization (WHO) termed this disease "BPDCN" in 2008; previous names included blastic NK cell lymphoma and agranular CD4+/CD56+ hematodermic neoplasm. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

On June 10, 2020 NantKwest, Inc. (Nasdaq: NK), a clinical-stage, natural killer cell-based therapeutics company, reported the publication of two peer-reviewed manuscripts in the Journal of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, NantKwest, JUN 10, 2020, https://ir.nantkwest.com/news-releases/news-release-details/nantkwest-announces-studies-collaboration-national-cancer?field_nir_news_date_value[min]= [SID1234560976]). These invitro and in-vivo studies, conducted in collaboration with the National Cancer Institute pursuant to a Cooperative Research and Development Agreement, support the mechanism and functionality of NantKwest’s clinical-stage engineered natural killer (NK) cell lines, haNK and first-in-class PD-L1 t-haNKTM, as effecting anti-tumor activity in treatment-refractory cancer types even in the hypoxemic setting of the solid tumor microenvironment.

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"These published studies provide important insight and validation for the mechanism and activity of our novel first-in-class engineered NK cells for use in notoriously difficult solid tumor types," said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of NantKwest. "NK cells have the potential to kill tumor cells; however, the hypoxic nature of the suppressive tumor environment has been shown to curb primary NK cell function. These published data indicate that our engineered haNK cells remain active in hypoxic conditions, which may be an important new mechanism of its anti-tumor activity. In addition, our NK cells appear to be resistant even to acute hypoxia and are capable of maintaining tumor killing activity in conditions comparable to a suppressive tumor microenvironment."

Dr. Soon-Shiong continued, "In addition, we are encouraged to observe anti-tumor activity in every cancer cell line tested by the investigators at NCI. The positive data in the in-vivo models of solid tumors with PD-L1 t-haNK, our engineered haNK cell line that also expresses a PD-L1 CAR, provides a novel approach to target tumors expressing PD-L1. This highly targeted NK cell therapy has the potential to address the evolution of tumors as they become resistant to chemotherapy, antibody therapy and, ultimately, checkpoint immunotherapy. We have hypothesized that cancer undergoes a quantum change and adapts to the therapy administered, resulting in the selection of resistant, cancer stem-like cells. It is at this stage of evolution where intractable tumors such as in patients with metastatic pancreatic cancer and triple negative breast cancer, are deemed incurable. It is our belief that these cancer "stem" cells, which do not divide and hence are untouchable by chemotherapy, become resistant and render checkpoint therapy futile by not expressing t-cell receptor ligands. In the face of this immunosuppressive milieu, our PD-L1 t-haNK cells can act to kill these otherwise highly resistant cancer cells, as demonstrated by these two important reports by our colleagues at the NCI. Our clinical results in the first patient with advanced metastatic pancreatic cancer to have received PD-L1 t-haNK demonstrated a durable complete response."

Study highlights from the publication titled "Overcoming hypoxia-induced functional suppression of NK cells" include:

NantKwest haNK cells engineered to express a high-affinity CD16 receptor as well as internal interleukin (IL)-2 for increased antibody-dependent cellular cytotoxicity (ADCC) and activation maintained killing activity under hypoxic conditions comparable to those of the suppressive tumor microenvironment, while healthy donor NK cell activity was significantly impaired
NK killing, serial killing and ADCC were maintained under hypoxia in haNK cells
haNK cells’ IL-2 is likely a driver of maintained killing capacity under hypoxic conditions
Study highlights from the article titled "PD-L1-targeting high-affinity NK cells (PD-L1 t-haNK) induce direct antitumor effects and target suppressive MDSC populations" include:

PD-L1.t-haNK cells engineered to express a high-affinity CD16 receptor, an internal interleukin (IL)-2 and PD-L1-specific chimeric antigen receptor (CAR) broke down all 15 human tumor cell lines tested, including those modelling historically treatment-refractory cancers (triple negative breast cancer, lung, and urogenital cancer)
In vitro, the cytotoxicity of PD-L1 t-haNK cells was correlated to the PD-L1 expression of the tumor targets
In mouse models of solid tumors, PD-L1 t-haNK inhibited the growth of engrafted TNBC, lung and bladder tumors in mice without toxicity

On June 10, 2020 Mateon Therapeutics Inc. (OTCQB:MATN) reported the fruition of its licensing of OT-101/IL-2 combination to Autotelic BIO based on an agreement entered into between Oncotelic and Autotelic BIO, a South Korean Company, during 2018 (Press release, Mateon Therapeutics, JUN 10, 2020, View Source [SID1234560975]).

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OT-101 has received orphan drug designation for glioblastoma, melanoma, and pancreatic cancer. Furthermore, FDA recently granted Rare Pediatric Designation for OT-101 against diffuse intrinsic pontine glioma (DIPG). OT-101 is also effective against coronavirus including COVID-19 and being deployed against the COVID-19 epidemic.

OT-101 has demonstrated robust efficacy against pancreatic cancer, glioblastoma, and melanoma during phase 2 clinical trials. The demonstration that OT-101 will synergize with IL-2 further demonstrate its utility as adjunct to other immunotherapies. Interleukin-2 (IL-2, Aldesleukin, PROLEUKIN) Immunotherapy is cancer treatment that stimulates the body’s immune system to fight cancer, such as melanoma.

"In addition to additional milestone payments under said agreement, Mateon also entitled to profit sharing and royalties arising from the commercialization and/or licensing of OT-101/IL-2 by Autotelic BIO," stated Amit Shah, CFO of Mateon Therapeutics. "We look forward to continue our collaboration with Autotelic BIO and to make this unique immunotherapy available to patients."