On August 4, 2020 bioAffinity Technologies, a privately held biotech company, reported a poster explaining the Company’s use of flow cytometry for diagnosis of lung disease, including cancer, at the International Society for Advancement of Cytometry CYTO 2020 (Press release, BioAffinity Technologies, AUG 4, 2020, View Source [SID1234562844]). The CYTO 2020 conference runs today and tomorrow in a virtual format due to COVID-19.

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"We are pleased to have the opportunity to share our cutting-edge use of flow cytometry for accurate, non-invasive lung cancer diagnosis. Our platform not only advances early lung cancer testing, but also can be developed to detect other diseases of the lung," bioAffinity President and Chief Executive Officer Maria Zannes said.

The Company’s first product, CyPath Lung, is a flow-cytometric test to aid in the diagnosis of lung cancer. Flow cytometry allows for quantitative analysis of cells and cell systems. In the CyPath Lung process, individual cells are suspended and then analyzed by flow cytometry one at a time through a focus of exciting light, which is scattered in patterns characteristic to the cells and their components. Cells are labeled with fluorescent markers so that light is first absorbed and then emitted at altered frequencies. A sensor in the flow cytometer detects the scattered or emitted light and measures the size and molecular characteristics of individual cells. This allows for cellular profiles of sputum samples that can used to distinguish cancerous from cancer-free lungs.

"Data acquisition and our automated analysis is very fast," Ms. Zannes said. "CyPath Lung can analyze an average sputum sample of about 21 million cells in less than 20 minutes."

CyPath Lung allows patients to collect sputum samples non-invasively at home and ship them overnight to the laboratory for processing. Sample data is acquired by flow cytometry. Using automated analysis of pre-set parameters, CyPath Lung profiles the lung environment, including the presence of cancer cells. Data acquisition and physician reports can be generated in minutes.

A test validation trial comparing people at high risk for lung cancer to patients with the disease resulted in CyPath Lung specificity of 88% and sensitivity of 82%, similar to far more invasive procedures and surgery currently used to diagnose lung cancer. CyPath Lung is a well-balanced, highly accurate test.

CyPath Lung has been licensed by Precision Pathology Services, a CAP/CLIA laboratory in San Antonio, Texas. 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 who are smokers and former smokers at high risk for lung cancer and who receive a positive screening result or otherwise are suspected of having the disease.

People who 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 are recommended for 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 successfully treated, but screening has a low Positive Predictive Value (PPV) that can lead to unnecessary and risky procedures.

Using CyPath Lung after a positive LDCT screen can improve the PPV by 5.6-fold compared to LDCT alone. Early diagnosis of lung cancer followed by treatment has been shown to increase the 10-year survival rate of the disease to 88% from the present 5-year survival rate of 21.7%.

On August 4, 2020 BostonGene Corporation (BostonGene), a biomedical software company focused on defining optimal precision medicine-based therapies for cancer patients, reported its collaboration with The Weinstock Laboratory, a translational research program focused on novel therapeutics for lymphoid malignancies, at Dana-Farber Cancer Institute, Inc (Press release, BostonGene, AUG 4, 2020, View Source [SID1234562843]). The collaboration aims to define predictors of response to PI3 kinase inhibition in relapsed/refractory T-cell lymphomas.

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The Weinstock Laboratory is leading the research efforts to reveal mechanisms of response and resistance, and possible cause of adverse effects to Duvelisib (PI3K delta & gamma inhibitor) in patients with T-cell lymphomas (TCLs). Their work is supported by the Leukemia and Lymphoma Society and by Verastem, the makers of Duvelisib. In this collaboration, BostonGene provides advanced computational analytics of genomic, transcriptomic, proteomic and multiplex imaging data sets to predict drug response and identify new biomarkers. BostonGene’s software uses a set of unique deconvolution algorithms that reveal cellular content of a tumor and surrounding microenvironment using transcriptome next generation sequencing (NGS) data, and image analysis algorithms to elucidate spatial parameters of tumor microenvironment distribution using immunofluorescence (IF) imaging data.

"We are excited to collaborate with BostonGene," said David Weinstock, MD, at Dana-Farber Cancer Institute, Inc. "Improving patient outcomes is our top priority and by partnering with BostonGene we hope to accurately predict which patients will benefit from treatment by identifying new biomarkers that could be useful for other patients with cancer. The results have the potential to bring significant advantages to physicians as they make individual treatment decisions."

"BostonGene is thrilled to collaborate with the Weinstock Laboratory at Dana-Farber Cancer Institute, Inc." said Andrew Feinberg, President and CEO of BostonGene. "Our sophisticated analysis of RNAseq and exome sequencing will identify genomic and transcriptional alterations that could serve as predictive biomarkers of response and resistance to PI3 kinase inhibition that could ultimately improve patient outcomes. "

On August 4, 2020 Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported that it has raised $22.2 million (€ 19 million) from the sale of 10.3 million shares of its minority stake in Tasly BioPharmaceuticals to a Chinese investment fund (Press release, Transgene, AUG 4, 2020, View Source [SID1234562842]). The shares that have been sold represent 38% of Transgene’s total holding in Tasly BioPharmaceuticals. The transaction enhances the Company’s cash position and strengthens its financial visibility until 2022.

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Following this share sale, Transgene holds 17.1 million shares in Tasly BioPharmaceuticals, equivalent to 1.58% of the Chinese company’s capital. Transgene’s remaining shareholding in Tasly BioPharmaceuticals would be valued at approximately $36.9 million based on the price of the current share sale.

In May 2020, Tasly Pharmaceuticals announced its plan to list its subsidiary Tasly Biopharmaceuticals on the Shanghai Stock Exchange’s Star Market.

Transgene has been a shareholder in Tasly BioPharmaceuticals since August 2018 when it received 27.4 million shares of Tasly Biopharmaceuticals in exchange for the sale of the Greater China rights of T101 and T601, two products respectively incorporating Transgene’s TG6002 and TG1050 patented technologies. At the time, these shares were valued at $48 million based on the pricing of a funding round conducted by Tasly concurrently with Transgene’s share subscription compared to the pre-IPO value of $59 million implied by the current operation.

On August 4, 2020 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a clinical-stage cancer immunotherapy company, reported it has been awarded a Small Business Innovation Research (SBIR) Direct to Phase II grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) (Press release, Immune-Onc Therapeutics, AUG 4, 2020, View Source [SID1234562841]). The grant, in the amount of $2.14 million over two years, will support development of IO-202, a first-in-class antibody targeting leukocyte immunoglobulin-like receptor B4 (LILRB4), for acute myeloid leukemia (AML), the most common acute leukemia in adults, and for chronic myelomonocytic leukemia (CMML), a rare form of leukemia. The highly competitive SBIR programs enable small businesses to explore technological potential and pursue commercialization of innovations.

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"We are honored to receive financial support and scientific endorsement from the National Cancer Institute," said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. "This Direct to Phase II SBIR award will help us advance our lead clinical program. We look forward to working with our investigators to initiate the first-in-human trial of IO-202 in two forms of leukemia: AML and CMML. We also plan to evaluate IO-202 in other blood cancers and solid tumors in the future."

In May, Immune-Onc’s IO-202 Investigational New Drug (IND) application received clearance from the U.S. Food and Drug Administration (FDA). In preclinical studies, IO-202 has shown evidence of activating T cell cytotoxicity against leukemia cells and blocking tumor infiltration. Immune-Onc’s first Phase I trial with IO-202 will evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity in AML patients with monocytic differentiation and in CMML patients.

ABOUT AML and CMML

AML, the most common acute leukemia (blood and bone marrow cancer) in adults, is characterized by the proliferation of abnormal myeloblasts (a type of white blood cell) in the bone marrow. Nearly 20,000 new cases are expected in the U.S. in 2020. Despite advances in treatment, less than 30 percent of acute myeloid leukemia patients are alive five years after initial diagnosis.

CMML is a cancer that starts in blood-forming cells in the bone marrow and invades the blood. The condition is rare, with about 1,100 cases in the U.S. each year.

ABOUT IO-202

IO-202 is a first-in-class monoclonal antibody that blocks signaling of leukocyte immunoglobulin-like receptor B4 (LILRB4), an immune inhibitory receptor, with high binding affinity and specificity. In October 2018, Immune-Onc and The University of Texas announced the publication of pioneering research in Nature (DOI: 10.1038/s41586-018-0615-z) illuminating the roles of LILRB4 in immune suppression and tumor infiltration in AML. IO-202 is the first T-cell activator for AML. Preclinical studies showed that IO-202 can convert a "don’t kill me" to "kill me" signal by activating T cell killing of AML cells and a "don’t find me" to "find me" signal by inhibiting leukemia infiltration. IO-202 will be evaluated in AML and CMML in a Phase I trial, and Immune-Onc plans to explore its potential in other hematologic malignancies and solid tumors in future trials.

On August 4, 2020 BryoLogyx, Inc. reported that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), to conduct a Phase I clinical trial with bryostatin-1 in pediatric and young adult patients with relapsing or refractory CD22 expressing acute lymphoblastic leukemia (ALL) and lymphoma (Press release, BryoLogyx, AUG 4, 2020, View Source [SID1234562840]). The study, expected to start later this year, will be the first in patients to evaluate the ability of bryostatin-1 to upregulate expression of CD22, a cancer immunotherapy target often downregulated following antibody drug conjugate or CAR T adoptive therapies. The Company is planning future clinical trials with bryostatin-1 to evaluate its ability to upregulate other antigen targets associated with B cell hematological malignancies.

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"This CRADA provides an accelerated path to demonstrating clinical proof-of-concept for our innovative approach that enhancing the response to cancer immunotherapy can be achieved by increasing expression of antigen targets," said Thomas M. Loarie, CEO of BryoLogyx. "Our collaboration builds on NCI’s pioneering work showing that relapse in patients undergoing ALL treatment with a CD22-directed CAR T therapy is associated with reduced CD22 antigen expression; and that in preclinical studies, bryostatin-1 upregulates CD22 density on the cancer cell, improves CAR T functionality, duration of response, and survival in CAR T-treated human xenograft models."

Under the CRADA, NCI researchers will test bryostatin-1 to evaluate its ability to modulate CD22 in patients with relapsed/refractory CD22+ ALL and lymphoma, while specifically evaluating its safety, defining the optimal biologic dose required to lead to an increase in CD22 site density, and anti-leukemic properties.

Mr. Loarie noted that BryoLogyx plans to follow this CRADA study with additional trials to expand the understanding of how bryostatin-1 increases tumor antigen expression and amplifies the immune response to several immune-oncology therapies in a variety of hematologic cancers.

The CRADA follows recent agreements entered into by BryoLogyx with Neurotrope to acquire a preclinical data package for a BryoLogyx-sponsored IND, along with study drug for the clinical trial.