On December 5, 2019 Epic Sciences, Inc. reported the presentation of new data demonstrating the feasibility of using its proprietary technology for the detection and characterization of rare cells to guide the treatment of breast cancer (Press release, Epic Sciences, DEC 5, 2019, View Source [SID1234551987]). The data to be presented show the use of Epic Sciences’ liquid biopsy test to profile circulating tumor cells (CTCs) based on morphological features, protein marker expression and genomic alterations. Epic Sciences will present the data at the 2019 San Antonio Breast Cancer Symposium held on December 10 – 14, in San Antonio, Texas.

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Epic’s platform detects and characterizes all circulating tumor cells in a blood sample in an effort to predict their response or resistance to drug therapies. Epic Sciences’ first application of this technology was successfully developed as a test for patients with metastatic castration-resistant prostate cancer and is currently marketed as the Oncotype DX AR-V7 Nucleus Detect test. The company and its research partners are utilizing its liquid biopsy solution to identify and analyze CTCs to guide treatment decisions in breast cancer.

"We are now applying our proven expertise in prostate cancer to breast cancer, a disease shown to have biological similarities. The ability to identify CTCs with great precision and provide multi-dimensional characterization may have significant impact in guiding treatment decisions in breast cancer," said Rick Wenstrup, MD, chief medical officer at Epic Sciences. "We’re excited about this promising data and our ability to identify cancer cell clones and subtypes. We look forward to sharing additional findings in the future."

Following are the details for the two poster sessions:
Title: Phenotypic profiling of circulating tumor cells (CTCs) in patients with metastatic breast cancer reveals clinically-relevant heterogeneity in CTC morphology and marker expression.
First Author: Tiziano Pramparo, PhD, Senior Biomarker Scientist
Date and Time: Friday, December 13, 2019, 7:00 am – 9:00 am
Poster Session: 4
Abstract: 874
Poster Board: P4-01-09

Title: Computer Vision and Machine Learning Allow for the Prediction of Genomic Instability Using Circulating Tumor Cell Morphology in Triple Negative Breast Cancer Patients
First Author: Adam Jendrisak, MBA, Data Scientist
Date and Time: Friday, December 13, 2019, 7:00 am – 9:00 am
Poster Session: 4
Abstract: 878
Poster Board: P4-01-03

On December 5, 2019 Thermo Fisher Scientific reported Clinical researchers who take a traditional sequential approach to analyze myeloid malignancies, a highly heterogeneous group of disorders, face a major hurdle: a laborious and time-consuming workflow (Press release, Thermo Fisher Scientific, DEC 5, 2019, View Source [SID1234551986]). To simplify and accelerate the genomic profiling process, Thermo Fisher Scientific announced that the Ion Torrent Oncomine Myeloid Research Assay* will be available in 2020 to run on the newly introduced Ion Torrent Genexus System*, the first fully integrated next-generation sequencing (NGS) platform featuring an automated workflow that delivers results economically in a single day with minimal user intervention and tissue sample input.

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"For the past two years we have been using Thermo Fisher’s NGS technology to analyze myeloid samples, and the Oncomine Myeloid Research Assay provides a comprehensive assessment to identify relevant variants in a single step," said Bekim Sadikovic, Ph.D., associate professor of pathology and laboratory medicine at Western University and division head of the Molecular Diagnostics Division in the Department of Pathology and Laboratory Medicine at London Health Sciences Centre. "Making this assay available on a platform that can deliver results in a single day would provide labs with the answers they need for key mutations such as FLT3-ITDs, TP53, CEBPA, NPM1, KIT, PML-RARA and other biomarkers."

Thermo Fisher introduced the Genexus System* in November, and will demonstrate the platform at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (booth #140) being held in Orlando, Fla. from December 7-10.

"The Genexus System holds promise to redefine the genomic profiling paradigm," said Andy Felton, vice president of product management for clinical next-generation sequencing and oncology at Thermo Fisher. "We have heard significant interest from our customers in the potential to run our Oncomine Myeloid Research Assay on the new platform. Delivering on that need will mean that hematology and oncology labs can quickly get the results they need."

Expanded Portfolio Addresses Full Range of Hematology Applications

Thermo Fisher also announced an expanded portfolio of NGS-based hematology-oncology research assays that make it easier to assess lymphoid malignancies. The new Oncomine BCR IGH-LR Assay provides accurate clonality assessment and somatic hypermutation in chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL). The Oncomine BCR IGH-SR Assay measures residual disease (MRD) in lymphoid malignancies with higher sensitivity and lower limit of detection (LOD) than traditional methods.

Thermo Fisher’s hematology portfolio includes the Oncomine Childhood Cancer Research Assay*. All of Thermo Fisher’s hematology and oncology assays are compatible with the Ion GeneStudio S5 System*, providing an end-to-end, streamlined NGS workflow for consolidated biomarker testing. The system also includes Thermo Fisher’s bioinformatics software to deliver more comprehensive information and easier interpretation of NGS biomarker testing.

For more information on Thermo Fisher’s portfolio of hematology and oncology assays, please visit www.oncomine.com/heme or visit the company’s booth (#140) at ASH (Free ASH Whitepaper) for a live demonstration of the Genexus System.

On December 5, 2019 Black Diamond Therapeutics, Inc., a precision oncology medicine company pioneering the discovery and development of small molecule, tumor-agnostic therapies, reported the completion of an oversubscribed Series C financing of $85 million led by Boxer Capital of the Tavistock Group (Press release, Black Diamond Therapeutics, DEC 5, 2019, View Source [SID1234551985]). Additional new investors Wellington Management Company, BVF Partners L.P., Deerfield Management, funds managed by Janus Henderson Investors, Casdin Capital, and Logos Capital joined current investors Versant Ventures, New Enterprise Associates, RA Capital Management, Nextech Invest, Invus, Perceptive Advisors, City Hill Ventures, and Roche Venture Fund in the round.

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Proceeds from the Series C financing will be used to support the Company’s growth and advance the development of Black Diamond’s lead product candidates targeting oncogenic driver mutations of the ErbB kinases in epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2). The Company plans to start a combined Phase 1/2 clinical trial of its most advanced product candidate, BDTX-189, in the first half of 2020. The funding will also support the continued expansion of the Company’s earlier stage research programs and proprietary Mutation-Allostery-Pharmacology (MAP) platform to identify and target oncogenic mutations. The Company initially operated in stealth mode from New York and from Versant’s Basel-based Ridgeline Discovery Engine and has raised $194 million since its founding.

David M. Epstein, President and CEO of Black Diamond commented, "We are privileged to have this impressive syndicate of thought-leading investors share our commitment to patients and support our vision to discover and develop therapies that will potentially transform how cancer is treated. There are currently no drugs approved by the FDA to target certain allosteric and other EGFR and HER2 mutations that are prevalent in a variety of cancers with a single therapy, including in patients with deadly cancers like lung cancer or glioblastoma that express these mutations. This funding will help accelerate development of our lead product candidates targeting undrugged oncogenic driver mutations of EGFR and HER2 so that we can get potential new treatments to patients as quickly as possible."

Commenting on the investment, Aaron Davis, CEO of Boxer Capital said, "Black Diamond’s ground-breaking MAP platform could revolutionize how we discover and develop new oncology treatments, particularly for some of the most difficult-to-treat cancers. We are delighted to partner with this group of leading investors and experienced management team in this endeavor."

In addition, Black Diamond announced the appointment of Samarth (Sam) Kulkarni, Ph.D., to its Board of Directors. An industry leader with expertise in strategy and operations in biotech and a wide range of pioneering therapeutic technologies, Sam currently serves as CEO of CRISPR Therapeutics AG. He joined CRISPR in 2015 in the early stages of the company as Chief Business Officer (CBO), and then served as President and CBO before being named its CEO in 2017.

"We are thrilled to have Sam join Black Diamond’s Board of Directors. His wealth of experience and proven track record of strategic business accomplishments and advancing innovative therapeutic technologies will be invaluable as we continue to progress our portfolio and design our programs for clinical success," added Dr. Epstein.

Prior to CRISPR, Sam was a partner at McKinsey & Company, where he had a leading role in the Pharmaceutical and Medical products practice. While at McKinsey, he co-led the biotechnology practice and focused on topics ranging from strategy to operations and led initiatives in areas such as personalized medicine and immunotherapy. Sam also serves as the Chairman of the Board of Directors of Casebia Therapeutics, a joint subsidiary formed by CRISPR and Bayer. He received a Ph.D. in bioengineering and nanotechnology from the University of Washington and a B. Tech. from the Indian Institute of Technology. While at the University of Washington, Sam conducted research on the delivery of biological drugs and in the field of molecular diagnostics. He has authored several publications in leading scientific and business journals.

"It is an exciting time to be joining Black Diamond’s Board of Directors. The Company has tremendous momentum and I believe has significant potential to change how we treat cancer through its MAP platform and discovery engine," said Dr. Kulkarni.

Black Diamond’s MAP platform
Black Diamond’s Mutation-Allostery-Pharmacology (MAP) platform is built on three central pillars – discover, reveal, and target. The Company uses population-level cancer genetic data obtained from all tumor types to identify potential families of mutations that occur within individual oncogenes and rank the mutations for potential oncogenicity. Black Diamond then uses its MAP platform to understand the mechanism for oncogenic activation and its team of experienced medicinal chemists then develops mutation spectrum-selective drugs for the identified targets.

Black Diamond’s MAP platform has generated a pipeline of orally available, potent, and selective small molecule kinase inhibitors that target a range of driver mutations in cancer. The Company’s first two disclosed programs are targeting groups of EGFR and HER2 allosteric mutants.

On December 5, 2019 ThermoGenesis Holdings, Inc. (Nasdaq: THMO) a market leader in automated cell processing tools and services in the cell and gene therapy field, reported Chris Xu, Ph.D., Chairman and Chief Executive Officer, will present a company overview at the LD Micro 12th Annual Main Event at the Luxe Sunset Boulevard Hotel in Los Angeles, California on Wednesday, December 11, at 1:20 pm PT (Press release, Thermogenesis, DEC 5, 2019, View Source [SID1234551984]).

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Management will also be available for one-on-one meetings with qualified investors. Interested parties can register and request meetings through the LD Micro Conference portal or contact Rx Communications to schedule a meeting.

A live webcast of the presentation will be available on the ThermoGenesis website at View Source An archived replay will be available for a period of 90 days after the conference.

On December 5, 2019 Select Medical Holdings Corporation ("Holdings") (NYSE: SEM), reported that Select Medical Corporation ("Select") proposes to commence an offering through a private placement, subject to market and other conditions, of $625 million aggregate principal amount of 6.250% senior notes due 2026 (Press release, Select Medical, DEC 5, 2019, View Source [SID1234551983]). It is anticipated that the notes will be issued as additional notes under the same indenture as Select’s existing $550 million aggregate principal amount of 6.250% senior notes due 2026 that were originally issued on August 1, 2019 and, as such, will form a single series and trade interchangeably with such previously issued notes. The notes will be senior unsecured obligations of Select and will be guaranteed by certain of Select’s subsidiaries.

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Select intends to use a portion of the net proceeds of the offering, together with a portion of the proceeds from a proposed incremental term loan, and, if needed, available cash, to make an intercompany loan to Concentra, Inc. ("Concentra"), a joint venture subsidiary of Select, which will use the proceeds from such intercompany loan to repay in full all of Concentra’s outstanding term loans, and to pay related fees and expenses.

The notes and related guarantees are being offered in a private placement, solely to qualified institutional buyers in reliance on Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"), or outside the United States to persons other than "U.S. persons" in compliance with Regulation S under the Securities Act. The notes and related guarantees have not been registered under the Securities Act or the securities laws of any other jurisdiction and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements.

This notice does not constitute an offer to sell the notes, nor a solicitation for an offer to purchase the notes, in any jurisdiction in which such offer or solicitation would be unlawful. Any offer of the notes will be made only by means of a private offering memorandum. This press release is being issued pursuant to and in accordance with Rule 135c under the Securities Act.