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 Xspray Pharma reported the company has successfully carried out a directed share issue at a subscription price of SEK 73 per share (the "Issue") (Press release, Xspray, DEC 5, 2019, View Source [SID1234650106]). The subscription price is in line with the volume-weighted average price of the Xspray share during the last 30 days. The subscription price has been determined through an accelerated book-building procedure.

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A group of Swedish and international institutional investors, among others C WorldWide Asset Management, Fourth Swedish National Pension Fund, Swedbank Robur, TIN Fonder, Third Swedish National Pension Fund and Unionen have subscribed for shares in the Issue. The Company believes that using the flexibility provided by a non-pre-emptive placing is the most appropriate transaction structure at this time in order to raise capital for the development of ongoing projects in a time and cost-effective manner. Moreover, through the Issue, the Company will further strengthen the shareholder base with institutional investors.

The Company intends to use the net proceeds from the Issue to:

enhance the Company’s financial flexibility ahead of anticipated registration application of its lead product, HyNap-Dasa, in 2020 and anticipated deal making pertaining to the launch of this candidate;
establish second source manufacturing;
working capital requirement at expected listing on Nasdaq Stockholm’s Main Market during the first half of 2020;
continue to expand its product portfolio;
general corporate purposes.
The Issue is expected to raise proceeds for the Company of approximately SEK 122 million before transaction costs. The subscription price has been determined through an accelerated book-building procedure. The Issue will result in an increase in the number of shares in Xspray of 1,675,162, from 15,076,460 to 16,751,622, and an increase in the share capital by SEK 1,675,162, from SEK 15,076,460 to SEK 16,751,622, resulting in a dilution of approximately 10 percent.

In connection with the Issue, the Company has, with customary exceptions, agreed to a lock-up undertaking on future share issuances for a period of 90 days after the Issue. In addition, the management and Board of Directors have undertaken not to sell any shares in Xspray during the same period, subject to customary exceptions.

The reason for using the flexibility provided by a non-pre-emptive placing is to raise capital for the development of ongoing projectsand to further strengthen the Company’s shareholder base in a time and cost-effective manner.

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 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 Genmab A/S (Nasdaq: GMAB) reported that it has achieved a USD 100 million sales volume milestone in its DARZALEX (daratumumab) collaboration with Janssen Biotech, Inc (Press release, Genmab, DEC 5, 2019, View Source [SID1234551951]). The milestone was triggered by confirmation from Janssen that sales of DARZALEX reached USD 2.5 billion in a calendar year. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize DARZALEX.

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"We remain very pleased with the robust uptake seen with DARZALEX since its initial launch and with new approvals this year and potential approvals in 2020, we hope that it becomes even more widely available for the many multiple myeloma patients in need," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The milestone was included in the original financial guidance issued by Genmab on February 20, 2019, and in the improved financial guidance issued on November 6, 2019, as such there is no change to the company’s financial guidance for 2019.

About DARZALEX(daratumumab)
DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in Europe: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy2. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,2,3,4,5,6

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis, NKT-cell lymphoma and B-cell and T-cell ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.