Five Prime Therapeutics Appoints Tom Civik as Chief Executive Officer

On April 14, 2020 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, reported the appointment of Thomas Civik as President and Chief Executive Officer and a member of the Board of Directors of the company (Press release, Five Prime Therapeutics, APR 14, 2020, View Source [SID1234556303]). Mr. Civik joins Five Prime from Foundation Medicine, where he served as Chief Commercial Officer. William Ringo, who has served as interim CEO since September 2019 and as Chairman of the Board, will step down as CEO and will continue as Chairman of the Board of Directors.

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"We are delighted to attract an oncology leader of Tom’s stature to propel Five Prime to its next level of achievement," said William Ringo, interim Chief Executive Officer and Chairman of the Board. "Having led teams through the launch, commercialization and lifecycle development of several blockbuster oncology products, including some of the most revolutionary cancer treatments and diagnostics, Tom brings leadership experience to a strong executive team that will enable Five Prime to realize its full potential. I also look forward to my continued work at Five Prime providing important continuity as I work with Tom and the Executive Team in my capacity as Chairman."

Mr. Civik is an industry leader with more than 25 years of commercial and lifecycle management experience in the biotech, biopharma, and diagnostics sectors. At Foundation Medicine, Mr. Civik built a commercial and lifecycle management team that launched FoundationOne CDX, the first FDA approved pan-cancer comprehensive genomic test, and FoundationOne Liquid, a second-generation liquid biopsy test, in addition to expanding the company’s global footprint. Prior to that, Mr. Civik built a distinguished career as an oncology executive at Genentech where he commercialized new and established global brands such as Avastin, Tarceva, Tecentriq, and Alecensa.

"I’m thrilled to join this science-driven organization that has several novel products in the clinic, an impressive portfolio of compounds in preclinical development, and the financial discipline to allocate resources to the most promising opportunities," said Tom Civik. "I consider it an honor to work in the life sciences and I’m excited to contribute to fulfilling the Five Prime mission, which is to fundamentally improve the lives of oncology patients in ways never before possible. I look forward to working with the Five Prime team, our board of directors, our advisors, and our partners to have a meaningful impact on the lives of people with cancer."

Five Prime is focused on advancing its pipeline of proprietary programs in clinical development, novel late-stage research programs and partnered programs. The company remains on track to achieve program milestones and clinical data disclosures in 2020 that will allow the company to prioritize future pipeline investments. The company has also implemented measures in response to the COVID-19 pandemic to protect the health and safety of its employees and their families while still allowing the continued execution of the company’s operations and progress of its programs.

Personalis, Inc. Expands Genomics Portfolio Across Disease Areas With Launch of Pharma Research Solutions for Use in Early Drug Discovery and Preclinical Studies

On April 14, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported the launch of their Pharma Research Solutions, the latest expansion of the company’s portfolio of comprehensive genomics assays and analytics (Press release, Personalis, APR 14, 2020, View Source [SID1234556319]). These solutions, which leverage Personalis’ patented ACE Technology, are designed for use in early drug discovery and preclinical studies in oncology, but also other disease areas. These offerings complement Personalis’ comprehensive immunogenomics platform, ImmunoID NeXT, which is currently used for clinical biomarker and companion diagnostic development in translational research and clinical trials by the company’s pharmaceutical partners.

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"Our Pharma Research Solutions provide our customers with access to a broad suite of both proprietary and standard assays from targeted DNA and RNA panels through to whole genome and whole exome and transcriptome services. Our expansive sample processing and sequencing capacity, combined with our experience and expertise in executing large-scale projects as part of biopharma oncology clinical trials as well as the VA Million Veterans Program, makes us the ideal partner for pharmaceutical companies aiming to harmonize their genomics strategy across all preclinical and clinical programs," said John West, CEO of Personalis. "Additionally, we have seen increasing interest amongst our pharma partners in leveraging ImmunoID NeXT and other solutions in areas such as inflammatory disease and other genetic disorders. This represents both the broad applicability of our technology and a potentially large growth opportunity for our business."

The Pharma Research Solutions integrate Personalis’ ACE Technology to improve sequencing performance in complex, difficult-to-sequence regions of the genome that are insufficiently covered by conventional NGS approaches. The assays and bioinformatics capabilities offered by Personalis’ Pharma Research Solutions can enable the identification of novel drug targets and the generation of deeper insights into drug candidates’ mechanisms of action and associated resistance mechanisms in human and non-human models — in a cost-effective and highly-scalable manner. These solutions also facilitate the company’s pursuit of new, large-scale population sequencing projects. Every step in the process from nucleic acid extraction and library preparation through to sequencing is performed in a CLIA-certified/CAP-accredited laboratory, with downstream analysis conducted using a framework of advanced algorithms.

Genmab Announces Net Sales of DARZALEX® (daratumumab) for First Quarter of 2020

On April 14, 2020 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab) as reported by Johnson & Johnson were USD 937 million in the first quarter of 2020 (Press release, Genmab, APR 14, 2020, View Source [SID1234556304]). Net trade sales were USD 463 million in the U.S. and USD 474 million in the rest of the world. Genmab will receive royalties on the worldwide net sales of DARZALEX under the exclusive worldwide license to Janssen Biotech, Inc. to develop, manufacture and commercialize DARZALEX.

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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 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 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 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 relapsed or refractory multiple myeloma. 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

NOXXON to Present Latest Clinical Data From the NOX-A12 / Keytruda® Combination Trial in Colorectal and Pancreatic Cancer at the AACR Virtual Annual Meeting 2020

On April 14, 2020 NOXXON Pharma N.V. (Paris:ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that its poster titled "Phase 1/2 study with CXCL12 inhibitor NOX-A12 and pembrolizumab in patients with microsatellite-stable, metastatic colorectal or pancreatic cancer" has been selected for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting 2020 (Press release, NOXXON, APR 14, 2020, View Source [SID1234556320]). The presentation will include a short video and commentary by the first author, Dr. Niels Halama, from National Center for Tumor Diseases (NCT) in Heidelberg, Germany, who will present the latest pharmacodynamic, safety, survival and more mature clinical data from the trial.

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The presentation will be freely available upon registration on the AACR (Free AACR Whitepaper) website in the Virtual Poster Session section as of Monday, April 27, 2020, 06.00 p.m. CEST. The abstract will be posted online to the AACR (Free AACR Whitepaper) website on Monday, April 27, 2020.

On April 6, 2020, the Board of Directors of the AACR (Free AACR Whitepaper) had announced that due to the COVID-19 outbreak it would not organize an in-person Annual Meeting in 2020, originally scheduled for April 24-29 in San Diego, California. Instead, the AACR (Free AACR Whitepaper) will feature selected program and presentations in Virtual Annual Meetings, on April 27-28 and June 22-24.

AMN Healthcare to Host First Quarter 2020 Earnings Conference Call on Monday, May 11, 2020

On April 13, 2020 AMN Healthcare Services, Inc. (NYSE: AMN), the leader and innovator in total talent solutions for healthcare organizations, reported that it has scheduled a conference call to discuss its first quarter 2020 financial results on Monday, May 11, 2020 at 5:00 p.m. Eastern Time (Press release, AMN Healthcare Services, APR 13, 2020, View Source [SID1234556268]). The same day, the Company also expects to issue an earnings news release after market close at approximately 4:15 p.m. Eastern Time.

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A live webcast of the call can be accessed through AMN Healthcare’s website at View Source Please log in at least 10 minutes prior to the conference call in order to download the applicable audio software. Interested parties may participate live via telephone by dialing (844) 721-7241 in the U.S., or (409) 207-6955 for international callers, and using participant code 4038932. Following the conclusion of the call, a replay of the webcast will be available at the Company’s website. Alternatively, a telephonic replay of the call will be available beginning at 7 p.m. Eastern Time on May 11, 2020, and can be accessed until 11:59 p.m. Eastern Time on May 25, 2020 by calling (866) 207-1041 in the U.S. or (402) 970-0847 internationally, with access code 1880818.