On November 14, 2018 Agilent Technologies Inc. (NYSE: A) reported it has completed the acquisition of ACEA Biosciences Inc. (ACEA), a developer of cutting-edge cell analysis tools, for $250 million in cash (Press release, Agilent, NOV 14, 2018, View Source [SID1234531314]). This acquisition brings together two pioneers in cellular function and metabolism measurements focused on real-time, live cell analyses.

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ACEA has developed two ground-breaking platforms that are complementary to Agilent’s current portfolio. The ACEA xCELLigence RTCA technology is a unique impedance platform for label-free, real-time cellular function measurements used in immuno-oncology, pre-clinical drug discovery and development, as well as in basic academic research. This technology is complemented by the introduction in recent years of the NovoCyte and NovoCyte Quanteon portfolio of high performance bench top flow cytometry systems.

ACEA also markets a clinical configuration of the NovoCyte platform, currently commercialized in China. This provides a unique opportunity in combination with Agilent’s Reagent Partnership business within Agilent’s Diagnostics and Genomics Group which provides reagents for flow cytometry.

"The Agilent and ACEA teams are united by a common goal to provide the most innovative high-performance solutions for cell analysis," said Todd Christian, Vice President & General Manager of Agilent’s Cell Analysis Division. "We are excited for the opportunities we have as a newly combined team to provide the most advanced tools for scientists performing cell analysis workflows."

ACEA is Agilent’s second acquisition this year in the cell analysis space. In January, Agilent acquired Luxcel Biosciences, a developer of real-time fluorescence plate-reader based in vitro cell assay kits. Cell analysis is a key area of strategic focus for Agilent.

ACEA was founded in 2002 and has its headquarters in San Diego and a large manufacturing and R&D footprint in Hangzhou, China. More than 2,500 ACEA instruments have been placed globally and have been used in more than 1,800 peer-reviewed publications.

On November 14, 2018 Rexahn Pharmaceuticals, Inc. (NYSE American: RNN), a clinical stage biopharmaceutical company developing innovative therapies to improve outcomes in cancers that are difficult to treat, reported that Douglas J. Swirsky, who has served as Rexahn’s president and chief financial officer since January 2018, has been named the company’s president and chief executive officer and appointed to the company’s board of directors effective immediately (Press release, Rexahn, NOV 14, 2018, View Source [SID1234531477]). Peter D. Suzdak, Ph.D., chief executive officer, has departed the company and resigned as a member of its board of directors.

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"On behalf of the board and everyone at Rexahn, I want to thank Peter Suzdak for his contributions to the company over the past six years," said Peter Brandt, chairman of the board of directors. "The board is confident that Doug has the experience and creativity to deliver on the promise of Rexahn’s innovative pipeline and lead the company forward through substantial value-creating milestones."

"I am excited about the future of Rexahn and believe significant opportunities exist to transform Rexahn into an industry-leading, cancer-focused company. I look forward to working with the board, the executive team and all stakeholders to achieve this goal," said Mr. Swirsky.

Prior to joining Rexahn, Mr. Swirsky was CEO and a director of GenVec, Inc., a publicly traded biotechnology company, a position he held from 2013 through the sale of the company in 2017. He also served as GenVec’s CFO from 2006 until he assumed the role of CEO in 2013. Prior to joining GenVec, Mr. Swirsky was a managing director and the head of life sciences investment banking at Stifel Nicolaus from 2005 to 2006 and held investment banking positions at Legg Mason from 2002 until Stifel Financial’s acquisition of the Legg Mason Capital Markets business in 2005. He has also previously held investment banking positions at UBS, PaineWebber and Morgan Stanley. Mr. Swirsky currently serves on the board of directors of Fibrocell Science, Inc., Cellectar Biosciences, Inc. and Pernix Therapeutics Holdings, Inc. He is a certified public accountant and a CFA charter holder. He received his B.S. in Business Administration from Boston University and his M.B.A. from the Kellogg School of Management at Northwestern University.

Mr. Swirsky will also continue to serve as the company’s principal financial officer.

On November 14, 2018 Precision BioSciences (Precision) and MaxCyte reported they have entered into a non-exclusive, clinical and commercial license agreement that will allow Precision to use MaxCyte’s Flow Electroporation technologies to robustly deliver Precision’s proprietary ARCUS genome-editing technology for use in next-generation gene edited allogeneic T-cell immunotherapies designed to treat a broad range of cancers (Press release, MaxCyte, NOV 14, 2018, View Source [SID1234537623]).

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David Thomson, Chief Development Officer of Precision, expressed his support for the agreement, noting, "Precision’s therapeutic grade ARCUS editing platform is sufficiently compact and specific to use with a range of delivery systems. In considering these, we have found MaxCyte’s electroporation technology complements our approach to allogeneic T cell manufacturing, which is focused on preserving cell quality throughout the process while maximizing overall yield."

The clinical and commercial license builds upon an existing research and clinical license agreement between Precision and MaxCyte for the delivery of Precision’s ARCUS technology into T-cells. MaxCyte will supply its technology platform to Precision as part of the license agreement and will receive future payments including milestones and technology access licensing fees.

"The initiation of this commercial license agreement with Precision, a leader in genome editing with its own proprietary ARCUS technology, signifies a key milestone for MaxCyte and demonstrates the value and versatility of our platform, our intellectual property, and our ability to foster important collaborations with companies generating life-changing gene therapies," said Doug Doerfler, President & CEO of MaxCyte, Inc.

MaxCyte’s Flow Electroporation Technology enables the engineering of a variety of therapeutically-relevant cell types at high efficiency while maintaining high viability and recovery. Precision’s lead allogeneic CAR T programs rely on genome editing, where ARCUS tools are used to transform healthy donor cells into therapeutics using the MaxCyte technology. These cell therapies can specifically target cancer cells in patients, potentially enabling a unique and specialized approach to cancer treatment.

On November 14, 2018 On November 9, 2018, Adhera Therapeutics, Inc. (the "Company") entered into Subscription Agreements (the "Purchase Agreements") with certain accredited investors and conducted a closing pursuant to which the Company sold 73 shares of the Company’s Series F convertible preferred stock, par value of $0.01 per share (the "Preferred Stock"), at a purchase price of $5,000 per share of Preferred Stock (Filing, 8-K, Marina Biotech, NOV 14, 2018, View Source [SID1234531299]). Each share of Preferred Stock is initially convertible into shares of the Company’s common stock, par value $0.006 per share (the "Common Stock"), at a conversion price of $0.50 per share of Common Stock. In addition, each investor received a 5-year warrant (the "Warrants", and collectively with the Preferred Stock, the "Securities", and the offering of the Securities, the "Private Placement") to purchase 0.75 shares of Common Stock for each share of Common Stock issuable upon the conversion of the Preferred Stock purchased by such investor at an exercise price equal to $0.55 per share of Common Stock, subject to adjustment thereunder.

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The Company received total net proceeds of approximately $0.31 million from the issuance of the Securities described above, after deducting placement agent fees and estimated expenses payable by the Company associated with such closing. The Company intends to use the proceeds of the Private Placement to fund its commercial operations relating to the sale and promotion of the Company’s Prestalia product and the potential acquisition of additional commercial assets. Prestalia is a single-pill fixed dose combination of perindopril arginine, an angiotensin-converting-enzyme inhibitor, and amlodipine besylate, a calcium channel blocker, which has been approved by the U.S. Food and Drug Administration and is actively marketed in the U.S.

The Securities were being offered and sold in a private placement pursuant to exemptions from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), afforded by Section 4(a)(2) and Rule 506(b) of Regulation D promulgated thereunder. To the extent that any shares of Common Stock are issued in connection with the conversion of the Preferred Stock or the exercise of the Warrants, the Common Stock may not be offered, transferred or sold in the United States absent registration or the availability of an applicable exemption from the registration requirements of the Securities Act.

The rights, preferences and privileges of the Preferred Stock are set forth in a Certificate of Designation of Preferences, Rights and Limitations of the Series F Convertible Preferred Stock of Adhera Therapeutics, Inc. (the "Certificate of Designation") that was filed with the Secretary of State of the State of Delaware on July 11, 2018. The Certificate of Designation was filed as Exhibit 3.1 to the Current Report on Form 8-K that the Company filed with the Securities and Exchange Commission on July 16, 2018 (the "July 8-K"), and the rights, preferences and privileges of the Preferred Stock were summarized in the July 8-K. The form of Warrant that was issued at the Closing was filed as Exhibit 4.1 to the July 8-K, and the terms and provisions thereof were summarized in the July 8-K.

The foregoing summaries of the material terms and provisions of the Certificate of Designation and the form of Warrant are not complete and are qualified in their entirety by reference to the full text thereof, copies of each of which are filed herewith as Exhibits 3.1 and 4.1, respectively, and incorporated by reference herein.

On November 14, 2018 Five Prime Therapeutics, Inc. (Nasdaq: FPRX), a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, reported it initiated patient dosing in a Phase 1 clinical trial of FPT155, a first-in-class CD80 fusion protein (Press release, Five Prime Therapeutics, NOV 14, 2018, View Source [SID1234531315]). The trial was initiated in Australia.

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"We are pleased to initiate patient dosing for FPT155, our first-in-class CD80-Fc fusion protein, which is engineered to activate T cells through multiple pathways," said Helen Collins, M.D., Senior Vice President and Chief Medical Officer of Five Prime. "In vivo, FPT155 demonstrates strong single-agent activity in multiple preclinical models, including some that are generally resistant to immune-modulating therapy. We look forward to testing FPT155 in the clinic to see if it has the potential to improve outcomes across multiple tumor indications where new treatment options are needed."

"FPT155 is further evidence of Five Prime executing on the strategy of leveraging our IND engine as a source of competitive advantage in developing first-in-class agents that have the potential to demonstrate single-agent activity or activity in tumors that typically do not respond to checkpoint inhibitors," said Aron Knickerbocker, Chief Executive Officer of Five Prime Therapeutics. "Beyond FPT155, this strategy can be seen across our robust pipeline, including with cabiralizumab, bemarituzumab and FPA150. These drug candidates target or engage multiple cells in the tumor microenvironment, including tumor cells, effector T cells, macrophages and NK cells."

The Phase 1a/1b open-label, multicenter, dose escalation, dose exploration and dose expansion study will evaluate the safety and tolerability of FPT155 in patients with advanced solid tumors. The Phase 1a dose escalation portion of the trial will characterize the safety and pharmacokinetic (PK)/pharmacodynamic (PD) profile of FPT155 and will identify a recommended dose for the Phase 1b portion of the trial. During the dose escalation, Five Prime will also open an exploratory cohort to investigate FPT155 monotherapy in select tumor types with high unmet need. The Phase 1b portion of the trial is intended to further characterize the safety, PK/PD profile, and preliminary efficacy of FPT155.

About FPT155

FPT155 is a first-in-class CD80 fusion protein that (i) directly engages CD28 to enhance its co-stimulatory T-cell activation activity without inducing super agonism, and (ii) blocks CTLA-4 from competing for endogenous CD80, allowing CD28 signaling to prevail in T-cell activation in the tumor microenvironment. FPT155 has also demonstrated its ability to retain anti-tumor activity independent of its engagement with CTLA-4, suggesting a differentiated mechanism of action from CTLA-4-blocking antibodies. Studies in preclinical models suggest FPT155 has the potential to be a potent T-cell co-stimulator with strong monotherapy anti-tumor activity.