On January 23, 2018 Tmunity Therapeutics, Inc., a private clinical-stage biotherapeutics company focused on saving and improving lives by delivering the full potential of next-generation T cell immunotherapy, reported the closing of a $100 million Series A financing (Press release, Tmunity Therapeutics, JAN 23, 2018, View Source [SID1234523496]). Syndicate investors, which include Ping An Ventures, Parker Institute for Cancer Immunotherapy, Gilead Sciences, Inc. and Be The Match BioTherapies, join seed round investors, the University of Pennsylvania and Lilly Asia Ventures. Tmunity is developing a diversified portfolio of novel treatments that exhibit best-in-class control over T cell activation and direction in the body. The proceeds from the Series A will be used to advance and expand the business and operational structure of Tmunity to support the rapid translation, development and manufacture of its portfolio of novel T cell based immunotherapies, first for the treatment of cancer.

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"Tmunity was created to integrate and advance proprietary, novel approaches to cell and gene therapies and we have pursued an equally unique approach to the selection of our visionary funding partners," said Usman "Oz" Azam, M.D., President and Chief Executive Officer of Tmunity. "Our mix of investors brings together global leaders in healthcare services and biopharmaceuticals in Ping An Ventures and Gilead, the visionary philanthropy of the Parker Institute for Cancer Immunotherapy, and Be The Match BioTherapies. Together, they share a common passion to work together to drive the next-generation of personalized therapies for patients. We appreciate their confidence in – and vision for – Tmunity to deliver on that potential. This is a very exciting time for us."

Pursuing Integrated Approaches to Engineered T Cell Therapies Leveraging Proprietary and External Technologies and Scientific Insight from the University of Pennsylvania

Tmunity was founded on an exclusive collaboration and license agreement with the University of Pennsylvania, offering proprietary technologies and unparalleled expertise in first-in-patient cell and gene therapies of its scientific founders, led by Carl H. June, M.D. Today, Tmunity is uniquely positioned to integrate the best technologies and pursue multiple approaches to engineered T cell therapies simultaneously in order to advance treatments into the clinic rapidly, optimize and scale manufacturing, pursue regulatory approvals aggressively, and thus deliver them effectively to patients.

"Tmunity is unlike any other cell-based immunotherapy ‘start-up’ because of the unrivaled expertise of its scientific founders and leadership team in cell and gene therapy and its proven translational and manufacturing success in T cell medicine," said Jiang Zhang, Managing Partner of Ping An Ventures. "We were also attracted to the global potential of the pipeline, especially the T cell therapies in oncology in China, as well as the scope beyond oncology into autoimmune and infectious diseases, as we begin to expand our investment portfolio."

About Series A Round Investors

Ping An Ventures

Ping An Ventures is the direct investment arm under Ping An Insurance (Group) Company of China, Ltd., one of the largest and most valuable financial service conglomerates in the world, ranked No. 39 on the Global Fortune 500. Ping An Ventures invests in healthcare industry in all stages with a specific focus on both growth-stage and PIPE investment. With multi-billion dollars asset under management in multiple funds, the investment team has invested in over 50 companies globally, covering all sectors in healthcare: Biotech, Diagnostics, Medical Device, Services, Healthcare IT, etc. The investment team includes many industry and financial veterans, and commits to discovering and helping fast-growing and leading healthcare companies in their sectors. For more information, visit www.pinganventures.com.

Parker Institute for Cancer Immunotherapy

The Parker Institute for Cancer Immunotherapy brings together the best scientists, clinicians and industry partners to build a smarter and more coordinated cancer immunotherapy research effort. The Parker Institute is an unprecedented collaboration between the country’s leading immunologists and cancer centers. The program started by providing institutional support to six academic centers, including Memorial Sloan Kettering Cancer Center, Stanford Medicine, the University of California, Los Angeles, the University of California, San Francisco, the University of Pennsylvania and The University of Texas MD Anderson Cancer Center. Recently, the institute also initiated programmatic support for top immunotherapy investigators, including a group of researchers at Dana-Farber Cancer Institute, Robert Schreiber, Ph.D., of Washington University School of Medicine in St. Louis, Nina Bhardwaj, M.D., Ph.D., of the Icahn School of Medicine at Mount Sinai and Phil Greenberg, M.D., of the Fred Hutchinson Cancer Research Center. The Parker Institute network also includes more than 40 industry collaborations, more than 60 labs and more than 300 of the nation’s top researchers focused on treating the deadliest cancers. The goal is to accelerate the development of breakthrough immune therapies capable of turning most cancers into curable diseases. The institute was created through a $250 million grant from The Parker Foundation. For more information, visit www.parkerici.org.

Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California. For more information, visit www.gilead.com.

Be The Match

Be The Match BioTherapies partners with organizations pursuing life-saving cellular therapies in every stage of development – from discovery through commercialization. The organization is built on the foundation established over the last 30 years by the National Marrow Donor Program (NMDP)/Be The Match, with unparalleled experience managing cellular therapies. Be The Match BioTherapies offers customizable solutions, such as cell therapy supply chain delivery for autologous or allogeneic therapies, enabled by high-touch, personalized case management and a robust, customizable technology platform, MatchSourceSM. Experience in cell sourcing and collection allows Be The Match BioTherapies to provide cells consented for research, clinical or commercial use. Researchers have access to clinical trial services through a partnership with the CIBMTR (Center for International Blood and Marrow Transplant Research). In addition, Be The Match BioTherapies has the infrastructure in place to collect, store and analyze patient samples post-cell or gene therapy treatment at the time points required by regulatory authorities. For more information, visit BeTheMatchBioTherapies.com.

On January 24, 2018 Novartis CEO Joe Jimenez reported fourth quarter and full year 2017 results (Press release, Novartis, JAN 23, 2018, View Source [SID1234523565]). In his remarks Jimenez said: "It was a landmark year for innovation resulting in a rich late-stage pipeline. With several key launches on the horizon and our new operating model in place, Novartis is poised for sustainable growth."

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Vas Narasimhan, designated CEO from February 1, commented: "I want to thank Joe and the Board for their leadership and guidance as I transition to my new role. I feel privileged to lead Novartis at this exciting time."

On January 23, 2018 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a company working to improve patient lives by providing high quality biologics manufacturing services to biotechnology and pharmaceutical companies, reported that its president and chief executive officer, Roger J. Lias, Ph.D., will deliver a corporate presentation at NobleCon14 – Noble Financial Capital Markets’ Fourteenth Annual Investor Conference, being held January 29-30, 2018 at the W Fort Lauderdale Beach Hotel in Fort Lauderdale, Florida (Press release, Peregrine Pharmaceuticals, JAN 23, 2018, View Source [SID1234523566]).

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Details of this presentation are as follows:

NobleCon14
Time/Date: 11:30 a.m. ET on Monday, January 29, 2018
Location: W Fort Lauderdale Beach Hotel
Room: Studio 1
Avid’s presentation at NobleCon14 will be webcast live and available for replay at: View Source

On January 22, 2018 Celgene Corporation (NASDAQ: CELG) and Juno Therapeutics, Inc. (NASDAQ: JUNO) reported the signing of a definitive merger agreement in which Celgene has agreed to acquire Juno (Press release, Juno, JAN 22, 2018, View Source [SID1234523416]). Under the terms of the merger agreement, Celgene will pay $87 per share in cash, or a total of approximately $9 billion, net of cash and marketable securities acquired and Juno shares already owned by Celgene (approximately 9.7% of outstanding shares). The transaction was approved by the boards of directors of both companies.

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Juno is a pioneer in the development of CAR (chimeric antigen receptor) T and TCR (T cell receptor) therapeutics with a broad, novel portfolio evaluating multiple targets and cancer indications. Adding to Celgene’s lymphoma program, JCAR017 (lisocabtagene maraleucel; liso-cel) represents a potentially best-in-class CD19-directed CAR T currently in a pivotal program for relapsed and/or refractory diffuse large B-cell lymphoma (DLBCL). Regulatory approval for JCAR017 in the U.S. is expected in 2019 with potential global peak sales of approximately $3 billion.

"The acquisition of Juno builds on our shared vision to discover and develop transformative medicines for patients with incurable blood cancers," said Mark J. Alles, Celgene’s Chief Executive Officer. "Juno’s advanced cellular immunotherapy portfolio and research capabilities strengthen Celgene’s global leadership in hematology and adds new drivers for growth beyond 2020."

"The people at Juno channel their passion for science and patients towards a common goal of finding cures by creating cell therapies that help people live longer, better lives," said Hans Bishop, Juno’s President and Chief Executive Officer. "Continuing this work will take scientific prowess, manufacturing excellence and global reach. This union will provide all three."

The acquisition will also add a novel scientific platform and scalable manufacturing capabilities which will complement Celgene’s leadership in hematology and oncology. In collaboration with Juno’s team in Seattle, Celgene plans to expand its existing center of excellence for immuno-oncology translational medicine by leveraging Juno’s research and development facility in Seattle, WA as well as Juno’s manufacturing facility in Bothell, WA.

Strategic Rationale for Acquiring Juno

Upon completion of the acquisition of Juno, Celgene will be positioned to become a preeminent cellular immunotherapy company. The strategic advantages of this acquisition will include the opportunity to:

• Leverage a novel scientific platform and scalable manufacturing capabilities to position Celgene at the forefront of future advances in the science of cellular immunotherapy

• Accelerate Juno’s pipeline development to capture the full potential of cellular immunotherapy

• JCAR017, a pivotal stage asset, with an emerging favorable profile in DLBCL, is expected to add approximately $3 billion in peak sales and significantly strengthen Celgene’s lymphoma portfolio

• JCARH125 will enhance Celgene’s campaign against BCMA (B-cell maturation antigen), a key target in multiple myeloma

• Additional cellular therapy assets in proof-of-concept trials for hematologic malignancies and solid tumors will add to Celgene’s existing pipeline

• Accelerate revenue diversification with meaningful growth drivers beyond 2020

• Capture 100% of the global economics on all Juno’s cellular immunotherapy assets
Terms of the Agreement

Celgene will acquire all the outstanding shares of common stock of Juno through a tender offer for $87 per share in cash, or an aggregate of approximately $9 billion, net of cash and marketable securities acquired and Juno shares already owned by Celgene. The transaction has been approved by the boards of directors of both companies and is subject to customary closing conditions, including the tender of a number of shares of Juno common stock, that when taken together with the shares of Juno common stock already directly and indirectly owned by Celgene, represent at least a majority of outstanding shares of Juno common stock, and expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The transaction is anticipated to close in Q1:18.

Celgene expects to fund the transaction through a combination of existing cash and new debt. The resulting capital structure will be consistent with Celgene’s historical financial strategy and strong investment grade profile providing the financial flexibility to pursue Celgene’s strategic priorities and take actions to drive post 2020 growth.

The acquisition is expected to be dilutive to adjusted EPS (earnings per share) in 2018 by approximately $0.50 and is expected to be incrementally additive to net product sales in 2020. There is no change to the previously disclosed 2020 financial targets of total net product sales of $19 billion to $20 billion and adjusted EPS greater than $12.50.

J.P. Morgan Securities LLC is acting as financial advisor to Celgene on the transaction. Morgan Stanley & Co. LLC is acting as financial advisor to Juno. Legal counsel for Celgene is Proskauer Rose LLP and Hogan Lovells, and Juno’s legal counsel is Skadden, Arps, Slate, Meagher and Flom, LLP.

On January 22, 2018 Enzo Biochem, Inc. (NYSE:ENZ), an integrated diagnostics company, reported validation of a cervical cancer biomarker detection test that provides a highly robust and cost-efficient solution for anatomical pathology (Press release, Enzo Biochem, JAN 22, 2018, View Source [SID1234523414]).

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Specifically, Enzo’s validated p16, a marker used extensively as a key diagnostic and prognostic biomarker of several cancers, is the latest addition to the company’s growing immunohistochemistry pipeline, including, among others, Ki-67, Her2 and p53.

Enzo’s validated p16 provides clear detection of tissue abnormalities in the field of cancer diagnostics, including cervical cancer’s progression. It complements the company’s POLYVIEW immunochemistry detection, the recent subject of a favorable article in the prestigious peer-reviewed Annals of Diagnostic Pathology. The article cited POLYVIEW as having no false-positives in tests unlike some of the leading products in the field, which were found to have large percentages of false-positives that could lead to unnecessary, costly and time-consuming interventions.

With current mounting cost and reimbursement pressures, Enzo’s new p16 test provides a highly cost-effective alternative. Other p16 tests on the market have of late become unaffordable as a result of increasing reagent costs outweighing average reimbursements. When p16 is used in combination with Enzo’s POLYVIEW detection system’s reduction of false-positives, the economics are substantially enhanced. This and other similar compounds comprise a $200 million market.

In an era of high product costs and shrinking reimbursements, Enzo has positioned itself as a growing provider of high quality, cost-effective tests that provide value in bolstering diagnostics profit margins.

"We launched our immunohistochemistry tests in response to market leaders raising prices," said Elazar Rabbani, Ph.D., Enzo CEO and Chairman. "By developing our own p16, Ki-67, and p53 tests, among others, and the fact that we have a truly unique integrated capability to develop, evaluate and manufacture these and other diagnostics, we believe we can alleviate pressure on clinical labs by providing low cost, clinically relevant products and services, which is what we are engaged in doing."

The expanded Anatomical Pathology global program at Enzo offers cost-effective clinically relevant solutions, enhances Enzo’s ongoing collaborations with clinical partners, and expands the company’s clinical and reference services nationwide. This complements Enzo’s long standing position within the women’s health field with a focus on cervical cancer testing dating back to the launch of the first in situ HPV cervical cancer detection system in the early 1980’s. In addition to these products, Enzo’s portfolio includes a line of assays for identification of women’s health infectious diseases as well as for the quantification of viral load in serum or plasma specimens.