The equity research company KEPLER CHEUVREUX initiates the coverage of ONXEO with a “Buy” recommendation

On July 1, 2019 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), (hereinafter "Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR) in oncology, in particular against rare or resistant cancers, reported the publication of an initiation report by KEPLER CHEUVREUX, a leading independent European financial services company specialized in research, execution and advisory services (Press release, Onxeo, JUL 1, 2019, View Source [SID1234537341]).

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KEPLER CHEUVREUX will now cover the ONXEO share on the stock exchange*.

The financial analysis published on June 28, 2019 by Kepler Cheuvreux is available on the website View Source, section "Research Public Access".

* This information does not constitute an offer to sell or subscribe, or the solicitation of an order to buy or subscribe for securities in France, Europe, the US or any other country. ONXEO and KEPLER CHEUVREUX have agreed on a service for the production and distribution of financial analyses.

NANOBIOTIX ANNOUNCES NEW ORGANIZATIONAL STRUCTURE AS THE COMPANY ENTERS ITS NEXT STAGE AFTER FIRST EUROPEAN MARKET APPROVAL

On July 1, 2019 NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported organizational changes to align with strategic priorities post European market approval for Hensify (NBTXR3) (Press release, Nanobiotix, JUL 1, 2019, View Source [SID1234537340]). The changes aim to reinforce necessary competencies as strategic priorities evolve, and to help accelerate the company’s longstanding mission to significantly improve outcomes for patients.

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New C-level Appointments and Executive Board Members
Recently appointed CMO Dr. Edwina Baskin-Bey will join the Executive Board. Ms. Anne-Juliette Hermant will be appointed CPO and will join the Executive Board as well.

C-level and Executive Board Departures
As mentioned in a previous press release, former CMO Dr. Elsa Borghi will leave the Executive Board to take on a new function leading innovation and drug discovery. CBO Dr. Bernd Muehlenweg will step down from the Executive Board and exit the company.

New Management Appointments and Responsibilities
Dr. Patrick Tricoli will remain CEO of Nanobiotix Corp, the company’s U.S. affiliate, while also taking on a new role as Global Head of Business Development. Mr. Brandon Owens will join Nanobiotix as its newly appointed VP of Strategic Marketing and Corporate Communications.

Newcomer Biographical Details
Ms. Anne-Juliette Hermant Anne-Juliette Hermant brings over 14 years of experience in HR, talent management and development, acquired across various entities at AXA. Ms. Hermant worked at AXA Partners for 3 years as Global Head of Talent, Development, Culture and Corporate Responsibility. Before AXA Partners, Anne-Juliette served as Chief Learning Officer of the AXA Group and was the Founder and Head of the AXA Research Fund, a €100 million fund created by the AXA Group to support frontier science in all fields related to an understanding of the risks faced by human society. 2 Anne-Juliette was born in Strasbourg, France and grew up between the French overseas territories of Guyane, Martinique and Guadeloupe. She relocated to Lyon and then to Paris to pursue her studies and has remained in the city throughout her career. Anne-Juliette graduated from the Ecole Normale Supérieure and studied Politics at Sciences Po Paris. She holds an Agregation and an M.A. in French literature.

Mr. Brandon Owens Brandon
Owens is a career communications professional that most recently functioned as a Vice President on the Citigroup account at Publicis New York. Mr. Owens was responsible for Citi’s global reputation management communications and focused on integrated campaigns meant to influence policy decisions relevant to banking in over 100 different countries.

Prior to Publicis, Brandon worked at agencies in both New York and Chicago, leading accounts including Procter and Gamble, Verizon Wireless, and Diageo.

Originally, Brandon comes from the Washington, D.C. area of the United States. After starting his career in sales for a small software firm in Baltimore, Maryland, he moved to Chicago to begin his career in advertising. From there he moved to New York City where he presently resides.

Brandon received his B.S. in Business from the Robert H. Smith School of Business at the University of Maryland.

Cytori Reports Summary of FDA Feedback Regarding its ATI-1123 Product

On July 1, 2019 Cytori Therapeutics, Inc. (NASDAQ: CYTX) reported an update on the development of its proprietary drug, ATI-1123, based on recently obtained feedback from the United States Food and Drug Administration (FDA) (Press release, Cytori Therapeutics, JUL 1, 2019, View Source [SID1234537339]). ATI-1123 is a substantially redesigned and reformulated new drug based in part, on the active pharmaceutical ingredient, docetaxel. ATI-1123 may have future clinical utility in a number of difficult to treat cancers.

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The purpose of the Company’s submission was to clarify certain key aspects of the future development plan including: (1) the suitability of the 505(b)(2) pathway for approval of the proposed ATI-1123 drug product, including the proposed listed drug (LD), (2) the adequacy of the referenced clinical, nonclinical and pharmaceutical quality information, in combination with the proposed drug development program, to support the new drug application and (3) any concerns that the FDA may have with regard to other filing issues specific to the product.

Key feedback from the FDA included that a 505(b)(2) application appears to be an acceptable regulatory approach with docetaxel injection as a potentially acceptable LD. Furthermore, the FDA agreed that the completed nonclinical studies are sufficient to support the initiation of the clinical trial of ATI-1123 in patients with platinum-sensitive small cell lung cancer who have progressed at least 60 days after initiation of first-line therapy.

"Small cell lung cancer is an aggressive neuroendocrine malignancy characterized by high metastatic potential and poor relative outcomes," said Dr. Marc H. Hedrick, M.D. "Due to the propensity of small cell lung cancer to metastasize widely and early in the disease course, it is considered the most lethal lung cancer subtype and new therapies such as ATI-1123, are desperately needed for these patients."

ATI-1123 has completed a phase I trial. Based on the FDA feedback, the Company plans to proceed with a follow-on phase II trial in platinum-sensitive small cell lung cancer who have progressed at least 60 days after initiation of first-line chemotherapy.

Century Therapeutics launches with USD 250M financing for induced pluripotent stem cells (iPSC) allogeneic cell therapy platform

On July 1, 2019 Century Therapeutics, a Versant Ventures-created company developing allogeneic or off-the-shelf immune cell therapies for cancer, reported with USD 250 million in financing commitments from Bayer, Versant and Fujifilm Cellular Dynamics Inc. (FCDI) (Press release, Bayer, JUL 1, 2019, View Source [SID1234537338]). The proceeds will enable Century to advance multiple programs into the clinic for hematologic and solid malignancies.

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Century’s foundational technology is built on induced pluripotent stem cells (iPSCs) that have unlimited self-renewing capacity. This enables multiple rounds of cellular engineering to produce master cell banks of modified cells that can be expanded and differentiated into immune effector cells to supply vast amounts of allogeneic, homogeneous therapeutic products. This platform differentiates Century from competitors that are developing cell therapies made from non-renewable donor-derived cells.

Today’s announcement establishes Leaps by Bayer as an integral partner in Century’s investor syndicate. Leaps by Bayer, the venture investment arm of the global life sciences company Bayer, is dedicated to making paradigm-shifting advances in the life sciences.

Curing and preventing cancer is one of the main focus areas of Leaps by Bayer, since this disease still represents one of today’s biggest health concerns with limited curative or preventative therapies available. Dr. Juergen Eckhardt, head of Leaps by Bayer, said: "We are very excited about the potential of Century’s platform. It represents a unique opportunity in the development of next generation cell therapies that promise to address previously incurable cancers."

Century was founded by Versant in 2018 and later that year formed a strategic partnership with FCDI, a subsidiary of Fujifilm Corporation, to develop iPSC-derived immune effector cells for cancer. FCDI’s vertically integrated iPSC platform has been optimized over the last 15 years to include the foremost reprograming technology that uses genome integration-free methods to generate GMP grade iPSC lines. Century also has exclusive access to FCDI’s leading immune effector cell differentiation protocols and intellectual property to manufacture GMP-grade immune effector cells at commercial scale. Under the terms of the iPSC platform license agreement, FCDI will serve as the primary manufacturer of Century’s cellular products.

"Versant believes that allogeneic reagents represent the next wave of innovation in cell therapy and created Century to engineer truly off-the-shelf products to treat both hematologic and solid tumors," said Carlo Rizzuto, PhD., a Versant partner and Century director. "Today’s financing marks an important milestone in our effort to enable cell therapies to treat a much broader array of cancer patients."

"Fujifilm’s mission is to bring new value to society through innovation and the creation of new technologies, products and services. We are confident that FCDI’s cutting edge iPSC technologies and promising regenerative medicine solutions currently under development, can create new value to fulfill unmet medical needs and improve the lives of patients around the world," said Toshikazu Ban, Corporate Vice President of Fujifilm Corporation. "By accelerating development of new cancer immunotherapies using allogeneic iPSC through Century, we aim to deliver the therapy to patients as soon as possible."

"The financial support and expertise from this consortium of partners will enable Century to realize the full potential of our iPSC platform and expand patient access to cell therapy," said Lalo Flores, PhD., CEO of Century. "I am grateful to have their experience to guide the development of our promising allogeneic cell therapies for cancers with high unmet need."

In addition to Dr. Flores, Century has attracted a highly experienced team in cell therapy research and development that includes Hyam Levitsky, MD, President of Research and Development; Luis Borges, PhD., Chief Scientific Officer; and Adrienne Farid, PhD., Chief Development Officer. The company also has a pair of world renowned scientific co-founders including Marcela Maus, MD, PhD., assistant professor of medicine at Harvard Medical School and director of the Cellular Immunotherapy Cancer Center at Massachusetts General Hospital, and Hiro Nakauchi, MD, PhD., professor of genetics at Stanford University School of Medicine.