On January 2, 2020 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for Lumoxiti (moxetumomab pasudotox-tdfk), a first-in-class medicine indicated for adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog (Press release, Innate Pharma, JAN 2, 2020, View Source [SID1234552647]).

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"If approved by the EMA, Lumoxiti will be the first treatment available in Europe for relapsed or refractory hairy cell leukemia patients in more than twenty years, potentially changing the standard of care for these patients," commented Pierre Dodion, MD, Executive Vice President and Chief Medical Officer of Innate Pharma. "We are dedicated in addressing the unmet need in this rare form of cancer that can result in serious and life-threatening conditions, and as such, are hopeful we can bring this important medicine to patients in Europe as soon as possible."

The EMA filing is based on the final analysis of the pivotal Phase III trial of Lumoxiti, presented at ASH (Free ASH Whitepaper) 2019 . These data showed that 36 percent (29/80) of the relapsed or refractory hairy cell leukemia patients achieved durable complete response, defined as a CR with a hematological remission maintained for at least 180 days. The objective response rate (ORR) was at 75 percent. Eighty-one percent of patients with CR experienced eradication of minimal residual disease as reflected by MRD-negative status. In addition, there was a 61 percent probability that patients who achieved a CR would maintain it after five years.

The EMA filling acceptance follows the U.S. Food and Drug Administration (FDA) approval of Lumoxiti in September 2018.

On January 1, 2020 Fountain Medical Development Limited ("Fountain Medical" or "Company"), a clinical stage CRO dedicated to offering high-quality one-stop services to pharmaceutical and medical device clients, reported that Mr. Ling Zhen, J.D., M.B.A., is appointed as the Co-Chairman of the Board of Directors and Chief Executive Officer (Press release, Fountain BioPharma, JAN 1, 2020, View Source [SID1234552646]).

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Mr. Zhen has over 25 years of professional experience in the CRO and life science industries, both in China and the US. Most recently, Mr. Zhen served as a Partner at Draper Dragon Venture Group, where he focused on biopharmaceutical and medical technology investments. Prior to that, Mr. Zhen spent over 12 years at IQVIA (previously known as Quintiles) where he served as a global Senior Vice President and the General Manager of Greater China. During this period, he helped to drive expansion and transform IQVIA China into the market leader, through innovative solutions and strategic growth in the region.

Prior to IQVIA and Quintiles, Mr. Zhen also worked in business development, portfolio management, and strategic consulting at world-leading companies such as Eli Lilly, GlaxoSmithKline and Ernst &Young in the US. Mr. Zhen holds a Master of Business Administration (MBA) degree from the Kelley School of Business in Indiana University and a Juris Doctor (JD) degree from the Law School of North Carolina Central University, and is a licensed attorney in the US.

"With the appointment of Mr. Ling Zhen as the Co-Chairman and CEO, Fountain Medical will be able to speed up its global expansion and strategic buildup, allowing us to better serve our existing and future clientele. His hands-on experience and strategic insight related to the CRO sector makes him the ideal leader to transform Fountain Medical into a China-centered, global full-service leading CRO," said Dr. Dan Zhang, Co-Chairman and Co-Founder of the Company.

"I feel very privileged to join Fountain Medical during this exciting time, where drug development and clinical research are undergoing transformational changes across China and rest of the world," said Mr. Zhen himself. "I look forward to working closely with Fountain Medical’s management team and shareholders, and developing a high-caliber team that delivers high-quality services, to help our customers accelerate the development of truly innovative therapies around the world."

On January 1, 2020 WuXi Biologics ("WuXi Bio") (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, reported its partner OncoImmune on the U.S. Food and Drug Administration (FDA) clearance of Investigational New Drug (IND) for ONC-392, a novel, next generation anti-CTLA-4 antibody (Press release, WuXi Biologics, JAN 1, 2020, View Source [SID1234552645]).

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As part of the collaboration, WuXi Biologics provided comprehensive and integrated services for the ONC-392 program, including CMC development and GMP manufacturing of the drug substance and drug product, through its world-class development and manufacturing capacities and capabilities.

"It has been our great pleasure working with WuXi Biologics on our ONC-392 program. The clearance of ONC-392 IND by the FDA is an important milestone for OncoImmune," said Yang Liu, PhD, Founder and CEO of OncoImmune. "WuXi Biologics’ state-of-the-art and full-service biologics platform enabled us to complete a solid CMC package in support of our IND submission and clearance. We are excited about the potential of this next generation anti-CTLA-4 antibody with its novel and differentiated mechanism of action to improve therapeutic outcomes while significantly reducing toxicity."

"Congratulations to OncoImmune on reaching this milestone for the ONC-392 program. We are glad to enable OncoImmune to accelerate the development of biologics from DNA to IND," said Dr. Chris Chen, CEO of WuXi Biologics. "We wish the program a great success to benefit more patients suffering from cancers. WuXi Biologics will continue empowering global partners to provide more life-saving treatments to meet health challenges."