On July 31, 2018 Laekna Inc., a biotechnology company headquartered in Shanghai, reported the signing of an agreement with Novartis Pharma AG for exclusive global rights to develop and commercialize two oral Novartis clinical-stage oncology assets (Press release, Laekna Therapeutics, JUL 31, 2018, View Source;article_id=32 [SID1234530438]). The candidates are oral pan-Akt kinase inhibitors. Over ten clinical Phase I/II studies for afuresertib (ASB183) and uprosertib (UPB795) have been conducted in several cancer indications including ovarian and gastric cancer, multiple myeloma, melanoma, and other indications. These trials demonstrated positive proof-of-concept results for clinical efficacy and tolerable safety profiles in cancer patients. Novartis will have an equity stake in Laekna, along with upfront and development milestone payments, and royalties on future sales. Details of the terms of the agreement were not disclosed.

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The Pten/PI3K/Akt signaling axis is one of the most critical oncogenic pathways driving cancer growth. Inhibiting this axis has been proven to be effective for many cancer patients, and early clinical results for afuresertib and uprosertib are extremely promising. Laekna has mapped out several clear registration paths for NDA approval potentially as the first in class medicine.

In 2017, Laekna struck its first deal with Novartis, acquiring global rights to develop a CYP17 inhibitor (CFG920), an oral androgen inhibitor, to treat prostate cancer. Before the in-licensing, Novartis had reported positive results from a proof-of-concept study of CFG920 in patients with metastatic castration-resistant prostate cancer.

"Novartis is a global leader in oncology drug innovation. This is the second licensing agreement between Laekna and Novartis, adding to the previous licensing of CFG920 less than a year ago", says Dr. Chris Lu, founder and CEO of Laekna. "We have demonstrated to Novartis that Laekna is a valuable collaborator with our strong commitment, experienced team and financing support from the top investment partners."

"We are dedicated to developing these products rapidly through the regulatory process and into commercialization, with the goal of ultimately benefitting patients around the world," added Amy Xie, VP Operations at Laekna.

On July 31, 2018 Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies (RCTs) that may offer rapid-onset pain relief and restored function, reported the appointment of E. Lynne Kelley, M.D., FACS as its Chief Medical Officer (Press release, Histogenics, JUL 31, 2018, View Source;p=RssLanding&cat=news&id=2360905 [SID1234528656]). Dr. Kelley brings more than 20 years of executive management and surgical experience in medical affairs, clinical operations, regulatory affairs and product development to Histogenics. Dr. Kelley will join Histogenics’ executive team and assume responsibility for leading medical affairs strategy and building out the department in anticipation of NeoCart’s potential commercial launch. Dr. Kelley will also work with the team on preparing the anticipated Biologics License Application (BLA) for NeoCart and spearheading related discussions with the United States Food and Drug Administration (FDA).

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"Lynne’s experience as a surgeon, medical affairs executive and educator across a wide variety of therapeutic areas and indications will be critical for Histogenics as we prepare for our top-line data, potential BLA submission and FDA review of NeoCart," stated Adam Gridley, President and Chief Executive Officer of Histogenics. "We are pleased to have Lynne join us at this exciting time to educate our customers and patients about the benefits of our novel restorative cell therapy platform through training, medical education and collaboration with our future commercial team. In addition, she will be working closely with our team to help drive additional product development initiatives, such as future trials in the U.S. and internationally."

Dr. Kelley is a board certified general and vascular surgeon having received her medical degree from Dartmouth Medical School and completed her Residency in General Surgery at Dartmouth Hitchcock Medical Center. During her training she was awarded an NIH-sponsored basic science research grant at Harvard Medical School. She completed a Fellowship in Vascular Surgery at Harvard Medical School, Massachusetts General Hospital and was awarded the Marco Polo Fellowship providing advance training in Endovascular Surgery at the University Paris Hospital, Henri Mondor. Dr. Kelley also received a B.A. in Biology from Boston University. Prior to Histogenics, Dr. Kelley held various medical affairs roles within the industry including: Chief Medical Officer at Senseonics, World Wide Vice President of Medical Affairs at Becton Dickinson & Company Medical Surgical Systems Division, Vice President and Medical Director at Kimberly Clark, and Medical Director at Boston Scientific Corporation’s (Boston Scientific) Peripheral Interventions and Vascular Surgery division. Prior to her work at Boston Scientific, Dr. Kelley was an assistant professor of vascular surgery and radiology at Yale University.

"I am thrilled to join the talented, cutting edge team at Histogenics. The potential of NeoCart in restoring function and thus improving the lives of patients with debilitating joint pain is extraordinary," shared Dr. Kelley. "I look forward to collaborating with the physician community globally to bring this exciting therapy to our patients."

In connection with the hiring of Dr. Kelley, the Compensation Committee of Histogenics’ Board of Directors approved a grant to Dr. Kelley of a stock option to purchase 200,000 shares of Histogenics’ common stock. The option was granted pursuant to the Nasdaq inducement grant exception as a component of Dr. Kelley’s employment compensation, and was granted as an inducement material to her acceptance of employment with Histogenics in accordance with Nasdaq Listing Rule 5635(c)(4). The option will have an exercise price equal to the closing price of Histogenics’ common stock on July 31, 2018. The option has a ten year term and vests with respect to 25% of the shares of common stock underlying the option on the one year anniversary of Dr. Kelley’s first day of employment with Histogenics and with respect to the remaining shares in equal monthly installments over the following 36 months, subject to Dr. Kelley’s continued service with Histogenics through the applicable vesting dates.

On July 31, 2018 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported that the company will present at the 2018 Wedbush PacGrow Healthcare Conference in New York (Press release, Corvus Pharmaceuticals, JUL 31, 2018, View Source;p=RssLanding&cat=news&id=2361086 [SID1234528636]). The presentation is scheduled for Wednesday, August 15, at 8:35 a.m. Eastern Time.

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A webcast of the presentation will be available live and for 90 days following the event. The webcast may be accessed via the conference website and from the investor relations section of the Corvus website.

On July 31, 2018 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that Christopher Haqq, M.D., Ph.D., the Company’s Executive Vice President of Research and Development and Chief Scientific Officer, will participate in a panel discussion at the Canaccord Genuity 38th Annual Growth Conference on Thursday, August 9, 2018 at 12:00 p.m. EDT (Press release, Atara Biotherapeutics, JUL 31, 2018, View Source [SID1234528633]). The conference will be held at the InterContinental Boston Hotel in Boston, MA.

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A live audio webcast of the panel discussion will be available by visiting the Investors section of the Atara website. An archived replay of the webcast will be available on the Company’s website for 14 days following the panel discussion.

On July 31, 2018 CANbridge Life Sciences, a biopharmaceutical company developing Western drug candidates in China and North Asia, reported that it strengthened the executive management team with the appointment of May Orfali, MD, as Chief Medical Officer, on July 23, 2018 (Press release, CANbridge Life Sciences, JUL 31, 2018, View Source [SID1234528470]). Dr. Orfali replaced Dr. Mark Goldberg, who was acting as interim Chief Medical Officer. She is based in Cambridge, MA.

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Dr. Orfali has a deep and extensive background in clinical drug development programs that spans two decades in multiple therapeutic areas, with a focus on rare diseases, oncology, hematology, infectious disease and women’s health. Most recently, she was Executive Director, Global Product Development, Pfizer, Inc., USA, where she was responsible for patient-focused drug development across multiple rare disease assets in hematology, sickle cell disease, hemophilia, endocrinology, gene therapy and TTR-amyloidosis. Prior to that role, Dr. Orfali was Senior Director and Global Medical Lead/Medicines Development Group, Specialty Care Business Unit, Pfizer, where she was responsible for developing rare disease drug development strategy, including gene therapy; oversaw global drug development in TTR-amyloidosis, and was Global Medical Lead for hematology, specifically in hemophilia A and B, across North America, Europe and Asia, including Japan and China. Prior to her time at Pfizer, Dr. Orfali held several clinical leadership positions, including Senior Director, Global Medical Monitor, Oncology at Wyeth Pharmaceutical Company, USA; VP Clinical Development and Medical Affairs at Artisan Pharma, Inc., USA; Vice President, Clinical Research and Medical Affairs, Aeris Therapeutics, USA; Medical Director, CDMA, Cubist Pharmaceuticals and Medical Director, Women’s Health Group at Boston Scientific Corporation.

Dr. Orfali holds a medical degree from the University of Baghdad, Baghdad, Iraq, and a Pharmaceutical Masters of Business Administration from Cambridge University, Cambridge, England. She was a practicing physician, specialized in CNS Oncology Clinical Research at Dana-Farber Cancer Institute, in Boston, MA and completed her Fellowship in Pediatric Oncology/Hematology at Massachusetts General Hospital and Children’s Hospital, Boston, MA.

"We are delighted that Dr. Orfali has chosen to join CANbridge as we become a fully-commercial biopharmaceutical company with a robust clinical trial program and pipeline," said James Xue, PhD, Chairman and CEO, CANbridge Life Sciences. "Her broad international experience, and proven track record of clinical trial success in multiple indications, will be key as CANbridge continues to advance our world-class programs in oncology and orphan-designated diseases, particularly in those that are severely underserved in China and Asia. We would also like to thank Dr. Mark Goldberg for serving as our interim Chief Medical Officer. He’s played an instrumental role in CANbridge’s current success and will continue to work with us in an advisory capacity."