On September 4, 2019 Sysmex Inostics’ novel SafeSEQ next-generation sequencing cell-free DNA technology, investigators from the Biomedical Research Institute of Malaga [(IBIMA)-CIMES-UMA, Malaga Spain] and collaborators reported have published the first pilot study to examine the use of a non-invasive liquid biopsy in early diagnosis of breast cancer (Press release, Sysmex Inostics, SEP 4, 2019, View Source [SID1234539286]). This study was unique in that the ctDNA analyses was performed before any invasive diagnostic procedure or treatment.

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The SafeSEQ liquid biopsy technology has shown sensitivity down to five mutant molecules in a background of ten thousand normal ones (or 0.05% mutant allele frequency also known as MAF). Utilizing the genes TP53 and PIK3CA, which are commonly mutated in breast cancer, investigators compared the results of traditional standard-of-care tissue biopsy with those of liquid biopsy to determine the degree to which a highly sensitive assay might complement clinical assessment of disease. Of the 13 mutations detected in 10 of the primary breast cancer patients (out of a total of 29 samples) 8 mutations had a variant allele frequency less than 0.39%.

Comparing tissue to liquid biopsy, eight patients had detectable mutations in ctDNA with concordant results between tissue and plasma. Liquid biopsy testing with SafeSEQ detected an additional three patients with ctDNA mutations that were not present in the tissue. The breast cancer samples with detected ctDNA biomarkers were significantly associated with a lower patient age, a higher tumor size, and higher imaging score (indicating higher likelihood of neoplastic disease).

"We have shown in this study how important a sensitive technology is for early detection of breast cancer, as trace amounts of circulating tumor DNA may be lost by the detection method leading to false-negative results", said Dr. Emilio Alba, senior author of the Biomedical Research Institute of Malaga. "Studies of this kind have not been attempted before due to limitations of the technology, and it is great to see Sysmex Inostics leading the path forward for early detection."

The publication "Detection of TP53 and PIK3CA mutations in circulating tumor DNA using Next-Generation Sequencing in the screening process for early breast cancer diagnosis", was published online in the Journal of Clinical Medicine in August of 2019. View Source

On September 4, 2019 Achilles Therapeutics, a biopharmaceutical company reported it launched in 2016, based on work led by Professor Charles Swanton of UCL and the Francis Crick Institute, has raised £100 million in Series B financing (Press release, UCLB, SEP 4, 2019, View Source [SID1234539255]).

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The financing was led by incoming U.S. investor RA Capital Management, corner-stoned by founding investor Syncona and joined by important new investors including Forbion, Invus, Perceptive Advisors and Redmile Group.

Proceeds from this financing will deliver two human proof-of-concept studies using a unique personalised T cell therapy approach targeting clonal neoantigens in non-small cell lung cancer and melanoma. These programmes are expected to enter the clinic this year. In addition, the financing will enable the Company to continue building out its manufacturing capabilities as well as broadening its growing solid tumour pre-clinical product pipeline.

On September 4, 2019 vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for diabetes and Alzheimer’s disease, reported that it is scheduled to present a general company update at the H.C. Wainwright 21st Annual Global Investment Conference on Tuesday, September 10, 2019 at 3:00 p.m. Eastern Time in New York City (Press release, vTv Therapeutics, SEP 4, 2019, View Source [SID1234539271]). Company management will also be meeting with members of the investment community during one-on-one meetings at the conference.

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A live webcast of the presentation can be accessed here and will be accessible for 30 days following the presentation at www.vtvtherapeutics.com.

On September 4, 2019 Alpha Tau Medical, developer of the breakthrough alpha radiation cancer therapy Alpha DaRT, reported the appointment of Dr. Robert B. Den, MD, as Chief Medical Officer (CMO) (Press release, Alpha Tau Medical, SEP 4, 2019, View Source [SID1234539288]). In his new role, and as a prominent expert and accomplished clinician, Dr. Den will lead the clinical research functions for Alpha Tau, furthering the company mission of innovation in cancer therapy.

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Dr. Den is currently an Associate Professor of Radiation Oncology, Cancer Biology, and Urology at Thomas Jefferson University, who specializes in radiation oncology and co-leads the Sidney Kimmel Cancer Center Multidisciplinary Genitourinary Clinic. Dr. Den’s research has spanned the basic science, translational, and clinical spectrum with over 120 publications and funding from the Prostate Cancer Foundation, American Cancer Society and United States Department of Defense. He has designed and completed several clinical trials incorporating novel agents with radiation therapy. He currently serves as the Chair for the Data Safety and Monitoring Committee and is a member of the Institutional Review Board.

"I envision alpha emitting radiation-based therapy being employed across multiple malignancies, either as primary therapy or in conjunction with immuno-oncology treatments. We have only scratched the surface of the potential indications for this technology. I am privileged to join the Alpha Tau team and take part in this exciting revolution in radiation oncology," commented Dr. Den. "The prospects for Alpha DaRT are tremendous, and I look forward to helping clinicians around the world unleash its full potential."

Dr. Den attended Yale University, and received his medical degree from Harvard Medical School in 2006. He performed his internship at Massachusetts General Hospital and residency at Thomas Jefferson University. Today, he treats a wide array of tumors, with particular focus on genitourinary and gynecologic malignancies. Dr. Den has vast experience in brachytherapy, developing the High Dose Rate Prostate Cancer Program and initiating Intravascular Coronary Artery Brachytherapy at Thomas Jefferson University.

"I am glad to see leaders in their fields continuing to join Alpha Tau," said Uzi Sofer, CEO of Alpha Tau Medical. "Having Dr. Den leading our medical team will be essential for our clinical efforts, especially as we approach the upcoming initiation of our clinical trials in the US and Canada, and discussions with regulators on a potential marketing approval. Bobby brings a unique mix of medical and clinical expertise that will serve us well as we rapidly expand the base of practitioners providing this potentially life-saving treatment to patients in need."

Alpha DaRT (Diffusing Alpha-Emitters Radiation Therapy) delivers high-precision alpha radiation that is released when radioactive substances decay inside the tumor. The short-range alpha particles effectively kill the cancer cells while sparing the surrounding healthy tissue.

Alpha Tau Medical is currently running clinical trials around the world in metastatic breast cancer as well as skin and head and neck cancer. The company’s first clinical study was recently completed in patients suffering from squamous cell carcinoma of the skin, head and neck. Most of the study patients had been previously treated by either surgery or radiotherapy. The results showed a complete response rate of more than 70%, as well as exceptional statistics on long-term followup.

Clinical collaborations with dozens of leading cancer centers worldwide are in process for the investigation of additional indications, including pancreatic, breast, prostate, gynecological, skin, and head and neck cancers. Collaborating centers include Memorial Sloan Kettering Cancer Center, USA, Montreal University Hospital Center, Canada, Tokyo Medical and Dental University and National Cancer Center, Japan.

On September 4 , 2019 PRA Health Sciences, Inc. (the "Company") (NASDAQ: PRAH) reported that its Board of Directors (the "Board") has authorized a $500 million share repurchase program, effective immediately (Press release, PRA Health Sciences, SEP 4, 2019, View Source [SID1234539256]).

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Under the program, the Company is authorized to repurchase shares of its common stock through open market purchases, privately-negotiated transactions, secondary offerings, block trades or otherwise in accordance with all applicable securities laws and regulations, including through trading plans complying with the rules and regulations of the Securities and Exchange Commission (the "SEC"). The repurchase program expires on December 31, 2021.

In addition, the Company announced that, subject to the completion of the announced underwritten secondary offering of the Company’s common stock by KKR PRA Investors L.P. (the "Selling Stockholder"), it intends to repurchase from the underwriter in such offering, out of the 6,666,684 shares of common stock, a number of shares having an aggregate purchase price of $300 million at a price per share equal to the price at which the underwriter will purchase the shares from the Selling Stockholder. The closing of such share repurchase is conditioned on, and expected to occur simultaneously with, the closing of the secondary offering, subject to the satisfaction of other customary conditions. The Company intends to fund such share repurchase with the proceeds of a $300 million incremental term loan under its existing credit facilities. Following the completion of such share repurchase, the Company will have approximately $200 million of remaining availability under the share repurchase program.

Future repurchases under the Company’s share repurchase program will be funded by available liquidity, including available cash or borrowings under existing or future credit facilities. The share repurchase program does not obligate the Company to repurchase any particular amount of its common stock, and it may be modified, suspended or terminated at any time at the Board’s discretion. The timing and amount of any purchases of common stock will be based on the Company’s liquidity, general business and market conditions, debt covenant restrictions and other factors, including alternative investment opportunities.

Contact:

PRA Health Sciences, Inc.

Laurie Hurst

Director, Communications and Public Relations

919-786-8435

[email protected]

Mike Bonello

Chief Financial Officer

919-786-8270

[email protected]