On February 7, 2018 BioTime, Inc. (NYSE American: BTX), a late-stage, clinical biotechnology company developing and commercializing products addressing degenerative diseases, reported that Adi Mohanty, Co-Chief Executive Officer of BioTime, will participate in the BIO CEO and Investor Conference, on February 12th and 13th 2018, at the New York Marriott Marquis (Press release, BioTime, FEB 7, 2018, View Source;p=RssLanding&cat=news&id=2330855 [SID1234523773]).

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The BIO CEO and Investor Conference is one of the largest investor conferences focused on established and emerging publicly traded and select private biotech companies. One-on-one meetings with Mr. Mohanty can be arranged by scheduling through the BIO CEO and Investor Conference 1×1 desk or by contacting David Nakasone, Director of Investor Relations at BioTime, at 510-871-4188 or [email protected].

On February 7, 2018 Roivant Sciences and ArQule, Inc. (NASDAQ: ARQL) reported the initiation of a collaboration to pursue the development of derazantinib, a pan-FGFR (fibroblast growth factor receptor) inhibitor, in Greater China (Press release, ArQule, FEB 7, 2018, View Source [SID1234523772]). As part of the collaboration, ArQule has granted a Roivant subsidiary an exclusive license to develop and commercialize derazantinib in the People’s Republic of China, Hong Kong, Macau, and Taiwan. Deal terms include an upfront payment to ArQule of $3 million and an additional $2.5 million development milestone within the first year. ArQule is also eligible for regulatory and commercial milestones and royalties on future sales of derazantinib in Greater China.

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ArQule is currently conducting a registrational trial for derazantinib in the United States and Europe as a potential treatment for intrahepatic cholangiocarcinoma (iCCA), a form of biliary tract cancer. The People’s Republic of China has one of the world’s highest incidences of iCCA, where it is the second most common form of liver cancer. Roivant intends to pursue the development of derazantinib in China for the treatment of iCCA while also pursuing further development in other tumor types with high rates of FGFR mutation.

"Intrahepatic cholangiocarcinoma is a devastating form of cancer, and there are no approved therapies globally," said Vivek Ramaswamy, Founder and CEO of Roivant Sciences. "The prevalence of this disease is exceptionally high in China and we will do our part to further the development of derazantinib in that region."

"We are pleased with Roivant’s commitment to develop derazantinib in China, where the need for novel therapies is so pressing," said Paolo Pucci, CEO of ArQule. "We share their commitment to ensuring broad geographic access to new medicines, and we look forward to developing derazantinib in iCCA and other FGFR-driven cancers."

About Derazantinib

Derazantinib is a potent, orally administered inhibitor of the fibroblast growth factor receptor (FGFR) family, a key driver of cell proliferation, differentiation, and migration. In a Phase 1/2 study in patients with iCCA harboring FGFR2 gene fusions, treatment with derazantinib resulted in an objective response rate of 21%, nearly 3 times higher than standard-of-care chemotherapy. ArQule is currently conducting a registrational study with derazantinib in patients with FGFR2 fusion-positive second-line iCCA. The open-label single-arm trial is recruiting in both the United States and Europe with objective response rate as the primary endpoint. More information on that program is available here.

About Intrahepatic Cholangiocarcinoma

Cholangiocarcinoma (CCA) is the most common biliary malignancy and the second most common hepatic malignancy after hepatocellular carcinoma (HCC).1 Depending on the anatomic location, CCA is classified as intrahepatic (iCCA), perihilar (pCCA), and extrahepatic (eCCA). iCCA originates from the intrahepatic biliary ductal system and forms an intrahepatic mass. iCCA is an aggressive cancer, with a median 5-year survival rate of 15% for patients diagnosed with early-stage disease.2 In China, the incidence of cholangiocarcinoma is more than 7 cases per 100,000 people, and the majority of cases are intrahepatic.3

On February 6, 2018 Varian (NYSE: VAR) reported the Halcyon cancer treatment platform has received Atomic Energy Regulatory Board (AERB) Certificate for Import and Supply in India (Press release, Varian Medical Systems, FEB 6, 2018, View Source [SID1234523896]). This registration allows Varian to now market this new system in India. Halcyon simplifies and enhances virtually every aspect of image-guided volumetric intensity modulated radiotherapy (IMRT), and is well suited to treat a majority of cancer patients, offering advanced treatments for prostate, breast, head & neck, and many other forms of cancer.

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"With AERB No Objection Certificate, clinicians in India now have access to Halcyon, which is engineered to revolutionize the clinical workflow and could help advance cost-effective cancer care across the country," said Ashok Kakkar, senior managing director, Varian India. "We look forward to continuing our close collaboration with clinical partners across India and helping realize a world without fear of cancer."

Halcyon is an advanced system that was designed to improve patient comfort, simplify operations, and shorten the time from installation to first-treatment without sacrificing quality. Its quiet operating environment, which is up to 2x quieter than other systems, has been designed with the patients in mind. Additionally, Halcyon has a low couch height for easy patient access, and soft indirect ambient lighting in the gantry opening.

Featuring a 100cm gantry opening, which is larger than those on standard CT machines, Halcyon is capable of rotations 4x faster than c-arm gantries for rapid imaging and treatment. The system is also capable of fast and sharp volumetric imaging in as little as 15 seconds. With Halcyon treatments, a complex image guided IMRT plan is clinically accelerated compared to those delivered on traditional devices.

Operationally, Halcyon features a streamlined workflow that only requires nine steps from the start to the end of treatment compared to up to more than 30 steps with older technologies. To assist in the reduction of time and construction costs from installation to first patient treatment, Halcyon comes pre-commissioned, requires less shielding than traditional systems, can fit in a vault as small as 5.9 meters (19.68 feet) x 5.539 meters (18.17 feet) x 2.743 meters (8.99 feet) high and can be installed in two weeks or less.

For more information on Halcyon visit www.varian.com/halcyon.

On February 6,2018 Redx (AIM: REDX), the drug discovery and development company focused on cancer and fibrosis, reported that it has commenced its Phase 1/2a study for the Porcupine inhibitor RXC004 with the first patient having now been dosed at The Christie in Manchester (Press release, Redx Pharma, FEB 6, 2018, View Source [SID1234524741]).

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RXC004 is a novel, oral, potent small molecule Porcupine inhibitor, which targets the Wnt pathway, an embryonic signalling pathway that is implicated in the maintenance of cancer stem cells in multiple cancer types. This pathway is associated with tumorigenesis, metastasis, recurrence and resistance in cancer. RXC004 has now progressed into the dose-finding Phase 1 element of the study in patients with cancer. Once completed, the selected dose will then be used as a monotherapy in a larger number of patients with difficult to treat cancers (Phase 2a). In addition, the Company will look to explore the potential of RXC004 in combination with a PD-1 checkpoint inhibitor following the completion of the safety and tolerability phase of this first in man clinical trial.

As mentioned at the time of the publication of the Company’s strategic update on 6 November 2017, Redx expects initial data from the 1a segment of this trial in H2 2018.

Iain Ross, Chairman of Redx Pharma plc, commented, "We are very excited by the potential of RXC004 to make a major difference in cancer treatment, and intend to progress RXC004 initially as a monotherapy and thereafter in combination with a (PD-1) checkpoint inhibitor through clinical development. We believe that RXC004 has great potential to treat some very challenging cancers that currently have very poor prognosis and we look forward to updating the market on our progress."

On February 6, 2018 MannKind Corporation (NASDAQ:MNKD) reported that David M. Kendall, MD, will join the company as Chief Medical Officer and assume full responsibility for leading MannKind’s scientific research, clinical development, regulatory, and medical affairs activity, effective February 12 (Press release, Mannkind, FEB 6, 2018, View Source [SID1234524353]). Dr. Kendall will report directly to Michael Castagna, Pharm.D., Chief Executive Officer, and will join the company’s executive leadership team. He will be based out of MannKind’s Westlake Village, California headquarters.

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"David is a world renowned diabetes expert and represents an important addition to our executive leadership team," said Castagna, Chief Executive Officer of MannKind. "His extensive experience in diabetes research, development, and clinical care in both U.S. and international markets, will be instrumental in helping us achieve the growth potential that we believe Afrezza clearly possesses."

Dr. Kendall’s career includes over 30 years of experience in diabetes and metabolism research, clinical management, research, and policy advocacy. Most recently, he served as Research Physician and Vice President of Global Medical Affairs for Lilly Diabetes, and during that time was responsible for all medical affairs activities and guided research and development strategy across multiple geographies. In this role, he worked to re-establish Lilly Diabetes as a world class medical organization — and added to his extensive experience with both injected and mealtime insulins, as well as devices and continuous glucose monitors. Prior to joining Eli Lilly, Dr. Kendall served as Chief Scientific and Medical Officer at the American Diabetes Association, where he was responsible for all medical affairs, medical education, research, outcomes, and medical policy activities. Earlier in his career, Dr. Kendall served as Medical Director at the International Diabetes Center, and the Park Nicollet Clinic, as well as at Amylin Pharmaceuticals. He received his M.D. and completed his Post Graduate Medical Training at the University of Minnesota, and earned a B.A. in Biology from St. Olaf College.

"The research and clinical response to Afrezza as a mealtime insulin supports ongoing efforts to establish this product as the standard of care for those living with type 1 or type 2 diabetes," said Dr. Kendall. "Afrezza is the only inhaled fast-acting mealtime insulin on the market, and offers the right patients a flexible, safe, and effective treatment option. I’m thrilled to join MannKind, and look forward to being part of a company that has the potential to transform the lives of so many people that are living with diabetes."