Beigene Ltd., of Beijing, said it dosed the first patient in a phase I trial of BGB-A317, an anti-PD-1 monoclonal antibody, in mainland Chinese patients with advanced solid tumors. The open-label study is designed to investigate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of BGB-A317. Beigene got the go-ahead to conduct the study in China in September. (See BioWorld Today, Sept. 13, 2016.)
India's Central Drugs Standard Control Organisation (CDSCO) said Thursday that the 45-day transition period for complying with regulations involving the import of radiopharmaceuticals will not be extended. The transition period, which followed a November CDSCO meeting with experts and stakeholders, ended last week. The regulations are intended to ensure that radiopharmaceuticals are used for therapeutic and diagnostic purposes within their short expiry.
The U.S. Department of Justice arrested Iat Hong, of Macau, Sunday in Hong Kong on insider trading and hacking charges. According to indictments unsealed this week, Hong, Bo Zheng, of Changsha, China, and Chin Hung, of Macau, all face U.S. charges stemming from an alleged scheme to hack the networks and servers of at least seven major New York law firms to gain access to the email of attorneys involved in high profile M&As and then trading on the stolen insider information. The trio successfully hacked two firms and tried to get access to the other five firms more than 100,000 times during a seven-month period last year. Based on the hacked information, the defendants purchased shares of at least five publicly traded companies, including Intermune Inc., before acquisition offers were announced and then sold the shares after the news became public, resulting in profits of more than $4 million. The three also are charged with hacking the networks and servers of two robotics companies to get confidential information and proprietary schematics to benefit their startup company, which developed robot controller chips and provided control system solutions. The case should be a wake-up call for law firms around the world, Manhattan U.S. Attorney Preet Bharara said, adding, "you are and will be targets of cyber hacking, because you have information valuable to would-be criminals."
Kubota Pharmaceutical Holdings Co. Ltd., of Tokyo, and SBI Holdings Inc., a Japanese financial services and asset management firm, said they signed a nonbinding letter of intent (LOI) to establish a joint venture designed to organize and manage special purpose entities to finance the development of ophthalmic drugs and devices. The LOI contemplates that the joint venture will be funded 51 percent by Kubota Pharma and 49 percent by SBI. Kubota Pharma and SBI have entered negotiations for a definitive joint venture agreement.
Mylan NV, of Hertfordshire, U.K., and Biocon Ltd., of Bangalore, India, said results of the HERITAGE study, published in the Journal of the American Medical Association, confirm the efficacy, safety and immunogenicity of MYL-1401O, the proposed biosimilar trastuzumab co-developed by Mylan and Biocon, in comparison to branded trastuzumab (Herceptin, Roche Holding AG). Branded trastuzumab is indicated to treat certain HER2-positive breast and gastric cancers. Results showed an overall response rate of 69.6 percent for MYL-1401O compared to 64 percent for branded trastuzumab. Tumor progression, progression-free survival and overall survival were not statistically different between proposed biosimilar trastuzumab and branded trastuzumab at week 48.
Prima Biomed Ltd., of Sydney, reported interim data for its TACTI-mel (Two ACTive Immunotherapeutics in melanoma) trial, with the database safety and monitoring board confirming that IMP321 is safe and well-tolerated at the first dose level when used in combination with a PD-1-blocking antibody, and dose-escalation can continue as planned. The phase I combo trial is testing IMP321, an antigen-presenting cell activator, with Keytruda (pembrolizumab, Merck & Co. Inc.) in patients with unresectable or metastatic melanoma who had suboptimal or no responses to Keytruda alone. The trial will now proceed to the next dose level of 6 mg. Further data from the study are expected throughout 2017.