Aslan Pharmaceuticals Pte. Ltd., of Singapore, said it concluded an IPO of 2.6 million shares of common shares at NT$68.92 (US$2.28). The shares were 29.4 times oversubscribed. The company will list the shares on the Taipei Exchange, which will commence trading on June 1.
Athenex Inc., of Buffalo, N.Y., said partner Guangzhou Xiangxue Pharmaceutical Co. Ltd., of Guangzhou, China, received CFDA approval of its IND to start clinical trials of KX-02 for glioblastoma under China's class I New Drug Regulation. KX-02 is a Src protein tyrosine kinase inhibitor and tubulin polymerization inhibitor developed by Athenex.
Bial SA, of Coronado, Portugal, and Eisai Co. Ltd., of Japan, said the EMA has approved Zebinix (eslicarbazepine acetate) for use as a once-daily monotherapy to treat adults with newly diagnosed partial-onset epilepsy. Eslicarbazepine acetate is already indicated in Europe as an adjunctive therapy in adults, adolescents and children, older than 6, with partial-onset seizures with or without secondary generalization. The approval is based on results from a phase III study (Study 311), which compared once-daily eslicarbazepine acetate as a monotherapy to twice-daily, controlled-release carbamazepine in newly diagnosed adults with partial-onset seizures. The data showed that 71.1 percent (n=276/388) of patients for eslicarbazepine acetate and 75.6 percent (n=300/397) of patients for controlled-release carbamazepine were seizure-free for six months or more, at the last evaluated dose. The one-year seizure-freedom rate at the last evaluated dose was 64.7 percent (n=251/388) on eslicarbazepine acetate and 70.3 percent (n=279/397) on controlled-release carbamazepine.
Canbridge Life Sciences Ltd., of Beijing, said it raised $25 million in a series B round with lead investor, Lapam Capital, a Beijing-based life science venture capital firm. Several other institutional investors also participated, including Qiming Venture Partners, Yuanming Capital, Yanyuan Capital, Biossom Investment Management and Wuxi App Tec. The company will use the proceeds to fund the clinical trial development of its two lead compounds, CAN-008, a fully human fusion onco-immunotherapy currently in a phase I/II trial for the treatment of glioblastoma multiforme (GBM) in Taiwan, and CAN-017, an antibody inhibitory onco-immunotherapy that will target esophageal squamous cell cancer. The company plans to initiate a phase II CAN-008 GBM trial in China next year.
The FDA issued a warning letter to Changzhou Jintan Qianyao Pharmaceutical Raw Materials just days after putting APIs produced at the plant in Changzhou City, China, on import alert this month. During a February inspection, an FDA investigator found that the company had no quality-related procedures in place before last August, even though it was manufacturing and shipping drugs to the U.S. By the time of the inspection, it had drafted some procedures, but it had yet to implement them. The company also lacked written procedures for testing and sampling incoming materials. Instead, its warehouse employees accounted for incoming raw material handling, sampling and testing "in their heads," according to the warning letter. Other citations included repeat assay testing over several days without documentation or investigation. Only the result of the final test was reflected in the certificate of analysis for the released batch. In addition, an operator used process parameter values from previous batches of an API to complete new batch records "when she was too tired to immediately record the data and had forgotten the values," the FDA said.
Elite Pharmaceuticals Inc., of Northvale, N.J., said it has acquired an approved, currently marketed abbreviated new drug application for trimipramine maleate capsules, 25 mg, 50 mg and 100 mg, from Mikah Pharma LLC, of Hillsborough, N.J. Hyderabad, India-based Dr. Reddy's Laboratories Inc. will market and sell the trimipramine products and Epic Pharma LLC, of New York, will manufacture the products per established contracts with Mikah. Elite assumes those contracts as part of the acquisition. Trimipramine is a generic version of Surmontil, a tricyclic antidepressant.
PD-L1 is best known as a checkpoint inhibitor that tumors produce to thwart T cells. But researchers from Duke University and the Chinese Fudan University have demonstrated that both melanoma tissues and normal neural tissues could produce PD-1 that had strong analgesic effects. Injecting mice with PD-L1 increased the threshold for inflammatory pain, while blocking PD-1 or neutralizing PD-L1 caused allodynia, or a hypersensitive response to normal stimuli. Injection of Opdivo (nivolumab, Bristol-Myers Squibb Co.) caused both allodynia and spontaneous pain responses in mice. The authors wrote that their findings "identify a previously unrecognized role of PD-L1 as an endogenous pain inhibitor and a neuromodulator," and "suggest the importance of examining the pain caused by individual tumor sites in patients with melanoma and other malignancies before, after and during immune therapies." Their work appeared in the May 22, 2017, online issue of Nature Neuroscience.
Immuron Ltd., of Victoria, Australia, has filed to raise about $8.8 million through the sale of 777,778 American depositary shares (ADS) and warrants to purchase 388,889 ADSs in a U.S. IPO on Nasdaq under the symbol IMRN. The company plans to use $3 million to advance clinical development of IMM-124E for the treatment of fatty liver diseases, likely completing its phase II programs in non-alcoholic steatohepatitis (NASH), alcoholic steatohepatitis and pediatric NASH. About $1.1 million would be dedicated to advancing development of IMM-529 through the completion of a planned phase I/II trial in the prevention of C. difficile (CDI) infection in patients with recurrent CDI. About $1 million would be used to support other programs, including a preclinical colitis program and a collaboration with the U.S. Army and U.S. Navy. Each warrant will have an estimated per-ADS exercise price of 125 percent of the per-ADS public offering price. Immuron expects to price each ADS between $10 and $12.50 and each warrant at $0.01 each. Each ADS represents 40 ordinary shares of Immuron, which has a listing on the Australian Securities Exchange under the symbol IMC.
Merck & Co. Inc., of Kenilworth, N.J., said it entered an exclusive worldwide license agreement with Teijin Pharma Ltd., of Tokyo, for the development, manufacture and commercialization of a preclinical antibody targeting the protein tau. In return, Merck will make an undisclosed up-front payment to Teijin, which will also be eligible to receive development, regulatory and sales milestone payments. In addition, Teijin will receive royalties on product sales and retains an option to co-promote an approved product in Japan.
Myovant Sciences Ltd., of Hamilton, Bermuda, disclosed data from a phase II extension study conducted by Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, evaluating relugolix in Japanese women with endometriosis-associated pain. Oral, once-daily treatment with relugolix (10, 20, or 40 mg) was generally well tolerated during the 24 weeks comprising the initial 12-week study and the 12-week extension study. Treatment-emergent adverse events for patients receiving relugolix, such as hot flush and menorrhagia, were consistent with the drug's mechanism of action as a gonadotropin-releasing hormone receptor antagonist.
Sun Pharmaceutical Industries Ltd., of Mumbai, India, said the FDA accepted its BLA for tildrakizumab, an IL-23p19 inhibitor, for the treatment of moderate to severe plaque psoriasis. The filing was submitted by partner Merck & Co. Inc., of Kenilworth, N.J. Tildrakizumab also is under review in the EU.
The Australian University of Melbourne's Samuel Berkovic is telling it like it is with respect to the medical use of cannabinoids in epileptic patients. Despite spectacular anecdotes in the lay press, peer-reviewed data supporting the practice has been sorely lacking. Now, however, a team led by New York University scientists has published a double-blind, placebo-controlled trial of cannabidiol, a non-hallucinogenic cannabinoid, in children and young adults with the developmental seizure disorder Dravet syndrome. The researchers found that treatment with cannabidiol reduced seizures by roughly 40 percent, a result that was statistically significant. In the accompanying editorial, Berkovic wrote that the trial "represents the beginning of solid evidence for the use of cannabinoids in epilepsy." Trial and editorial were published in the May 24, 2017, issue of the New England Journal of Medicine.
An SEC filing indicating that Zai Venture Partners I LLC is raising $150 million lists Shanghai-based Zai Labs Ltd. CEO Samantha Du as director. Du previously saw investing success as part of Sequoia Capital China Fund, where she served as head of health care investments between 2012 and 2014, investing in four health care companies, including JHL Biotech Co. Ltd., of Taipei. She later founded Zai Labs in 2013. (See BioWorld Today, Dec. 11, 2013, and Aug. 22, 2014.)