Ascend Biopharmaceuticals Ltd., of Melbourne, Australia, said the first nodular basal cell carcinoma patient was dosed with ASN-002, an injectable immunotherapy, in a phase I/IIa study. ASN-002 is a biologic therapeutic based on an adenovirus that has been engineered to produce the immunostimulatory anti-cancer protein interferon-g. Ascend has an exclusive worldwide license to develop ASN-002 (formerly TG1042) from Paris-based Transgene SA. Three clinical studies have already been completed in 64 patients with cutaneous lymphomas and advanced melanomas. These studies demonstrated that ASN-002 was safe, well tolerated and conferred favorable clinical outcomes.
Beigene Ltd., of Beijing, said the first patient was dosed with BGB-283 in a phase I trial in China, which is testing the RAF dimer inhibitor for the treatment of solid tumors harboring B-RAF mutations and other aberrations in the RAS-MAPK (mitogen-activated protein kinase) pathway. The study is designed to assess BGB-283 as a single agent. Key objectives include determining the maximum tolerated dose, pharmacokinetics, pharmacodynamics and preliminary antitumor activity in Chinese patients. Disease-specific expansion cohorts will be dosed to investigate the preliminary antitumor activity of BGB-283 in selected solid tumors. (See BioWorld Today, April 30, 2015.)
Biogen Inc., of Cambridge, Mass., Swedish Orphan Biovitrum AB, of Stockholm, and the World Federation of Hemophilia, of Montreal, said a major shipment of hemophilia therapy is being delivered to treatment centers in several developing countries. The donations include up to 500 million units of hemophilia treatments over five years as part of the expansion of the 20-year-old Humanitarian Aid Program. The new initiative is part of a 10-year program involving Biogen and Swedish Orphan to produce 1 billion international units of the therapy for humanitarian aid. The first shipments are being sent to Senegal, Kenya, the Philippines, Dominican Republic, Uzbekistan, Jordan, Egypt, Morocco, Pakistan, El Salvador, Indonesia, Ghana, Myanmar, India, Sri Lanka and Nigeria.
Bionomics Ltd., of Adelaide, Australia, extended its strategic collaboration with Merck & Co. Inc., of Kenilworth, N.J., for the discovery and development of drug candidates to treat chronic and neuropathic pain. The latest agreement builds upon the deal signed in July 2013 focused on Bionomics' ionx and Multicore drug discovery platforms. Separately, Merck will purchase 21.66M ordinary shares of Bionomics at A$0.5938, a 29 percent premium.
Boston Therapeutics Inc., of Manchester, N.H., said its affiliate, Advance Pharmaceutical Co. Ltd., of Hong Kong, completed enrollment at the Chinese University of Hong Kong (CUHK) for a trial evaluating BTI-320 in 60 pre-diabetic subjects. The study is expected to confirm the assessment of prevention biomarker parameters associated with postprandial glucose spikes. The CUHK trial, designed to supplement an ongoing trial of BTI-320 in mainland China, fully enrolled ahead of schedule and is expected to be completed by year-end. In January 2016, the companies plan to submit the dossier seeking countrywide approval of BTI-320.
CSL Ltd., of Melbourne, Australia, said it closed a CHF400 million (US$416 million) and $100 million private placement in the U.S. The private placement has a weighted average fixed interest rate of 1.43 percent and an average life of 9.4 years. Proceeds will be used to fund the group's capital management plan and for general corporate purposes.
Greenpeptide Co. Ltd., of Fukuoka, Japan, filed an investigational new drug application with the FDA to conduct a U.S. phase I study of GRN-1201 to treat melanoma. The cancer vaccine candidate combines HLA-A peptides derived from four tumor-associated antigens. The company's preclinical study also was conducted in the U.S.
A subcommittee tasked with examining Internet sales of drugs under the India Drugs and Cosmetics Act extended the deadline for public comments on the subject, according to a notice issued Monday by India's Food and Drugs Administration commissioner. Originally, when the comment period was opened last month, people were given just one week to submit comments. The new deadline is Oct. 30. In addition to looking at how developed countries are regulating Internet sales, the subcommittee is to evaluate the risks and concerns of online drug sales and the impact they have on public health. Meanwhile, the All India Organisation of Chemists and Druggists is planning a nationwide strike Friday to protest illegal online sales of drugs.
Lonza Group Ltd., of Basel, Switzerland, and Benitec Biopharma Ltd., of Sydney, said they inked a service agreement to develop a manufacturing process for Benitec's DNA-directed RNA interference-based, adeno-associated virus (AAV)-delivered therapeutic products. Under the deal, Lonza will design and develop a cost-effective, scalable suspension culture based platform to produce material needed for AAV-based gene therapeutics to treat diseases such as hepatitis C. Financial terms were not disclosed.
The Medicines Co., of Parsippany, N.J., and Symbio Pharmaceuticals Ltd., of Tokyo, said they have formed a partnership for Ionsys (fentanyl iontophoretic transdermal system) in Japan. Under the deal, Symbio obtains an exclusive license in Japan to develop and commercialize the product, which was approved by the FDA in April for short-term management of acute post-op pain in hospitalized adults. Last month the Committee for Medicinal Products for Human Use of the EMA issued a positive opinion and recommended marketing authorization for Ionsys. Financial terms include net sales royalties payable to Medicines as well as a $10 million up-front payment and certain regulatory and commercial milestones.
A team from the South Korean National Cancer Center, Brigham and Women's Hospital, and Harvard Medical School has taken a look at the inverse problem, namely how tumor suppressors are inactivated. In their work, the authors looked at the actual mechanisms by which single nucleotide variants (SNVs) led to tumor suppressor inactivation by studying RNA expression and exome sequencing data from about 1,800 cancer patients. They identified about 900 SNVs that disrupted splicing. More than 160 of those introns caused either intron retention or exon skipping. "Notably, SNVs causing intron retention were enriched in tumor suppressors, and 97 percent of these SNVs generated a premature termination codon, leading to loss of function through nonsense-mediated decay or truncated protein," the authors wrote. "Overall, this work demonstrates that intron retention is a common mechanism of tumor-suppressor inactivation." The findings appeared in the Oct. 5, 2015, issue of Nature Genetics.
Taiwan Liposome Co. Ltd. (TLC), of Taipei, Taiwan, and Main Life Corp. Ltd., of Hong Kong, inked a distribution deal under which Main Life will be responsible for distribution of TLC's liposomal amphotericin B product, Ambil, in Hong Kong and Macau, adding to Ambil's existing out-licensed territories of Europe, the U.S., Taiwan and Korea.
Scientists from the Australian University of New South Wales have found three biomarkers that could predict how quickly an HIV patient's viral load would rebound after antiretroviral treatment (ART) was discontinued. HIV has gone from a deadly disease to a chronic one, but persists in the body of treated patients in reservoirs that have so far thwarted all attempts at clinically relevant eradication. In their work, the researchers retrospectively analyzed biomarkers of T cells in HIV patients whose treatment was interrupted. They found three separate biomarkers that were predictive of how long it took the virus to rebound. Patients with high levels of the markers, which are indicative of T-cell exhaustion, saw their viral load rebound significantly faster. One of the markers was the checkpoint blocker PD-1, suggesting that PD-1 inhibitors that have been successful in treating cancer patients might also have a role in fighting HIV. The work appeared in the Oct. 9, 2015, online issue of Nature Communications.
Xenetic Biosciences Inc., of Lexington, Mass., said several of its major shareholders, including Baxalta Inc., Synbio LLC and Serum Institute of India Ltd., entered lock-up letter agreements. Shareholders agreed to not sell any shares before June 30, 2016, and also to limit the sales of shares until December 2016 to no less than $1.25 per share. The agreement covers more than 58 percent of Xenetic's common stock.