Aeterna Zentaris Inc., of Charleston, S.C., and Specialised Therapeutics Asia, of Singapore, said they signed an exclusive license agreement for Aeterna's lead cancer compound, Zoptrex (zoptarelin doxorubicin) for the territories of Australia and New Zealand. Under the terms, Aeterna will be entitled to a nonrefundable up-front payment and additional milestone payments, plus double-digit royalties on future sales. Specific terms were not disclosed. Zoptrex, a synthetic peptide carrier linked to doxorubicin, is in a fully enrolled phase III trial in endometrial cancer, which, if positive, should lead to an FDA new drug application in the first half of 2017.
Aslan Pharmaceuticals Pte. Ltd., of Singapore, entered a licensing and research collaboration with Nanyang Technological University to develop modybodies. The stabilized heavy chain monoclonal antibody fragments, which are thought to improve tissue penetration due to their size, also can be linked into heterodimers/trimers to create novel molecules. The partners will initiate development of modybodies against three targets of Aslan's choice, with the first candidate expected to enter the clinic in 2018. Aslan gained an exclusive option, under pre-negotiated terms, to obtain global rights to develop and commercialize modybodies. Financial terms were not disclosed.
China Biologic Products Inc., of Beijing, said Shandong Taibang Biological Products Co. Ltd., its majority-owned subsidiary, recently obtained CFDA approval to begin clinical trials of its human antithrombin III (ATIII) product, which is intended to treat hereditary and acquired ATIII deficiency in connection with surgical or obstetrical procedures, and to treat thromboembolism. Studies are slated to start in 2017.
Cynata Therapeutics Ltd., of Melbourne, Australia, said it received data from a proof-of-concept study of its Cymerus mesenchymal stem cells (MSCs) in a model of asthma, showing that intravenous administration of the MSCs in mice subjected to ovalbumin sensitization produced a statistically significant (60 percent to 70 percent) decrease in airway hyper responsiveness (AHR) relative to untreated sensitized animals (p<0.01). Intranasal administration of Cynata's MSCs also completely normalized AHR, to a level that was no longer different to healthy animals, in which the asthma model had not been induced. No adverse safety findings were observed during the study.
Daiichi Sankyo Co. Ltd., of Tokyo, and the Dana-Farber Cancer Institute inked a preclinical research collaboration focused on lung cancer. A team of Dana-Farber scientists will partner with Daiichi Sankyo on the development of a translational pharmacology package with experimental animal and patient-derived xenograft models established at the institute. Financial terms of the agreement were not disclosed.
Chromocell Corp., of North Brunswick, N.J., and Tokyo-based Astellas Pharma Inc. said the FDA granted fast track designation for drug candidate CC8464/ASP1807 development program for the management of neuropathic pain associated with idiopathic small fiber neuropathy. In 2015, the companies entered a license and collaboration agreement for the development and commercialization of the compound for the management of neuropathic and other pain indications. Chromocell recently dosed the first subject in a phase I trial to evaluate the safety, tolerability and pharmacokinetics of the oral formulation of CC8464/ASP1807, a highly selective, peripherally restricted inhibitor of NaV1.7, which has been shown to be efficacious in multiple animal models of human neuropathic and inflammatory pain.
Clinuvel Pharmaceuticals Ltd., of Melbourne, Australia, said it will meet with the FDA on Nov. 7 to formally discuss lodging its new drug application for Scenesse (afamelanotide 16 mg), which will focus on finalizing requirements for the treatment of adult patients with the rare genetic disorder erythropoietic protoporphyria (EPP). The drug provides photoprotection to EPP patients who suffer from acute reactions to visible light and sun (phototoxicity).
Kymab Ltd., of Cambridge, U.K., and Epimab Biotherapeutics Inc., of Shanghai, signed a crosslicensing and development agreement to develop bispecific therapeutic antibodies against multiple targets. They will focus their efforts on immuno-oncology and will combine antibodies sourced from Kymab's Kymouse platform with Epimab's Fabs-In-Tandem Immunoglobulin, or FIT-Ig, platform to generate multiple bispecific antibodies. Kymab will have the development and commercialization rights to those bispecifics in all geographical regions outside of China, and, under the terms of the agreement, Epimab will have the rights to the China market. Each company is eligible to receive milestone payments and royalties for development programs pursued by the other.
Starpharma Holdings Ltd., of Melbourne, Australia, said it completed patient enrollment for its pivotal phase III trials evaluating the efficacy and safety of Vivagel BV (astodrimer sodium) for prevention of recurrent bacterial vaginosis (BV). Trial completion is expected in the first quarter of calendar 2017, with top-line results available early-to-mid second quarter of calendar 2017. The study is being conducted under a special protocol assessment agreement with the FDA. Vivagel already is approved in Europe for the treatment of BV.
Anticancer drug developer Tot Biopharm Co. Ltd., of Suzhou, China, broke ground on stage II construction of the second phase of a monoclonal antibody drug production facility at Suzhou Industrial Park. The facility will have five production lines with a cell culture capacity of 2,000L and a production capacity of 10,000L of monoclonal antibody drugs.
Failure to test batches of finished drugs sent to the U.S. landed Yangzhou Hengyuan Daily Chemical Plastic Co. Ltd., of Yangzhou, China, on the FDA's import alert list and earned it a warning letter. The agency collected samples of the company's product at the port of entry and found that the drug didn't contain the specified API. Consequently, the FDA denied entry of the shipment and notified the U.S. customer, which filed a complaint with the Chinese company. Upon further investigation, Hengyuan discovered that the wrong ingredient had been added to the batch, according to the letter. During an FDA inspection of the Yangzhou facility, company officials acknowledged that the firm did not test all batches of finished drug product prior to release.