Affibody AB, of Solna, Sweden, said it will receive an undisclosed clinical milestone payment from partner Daiichi Sankyo Co. Ltd., of Tokyo, which initiated a phase I study of a molecule stemming from the companies' 2013 license agreement regarding the Albumod platform. That platform is designed to extend the circulatory half-life of biopharmaceuticals leading to superior pharmacokinetics tailored to the disease state and increased patient compliance.
Aslan Pharmaceuticals Pte Ltd., of Singapore, said it raised $34 million in series C funding led by Accuron Technologies, a wholly owned subsidiary of Temasek Holdings, to advance work on therapies directed toward prevalent tumor types in Asia, including gastric cancer, cholangiocarcinoma and hepatocellular carcinoma. Other new investors include Tianda Pharmaceuticals and Haitong International, and they were joined by existing investors Morningside, Bioveda, Cenova and Sagamore Bioventures. Aslan previously raised $12 million in a 2011 series A round and $22 million in a 2013 series B round. (See BioWorld Today, Oct. 18, 2013.)
Astellas Pharma Inc., of Tokyo, and Ironwood Pharmaceuticals Inc., of Cambridge, Mass., said the phase III Japan study of linaclotide in adults with irritable bowel syndrome with constipation (IBS-C) met its primary endpoints. Top-line data showed linaclotide-treated patients had statistically significant improvement compared to placebo-treated patients for both of the two co-primary endpoints. Thirty-four percent of linaclotide-treated patients were Global Assessment of Relief of IBS Symptoms responders, compared to 18 percent of placebo-treated patients (p<0.001), while 35 percent of linaclotide-treated patients were Complete Spontaneous Bowel Movement overall responders, compared to 19 percent of placebo-treated patients (p<0.001). Improvements also were achieved in pre-specified secondary endpoints covering abdominal and constipation symptoms, including bloating and abdominal pain/discomfort. Diarrhea rates were 9.6 percent for linaclotide vs. 0.4 percent for placebo, and all cases were characterized as mild or moderate in severity. Astellas expects to submit a new drug application to the Ministry of Health, Labor and Welfare in Japan in 2016. Linaclotide, a guanylate cyclase C agonist, is currently approved in the U.S. for the treatment of adults with IBS-C and chronic idiopathic constipation (CIC) and is approved for adults with IBS-C or CIC in more than 30 other countries.
Biontech Diagnostics GmbH, a Mainz, Germany-based subsidiary of Biontech AG, and Shuwen Biotech Co. Ltd., of Deqing, China, formed a strategic partnership to commercialize Biontech's molecular breast cancer stratification test Mammatyper in China. Mammatyper is a molecular diagnostic test for stratification of breast cancer by molecular subtyping of routine tumor tissue samples. Based upon measurements of gene expression by RNA analysis, it has the potential to improve the standard of diagnosis and, ultimately, treatment of breast cancer patients, the companies said. Under the terms of the agreement, Shuwen will undertake clinical studies for regulatory approval of Mammatyper in China, and will become the exclusive distributor there.
Biotron Ltd., of Sydney, said data from a phase Ib/IIa study testing BIT225 in HIV-1-infected subjects were published in the Journal of Antimicrobial Chemotherapy, showing that BIT225 can target and reduce levels of HIV-1 residing in long-lived monocyte/macrophage reservoirs. Those reservoirs exist even in patients undergoing treatment with current antiretroviral drugs, and are responsible for ongoing cycles of reseeding HIV-1 infection. The study also indicated that BIT225 may impact immune activation. Biotron anticipates moving into phase II to test BIT225 in combination with current antiretroviral drugs during the first half of 2016.
Biovista Inc., of Charlottesville, Virginia, entered a drug repositioning collaboration with Tokyo-based Astellas Pharma Inc. The collaboration is focused on identifying new indications for a number of undisclosed Astellas compounds using Biovista's Clinical Outcome Search Space technology. No terms were disclosed.
Bluebird Bio Inc., of Cambridge, Mass. and Seoul, South Korea-based Viromed Co. Ltd. said they entered an exclusive license agreement to research, develop and commercialize chimeric antigen receptor (CAR) T-cell therapies using Viromed's humanized antibody to an undisclosed cancer target for solid tumors. Bluebird will leverage its lentiviral gene therapy platform and CAR T capabilities to develop CAR T therapies against the target. Financial terms include a $1 million up-front payment and subsequent milestone payments to Viromed, which together could total more than $48 million per licensed product if certain development and regulatory milestones are achieved. Viromed is also eligible to receive tiered royalties on product sales. Bluebird will conduct and fund clinical development as well as regulatory and commercial activities.
Clinuvel Pharmaceuticals Ltd., of Melbourne, Australia, updated its development program for Scenesse (afamelanotide 16 mg) in the depigmentation disorder vitiligo, stating it will focus global development on patients with naturally darker skin types for whom vitiligo has an intense psychological and significant social impact. Scenesse, which is designed to work by activating melanin in skin, is being evaluated as a combination therapy alongside narrowband UVB light therapy for vitiligo.
Cynata Therapeutics Ltd., of Melbourne, Australia, said it signed a letter of intent regarding a future strategic alliance with Regience K.K., of Tokyo, for Japan and certain other Asian countries. The companies said they identified a mutually beneficial business opportunity to enter a business partnership under which Regience would license, develop and commercialize Cynata's Cymerus therapeutic mesenchymal stem cell technology in certain territories, including Japan. During the coming weeks, the firms will evaluate and define a commercial relationship, and, if appropriate, enter a strategic alliance agreement.
Egalet Corp., of Wayne, Pa., disclosed the end of its collaboration with Shionogi & Co. Ltd., of Osaka, Japan, for its abuse-deterrent, extended-release hydrocodone product. With the close of the partnership, Egalet gains worldwide rights to phase I candidate S-718632. The collaboration, which began in November 2013, was ended due to Shionogi's internal prioritization process, Egalet said. Through the collaboration, Egalet received up-front and milestone payments totaling $20 million, as well as an investment of $15 million in Egalet's common stock in connection with Egalet's 2014 IPO. All development to date for S-718632 has been funded by Shionogi. Egalet said it is evaluating options with respect to the further development of the program.
Incarda Therapeutics Inc., of San Francisco, established a subsidiary in Australia where it is planning to undertake its first clinical trial for an inhaled therapy intended to treat paroxysmal atrial fibrillation during the first half of 2016. The company has contracted with Australian clinical research organizations and is conducting formulation manufacturing and testing in Australia in preparation for the upcoming study, it said. The trial will be substantially subsidized by the Australian government through R&D incentives.
Living Cell Technologies Ltd., of Sydney, Australia, completed contracts to secure the supply and manufacture of Ntcell, an alginate coated capsule containing clusters of neonatal porcine choroid plexus cells. After transplantation, Ntcell functions as a biological factory producing factors to promote new central nervous system growth and repair disease induced nerve degeneration. The purchase of plant, designated pathogen-free pigs and inventory is estimated to increase cash outflows by approximately $50,000 for each of the next 12 months. The facilities will provide sufficient capacity to manufacture Ntcell for the phase IIb clinical trial of Ntcell for Parkinson's disease and to treat patients under provisional consent.
Merck & Co. Inc., of Kenilworth, N.J., said Samsung Bioepis Co. Ltd., of Incheon, Korea, received approval of Renflexis (infliximab), a biosimilar of Remicade (Johnson & Johnson) by the Ministry of Food and Drug Safety in Korea. Merck will commercialize the drug in Korea as part of its commercialization partnership with Samsung Bioepis.
The Queensland Emory Drug Discovery Initiative (QEDDI), a collaborative effort of Uniquest Pty Ltd., of Brisbane, Australia, the commercialization company of the University of Queensland, and Emory University's Drug Innovation Ventures at Emory LLC (DRIVE), of Atlanta, will be searching for treatments for Ross River virus. QEDDI is receiving three year funding of $4.169 million from the Queensland government. DRIVE will deliver potential drugs to the UQ for antiviral testing on Ross River virus.
Samsung Bioepis Co. Ltd., of Incheon, South Korea, said Korea's Ministry of Food and Drug Safety (MFDS) has approved Renflexis, a biosimilar version of Remicade (infliximab, Johnson & Johnson), for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, pediatric Crohn's disease, ulcerative colitis, pediatric ulcerative colitis, psoriatic arthritis and plaque psoriasis. It marks the second approval for Samsung Bioepis in Korea. In September, the MFDS approved Brenzys, a biosimilar version of Enbrel (etanercept, Amgen Inc.) (See BioWorld Today, Sept. 10, 2015.)
Starpharma Holdings Ltd., of Melbourne, Australia, said Astrazeneca plc, of London, has selected a second Dendrimer Drug Delivery (DEP) candidate and Starpharma will now commence a new DEP project incorporating the second Astrazeneca oncology molecule. The development of the new candidate will be conducted under the recently signed multi-product license agreement between Starpharma and Astrazeneca. Dendrimer-enhanced versions of selected drugs have been found to be superior to the unmodified drugs in preclinical studies, often having improved efficacy and fewer side effects or toxicities, such as Starpharma's drug DEP docetaxel which is currently in phase 1 clinical studies, the company said.
Sucampo Pharmaceuticals Inc., of Rockville, Md., said it completed its acquisition of Japanese firm R-Tech Ueno Ltd. and all remaining outstanding shares. Under terms of the deal, inked earlier this year, Sucampo paid about ¥32.8 billion, or about $275 million. (See BioWorld Today, Sept. 2, 2015.)
Taigen Biotechnology Co. Ltd., of Taipei, Taiwan, said the intravenous (I.V.) formulation of Taigexyn achieved the primary endpoint, defined as clinical success rate at visit four in the evaluable modified intent-to-treat (mITT) population, in the phase III study of community-acquired pneumonia. The randomized, double-blinded study enrolled 525 patients from Taiwan and Mainland China and compared I.V. formulations of Taigexyn 500 mg vs. levofloxacin 500 mg. The clinical success rates for Taigexyn and levofloxacin were 92.8 percent and 87 percent, respectively, in evaluable mITT subjects. Taigexyn was shown to be noninferior to levofloxacin in that the lower limit of the 95 percent CI of the treatment difference was greater than -10 percent (p<0.05). Based on those results, Taigen said it plans to file a new drug application with the CFDA in 2016.
Tianyin Pharmaceutical Inc., of Chengdu, China, said it received notice from NYSE MKT LLC indicating that the firm is below certain continued listing standards, due to the delay in filing a Form 10-Q for the quarter ending Sept. 30, 2015, in addition to the delay of its 10-K annual report for the year ended June 30, 2015. The company said it intends to submit a supplement to its compliance plan by Dec. 4.
Ultragenyx Pharmaceutical Inc., of Novato, Calif., said it started a phase III study of KRN23 for the treatment of adults with X-linked hypophosphatemia (XLH), an inherited metabolic bone disease characterized by short stature, skeletal deformities, bone pain, fractures and muscle weakness. The drug, a recombinant fully human monoclonal IgG1 antibody, is partnered with Kyowa Hakko Kirin Co. Ltd., of Tokyo. The randomized, double-blind, placebo-controlled study will assess the efficacy and safety of monthly KRN23 at 24 weeks in about 120 adult XLH patients in the U.S., EU, Canada, Japan and Korea. The primary endpoint will be serum phosphorus levels through 24 weeks and the key secondary endpoint is the Brief Pain Inventory Question 3 (pain at its worst in the last 24 hours) at week 24. Other secondary endpoints include patient-reported outcomes assessing skeletal pain, stiffness, fatigue, motor function and quality of life. Ultragenyx also plans to initiate a 48-week, open-label, bone-quality study in about 10 adult XLH patients evaluating the potential impact of KRN23 on the underlying osteomalacia via bone biopsy.