Anges Inc., of Osaka, Japan, and Istanbul-based Er-kim Ilac A.S. announced an exclusive licensing and distribution agreement for Er-Kim to commercialize Anges’ gene therapy product Collategene (beperminogene perplasmid) for critical limb ischemia patients in Turkey. Er-kim will be responsible for obtaining regulatory approvals and, thereafter, sales, marketing and local medical affairs activities. In the meantime, the companies will make Collategene available through a named patient program.
Aslan Pharmaceuticals Ltd., of Singapore, said it plans to develop its dihydroorotate dehydrogenase inhibitor, ASLAN-003, for autoimmune disorders such as multiple sclerosis (MS) after preclinical and clinical work appeared supportive of the endeavor. CEO Carl Firth said there's a need for MS therapies "that can deliver improved efficacy and addresses the risks of toxicity associated with this and other classes of drug in the field." The company said further details would be shared in early 2021.
Beyond Air Inc., of Garden City, N.Y., said new in vitro and in vivo preclinical data suggest its gaseous nitric oxide treatment may be of use in "treating lung cancer locally and its metastases systemically, potentially via stimulation of an anti-tumor immune response." The data are being presented at the International Association for the Study of Lung Cancer’s North America Conference on Lung Cancer 2020.
The Institute for Clinical and Economic Review, of Boston, said that it has assessed Hemlimbra (emicizumab, Genentech Inc.) as providing comparable or better clinical benefits when compared to common current dosing levels of prophylactic factor VIII. Hemlimbra "is also cost-saving but only because factor VIII prices are extremely high and have not moderated with competition," ICER said. Though a potentially competitive therapy developed by Biomarin Pharmaceutical Inc., Roctavian (valoctocogene roxaparvovec) received a complete response letter from the FDA in August, ICER said that a review of that candidate based on data available prior to FDA decision suggest that, at a price of $2.5 million, valoctocogene roxaparvovec would also be cost-saving vs. current factor VIII dosing levels.
The Institute for Clinical and Economic Review, of Boston, released a final evidence report assessing the comparative clinical effectiveness and value of the following targeted immune modulators that treat moderate to severe ulcerative colitis. It said that an independent appraisal committee voted that the evidence is adequate to demonstrate clinical superiority of Takeda Pharmaceutical Co. Ltd.'s Entyvio (vedolizumab) over Abbvie Inc.'s Humira (adalimumab). The group also said that "the significantly lower prices seen for infliximab and its biosimilars speaks to the important potential for improved value with broader availability and uptake of biosimilar treatment options."
Macrogenics Inc., of Rockville, Md., highlighted publication of an article in Blood Advances illuminating "the role of flotetuzumab in the immunotherapy of TP53-positive acute myeloid leukemia." The results "further support our decision to conduct a pivotal study of flotetuzumab in AML patients who have previously experienced either a primary induction failure or an early relapse when treated with standard-of-care chemotherapy regimens," said Macrogenics president and CEO Scott Koenig.
Omeros Corp., of Seattle, reported preclinical data on OMS-906, its monoclonal antibody targeting mannan-binding lectin-associated serine protease-3, at the 4th Complement-based Drug Development Summit. A single dose of OMS-906 decreased mature complement factor D (CFD) and increased pro-CFD, which remained detectable for more than three weeks. Lowest levels of detectable mature CFD correlated with complete inactivation of the complement system’s alternative pathway.