DUBLIN – DBV Technologies SA hopes to move its Viaskin Milk (VM) desensitization therapy for IgE-mediated cow's milk protein allergy (CMPA) into phase III trials next year, on the back of phase I/II efficacy data it unveiled Sunday at the European Academy of Allergy and Clinical Immunology (EACCI) congress in Munich. That depends on FDA agreement, however, and the Paris-based firm plans to meet with the regulator to discuss its next steps later this year. The treatment missed the primary endpoint of the trial but at the same time showed definite efficacy trends.
DUBLIN – Lava Therapeutics BV raised €16 million (US$18.8 million) in a series A round to take forward its bispecific gamma-delta T-cell engager technology for training a gamma-delta T-cell response on solid and liquid tumors.
DUBLIN – Apogenix AG plans to file late next year for conditional approval in Europe for its CD95 antagonist, asunercept (formerly APG-101), following a review of a phase II trial in recurrent glioblastoma, which uncovered a five-year overall survival rate of 7 percent for patients who received the drug in combination with radiotherapy. While that may not seem an overly dramatic efficacy signal, it is, by some distance, superior to the 0 percent rate for patients in the control group, who received radiotherapy only.
DUBLIN – The current Ebola outbreak in the Democratic Republic of the Congo (DRC), which by last Thursday had claimed 25 lives, is not yet sufficiently alarming to trigger "a public health emergency of international concern," the World Health Organization concluded Friday. So far, 45 cases have been reported, 14 of which have been confirmed by laboratory testing. Three of the cases involved health workers.
DUBLIN – Last week Philadelphia-based Spark Therapeutics Inc. reported $2.4 million revenue for the debut quarter of Luxturna (voretigene neparvovec-rzyl), its gene therapy for an inherited form of vision loss, which gained FDA approval last year. Novartis AG also recently reported its first quarterly sales figure for Kymriah (tisagenlecleucel). The chimeric antigen receptor T-cell (CAR-T) therapy took in $12 million in the first quarter, its second on the market since its approval last August for children and young adults with B-cell precursor acute lymphoblastic leukemia (ALL). Gilead Sciences Inc. reported Q1 sales of $40 million for Yescarta (axicabtagene ciloleucel), the CD19-directed CAR-T therapy approved for diffuse large B-cell lymphoma, following sales of $7 million in Q4 2017, its first quarter on the market. Although modest, the numbers demonstrate that the new era of cell and gene therapy has – after several false dawns in Europe – finally arrived.
DUBLIN – Takeda Pharmaceutical Co. Ltd. has convinced the board of Shire plc of the merits of its £46 billion (US$62.1 billion) cash-and-shares takeover offer. Now it must do likewise with Shire's investors – as well as its own.
DUBLIN – Early stage Swiss firm Memo Therapeutics AG raised CHF5 million (US$5 million) in a series A2 round to fund preclinical development of its antibody discovery platform, which is based on a proprietary method of capturing and banking an individual's antibody repertoire.
DUBLIN – Takeda Pharmaceutical Co. Ltd. has convinced the board of Shire plc of the merits of its £46 billion (US$62.1 billion) cash-and-shares takeover offer. Now it must do likewise with Shire's investors – as well as its own.
DUBLIN – Cellectis SA is supplying its transcription activator-like effector nuclease (Talen) genome editing technology to what has been billed as the first "grand-scale community-wide project" of the Genome Project Write (GP-Write) initiative, an effort to develop a cell line that is resistant to naturally occurring viruses.
