MedImmune Inc., part of AstraZeneca plc, started the first patient in its Phase III hairy-cell leukemia (HCL) trial with its first-in-class antibody-drug conjugate moxetumomab pasudotox (MP), a CD22 immunotoxin made up of an anti-CD22 antibody fused to a toxin. The molecule binds to CD22, gets internalized and processed, and then releases the toxin payload to blast the tumor.
Gradalis Inc.'s interim Phase II data with its personalized cancer vaccine for advanced ovarian cancer showed the approach more than doubled the benefit in patients given therapy known as FANG, a rough acronym for "furin and granulocyte-macrophage colony-stimulating factor (GMCSF)."
AbbVie Inc.'s $70 million up front buys an option to acquire Alvine Pharmaceuticals Inc.'s drug candidate for celiac disease or the company itself, after Phase IIb trials are finished with ALV003, a two-enzyme combo that degrades gluten.
Few of the pundits and tea-leaf readers handicapping the chances for approval of once-daily inhaled Breo (fluticasone furoate /vilanterol) in the wake of last month's FDA advisory panel were surprised by the agency's go-ahead for the chronic obstructive pulmonary disease (COPD) treatment from GlaxoSmithKline plc and Theravance Inc.
Trevena Inc.'s deal with a subsidiary of Forest Laboratories Inc. brings a $30 million equity investment in exchange for an option to license worldwide rights to TRV027, an angiotensin II Type I receptor (AT1R) biased ligand for acute decompensated heart failure (ADHF), after results are clear from a 500-patient Phase IIb trial, slated to begin by the end of the year.
With Phase II trials on the runway for several forms of adult and pediatric cholestatic liver disease, a rare condition for which no therapy exists, Lumena raised $23 million in a Series A financing that is expected to get the company through those studies, after which the firm will deliberate the matter of whether to bring aboard a partner in the rare-disease effort.
Array BioPharma Inc.'s Phase III trial planned for this summer in recurrent low-grade serous ovarian cancer (LGSOC) with its Novartis AG-partnered MEK inhibitor is one of a handful of late-stage studies expected to roll out this year.
Concert Pharmaceuticals Inc.'s third deal in just over two years with its deuterium-modifying platform brought Celgene Corp. aboard for a single project at first – an up-front payment along with more than $300 million possible in milestone rewards – but with the potential for more compounds that would bring similar financial terms.
An existing partner with two other deals jumped aboard Ambrx Inc.'s site-specific, antibody drug conjugate (ADC) bandwagon, as Bristol-Myers Squibb Co. provided $15 million up front plus funding for discovery and research, as well as milestone payments of that could total $97 million per oncology product emerging from the collaboration.