As Aurinia Pharmaceuticals Inc. marches ahead with the phase III trial testing what could become the first approved lupus nephritis (LN) therapy, company backers are watching with interest another, lesser known indication where the cyclosporine analogue voclosporin might also work: focal segmental glomerular sclerosis (FSGS), a glomerular disease that can cause nephrotic syndrome. A phase II experiment is slated to start next month. Both conditions involve high amounts of protein in the urine, or proteinuria.
Amgen Inc. having scored the first of four expected approvals in the calcitonin gene-related peptide (CGRP) receptor class with Aimovig (erenumab) for preventing migraine, Wall Street set about handicapping odds for the others in a large market.
Onconano Medicine Inc.'s $11.7 million in series A money should let the company finish phase I trials with its imaging agent and bring a therapeutic candidate to IND-enabling studies, CEO Ravi Srinivasan told BioWorld, as the company works with a "phenomenon [that] has not been exploited so far, even though it's been well-known and well-established in the cancer field."
With the countdown continuing to the Aug. 13 PDUFA date for Amicus Therapeutics Inc.'s migalastat in Fabry disease, Idorsia Ltd. has enrolled its first patient in a phase III registration study investigating the oral monotherapy lucerastat in that indication as well.
Company watchers differed over the half-empty, half-full glass of a $125 million financing agreement signed by La Jolla Pharmaceutical Co. (LJP) with Healthcare Royalty Partners (HCR) for Giapreza (angiotensin II), approved late last year and introduced to the market in March to increase blood pressure in adults with septic or other distributive shock.
Exelixis Inc.'s pivotal phase III blowup in colorectal cancer (CRC) may have little read-through to an ongoing melanoma study trying the same two drugs plus a third, and investors still have plenty to cheer about in the strong-selling renal carcinoma (RCC) therapy Cabometyx (cabozantinib).
Escient Pharmaceuticals Inc. CEO Alain Baron told BioWorld that the company's $40 million in series A cash will "take us through 2021, we believe, and we expect to be in the clinic in that time in at least one indication, and perhaps even as far as proof of concept in one indication."
Lodo Therapeutics Corp. chalked up with Roche Holding AG's Genentech arm its first major deal for a platform that involves making bioactive natural products directly from the microbial DNA sequence information contained in soil, with Genentech pledging as much as $969 million, which includes an up-front payment of an undisclosed amount.
The recent deal between OSE Immunotherapeutics SA and Boehringer Ingelheim GmbH may have brought renewed interest in CD47, a controversial target in immuno-oncology (I-O), but plenty of biotech outfits started before word of the tie-up. Nantes, France-based OSE licensed the preclinical SIRP-alpha antibody OSE-172, to Boehringer, of Ingelheim, Germany, for €15 million (US$18.5 million) up front, with the potential for another €15 million when the phase I study starts. Down the road, OSE could collect more than €1.1 billion if undisclosed development, commercialization and sales milestones are met, plus royalties on worldwide net sales. (See BioWorld Today, April 5, 2018.)
