A little more than four years after striking its first deal with Aduro Biotech Inc., Johnson & Johnson's Janssen Biotech Inc. is terminating research and licensing agreements for the Berkeley, Calif.-based company's experimental lung and prostate cancer treatments. The termination leaves about $1.1 billion in potential milestone payments to Aduro unrealized, and returns three programs based on its live, attenuated double-deleted Listeria (LADD) technology platform to the company. (See BioWorld Today, Oct. 17, 2014.)
Velosbio Inc., a San Diego-based startup developing antibody-drug conjugates to treat blood cancers and solid tumors, has landed a $58 million series A financing co-led by Arix Bioscience plc and Sofinnova Ventures. Other investors included Pappas Ventures, Chiesi Ventures, Takeda Ventures Inc. and Decheng Capital. While the company has said little about its initial pipeline, the new financing is projected to help it complete a first investigational new drug application soon, Velosbio's CEO Dave Johnson told BioWorld.
An accelerated approval for Insmed Inc.'s Arikayce (amikacin liposome inhalation suspension) has poised the company, within weeks, to offer the first and only FDA-approved therapy for refractory nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) in adults. The drug, which addresses a rare and often chronic infection that can cause irreversible lung damage, is also the first to be granted approval under the agency's limited population pathway for antibacterial and antifungal drugs (LPAD), created by the FDA to spur development of antibiotics for unmet medical needs.
FDA approval for Eli Lilly and Co.'s migraine prevention therapy, Emgality (galcanezumab-gnlm), completes a trio of anticipated 2018 calcitonin gene-related peptide (CGRP) entries into a fiercely competitive field where months of free drug is par for the course. The green light follows an earlier September approval for Teva Pharmaceutical Industries Ltd.'s Ajovy (fremanezumab-vfrm) and, in May, for Amgen Inc.'s Aimovig (erenumab-aooe).
After years of seeing cancer immunotherapies fall short of their full potential, industry oncology veterans are taking a new tack. Under the banner of Akrevia Therapeutics Inc., they've put together a $30 million series A financing "with the aim of going big," Tim Clackson, president and head of R&D for the new venture, told BioWorld.
With generic competition poised to cut deep into revenue from its top product, the preterm birth drug Makena (hydroxyprogesterone caproate), Amag Pharmaceuticals Inc. has moved to acquire a midstage preeclampsia drug from Velo Bio LLC. If successful, it could transform the old digoxin poisoning treatment into an essential maternal care product for an indication with no FDA-approved therapy, a scenario that CEO Bill Heiden called "a potential $1 billion project opportunity."
Shares of TG Therapeutics Inc. plunged 44.3 percent to $5.15 on Tuesday as uncertainty over timing of a key interim readout for its two-drug chronic lymphocytic leukemia (CLL) treatment led it to scrub plans to seek accelerated approval for the combo.
Interim data from a phase IIa test of Anaptysbio Inc.'s etokimab showed a single dose of the drug improving lung function for a small group of adults with severe eosinophilic asthma by an amount that put it "in roughly the same ballpark" as Dupixent (dupilumab) and Fasenra (benralizumab), Evercore ISI analyst Josh Schimmer suggested. Anaptysbio's president and CEO, Hamza Suria, dismissed direct comparisons as unsupported by the trial's design. Meanwhile, investors, enthused by the comparison or simply encouraged by the data alone, lifted company shares (NASDAQ:ANAB) 9.9 percent higher Monday to close at $101.95.
Shares of Gtx Inc. (NASDAQ:GTXI) dropped 92.3 percent to $1.80 on Friday after a phase II trial found two doses of its sole clinical candidate, a selective androgen receptor modulator (SARM), failed to separate from placebo in helping postmenopausal women reduce stress urinary incontinence (SUI). The candidate, enobosarm, has been evaluated in 27 trials to date. Barring a compelling finding in the full data, the program will likely be wound down, Executive Chairman Rob Wills told BioWorld. The Gtx team will now turn its attention to identifying a lead from its preclinical selective androgen receptor degrader (SARD) program, he said.
Rare disease specialist Amicus Therapeutics Inc. is breaking into the gene therapy field with the acquisition of 10 new assets through its purchase of Ohio-based Celenex Inc. for $100 million up front. The deal also features up to $277 million in development and regulatory milestones, plus potential sales-based payments. Two clinical-stage programs in Batten disease lead the in-licensed portfolio, which also includes lysosomal storage disorder programs in Niemann-Pick type C, Wolman disease and Tay-Sachs.
