Shanghai Junshi Biosciences Co. Ltd. and Coherus Biosciences Inc. have disclosed positive data from a phase III trial of the anti-PD-1 antibody toripalimab in combination with chemotherapy in China. Though already approved for several indications, they’re seeking to position it as a first-line treatment of advanced squamous or non-squamous non-small-cell lung cancer (NSCLC). The final data largely confirmed interim findings from the study, first reported in August 2021.
Tiziana Life Sciences Inc.’s intranasal, fully human anti-CD3 monoclonal antibody will need testing in 10 or 20 more patients to confirm the signal in secondary progressive multiple sclerosis (SPMS), but key opinion leaders on a conference call March 14 sounded optimistic as they checked out the prospect’s early efficacy.
New data from two phase II studies from two companies showed progress in their respective Parkinson’s disease programs. The data for both therapies, from Anavex Life Sciences Corp. and Sage Therapeutics Inc., were presented on opening day, March 15, at the AD/PD 2022 Advances in Science & Therapy International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders, being held in Barcelona until March 20.
Big pharma sponsors of clinical trials in Ukraine are putting studies on hold in Russia, Ukraine and Belarus as the conflict continues into its third week. As revealed by BioWorld last week, hundreds of clinical trials were being conducted in the two countries at the time Russian President Vladimir Putin gave orders to invade Ukraine on Feb. 20.
Sanofi SA has suffered a setback in its bid to find a successor to Astrazeneca plc’s breast cancer drug Faslodex (fulvestrant) as amcenestrant failed to improve progression-free survival in advanced breast cancer in a mid-stage trial.
Discussions with regulators on a proposed phase III trial design are up next for Bridgebio Pharma Inc., which reported positive phase II data for BBP-418 (ribitol) in patients with limb-girdle muscular dystrophy type 2 (LGMD2i), the first of several clinical readouts expected in 2022, as the Palo Alto, Calif-based company looks to regain its footing after disappointing top-line data for its phase III program in transthyretin amyloid cardiomyopathy leveled the stock late last year.
In top-line data from the Pathway phase III trial with Transcon PTH in hypoparathyroidism, Ascendis Pharma A/S provided “what many have been waiting for: a way of therapy to not only boost serum calcium into the normal range, but to make sure that the kidney issues [are] also handled,” said Aimee Shu, vice president of clinical development in endocrinology and co-director of the study, during a conference call with investors.
Four years after Bristol Myers Squibb Co.’s (BMS) $1.85 billion investment in Nektar Therapeutics Inc., the pair’s collaboration has stumbled mightily with a phase III failure. A first analysis their melanoma study, PIVOT IO-001, showed it missed three primary endpoints. The study of interleukin-2-targeting NKTR-214 (bempegaldesleukin) combined with Opdivo (nivolumab) compared to Opdivo monotherapy as a first-line treatment for previously untreated, unresectable or metastatic melanoma did not meet the primary endpoints of progression-free survival and objective response rate.
Novo Nordisk A/S, best known for its range of diabetes drugs and insulins, has said that growing its rare disease unit will be an important part of its business strategy this decade. Novo Nordisk has actually been operating in rare diseases for 40 years, starting in hemophilia and gradually growing its presence. But the Bagsværd, Denmark-based company has big plans for its rare diseases arm in the next few years, with a pipeline of drugs aimed at the busy hemophilia market and for rare endocrine disorders.
Tyra Biosciences Inc.’s recent deal with Xcures Inc. drew more attention to the already popular FGFR inhibitor space in oncology, as the pair made known a collaboration on a real-world biomarker study involving patients with FGFR-mutant bladder cancer who are given once-daily, oral Balversa (erdafitinib, Johnson & Johnson), a pan-FGFR blocker approved in April 2019.
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