Zai Lab Ltd. has shared positive top-line data from its phase III study for PARP inhibitor Zejula (niraparib) in the treatment of newly diagnosed ovarian cancer following a response to platinum-based chemotherapy. The study, called Prime, involved 384 advanced ovarian cancer patients in China and met its primary endpoint.
One of Pfizer Inc.’s last decisions of 2021 was to shell out $6.7 billion for San Diego’s Arena Pharmaceuticals Inc., a deal centered around the pipeline inflammatory disease pill etrasimod. A potential successor to Xeljanz (tofacitinib), the price New York-based Pfizer paid suggests blockbuster potential for etrasimod. Phase III results announced March 23 suggest Pfizer’s big acquisition, the fifth largest in biopharma in 2021, was money well spent.
Oric Pharmaceuticals Inc. is quitting development of ORIC-101 after interim analyses of two phase Ib studies concluded that the clinical activity does not justify going forward with the compound. The company was testing ORIC-101, a glucocorticoid receptor antagonist, combined with Abraxane in various solid tumors and paired with Xtandi in metastatic prostate cancer.
Wall Street was not as pleased as some might have expected by Immunogen Inc.’s full results from the pivotal study called Soraya testing mirvetuximab soravtansine (mirv) monotherapy in patients with folate receptor (FR) alpha-high, platinum-resistant ovarian cancer (PROC) who have been previously treated with Avastin (bevacizumab, Roche Holding AG). Analysts hailed the results as positive but shares (NASDAQ:IMGN) closed at $4.30, down 96 cents, or 18.25%.
Headlines the world over have been dominated by the resilience of the Ukrainian military – but the country’s clinical research body said that amid the chaos of war, trials are carrying on despite the destruction of hospitals and civilian infrastructure. As revealed by BioWorld, big pharma sponsors are putting clinical studies on hold in Russia, Ukraine and Belarus as the war plays havoc with medical supplies and the normal functioning of society.
The recent start of Neurogene Inc.’s first-in-human trial testing NG-101 in ceroid lipofuscinosis type 5 (CLN5) Batten disease (BD) drew investor attention to the space, where a handful of developers vie for new therapies against the challenging indication.
Despite global drops in COVID-19 infections and because variants never rest, Eiger Biopharmaceuticals Inc. is taking its strong top-line phase III data of pegylated interferon lambda to global regulatory agencies for approval. The type III interferon that stimulates immune responses significantly reduced the risk of COVID-19-related hospitalizations or emergency room visits longer than six hours by 50% and death by 60%. The results prompted Eiger to say it would submit the data to the FDA for an emergency use authorization – and also to the EMA and Asian agencies – as soon as it could.
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.
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