The volume of clinical data in 2022 is down by 16.9% from last year. Pandemic efforts are still decreasing while three therapeutic areas dominate the news. Through the last week of July, there have been a total of 1,997 clinical entries, compared with 2,402 by this point in 2021.
After an eight-year odyssey, the first cytidine triphosphate synthase 1 (CTPS1) inhibitor has entered the clinic, with Step Pharma SAS announcing it has simultaneously begun studies in the U.S. and the U.K. The phase I/II trial is assessing Step’s lead program, STP-938, in relapsed/refractory B- and T-cell lymphomas, with the first U.S. site opening for enrollment this week.
The U.S. FDA’s summer 2021 approval of Skytrofa (lonapegsomatropin) from Ascendis Pharma A/S served to sharpen appetites for an even better therapy to treat for pediatric growth hormone deficiency (GHD). Among players in the forefront is Lumos Pharma Inc., with an oral candidate that could disrupt the competitive space.
Wall Street apparently wants to see longer-term data from Bridgebio Pharma Inc. with oral infigratinib in children with achondroplasia (ACH) before deciding about the drug’s chances against the approved therapy Voxzogo (vosoritide) from Biomarin Pharmaceutical Inc.
Ipsen SA’s $247 million buyout of Epizyme Inc., and the recent decision by Nordic Nanovector SA to dump its phase IIb program with CD-37-targeted Betalutin (177Lu lilotomab satetraxetan), served to highlight the hot space of relapsed/refractory follicular lymphoma, where bispecifics have been showing particular promise.
Top-line results from Vistagen Therapeutics Inc.’s Palisade-1 phase III study of PH-94B for treating social anxiety disorder showed the therapy fell shy of the primary endpoint. The South San Francisco-based company’s stock (NASDAQ:VTGN) fell dramatically on the results July 22 as shares closed 86% lower at 15 cents each.
With enrollment set to finish any day in Selecta Biosciences Inc.’s Dissolve II study testing SEL-212 in chronic refractory gout (CRG), investor appetite runs high in the space, as contenders line up to take on Horizon Therapeutics plc’s Krystexxa (pegloticase), the only product approved for CRG.
Stem cell therapy company Mesoblast Ltd. said that for patients with chronic heart failure with reduced ejection fraction, treatment with rexlemestrocel-L, its allogeneic product candidate, resulted in greater improvement in a prespecified analysis of left ventricular ejection fraction at 12 months relative to controls in the phase III DREAM-HF trial.
After political leaders across the globe made patents and other intellectual property safeguards the scapegoat for disparities in access to COVID-19 vaccines, the biopharma industry is sharing its vision for how to deal with the foundational issues of equitable access in pandemics to come – and it has nothing to do with IP waivers like the one World Trade Organization members adopted last month.
VBL Therapeutics Inc.’s phase III study of its gene therapy, ofranergene obadenovec, in treating ovarian cancer missed its primary endpoints, prompting the company to discontinue the trial and investors to pull way back. Shares of the Tel Aviv, Israel, and New York-based company’s stock (NASDAQ:VBLT) plunged 79% on July 20 to close at 43 cents per share. The $1.62 per share drop in value made it a penny stock. VBL shares hit their high on Nov. 8, closing at $2.53 each. Top-line data for ofra-vec, also known as VB-111, showed no statistically significant improvement in progression-free survival or overall survival.
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