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BioWorld - Sunday, December 21, 2025
Home » Topics » Clinical

Clinical
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Oric marches on post-ASH as others trod adenosine pathway with CD73s

Jan. 28, 2022
By Randy Osborne
Oric Pharmaceuticals Inc.’s preclinical data at last December’s meeting of the American Society of Hematology didn’t please everyone but infused the CD73 drug space with more rationale for the target, and a number of other prospects continue to move through pipelines. Previous early stage findings also have suggested favorable knockdown of adenosine in comparison to Astrazeneca plc’s oleclumab and Arcus Biosciences Inc.’s small molecule, AB-680, also known as quemliclustat. Companies developing CD73 therapies also include Corvus Pharmaceuticals Inc. and Novartis AG.
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BD Max system in use

Clinicians miss 45% of vaginitis cases, BD says

Jan. 27, 2022
By Annette Boyle
Molecular diagnostics could dramatically improve care for one of the most common infections women face, vaginitis. A study by Becton, Dickinson and Co. (BD) found that clinicians miss more than 45% of positive cases and misidentify an additional 12% of negative cases as positives when compared to diagnostic findings.
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Taking a Cue from IL-2 in HPV cancers; pivotal HNSCC study near?

Jan. 27, 2022
By Randy Osborne
Cue Biopharma Inc.’s Kenneth Pienta, acting chief medical officer, called “very strong” the latest phase Ib data with IL-2-based candidate CUE-101 in HPV-positive, recurrent head and neck squamous cell carcinoma (HNSCC), and “by midyear, we're going to have enough data to go forward to talk to the FDA to develop a strategy with them” for a registrational study, likely in third-line patients. Meanwhile, Wall Street sifted through the latest findings from Cambridge, Mass.-based Cue, which closed (NASDAQ:CUE) at $7.99, down $2.61, or 24%. The stock had been posting a gradual run-up for several days.
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China flag and vial

Early trial win bolsters Abogen entrant in China’s COVID-19 vaccine race

Jan. 27, 2022
By Doris Yu

With phase Ib data published in The Lancet Microbe showing Suzhou Abogen Biosciences Co. Ltd.’s mRNA COVID-19 vaccine candidate ARCoV had acceptable safety and induced a strong immune response in the 120 people who received it, company partner Walvax Biotechnology Co. Ltd. is continuing to enroll participants in a large phase III test of the vaccine. If successful, the program could become the first of several Chinese-developed mRNA vaccines poised to take on the pandemic.



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Australian homegrown COVID-19 pipeline shows signs of maturity

Jan. 27, 2022
By Tamra Sami
PERTH, Australia – As COVID-19 infections in Australia continue to mount, a dozen or so Australian compounds are winding their way through the pipeline that could offer additional protection to the vaccines and antivirals that are already provisionally approved by Australia’s Therapeutic Goods Administration.
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Intersect ENT Propel sinus implants

Ahead by more than a nose: Intersect study shows lower health care usage with sinus implant

Jan. 26, 2022
By Annette Boyle
Patients who received Intersect ENT Inc.’s Propel sinus implant had fewer doctor visits, emergency department and urgent care visits and subsequent endoscopies following surgery for chronic rhinosinusitis, a real-world evidence study found.
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Gilead hits the brakes on five studies as FDA places partial clinical hold on magrolimab

Jan. 26, 2022
By Lee Landenberger
Nearly two years after Gilead Sciences Inc. spent $4.9 billion to buy Forty Seven Inc. and its lead candidate, magrolimab, the FDA clamped a partial clinical hold on five of Gilead’s clinical trials combining the therapy with azacitidine. The cause, according to Gilead’s management, is “an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions between study arms.” The company said it has not identified a clear trend in the adverse reactions or new safety signals.
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Pfizer-Biontech vaccine and syringe

Just in case: Pfizer-Biontech study an omicron-targeted vaccine

Jan. 25, 2022
By Lee Landenberger
Pfizer Inc. CEO Albert Bourla has been talking for the past few weeks about creating a vaccine to control the omicron variant. Now the company, with partner Biontech SE, has initiated a clinical study of its new candidate by testing it in healthy adults. Bourla has said the company can adapt its vaccine to new variants in under three months and could have one ready to go in March if necessary.
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Lab sample and bone marrow illustration

Sierra builds approval Momentum with phase III MF data

Jan. 25, 2022
By Randy Osborne
Sierra Oncology Inc. plans an NDA in the second quarter of this year for momelotinib (MMB), thanks to data from the phase III Momentum study with the drug in myelofibrosis (MF) patients who are symptomatic and anemic after treatment with an approved JAK inhibitor. Momentum, which pitted momelotinib against the androgen danazol, met all of its primary and key secondary endpoints. MMB inhibits JAK1/2 and ACVR1/ALK2. Shares of San Mateo, Calif.-based Sierra (NASDAQ:SRRA) closed Jan. 25 at $22.68, up $7.17, or 46%.
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Syringe and capsules atop lab chart

Despite a busy 2021, clinical data slows to pre-pandemic levels

Jan. 25, 2022
By Karen Carey
The amount of clinical data reported in January so far is currently 30% below the amount reported during the same month last year, which was the slowest month of 2021.
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