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BioWorld - Wednesday, March 11, 2026
Home » Topics » Clinical

Clinical
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In the clinic for July 1, 2021

July 1, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adocia, Alnylam, Altimmune, Angion, Arrowhead, Atea, Axcella, Bone, Brickell, Compugen, Cynata, Cytokinetics, Diffusion, Embera, Gensight, Histogen, International Stem Cell, Lyra, Madrigal, Meissa, NMD, Novome, Oasmia, Ocuphire, Pharmajet, Retrotope, Saniona, Sellas, Sinovac, Sirnaomics, United, Vedanta.
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Illustration of RNS system placement in brain

Neuropace garners $9M NIH grant for epilepsy study

June 30, 2021
By Annette Boyle
Neuropace Inc. nabbed $9 million in the form of a five-year NIH grant as part of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative. The grant will support the study of the Mountain View, Calif.-based company’s Responsive Neurostimulation (RNS) system in patients with Lennox-Gastuat syndrome (LGS), a debilitating form of epilepsy.
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Altimmune and Angion shares slide after COVID-19 trial disappointments

June 30, 2021
By Richard Staines
Shares in Altimmune Inc. and Angion Biomedica Corp. were sharply down after the companies announced trial disappointments from a nasal COVID-19 vaccine and two investigational therapies. Altimmune was worst hit, with shares (NASDAQ:ALT) dropping 38% to $9.80 June 30 after announcing its nasal COVID-19 vaccine did not produce enough immune response and axing an immunotherapy trial after encountering problems finding enough subjects.
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Hightide’s HTD-1801 meets primary endpoint in phase II trial for PSC

June 30, 2021
By Elise Mak
Hightide Therapeutics Inc. presented top-line results of its lead program, HTD-1801, from a multicenter phase II trial in primary sclerosing cholangitis (PSC), which showed the drug candidate reduced alkaline phosphatase levels compared to placebo.
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In the clinic for June 30, 2021

June 30, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Addex, Astrazeneca, Brim, Celularity, Cerevel, Ciclomed, Compass Pathways, Elicio, F-star, Harmony, Horizon, Iovance, Moderna, Orchard, Pfizer, Propella, Synthetic Biologics, Trillium, VBI.
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Medigen EV71 vaccine shows 100% efficacy in phase III trial

June 29, 2021
By Doris Yu
Medigen Vaccine Biologics Corp. released results from a phase III trial of its enterovirus 71 (EV71) vaccine that showed efficacy of 100% against a virus that causes hand, foot and mouth disease and continues to emerge on a regular basis across Asia.
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Embryo evaluation

Aivf study shows AI can determine which embryos have best chance for successful pregnancy

June 29, 2021
By Annette Boyle
A study presented this week at the European Society of Human Reproduction and Embryology (ESHRE) annual conference demonstrated that the noninvasive artificial intelligence (AI) technology developed by Aivf Ltd. can instantly differentiate between genetically normal and abnormal human embryos, increasing the likelihood of successful pregnancy for couples using in vitro fertilization.
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Medtronic study app and Linq device

Medtronic launches app-based study on atrial fibrillation

June 29, 2021
By Meg Bryant
Medtronic plc kicked off an app-based research study to improve understanding of atrial fibrillation (AF) disease burden and its impact on patient outcomes, quality of life and health care utilization. The first patients in the DEFINE AFib study were enrolled at Duke University Medical Center and the Florida Electrophysiology Associates in Atlantis, Fla. “When it comes to managing atrial fibrillation, there is not a ‘one-size-fits-all’ approach, and the hope is that DEFINE AFib may give us the tools to help personalize AF management based on a patient’s individual health profile and physiology,” said Jonathan Paul Piccini, director of cardiac electrophysiology and associate professor of medicine at Duke University School of Medicine and chair of the DEFINE AFib Steering Committee. “DEFINE AF will harness the power of digital health to make fundamental discoveries about how we can manage atrial fibrillation better in each and every one of our patients.”
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Back to the dojo

Underwhelmed by lead cancer vaccine, Sensei moves to reprioritize, refocus

June 29, 2021
By Michael Fitzhugh
Shares of Sensei Biotherapeutics Inc. (NASADQ:SNSE) fell 16% to $9.10 on June 29 after an announcement by President and CEO John Celebi that the antigen display technology used in its prior lead candidate, SNS-301, "is suboptimal for use in an active cancer vaccine." A phase I/II trial evaluating it will be discontinued, he said. Now, work on a next-generation vaccine, SNS-401-NG, and the monoclonal antibody SNS-VISTA will take precedence in a portfolio reprioritization at the company, with IND-enabling studies for the anti-VISTA program planned to start by the end of 2021 and for the next-gen vaccine in second half of 2022.
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Kidneys

No filter: Diamedica kidney picture clouded after interim phase II viewing

June 29, 2021
By Randy Osborne
Diamedica Therapeutics Inc.’s chief medical officer, Harry Alcorn, said that “due to the complexity [of diabetic kidney disease (DKD)], there's not a clear answer” as to why such patients did less well in the company’s Redux phase II trial with DM-199 (recombinant human tissue kallikrein 1 [KLK1]). “But I wouldn't say that there wasn't a response in the DKD group,” he said, citing upside in 30% of subjects.
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