Clinical trial news - the latest biotech news from Labiotech.eu

Molecure raises $12M and gets FDA clearance for pulmonary sarcoidosis trial

Jim Cornall — Tue, 25 Jul 2023 09:15:00 +0000

Molecure S.A. has received clearance from the U.S. Food and Drug Administration (FDA) on its Investigational New Drug (IND) application to conduct phase II clinical testing of OATD-01. The announcement follows the company closing a secondary public offering and entering into subscription agreements for all 2,776,000 H-shares offered by way of private placement, within the […]

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Roche and Alnylam to work on RNAi therapeutic to treat hypertension

Jim Cornall — Tue, 25 Jul 2023 09:00:00 +0000

Roche has announced a partnership with Alnylam to develop and commercialize zilebesiran, an investigational RNAi therapeutic currently in phase 2 for the treatment of hypertension. Hypertension affects more than 1.2 billion adults worldwide and is the main, independent, preventable risk factor for death and disability, with approximately 80% of the adults with hypertension worldwide not […]

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Crescendo Biologics raises $32M and expands cancer trial

Jim Cornall — Tue, 25 Jul 2023 08:21:48 +0000

Crescendo Biologics Ltd, a clinical stage immuno-oncology company developing novel, targeted T cell enhancing therapeutics, has announced that it plans to augment the ongoing phase 1b clinical trial of CB307 through the addition of a new pembrolizumab (anti-PD-1) combination expansion cohort. Additional financing of $32 million has been secured with the support of all major […]

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Biomica announces interim positive results from irritable bowel syndrome program

Jim Cornall — Thu, 20 Jul 2023 10:00:00 +0000

Biomica Ltd., a clinical-stage biopharmaceutical company developing microbiome-based therapeutics, has released interim positive results from pre-clinical studies in its irritable bowel syndrome (IBS) program. The work was performed in collaboration with the lab of Kara Gross Margolis, associate director for clinical and translational research for the New York University Pain Research Center and an associate […]

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Moleculin issues acute myeloid leukemia drug data

Jim Cornall — Wed, 19 Jul 2023 09:24:12 +0000

Moleculin Biotech, Inc., a clinical stage pharmaceutical company with drug candidates targeting hard-to-treat tumors and viruses, has published data from its completed MB-105 European phase 1 clinical trial assessing the safety and efficacy of annamycin as a single agent for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML). ‘Results of a […]

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Hope for Alzheimer’s patients after Lilly drug results

Jim Cornall — Mon, 17 Jul 2023 16:15:00 +0000

Eli Lilly and Company has presented full results from its phase 3 TRAILBLAZER-ALZ 2 study showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease (AD). The data were shared at the 2023 Alzheimer’s Association International Conference (AAIC) as a featured symposium and simultaneously published in the Journal of […]

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TME Pharma provides positive glioblastoma trial results

Jim Cornall — Fri, 14 Jul 2023 09:30:00 +0000

TME Pharma N.V. has announced a positive clinical update on the best response to therapy, reporting one patient achieving complete response in the GLORIA expansion arm evaluating NOX-A12, TME Pharma’s CXCL12 inhibitor, in combination with standard of care radiotherapy and anti-VEGF, bevacizumab, in first-line glioblastoma. TME Pharma is a biotechnology company focused on developing novel […]

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Calliditas reveals ‘encouraging results’ from head and neck cancer trial

Jim Cornall — Fri, 14 Jul 2023 08:46:44 +0000

Calliditas Therapeutics AB has announced interim data from its proof-of-concept phase 2 trial in patients with squamous cell carcinoma of the head and neck (SCCHN) with its lead NOX 1 and 4 inhibitor product candidate, setanaxib. The analysis reflects encouraging early clinical progression-free survival (PFS) results and is supportive of the presumed anti fibrotic mode […]

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ADC Therapeutics pauses clinical trial following patient deaths

Jim Cornall — Wed, 12 Jul 2023 14:00:00 +0000

ADC Therapeutics SA has announced a voluntary pause in the enrollment of new patients in the phase 2 LOTIS-9 clinical trial evaluating ZYNLONTA (loncastuximab tesirine-lpyl) and rituximab (Lonca-R) in unfit or frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL). The action was taken by ADC Therapeutics after a recent review of aggregate data […]

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NodThera first to show reduction in neuroinflammation with inflammasome inhibitor

Jim Cornall — Tue, 11 Jul 2023 10:00:00 +0000

NodThera has announced positive, initial data from four subjects in the elderly volunteer stage of its phase Ib/IIa study evaluating the effects of its lead candidate NT-0796 on inflammatory and disease-specific biomarkers in the blood and cerebrospinal fluid (CSF). NodThera is a clinical-stage biotech developing brain-penetrant NLRP3 inflammasome inhibitors to treat chronic inflammatory diseases. Alan […]

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CytoMed Therapeutics receives US patent for CAR-Gamma Delta T-cell technology

Jim Cornall — Fri, 07 Jul 2023 10:43:25 +0000

CytoMed Therapeutics Limited, a Singapore-based biopharma company focused on novel donor cell-based immunotherapies for the treatment of various cancers, has announced that its CAR-gamma delta T cell (CAR-γδ T cell) technology, which it has licensed from A*STAR, has been granted a patent by the US Patent and Trademark Office (USPTO). The patent covers technologies for […]

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TolerogenixX expands trial and closes €12M financing

Jim Cornall — Fri, 07 Jul 2023 09:30:00 +0000

TolerogenixX GmbH, a biopharmaceutical company developing personalized cellular therapies aimed at achieving sustained immune tolerance to combat organ rejection and autoimmune diseases, has announced that its phase IIb study in renal transplant patients has received the green light to initiate the B arm of the study. This arm consists of patients receiving minimal immune suppression […]

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Positive data from Sensorion hearing loss study

Jim Cornall — Thu, 06 Jul 2023 10:00:00 +0000

Sensorion, which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, has reported further analysis from its Proof of Concept (POC) phase 2a clinical trial of SENS-401 for residual hearing preservation in adult patients following cochlear implantation. In June 19, Sensorion announced that in preliminary […]

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AstraZeneca non-small cell lung cancer drug meets primary endpoint

Jim Cornall — Thu, 06 Jul 2023 09:40:00 +0000

Positive high-level results from AstraZeneca’s TROPION-Lung01 phase III trial showed datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant improvement for the dual primary endpoint of progression-free survival (PFS) compared to docetaxel, the current standard of care chemotherapy, in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior therapy. […]

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Five latest advancements in osteoporosis research

Willow Shah-Neville — Wed, 21 Jun 2023 10:00:00 +0000

Osteoporosis is a condition that causes bones to become extremely weak, making them more likely to break. In fact, in extremely serious cases of osteoporosis, even a cough or a minor bump can result in a fracture. Often referred to as a ‘silent disease’, many people who develop the condition will not be aware they […]

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NodThera announces positive inflammatory disease data

Jim Cornall — Tue, 20 Jun 2023 10:00:00 +0000

NodThera has announced positive data from first-in-human studies of its lead therapeutic candidates, NT-0249 and NT-0796. In the studies, both candidates were shown to clearly inhibit the NLRP3 inflammasome, a highly validated drug target that plays a pivotal role in controlling inflammatory diseases. The differentiated design characteristics of each candidate enabled them to penetrate different […]

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Lighting up cancer: FluoGuide announces positive results from head & neck cancer trial

Jim Cornall — Tue, 20 Jun 2023 09:40:00 +0000

FluoGuide A/S, a Danish biotech company, has announced positive interim results from the phase IIa trial of its lead product FG001 in head & neck cancer. FG001 was shown to illuminate tumors in all of the patients. Data show all 12 patients in the first two cohorts, undergoing surgery for head & neck squamous cell […]

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FDA puts hold on Arcellx myeloma program following patient death

Jim Cornall — Tue, 20 Jun 2023 09:20:00 +0000

Arcellx, Inc. has received notification from the U.S. Food and Drug Administration (FDA) that a clinical hold has been placed on its CART-ddBCMA investigational new drug (IND) for the treatment of patients with relapsed or refractory multiple myeloma (rrMM). The clinical hold was received on June 16, following a recent patient death. The company said […]

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Allgenesis says dry eye patients’ trial data ‘encouraging’

Jim Cornall — Mon, 19 Jun 2023 15:25:41 +0000

Allgenesis Biotherapeutics Inc., a clinical-stage specialty pharmaceutical company focused on developing novel ophthalmic drugs, has announced topline data from its phase 1b clinical trial for AG-80308, a first-in-class, formyl peptide receptor (FPR) agonist formulated as an aqueous solution eye drop for the treatment of dry eye disease (DED). AG-80308 was considered safe at all doses […]

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Trial shows colorectal cancer drug efficacy

Jim Cornall — Mon, 19 Jun 2023 13:00:02 +0000

HUTCHMED (China) Limited and Takeda have announced results of their phase III FRESCO‑2 study evaluating fruquintinib in patients with previously treated metastatic colorectal cancer (CRC), which were published in The Lancet. Fruquintinib is a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3. FRESCO-2 is a global phase […]

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