Search Results for “Clinical Trial” – Page 15 – media

Kezar stalls solid tumour trial to focus on autoimmune disease candidate

Clinical stage biopharma Kezar Life Sciences will drop its Phase I solid tumour drug to streamline focus on its lead autoimmune disease drug zetomipzomib. The San Francisco-based biotech shared this update in its 2Q financial results. The candidate, dubbed KZR-261, was being investigated in a Phase I trial (NCT05047536) in patients with solid tumours. Of the 61 enrolled patients, five experienced stable disease for four months or longer, with two of these patients experiencing stable disease for a year or longer. No objective responses have been reported. Enrolment in the trial has been halted, but the 61 patients will continue to have access to KZR-261. All eyes will now be on zetomipzomib, a selective immunoproteasome inhibitor. The candidate is being evaluated in a Phase IIb PALIZADE clinical trial (NCT05781750) for lupus nephritis and a Phase IIa PORTOLA clinical trial (NCT05569759) for autoimmune hepatitis. Everest Medicines secured the Greater China, South ...
- Source: drugdu
- 69
- August 16, 2024
ImmunityBio Launches Study to Evaluate Combination of Anktiva, AdHER2DC Cancer Vaccine for Endometrial Cancer

By Don Tracy, Associate Editor The study aims to explore Anktiva as a potential cornerstone of future immunotherapy treatments for endometrial cancer and other forms of the disease. ImmunityBio has initiated a clinical trial to evaluate the combination of Anktiva, their IL-15 superagonist, with the investigational AdHER2DC cancer vaccine, a product of the National Cancer Institute (NCI), as a potential treatment for endometrial cancer. According to the company, the purpose of the trial is to assess the safety and efficacy of this combination therapy in patients with HER2-positive endometrial cancer. The trial comes amid Anktiva’s recent FDA approval for treating BCG-unresponsive non-muscle invasive bladder cancer.1,2 “We are pleased to partner with the NCI on this important cancer control study involving Anktiva, which has demonstrated in clinical trials that activation of memory T cells may help deliver long-duration response well beyond that of checkpoint inhibitors alone,” said Patrick Soon-Shiong, MD, executive ...
- Source: drugdu
- 63
- August 10, 2024
DCGI waives off local trials for drugs approved in well-regulated markets

The CDSCO, with approval from the Central government, has notified a list of countries under rule 101 of the New Drugs and Clinical Trial Rules, 2019 that would, subject to conditions, consider the waiver of local clinical trials for several drugs if already approved in well-regulated markets. The countries on the list include the US, UK, Japan, Australia, Canada and the European Union. The categories of new drugs specified are: • Orphan drugs for rare diseases • Gene and cellular therapy products • New drugs used in pandemic situation • New drugs used for specific defence purpose • New drugs having significant therapeutic advance over the current standard care The move is expected to accelerate access to innovative therapies within the country. Lauding the decision, Anil Matai, Director General, OPPI, says that this move will significantly benefit both domestic and foreign drug manufacturers by expediting the approval process and facilitating ...
- Source: drugdu
- 52
- August 10, 2024
HilleVax slashes workforce by 40% after norovirus vaccine trial failure

US-based vaccine company HilleVax is slashing its workforce by 40% after its lead vaccine failed a Phase IIb study last month. HilleVax announced that it will let go of 41 employees, after a Phase IIb trial (NCT05836012) with its norovirus vaccine, HIL-214, failed to meet primary and secondary endpoints. The company’s stock plummeted by more than 80% following the 8 July announcement of the failed results. The vaccine showed an efficacy of 5% in the 2,800 infants enrolled in the study aged four months of age at the time of enrolment in the US and Latin American countries, who had norovirus-related acute gastroenteritis (AGE). The study did not meet the key endpoint of demonstrating efficacy against moderate or severe AGE events caused by the GI.1 or GII.4 norovirus genotypes. The experimental vaccine had previously shown success in adults, with one Phase IIb field efficacy trial (NCT02669121) in 4,712 adults showing ...
- Source: drugdu
- 70
- August 3, 2024
Daiichi Sankyo, Merck Launch Phase III Trial Evaluating Safety, Efficacy of Ifinatamab Deruxtecan in Patients with Relapsed Small Cell Lung Cancer

By Don Tracy, Associate Editor IDeate-Lung02 will compare ifinatamab deruxtecan to a physician’s choice of chemotherapy in patients with relapsed small cell lung cancer. Daiichi Sankyo and Merck have commenced the IDeate-Lung02 Phase III clinical trial, which aims to compare the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) vs. physician’s choice of chemotherapy in patients with relapsed small cell lung cancer (SCLC) following disease progression with only one prior line of platinum-based chemotherapy. According to both companies, the initiation of the trial was based on results from a subgroup analysis of the IDeate-PanTumor01 Phase I/II trial of ifinatamab deruxtecan, which was presented at the 2023 World Conference on Lung Cancer.1 “Patients living with small cell lung cancer face poor outcomes with currently available treatments,” said Mark Rutstein, MD, global head, oncology clinical development, Daiichi Sankyo, in a press release. “The IDeate-Lung02 trial is an important next step as we ...
- Source: drugdu
- 82
- August 3, 2024
FDA committee proposes overhaul of perioperative lung cancer trials

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has called for changes in how clinical trials are conducted for treatments involving surgery for early-stage non-small cell lung cancer (NSCLC). In the 25 July meeting, the ODAC highlighted that it’s important to separately evaluate the effectiveness of each part of the treatment process, which includes pre-operative and post-operative phases. The committee meeting – which ended with a 11–0 vote in favour of changing how perioperative trials are run– came after AstraZeneca proposed to use Imfinzi (durvalumab) as a treatment with chemotherapy both before and after surgery. The pharma giant conducted the Phase III AEGEAN study (NCT03800134) to support this label expansion. The committee did not vote on Imfinzi’s approval in this indication, but the overall majority suggested that it should be approved. Following a lengthy discussion as to whether there should be another trial, Ravi Madan, medical ...
- Source: drugdu
- 84
- July 29, 2024
ANKE Bio received clinical approval for another therapeutic mRNA vaccine

ANKE Bio (Group) Co., Ltd. and Hefei Alfana Biotechnology Co., Ltd. jointly developed a Class 1 new drug that received clinical approval from the Drug Administration (Drug Clinical Trial Approval Notification: 2024LP01608), with an indication for the treatment of cervical intraepithelial neoplasia. It is reported that this is the first therapeutic mRNA vaccine approved for clinical use in cervical intraepithelial neoplasia in China. Pre-cancerous lesions and their eventual malignant changes caused by viral infections are a serious threat to people’s lives and health. Globally, approximately 600 million people are infected with human papillomavirus (HPV), in addition to approximately 250 million people infected with hepatitis B virus (HBV), and 71 million people infected with hepatitis C virus (HCV). People infected with each of these viruses face a potential cancer risk. For example, approximately 30 million women are diagnosed each year with cervical intraepithelial neoplasia (CIN), an important precursor to cervical cancer. ...
- Source: drugdu
- 80
- July 25, 2024
Tau-Focused Asceneuron Adds $100M as Oral Alzheimer’s Drug Advances to Phase 2 Trial

Novo Holdings led Asceneuron’s $100 million Series C financing. The Merck Serono spinout’s lead program is an oral small molecule designed to prevent aggregation of tau protein in neurodegenerative disorders. By Frank Vinluan Alzheimer’s disease patients can now choose between new two intravenously infused therapies that work by breaking up plaques of amyloid protein in the brain. Asceneuron takes a different approach with oral therapies that address the buildup of tau, a protein that’s also associated with the neurodegenerative disorder. The biotech now has $100 million to advance its lead program to Phase 2 testing. The Series C financing announced Tuesday was led by Novo Holdings, the company that manages the assets of the Novo Nordisk Foundation, the controlling shareholder of metabolic drug giant Novo Nordisk. Using a drug to target and break up pathological proteins associated with Alzheimer’s has been validated by Eisai’s Leqembi, approved by the FDA last year, ...
- Source: drugdu
- 124
- July 18, 2024
MSD closes $1.3bn EyeBio acquisition, plans pivotal trial for lead asset

Two months after MSD (Merck & Co) set its eye on acquiring Eyebiotech (EyeBio), the former has closed the deal, making EyeBio its subsidiary. MSD has acquired all outstanding shares of the privately held UK-based biotech through a subsidiary as part of the agreement. EyeBio’s shareholders will receive approximately $0.50 per share, totalling $1.3bn. Following the acquisition, MSD has gained access to EyeBio’s lead asset Restoret (EYE-103), a tetravalent, tri-specific antibody that targets the Wingless-related integration site (Wnt) signalling pathway. A Phase IIb/III trial investigating Restoret in patients with DME is expected to begin in H2 this year. In February, EyeBio reported positive data from the Phase Ib/IIa AMARONE trial (NCT05919693) in patients with treatment-naïve diabetic macular oedema (DME) and treatment-naive neovascular age-related macular degeneration (AMD). In the study, Restoret improved vision in 26 participants with DME, leading to an improved best-corrected visual acuity by +11.2 letters and a mean ...
- Source: drugdu
- 55
- July 16, 2024
Carvykti Demonstrates Clinically Meaningful Improvement in Patients with Relapsed or Lenalidomide-Refractory Multiple Myeloma After One Line of Prior Therapy

By Don Tracy, Associate Editor Results of the Phase III CARTITUDE-4 study showed that treatment with Carvykti achieved a more significant improvement in overall survival (OS) compared to standard therapies. Results from the second interim analysis of the Phase III CARTITUDE-4 study, which evaluated Johnson & Johnson’s (J&J) Carvykti (ciltacabtagene autoleucel; cilta-cel) for patients with relapsed or lenalidomide-refractory multiple myeloma after one prior line of therapy showed that the treatment achieved a statistically significant and clinically meaningful improvement in overall survival (OS) compared to standard therapies such as omalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd).1 “Carvykti, a one-time infusion, is now the first cell therapy to significantly improve overall survival versus standard of care for patients with myeloma as early as second line,” said Jordan Schecter, MD, VP, disease area leader, multiple myeloma, Johnson & Johnson Innovative Medicine, in a press release. “As we continue to ...
- Source: drugdu
- 111
- July 8, 2024

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