February 28, 2024 Davy James NVL-520 is a novel, brain-penetrant, ROS1-selective tyrosine kinase inhibitor under evaluation for patients with metastatic ROS1-positive non–small cell lung cancer. Nuvalent, Inc’s novel, brain-penetrant, ROS1-selective tyrosine kinase inhibitor (TKI) NVL-520 has been granted Breakthrough Therapy Designation by the FDA to treat patients with metastatic ROS1-positive non–small cell lung cancer (NSCLC) who received prior therapy with at least two ROS1 TKIs.1 NVL-520 was developed with the intention of addressing treatment challenges that limit the use of current ROS1 TKIs, including treatment resistance, brain metastases, and off-target central nervous system (CNS) adverse events (AEs) that have been linked to inhibiting the structurally-related tropomyosin receptor kinase family.1 “In line with our commitment to bringing new potential best-in-class medicines to patients with cancer as quickly as possible, we are always looking for opportunities to further accelerate our programs,” James Porter, PhD, CEO of Nuvalent, said in a press release. ...
Don Tracy, Associate Editor Amtagvi is the first one-time, individualized T-cell therapy approved by the FDA for any solid tumor cancer. WuXi Advanced Therapies announced that it has officially received approval from the FDA to begin analytical testing and manufacturing of Amtagvi (lifileucel), Iovance Biotherapeutics’ recently approved treatment for advanced melanoma. According to a company press release, the treatment is a tumor-derived autologous T cell immunotherapy, specifically developed for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody. This also marks the first one-time, individualized T cell therapy to be approved by the FDA for any solid tumor cancer. “We congratulate Iovance on this major milestone in their quest to address unmet patient needs in the treatment of advanced melanoma. WuXi ATU has partnered with Iovance since 2015, and we are thrilled to help them through each step of the drug development pipeline – from ...
Today, the U.S. Food and Drug Administration approved Amtagvi, the first cellular therapy indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that previously has been treated with other therapies (a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor). “Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). “The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options.” Melanoma is a form of skin cancer that is often caused by exposure to ultraviolet light, which can come from sunlight ...
Dragonfly Therapeutics has entered a clinical collaboration with Gilead Sciences to assess the potential of its investigational drug candidate DF1001 with the latter’s Trodelvy for two cancer indications. The study of the combination regimen will focus on metastatic breast cancer (mBC) and non-small cell lung cancer (NSCLC). DF1001 is designed to act on natural killer (NK) cells and T-cell activation signals, leveraging co-stimulation of NK receptor NKG2D and CD16 for NK cell activation. Trodelvy is a Trophoblast cell-surface antigen 2-directed antibody-drug conjugate. Dragonfly will maintain operational control of the trial, with the first patients receiving the combination treatment in the second quarter of 2024. Study sites are already operational in the US, Belgium, France, Denmark and the Netherlands. The study is set to expand, with additional sites in Europe, North America and Asia Pacific. Developed using Dragonfly’s TriNKET platform, DF1001 is being evaluated in adult patients for the treatment of ...
After a high-profile failure in an Alzheimer’s related agitation trial earlier this week, Otsuka has garnered a positive update with a breakthrough therapy designation for its rare kidney disease drug sibeprenlimab. The US Food and Drug Administration (FDA) designation is for sibeprenlimab’s use in immunoglobulin A nephropathy (IgAN), sometimes referred to as Berger’s disease, a disorder that occurs when antibody immunoglobin A builds up in the kidneys, leading to inflammation and damage. This results in blood and protein in urine, as well as high blood pressure and kidney failure over time. The FDA made the decision following positive results from the Phase II ENVISION trial (NCT04287985), announced in November 2023. The 155-patient study evaluated the dose response of different doses of sibeprenlimab by measuring proteinuria or high levels of protein in the urine. Data from the trial, published in The New England Journal of Medicine, showed that after 12 months, ...
Hemogenyx has received the all-clear from the US Food and Drug Administration (FDA) to begin a Phase I clinical trial of its acute myeloid leukaemia (AML) chimeric antigen receptor (CAR) T-therapy in the US. In June 2023, the US FDA placed a clinical hold on the trial for HEMO-CAR-T, requesting additional information from Hemogenyx after a splicing deficiency during manufacture of the lentivirus used to produce CAR-T cells. Hemogenyx produced a plan, supported by laboratory tests to address FDA’s concerns in August 2023, which was accepted the following month. In January, the London, UK-based biopharma issued a complete response to the agency to lift the hold. Hemogenyx’s stock price has increased by 62% following the announcement of the lifting of the hold today (9 February) since the market close yesterday. CAR-T therapies have been hitting the headlines recently after the FDA launched an investigation into the incidence of potentially associated ...
Innovate UK has awarded a £1m ($1.26m) grant for a collaborative initiative called AI-VISION to aid treatment decisions for breast cancer patients. The project involves the Institute of Cancer Research (ICR), Durham University, the Royal Marsden Hospital and techbio company Concr. It will support clinical decision-making, including directing breast cancer patients on the use of immunotherapy. AI-VISION is a 24-month observational clinical study to assess tissue samples from early triple-negative breast cancer (TNBC) patients. These subjects will be analysed to define and establish chemotherapy response biomarkers, irrespective of immunotherapy status. The study aims to validate the safety and performance of new computational methods to offer precision therapies for patients. Concr will apply Bayesian computational frameworks, inspired by astrophysics, to interconnect diverse oncology data, enabling researchers to detect and develop biomarkers indicative of drug response. The ICR will contribute genomic data from its genomics facility, which will be integrated with clinical ...
Swedish biotech Vicore Pharma has entered an exclusive licensing agreement for the Japanese rights for its idiopathic pulmonary fibrosis (IPF) therapy C21 with Nippon Shinyaku. Vicore will receive a $10m upfront payment and will be in line to receive up to $275m in development and commercial milestone-based payments. The company will also be placed to get tiered royalties that extend into “the low 20s” based on annual net sales of C21 in Japan, as per a 9 February press release. As per the agreement, Nippon will hold exclusive rights to develop and commercialise C21 in Japan. The company will be responsible for operational and financial costs for developing C21 in the country. Nippon will also contribute financially to the Japanese trial sites and patients in the global late-stage development of C21. Following the news, Vicore’s stock was up over 18% in trading today. The company’s market ...
Hemogenyx has received the all-clear from the US Food and Drug Administration (FDA) to begin a Phase I clinical trial of its acute myeloid leukaemia (AML) chimeric antigen receptor (CAR) T-therapy in the US. In June 2023, the US FDA placed a clinical hold on the trial for HEMO-CAR-T, requesting additional information from Hemogenyx after a splicing deficiency during manufacture of the lentivirus used to produce CAR-T cells. Hemogenyx produced a plan, supported by laboratory tests to address FDA’s concerns in August 2023, which was accepted the following month. In January, the London, UK-based biopharma issued a complete response to the agency to lift the hold. Hemogenyx’s stock price has increased by 62% following the announcement of the lifting of the hold today (9 February) since the market close yesterday.CAR-T therapies have been hitting the headlines recently after the FDA launched an investigation into the incidence of potentially associated secondary ...
Neuralace Medical announced today that it received FDA clearance for its chronic painful diabetic neuropathy (PDN) treatment. San Diego–based Neuralace says this marks the first-ever FDA clearance of a non-invasive, magnetic peripheral nerve stimulation (mPNS) treatment for PDN. The company says its Axon Therapy could offer “new hope” to millions with the condition. Axon Therapy uses mPNS to deliver a quick, painless and non-invasive treatment in sessions lasting just 13.5 minutes, according to Neuralace. Each session utilizes magnetic pulses to provide relief for a potential improvement in pain management. Neuralace said a recent trial of 71 patients demonstrated efficiency, plus significant improvements in subject outcomes. The company believes its therapy represents a paradigm shift in PDN treatment. Axon Therapy offers a non-pharmacological and non-invasive option that could reduce dependence on medications and their associated side effects. The company says FDA clearance paves the way for broader access to innovative pain ...
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