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Adaptimmune’s Tecelra gains accelerated approval for synovial sarcoma

Oxford-based cell therapy company Adaptimmune Therapeutics has received accelerated approval from the US Food and Drug Administration (FDA) for Tecelra (afamitresgene autoleucel) for treatment of synovial sarcoma. Tecelra is the first engineered cell therapy for solid tumours approved in the US, and represents the first therapy option against synovial sarcoma in more than a decade. It is indicated to treat adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, and whose tumours express the MAGE-A4 antigen. Additionally, the tumours need to have a certain HLA type— HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive. The approval was granted based on results from the Phase II SPEARHEAD-1 trial (NCT04044768). Amongst 44 patients with synovial sarcoma, the overall response rate (ORR) to treatment was 43% with a median duration of response of six months (95% CI: 4.6, not reached). Continued approval remains subject to verification of clinical benefit in further trials. ...
- Source: drugdu
- 74
- August 5, 2024
Vir Bio trims staff and pipeline to focus on Sanofi-licensed programmes

Vir Biotechnology has signed a licensing agreement with Sanofi for three clinical-stage masked T-cell engagers (TCE) for cancer treatment. The US-based company has also started strategic restructuring, which includes a workforce reduction of approximately 25% and the discontinuation of its influenza and Covid-19 programmes. Vir will also phase out its T cell-based viral vector platform. The company expects to save approximately $50m each from staff cuts and pipeline reprioritisation, which will be reinvested into the Sanofi-licensed programmes. Vir reported $1.43bn in cash reserves at the end of Q2. The Sanofi-licensed TCE candidates include SAR446309, a dual inhibitor of HER2 and CD3; SAR446329, a dual-masked PSMA and CD3 TCE; and SAR446368, a dual-masked EGFR and CD3 TCE. The TCE candidates were developed using the protease-cleavable masking platform, which Sanofi acquired from Amunix Pharmaceuticals. Both SAR446309 and SAR446329 are being evaluated in Phase I trials in patients with metastatic treatment-resistant HER2-positive tumours ...
- Source: drugdu
- 83
- August 5, 2024
HDR UK and DPUK granted £2m for new motor neurone disease research initiative

The rapidly progressive neurological condition affects around 5,000 people in the UK Health Data Research UK (HDR UK) and Dementias Platforms UK (DPUK) have received £2m in funding to launch a new initiative to accelerate motor neurone disease research. Supported by the UK Dementia Research Institute, the MND Research Data Catalyst is funded by the Department of Health and Social Care and delivered through the National Institute of Health and Care Research (NIHR). Currently affecting around 5,000 people in the UK, MND is a fatal, rapidly progressing neurological condition caused by the accumulation of proteins in the brain that clump together to gradually stop cells from working. Supported by the UK government in partnership with charities and organisations including the NIHR, UK Research and Innovation, MND Association, My Name’5 Doddie Foundation, MND Scotland and LifeArc, along with the MND research community, the new initiative aims to accelerate the discovery of ...
- Source: drugdu
- 98
- August 3, 2024
NHS Scotland, AZ and Scottish universities partner for kidney health research

NHS Scotland, AstraZeneca (AZ) and the Universities of Glasgow and Dundee have entered into a partnership to accelerate research into treating chronic kidney disease (CKD). The collaboration aims to develop new medicines to slow down the progression of CKD, build infrastructure and enhance expertise in renal clinical trial delivery in Scotland to improve patient outcomes. Affecting nearly 850 million people worldwide, CKD is a serious, progressive condition caused by decreased kidney function, commonly caused by diabetes, hypertension and glomerulonephritis. By preventing the progression of CKD, patients will live longer, better lives, free from other consequences of the condition, including heart failure, cardiovascular disease and stroke, while also reducing pressure on the NHS. In addition to slowing the progression of CKD, NHS Scotland, AZ and the Universities of Glasgow and Dundee will work to reduce the risk of patients potentially needing dialysis, a procedure to remove waste products and excess fluid ...
- Source: drugdu
- 116
- August 3, 2024
Otsuka snaps up Jnana with its phenylketonuria drug for $800m

Otsuka Pharmaceutical is looking to acquire US-based Jnana Therapeutics in a deal worth up to approximately $1.1bn. The Japanese company will pay Jnana’s shareholders $800m through its US subsidiary, Otsuka America. Jnana will also be in line to receive up to $325m in milestone-based payments. The deal is expected to close in Q3 this year. Otsuka plans for Jnana to operate as its subsidiary following the acquisition. To achieve this, it plans to merge Jnana with a special purpose company, established under Otsuka America, with the Jnana remaining as the surviving company. Jnana’s lead asset is JNT-517 being developed to treat phenylketonuria (PKU), a rare inherited metabolic disorder that causes an amino acid called phenylalanine to build up in the body. JNT-517 inhibits SLC6A19 or solute carrier family 6 member 19, a transmembrane protein that regulates phenylalanine absorption and reuptake in the small intestine and kidney. In June, Jnana reported ...
- Source: drugdu
- 132
- August 3, 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
- 102
- August 3, 2024
Routine Blood Tests Could Speed Up Cancer Diagnosis for People with Abdominal Symptoms

Early detection is critical for successful cancer treatment. Yet, many patients with cancer visit their primary care providers with vague symptoms that could result from various benign conditions, complicating the determination of who needs further diagnostic testing or a referral. Most existing guidelines highlight specific “alarm” symptoms for different cancers to guide referrals, but advice on nonspecific symptoms that span multiple cancer types is scarce. Now, a new study has found that incorporating data from routine blood tests could improve cancer risk assessment for patients presenting with abdominal symptoms. Conducted by researchers at University College London (London, UK), the study utilized data from the UK Clinical Practice Research Datalink, examining over 470,000 patients aged 30 and older who consulted their general practitioner for abdominal pain or bloating. Within one year of these consultations, about 9,000 patients with abdominal pain and 1,000 with bloating were diagnosed with cancer. The study assessed ...
- Source: drugdu
- 77
- August 3, 2024
Cutting-Edge AI Analyzes Blood Samples to Predict Disease 10 Years Before Diagnosis

Scientists have developed an advanced artificial intelligence (AI) approach that can predict the likelihood of developing age-related conditions such as Alzheimer’s and heart disease up to a decade before symptoms manifest. By analyzing blood samples from over 45,000 individuals using machine learning, researchers identified specific protein patterns associated with an increased risk of disease. This capability to predict the probability of developing a health condition before any symptoms are observed could potentially enhance personalized medicine by providing early warnings, thereby opening doors for preventative interventions. Researchers from the University of Edinburgh (Edinburgh, UK) participated in a study that used data from the UK Biobank, which contains genetic and health information from half a million UK participants. They applied AI and machine learning to detect protein patterns in blood that correlate with the onset of common ailments including Alzheimer’s, heart disease, and type 2 diabetes. The analysis was based on medical ...
- Source: drugdu
- 72
- August 3, 2024
Biotech Startup AIRNA Adds $60M to Advance RNA-Editing Therapy for Rare Protein Deficiency

AIRNA’s therapy for alpha1 antitrypsin deficiency, or AATD, edits RNA to address the underlying cause of this rare inherited disease. Wave Life Sciences and Korro Bio are both further along in the development of RNA-editing therapies for AATD, but AIRNA claims its therapy could be best in class. By Frank VinluanA particular protein deficiency that leads to liver and lung damage is currently treatable only with decades-old therapies that all have limitations. Biotech startup AIRNA is part of a field of companies developing novel treatments for this inherited disorder, and it aims to stand apart with a genetic medicine it contends could become best in class. AIRNA is preparing to advance this program to clinical testing and on Wednesday it revealed a fresh round of $60 million to support its plans. The disease that Cambridge, Massachusetts-based AIRNA aims to treat is alpha-1 antitrypsin deficiency, or AATD. This rare disease, affecting ...
- Source: drugdu
- 73
- 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
- 110
- August 3, 2024

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