The US Food and Drug Administration (FDA) has granted Candel Therapeutics’ immunotherapy candidate CAN-2409 (aglatimagene besadenovec) orphan drug designation for the treatment of pancreatic cancer. Orphan drug designations are granted to medicines intended to treat rare conditions and come with benefits such as tax credits for US-based clinical trials and potentially seven years of market exclusivity in the designated indication upon agency approval. Pancreatic cancer is one of the most lethal forms of cancer, with a survival rate beyond ten years of around 5%. CAN-2409 was also granted fast track designation in pancreatic cancer by the FDA in December 2023, meaning the candidate is in line for expedited development and review times. CAN-2409 is an off-the-shelf immunotherapy that is a combination of a genetically modified adenovirus and the herpes simplex virus thymidine kinase (HSV-tk) gene. The drug works by inducing T cell response at both the targeted tumour and at ...
Prostate cancer is responsible for around 12,000 deaths a year in the UK and is the second biggest cause of death for men Researchers from the Universities of Bristol, Oxford and Cambridge have revealed that a prostate-specific antigen (PSA) blood test for prostate cancer has a small impact on reducing deaths and can lead to overdiagnosis and missed early detection of aggressive forms of cancer. Published in the Journal of the American Medical Association and funded by Cancer Research UK (CRUK), the CAP trial studied over 400,000 men aged 50 to 69 years from 570 GP practices in the UK. Currently the second biggest cause of death for men in the UK, responsible for around 12,000 deaths a year, prostate cancer is a disease that occurs when malignant cells grow in the prostate gland. Widely used for diagnosis, a PSA blood test measures the amount of PSA, a protein made ...
Ovarian cancer is one of the most common causes of cancer deaths among women and has a five-year survival rate of around 50%. The disease is particularly lethal because it often doesn’t cause symptoms in its early stages. The absence of effective screening tools and the disease’s asymptomatic nature contribute to its diagnoses during the later stages when treatment options are less effective. A cost-effective, accessible detection method could revolutionize the clinical approach to ovarian cancer screening and potentially save lives. Although liquid biopsy technologies, which analyze blood for tumor-derived DNA, have been explored for noninvasive cancer detection, their utility in ovarian cancer has been limited. Now, a retrospective study presented at AACR 2024 has demonstrated that a blood-based machine learning assay, which combines cell-free DNA (cfDNA) fragment patterns with levels of the proteins CA125 and HE4, can effectively distinguish patients with ovarian cancer from healthy controls or patients with ...
Novartis gains global rights to an Arvinas protein degrading drug that targets the androgen receptor to treat prostate cancer. The deal also includes a preclinical molecule addressing an androgen receptor variant.Novartis, whose presence in prostate cancer is mainly through the radiopharmaceutical Pluvicto, is expanding its prospects in the disease, striking a deal that brings a Phase 3-ready small molecule in the emerging therapeutic modality called targeted protein degradation. The drug, ARV-766, was developed by New Haven, Connecticut-based Arvinas. The deal announced Thursday calls for Novartis to pay $150 million up front. The Swiss pharmaceutical giant could shell out up to $1 billion more if the molecule achieves development, regulatory, and commercial milestones. Targeted protein degradation involves using a small molecule to target a disease-causing protein, marking it for disposal by the cell’s built-in system for eliminating old or damaged proteins. Arvinas specializes in protein degrader drugs, and the company’s pipeline ...
Bio-Rad Laboratories and Alleghany Health Network (AHN) have partnered to advance clinical evidence for monitoring solid tumour cancers using Bio-Rad’s Droplet Digital PCR (ddPCR) technology. The collaboration will use ddPCR technology for molecular residual disease (MRD) monitoring of patients across a range of solid tumour types. Accounting for approximately 90% of all adult human cancers and half of childhood malignancies, solid tumour cancers can develop in many parts of the body, including the breast, lung, prostate and colon. Used to provide a critical indication of both remission and potential relapse in patients, MRD testing has been widely adopted for monitoring haematological malignancies and is now being implemented for solid tumour diseases. As part of the agreement, the collaboration will combine Bio-Rad’s digital PCR technology and expertise in molecular oncology, assay design and development with AHN’s cancer-care expertise, clinical data and patient samples collected via its Cancer Institute’s Moonshot programme, which ...
A clinical trial led by researchers from University College London (UCL) and University College London Hospitals NHS Trust Foundation (UCLH) has revealed that removing a step from a three-part MRI scan could make prostate cancer diagnosis quicker, cheaper and more accessible. The PRIME study was funded by Prostate Cancer UK and the John Black Charitable Foundation. Currently the most common form of cancer in men, prostate cancer is responsible for around 52,000 new cases and 12,000 deaths every year in the UK. In the UK, a three-part multiparametric MRI of the prostate is the current standard of care for patients suspected of having prostate cancer, which includes a dye injection as its third step to identify abnormalities to be seen on the MRI scan. In the study, cancer experts from 22 hospitals from 12 different countries recruited 555 patients and performed full-three-part multiparametric scans on them. Radiologists then assessed the ...
The FDA expanded Enhertu’s approval to encompass advanced solid tumors positive for the HER2 cancer protein, regardless of tumor type. Analysts say the regulatory decision paves the way for similar broader approvals of other medications in the ADC cancer drug class.The AstraZeneca and Daiichi Sankyo targeted cancer drug Enhertu is now the first therapy in its class approved for treating solid tumors regardless of either the cancer type or where the disease started in the body. Enhertu had previously won FDA approvals for treating certain advanced cases of breast, gastric, and lung cancers that express a protein called HER2. Late Friday, the FDA expanded the drug’s approval to broadly include the treatment of adults who have HER2-expressing solid tumors. These patients must have a cancer that cannot be removed surgically or has advanced following a prior systemic treatment. The expanded approval came nearly two months ahead of the May 30 ...
Culmination Bio has announced a partnership with BillionToOne to develop and advance diagnostic tests in oncology that are accessible to all. Both companies will work together to facilitate the development and validation of robust and impactful oncology diagnostics. According to the Centers for Disease Control, skin cancer is currently the most common type of cancer in the US, responsible for more than 9,500 new cases every day, followed by lung cancer, prostate cancer and breast cancer. The molecular diagnosis company, BillionToOne, is developing these new diagnostics in an effort to address the challenges associated with accurately profiling cancer to assess the best treatment and monitor responses to determine the effectiveness of the cancer treatment. As part of the agreement, the data and technology company will use its Data Lake and patient recruitment abilities to help BillionToOne validate the clinical performance of two new diagnostic tests: Northstar Select, an ultra-sensitive, NGS-based ...
Researchers from the Johns Hopkins Kimmel Cancer Center and its Convergence Institute have revealed promising results of a personalised vaccine for liver cancer in a clinical trial. Results from the study were published in Nature Medicine and were recently presented at the American Association for Cancer Research’s annual meeting. Recognised as the most common type of liver cancer, hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related deaths globally, with fewer than one in ten patients surviving five years after diagnosis. Researchers took tumour biopsy cells from 36 HCC patients to identify cancer-associated genetic mutations in the tumour to manufacture a personalised vaccine containing DNA for selected mutated genes. Involving 36 patients living with HCC, investigators added a personalised anti-tumour vaccine to Merck & Co’s – known as MSD outside the US and Canada – PD-1 inhibitor therapy, Keytruda (pembrolizumab), a standard immunotherapy. The personalised vaccine works by ...
Small cell lung cancer (SCLC), a rapidly progressing neuroendocrine malignancy, exhibits low survival rates. Despite its molecular and clinical heterogeneity, SCLC is presently treated as a single entity, without the use of predictive biomarkers, which leads to poor patient outcomes. Recent research has proposed dividing SCLC into four subtypes—labeled “A”, “N”, “P”, and “I”—each characterized by distinct molecular signatures and treatment vulnerabilities. Initially, this classification relied on gene expression (RNA-seq) data. Further studies indicated that the same categorization could be recapitulated through the use of a reduced-representation bisulfite sequencing (RRBS) methylation profile. Although this classification system effectively predicts treatment responses, including to immunotherapy, in retrospective analyses, both RNAseq and RRBS techniques are too labor-intensive and slow for quick treatment decisions in an aggressive malignancy. Now, a pilot study published in the journal Cancer Cell has demonstrated the feasibility of a simple PCR assay to accurately differentiate between SCLC SCLC subtypes. ...
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