Small cell lung cancer (SCLC) is a highly aggressive type of cancer known for its ability to metastasize. The behavior of tumors is largely governed by which genes are turned on, or transcribed, irrespective of whether mutations are present. Researchers have identified various signature patterns of gene activation in SCLC, and these subtypes dictate how the cancer responds to treatments and its specific vulnerabilities. There is a significant need for blood-based tests that can determine SCLC subtypes, track disease progression, recognize transformations into other types of lung cancer, and identify potential treatment targets, especially when standard biopsies are not feasible. Scientists have now made progress towards a liquid biopsy capable of distinguishing between multiple SCLC subtypes from blood samples. New research at Fred Hutch Cancer Center (Seattle, WA, USA) has revealed that big-picture patterns of DNA packaging, gene activation, and mutations may provide the information required to develop a blood-based ...
Affecting over 500,000 people in the UK, IBD comprises Crohn’s disease and ulcerative colitis The study, published in Nature Immunology, could help identify new ways to treat inflammatory bowel disease (IBD). Collectively known as IBD, Crohn’s disease and ulcerative colitis are incurable conditions that involve excessive inflammation in the gut and affect over 500,000 people in the UK, according to Crohn’s & Colitis UK. In this study, researchers deleted two proteins, c-Maf and Blimp-1, from T cells in mice to understand their role in maintaining gut health via IL-10. Mutations in the cytokine IL-10 or its receptor can result in IBD in children and it has previously been shown that c-Maf and Blimp-1 can drive the activity of the IL-10 gene in T cells. They found that, when combined with an environmental trigger – an infection with the Helicobacter hepaticus bacterium – IL-10 activity in T cells was reduced and ...
Approximately 14% of the competition-submitted proposals were selected to receive funding Nine researchers from University College London (UCL) have secured nearly £560m in funding from the European Research Council’s (ERC) Advanced Grants to advance researchers in fields including biochemistry, nanotechnologies and regenerative medicine. Approximately 14% of the competition-submitted proposals were selected for funding, comprising 255 researchers, and could create over 2,000 new jobs. Set up in 2007 by the EU, the ERC has been funding research via the Advanced Grant to universities and research centres across 19 EU member states and associated countries, including the UK, Germany and France. The funding will be used for projects including the study of the roles of priority proteins in cellular quiescence and ageing, the thymus gland’s functions within the immune system and lung cancer. UCL professor Charles Swanton from the UCL Cancer Institute, along with UCL professor Paola Bonfanti and senior group leader ...
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 ...
On April 12, 2024, Shanghai Yuansong Biotechnology Co., Ltd (“Yuansong Biotechnology”) announced that its self-developed lysosomal virus Class I new drug “Recombinant L-IFN Adenovirus Injection (YSCH-01)” has received implied clinical trial approval from the Center for Drug Evaluation of the State Drug Administration (CDE) and has been approved to conduct Class I clinical trials in China. The Center for Drug Evaluation (CDE) of the State Drug Administration has granted implied consent for clinical trials and approved to conduct Phase I clinical trials in China for the indication of advanced solid tumors. The approval of this IND filing by the CDE in China is another important progress made by YuanSong Biotech in exploring the clinical study of YSCH-01, in addition to the clinical approval by the US FDA in December 2023 for two original IIT programs under development, including capsular delivery for recurrent gliomas and lysosomal viral nebulized delivery for the ...
Following Johnson & Johnson’s (J&J) recent US Food and Drug Administration (FDA) fast track designation of nipocalimab for the reduction of foetal and neonatal alloimmune thrombocytopenia (FNAIT) risk in pregnant adults, Rallybio has announced a collaboration with the pharma giant to advance complementary therapeutic solutions for the rare disorder. The collaboration will see the development of therapeutic approaches that comprehensively address FNAIT, as J&J aims to treat patients who have already alloimmunised while Rallybio focuses on preventing alloimmunisation altogether, Dr. Steve Uden, Rallybio’s CEO, told Pharmaceutical Technology in an exclusive interview. “They are very much complementary and not competitive approaches; and both are needed,” said Uden. As per the 10 April press release, the clinical-stage biotech received an equity investment of $6.6m from J&J, with eligibility for future milestone payments. The funds will be deployed to support a FNAIT natural history study that will be conducted across North America and ...
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 ...
Pfizer has reported positive top-line results from its Phase III MONeT study (NCT05842967) evaluating the efficacy of single-dose Abrysvo for adults at risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD). As per the 9 April press release, Abrysvo met its co-primary immunogenicity and safety endpoints, with patients demonstrating non-inferior RSV-A and RSV-B neutralising responses compared to the Phase III RENOIR study (NCT05842967) where the vaccine previously showed efficacy. Compared to pre-vaccination, the vaccinated patients also demonstrated a minimum of a four-fold increase in serum-neutralising titers for RSV-A and RSV-B a month after being vaccinated. The MONeT trial did not identify any new safety signals for Abrysvo. The pharma giant plans to publish the findings in a peer-reviewed journal and submit the results to regulatory agencies in a bid to expand the vaccine’s label from its current indication to include adults 18 years and older, the ...
Oryzon Genomics is set to commence a Phase I/II clinical trial of iadademstat (ORY-1001) plus immune checkpoint inhibitors (ICI) in patients with first-line small cell lung cancer (SCLC). The development comes after the US Food and Drug Administration (FDA) cleared the Spain-based biotech’s investigational new drug application (IND) to initiate the study. The Phase I/II trial (NCT06287775) will be conducted and sponsored by the National Cancer Institute (NCI), enrolling 45-50 patients. In the first phase, patients will receive iadademstat on days 1, 8, 15, and 22 or days 1 and 15 of each cycle. Patients will also continue to receive their initial ICI treatment, Tecentriq (atezolizumab) intravenously (IV), or Imfinzi (durvalumab) IV over 60 minutes on day one of each cycle. Cycles will repeat every 28 days in the absence of disease progression or unacceptable toxicity. In the second phase of the study, patients are randomised to two different arms ...
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 ...
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