SHANGHAI, April 19, 2024 /PRNewswire/ — GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced US Food and Drug Administration (FDA) has granted the clinical trial approval for GFH925 (KRAS G12C inhibitor) in a multi-center, open-label, randomized and controlled phase III study treating refractory metastatic colorectal cancer (CRC) patients. It is the first phase III trial of KRAS G12C inhibitor monotherapy targeting CRC patients worldwide, with GFH925 being the first G12C inhibitor that received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for previously treated advanced CRC. GFH925 was also granted BTD and New Drug Application acceptance with Priority Review Designation by NMPA for previously treated advanced non-small cell lung cancer(NSCLC)patients with G12C mutation. The trial (GFH925X0301) will enroll refractory metastatic CRC patients harboring KRAS G12C mutation who have progressed or experienced disease recurrence on or after at least two prior ...
Current strategies for matching cancer patients with specific treatments often depend on bulk sequencing of tumor DNA and RNA, which provides an average profile from all cells within a tumor sample. However, tumors are heterogeneous, containing multiple subpopulations of cells, or clones, each potentially responding differently to treatments. This variability may explain why some patients either fail to respond to certain treatments or develop resistance. Single-cell RNA sequencing offers higher-resolution data than bulk sequencing, capturing data at the single-cell level. This approach to identify and target individual clones may lead to more lasting drug responses, although, single-cell gene expression data are more expensive to generate and less accessible in clinical environments. In a proof-of-concept study, researchers at the National Institutes of Health (NIH, Bethesda, MD, US) have developed an artificial intelligence (AI) tool that leverages data from individual tumor cells to predict how well a person’s cancer might respond to ...
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 ...
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 ...
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 ...
Around three million people in the UK were estimated to be living with cancer in 2022 Alliance Healthcare has announced it has opened access to UK pharmacies of its ‘Not Normal for You?’ (NNFY) cancer symptom referral scheme to allow pharmacists to refer patients showing potential cancer symptoms to their GPs. The expansion follows the successful launch of the scheme across Alphega Pharmacy’s network, a brand under Alliance Healthcare comprising a network of independent pharmacies across the world. According to Macmillan Cancer Support, around three million people in the UK were estimated to be living with cancer in 2022. The most common cancers in the UK are breast cancer, which accounts for 15% of all cases, followed by prostate cancer (14%), lung cancer (13%) and bowel cancer (11%). As part of the rollout, Alliance Healthcare will provide pharmacies with marketing materials such as leaflets and referral cards, free of charge, ...
EUR 20m to identify new targets and develop first in class drugs DISCO Pharmaceuticals – a company specialising in unlocking the surfaceome of cancer cells at scale – has raided EUR 20m to identify new targets and develop first in class drugs. The funding round was backed by a formidable investor syndicate, including Sofinnova Partners, Panakes Partners, M Ventures and AbbVie Ventures. The development of new treatment modalities in oncology is increasing, however, the lack of cell surface targets limits the application to some clinically effective targets. Also, the development of new biologics, such as bi-specific antibodies and antibody drug conjugates, is increasing and there are currently less than 30 molecular targets, which form the basis of all antibody-based therapies. Consequently, there is a significant need to identify novel cancer-selective targets and target pairs. DISCO’s surfaceome mapping platform transforms the current approach of target discovery for large molecule R&D. This ...
Merck drug Winrevair is the first in a new class of pulmonary arterial hypertension therapies that address a key signaling pathway behind the disease. The drug comes from Merck’s $11.5 billion acquisition of Acceleron Pharma. By FRANK VINLUANPulmonary arterial hypertension, a disease that leads to worsening lung and heart problems that eventually become life-threatening, is treated with drugs that alleviate symptoms. FDA approval of a new Merck drug marks the first for a therapy addressing an underlying cause of the disease. The Tuesday approval of the Merck drug covers the treatment of adults whose pulmonary arterial hypertension (PAH) is at intermediate or high risk of progression. The drug, known in development as sotatercept, will be marketed under the brand name Winrevair. Hypertension—high blood pressure—is common. PAH is a rare form of hypertension that specifically affects the arteries carrying blood from the right side of the heart and into the lungs. ...
Davy James MVR-T3011 IT is in development to treat patients with recurrent or metastatic head and neck squamous cell cancer whose disease progressed following platinum-based chemotherapy and at least one prior line of a PD-1/PD-L1 therapy. ImmVira’s oncolytic herpes simplex virus (oHSV) therapy MVR-T3011 IT for intratumoral injection has been granted Fast Track designation by the FDA to treat patients with recurrent or metastatic head and neck squamous cell cancer (HNSCC) whose disease progressed following platinum-based chemotherapy and at least one prior line of an anti–programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy.1 The novel oHSV treatment is a genetically engineered virus developed to produce replication potency in tumor cells as well as highly restricted replication in normal cells. The ability of MVR-T3011 to boost the immune response within the tumor microenvironment is increased by adding a PD-1 antibody and IL-12 into the construct, according to ImmVira. “Attaining ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.