Introduction: The era of chemotherapy cannot solve the “pain points” of relapsed and refractory diffuse large B-cell lymphoma, but the era of new cell drugs has solved them. And this new cellular drug, CAR-T cell therapy, which has become a hot topic in recent years, has opened up a new era of medical treatment, with a market size of trillions of dollars. Immune cell therapy aims to enhance the immune system’s ability to fight cancer. Manufacturing cell therapy requires collecting a specific set of cells from the blood, modifying them to produce more powerful attacks on the patient’s cancer cells, and then re injecting them into the patient’s body. At present, many types of cancer cell therapies are being explored, including CAR-T cells, other genetically modified T cells, tumor infiltrating lymphocytes (TIL), NK cells, CIK cells, B cells, etc. Extracting immune cells from patients’ bodies and modifying them to make ...
In September, several domestic companies focused on the field of cell and gene therapy (CGT) announced progress in financing. This article will share basic information about its 7 companies based on publicly available materials. Xingsairui has successfully completed tens of millions of yuan in angel round financing On September 14th, Hangzhou Xingsai Ruizhen Biotechnology Co., Ltd. (hereinafter referred to as “Xingsai Ruizhen”) announced the completion of tens of millions of yuan in angel round financing and officially launched the angel+round financing plan! This round of financing is jointly invested by Fosun Pharma’s Rehabilitation Capital New Drug Innovation Fund and Chuangrui Investment Jiaxing Chuangyan Fund. This round of financing will be used for the continuous promotion of core pipelines and platforms, as well as the construction of the company’s team and research and development laboratories. Xingsai Ruizhen was founded in July 2022 and incubated by the New Drug Innovation ...
Recently, Fosun Pharma (stock code: 600196.SH; 02196.HK) announced that its subsidiary, Fosun Pharma Industry, plans to invest $27 million in cash to acquire 50% of the equity of Fosun Kite held by Kite Pharma. Once this equity transfer is completed, Fosun Pharma will wholly own Fosun Kite and plans to invest an additional $10 million or its equivalent in renminbi as a capital increase for Fosun Kite. On the same day the equity transfer agreement was signed, Fosun Kite and Kite Pharma comprehensively revised and restated their original licensing agreement, signing a “Revised and Restated Licensing Agreement.” According to this agreement, Fosun Kite has obtained exclusive rights to develop, produce, and commercialize Yescarta® and Brexu-Cel (Fosun Kite’s research project FKC889) in mainland China, Hong Kong, and Macau, and within the field of cancer treatment. Additionally, Fosun Kite plans to change its name to Fosun Kairui and will function as Fosun ...
The US Food and Drug Administration (FDA)-mandated monitoring time for CAR-T therapy patients could be halved, according to a new study. Chimeric antigen receptor (CAR)-T therapy involves modifying a patient’s T cells to recognise and attack cancer cells. There are three approved therapies to treat diffuse large B-cell non-Hodgkin lymphoma (DLBCL), notably Gilead’s Yescarta (axicabtagene ciloleucel) and Novartis’s Kymriah (tisagenlecleucel), which were approved by the FDA in 2017; and Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel), which won approval in 2021. Safety concerns surrounding CAR-T cell therapies related to cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS), led to strict FDA-mandated monitoring requirements when the therapies were first approved in 2017. To allow for the safe use of these therapies, the FDA established a risk evaluation and mitigation strategy (REMS) programme, which covered these monitoring requirements. Under the REMS programme, patients need to stay near the treatment centre ...
By Don Tracy, Associate Editor Results of the Phase III CARTITUDE-4 study showed that treatment with Carvykti achieved a more significant improvement in overall survival (OS) compared to standard therapies. Results from the second interim analysis of the Phase III CARTITUDE-4 study, which evaluated Johnson & Johnson’s (J&J) Carvykti (ciltacabtagene autoleucel; cilta-cel) for patients with relapsed or lenalidomide-refractory multiple myeloma after one prior line of therapy showed that the treatment achieved a statistically significant and clinically meaningful improvement in overall survival (OS) compared to standard therapies such as omalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd).1 “Carvykti, a one-time infusion, is now the first cell therapy to significantly improve overall survival versus standard of care for patients with myeloma as early as second line,” said Jordan Schecter, MD, VP, disease area leader, multiple myeloma, Johnson & Johnson Innovative Medicine, in a press release. “As we continue to ...
Don Tracy, Associate Editor Joint venture aims to develop up to 10 new cell and gene therapy products targeting areas with high unmet medical needs. AstraZeneca announced that it has officially completed its equity investment and research collaboration agreement with Cellectis, a biotechnology company specializing in gene editing technologies. According to the company, the agreement is expected to result in a collaboration to develop up to 10 different cell and gene therapy (CGT) products in areas such as oncology, immunology, and rare diseases. Regarding terms of the deal, Cellectis earned an upfront payment of $105 million, which included $25 million in cash and $80 million in an equity investment. Cellectis will have the opportunity to profit further through an investigational new drug (IND) option fee, and additional payments based on development, regulatory, and sales milestones that could range from $70 million to $220 million.1 The collaboration, which was first announced ...
The concentration of circulating cell-free DNA (cfDNA) in the bloodstream is an important indicator that can help track how well cancer treatments are working. Before starting treatment, measuring cfDNA levels can give doctors a snapshot of the extent of the cancer’s spread in the body. High levels of cfDNA often mean the cancer is widespread or aggressive. As treatment goes on, doctors can keep an eye on cfDNA levels to see if the treatment is effective. A drop in cfDNA levels could mean the treatment is working and the tumor is getting smaller. But if cfDNA levels remain unchanged or rise, it might mean the treatment isn’t working, and the cancer is still growing or has become resistant to treatment. Now, a simple blood test monitors this liquid biomarker in real time to track how well a cancer treatment is working. DiaCarta’s (Pleasanton, CA, USA) RadTox Test is a liquid ...
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 ...
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 ...
Monitoring the response of the immune system of cancer patients during disease and treatment is important for achieving favorable outcomes. To do this, labs utilize flow cytometry to perform immune profiling, which involves identifying and quantifying a patient’s immune cells at a specific time. This information is vital for determining the most effective treatment for a cancer patient. Continuing this profiling during treatment helps clinicians understand how well the treatment is working. Despite the promise of immune profiling in guiding therapy being a burgeoning area in cancer research and treatment, it hasn’t been widely adopted in clinical practice due to the high cost, large size, and complexity of flow cytometry equipment. These machines are confined to specialized labs, and transporting blood samples to these facilities is time-consuming and requires special conditions to keep the cells viable, making routine monitoring of cancer patients challenging. Now, a novel cell sorter chip technology ...
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