In the past week, the field of allogeneic CAR-T has heated up again due to the participation of Roche. On November 26, Roche announced that it would acquire the biotech company Poseida for up to $1.5 billion. Poseida’s R&D pipeline includes spot (allogeneic) CAR-T therapies in multiple therapeutic areas, covering hematological malignancies, solid tumors and autoimmune diseases. Due to a series of factors such as cycle and cost, the commercialization process of autologous CAR-T has been subject to certain restrictions, so the industry has never stopped exploring allogeneic CAR-T. The market has high hopes for allogeneic CAR-T. Of course, this is not smooth sailing, because due to a series of factors such as effect, it will take some time for allogeneic CAR-T to break through. Roche’s investment in Poseida this time is mainly based on the latter’s technology platform. Poseida’s non-viral platform is able to generate off-the-shelf CAR-T therapies ...
On November 28, the results of the 2024 medical insurance catalog negotiation were announced: 91 new drugs were added to the national medical insurance drug catalog, of which 89 were included by negotiation/bidding, and another 2 were selected in the national centralized procurement. After checking the medical insurance drugs, Sina Medical Editor found that the 4 CAR-T products that had passed the preliminary review did not appear on the list. Regarding “Why is it difficult for CAR-T to enter the medical insurance catalog”, at the press conference held by the National Medical Insurance Administration on the morning of November 28, Wang Guodong, deputy director of the Medical Insurance Management Center of the National Medical Insurance Administration, introduced that some expensive cell and gene therapy drugs have been launched one after another, and it is difficult to fully support them by relying solely on basic medical insurance. At present, the National ...
According to the latest news released yesterday (November 18, 2024), Gilead will lay off 104 employees at its headquarters (Foster City), effective March 14, 2025. About a few days ago (November 14, 2024), Gilead also announced that it would close its office in Seattle, and 75 employees in the office would be laid off as a result (effective January 17, 2025). In addition, Gilead will also close a Kite factory in Philadelphia by mid-2024, and the specific number of layoffs is unknown. This was a decision made shortly after Gilead released its third-quarter financial report. According to the report, the revenue for the quarter was US$7.5 billion, a year-on-year increase of 7%. The total revenue for the first three quarters was US$21.185 billion, a year-on-year increase of 6%. Its cell therapy segment seems to show a trend of weak growth, with a total sales revenue of US$485 million in Q3 ...
This morning, the much-anticipated on-site negotiations for the 2024 National Health Insurance Drug List adjustment concluded. According to First Financial News, CAR-T drugs have once again been absent from this round of negotiations, marking the fourth consecutive time they have not participated. “None of us appeared at the health insurance negotiation site,” a representative from a CAR-T company told First Financial News. The latest negotiations began on October 27, with 25 health insurance negotiation experts divided into five groups, negotiating and bidding for 162 types of drugs. The list of drugs under negotiation included commonly used medications for diabetes, hypertension, and infections, as well as medications for tumors and rare diseases. The final results of the on-site negotiations and bidding will be announced separately. Earlier, on August 27, the National Health Insurance Administration published a notice regarding the drug list adjustments for the 2024 National Basic Health Insurance, Work Injury ...
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 ...
Biological Products Circle September 3, 2024 09:20 Hubei The following article is from the Engineering Bacteria Planet, written by the author Yaojun, who has doubled in numberCurrently, the FDA has approved multiple chimeric antigen receptor (CAR) – T-cell therapies for cancer immunotherapy. However, the production technology based on viral vectors and in vitro cell culture has led to high production costs and potential long-term side effects. With the development of mRNA and lipid nanoparticle (LNP) technology, the idea of in vivo delivery of CARs based on LNP, a non viral vector, is expected to be realized. The primary challenge faced by mRNA LNP mediated CAR-T therapy due to its liver tropism is how to achieve mRNA T cell targeting The use of antibody modified LNP (also known as antibody conjugated LNP, Ab LNP) is an effective solution. So, what are the markers on the surface of T cells and how ...
Chinese player Legend Biotech reached a new turning point last month when its Johnson & Johnson-partnered Carvykti became the first BCMA-targeted CAR-T cell therapy to be approved by the FDA for second-line treatment of multiple myeloma. From its original roots in China to its first FDA approval in 2022, the company has remained uniquely focused on CAR-T cells targeting the BCMA protein. Humble Beginnings and a Breakthrough Approval Back in 2014, a team of Chinese scientists began investigating cell therapies for cancer under the banner of the “Legend Project,” operating in what the company calls “a room the size of a freight elevator.” After making the decision to focus its research solely on chimeric antigen-receptor T-cells (CAR-T) targeting the BCMA protein in 2015, Legend began conducting its first clinical trials in 2016. The pioneering biotech landed its first major vote of confidence from the global life sciences community in 2017, ...
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 ...
A new editorial paper was published in Oncoscience (Volume 11) on April 25, 2024, entitled, “The price of hope: CAR-T therapy in pediatric leukemia.” We stand at the crossroads of medical innovation, where cutting-edge scientific discoveries intersect with the resilience of the human body, providing hope to families grappling with a diagnosis of pediatric leukemia. In this new editorial, researcher Alex Hoover from the University of Minnesota Medical School’s Division of Pediatric Blood and Marrow Transplantation discusses the chimeric antigen receptor T-cell (CAR-T) therapy tisagenlecleucel (tisa-cel) -; a groundbreaking development in the treatment of B-cell lineage acute lymphoblastic leukemia (B-ALL) (the most common childhood cancer). Following the pivotal ELIANA trial, tisa-cel was approved in the United States for the treatment of refractory or second or greater relapse of B-ALL in patients under age 25. This innovative therapy involves genetically modifying a patient’s native T-cells – immune cells with the ability ...
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 ...
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