Latest news with #CAR-T
Yahoo
11 hours ago
- Business
- Yahoo
CARsgen Presents Research Results on Satri-cel in The Lancet and at the 2025 ASCO Annual Meeting
SHANGHAI, June 1, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: a company focused on developing innovative CAR T-cell therapies, announces that the results of the pivotal Phase II clinical trial in China (CT041-ST-01, NCT04581473) investigating satricabtagene autoleucel ("satri-cel", CT041) (a Claudin18.2-specific autologous CAR T-cell product candidate) in patients with Claudin18.2-positive, advanced gastric/gastroesophageal junction cancer refractory to at least two prior lines of treatment, have been published in The Lancet and were orally presented at the 2025 ASCO Annual Meeting. Further details have been posted on the corporate website The article in The Lancet was titled "Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) versus treatment of physician's choice for previously treated advanced gastric or gastro-oesophageal junction cancer (CT041-ST-01): a randomised, open-label, phase 2 trial". Full article available at: The oral presentation at the 2025 ASCO Annual Meeting (Abstract 4003) was titled "Claudin18.2-specific CAR T cells (Satri-cel) versus treatment of physician's choice (TPC) for previously treated advanced gastric or gastroesophageal junction cancer (G/GEJC): Primary results from a randomized, open-label, phase II trial (CT041-ST-01)". Professor Lin Shen from Beijing Cancer Hospital, the principal investigator of this study, said, "The CT041-ST-01 trial represents the world's first randomized controlled clinical study of CAR-T cell therapy for solid tumors. In patients with heavily pretreated, advanced gastric/gastroesophageal junction cancer who have extremely limited treatment options and poor prognosis, satri-cel has demonstrated breakthrough efficacy with significant clinical benefits, including much improved progression-free survival (PFS), overall survival (OS), and tumor response rates. This brings new hope to patients with otherwise medically untreatable conditions. We are further exploring satri-cel's potential in adjuvant settings and as first-line sequential therapies, aiming to intervene earlier in the disease course, extend patients' survival, and ultimately pursue potential cures." Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "We are honored that the CT041-ST-01 study results were published in The Lancet—a premier, global medical journal—and presented at the 2025 ASCO Annual Meeting. The positive result of this randomized controlled trial marks a major milestone in solid tumor CAR-T therapy. These achievements are a testament to the whole research team's years of dedication, and we extend our deepest gratitude to patients and their families for their trust and participation. This year, satri-cel has been granted Breakthrough Therapy Designation and Priority Review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy. We plan to submit a New Drug Application (NDA) for satri-cel to the NMPA this month and anticipate its approval as the world's first commercially available CAR-T product for solid tumors, bringing benefits to patients." About Satri-cel Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be the first-in-class globally. Satri-cel targets the treatment of Claudin18.2-positive solid tumors with a primary focus on G/GEJA and pancreatic cancer (PC). Initiated trials include investigator-initiated trials (CT041-CG4006, NCT03874897), a confirmatory Phase II clinical trial for advanced G/GEJA in China (CT041-ST-01, NCT04581473), a Phase Ib clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), an investigator-initiated trial for satri-cel be used as consolidation treatment following adjuvant therapy in patients with resected G/GEJA (CT041-CG4010, NCT06857786), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595). Satri-cel has been granted Priority Review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy in May 2025. Satri-cel has been granted Breakthrough Therapy Designation by the CDE of China's NMPA for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy in March 2025. Satri-cel was granted Regenerative Medicine Advanced Therapy designation by U.S. FDA for the treatment of advanced G/GEJA with Claudin18.2-positive tumors in January 2022. Satri-cel received Orphan Drug designation from the U.S. FDA in September 2020 for the treatment of G/GEJA. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company focusing on developing innovative CAR T-cell therapies to address the unmet clinical needs including but not limited to hematologic malignancies, solid tumors and autoimmune diseases. CARsgen has established end-to-end capabilities for CAR T-cell research and development covering target discovery, preclinical research, product clinical development, and commercial-scale production. CARsgen has developed novel in-house technologies and a product pipeline with global rights to address challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs, etc. CARsgen's mission is to be a global biopharmaceutical leader that provides innovative and differentiated cell therapies for patients worldwide and makes cancer and other diseases curable. Forward-looking Statements All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release. Contact CARsgen For more information, please visit View original content to download multimedia: SOURCE CARsgen Therapeutics Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
The Sun
18 hours ago
- Health
- The Sun
Cancer treatment turbocharges patients' own blood cells to kill solid tumours for first time
A LIVING cancer drug has been proven to work against solid tumours for the first time. Immune-boosting CAR-T therapy removes a patient's white blood cells and engineers them into highly specialised cancer killers in a lab. 1 They are then injected back into the patient and let loose against the disease. It is currently only used for blood cell cancers like leukaemia but research by Peking University in China has found it can also work against tumours that form as lumps. In a study of 266 people with stomach cancer, patients who received the treatment survived an average of 7.9 months compared to 5.5 months without it. It took 3.3 months for their cancer to worsen, compared to 1.8 months without. Study author Dr Changsong Qi said the results showed a 'significant increase in progression-free survival and clinically meaningful increase in overall survival'. More than 90 per cent of cancers are solid tumours that grow as a physical mass, including the big four of bowel, breast, lung and prostate. The findings raise the hope that tens or even hundreds of thousands more patients will one day benefit from the pioneering approach using their own immune systems instead of harsh drugs. 'Groundbreaking milestone' Dr Carl June, of the University of Pennsylvania, is credited with inventing the therapy and commented: 'This is a groundbreaking milestone for the field of CAR-T therapies against solid tumours.' CAR-T therapy, full name chimeric antigen receptor T-cell therapy, is an advanced type of immunotherapy that turbocharges the body's own defences to fight off cancer. It is intended to be more accurate and cause less collateral damage and side effects by only attacking cancerous cells and not healthy ones. Sun Health Explainer: What is cancer? Young Sunderland fan Bradley Lowery took part in a major clinical trial of it in 2017 before dying from neuroblastoma aged six. It is currently available on the NHS in England for certain types of leukaemia and lymphoma. More than 650 forms of the treatment are now in development for solid cancers. Dr John Haanen, from the Netherlands Cancer Institute, said: 'There is clearly now evidence that this treatment can benefit patients with solid cancers. It is an important development.' The study was published in The Lancet and presented at the conference of the American Society for Clinical Oncology. Dr Catherine Elliott, of Cancer Research UK, said: 'This is an encouraging early sign and further trials will now be needed.'
Reuters
a day ago
- Business
- Reuters
Gilead's CAR-T cell therapy shows promise in deadly brain cancer
CHICAGO, June 1 (Reuters) - A Gilead Sciences-backed therapy made with a patient's own white blood cells shrank tumors in 62% of patients with recurrent glioblastoma, a rare event for a fatal brain cancer with few treatment options, researchers reported on Sunday. The study, presented at the American Society of Clinical Oncology meeting in Chicago and published in Nature Medicine, is the latest among several efforts testing next-generation chimeric antigen receptor T-cell or CAR-T treatments, a type of immunotherapy in which patients' immune cells are engineered to recognize and kill cancer cells. The work, from researchers at the University of Pennsylvania and Gilead's (GILD.O), opens new tab Kite cell therapy unit, tested a dual CAR-T treatment in an effort to overcome the defenses of glioblastoma, the most common brain tumor in adults. CAR-T therapy is already used to treat blood cancers including leukemia, lymphoma and multiple myeloma, and those treatments typically only take aim at one target on the tumor. But solid tumors such as glioblastoma tend to have multiple subpopulations of tumor cells, suggesting that treatments will need more than one target to succeed, said University of Pennsylvania researcher Dr. Stephen Bagley, who led the study. For the treatment, which is injected directly into spinal fluid, the team selected EGFR, which is found in 50% to 60% of all glioblastoma tumors, and a second target called interleukin-13 receptor alpha 2, found in an estimated 75% of glioblastoma tumors. Typically, advanced glioblastoma patients whose cancers return after initial treatment with surgery, radiation and chemotherapy live six to 10 months. Interim results of just six patients were published in March 2024 in Nature Medicine, opens new tab. The current study now includes 18 patients treated with the experimental therapy after their tumors returned following standard treatment. Of these, only 13 had a measurable tumor at the time the cells were introduced, and of those, eight, or 62%, had their tumors shrink, Bagley said. "That was pretty remarkable to us because historically for recurrent glioblastoma tumors, we usually don't see anything shrink them." Several patients lived 12 months or longer, and in one patient, the disease remained stable for 16 months. But so far, the benefit is largely temporary, with many patients relapsing two to three months later. Most patients experienced fevers and neurotoxicity such as lethargy or confusion for two or three days after the cells are injected, but the side effects were manageable, Bagley said. Cindy Perettie, executive vice president of Gilead's Kite cell therapy unit, said she is encouraged by the 62% response. "What we didn't see that we wanted to in a majority of the patients was persistence," she said. Kite is working to develop a third target that will allow the drug to remain in the brain longer. "We will be putting that construct into the clinic sometime next year," she said. Meanwhile, the team wants to test the therapy in 12 patients with newly diagnosed disease. "We know patients in the frontline setting are going to be healthier," she said, and the hope is to see more persistent results. Demand for the trial has been great. Perettie estimates there are 10 times as many patients seeking enrollment for every open slot, and some doctors are referring patients from as far away as Hawaii. "Today, there's only one approved therapy outside of radiation, so for these patients, this is really exciting to see any kind of response," she said. Kite hopes to expand to three or four centers with its triple-target version of the product. "I think we're on the right track," Bagley said, adding that he believes there will be longer-lasting treatments in the next few years.
Yahoo
a day ago
- Business
- Yahoo
Cancer patients live 40pc longer after experimental treatment
Cancer patients given experimental treatment that programmes the body to attack rogue cells live 40 per cent longer, major research shows. Chimeric antigen receptor (CAR) T-cell therapy is a form of immunotherapy where a patient's own T-cells – a type of white blood cell – are altered in a lab to target and kill cancer cells. The engineered cells are then reintroduced into the patient's bloodstream. CAR T-cell therapy works by genetically engineering a patient's T-cells to recognise and destroy cancer cells. T-cells are a type of white blood cell that can recognise and destroy foreign cells, including cancer cells, but because cancer is very good at evading immune detection, they often miss their mark. CAR T-cells are engineered to make them better at detecting cancer cells. The pioneering therapy had already been hailed by scientists as one of the most significant breakthroughs in treatment for its success in treating blood cancers. Now, new findings suggest it could also revolutionise treatment for solid tumours. Experts at the American Society of Clinical Oncology's (Asco) annual meeting in Chicago, the world's largest cancer conference, said the findings heralded 'a new generation of treatment'. Solid tumours represent roughly 90 per cent of all adult human cancers, including breast, lung and pancreatic cancer. Currently, over 650 CAR-Ts are in active development for a solid tumour indication. The new study – the first ever randomised controlled trial of CAR T-cell therapy in solid tumours – involved patients with advanced gastric or gastro-oesophageal junction (GEJ) cancer. Those given the radical treatment lived on average approximately 40 per cent longer than patients who received standard care, a clinical trial found. The results have been simultaneously published in the medical journal The Lancet. Dr Carl June, a leading expert on CAR T-cell therapy at the University of Pennsylvania, who was not involved with the trial, said the findings were 'groundbreaking'. He said: 'This is an exciting study showing the first positive results from a randomised trial testing CAR T-cells for a solid cancer.' In the trial, over 100 patients in China with advanced gastric or GEJ cancer were randomised to receive either CAR T-cell therapy or one of the standard-of-care medications. Patients who received CAR T-cell therapy lived an average of 7.9 months after randomisation, compared to 5.5 months with standard care. Patients receiving the designer immunotherapy also experienced 3.3 months without the cancer advancing, versus 1.8 months in the standard care group. The researchers, from Peking University Cancer Hospital and Institute in Beijing, said CAR-T-cell therapy 'showed a statistically significant improvement in progression-free survival and clinically meaningful improvement in overall survival'. The results suggest CAR T-cell 'could represent a paradigm shift' in care, addressing a crucial unmet need for some patients, they added. A second study on CAR T-cell led by the University of Pennsylvania and due to be presented at Asco on Sunday, suggested the approach could also be used to treat brain tumours. Results from that trial are expected to show CAR T-cell can shrink tumours in glioblastoma, a notoriously aggressive and fast-growing brain cancer, and help patients live much longer. Oncologists in Chicago said they were increasingly optimistic about the potential of the therapy to revolutionise treatment of solid tumours, after dramatic success with blood cancers. Dr John Haanen, of the Netherlands Cancer Institute, who will deliver a presentation on CAR T-cell therapy at the Asco meeting, said the breakthroughs suggest 'a new generation of treatment that wasn't there for medical oncologists before'. Dr Catherine Elliott, director of research at Cancer Research UK, said: 'CAR T-cell therapy – a highly personalised treatment that modifies a patient's own immune cells to recognise and destroy their cancer – has already shown success in treating some blood cancers, but it hasn't yet worked well for solid tumours.' She said it was 'encouraging' to see early signs that it might help those with advanced stomach or gastroesophageal junction cancer, who lived an extra two and a half months longer than those given standard care. Broaden your horizons with award-winning British journalism. Try The Telegraph free for 1 month with unlimited access to our award-winning website, exclusive app, money-saving offers and more.
Telegraph
a day ago
- Health
- Telegraph
Cancer patients live 40pc longer after experimental treatment
Cancer patients given experimental treatment that programmes the body to attack rogue cells live 40 per cent longer, major research shows. Chimeric antigen receptor (CAR) T-cell therapy is a form of immunotherapy where a patient's own T-cells – a type of white blood cell – are altered in a lab to target and kill cancer cells. The engineered cells are then reintroduced into the patient's bloodstream. CAR T-cell therapy works by genetically engineering a patient's T-cells to recognise and destroy cancer cells. T-cells are a type of white blood cell that can recognise and destroy foreign cells, including cancer cells, but because cancer is very good at evading immune detection, they often miss their mark. CAR T-cells are engineered to make them better at detecting cancer cells. The pioneering therapy had already been hailed by scientists as one of the most significant breakthroughs in treatment for its success in treating blood cancers. Now, new findings suggest it could also revolutionise treatment for solid tumours. Experts at the American Society of Clinical Oncology 's (Asco) annual meeting in Chicago, the world's largest cancer conference, said the findings heralded 'a new generation of treatment'. Solid tumours represent roughly 90 per cent of all adult human cancers, including breast, lung and pancreatic cancer. Currently, over 650 CAR-Ts are in active development for a solid tumour indication. The new study – the first ever randomised controlled trial of CAR T-cell therapy in solid tumours – involved patients with advanced gastric or gastro-oesophageal junction (GEJ) cancer. 'A paradigm shift' Those given the radical treatment lived on average approximately 40 per cent longer than patients who received standard care, a clinical trial found. The results have been simultaneously published in the medical journal The Lancet. Dr Carl June, a leading expert on CAR T-cell therapy at the University of Pennsylvania, who was not involved with the trial, said the findings were 'groundbreaking'. He said: 'This is an exciting study showing the first positive results from a randomised trial testing CAR T-cells for a solid cancer.' In the trial, over 100 patients in China with advanced gastric or GEJ cancer were randomised to receive either CAR T-cell therapy or one of the standard-of-care medications. Patients who received CAR T-cell therapy lived an average of 7.9 months after randomisation, compared to 5.5 months with standard care. Patients receiving the designer immunotherapy also experienced 3.3 months without the cancer advancing, versus 1.8 months in the standard care group. The researchers, from Peking University Cancer Hospital and Institute in Beijing, said CAR-T-cell therapy 'showed a statistically significant improvement in progression-free survival and clinically meaningful improvement in overall survival'. The results suggest CAR T-cell 'could represent a paradigm shift' in care, addressing a crucial unmet need for some patients, they added. A second study on CAR T-cell led by the University of Pennsylvania and due to be presented at Asco on Sunday, suggested the approach could also be used to treat brain tumours. Results from that trial are expected to show CAR T-cell can shrink tumours in glioblastoma, a notoriously aggressive and fast-growing brain cancer, and help patients live much longer. Oncologists in Chicago said they were increasingly optimistic about the potential of the therapy to revolutionise treatment of solid tumours, after dramatic success with blood cancers. Dr John Haanen, of the Netherlands Cancer Institute, who will deliver a presentation on CAR T-cell therapy at the Asco meeting, said the breakthroughs suggest 'a new generation of treatment that wasn't there for medical oncologists before'. Dr Catherine Elliott, director of research at Cancer Research UK, said: 'CAR T-cell therapy – a highly personalised treatment that modifies a patient's own immune cells to recognise and destroy their cancer – has already shown success in treating some blood cancers, but it hasn't yet worked well for solid tumours.' She said it was 'encouraging' to see early signs that it might help those with advanced stomach or gastroesophageal junction cancer, who lived an extra two and a half months longer than those given standard care.
