相关临床试验
7
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2018
招募中
3
42.9%
终止
3
42.9%
撤回
1
14.3%
暂无批准数据
- AbCellera has appointed Dr. Lynn Seely, an experienced biopharmaceutical executive, to its Board of Directors as an independent director. - Dr. Seely previously led the clinical development of Xtandi (enzalutamide) at Medivation through global approvals, culminating in a $14 billion acquisition by Pfizer. - As CEO of Myovant Sciences, she successfully commercialized Myfembree and Orgovyx, demonstrating expertise in endocrinology and women's health. - Dr. Seely currently serves as president and CEO of Lyell Immunopharma, advancing next-generation CAR T-cell therapies for hematologic malignancies and solid tumors.
- Century Therapeutics appointed Dr. Han Lee and Dr. Martin Murphy to its Board of Directors to provide strategic oversight as the company advances its iPSC-derived cell therapy programs. - Dr. Lee brings extensive capital formation and corporate development experience from leadership roles at ImmPACT Bio, Neogene Therapeutics, and Arcellx. - Dr. Murphy contributes significant life science investment expertise as co-founder of Syncona Limited and current board positions at multiple biotech companies. - The appointments come as Century focuses on bringing CNTY-813, a potential curative treatment for type 1 diabetes, and other pipeline candidates closer to clinical trials.
- Ronde-cel demonstrated a 93% overall response rate and 76% complete response rate with 18-month median progression-free survival in third-line or later large B-cell lymphoma patients. - The dual-targeting CD19/CD20 CAR T-cell therapy achieved an 83% overall response rate in second-line patients, with 94% having primary refractory disease. - Safety profile showed no high-grade cytokine release syndrome and only 5% of patients experienced Grade 3 or higher immune effector cell-associated neurotoxicity syndrome. - Two pivotal trials are underway, including the first head-to-head CAR T-cell comparison trial against approved therapies.
- Lyell Immunopharma announced a private placement agreement for up to $100 million in gross proceeds to advance its next-generation CAR T-cell therapy programs. - The funding includes an initial $50 million closing at $13.32 per share, with potential for an additional $50 million upon achieving clinical milestones related to the LYL314 PiNACLE pivotal trial. - The proceeds will fund two pivotal-stage clinical trials of LYL314 and extend the company's cash runway into mid-2027, supporting a planned Biologics License Application submission for large B-cell lymphoma treatment. - LYL314 is a dual-targeting CD19/CD20 CAR T-cell therapy designed to improve complete response rates and duration compared to approved CD19-targeted therapies.
- The FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Lyell Immunopharma's LYL314, a dual-targeting CD19/CD20 CAR T-cell therapy for relapsed/refractory large B-cell lymphoma. - Phase 1/2 trial data showed promising efficacy with a 94% overall response rate and 71% complete response rate in third-line or later LBCL patients, with favorable safety profile including no Grade 3+ cytokine release syndrome. - Lyell plans to initiate pivotal trials in mid-2025 for third-line or later patients and by early 2026 for second-line patients, with additional clinical data expected throughout 2025.
- DelveInsight's latest report reveals a robust pipeline with over 195 companies developing 200+ therapies for colorectal cancer, highlighting significant innovation in targeted treatments and immunotherapies. - Key drug candidates include XL092 (Exelixis), Adagrasib (Mirati Therapeutics), Olaparib (Merck/AstraZeneca), and novel approaches like LYL845, an autologous tumor-infiltrating lymphocyte therapy from Lyell Immunopharma. - The metastatic colorectal cancer segment shows particular promise with 150+ companies advancing 180+ pipeline therapies, including innovative treatments targeting specific mutations and immune pathways.
- Lyell Immunopharma is prioritizing IMPT-314, a dual-targeting CD19/CD20 CAR T-cell therapy, for aggressive large B-cell lymphoma, based on promising Phase 1-2 data. - Pivotal trials for IMPT-314 in 3rd line+ are expected to commence in 2025, with 2nd line trials anticipated to begin by early 2026, marking significant clinical milestones. - Lyell is streamlining its pipeline, discontinuing LYL119 development, to focus resources on IMPT-314 and next-generation CAR T-cell programs for solid tumors. - With a projected net cash use of $175M-$185M for 2025, Lyell extends its financial runway into 2027, supporting multiple value-creating clinical catalysts.
• Lyell Immunopharma announced encouraging initial clinical data for IMPT-314 in patients with large B-cell lymphoma who have not previously received CAR-T therapy. • IMPT-314, a ROR1-targeting CAR-T cell therapy, demonstrated notable anti-tumor activity in early-stage clinical trials, offering a potential new treatment option. • The data suggests IMPT-314 could provide a meaningful clinical benefit for patients who are ineligible for or have relapsed after standard CAR-T cell therapies. • Further studies are planned to evaluate the safety and efficacy of IMPT-314 in a larger patient population and across different lymphoma subtypes.
- Lyell's IMPT-314 demonstrated a 94% objective response rate and a 71% complete response rate in CAR T-naive patients with large B-cell lymphoma. - The Phase 1-2 trial of IMPT-314 showed a manageable safety profile, with no high-grade cytokine release syndrome reported. - IMPT-314 is a dual-targeting CD19/CD20 CAR T-cell therapy designed to enhance antitumor activity and prolong response duration. - Lyell plans to initiate a pivotal trial of IMPT-314 in 2025 for CAR T-naive patients with large B-cell lymphoma in the 3rd-line+ setting.
- Abeona Therapeutics has resubmitted its BLA to the FDA for prademagene zamikeracel (pz-cel) for recessive dystrophic epidermolysis bullosa (RDEB) treatment. - Nanoscope Therapeutics' MCO-010 gene therapy demonstrated improved visual acuity in retinitis pigmentosa (RP) patients in a Phase 2b trial compared to placebo. - Lyell Immunopharma will acquire ImmPACT Bio, prioritizing development of CD19/CD20-directed CAR-T therapy IMPT-314 for large B-cell lymphoma.