相关临床试验
4
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
1999
招募中
4
100.0%
暂无批准数据
- Arbitration tribunal ruled in favor of Servier, reaffirming Allogene's full development and commercial control of cemacabtagene ansegedleucel (cema-cel) in the US, EU, and UK markets. - The decision rejected Cellectis's breach allegations and financial claims, with milestone payments only due upon FDA acceptance of a Biologics License Application. - Allogene approaches a critical 1H 2026 interim futility analysis for its pivotal Phase 2 ALPHA3 trial testing cema-cel in first-line large B-cell lymphoma consolidation.
- Cellectis' allogeneic CAR-T therapy lasme-cel demonstrated a 100% overall response rate in the target Phase 2 population of heavily pretreated relapsed/refractory B-cell acute lymphoblastic leukemia patients. - The therapy showed strong safety profile with manageable adverse events and enabled 100% of patients in the target population to become transplant eligible, with 78% proceeding to transplant. - Following successful regulatory meetings with FDA and EMA, Cellectis initiated the pivotal Phase 2 BALLI-01 trial with BLA submission anticipated in 2028. - The company estimates lasme-cel could achieve up to $700 million in potential peak gross sales across the U.S., EU4, and UK by 2035.
- Cellectis presents breakthrough research on circular single-stranded DNA (CssDNA) templates that achieved high gene insertion frequency in hematopoietic stem cells and showed superior engraftment compared to AAV-edited cells. - The company's TALE base editors (TALEB) demonstrated strong safety profile with no evidence of off-target editing biases in nuclear genome analysis of primary T cells. - These findings support the potential of non-viral gene therapy approaches and base editing technologies for therapeutic applications in cell and gene therapy development.
- Factor Bioscience filed a patent lawsuit against Cellectis and AstraZeneca in Delaware federal court, alleging infringement of three foundational gene-editing patents related to mRNA TALEN technology. - The lawsuit claims Cellectis copied Factor's patented technology for designing gene-edited cells for cancer therapies, particularly for treating leukemia and lymphoma. - AstraZeneca is accused of violating patent rights through its 2023 licensing agreement with Cellectis for gene-editing technology development in oncology and other therapeutic areas. - Factor CEO Matt Angel warns that allowing large pharmaceutical companies to exploit smaller biotech innovations could chill future research and delay new therapy development.
- Allogene Therapeutics narrowed its GAAP net loss to $0.23 per share in Q2 2025, beating estimates of $0.27 per share while maintaining a strong cash position of $302.6 million. - The company delayed key clinical trial timelines for its lymphoma and autoimmune disease programs by approximately two quarters due to operational challenges at trial sites. - Over 250 patients have been consented for screening across trials, with the ALPHA3 futility analysis for cema-cel now expected in the first half of 2026. - The company's cash runway is projected to extend into the second half of 2027, supporting continued development of its off-the-shelf CAR-T therapy pipeline.
- Cellectis presents breakthrough research on TALEN-mediated non-viral transgene insertion technology that addresses manufacturing constraints and genomic toxicity risks associated with traditional viral methods. - The company's TALE base editors (TALEB) demonstrate high-fidelity C-to-T editing with no detectable off-target effects in primary cells, enhancing specificity for therapeutic applications. - Research shows circular single-stranded DNA templates maintain better hematopoietic stem cell fitness and provide more stable gene editing compared to viral donor templates. - These innovations expand Cellectis' gene editing toolbox for developing next-generation therapies targeting cancer, autoimmune diseases, and monogenic disorders.
• Beam Therapeutics reported a patient death in their BEAM-101 sickle cell disease trial, likely due to the conditioning regimen. • AstraZeneca scientists engineered PsCas9 for therapeutic genome editing in mouse liver, showing promise for hypercholesterolemia treatment. • YolTech Therapeutics' novel LNP system delivers base editor mRNA to bone marrow cells, activating foetal haemoglobin production for blood disorder treatment.
- Cellectis' cash reserves surged to $264 million, fueled by a strategic investment and collaboration revenue from AstraZeneca, extending the company's financial runway to 2027. - Three new R&D programs have been initiated with AstraZeneca, encompassing allogeneic CAR T therapies for hematological malignancies and solid tumors, plus an in vivo gene therapy. - The UCART123 program for relapsed/refractory acute myeloid leukemia is being deprioritized to concentrate resources on the more promising BALLI-01 and NATHALI-01 studies. - Phase I data for the BALLI-01 (UCART22) and NATHALI-01 (UCART20x22) studies are expected in 2025, with strong patient demand reported for the UCART20x22 program.
