Phase I/II Trial to Determine the in Vivo Engraftment, Safety and Clinical Activity of Allogeneic CIK Cells Transduced With a Transposon CD19-chimeric Antigen Receptor (CARCIK-CD19) Gene in Adult and Pediatric Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

This is a single arm, open-label, multi-center, phase I/II study to determine the engraftment, safety and clinical activity of allogeneic CARCIK-CD19 cells in adult and pediatric patients with relapsed/refractory mature B-cell neoplasia expected to express CD19 i.e. B-cell NHL and CLL.
CARCIK-CD19 will be produced from the peripheral blood of an at least haploidentical familial donor.

开始日期2023-12-01

申办/合作机构-

NCT03389035

/ Completed临床1/2期IIT

Phase 1-2a Trial to Determine the Feasibility and Safety of a Single Dose of Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Adult and Pediatric Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia, After Hematopoietic Stem Cell Transplantation

This is a single arm, open-label, multi-center, phase 1-2a study to determine the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose and the safety of CARCIK-CD19 in adult and pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

开始日期2017-12-20

申办/合作机构

Fondazione Matilde Tettamanti e Menotti de March

100 项与 CIK-CAR CD19 immunotherapy (CoImmune) 相关的临床结果

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100 项与 CIK-CAR CD19 immunotherapy (CoImmune) 相关的转化医学

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100 项与 CIK-CAR CD19 immunotherapy (CoImmune) 相关的专利（医药）

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项与 CIK-CAR CD19 immunotherapy (CoImmune) 相关的文献（医药）

Blood Cancer Journal

Donor-derived CARCIK-CD19 cells engineered with Sleeping Beauty transposon in acute lymphoblastic leukemia relapsed after allogeneic transplantation

Article

作者: Tettamanti, Sarah ; Capelli, Chiara ; Montini, Eugenio ; Spinozzi, Giulio ; Valsecchi, Maria Grazia ; Benedicenti, Fabrizio ; Balduzzi, Adriana ; Ferrari, Silvia ; Belotti, Daniela ; Gotti, Elisa ; Rambaldi, Benedetta ; Rambaldi, Alessandro ; Napolitano, Sara ; Meli, Cristian ; Galimberti, Stefania ; Cabiati, Benedetta ; Gaipa, Giuseppe ; Borleri, Gian Maria ; Introna, Martino ; Paganessi, Muriel ; Risca, Giulia ; Cazzaniga, Giovanni ; Gritti, Giuseppe ; Biondi, Andrea ; Rizzuto, Giuliana ; Grassi, Anna ; Lussana, Federico ; Pais, Giulia ; Magnani, Chiara F ; Golay, Josée ; Dastoli, Giuseppe ; Buracchi, Chiara ; Moretti, Alex

Non-viral engineering can ease CAR-T cell production and reduce regulatory and cost requirements. We utilized Sleeping Beauty transposon to engineer donor-derived anti-CD19.CD28.OX40.CD3zeta T cells differentiated in cytokine-induced killer (CARCIK-CD19) for B-cell precursor acute lymphoblastic leukemia (BCP-ALL) patients relapsed after allogeneic hematopoietic stem cell transplantation (alloHSCT). We report the results of CARCIK-CD19 observed in 36 patients (4 children and 32 adults) treated according to the final recommended dose. Cytokine release syndrome of grade 2 or lower occurred in 15 patients, ICANS grade 2 in 1 patient, and late-onset peripheral neurotoxicity of grade 3 in 2 patients. GVHD never occurred after treatment with allogeneic CARCIK-CD19. Complete remission was achieved by 30 out of 36 patients (83.3%), with MRD negativity in 89% of responders. With a median follow-up of 2.2 years, the 1-year overall survival was 57.0%, and event-free survival was 32.0%. The median duration of response at 1 year was 38.6%. CAR-T cells expanded rapidly after infusion and remained detectable for over 2 years. Integration site analysis after infusion showed a high clonal diversity. These data demonstrated that SB-engineered CAR-T cells are safe and induce durable remission in heavily pretreated patients with BCP-ALL relapsed after alloHSCT. Trial registration: The phase 1/2 and phase II trials are registered at www.clinicaltrials.gov as NCT#03389035 and NCT#05252403.

项与 CIK-CAR CD19 immunotherapy (CoImmune) 相关的新闻（医药）

2024-09-11

·Pharmaceutical Technology

IBA venture PanTera gains €134m in funding to scale up actinium-225 production

PanTera aims to accelerate actinium-225 production, used in promising targeted alpha therapy for cancer. Image: Getty Images / Love Employee. PanTera, a Belgian radioisotope producer, announced today (11 September) that it had secured €93m ($102.4m) in an oversubscribed Series A financing round to accelerate production of actinium-225. The radioactive isotope is integral to several investigational cancer therapies. This is the largest Series A financing round in the Belgian life sciences sector to date. The round was led by EQT Life Sciences. Ion Beam Applications (IBA), which invested in the joint venture PanTera with SCK CEN (the Belgian Nuclear Research Centre), and SFPIM—Belgium’s sovereign wealth fund, will also convert loans into €7.2m in equity. Along with €33.8m in debt financing, PanTera will have raised a total of €134m, increasing their valuation to €280m. The deal will see IBA’s shareholding in PanTera drop from 47.8% to 31.3% but will net IBA roughly €23m in profit as a result. Following the announcement, IBA share price was up by 4% when the market opened today, bringing its market cap to €3.29bn. Actinium-225 is a crucial component of targeted alpha therapy. The isotope is conjugated with cancer antigen-targeting elements to deliver localised radiation to cancer cells while minimising damage to healthy tissue. Several investigational treatments for metastatic castration-resistant prostate cancer (mCRPC) depend on actinium-225, including Johnson & Johnson’s JNJ-6420 , Eli Lilly’s PNT-2001, and Novartis ’s AAA-802. The funds are set to support PanTera’s patented photo-nuclear ‘gamma’ process which converts radium-226 to actinium-225. Already, the company is on track to produce 1.5 – 2 Curies (Ci) of the isotope annually from early 2025, a large portion of the estimated 3 Ci per year global supply. Through the gamma process, PanTera claims they will produce over 100 Ci annually by 2029, enough to treat more than 100,000 patients. See Also: CMN-005 by CoImmune for Extranodal Marginal Zone B-Cell Lymphoma (Mucosa-Associated Lymphoid Tissue or MALT-Lymphoma): Likelihood of Approval CMN-005 by CoImmune for Nodal Marginal Zone B-Cell Lymphoma: Likelihood of Approval PanTera CEO Sven Van den Berghe said the company aims to radically improve supply in the short and long term to address what Marijn Kleijwegt, Partner at EQT Life Sciences, described as a “critical actinium-225 supply shortage”. PanTera seeks to employ SCK CEN’s large radium-226 stock and IBA’s Rhodotron electron accelerator to overcome the issues of complexity and infrastructure contributing to the global shortage. As pharmaceutical companies ramp up clinical trialling for alpha particle-targeted therapies across various cancers, demand is poised to increase further. The company has signed supply deals with pharmaceutical manufacturers, such as Bayer for their therapies BAY-3563254 and BAY-3546828, both in Phase I trials for mCRPC. It expects to arrange deals to account for over 80% of its productive capacity before production begins.

放射疗法临床1期

2024-09-10

·Pharmaceutical Technology

T-cell targeting Candid Therapeutics launches with $370m

Candid plans to develop antibody drugs for inflammatory diseases such as rheumatoid arthritis. Credit: Drazen Zigic via Shutterstock. T cell engager (TCE) startup Candid Therapeutics has debuted with $370m in its pocket to develop antibody drugs for inflammatory diseases. Candid plans to develop T cell engager antibodies to selectively target and deplete specific B lymphocyte populations that play a role in autoimmune diseases. Selective depletion of B lymphocytes has shown clinical effectiveness in patients with conditions such as rheumatoid arthritis and myasthenia gravis. Headquartered in San Diego, California, the company’s Series A funding round was co-led by Venrock Healthcare Capital Partners, Fairmount, TCGX and venBio Partners, with Foresite Capital and Third Rock Ventures also taking part, among others. As part of its debut, Candid inherited two advanced bispecific antibodies to kick off its portfolio. CND106 is a BCMAxCD3 antibody from Vignette, and CD20xCD3 is an antibody from TRC 2004. Both candidates, which have completed Phase I trials with over 130 oncology patients, show potential as therapies for autoimmune diseases, according to Candid. TCE antibodies have the most promise in becoming scalable and patient-friendly drugs that deplete B cells for the treatment of several autoimmune conditions, said Candid’s new CEO Ken Song, whose previous company RayzeBio was acquired by Bristol Myers Squibb in December 2023. See Also: CMN-005 by CoImmune for Extranodal Marginal Zone B-Cell Lymphoma (Mucosa-Associated Lymphoid Tissue or MALT-Lymphoma): Likelihood of Approval CMN-005 by CoImmune for Nodal Marginal Zone B-Cell Lymphoma: Likelihood of Approval Candid joins a number of high-profile companies that are making waves in the space. In January 2024, MSD acquired Harpoon in a $680m deal, which included Harpoon’s T cell engagers. One of the candidates, named HPN328, is being tested in a Phase I/II trial (NCT04471727) for some types of lung cancer and neuroendocrine tumours. HPN328 was developed using Harpoon’s TriTAC platform. In April, Roche shared data from a trial of its bispecific T cell engager Columvi (glofitamab). The drug, which targets CD3 on T cells and CD20 on B cells, improved survival in a Phase III lymphoma trial. The 270 participants received either Columvi or Rituxan (rituximab) on top of a regimen of two chemotherapy drugs, gemcitabine and oxaliplatin. In the announcement accompanying the launch, Song said that Candid’s drugs have the potential to “go above and beyond the clinical and commercial success of Humira and Rituxan.” AbbVie ’s Humira (adalimumab) and Biogen and Genentech’s Rituxan are blockbuster autoimmune drugs that pulled in $14.5bn and $1.8bn last year, respectively, as per the company’s financials.

临床1期免疫疗法临床3期临床结果并购

2024-09-09

·Pharmaceutical Technology

Formosa Pharma ships APP13007 ophthalmic drug to US

Eyenovia has initiated pre-launch activities and is expected to begin the commercialisation of APP13007 by late September 2024. Credit: Formosa Pharmaceuticals Inc. Formosa Pharmaceuticals has announced the first shipment of its ophthalmic asset, clobetasol propionate ophthalmic suspension 0.05% (APP13007),to the US to facilitate commercialisation. The drug, developed using Formosa’s APNT nanotechnology platform, is the first US Food and Drug Administration (FDA)-approved ophthalmic solution featuring the super-potent corticosteroid clobetasol propionate. Bora Pharmaceuticals Ophthalmic has manufactured the shipment of APP13007, which offers a twice-daily dosing regimen that is more convenient than the four doses per day required by other treatments. Eyenovia , Formosa Pharma’s US partner, initiated pre-launch activities and is expected to begin the commercialisation of APP13007 by late September 2024. In 2023, Eyenovia acquired exclusive licensing and commercialisation rights for APP13007 in the US from Formosa Pharmaceuticals in an $86m deal. See Also: CMN-005 by CoImmune for Extranodal Marginal Zone B-Cell Lymphoma (Mucosa-Associated Lymphoid Tissue or MALT-Lymphoma): Likelihood of Approval CMN-005 by CoImmune for Nodal Marginal Zone B-Cell Lymphoma: Likelihood of Approval In August 2024, Formosa obtained a drug export licence from Taiwan’s Food and Drug Administration. The licence has enabled the company to co-ordinate its first shipment to the US, a key step in its strategy for global commercialisation. In anticipation of demand within the US market, Formosa is also collaborating with partners in other regions to prepare for regulatory submissions. The goal is to make APP13007 available in international markets, expanding its reach beyond the US. Formosa Pharmaceuticals focuses primarily on ophthalmology and oncology. Its APNT technology enhances the dissolution, bioavailability and stability of active pharmaceutical ingredients, enabling the use of poorly soluble or highly potent drug agents. Formosa Pharma president and CEO Dr Erick Co said, “This first shipment to Eyenovia for the much-anticipated commercial US launch is an exclamation point on our development of APP13007. “We thank all our partners for making this journey with us and are eager to provide this formidable therapy to ocular surgery patients worldwide. We look forward to creating continued value for our stakeholders and shareholders.”

引进/卖出

100 项与 CIK-CAR CD19 immunotherapy (CoImmune) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
难治性B细胞淋巴瘤	临床2期	意大利	-	2023-12-01
里氏综合症	临床2期	意大利	-	2023-12-01
难治性 B 细胞急性淋巴细胞白血病	临床2期	意大利	Fondazione Matilde Tettamanti e Menotti de March	2017-12-20
T细胞急性淋巴细胞白血病复发	临床2期	意大利	Fondazione Matilde Tettamanti e Menotti de March	2017-12-20
急性淋巴细胞白血病	临床2期	意大利	CoImmune, Inc.	2017-08-29
非霍奇金淋巴瘤	临床前	意大利	Formula Pharmaceuticals, Inc.	2020-11-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03389035 (FT01CARCIK, ASH 12022 \| ASH 22022) 人工标引	临床1/2期	CD19阳性B细胞急性淋巴细胞白血病	27	CARCIK-CD19	築衊醖觸鹹憲蓋鹽餘選(顧構鬱鏇窪鬱築夢艱鹹) = 襯壓鬱鹽膚鬱齋蓋範築廠範齋獵夢糧遞糧願廠 (廠餘廠蓋壓選鑰淵廠顧 ) 更多	积极	2022-11-15