Rexin-G is a tumor-targeted gene medicine that is designed to seek out and destroy both primary tumors and metastatic cancers without the side effects of standard chemotherapy. The objectives of the study are: (1) to evaluate the clinical effectiveness of intravenous injections of Rexin-G, a tumor-targeted gene vector, in controlling tumor growth and prolonging life, and (2) to evaluate its over-all safety.

开始日期2007-12-01

申办/合作机构-

NCT00504998

/ Completed临床1/2期

Phase I/II Evaluation of Safety and Efficacy of Rexin-G for Recurrent or Metastatic Pancreatic Cancer

The goal of the adaptive trial design is to determine the over-all safety of escalating doses of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the significant clinical benefits required to support a Phase II registration protocol.

开始日期2007-07-01

申办/合作机构-

NCT00505271

/ Completed临床1/2期

Phase I/II Evaluation of Safety and Efficacy of Pathotropic Nanoparticles Bearing a Dominant Negative Cyclin G1 Construct (Rexin-G) as Intervention for Recurrent or Metastatic Breast Cancer

The goal of the adaptive trial design is to confirm the over-all safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the significant clinical benefits required to support a Phase II registration protocol for recurrent or metastatic breast cancer.

开始日期2007-07-01

申办/合作机构-

100 项与 Rexin-G 相关的临床结果

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100 项与 Rexin-G 相关的转化医学

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100 项与 Rexin-G 相关的专利（医药）

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项与 Rexin-G 相关的文献（医药）

2024-07-01·Cytotherapy

CAR-T cell expansion platforms yield distinct T cell differentiation states

Article

作者: Taylor, Naomi ; Highfill, Steven L. ; Underwood, Sarah ; Cheuk, Adam T ; Fellowes, Vicki ; Khan, Javed ; Song, Hannah W ; Somerville, Robert P ; Shao, Lipei ; Prochazkova, Michaela ; Shi, Rongye ; Jin, Ping ; Song, Hannah W. ; Stroncek, David F ; Pouzolles, Marie ; Cheuk, Adam T. ; Highfill, Steven L ; Somerville, Robert P. ; Stroncek, David F. ; Traynor, Roshini ; Chou, Hsien-Chao ; Black, Mary

With investigators looking to expand engineered T cell therapies such as CAR-T to new tumor targets and patient populations, a variety of cell manufacturing platforms have been developed to scale manufacturing capacity using closed and/or automated systems. Such platforms are particularly useful for solid tumor targets, which typically require higher CAR-T cell doses. Although T cell phenotype and function are key attributes that often correlate with therapeutic efficacy, how manufacturing platforms influence the final CAR-T cell product is currently unknown. We compared 4 commonly used T cell manufacturing platforms (CliniMACS Prodigy, Xuri W25 rocking platform, G-Rex gas-permeable bioreactor, static bag culture) using identical media, stimulation, culture length, and donor starting material. Selected CD4⁺CD8⁺ cells were transduced with lentiviral vector incorporating a CAR targeting FGFR4, a promising target for pediatric sarcoma. We observed significant differences in overall expansion over the 14-day culture; bag cultures had the highest capacity for expansion while the Prodigy had the lowest (481-fold versus 84-fold, respectively). Strikingly, we also observed considerable differences in the phenotype of the final product, with the Prodigy significantly enriched for CCR7⁺CD45RA⁺ naïve/stem central memory (T_n/scm)-like cells at 46% compared to bag and G-Rex with 16% and 13%, respectively. Gene expression analysis also showed that Prodigy CAR-Ts are more naïve, less cytotoxic and less exhausted than bag, G-Rex, and Xuri CAR-Ts, and pointed to differences in cell metabolism that were confirmed via metabolic assays. We hypothesized that dissolved oxygen level, which decreased substantially during the final 3 days of the Prodigy culture, may contribute to the observed differences in T cell phenotype. By culturing bag and G-Rex cultures in 1% O₂ from day 5 onward, we could generate >60% T_n/scm-like cells, with longer time in hypoxia correlating with a higher percentage of T_n/scm-like cells. Intriguingly, our results suggest that oxygenation is responsible, at least in part, for observed differences in T cell phenotype among bioreactors and suggest hypoxic culture as a potential strategy prevent T cell differentiation during expansion. Ultimately, our study demonstrates that selection of bioreactor system may have profound effects not only on the capacity for expansion, but also on the differentiation state of the resulting CAR-T cells.

2024-07-01·Anticancer Research

Proceedings of the Think Tank for Osteosarcoma Medical Advisory Board

Review

作者: Jones, Robin ; Subbiah, Vivek ; Schwab, Joseph ; Chawla, Neal S ; Spencer, H Trent ; Federman, Noah ; Gordon, Erlinda M ; Swaney, William ; VAN Tine, Brian ; Feldman, Nancy ; Afshar, Nima ; Hoos, Willy ; Chawla, Sant P

A "Think Tank for Osteosarcoma" medical advisory board meeting was held in Santa Monica, CA, USA on February 2-3, 2024. The goal was to develop a strategic approach to prevent recurrence of osteosarcoma. Osteosarcoma metabolism and the genomic instability of osteosarcoma, immunotherapy for osteosarcoma, CAR-T cell therapy, DeltaRex-G tumor-targeted gene therapy, repurposed drugs, alternative medicines, and personalized medicine were discussed. Only DeltaRex-G was voted on. The conclusions were the following: No intervention has been demonstrated to improve survival in a clinical trial. Additionally, the consensus (10/12 in favor) was that DeltaRex-G without immunotherapy may be administered for up to one year. Phase 2/3 randomized studies of DeltaRex-G should be performed to determine whether the incidence of recurrence could be reduced in high-risk individuals. Furthermore, a personalized approach using drugs with minimal toxicity could be attempted with the acknowledgement that there are no efficacy data to base this on. Repurposed drugs and alternative therapies should be tested in mouse models of osteosarcoma. Moreover, unmodified IL-2 primed Gamma Delta (NK) cell therapy may be used to prevent recurrence. Lastly, rapid development of CAR-T cell therapy is recommended, and an institute dedicated to the study of osteosarcoma is needed.

2023-06-01·Anticancer Research

Early-stageCCNG1+ HR+ HER2+ Invasive Breast Carcinoma in Older Women: Current Treatment and Future Perspectives for DeltaRex-G, aCCNG1Inhibitor

Review

作者: Iyengar, Geeta ; Foshag, Leland ; Hall, Frederick L ; Thomas, Sonu ; Brigham, Don A ; Gordon, Erlinda M ; Omelchenko, Nadezhda ; Olevsky, Olga ; Suryamohan, Kushal ; Chawla, Sant P

Women with HR+HER2+ early-stage breast cancer are disadvantaged by the lack of clinical trials focused on women ≥70 years of age. In the past years, there has been increasing controversy on the use of toxic chemotherapy as standard of care treatment for early- stage HR+ HER2+ breast carcinoma in older women. With precision medicine coming of age, molecular profiling of tumors and circulating tumor DNA has identified target oncogenes that could be used in designing an optimal treatment for this group of women. This article reviews the current treatment of early-stage triple receptor positive breast cancer, the risks of chemotherapy in older women, and CCNG1, a novel biomarker in development for the use of DeltaRex-G, a CCNG1 inhibitor. Further, future perspectives for DeltaRex-G in older women with early stage CCNG1+ HR+ HER2+ breast cancer are discussed.

项与 Rexin-G 相关的新闻（医药）

2024-09-17

·PRNewswire

Verismo Therapeutics Awarded a ScaleReady™ G-Rex® Grant

PHILADELPHIA, Sept. 17, 2024 /PRNewswire/ -- Verismo Therapeutics, a clinical-stage CAR T company developing the novel KIR-CAR platform technology, today announced that it has been awarded a $150,000 G-Rex Grant by ScaleReady™. This grant will support Verismo Therapeutics' ongoing efforts to optimize the development and manufacturing of its KIR-CAR platform using the G-Rex. The G-Rex Grant is part of ScaleReady's $20 million grant program aimed at advancing Cell and Gene Therapy (CGT) development and manufacturing. The G-Rex Grant Program offers recipients significant support allowing for expeditious optimization of cell manufacturing processes. "We are grateful to have been chosen for the G-Rex Grant at Verismo Therapeutics," stated Raymond Luke, Director of Manufacturing Science and Technology at Verismo Therapeutics. "This funding will help us further optimize our cell therapy manufacturing processes by transitioning our active and future pipeline to G-Rex®, ensuring we can deliver life-saving treatments to patients more efficiently and cost-effectively. We are excited to work with ScaleReady to drive forward innovative solutions in cell therapy production." "We are excited to support Verismo Therapeutics through the G-Rex Grant program. Their commitment to advancing cell and gene therapy aligns perfectly with our mission to provide hope to cancer patients one G-Rex at a time. We look forward to seeing the impactful advancements Verismo Therapeutics will achieve with this grant." said John Wilson, CEO of Wilson Wolf Manufacturing and co-inventor of G-Rex. As part of the G-Rex® Grant, Verismo will complete optimization of their G-Rex-based KIR-CAR T process and plans to implement this as a platform manufacturing process. Additionally, Verismo will evaluate a suite of critical reagents from Bio-Techne (R&D Systems) including GMP cytokines. Specifically, Verismo will get early access to a line of new, closed system reagents from Bio-Techne, called ProPakTM GMP cytokines, that are tailor-made for use with G-Rex. The ProPakTM line of GMP reagents are estimated to be commercially available by the end of 2024. Verismo Therapeutics is committed to pioneering new therapies and technologies that improve patient outcomes. The G-Rex Grant will play a pivotal role in advancing the company's research and development efforts, ultimately contributing to the broader goal of making innovative treatments accessible to those in need. About the KIR-CAR Platform The KIR-CAR platform is a multi-chain CAR T cell therapy and has been shown in preclinical animal models to be capable of maintaining antitumor T cell activity even in challenging tumor microenvironments. Using NK cell derived KIR and DAP12 split signaling provides a novel combined activation and co-stimulation separate from the usual T cell stimulation pathways. It also enables sustained chimeric receptor expression and improves KIR-CAR T cell long term function. This results in prolonged T cell functional persistence and leads to regression of solid tumors in preclinical models that are resistant to traditional CAR T cell therapies. About Verismo Therapeutics Verismo Therapeutics is a pioneer in multi-chain KIR-CAR technology, with its first assets SynKIR™-110 and SynKIR™-310 currently in Phase 1 clinical trials. Verismo is the only company developing the KIR-CAR platform, using a modified NK cell derived receptor and DAP12 pairing, designed to improve persistence and efficacy against aggressive tumors. The KIR-CAR platform technology was developed specifically to address areas of high unmet medical need, including advanced solid tumors and B cell associated disorders and malignancies. For more information, visit: About ScaleReady™ ScaleReady provides the field of cell and gene-modified cell therapy (CGT) with a G-Rex centric manufacturing platform that enables the world's most practical, flexible, scalable, and affordable CGT drug product development and manufacturing. The G-Rex manufacturing platform is currently used by a rapidly growing list of over 800 organizations and is producing drug products for approximately 50% of CGT clinical trials as well as 4 commercially approved CGT drugs. CGT entities relying on the breadth and scope of ScaleReady's expertise can expect to save years of time and millions of dollars on the path to CGT commercialization. For more information about the ScaleReady G-Rex® Grant Program, please contact [email protected]. About Wilson Wolf Manufacturing Corporation Wilson Wolf () is dedicated to simplifying cell and gene-modified cell (CGT) therapy research, process development, and manufacturing. This is being accomplished through its scalable G-Rex® technology, which is used throughout the world in CGT applications ranging from basic research to commercial drug production. Wilson Wolf's mission is to create hope for cancer patients, one G-Rex® device at a time. About Bio-Techne Corporation Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne, in partnership with Wilson Wolf, is creating products such as media and cytokines that are specifically tailored to G-Rex® Bioreactors, including right-sized reagent quantities in containers that are tailored to high throughput closed-system manufacturing. For more information on Bio-Techne and its brands, please visit or follow the Company on social media at: Facebook, LinkedIn, Twitter or YouTube. Contact: David Clair, Vice President, Investor Relations & Corporate Development [email protected] 612-656-4416 SOURCE Verismo Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

细胞疗法临床1期

2023-12-12

·Business Wire

Sarcoma Oncology Center Leverages BostonGene’s AI-Driven Molecular and Immune Profiling Platform to Identify Novel Treatment Options for Patients with Advanced Cancers

WALTHAM, Mass.--( BUSINESS WIRE )-- BostonGene , a leading AI-based molecular and immune profiling solutions provider, and the Sarcoma Oncology Center , announced a collaboration to expedite the availability of DeltaRex-G. This groundbreaking platform therapy, authorized by the FDA's Center for Biologics Evaluation and Research (CBER), holds immense promise for patients battling advanced pancreatic cancer, osteosarcoma, soft tissue sarcoma, and breast cancer. The designation of DeltaRex-G, a CCNG1 inhibitor, as a platform therapy with the potential to incorporate other FDA-approved drugs, was enabled by BostonGene's pivotal identification of elevated CCNG1 levels in these different cancer types. Sarcoma Oncology Center, located in Santa Monica, California, is a cancer treatment and clinical research center, recognized for its clinical trials and clinical expertise in treating patients with sarcoma. Sarcomas, rare tumors that originate in bone and connective tissue, pose a unique treatment challenge since most sarcoma subtypes have no approved standard of care treatment and are typically chemotherapy-refractory. The best treatment approach for patients with advanced sarcomas consists of understanding their unique tumor molecular profile, and selection of a therapy that is “matched” to the molecular alterations. Sarcoma Oncology Center partnered with BostonGene for its innovative computational platform, which leverages AI-based molecular and immune profiling. The BostonGene Tumor Portrait™ test uncovers intricate correlations between different “omic” profiles including genomic alterations on tumor cells, profiling of a tumor’s immune landscape, and the potential to use these findings to understand which patients are most likely to benefit from treatment . The authorization of investigational agent DeltaRex-G, a CCNG1 inhibitor, as a platform therapy open to incorporating other FDA-approved drugs and immunotherapies stems from BostonGene's pivotal identification of heightened CCNG1 levels across all tumors tested, including osteosarcoma, soft tissue sarcoma, pancreas, breast, urothelial and testicular carcinoma . " Our partnership with BostonGene provides us with an AI-driven, molecular perspective of the dynamic tumor microenvironment and immune landscape, thereby expanding the treatment horizons for our patients," said Erlinda Gordon, MD. " This collaboration has broadened our cancer treatment options, as BostonGene is the only molecular profiling company reporting on the CCNG1 expression in tumors," said Sant P. Chawla, MD, Director at Sarcoma Oncology Center. “ We are pleased to be working with the Sarcoma Oncology Center to support their efforts in personalizing treatments for their patients. Our advanced sequencing and analytical capabilities will be indispensable in guiding treatment decisions for these cancer patients who would otherwise have very limited options," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. About BostonGene Corporation BostonGene has a mission to provide transformative, AI-integrated molecular analytics and biomarker discovery for precision matching of therapies to improve the lives of patients living with cancer and other immune-related diseases. BostonGene’s concierge-service model provides customized client solutions using a multi-omic approach prioritized for real-world impact to optimize standard-of-care therapies, accelerate research and provide cost-effective, measurable data-driven results. BostonGene’s tests reveal key drivers of each patient’s unique disease profile, including an in-depth profile of the immune microenvironment, actionable mutations, biomarkers of response to diverse therapies, and recommended therapies. Through these comprehensive analyses, BostonGene’s tests generate a personalized roadmap for therapeutic decision-making for each patient. For more information, visit BostonGene at http://www.BostonGene.com .

免疫疗法

100 项与 Rexin-G 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
实体瘤	菲律宾	GenVivo, Inc.	2009-06-10
乳腺癌	菲律宾	GenVivo, Inc.	2007-01-01
结直肠癌	菲律宾	GenVivo, Inc.	2007-01-01
骨肉瘤	菲律宾	GenVivo, Inc.	2007-01-01
胰腺癌	菲律宾	GenVivo, Inc.	2007-01-01
肉瘤	菲律宾	GenVivo, Inc.	2007-01-01

未上市

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适应症	最高研发状态	国家/地区	公司	日期
转移性骨肉瘤	临床2期	美国	-	2007-12-01
转移性乳腺癌	临床2期	美国	-	2007-07-01
转移性胰腺癌	临床2期	美国	-	2007-07-01

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临床结果

适应症

分期

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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


ASGCT2021	临床1/2期	早期乳腺癌一线 ER+ \| PR+ \| HER2 amplified	1	DeltaRex-G	窪醖鏇簾壓鏇醖願廠觸(願簾窪觸選艱壓齋夢淵) = 窪獵醖夢顧構觸願範觸鹽簾顧廠齋遞夢選網築 (糧獵繭壓齋齋遞遞醖壓 ) 更多	积极	2021-04-27
ASGCT2019	临床1/2期	转移性乳腺癌	20	Rexin-G i.v. 8x10e11 cfu	(範觸蓋獵鏇餘鑰積選窪) = Grade 1-2 treatment-related adverse events included chills (n=1), pruritus (n=2), dry skin (n=1), hot flush (n=1), dysgeusia (n=3) 淵鏇範鹹積構觸襯糧簾 (蓋網廠壓積齋憲簾鬱選 ) 更多	积极	2019-04-22
ASGCT2019	临床1/2期	转移性乳腺癌	20	Rexin-G i.v. 48x10e11 cfu		积极	2019-04-22
WCLC2018	N/A	晚期非小细胞肺癌三线	11	Low dose Apatinib + original targeted drugs	(壓窪衊選製觸範鹽顧觸) = 20% (2/10) 製糧簾鬱鑰選選築鏇獵 (膚壓淵夢蓋鑰壓壓積鏇 ) 更多	-	2018-09-26
ASCO2009	N/A	难治性骨肉瘤	42	Rexin-G	膚鹽鹹積膚繭窪鑰鏇顧(衊簾衊選積糧顧壓積襯) = 1 選襯構餘鏇簾憲鬱膚鬱 (願範鑰膚鹽醖範窪觸襯 ) 更多	-	2009-05-20
ASCO2008	临床1期	可见病灶	-	Rexin-G	醖艱醖淵夢積衊衊淵鏇(製襯壓構醖蓋鬱築構獵) = detected, by immunohistochemical staining, in tumors indicating successful targeted delivery in vivo of the GM-CSF gene 鑰製餘網廠憲觸構糧範 (鑰鹽糧顧遞遞艱觸艱醖 )	-	2008-05-20