CAR cell therapy trials in China

by Alexey Bersenev on February 13, 2017 · 0 comments

in Uncategorized

Many of you know that China is very active in CAR cell therapy field. However, it is not easy to track this activity. I made an attempt to analyze CAR cell trials data from China, using All CAR-T Trials dataset from Cell Trials Data. Here are some of my findings.

Until 2010, all CAR cell therapy trials were conducted only in US. The first CAR cell trial in China was listed in database in 2012. Since that time, China made a huge leap in total number of trials.

The figure below demonstrates a relative percentage of Chinese CAR cell trials among US and others countries (click on figure to enlarge):

CAR_China1

As you can see, the share of China, among all other countries with CAR cell therapy trials, has progressively increased from 9% (1 trial) in 2012 to 41% in 2015 and to 72% in 2016.

Since 2004, 48% of all CAR cell therapy active trials worldwide are listed in China. Total number of CAR cell therapy trials in China until Dec. 31 of 2016 was 113. 26% of all Chinese trials (29/113) were listed in ChiCTR database, the rest – in NCT database. It means that if you’re mining only NCT database you’re roughly missing 1/3 of Chinese CAR cell trials.

38 academic institutions and hospitals were identified as sponsors of CAR cell therapy trials in China. About half of Chinese trials, registered in 2016 were commercial (company listed as sponsor or collaborator). 17 companies were identified. Here is a list:

  1. Beijing Biohealthcare Biotechnology Co.,Ltd
  2. Marino Biotechnology
  3. Hebei Senlang Biotechnology Inc., Ltd.
  4. Sinobioway Cell Therapy Co., Ltd.
  5. PersonGen BioTherapeutics (Suzhou) Co., Ltd.
  6. Carsgen Therapeutics, Ltd.
  7. Wuhan Bio –Raid Biotechnology Co
  8. Keji Biomedical (Shanghai) Co., Ltd
  9. Union Stem cell & gene engineering Co.
  10. Wuhan Sian Medical Technology
  11. Cellular Biomedicine Group
  12. Shanghai GeneChem Co.
  13. The Beijing Pregene Science and Technology Company, Ltd.
  14. Beijing Sanwater Biological Technology Co., Ltd.
  15. iCarTAB BioMed Inc.
  16. Innovative Cellular Therapeutics Co., Ltd.
  17. Beijing Doing Biomedical Co.

Companies like Shanghai GeneChem and PersonGen BioTherapeutics have 8 (each) active trials listed. Thee companies (Marino Biotechnology, Sinobioway Cell Therapy and Wuhan Bio –Raid Biotechnology) have 5 listed trials each.

Also I’d like to mention here some other Chinese CAR cell therapeutic companies, which were not identified in databases:

  • SiDanSai Biotechnology Co., Ltd
  • Super-T Cell Cancer Company
  • Sino-Biocan
  • Fosun Pharmaceutical (JV with Kite Pharma)
  • 3SBio (Shenyang Sunshine Pharmaceutical Co.) (JV with Sorrento)
  • JW Biotechnology (Shanghai) Co., Ltd (Juno’s Therapeutics daughter company).

Overall, I’d like to conclude that China is currently dominating any other country in CAR cell therapy field in terms of total number of active trials and supporting hospitals. China also has all “latests” CAR cell technologies in trials, such as humanized scFv, 4th generation constructs, bispecific CARs, 2x CARs (CD19+CD20 or CD19+CD22 or CD19+CD30) in one treatment and so on. You can find information about many CAR cell therapy deals in China, building of manufacturing facilities and results of the trials. So, China is hot! Must follow!

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Number of CAR cell therapy trials worldwide

by Alexey Bersenev on February 10, 2017 · 1 comment

in Uncategorized

CAR (Chimeric Antigen Receptor)-based cell clinical trials is one of the hottest areas in cell therapy right now. Today, I’d like to share with you a trend for total number of CAR cell trials, registered worldwide. Importantly, I made figures available for free download on FigShare. You can get it in high resolution and use it for your presentations!

Methodology:
10 International public databases (including NCT, EudraCT, UMIN, ChiTCR, ANZCTR…) were screened to identify CAR clinical trials, registered in any period of time until December 31 of 2016. At least 10 combinations of key words were used in search queries (including “cell”, “CAR cell”, “chimeric antigen”, “T cell”, “T cell gene modified”…). Only CAR genetic modification of cells was included. At least 23 parameters were captured manually, if information was available. Validity of captured data was verified by second researcher (CellTrials.org). Overlaps between databases were excluded from analysis. Statistical information was analyzed in MS Exel.

Results:
252 unique trials were identified from 2004 to the end of 2016. 11 overlaps between registries were found. The first CAR trial was registered in 2004. 245/252 (97%) of CAR cell trials involved T-cells. In 2016 alone was registered 116 CAR cell trials. About 75% of all registered trials are currently listed as active. 2 listings from 2015 and 5 listings from 2016 were identified as “follow-up studies”, but not actual trials. However, for completeness of the CAR cell data, these listings were also included in CellTrials.org dataset and statistical analysis below.

Figures:
1. A trend for total number of trials, registered year-to-year (not cumulative data), starting from 2007 (click to enlarge):

CAR_#trials_trend
FigShare link
How to cite: Bersenev, Alexey (2017): Total number of CAR cell therapy trials listed in databases. figshare. https://doi.org/10.6084/m9.figshare.4628557.v2
DOI: 10.6084/m9.figshare.4628557

2. Phases of registered CAR cell trials (click to enlarge):

CAR trials trend 2
FigShare link
How to cite: Bersenev, Alexey (2017): Phases of CAR cell therapy trials registered worldwide. figshare. https://doi.org/10.6084/m9.figshare.4640302.v2
DOI: 10.6084/m9.figshare.4640302

Please feel free to download figures, share, embed and cite!
Access raw CAR cell trials data to make your own graphs!

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Cell therapy trials data

by Alexey Bersenev on January 25, 2017 · 0 comments

in Uncategorized

Dear readers, as you know I have been collecting cell therapy clinical trials data for several years now. I posted some snapshots, based on my own raw data analysis as “annual reports“. However, I have not shared or offered raw data before. I’m happy to tell you that now everyone can get raw data and create your own cell therapy analytics.

CTD_banner1

Recently, I started a partnership with Parent’s Guide to Cord Blood Foundation (PGCBF) in order to make cell therapy trials data available for sale. PGCBF for many years has been involved in data capture, related to perinatal cells/ tissues banking and therapeutic use. Now, we have combined our expertise and efforts in data collection. I was waiting for years when somebody will take time and verify all data, collected by me. Finally, it happened! I’m happy to introduce our new project Cell Trials Data.

When I started this project with PGCBF, we decided to use definition of Advanced Cell Therapy to set inclusion and exclusion criteria for the most comprehensive data capture. To simplify, our definition is very close to cell-based ATMP (as defined by EMA), but read more about it here. In my previous reports I excluded some trials, which could fit definition of ATMP (for example, CD34+ cells gene-modified ex vivo or cord blood cells expanded/ stimulated ex vivo), now we have included them. Also, we expanded our search strategy to include more key words and found more trials that were missed in my earlier reports. Therefore, the total number of trials increased and I’ll update you with fresh pieces of analysis soon.

Now, I’d like to highlight some advantages of our new project, compared with other (published or available online) data compilations and (unpublished) business reports:

  1. We are the only one, who offers the raw data (in a form of Exel spreadsheets). Yes, the data freely available in registries, but you have to spend a lot of time to capture them all accurately and fully. If you ever did a search in clinical trials database, you know how it could be hard to sort through the junk. We’ve done it for you already.
  2. The data is verified by 2 independent experts – me and Pedro Couto (from PGCBF). After studying of all available published data compilations in the field, we think, that our datasets are the most complete, detailed and comprehensive.
  3. Most of the available data compilations based on only search of ClinicalTrials.gov, whereas we search a dozen trial registries that cover the whole world. So, we think, nothing is missed!
  4. The beauty of raw data is a possibility to build upon and make your own analytics. You can slice and dice it in any possible way, generate statistical data, trends, make graphs and present it on conferences! What could be better than that?
  5. Unlike our datasets, you cannot verify accuracy of commercial market reports. You won’t know how credible they are. Every trial in our datasets is linked to original public source, which you can verify.
  6. We are updating our datasets and making new ones constantly. We are also offering custom data packages and we are very open to suggestions and feedback.

Please let me know if you have any questions about Cell Trials Data site.

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Cell Therapy 2016 – Year in Review (part 2)

January 2, 2017

This is the second part of my overview of the most significant events in cell therapy in 2016. CRISPR-modified cells go clinical This year, for the first time, CRISPR gene-edited cells were used in human. Chinese oncologists from Sichuan University used CRISPR editing method to knockout PD-1 gene on autologous T-cells of the patient with […]

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Cell Therapy 2016 – Year in Review (part 1)

December 31, 2016

In the last day of 2016 I’d like to look at back and overview the most interesting events (in my opinion) and trends of the year. I’m going to split this overview for 2 parts without any particular order. Results of pivotal CAR-T cell trials Two major commercial developers of CD19 CAR-T cell therapies – […]

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What does the Cures Act mean for regulation of cell therapy in US

December 18, 2016

New law, called “21st Century Cures Act”, has been signed this week in US. This is huge legislation, which covers new developments and initiatives, aimed to improve healthcare system. Few sections of the Cures Act specifically dedicated to regenerative medicine. These sections were proposed by industry lobby organization Alliance of Regenerative Medicine (ARM) as the […]

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Presentation: CELL THERAPY – Definitions, Classifications and Trends

October 14, 2016

Here is my talk that I gave on August 15 this year during annual BioProcessing Summit in Boston. Cell Therapy – Definitions and Classifications from nanog Link Transcript: 2. Cell therapy is mostly experimental field right now. So, one of the best ways to track activities in this field is to look at number of […]

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Historic FDA public hearing on regulation of cell therapy in US

September 18, 2016

On September 12 and 13 of 2016, FDA conducted public hearing on clarification of regulatory guidances for cell therapy. In my view, it was historic event, because it was the first-of-its-kind public hearing for cell therapy field. The reason for the hearing was unexpectedly high number of controversial comments about 4 guidances that FDA released […]

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Whom should we blame for the absence of approved stem cell products in US?

September 14, 2016

Few months ago I was watching presentations from Bipartisan Policy Center on support of REGROW Act as alternative regulation for cell therapy, proposed to FDA. I was especially intrigued by presentation of Randal Mills – President and CEO of California Institute for Regenerative Medicine (CIRM). Here is a quote that I’d like to discuss today […]

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Why price for cell/ gene therapy products is so high?

September 6, 2016

The topic of pricing cell and gene therapies is very hot right now. The price tags for the most approved cell/gene therapy products are high and there is no one simple solution to address their reimbursement and adoption. The world’s most expensive drug is gene therapy drug Glybera, has captured a lot of attention in […]

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