Category Archives: Cell Therapy

DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "The Market For Cell Therapy Manufacturing - Strategies for Pricing, Cost Control, Reimbursement, Distribution, & More" report to their offering.

This global strategic report provides detailed analysis of ten leading cell therapy companies worldwide, evaluating the strengths of each company, as well as identifying cell therapy products in development, manufacturing strategies, and partnerships.

The report analyzes time frames for cell therapy product development, distribution channels, key trends and technologies impacting cell therapy manufacturing, cost control measures, and challenges and considerations affecting with cell therapy manufacturing.

Additionally, the report identifies cell therapy products that have been reviewed and approved by internationally-recognized regulatory agencies, as well as products brought to market in the U.S. with FDA approval. It also specifies which cell therapies have since been pulled from market, due to factors such as low adoption rates, unsuccessful reimbursement strategies, or high cost of manufacturing.

It provides an overview of the regulatory environment affecting cell therapy manufacturing in key countries worldwide, evaluating the importance of the recent FDA guidelines for Human Cell and Tissue-based Products (HCT/Ps) and the 21st Century Cures Act, as well as accelerated pathways for cell therapy approvals in Japan, including the:

- Act on the Safety of Regenerative Medicine (Law No. 85/2013)

- Pharmaceuticals and Medical Device (PMD) Act (Law No. 84/2013)

Key Topics Covered:

1. Introduction to Cell Therapy Manufacturing

2. Leading Cell Therapy Companies

3. Approved Cell Therapy Products

4. Pricing Analysis for Cell Therapy Products

5. Cost-Control for Cell Therapy Products

6. Time Frames for Cell Therapy Product Development

7. Reimbursement of Cell Therapy Products

8. Distribution Channels for Cell Therapy Products

9. Market Trend Analysis - Key Trends Impacting the Marketplace

10. Technologies Impacting the Cell Therapy Manufacturing Market

11. Market Potential for Autologous vs. Allogeneic Manufacturing

12. Cell Therapy Manufacturing Challenges and Considerations

13. Conclusions

Cell Therapies Mentioned:

- Apligraf (Organogenesis, Inc. & Novartis AG)

- Carticel (Genzyme)

- Cartistem (MEDIPOST)

- ChrondoCelect (TiGenix NV)

- Cupistem (Anterogen)

- Dermagraft (Advanced Tissue Sciences)

- Epicel (Vericel)

- Hearticellgram-AMI (FCB Pharmicell)

- Holoclar (Chiesi Farmaceutici)

- Osteocel (NuVasive)

- Prochymal (Mesoblast)

- Provenge

- Strimvelis (GSK)

- TEMCELL (JCR Pharmaceuticals Co. Ltd., Licensee of Mesoblast Ltd.)

For more information about this report visit https://www.researchandmarkets.com/research/rspfrk/the_market_for

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Cell Therapy Manufacturing Market Report 2017 - Strategies for Pricing, Cost Control, Reimbursement, Distribution ... - Business Wire (press release)

Takeda says it is assessing manufacturing options ahead of potential European approval later this year of the Crohns disease stem cell therapy licensed from TiGenix.

Following its acceptance for review by the European Medicines Agency (EMA), Takeda and TiGenix announced this week Swissmedic has accepted for review the file for compound Cx601, an allogeneic expanded adipose-derived stem cell (eASC) therapy for the treatment of complex perianal fistulas in patients with Crohns disease.

The therapy is being made from TiGenix site in Madrid, Spain but CEO Eduardo Bravo told Biopharma-Reporter its partner Takeda which holds the rights for Cx601 in non-US markets following a licensing agreement inked last year will take responsibility for its manufacture from 2021 from a purpose built manufacturing facility in Europe.

Takeda spokesman Luke Willats told this publication: After a transition period for technology transfer during which TiGenix will manufacture Cx601, Takeda will assume responsibility for manufacturing the compound.

But while Willats added the firm is exploring how itcan best meet manufacturing responsibilities for Cx601 following a potential European Commission (EC) approval decision for the compound in 2017, he could not comment further on specific plans or CAPEX investments.

The Japanese pharma firm has its European headquarters in Switzerland, with production sites in Austria, Belgium, Denmark, Estonia, Germany, Ireland, Italy, Norway, Poland and Russia.

Fat chance

Cx601 is produced by TiGenix in plastic flasks in incubators at a one-litre scale, using stem cells taken from healthy volunteers who have undergone liposuction for cosmetic reasons, Bravo told us.

The fat gets sent to our facility in Madrid and is processed to extract the stem cells, which account for about 2% of the material. These are placed in plastic flasks with serum to multiply the number. This is repeated until there is a large population and then the cells are frozen, creating the master cell bank (MCB).

According to Bravo, one liposuction when expanded produces upwards of 360 billion cells, enough to treat 2,400 patients.

While TiGenix is considering using bioreactors for its future pipeline, it will continue making the product as it does now due to not needing to increase volume and the challenges of making production changes in the middle or end of development.

For cell therapies, the process defines the product. Anything you change could change the cells themselves, effectively changing the product.

US deal with Lonza

TiGenix holds the US rights to Cx601 and is discussing with the US Food and Drug Administration (FDA) whether it can file using EMA data, something Bravo said would be decided in the next six-to-eight months.

US trial material will be produced by TiGenixs contract manufacturing organisation (CMO) Lonza , which is undergoing tech transfer at its site in Maryland.

But looking ahead to commercialisation, Bravo said it is not yet decided whether we continue using a CMO or build our own [US] facility.

See the rest here:
Takeda preps for EU Crohn's disease stem cell therapy manufacture - BioPharma-Reporter.com

IANS | Mumbai June 23, 2017 Last Updated at 00:16 IST

Raising hopes of new and less painful treatment for burn injuries, a 26-year-old patient with Grade 2 burn injuries was successfully treated using stem cell therapy at a city-based hospital, doctors said on Thursday.

Anand Tiwari suffered burns after accidentally falling in a boiler unit while at work. He sustained Grade 2 and early Grade 3 burns in all parts of the body below his neck.

When admitted to the city based StemRx Bioscience Solutions hospital, he had severe burning sensation and pain all over the body. Blisters and swellings were noticed in many areas of his chest and limbs.

According to doctors, after initial care and stabilisation of the patient, for treatment of burns, a treatment protocol was prepared by Pradeep Mahajan, a regenerative medicine researcher at Stemrx Bioscience Solutions Hospital.

Explaining the treatment procedure, Mahajan said: "This involved the use of growth factors and fibroblasts and collagen based gel. These biological agents stimulate natural healing mechanisms in the body."

"The advantage of these growth factors is that they can be obtained from the patients' own body and hence are safe and effective. Additionally, unlike conventional treatment options, biological agents promote faster recovery," he said.

Under the stem cell therapy, the treatment process has to be repeated continuously so as to get rid of the problem completely and accordingly the procedure was performed.

"During the entire treatment, the patient was not given any closed dressing. He also underwent blood and supplementary fluid transfusion as required to maintain systemic homeostasis," said Mahajan.

He said that changes in the patient were observed as early as two-three days after the initiation of therapy. Drying of superficial burns began and swelling started reducing.

"Gradually, dry crusts started peeling and by the end of the third week, initial healing of most areas was complete. There was no odour or oozing from any wound and he did not complain of pain or burning sensation anymore.

"After a month-long treatment, healthy skin formation is being observed and further healing is progressing at an impressive rate," said Mahajan, adding that in treatment through conventional modalities, it takes more than eight weeks for healing to happen and further several months for patient to be able to regain joint and facial movements.

--IANS

rup/nir

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

Raising hopes of new and less painful treatment for burn injuries, a 26-year-old patient with Grade 2 burn injuries was successfully treated using stem cell therapy at a city-based hospital, doctors said on Thursday.

Anand Tiwari suffered burns after accidentally falling in a boiler unit while at work. He sustained Grade 2 and early Grade 3 burns in all parts of the body below his neck.

When admitted to the city based StemRx Bioscience Solutions hospital, he had severe burning sensation and pain all over the body. Blisters and swellings were noticed in many areas of his chest and limbs.

According to doctors, after initial care and stabilisation of the patient, for treatment of burns, a treatment protocol was prepared by Pradeep Mahajan, a regenerative medicine researcher at Stemrx Bioscience Solutions Hospital.

Explaining the treatment procedure, Mahajan said: "This involved the use of growth factors and fibroblasts and collagen based gel. These biological agents stimulate natural healing mechanisms in the body."

"The advantage of these growth factors is that they can be obtained from the patients' own body and hence are safe and effective. Additionally, unlike conventional treatment options, biological agents promote faster recovery," he said.

Under the stem cell therapy, the treatment process has to be repeated continuously so as to get rid of the problem completely and accordingly the procedure was performed.

"During the entire treatment, the patient was not given any closed dressing. He also underwent blood and supplementary fluid transfusion as required to maintain systemic homeostasis," said Mahajan.

He said that changes in the patient were observed as early as two-three days after the initiation of therapy. Drying of superficial burns began and swelling started reducing.

"Gradually, dry crusts started peeling and by the end of the third week, initial healing of most areas was complete. There was no odour or oozing from any wound and he did not complain of pain or burning sensation anymore.

"After a month-long treatment, healthy skin formation is being observed and further healing is progressing at an impressive rate," said Mahajan, adding that in treatment through conventional modalities, it takes more than eight weeks for healing to happen and further several months for patient to be able to regain joint and facial movements.

--IANS

rup/nir

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

IANS

http://bsmedia.business-standard.com/_media/bs/wap/images/bs_logo_amp.png 177 22

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Patient with severe burns treated using stem cell therapy | Business ... - Business Standard

Dive Brief:

Even more than traditional drug development, manufacturing is a crucial step in the development of complex therapeutics like cell therapies. As the field evolves, it will likely be a difference maker between success and setback. Such focus on production and logistics can be see in the attention paid to the processes set up by the more advanced CAR-T developers like Kite Pharma, Novartis and Juno Therapeutics.

With this deal, Cell Medica has seized on an opportunity to gain access to an existing GMP facility, taking a short cut to support further development and potential commercialization of the WT1-TCR therapy. More cell therapy products might also be produced at the site in the future, Cell Medica said.

Catapult Therapy TCR was created by CGT Catapult, UCL Business and Imperial Innovations the technology transfer arms of University College London and Imperial College, London in order to develop the WT1-TCR cell therapy.

By acquiring Catapult Therapy TCR, Cell Medica can also integrate WT1-TCR cell therapy into its Dominant TCR platform technology. This has potential to improve efficacy, Cell Medica believes, and to expand use of the therapeutic from its existing focus on blood cancers to hard-to-treat solid tumors such as mesothelioma and ovarian cancer.

Cell Medica recently upped its financial firepower,closinga 60 million ($75.9 million) Series C investor round in March 2017 to further develop its cell-based cancer immunotherapies.

More here:
Cell Medica boosts manufacturing capacity in cell therapy deal - BioPharma Dive

Sweden aims to establish a new Center for Advanced Medical Products (CAMP) as part of a SEK 320-million ($36.6-million), 8-year Swedish government initiative to position the country as a leading biologics developer.

Swedish regenerative medicine firm Xintela has been appointed a partner in the 6-year project to establish the CAMP cell and gene therapy research center, with SEK 48 million ($5.5 million) in funding from the countrys innovation agency and research council, Vinnova and Vetenskapsrdet. Xintel said that as one of the CAMP initiative founders, it will work with Swedens universities, research institutes, and with firms including AstraZeneca, GE Healthcare and Pfizer. Xintela will initially act as an advisor for development of the center, but in the longer term expects to benefit from emerging R&D.

It is gratifying that the Swedish government, Vinnova and Vetenskapsrdet acknowledge the huge potential of cell and gene therapy and the strong position that Sweden has in this research field,commented Xintela CEO Evy Lundgren-kerlund. Xintela is one of the companies in Sweden with large development potential in cell therapy, which makes us a natural partner for this project.

In the short term CAMP aims to establish itself as an internationally recognised center for R&D, innovation and clinical practice, and to promote industrial growth and SMEs. Longer-term goals include attracting investment from the global pharmaceutical and biotech sectors.

Xintela is exploiting its XINMARK protein marker technology and XACT (Xintela assay for cell therapy) assay platform to develop an allogeneic mesenchymal stem cell-based therapy for repairing cartilage damage in osteoarthritis, and to progress a tumor-targeting antibody treatment for glioblastoma.

Last month the firm established a collaboration with Germany-based CO.DON, which develops autologous cell therapies for cartilage repair. The firms will work together on the development of Xintelas markers both for a next generation CO.DN cell therapy program and for Xintelas cartilage repair cell therapy product.

Read more from the original source:
Sweden Launches Initiative to Establish Center for Cell and Gene Therapy Research - Genetic Engineering & Biotechnology News

While Flagship Pioneering was unwrapping a huge $120 million round for Rubius this morning, the busy venture group also launched a biotech on a mission to create a new type of encapsulated cell therapy.

Turning to two scientific founders MITs Daniel Anderson and the prolific Robert Langer the discovery group at Flagship has been working on permeable biomaterials that are designed to implant cells in tissue to deliver proteins in a sustained fashion, without triggering fibrosis.

Paul Wotton, CEO, Sigilon

Researchers have been refining this tech in Flagships VentureLabs for the past two years, and now they are pursuing it at Sigilon Therapeutics with a $23.5 million A round.

Imagine the potential of a living therapeutic that could be implanted in the body and manufacture and release therapeutic proteins at steady levels for long periods of time, avoiding the critical limitations of intermittent infusion required with current therapies, said CEO Paul Wotton.

Flagship has pulled together another veteran team for this new player.

Wotton ran Ocata until it was bought out by Astellas. This rest of the team includes chief technology officer David Peritt, a Pfizer vet, and chief strategyofficer and head of operations Devyn Smith, who was previously head of operations and strategy for the medicinal sciences division of worldwide R&D at Pfizer. James Watson, chief business officer of Sigilon Therapeutics, previously served as CBO at Alvine Pharmaceuticals.

News reports for those who discover, develop, and market drugs. Join 16,000+ biopharma pros who read Endpoints News articles by email every day. Free subscription.

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Langer-backed Sigilon sets sail with $23M and new 'living' cell ... - Endpoints News

ImmunoCellular Therapeutics Ltd has halted a Phase III trial of its brain cancer cell therapy ICT-107 due to a lack of funds and is looking for a buyer or partner for the programme.

The Los Angeles, US-based biotech announced the move on June 21, explaining it is unable at this time to secure sufficient additional financial resources to complete the phase III registration trial of ICT-107.

ImmunoCellular said it is looking for a partner or buyer for the programme adding that the suspension of the phase III registration trial of ICT-107 is expected to reduce the amount of cash used in the Companys operations.

ICT-107 is a dendritic cell (DC) vaccine designed to activate a patients immune system to target six different antigens associated with glioblastoma multiforme, a form of brain cancer.

ThePhase III trial is being conducted at sites in the US, Austria and Canada.

The halt comes weeks after ImmunoCellular Therapeutics signalled its intention to raise funds to allow it to continue the study.

R&D costs

According to a first quarter filing ,ImmunoCellular Therapeutics has cash reserves of $5.3m (4.68m), which is just under half of what it had in reserve this time last year.

The document also revealed the firm spent $5.4m in the quarter, the majority of which was used for R&D.

Supplies of ICT-107 for the trial were produced by Netherlands-based contractor PharmaCell, under an agreement announced in 2015 , andCaladrius subsidiary PCT under an deal signed the same year.

Financial details of the contracts have not been disclosed, althoughImmunoCellular Therapeutics does state in its Q1 filing that it is paying PharmaCell for "manufacturing services."

Similarly, while ImmunoCellular Therapeutics does not provide specifics about itsdeal withPCT, it does is say the contractoris providing manufacturing services for the Phase III ICT-107 trial and for a Phase 1 study of ICT-121, a second cell therapy candidate.

ImmunoCellular Therapeutics is alsopaying PCT monthly fees for the use of a controlled environment room and personnel performing the services.

PharmaCell was acquired by Swiss life sciences supplier Lonza last week .

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ImmunoCellular Therapeutics halts brain cancer cell therapy trial due to lack of cash - BioPharma-Reporter.com

A new study at Tel Aviv University shows that stem cell therapy, one of the few treatments available to patients with severe and end-stage heart failure, can actually harm them unless it is done differently.

We concluded that stem cells used in cardiac therapy should be drawn from healthy donors or be better genetically engineered for the patient, said lead researcher Jonathan Leor of the universitys Sackler Faculty of Medicine and Sheba Medical Center.

Doctors use tissue or adult stem cells to replace damaged tissue, which encourages regeneration of blood vessel cells and new heart muscle tissue. But cardiac stem cells from a diseased heart can lead to a toxic interaction via a molecular pathway between the heart and the immune system, the study found.

We found that, contrary to popular belief, tissue stem cells derived from sick hearts do not contribute to heart healing after injury, Leor said. Furthermore, we found that these cells are affected by the inflammatory environment and develop inflammatory properties. The affected stem cells may even exacerbate damage to the already diseased heart muscle.

[Read the fully study here (behind paywall)]

The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion, and analysis. Read full, original post:Study says some stem cells dangerous for heart patients

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Stem cell therapy relying on patient's own unhealthy heart may be dangerous - Genetic Literacy Project

SAN FRANCISCO, Calif. Mayo Clinic Ventures has partnered with a California-based company to make cancer-fighting gene therapies available to the public.

Vineti, a pioneering cell and gene therapy software and analytics company, announced Tuesday that it had completed its initial round of funding raising $13.75 million aimed at delivering "the first cloud-based software solution to improve patient access, accelerate life-saving treatment delivery, and promote safety and regulatory compliance for individualized cell therapies."

The funding was provided by Mayo Clinic Ventures, GE Ventures, DFJ and LifeForce Capital. It's just the 15th company that Mayo Clinic Ventures has backed since it was formed, according to Andy Danielson, vice chairman of Mayo Clinic Ventures.

"One thing with Vineti that we liked is that we have a commitment to cell and gene therapies at Mayo," Danielson told TechCrunch.com. "Vineti will make the gene and cell therapy production process more efficient and as a result, less costly. It's all part of the equation of making these therapies more affordable and opening them up to a greater number of people."

The targeted cancer therapy under development by Vineti is part of a thriving field that conducted more than 800 clinical trials in 2016 while investing nearly $6 billion. It's all aimed at positively impacting the oncology field, the largest market in medicine that's expected to grow to $165 billion by 2021.

The first two cell therapies are expected to hit the market later this year.

Vineti touts its plans as one that "integrates logistics, manufacturing and clinical data to improve product performance overall and enable faster, broader access for patients."

"Physicians, medical researchers and pharmaceutical companies are working together to develop successful therapies, transitioning from a one-size-fits-all model to individualized treatments for each patient," said Amy DuRoss, CEO at Vineti. "Now, the process for creating and delivering these treatments can be as innovative as the therapies themselves. We are developing the Vineti platform to help these treatments reach the patients who need them the most, and are confident the partnership between our advances technologies and leading medical research will deliver better outcomes across the globe."

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Mayo Clinic Ventures funds new cancer-fighting cell, gene therapy - Post-Bulletin

Cell Medica just acquired Catapult Therapy TCR, set up by UKs CGT Catapult, gaining the rights to its TCR therapy candidate to treat solid tumors.

Cell Medica says its all set to leverage itsDominant T cell receptor (TCR) platform technology, which the company licensed from University College London (UCL) last year, toenhance existing T cell therapies for the treatment of solid tumors. The company justacquiredCatapult Therapy TCR, a subsidiary of Cell and Gene Therapy (CGT) Catapult for its WT1-TCR therapy. Now, Cell Medica plans to showcase its technology by upgrading the new TCR candidate to treat solid tumors such asmesothelioma and ovarian cancer.

The WT1-TCR therapy resulted from earlier research at UCL and the Imperial College London and was spun out into a companyby CGT Catapult, UCL Business, and Imperial Innovations. The technology hinges on engineering the patients own T cells to target the WT1-antigen, which is expressed in a number of cancers.

While CGT catapult has already advanced the immuno-oncology candidate through Phase I/II to treat blood cancers, Cell Medica plans to retool the candidate using its Dominant TCR technologyand expects to start clinical trials with the upgraded WT1-TCR version in late 2018 to treat solid tumors.

Our objective is to show how we can enhance any existing TCR cell therapy with the Dominant TCR technology to create a more effective treatment for patients with solid tumors who otherwise have a very poor prognosis, commentedGregg Sando, CEO of Cell Medica, in a press release.

No financial details of the new deal were disclosed, but CGT Catapult will remain involved. Cell Medica is also setting up its cell therapy manufacturingat CGT Catapults GMP manufacturing facility in Stevenage, UK, where the two will work to develop a commercial scale production process

Apart from its recent deal with UCL, Cell Medica has also bolstered its pipeline with the acquisition of Delenex last year, to advance the biotechs assets in the CAR-T field. The company has also partnered up with the infamous Baylor College of Medicine, toexplore the use of allogeneic, off-the-shelf,Natural Killer T (NKT) cells.

Establishing a solid technology base could improve Cell Medicas chances within the over-crowded and unpredictable immuno-oncology space, where it will have to compete against biotech success stories like Adaptimmune or Cellectis.

Images via shutterstock.com /xrenderandcellmedica.com

Originally posted here:
British Biotech Tops up its Cancer Pipeline with New TCR Therapy - Labiotech.eu (blog)