Category: Cell Therapy

Cell Therapy Pipeline Update: Talaris Therapeutics Announces Initiation of Phase 3 Clinical Trial

Cell Therapy pipeline update, Talaris Therapeutics, a late-clinical stage biotechnology company based in Boston, MA and Louisville, KY, announced the initiation of FREEDOM-1 (NCT03995901), the company’s Phase 3 clinical trial of FCR001 in living donor kidney transplant (LDKT) recipients. What is the objective of the trial: This pivotal trial will evaluate the safety and efficacy of a

CARsgen anti-BCMA CAR T CellTherapy Receives RMAT Designation

On 28 October 2019, CARsgen Therapeutics, a clinical-stage biopharma company, announced that the FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational CT053 CAR-T cell therapy. What is CT-053: CT053 is a fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cell therapy for the treatment of relapsed and/or refractory multiple

Gene Therapy Pipeline Update: AGTC Presents Promising Data of its AAV Vectors for Ocular Gene Therapy

Applied Genetic Technologies Corporation (AGTC), a clinical-stage biotechnology company, developing transformational genetic therapies for patients suffering from rare and debilitating diseases, announced new data from non-clinical studies evaluating the effect of pre-existing anti-AAV antibodies on the transduction and expression efficiency of AAV vectors. Presently, over 250 companies are engaged in the gene therapy pipeline, the gene

BioNtech Reports Preliminary Phase I/II Results of its CAR T Cell Therapy CarVAC and BNT211-01 (NEO-PTC-01) at European Society for Medical Oncology (ESMO) Conference

On 24 October 2023, BioNtech announced the preliminary results of phase I/II trial evaluating BNT.221-01, a combination of Claudin 6 (CLDN6)-targeted CAR T cell therapy and the mRNA-based CAR T booster CarVac at ESMO conference in Madrid. BioNtech reported acceptable safety and tolerability data and first hints to efficacy in solid tumours. The CAR T

Cell Therapy Consumables Industry: Current Scenario and Future Trends

Cell therapy is the therapeutic approach which involves the injection of healthy cells in the human body, in order to replace the diseased / non-functioning cells to regulate certain functions. Driven by the benefits offered by cellular therapies and recent approvals by regulatory authorities, the demand for such therapies has increased considerably. This trend has

Cell and Gene Therapy CROs: The Next Growth Opportunity

Over the years, cell and gene therapy (CGT) and other advanced therapy medicinal products (ATMPs) have managed to capture the interest of both drug developers and healthcare investors. Their popularity can be attributed to various factors, such as minimal side effects, clinical efficacy and their personalized nature. However, there are several complexities associated with the

Cell Therapy – The Revolutionary Therapeutic Modality: All Set To Obliterate Oncological Disorders

The American Society of Gene and Cell Therapy (ASGCT) defines cell therapy as a therapeutic modality that involves the administration of either normal or modified cells to patients for the treatment of various diseases. In this form of therapy, patients are injected with living and intact human cells that are deemed to be capable of

Advancements in Automation of Processes: Key Value Driver for Escalated Interest in Cell Therapies Manufacturing Domain

Considering the vast potential of cell therapies in the treatment of rare disorders and sufficient body of evidence validating the clinical benefits / therapeutic potential of this complex class of biologic drugs, cell therapies have garnered considerable attention of players engaged in the healthcare industry, in the past few years. The focus of stakeholders has

CAR-T Cell Therapy: Addressing Key Unmet Needs in Oncology

Amidst the active initiatives undertaken to develop more targeted anti-cancer therapies, CAR-T therapies have emerged as a promising option, given their ability to eradicate tumor cells from the body with minimal treatment-related side effects. Further, CAR-T cell therapy, relatively recent addition to the gamut of anticancer interventions, has demonstrated significant promise. Overall, this highly specific

Treg Cell Therapy: A Hotspot in the Field of Immunotherapy

Classification of Treg Cell Therapy The Treg cell therapy (Tregs) is a therapeutic modality based on the mature subpopulation of T-cell therapy that plays a critical role in mediating immunological tolerance to self-antigens and suppress immune responses that are harmful to the host, thereby, enabling homeostasis. These mainly develop in thymus from CD4+ thymocytes and

Cell Therapy Packaging Market – Importance and Future Potential

Over the years, the pharmaceutical industry has witnessed several advancements in drug development. It has gradually shifted from a one-drug treats all model to a more personalized approach of treatment, which involves the use of personalized cell and gene therapies for various disease indications. This shift has led to an evident change in the pharmaceutical

Cell Line Development: An Ocean of Opportunities for Stakeholders

The growing pipeline of monoclonal antibodies, vaccines, enzymes, biosimilars and other therapeutic proteins have created an ever- increasing demand for highly- productive and stable cell lines. Many of the recombinant biotherapeutic products, produced in cellular systems, have been translated into commercial successes; these include ALPROLIX®, ELOCTATE® and ELAPRASE®.  Given their impact on the overall quality

Cell and Gene Therapy Manufacturing: COVID-19 Impact

With close to half-million infections and the economy showing signs of the 2008 financial crisis, COVID-19 has impacted several industries. Government institutes and industry players have announced various steps to deal with the ongoing situation. In this article, we will highlight the developments in the cell and gene therapy manufacturing industry amid the ongoing COVID-19

Cell Therapy Manufacturing: Here are the Key Innovations

Last week, during our weekly industry update sessions, our prime focus was to understand the recent innovations in the field of cell therapy manufacturing. We were also looking out for players that are driving these innovations. To start with, the first news that caught our attention was Novartis’ decision to sidestep Europe travel ban to

Cell Therapy and The Rise of Novel Technologies

Roots Analysis has actively tracked the developments in the field of cell therapy and gene therapies. The team has focused on identifying the key challenges that are hampering the growth of these revolutionary therapies. To identify the challenges, the team has interviewed several stakeholders involved in cell therapy development and manufacturing. In addition, a recent

CAR-T Pipeline Update: Celgene posts pivotal data ahead of FDA filing

Celgene has recently published positive data from a pivotal trial (NCT02631044) of its CAR-T therapy. As per the reports, the data look competitive against Gilead’s Yescarta and Novartis’ Kymriah, leading analysts to predict Celgene will win FDA approval next year. This is a big news for the overall CAR-T pipeline. As per the reported data, the

Cell Therapy Manufacturing: A Rising Opportunity for Stakeholders

The Compal Group’s Raypal Biomedical and Kaohsiung Medical University Chung-Ho Memorial Hospital on October 22 signed an MoU to jointly set up a GTP (good tissue practice) cell therapy manufacturing laboratory in Kaohsiung City, southern Taiwan. What are the key capabilities of Raypal in cell therapy manufacturing: Founded in 2016, Raypal specializes in R&D of

Cell Therapy Market Update: MaxCyte Advances Phase I Clinical Trial of Lead mRNA-based Cell Therapy

MaxCyte, the global Cell Therapy, and life sciences company, announced the initiation of dosing in the third cohort of patients of MaxCyte’s Phase I clinical trial (NCT03608618) with the next higher cell dose of MCY-M11. The dose-escalation trial is evaluating the safety and tolerability, as well as preliminary efficacy, of MCY-M11 administered intraperitoneally across a series

Cell Therapy Manufacturing Update: United Therapeutics Receives Permit

As per recent news coverage, United Therapeutics has received a permit for $9.5 million build-out of its cell therapy facility on the second floor of Mayo Clinic’s Discovery and Innovation Building. What is the area of the facility:  The facility will have a total of 21,843-square-foot space. What are the capabilities at the facility:  The facility will house

Cell and Gene Therapy Technology Update: ReNeuron Presents Positive Data

ReNeuron, the UK based, clinical-stage stem cell therapeutics company, announced that new data relating to its CTX stem cell platform will be presented today at the 27th Annual Congress of the European Society of Gene and Cell Therapy (ESGCT). Dr. Steve Pells, Principal Investigator at ReNeuron, will present new data showing the phenotypic stability and scalability

Cell Therapy Manufacturing Update: Merck Becomes the First to Introduce Acoustic Technology

With its acquisition of FloDesign Sonics earlier this month, Merck/MilliporeSigma has become the first company to introduce acoustic technology in cell therapy manufacturing. The acquisition of FloDesign Sonics is a strategic fit for Merck, strengthening its ability alongside to manufacture cell-based therapies for patients. What is Acoustic Cell Processing: Acoustic cell processing is a disruptive technology that allows

Vector Manufacturing: Growing Cell and Gene Therapy Market

Cell and Gene Therapy CROs are the new entrants in the pharma Superstar Club. They are selling tickets faster than a Queen’s concert in the 1980s. In fact, as per the Alliance of Regenerative Medicine’s recent findings, there has been more than 75% year on year increment in funding to support the development of various cell and gene

Natural Killer Cell Therapies: Pipeline Review

Natural killer (NK) Cell Therapies , or killer (K) cells, represent an important subset of cellular mediators of the innate immune system. These cells are known to be instrumental in containing viral infections and regulating tumor development, while the adaptive immune system generates an antigen-specific response. Several studies have demonstrated the various benefits of NK

The Emergence of Encapsulated Cell Therapies and Affiliated Technologies

Extensive research on  Cell Therapies encapsulation strategies have enabled the development of a variety of technologies capable of confining therapeutic entities within biocompatible matrices / carriers. Since 2013, over 3,000 patents have been published related to the aforementioned type of therapy, indicating the rapid pace of R&D activities in this domain. I have highlighted below

Stem Cell Therapies: Upcoming Opportunities in Cardiovascular and Metabolic Disorders (CVMD)

Cardiovascular disorders and metabolic disorders are considered to be amongst the leading causes of death worldwide. In fact, approximately one-third of the annual number of deaths across the globe are attributed to cardiovascular disorders.  Likewise, a significant proportion of the global population suffers from diabetes or some form of metabolism related clinical condition. As per

Cell Therapy Manufacturing: A Niche but Rapidly Growing Multi-Billion Dollar Industry

Post the approval of first cell-based therapy, Carticel®, in 1997 in the US, the field has rapidly advanced and a number of such therapies are currently under development. The ‘Cell Therapy Manufacturing Market, 2017-2027’ report provides an extensive study of the rapidly growing market of cell therapy manufacturing and focuses both on contract manufacturers and cell