IPSC derived NK cells - Pipeline Insight, 2024

This “IPSC derived NK cells- Pipeline Insight, 2024” report provides comprehensive insights about 12+ companies and 15+ pipeline drugs in IPSC derived NK cells pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

IPSC derived NK cells: Understanding

IPSC derived NK cells: Overview

Induced pluripotent stem cell (iPSC)-derived natural killer (NK) cells are a novel therapeutic approach that combines the regenerative capabilities of iPSCs with the potent anti-tumor and anti-viral properties of NK cells. NK cells are a critical component of the innate immune system, known for their ability to recognize and kill cancer cells and infected cells without prior sensitization. By generating NK cells from iPSCs, researchers aim to produce a scalable and standardized source of highly functional NK cells for therapeutic applications, particularly in cancer immunotherapy. Characteristics and generation includes Pluripotency of iPSCs: iPSCs can differentiate into any cell type, including NK cells. This process involves reprogramming somatic cells (e.g., skin or blood cells) into iPSCs using defined transcription factors (OCT4, SOX2, KLF4, and c-MYC), followed by directed differentiation into NK cells. Differentiation process; the differentiation of iPSCs into NK cells involves mimicking the natural developmental pathways of NK cells. This is typically achieved by culturing iPSCs in the presence of specific cytokines and growth factors that promote NK cell lineage commitment and maturation and enhanced functional properties iPSC-derived NK cells can be genetically engineered to express enhanced receptors and cytokines that improve their targeting and killing of cancer cells. These modifications can include chimeric antigen receptors (CARs) for better recognition of tumor-specific antigens, as well as modifications to increase persistence and resistance to the immunosuppressive tumor microenvironment.

Applications of the IPSC derived NK cells includes cancer immunotherapy iPSC-derived NK cells are primarily being developed for the treatment of various cancers. Their ability to recognize and kill tumor cells makes them ideal candidates for targeting hematologic malignancies (e.g., leukemia, lymphoma) and solid tumors. Viral infections these cells also hold potential in treating viral infections, leveraging their natural ability to target and destroy virally infected cells. Allogeneic Therapy one significant advantage of iPSC-derived NK cells is the possibility of creating an "off-the-shelf" allogeneic cell therapy product. Unlike autologous therapies that require cells from the patient, allogeneic therapies can be derived from a universal donor and used to treat multiple patients, increasing accessibility and reducing costs.

Future Directions include clinical trials ongoing and future clinical trials will be critical in determining the therapeutic potential and safety profile of iPSC-derived NK cells. These trials will provide valuable data on their effectiveness in treating various cancers and other diseases. Advanced genetic engineering innovations in genetic engineering, such as CRISPR/Cas9, will continue to enhance the functionality and specificity of iPSC-derived NK cells. These advancements may include improved targeting mechanisms, resistance to tumor-induced immunosuppression, and enhanced survival in the hostile tumor microenvironment. Combination Therapies combining iPSC-derived NK cells with other treatments, such as immune checkpoint inhibitors, chemotherapies, or other cell-based therapies, could provide synergistic effects and improve overall treatment outcomes. Personalized medicine further research into patient-specific iPSC-derived NK cells could pave the way for personalized immunotherapies tailored to individual patients' genetic and molecular profiles, maximizing therapeutic efficacy and minimizing adverse effects.

"IPSC derived NK cells- Pipeline Insight, 2024" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the IPSC derived NK cells pipeline landscape is provided which includes the disease overview and IPSC derived NK cells treatment guidelines. The assessment part of the report embraces, in depth IPSC derived NK cells commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, IPSC derived NK cells collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence IPSC derived NK cells R&D. The therapies under development are focused on novel approaches to treat/improve IPSC derived NK cells.

IPSC derived NK cells Emerging Drugs Chapters

This segment of the IPSC derived NK cells report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

IPSC derived NK cells Emerging Drugs

CNTY-101: Century Therapeutics

CNTY-101 is an investigational off-the-shelf immunotherapy product candidate that utilizes iPSC-derived natural killer (NK) cells with a CD19-directed chimeric antigen receptor (CAR) and includes Century’s core Allo-Evasion™ edits designed to overcome the three major pathways of host versus graft rejection - CD8+ T cells, CD4+ T cells and NK cells. In addition, the product candidate is engineered to express IL-15 to provide homeostatic cytokine support, which has been shown pre-clinically to improve functionality and persistence. Further, to potentially improve safety, the iNK cells were engineered with an EGFR safety switch, and proof-of-concept studies have demonstrated that the cells can be quickly eliminated by the administration of cetuximab, an antibody against EGFR approved by the U.S. Food and Drug Administration for certain cancers. Century is currently assessing CNTY-101 in patients with relapsed or refractory CD19-positive B-cell lymphomas in its Phase I ELiPSE-1 clinical trial and intends to initiate its second Phase I clinical trial assessing CNTY-101 in patients with moderate to severe systemic lupus erythematosus. Currently, the drug is in Phase I stage of its development for the treatment of B cell malignancies.

CTH-401: Cartherics Pty ltd

CTH-401 is an investigational allogeneic induced pluripotent stem cell (iPSC)-derived, chimeric antigen receptor (CAR) natural killer (NK) cell therapy designed to target solid tumors. CTH-401 is genetically engineered to integrate a proprietary second-generation CAR construct that specifically targets tumor-associated glycoprotein-72 (TAG-72) and includes the deletion of two genes associated with immunosuppression. The TAG-72 CAR delivers precise on-target cytotoxic action while the gene deletions extend CTH-401’s survival and enhance its long-term efficacy. The final product is derived from a precisely characterized, clonal, iPSC master cell bank. Following a successful pre-investigational new drug (pre-IND) meeting with the US Food and Drug Administration (FDA), CTH-401 is planned to enter clinical trials for ovarian cancer in 2025. Subject to early clinical data, CTH-401 will subsequently enter a basket trial to target other TAG-72+ solid cancers. Currently, the drug is in preclinical stage of its development for the treatment of ovarian cancer.

IPSC derived NK cells: Therapeutic Assessment

This segment of the report provides insights about the different IPSC derived NK cells drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in IPSC derived NK cells

• There are approx. 12+ key companies which are developing the therapies for IPSC derived NK cells. The companies which have their IPSC derived NK cells drug candidates in the most advanced stage, i.e. phase III include, Century Therapeutics.

Phases

This report covers around 15+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

IPSC derived NK cells pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

IPSC derived NK cells: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses IPSC derived NK cells therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging IPSC derived NK cells drugs.

IPSC derived NK cells Report Insights

• IPSC derived NK cells Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

IPSC derived NK cells Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing IPSC derived NK cells drugs?
• How many IPSC derived NK cells drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of IPSC derived NK cells?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the IPSC derived NK cells therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for IPSC derived NK cells and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Centuary Therapeutics
• Cartherics Pty ltd
• Artiva Biotherapeutics
• Fate Therapeutics
• Glycostem Therapeutics
• ONK Therapeutics Limited

Key Products

• CNTY-101
• CTH-401
• AlloNK
• FT825
• oNKord®
• ONKT105

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