NK Cell therapy - Pipeline Insight, 2025

This “NK Cell Therapies - Pipeline Insight, 2025” report provides comprehensive insights about 140+ companies and 160+ pipeline drugs in NK Cell Therapies 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

NK Cell Therapies: Understanding

NK Cell Therapies: Overview

Natural killer cells, also known as NK cells are a type of lymphocytes and are key components of the innate immune system. They are highly specific predators that play a major role in the host rejection of both tumors and viral infected cells. NK cells have cytotoxic small granules, which contain special proteins such as perforins and proteases, are known as granzymes in their cytoplasm. Perforins form pores in the cell membrane of the target cell through which the granzymes and associated molecules induce apoptosis. NK cells are derived from the common lymphoid progenitor cells (lymphoblasts), which also generate B and T lymphocytes. They differentiate and mature in the bone marrow, lymph nodes, spleen, tonsils, and thymus, where they then enter into the bloodstream.

NK cells are capable of extravasations and infiltration into tissues and they are activated by interleukins. Natural Killer (NK) cells are capable of secreting cytokines. They act as both cytotoxic effectors and regulators of immune responses and also help in recognizing microbial infection and tumor transformation. They are developed from lymphoid progenitor cells present in the bone marrow. By recognizing self MHC class I molecules, these cells become self-tolerant. After maturation NK cells migrate to lymphoid organs including the liver, uterus, and thymus where they give rise to tissue-specific, functionally distinct mature NK cell subsets.

NK cells act on a large number of receptors that deliver either activating or inhibitory signals. The relative balance of inhibitors and activator signals controls the NK cell activity. NK cell activates post detection of abnormalities in the target cell. It may be due to loss of MHC class I expression or up-regulation of stress-induced ligands that occurs in response to infection or malignant transformation.

NK cells surveillance system includes a number of cell surface activating and inhibitory receptors that control the cytolytic activity of NK cells by sending an either stimulatory or inhibitory signal. The fine balance between activation and inhibition NK cells decides their final action. The inhibitory receptor’s ligands include self-MHC class I molecules that are present on all nucleated cells of the body which helps in avoiding the NK cells activity on normal cells. NK cells have also potent producers of inflammatory cytokines, such as TNF-α and IFN-γ.

"NK Cell Therapies- Pipeline Insight, 2025" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the NK Cell Therapies pipeline landscape is provided which includes the disease overview and NK Cell Therapies treatment guidelines. The assessment part of the report embraces, in depth NK Cell Therapies 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, NK Cell Therapies 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 NK Cell Therapies R&D. The therapies under development are focused on novel approaches to treat/improve NK Cell Therapies.

NK Cell Therapies Emerging Drugs Chapters

This segment of the NK Cell Therapies report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, 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.

NK Cell Therapies Emerging Drugs

Bemarituzumab: Amgen

Bemarituzumab is a first-in-class, isoform-selective, humanized monoclonal antibody in clinical development as a targeted immunotherapy for tumors that overexpress FGFR2b, a splice variant of a receptor for some members of the fibroblast growth factor (FGF) family. Bemarituzumab blocks FGFs 7, 10, and 22 from binding to FGFR2b, and has been engineered for enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) to increase direct tumor cell killing by recruiting natural killer (NK) cells. Clinical results to date suggest that the specificity of bemarituzumab avoids the dose-limiting toxicities that have been noticed with less selective pan-FGFR tyrosine kinase inhibitors that act on multiple FGFRs, including FGFR2. In December 2017, Five Prime and Zai Lab announced a strategic collaboration for the development and commercialization of bemarituzumab in Greater China. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Gastric and Gastroesophageal Junction (GEJ) Cancers.

• Monalizumab: Innate Pharma

Monalizumab (IPH2201) is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor-infiltrating cytotoxic CD8+ T cells and NK cells. NKG2A is an inhibitory checkpoint receptor for HLA-E, which cancer cells frequently overexpress to protect themselves from NKG2A+ immune cells. By blocking this inhibition, monalizumab prevents HLA-E-expressing tumor cells from evading immune detection. This re-establishes a broad anti-tumor response mediated by NK and T cells, simultaneously enhancing the cytotoxic potential of other therapeutic antibodies. Through its dual action on innate and adaptive immunity, monalizumab holds promise for reactivating immune responses against a variety of solid tumors and hematological malignancies. Currently, the drug is in Phase III for Unresectable Stage III Non-small Cell Lung Cancer and in Phase II for Neoadjuvant NSCLC, other cancer types.

L1 t-haNK: ImmunityBio

PD-L1.t-haNK cells are a human-derived, allogeneic, natural killer cell line engineered to express a chimeric antigen receptor (CAR) targeting PD-L1, whose origins arise from NantKwest’s proprietary NK-92 (aNK) master cell bank. In addition to targeting PD-L1, PD-L1.t-haNK is engineered to produce intracellular IL-2 for enhanced CD16-targeted antibody-dependent cellular cytotoxicity capabilities. Currently, the drug is in the Phase II clinical studies for the treatment of gastric cancer, pancreatic cancer, squamous cell cancer, glioblastoma, and non-small cell lung cancer.

• M ceNK: ImmunityBio

The first-in-class, memory cytokine-enriched Natural Killer (m-ceNK) cells are the patient’s own NK cells that have been enriched with cytokines, including ImmunityBio’s IL-15 super agonist Anktiva (N-803). These m-ceNK cells, or memory-cytokine enriched NK cells, have been designed for autologous cell therapy, but have also been generated as an allogeneic product from cord blood. M-ceNK provides a unique opportunity in clinics due to its ease of use and potential suitability for use in the ambulatory setting. ImmunityBio has successfully enriched and expanded donor natural killer cells obtained from peripheral blood of donors using a technique called apheresis, to generate a unique NK cell phenotype which exhibits both high cytotoxicity and interferon-g production together with a memory-like effect. M-ceNK cells are currently being investigated in Phase I stage of development for the treatment of Solid Tumor. The company is currently investigating the M-cenk in Phase II stage of development for the treatment of Acute Myeloid Leukemia (AML) and Ovarian cancer, however the details are yet to be announced by the company.

DF6002: Dragonfly Therapeutics

DF6002 is a monovalent IL-12 immunoglobulin Fc fusion protein proposed to achieve strong anti-tumor efficacy by establishing an inflammatory tumor microenvironment necessary for productive anti-tumor responses. DF6002, Dragonfly's extended half-life IL12 cytokine, is an investigational immunotherapy being evaluated in adult patients for the treatment of advanced solid tumors. DF6002 has the potential to stimulate effective anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies. The drug is currently being investigated in the Phase I/II stage of development for the treatment of solid tumors.

• oNKord: Glycostem Therapeutics

Allogeneic Natural Killer Cell Therapy (also known as oNKord) comprises natural killer cells (NK-cells) generated ex vivo from umbilical cord blood progenitor cells. The system for the generation of these cells is quite efficient and effective. The process is capable of generating a superior expansion of NK cells, i.e., 5-10,000 fold expansion is achievable. The cells that are produced are of superior quality which is over 95% pure and devoid of contaminating T- and B-cells. These NK cells are already activated and are ready to attack cancer cells. The output of these cells has been proven to be highly reliable and reproducible. As per Glycostem, oNKord are also capable of treating other diseases such as Multiple Myeloma, hematological cancers and solid tumors such as colorectal cancer, head-neck cancer, lung cancer and breast cancer. The drug is currently being evaluated under Phase I/II clinical trial for the treatment of acute myeloid leukemia (AML).

KUR-501: Athenex

KUR-501 is an autologous cell therapy that is developed by using Cell Medica natural killer T (NKT) cell platform technology in combination with genetically engineered chimeric antigen receptors (CARs) and secretion of the IL-15 cytokine to sustain the activity of the therapeutic cells within the immunosuppressive tumor microenvironment. CAR.GD2-IL-15 NKTs is a GD2 specific chimeric antigen receptor (CAR) and Interleukin-15 Expressing autologous natural killer T-cells. The molecule designed specifically to contain artificial genes called chimeric antigen receptor (CAR), from an antibody called 14g2a that recognizes GD2, a molecule found on almost all neuroblastoma cells (GD2-CAR). The chimeric antigen receptor also contains a gene segment called CD 28 to make the NKT cells last longer. The molecule was further modified by adding a gene expressing Interleukin -15 (IL-15). The combination of these three components showed the most antitumor activity by CAR-expressing NKT cells and improved the cell survival in various animal models. The company currently conducting a Phase I trial in sponsorship with Baylor College of Medicine (BCM) in pediatric patients for the treatment of neuroblastoma.

NK Cell Therapies: Therapeutic Assessment

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

Major Players in NK Cell Therapies

• There are approx. 140+ key companies which are developing the therapies for NK Cell Therapies. The companies which have their NK Cell Therapies drug candidates in the most advanced stage, i.e. Phase III include, Amgen and Innate Pharma.

Phases

The report covers around 160+ 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

NK Cell Therapies 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.

NK Cell Therapies: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses NK Cell Therapies 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 NK Cell Therapies drugs.

NK Cell Therapies Report Insights

• NK Cell Therapies Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

NK Cell Therapies 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 NK Cell Therapies drugs?
• How many NK Cell Therapies drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of NK Cell Therapies?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the NK Cell Therapies 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 NK Cell Therapies and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Amgen
• Innate Pharma
• ImmunityBio
• Dragonfly Therapeutics
• Glycostem Therapeutics
• Athenex
• Takeda
• Wugen
• Affimed Therapeutics
• VERAXA
• Asclepius Technology Company Group
• NKGen Biotech
• Sanofi
• Indapta Therapeutics
• Celularity
• GT Biopharma
• Biohaven Pharmaceuticals
• Acepodia
• Allife Medical Science and Technology
• Bright Path Biotherapeutics

Key Products

• Bemarituzumab
• Monalizumab
• L1 t-haNK
• M ceNK
• DF6002
• oNKord
• KUR-501
• TAK-007
• WU-NK-101
• AFM24
• FLYSYN
• DF1001
• BCMA CAR-NK 92 cells
• SNK01
• SAR445514
• IDP-023
• CYNK-001
• GTB-3550
• BHV-1100
• ACE1702
• Anti-CD19/CD22 CAR NK cell therapy

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