Natural Killer (NK) cell therapy - Pipeline Insight, 2024

This “Natural Killer (NK) cell therapy - Pipeline Insight, 2024,” report provides comprehensive insights about 100+ companies and 185+ pipeline drugs in Natural Killer (NK) cell therapy 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

Natural Killer (NK) cell therapy Understanding

Natural Killer (NK) cell therapy: 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 cell therapy has been most successful in hematopoietic malignancies, such as leukemias. NK cell immunotherapy can be achieved by either activating endogenous NK cell response by administering NK stimulants or using exogenous NK cells via HSCT or adoptive cell transfer. Several strategies for NK cell immunotherapies for human cancer have been proposed to date. The upcoming technologies and recent advances in understanding the manipulation of NK cell activation and development have led to the hope that NK cells could be harnessed as immunotherapy for cancers and other diseases.

Natural Killer (NK) cell therapy - Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Natural Killer (NK) cell therapy pipeline landscape is provided which includes the disease overview and Natural Killer (NK) cell therapy treatment guidelines. The assessment part of the report embraces, in depth Natural Killer (NK) cell therapy 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, Natural Killer (NK) cell therapy 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 Natural Killer (NK) cell therapy R&D. The therapies under development are focused on novel approaches to treat/improve Natural Killer (NK) cell therapy.

Natural Killer (NK) cell therapy Emerging Drugs Chapters

This segment of the Natural Killer (NK) cell therapy 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.

Natural Killer (NK) cell therapy Emerging Drugs

NKTR-214: Nektar Therapeutics Nectar Therapeutics is developing NKTR-214 which is an intravenously administered, investigational, engineered IL-2 cytokine for the treatment of solid tumors. NKTR-214 is a prodrug, as it is delivered to the body in an inactive form. The body breaks down the prodrug to produce a signaling molecule that is biased toward binding to and activating CD122, a subunit of IL-2R. When NKTR-214 binds to CD122, it triggers an increase in the number of TILs. In August 2019, Nektar Therapeutics and Bristol-Myers Squibb announced that the US FDA has granted Breakthrough Therapy Designation for investigational agent bempegaldesleukin (NKTR-214) in combination with Bristol-Myers Squibb's Opdivo® (nivolumab) for the treatment of patients with previously untreated unresectable or metastatic melanoma. In February 2021, Nektar has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside the United States and Canada) for a Phase II/III study of Bempegaldesleukin.

Monalizumab: Innate Pharma Monalizumab (also known as IPH2201) is a first-in-class humanized IgG4 targeting NKG2A receptors expressed on tumor-infiltrating cytotoxic NK and CD8 T lymphocytes. It is under development by Innate Pharma in Phase III stage for the treatment of Squamous Cell Carcinoma of the Head and Neck and in Phase II stage of development for the treatment of gynecological cancers, chronic lymphocytic leukemia, and head and neck cancer. It is in the Phase I stage of development for the treatment of advanced solid tumors and hematologicalmalignancies.

Bemarituzumab: Five Prime Therapeutics 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.

ALT 803: ImmunityBio ALT 803 is a novel IL-15 superagonist complex, with improved pharmacokinetic properties and enhanced anti-tumor activity compared to recombinant human IL-15. It has also shown to potently activate human effector NK cells and enhance antibody-dependent cell-mediated cytotoxicity (ADCC) of anti-CD20 antibodies against human lymphoma cells in various tumor models. It is under development by Altor Bioscience Corporation and is currently in Phase II/III for Bladder Cancer. It is in Phase II stage for the treatment of Acute Myelogenous Leukemia (AML); Non-muscle Invasive Blood Cancer, in Phase I/II stage for the treatment of Acute Lymphoblastic Leukemia (ALL); Myelodysplastic Syndromes (MDS); Multiple Myeloma; Advanced Pancreatic Cancer; Non-small Cell Lung Cancer and Relapsed/Refractory Indolent B Cell Non-Hodgkin Lymphoma. It is in Phase I stage for the treatment of Human Immunodeficiency virus (HIV) and Melanoma, Renal Cell, and Squamous Cell Head and Neck Cancer. It is developed by using IL-15 Protein Super agonist and Scaffold Technology and is administered by intravenousroute.

Cell Protect: XNK Therapeutics CellProtect is a novel cell therapy based on autologous NK cells that are expanded and their cytotoxic activity restored through a patented process. The cells are then infused into the patient to treat the disease. Cell Protect is under development by CellProtect Nordic Pharmaceuticals and is currently in Phase II stage for the treatment of Multiple Myeloma at the Karolinska University Hospital in Huddinge, Sweden and Sanofi’s support by providing Sarclisa. It is manufactured under GMP conditions at the core facility Vecura at Karolinska UniversityHospital.

K-NK002: Kiadis Pharma NK002 is a natural killer cell-based immuno-oncology therapy. The molecule is made up of company’s proprietary off-the-shelf NK-cell platform. K-NK002 is an NK cell product derived from peripheral blood leukocytes collected from a related donor (HLA-haploidentical matched) and enriched for NK cells with depletion of CD3+ T-lymphocytes (T-cells) followed by enriched ex-vivo expansion. K-NK002 is under Phase II clinical development by Kiadis Pharma for the treatment of acute myeloid leukemia and Myelodysplastic syndromes. CytoSen's lead NK-cell therapy candidate, CSDT002-NK is now known as K-NK002 after the company being acquired by Kiadis Pharma in 2019.

NK-92: ImmunityBio NK-92 also known as aNK is activated natural killer (NK) cells and administered intravenously. It is the only cell line that can be commercialized as a direct, scalable and off-the-shelf product, which attacks and kills abnormal cells on contact. NK-92 does not require an intact immune system for killing the diseased cells in the body. It targets NK ligand and activates its action. NK-92 cells are also being engineered to target specific cancers and also to express a receptor that will couple with monoclonal antibodies to enhance their cancer-killing effects. NK-92 is being evaluated in Phase II stage of development for the treatment of stage IIIB & IV Merkel cell carcinoma as monotherapy and in combination with ALT-803, in Phase I stage of development for acute myeloid leukemia, Hematological Malignancies and solid tumors and in the Pre-IND phase for hepatocellular carcinoma and infectiousdisease.

WU-NK-101: Wugen WU-NK-101 is a cytokine-induced memory-like NK cell product derived from leukapheresed allogeneic donor NK cells. The drug is in Phase II clinical development studies for acute myelogenous leukemia (AML) and myelodysplastic syndromes treatment. In an ongoing Phase I/II clinical trial, WU-NK-101 had demonstrated an impressive complete response rate in relapsed/refractoryAML.

Anti-CD33 CAR-NK cells: PersonGen Bio TherapeuticsAnti-CD33 CAR-NK cells is novel specific chimeric antigen receptor NK cells with specificity for CD33 antigen receptor. The allogenic NK cell lines (NK-92 cell lines for clinical use) are engineered to contain anti-CD33 which is attached to TCRzeta, CD28, and 4-1BB signaling domains. The cell line immunotherapy is developed by PersonGen Biotherapeutics using its CART- NK- cell amplification Technology. The modified cell lines have specificity for CD 33 antigen after infusion which can be used in the treatment of Acute Myeloid Leukemias. The company is evaluating the feasibility of CAR-p NK cell line immunotherapy in Phase I/II clinical trials for CD 33 Positive Relapsed or Refractory AcuteMyeloidLeukemias.

ALECSAT: CytoVac ALECSAT (Autologous Lymphoid Effector Cells Specific against Tumor-cells) is a therapy that supplements and strengthens the patient’s immune system so it can fight the cancer cells in the same way as the body originally should have reacted. Natural Killer Cells used, in the ALECSAT therapy attack, the cancer cells in several ways, as they can recognize more than one property of the cancer cells. ALECAST is being evaluated for breast cancer and newly diagnosed glioblastoma in Phase II stage ofdevelopment.

Natural Killer (NK) cell therapy: Therapeutic Assessment

This segment of the report provides insights about the different Natural Killer (NK) cell therapy drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Natural Killer (NK) cell therapy

There are approx. 100+ key companies which are developing the therapies for Natural Killer (NK) cell therapy. The companies which have their Natural Killer (NK) cell therapy drug candidates in the most advanced stage, i.e. Phase III include, Nektar therapeutics.

Phases

This report covers around 185+ 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

Natural Killer (NK) cell therapy 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
• Parenteral
• Intravenous
• Subcutaneous
• Topical.

Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

Product Type

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

Natural Killer (NK) cell therapy: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Natural Killer (NK) cell therapy 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 Natural Killer (NK) cell therapy drugs.

Natural Killer (NK) cell therapy Report Insights

• Natural Killer (NK) cell therapy Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

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