Artiva Therapeutics

Overview

Artiva Therapeutics is a clinical-stage biotechnology company developing allogeneic, off-the-shelf natural killer (NK) cell therapies for autoimmune diseases and oncology. Its lead candidate, AlloNK (AB-101), is a non‑genetically modified, cryopreserved NK cell product designed to enhance antibody-dependent cellular cytotoxicity (ADCC) of monoclonal antibodies to drive B-cell depletion. The company pursues B-cell–driven autoimmune indications and oncology programs, including CAR-NK assets.

Lead program and clinical strategy

• AlloNK is being studied in combination with B-cell–targeted monoclonal antibodies across multiple clinical trials, with a lead indication of refractory rheumatoid arthritis (RA).
• Ongoing studies:
  • Company-sponsored Phase 2 basket study across RA, Sjögren’s disease (SjD), systemic sclerosis (SSc), and idiopathic inflammatory myopathies (IIMs).
  • Company-sponsored Phase 1/1b trial in systemic lupus erythematosus (SLE) / lupus nephritis (LN).
  • Investigator-initiated basket trial (IIT) including RA, pemphigus vulgaris (PV), granulomatosis with polyangiitis / microscopic polyangiitis (GPA/MPA), and SLE.
• Regulatory milestones:
  • FDA Fast Track designation for AlloNK in combination with rituximab for refractory RA (granted October 2025).
  • IND cleared (April 2024) for the IRIS IIT studying AlloNK with rituximab in RA, PV, GPA/MPA, and SLE; first patient treated August 2024.
• Treatment regimen under evaluation typically includes lymphodepletion (cyclophosphamide and fludarabine) followed by AlloNK and a monoclonal antibody, with multiple cycles and dose levels being tested.

Clinical data highlights (autoimmune program, data cutoff Oct 1, 2025)

• Data cutoff: October 1, 2025.
• Peripheral B-cell depletion: In 32 autoimmune patients treated across all autoimmune studies, all evaluable samples showed B-cell depletion to non-quantifiable levels by Day 13 when given Cy/Flu + AlloNK + anti-CD20 mAb.
• High-sensitivity B-cell assay: All evaluated patients had non-quantifiable peripheral CD19+ B cells; reconstitution tended toward naïve/transitional B cells.
• Immunoglobulins and platelets: Total immunoglobulins largely remained within normal range; no cases of hypogammaglobulinemia reported by the data cutoff.
• Phase 1/1b (non-Hodgkin lymphoma readthrough): In the CAR-T–naïve subgroup (n=14), complete response rate (CRR) was 64% by Lugano 2014 criteria; several responses remain ongoing with duration of response not yet reached in multiple cases.
• Safety: Across the 32 autoimmune patients, no cytokine release syndrome (CRS) or immune effector cell–associated neurotoxicity syndrome (ICANS) were reported. Most treatment-emergent adverse events were Grade 1–2 and related to conditioning. One hospitalization was reported within 28 days post-treatment (skin infection, unrelated to AlloNK).
• Administration setting: Trials were conducted largely in community rheumatology sites without requirement for specialized oncology oversight for AlloNK administration.

Manufacturing, process, and scale

• Manufacturing-first strategy developed in collaboration with GC Cell, with an end-to-end NK cell manufacturing platform for large-scale, off-the-shelf products.
• Donor source and cell characteristics:
  • Cord blood units are pre-screened for KIR-B haplotype and high-affinity CD16 (158V/V) to enhance ADCC.
  • Cord blood NK cells expand more efficiently in the company’s proprietary system than peripheral-blood NK cells.
• Facilities and capacity:
  • San Diego footprint includes a 9,000 sq ft cGMP cell production center, 52,000 sq ft headquarters with R&D and process development labs, and a separate 9,000 sq ft dedicated cGMP manufacturing facility.
  • Three 50 L bioreactors for drug-product manufacturing; capacity to run up to 60 batches per year across facilities.
• Yields and throughput:
  • From a single cord blood unit, the process yields 50–80 intermediate cell bank (ICB) units. Each ICB can seed a second expansion to yield 80–100+ one-billion-cell AlloNK vials per batch.
  • Cumulative potential demonstrated of over 4,000 one‑billion‑cell vials per cord blood unit, which could treat approximately 250–1,000 autoimmune patients depending on dose (one to four billion cells per dose; three doses per treatment).
• Cryopreservation and release:
  • Cryopreservation yields greater than 90% viability upon thaw and is validated to maintain activity after thaw. Release testing is conducted on multiple donor-derived products.
• Commercial cost context:
  • Estimated commercial cost of goods sold (COGS) per patient projected at $3,000 to $12,000, materially lower than typical autologous CAR-T costs.

Product portfolio beyond AlloNK

• CAR-NK programs:
  • AB-201: HER2-targeted CAR-NK; orphan drug designation in the U.S.
  • AB-205: CD5-directed CAR-NK for T-cell malignancies.
• Rights and partnerships:
  • Artiva holds ex-APAC rights to these CAR-NK programs. GC Cell remains a partner with ongoing collaboration and manufacturing integration.

Intellectual property

• Core IP framework established with GC Cell covering non‑genetically modified and genetically modified NK cell technologies, including manufacturing and processing methods.
• Licensed patent families from GC Cell cover NK manufacturing processes, CAR components, and novel antibodies/antigen-binding fragments.
• Co-owned and owned families include IL-15 related inventions, CAR constructs (HER2, CD19, and others), and anti-HER2 antibody fragments.
• Patent coverage spans U.S. and international families, with expiration timelines generally extending into the 2030s–2040s, subject to allowable term adjustments and extensions, including potential Hatch-Waxman and pediatric exclusivity provisions.

Collaborations and strategic relationships

• GC Cell: Core technology and manufacturing partner with exclusive license framework for NK cell products and rights to provide manufacturing services; option-based licensing for AB-101, AB-201, AB-205, and related products.
• Affimed: Collaboration to study AlloNK with acimtamig (CD30-targeted NK engager) in Hodgkin lymphoma; collaboration terminated July 2025 after Affimed’s insolvency.
• IRIS IIT: Investigator-driven basket trial funded and supplied by Artiva; first patient treated August 2024. IRIS serves as the regulatory sponsor for the IIT.
• Other collaborations: Ongoing partnerships to expand NK platform capabilities and manufacturing scale.

Regulatory pathway and market considerations

• Products are regulated as biologics and must comply with cGMP manufacturing requirements.
• Regulatory pathway includes IND filings and, for approval, a BLA submission. The company may seek expedited pathways such as Fast Track, Breakthrough Therapy, or Priority Review where applicable.
• Development strategy includes pursuing orphan designations and exclusivity opportunities where appropriate.
• Pricing and reimbursement considerations recognize uncertainty for new biologics, with potential pricing flexibility given projected COGS advantages.

Summary

Artiva develops off-the-shelf, allogeneic NK cell therapies to enhance B-cell depletion when combined with B-cell–targeted monoclonal antibodies, targeting autoimmune diseases and oncology. The company maintains a vertically integrated manufacturing platform based on cord-blood–derived NK cells, scalable expansion, and validated cryopreservation. Clinical programs span multiple autoimmune indications and CAR-NK oncology candidates, supported by strategic collaborations, a comprehensive IP portfolio, and manufacturing capacity intended to support broader commercialization.