Artiva Biotherapeutics announces FDA clearance of IND for AlloNK and Rituximab combo

Betsy Goodfellow | August 17, 2023 | News story | Research and Development FDA, IND, Immunology, lupus nephritis, pharma 

On 16 August 2023, the US Food and Drug Administration (FDA) officially cleared Artiva Biotherapeutics’ Investigational New Drug (IND) application for AlloNK in combination with Rituximab in order to treat Lupus Nephritis (LN).

AlloNK is a non-genetically modified, allogenic, cryopreserved NK cell therapy candidate, designed to improve antibody-dependent cellular cytotoxicity. It is currently being investigated in two cancer clinical trials in combination with antibody or NK-engager biologics.

Fred Aslan, chief executive officer of Artiva, commented: “Seminal clinical data has been generated using autologous CAR-T cells suggesting that a deeper B cell depletion can induce complete and long-lasting responses in patients with lupus nephritis. However, the use of autologous CAR-T cells requires apheresis, likely hospitalization, and the potential for serious side effects. AlloNK given in combination with rituximab, an anti-CD20 antibody that targets B-cells, is already driving complete responses in late line B-NHL patients in an ongoing phase 1 study by enhancing the activity of rituximab. Our hypothesis is that AlloNK plus rituximab also has the potential to drive deep B-cell depletion in LN patients with an off-the-shelf therapy that could be administered and managed in an outpatient setting.”

LN is a chronic autoimmune disease characterized by abnormal B-cell function and autoantibody production, potentially resulting in organ damage or death. It is the most common form of systemic lupus erythematosus (SLE) and more than 40% of patients will develop end-stage renal disease requiring dialysis and transplant within 15 years.

Kenneth Kalunian, clinician and professor of medicine at UC San Diego, stated: “Although rituximab has been used off-label in the treatment of SLE, rituximab alone has been shown to give incomplete B-cell depletion. The addition of allogeneic NK cells as an ADCC-enhancing therapy could significantly enhance rituximab’s ability to drive deeper levels of B-cell depletion. Furthermore, SLE patients may have lower levels of NK cells than healthy subjects, and these cells may be functionally impaired. An effective off-the-shelf cell therapy that can be administered and managed in the community setting could be well received by lupus patients and physicians.”

Rebecca Lee

Related Content

FDA grants marketing authorisation to DNA test for predisposition to certain cancers

The US Food and Drug Administration (FDA) has granted de novo marketing authorisation to the …

Biogen’s biosimilar Tofidence approved by FDA

Biogen has announced that the US Food and Drug Administration (FDA) has approved Tofidence (tocilizumab-bavi) …


Karuna Therapeutics submits NDA to FDA for schizophrenia treatment

Karuna Therapeutics has announced that it has submitted a New Drug Application (NDA) to the …

Latest content