• Artiva recognized for advancing AlloNK®, the first allogeneic, off-the-shelf NK cell therapy with an IND allowance for autoimmune disease
• AlloNK in combination with rituximab aims to be a safe and effective option for patients with lupus nephritis and has scalable potential for future applications in other autoimmune diseases

Artiva Biotherapeutics, Inc., a clinical stage company with the mission to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases and cancers, today announced it has been awarded Immunology Innovation of the Year in the third annual BioTech Breakthrough Awards program, which conducts the industry’s most comprehensive analysis and evaluation of the top companies, solutions and products in the life sciences and biotechnology industry. This year’s program attracted more than 1,500 nominations from over 12 different countries throughout the world.

Artiva Biotherapeutics is an immunotherapy company with the ability to produce off-the-shelf, allogeneic NK cell therapies at a massive scale, and has the first IND clearance for an off-the-shelf NK or CAR-T cell therapy candidate in autoimmune disease. Artiva’s lead program, AlloNK (also known as AB-101), is an allogenic, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity (ADCC) effect of monoclonal antibodies or NK cell engagers. Seminal clinical data with autologous CAR-T cells suggests that deep B cell depletion can induce complete and long-lasting responses in patients with lupus nephritis. Artiva is leveraging AlloNK to enhance the ADCC activity of rituximab, a monoclonal antibody targeting CD20, to deplete B-cells in the treatment of systemic lupus erythematosus (SLE) in patients with active lupus nephritis (LN).

“We are pleased to receive this BioTech Breakthrough Award for the role AlloNK could play in enhancing the ADCC activity of monoclonal antibodies in the treatment of lupus and other autoimmune diseases,” said Fred Aslan, M.D., CEO of Artiva. “The use of autologous CAR-T cells requires apheresis, likely hospitalization, and the potential for serious side effects. AlloNK is an off-the-shelf product with the potential for greater safety and accessibility for patients.”

Developed with safety and accessibility in mind, AlloNK has not shown severe cytokine release syndrome or neurotoxicity often associated with CAR-T therapies. In addition, the use of NK cells allows the treatment to be used in an allogeneic, mismatched setting without induction of graft versus host disease (GVHD), enabling the treatment of many patients from the same donor cells. Using the company’s cell therapy manufacturing platform, Artiva can generate thousands of doses of cryopreserved, infusion-ready AlloNK cells from a single umbilical cord blood unit while retaining the high and consistent expression of CD16 and other activating NK receptors.

“We’re pleased to recognize Artiva with ‘Immunology Innovation of the Year’ for their pipeline of off-the-shelf, allogeneic NK cell therapies that have the potential to be safe and immediately accessible to patients in need,” said Bryan Vaughn, Managing Director of BioTech Breakthrough Awards. “AlloNK leverages the safety and accessibility of allogeneic, non-genetically modified NK cells combined with approved therapeutic antibodies with the goal of enhancing antibody-dependent cellular cytotoxicity (ADCC) and driving therapeutic efficacy in autoimmune diseases.”

About AlloNK®

AlloNK® (also known as AB-101) is an allogeneic, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity (ADCC) effect of monoclonal antibodies or NK cell engagers. AlloNK is a cryopreserved, off-the-shelf therapy with the potential to be administered in the community setting. AlloNK recently became the first allogeneic, off-the-shelf NK or CAR-T cell therapy candidate to receive an IND clearance in autoimmune disease. AlloNK will be administered in combination with rituximab for treatment of systemic lupus erythematosus (SLE) in patients with active lupus nephritis (LN). AlloNK is also being investigated in two clinical trials in cancer. Artiva is conducting a Phase 1/2 multicenter clinical trial (ClinicalTrials.gov Identifier: NCT04673617) to assess the safety and clinical activity of AlloNK, alone and in combination with rituximab in patients with relapsed or refractory B-cell-non-Hodgkin lymphoma (B-NHL). Artiva presented data at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrating the favorable safety profile and ADCC enhancing effect of AlloNK in combination with rituximab, and Artiva has received a Fast Track designation for treatment of relapsed/refractory non-Hodgkin lymphoma of B cell origin patients with AlloNK in combination with rituximab. Artiva is also collaborating with Affimed N.V. in a Phase 2, open-label, multi-center, multi-cohort study (NCT05883449, LuminICE-203) testing a combination therapy, comprised of AlloNK and the innate cell engager AFM13, for the treatment of patients with relapsed/refractory CD30-positive lymphomas. Using the company’s cell therapy manufacturing platform, Artiva can generate thousands of doses cryopreserved, infusion-ready AlloNK cells from a single umbilical cord blood unit while retaining the high and consistent expression of CD16 and other activating NK receptors.

About Artiva Biotherapeutics

Artiva is an immunotherapy company with the ability to produce off-the-shelf, allogeneic NK cell therapies at a massive scale. Artiva’s mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases and cancers. Artiva’s lead program, AlloNK®, is an allogenic, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity (ADCC) effect of monoclonal antibodies or NK cell engagers. Artiva’s pipeline also includes a pipeline of CAR-NK candidates targeting both solid and hematopoietic cancers. Artiva’s cell therapy manufacturing platform incorporates cell expansion, activation, and engineering technology developed by Artiva’s strategic partner, GC Cell Corporation, a member of the GC family of companies, a leading healthcare company in Korea. Artiva is headquartered in San Diego. For more information, visit www.artivabio.com.

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