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news.The US Food and Drug Administration (FDA) has granted fast track designation to clinical stage company Artiva Biotherapeutics’s lead programme AB-101.
Image: Micrograph of mantle cell lymphoma, a type of non-Hodgkin lymphoma. Credit: Nephron/Commons.wikimedia.org.
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AB-101 is a non-genetically modified, cord blood-derived, allogeneic, cryopreserved, ADCC-enhancing NK cell therapy candidate for use along with monoclonal antibodies or innate-cell engagers in the out-patient environment.
Artiva chooses cord blood units with the high affinity variant of the receptor CD16 and a KIR-B haplotype for improved product activity.
Leveraging the firm’s AlloNK platform, Artiva can produce thousands of doses of pure, cryopreserved, infusion-ready NK cells just from a single umbilical cord blood unit while maintaining the high and consistent expression of CD16 and other tumour-engaging receptors, without the requirement for engineering.
Artiva believe this makes AB-101 an optimal adjunct therapy to targeted, ADCC-mechanistic biologics.
Artiva chief medical officer Thorsten Graef said: “We are excited to announce this advantageous regulatory designation as we continue our clinical evaluation of the AB-101/rituximab combination in the treatment of relapsed/refractory B-cell NHL, including in patients who have failed prior CAR-T treatment.
“We are encouraged by the early clinical data we are seeing with AB-101 and look forward to expanding its evaluation in this indication as well as with additional biologic therapy combinations through internal and partnered clinical programs.”
Artiva CEO Fred Aslan said: “We are committed to our mission of delivering AB-101 as an off-the-shelf cell therapy with an efficacy and tolerability profile suitable for administration and management in the community setting.
“Given the maturity of our highly scalable manufacturing process, we believe we are well positioned to pursue a first-in-class allogeneic NK cell therapy registration in either non-Hodgkin lymphoma in combination with rituximab, or in Hodgkin lymphoma in combination with Affimed’s AFM13.”
Artiva is carrying out a Phase I/II multicentre clinical trial to evaluate assess the safety and clinical activity of AB-101 alone as well as along with the anti-CD20 monoclonal antibody, rituximab, in patients suffering with relapsed or refractory B-cell-non-Hodgkin lymphoma (NHL) who have advanced beyond two or more previous lines of therapy including CAR-T therapy.
