NKMAX's 'Targeted NK Immuno-Oncology Drug' Joint Clinical Trial Approved by US FDA

[Asia Economy Reporter Hyunseok Yoo] NKMax announced on the 1st that it has completed IND approval for the US Phase 1/2a clinical trial of the ‘targeted NK immuno-oncology drug’ jointly conducted with Affimed NV.

This is a large-scale clinical trial involving 139 patients with EGFR-positive solid tumors, conducted under the joint development agreement signed by NKMax and Affimed in October last year. The trial is planned to be conducted simultaneously at up to 15 hospitals in the United States.

▲ In cohorts 1-3, 12 to 18 patients will receive a combination of SuperNK (4 billion cells) and AFM24 (dose escalated by phase) to confirm the recommended Phase 2 dose (RP2D) and safety. Subsequently, to evaluate efficacy, an expanded new cohort 1-3 will administer the combination of SuperNK (4 billion cells) and AFM24 (dose determined through cohorts 1-3) to 40 patients with metastatic colorectal cancer, 41 patients with head and neck squamous cell carcinoma, and 40 patients with non-small cell lung cancer. The new cohorts 1-3 will assess treatment response rate (ORR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and clinical benefit rate (CBR) following combination therapy.

Dr. Andreas Harstrick, Chief Medical Officer (CMO) of Affimed, stated, “This clinical trial represents a significant business opportunity to extend Affimed’s bispecific antibody technology, which links NK cells and cancer cells, to solid tumors. The excellent binding affinity and cancer cell-killing ability of SuperNK and AFM24 will create synergy in cancer patient treatment.” He added, “It will offer a new treatment method that complements areas not addressed by targeted therapies.”

Stephen Chen, Chief Operating Officer (COO) and Chief Technology Officer (CTO) of NKMax America, said, “This IND approval is an important milestone in the development of NK cell therapies. We are highly optimistic as this trial will also confirm the therapeutic effects of SuperNK+AFM24 on three representative cancer types expressing EGFR.”

He emphasized, “Through the ‘targeted NK immuno-oncology drug’ clinical trial combining AFM24’s cancer cell-tracking ability and SuperNK’s cancer cell-killing ability, we believe it will overcome the limitations of existing therapies in terms of treatment efficacy, production efficiency, and cost-effectiveness.”