NKMAX Announces Preclinical Results of ‘HER2 CAR-SNK02’ at SITC... "Overcoming Limitations of Existing Treatments"

NKMAX announced on the 6th that it presented preclinical efficacy data of the CAR-SNK02 pipeline in a poster session at the Society for Immunotherapy of Cancer (SITC) in the United States.

SITC is the largest global conference in the field of immuno-oncology, with over 4,600 clinicians, scientists, and researchers from 63 countries worldwide as members. This year, it was held in San Diego, USA, from the 1st to the 5th.

At this conference, NKMAX presented research on the successful ex vivo expansion results of ‘HER2 CAR-SNK02’ and its strong anticancer effects against HER2-positive cancers. HER2 CAR-SNK02 is an allogeneic CAR-NK cell therapy product that is manufactured using NKMAX’s culturing technology by loading CAR (chimeric antigen receptor) targeting HER2 and cytokines that extend the in vivo survival and activation of NK cells onto SNK02, followed by cryopreservation.

The HER2 gene is highly expressed in patients with breast cancer, gastric cancer, and other cancers. Although trastuzumab is currently used for HER2-positive cancers, it has the drawback of frequent resistance despite maintained HER2 expression, making long-term treatment difficult.

According to the research results, HER2 CAR-SNK02 introduces the HER2-targeting chimeric antigen receptor and surface-attached cytokine genes into isolated NK cells. Then, using the existing SNK02 production process, it was produced by mass expansion up to one billion-fold during the culturing period (45?46 days) while maintaining the expression and function of the HER2-targeting chimeric antigen receptor.

HER2 CAR-SNK02 demonstrated enhanced anticancer ability and survival against HER2-positive cancer cells while maintaining the advantages of SNK02, an allogeneic NK cell therapy currently under development. Notably, it maintained improved cytotoxicity against HER2-positive cancer cells compared to SNK02 even after freezing and thawing. Additionally, in a mouse model implanted with human gastric cancer cell lines, experiments on antitumor activity confirmed in vivo long-term survival and anticancer effects.

Yongman Kim, head of NKMAX’s research institute, said, “We confirmed the potential of HER2 CAR-SNK02 in both therapeutic efficacy and culturing and cryopreservation technology.” He added, “It is particularly encouraging that it effectively eliminates cancer cells with low HER2 expression, where trastuzumab’s effect is limited, surpassing the limitations of existing treatments.”

Meanwhile, NKMAX has received approval from the Ministry of Food and Drug Safety for phase 1 and phase 1/2a clinical trial plans (IND) of the allogeneic NK cell therapy ‘SNK02’ targeting solid tumors and gastric cancer patients. In the United States, its subsidiary NKGen Biotech has received FDA approval for a phase 1 clinical trial of SNK02 for solid tumors and is currently conducting the clinical trial.

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