NKGen Biotech’s trial for SNK02 was initiated following the clearance of an investigational new drug application by the FDA in October 2022.
The first patient has been dosed in a phase 1 clinical trial (NCT05990920) evaluating NKGen Biotech’s SNK02, an allogeneic natural killer (NK) cell therapy intended to treat solid tumors.1
SNK02, which is comprised of NK cells isolated from the peripheral blood mononuclear cells of healthy donors that are expanded ex vivo, is manufactured using a proprietary process capable of producing hundreds of thousands of potential doses from a single donation. It is injected intravenously. Furthermore, the company's cryopreservation process allows the therapy to retain potency in its antitumor activity.2 The trial was initiated following the clearance of an investigational new drug application by the FDA in October 2022.
“We are excited to have dosed our first patient in the phase 1 SNK02 clinical trial in refractory cancer patients with limited treatment options,” Paul Y. Song, MD, the CEO of NKGen, said in a statement.1 “SNK02 seeks to be one of the first cryopreserved allogeneic NK cell therapy for solid tumors that does not require lymphodepletion before administration. We believe the lack of lymphodepletion has the potential to better preserve the already fragile immune function of heavily pre-treated cancer patients with advanced disease. If successful, this therapy may lead to better overall synergy in future combination regimens with immune checkpoint inhibitors where a robust T-cell response is needed.”
According to the clinicaltrials.gov page, the multicenter, open-label, dose-escalation trial will seek to recruit approximately 12 patients with any type of refractory cancer, although the company notes an emphasis on solid tumors. For 8 weeks, participants will receive administration of the cell therapy weekly. The study’s primary end points are the number of participants who experience dose-limiting toxicities, the maximum tolerated dose and/or ready for phase 2 dose, and the number of participants who experience treatment-related adverse events.
Alongside the announcement of the first patients’ dosing, NKGen Biotech also noted that it recently entered an agreement for a business combination with Graf Acquisition Corp IV. In mid-August, the US Securities and Exchange Commission declared effective Graf’s registration statement on Form S-4 for the proposed business combination.3 Through the combination, NKGen will become a publicly traded company.4
“The team at Graf fully understands and appreciates our novel NK cell therapy platform technology and our overall mission to help patients in real clinical need, especially those with neurodegenerative diseases,” Song said in an April 2023 statement.4 “We believe that the Business Combination represents a key step in our overall growth strategy. We believe having access to the public markets will help enable us to fund our clinical development in advanced neurodegenerative diseases and support the launch of our off-the-shelf allogenic program in oncology. We are looking forward to highlighting our technology and the many key roles NK cells play in human health, and we expect to demonstrate how our portfolio of autologous (SNK01), allogeneic (SNK02), and CAR-NK products may be used not only for cancer, but for neurodegenerative and autoimmune diseases as well.”
SNK01, an autologous NK cell therapy, is NKGen’s lead product candidate.5 It is currently being assessed in clinical trials as a monotherapy and as part of combination therapies with other treatments,such as checkpoint inhibitors and cell engagers, in patients with advanced refractory solid tumors. In February of this year, SNK01 was approved by the FDA for compassionate use in a patient with Parkinson disease.6