SNK02 / NKMAX - LARVOL DELTA

Study of Allogeneic Blood-derived Natural Killer Cells to Evaluate Safety and Tolerability in Cancer Refractory to Conventional Therapy (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: NKGen Biotech, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Apr 2024 | Trial primary completion date: Aug 2024 ➔ Apr 2024

Trial completion • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

NKGen Biotech Presents Updated Phase 1 Data on SNK02 Allogeneic NK Cell Therapy for Solid Tumors at the 6th Annual Allogeneic Cell Therapies Summit 2024 (GlobeNewswire) - "NKGen Biotech, Inc...presented details on its novel allogeneic blood-derived NK cell therapy ('SNK02') commercial manufacturing and cryopreservation process....The presentation also included a discussion on the results from the Company’s Phase 1 SNK02 clinical study in solid tumors previously disclosed in a publication at the 2024 American Society for Clinical Oncology annual meeting....Four of six patients completed 8 cycles of SNK02. The best objective response of stable disease (tumor stopped growing) was demonstrated in 100% of patients that completed the 8 cycles....There did not appear to be any correlation with KIR mismatch or HLA subtyping with AEs or tumor response."

Clinical • P1 data • Angiosarcoma • Colorectal Cancer • Endometrial Adenocarcinoma • Endometrial Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Leiomyosarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma

Interim analysis of a phase I study using cryopreserved non-genetically modified allogeneic natural killer cells with enhanced cytotoxicity (SNK02) in patients with advanced solid tumors without lymphodepletion. (ASCO 2024) - P1 | "SNK02 was well tolerated as a monotherapy and appears to have some clinical activity against pretreated solid tumors despite the lack of lymphodepletion. SNK02 will continue to be studied as a monotherapy and in potential combination treatment regimens with monoclonal antibodies and immune checkpoint inhibitors. Clinical trial information: NCT05990920."

Clinical • IO biomarker • Metastases • P1 data • Angiosarcoma • Colorectal Adenocarcinoma • Colorectal Cancer • Endometrial Adenocarcinoma • Endometrial Cancer • Fatigue • Gastrointestinal Cancer • Leiomyosarcoma • Oncology • Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma • NKG2D

NKGen Biotech To Present Updated Phase 1 Data on SNK02 Allogeneic NK Cell Therapy in Solid Tumors at the 6th Annual Allogeneic Cell Therapies Summit 2024 (GlobeNewswire) - "NKGen Biotech...announced that Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen Biotech, will present details on their cryopreserved allogeneic NK cell therapy platform as well as updated Phase 1 data on its use in solid tumors without lymphodepletion at the 6th Annual Allogeneic Cell Therapies Summit....Dr. Song’s presentation will detail the Company’s novel allogeneic blood-derived NK cell therapy ('SNK02' commercial manufacturing and cryopreservation process, as well provide an update on their initial Phase 1 results using SNK02 to treat patients with advanced refractory solid tumors....The presentation will also include a discussion on an unexpected discovery from the SNK02 Phase 1 trial, hinting at its possible applicability as a treatment for patients beyond cancer."

P1 data • Solid Tumor

NKGen Biotech Publishes Phase 1 Interim Analysis Results of SNK02 Allogeneic NK Cell Therapy in Advanced Solid Tumors at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - P1 | N=6 | NCT05990920 | Sponsor: NKGen Biotech, Inc. | "This Phase 1 clinical trial is a multi-center, open-label study evaluating the safety and tolerability of SNK02...Highlights from the online publication include: Five patients with advanced refractory solid tumors were enrolled in the trial...Four of five patients completed 8 cycles of SNK02. The best objective response of stable disease (tumor stopped growing) was demonstrated in 100% of patients that completed the 8 cycles; Out of the 36 doses administered through Cycle 8, there were 17 Grade 1, 3 Grade 2, and 1 Grade 3 adverse events (AEs) related to investigational product (IP). The Grade 3 AE of increased fatigue resolved after 1 day with no intervention required...SNK02 was well tolerated as a monotherapy and appears to have some clinical activity against pretreated solid tumors despite the lack of lymphodepletion. SNK02 will continue to be studied as a monotherapy and in potential combination treatment..."

P1 data • Oncology • Solid Tumor

NKGen Biotech Announces Upcoming Publication at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - "NKGen Biotec...announced an online publication at the upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting to be held virtually and at the McCormick Place Convention Center in Chicago, Illinois from May 31–June 4, 2024."

P1 data • Solid Tumor

Study of Allogeneic Blood-derived Natural Killer Cells to Evaluate Safety and Tolerability in Cancer Refractory to Conventional Therapy (clinicaltrials.gov) - P1 | N=6 | Active, not recruiting | Sponsor: NKGen Biotech, Inc. | Recruiting ➔ Active, not recruiting | N=12 ➔ 6

Enrollment change • Enrollment closed • Gastrointestinal Cancer • Oncology • Solid Tumor

Study of Allogeneic Blood-derived Natural Killer Cells to Evaluate Safety and Tolerability in Cancer Refractory to Conventional Therapy (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: NKGen Biotech, Inc.

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Oncology • Solid Tumor

SNK-02 cell therapy clears tumors in HER2-driven tumor models (Bioworld) - "Researchers from Nkgen Biotech Inc. have developed an anti-HER2 CAR NK cell therapy, named SNK-02, as a potential immunotherapeutic for HER2-overexpressing tumors. SNK-02 was tested in a xenografted murine model of cancer."

Preclinical • Oncology • Solid Tumor

HER2-specific highly scalable CAR NK cell (anti-HER2-CAR SNK02) exhibits a significantly enhanced antitumor activity against HER2-expressing tumors as an off-the-shelf allogeneic immune cell therapy (SITC 2023) - "Background Although anti-HER2 monoclonal antibodies (e. g. , trastuzumab) are currently recognized as effective therapeutics in patients with HER2-overexpressing tumors, a significant number of patients demonstrate resistance to this treatment. In addition, the SNK02 platform serves as a valuable foundation for further exploration and advancement of genetically engineered NK cell therapies. We are currently testing the antitumor activity of the CAR-SNK02 cells in a xenograft mouse model of cancer expressing HER2 for future translation into human trials."

Immune cell • Oncology • Solid Tumor • IL15 • IL2

NKMAX 'Approved for domestic phase 1 clinical trial of allogeneic NK cell therapy for solid cancer' [Google translation] (Chosun Biz) - "NK Max announced on the 11th that it has received approval from the Ministry of Food and Drug Safety for a phase 1 clinical trial plan for its allogeneic natural killer (NK) cell therapy 'SNK02' for solid cancer patients....The main goal of this phase 1 clinical trial is to evaluate the tolerability and safety of SNK02 as well as confirm its anti-tumor effect. Therefore, a clinical trial will be conducted on 9 patients with solid cancer who have failed standard therapy. Clinical trials are planned to be conducted at Korea University Anam Hospital and Sinchon Severance Hospital."

New P1 trial • Oncology • Solid Tumor

Study of Allogeneic Blood-derived Natural Killer Cells to Evaluate Safety and Tolerability in Cancer Refractory to Conventional Therapy (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: NKGen Biotech, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Gastrointestinal Cancer • Oncology • Solid Tumor

NKGen Biotech, Inc. Announces First Patient Dosed in Phase I Clinical Trial of SNK02, Allogeneic NK Cell Therapy Product Candidate, for the Treatment of Solid Tumors (GlobeNewswire) - "NKGen Biotech, Inc...today announced the first patient has been dosed in a Phase I, multi-center, open-label, dose-escalation study evaluating its cryopreserved investigational allogeneic blood-derived NK cell therapy ('SNK02')....This Phase I clinical trial is evaluating the safety and tolerability of SNK02 in participants with pathologically confirmed solid tumors refractory to standard of care therapy. The study drug, SNK02, will be administered as an intravenous infusion, weekly for eight weeks."

Trial status • Oncology • Solid Tumor

Study of Allogeneic Blood-derived Natural Killer Cells to Evaluate Safety and Tolerability in Cancer Refractory to Conventional Therapy (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: NKGen Biotech, Inc.

New P1 trial • Gastrointestinal Cancer • Oncology • Solid Tumor

NKMAX announces research results of allogeneic CAR-NK cell therapy at SITC in the US [Google translation] (Medifonews) - "NKMax announced on the 3rd that its subsidiary, NKgen Biotech, will present a poster presentation of the research abstract at the American Society for Immuno-Oncology (SITC) to be held in November. The SITC Conference will be held in San Diego, California, USA from November 3rd to 5th....The abstract adopted this time is the anti-tumor effect of 'HER2-CAR SNK02' on HER2-expressing tumors..."

Preclinical • Oncology • Solid Tumor • HER-2

NKGen Biotech, Inc. to Become Publicly Traded Company via Business Combination with Graf Acquisition Corp. IV (GlobeNewswire) - "NKGen Biotech...and Graf Acquisition Corp. IV...announced today that they have entered into a definitive agreement (the 'Merger Agreement') for a business combination (the 'Business Combination'). Upon the closing of the Business Combination, Graf will be renamed 'NKGen Biotech, Inc.' and is expected to be listed on the New York Stock Exchange, NYSE American or Nasdaq under the ticker symbol 'NKGN'. Using cell expansion and activation technology and cell therapy manufacturing expertise, NKGen believes it can ultimately expand natural killer cells at commercial scale while significantly enhancing cytotoxicity."

M&A • Alzheimer's Disease • CNS Disorders • Oncology • Solid Tumor • Tauopathies And Synucleinopathies

NKMax applies for solid cancer phase 1 IND for allogeneic NK cell therapy [Google transaltion] (Pharm News) - "NKMax announced on the 3rd that it had applied for a clinical trial plan (IND) to administer its allogeneic NK cell therapy (SNK02) to patients with solid cancer to the Ministry of Food and Drug Safety. This clinical trial is a multicenter phase 1 clinical trial to evaluate SNK02 tolerability, safety, and antitumor effect in nine patients with metastatic or locally advanced solid cancer who have failed standard therapy....NKMAX has been approved for phase 1/2a clinical trials for advanced gastric cancer patients in Korea and phase 1 clinical trials for administering SNK02 to solid cancer patients in the United States, and is about to start clinical trials in the first half of the year."

New P1/2 trial • Trial status • Oncology • Solid Tumor

NKGen Biotech Receives IND Clearance from FDA for SNK02 Allogeneic Natural Killer Cell Therapy for Solid Tumors (GlobeNewswire) - "NKGen Biotech...announced that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance to commence a Phase 1, open-label, dose-escalation study of its cryopreserved 'off-the-shelf' allogeneic blood-derived NK cell therapy (SNK02) to evaluate safety and tolerability in participants with pathologically confirmed solid tumors refractory to standard of care therapy....The SNK02 clinical study will be a multi-center, open label, Phase 1 study of SNK02 in patients with advanced solid tumors who have failed at least one prior standard of care therapy....Initiation of the Phase 1 study in the U.S. is expected in Q1 2023."

IND • New P1 trial • Oncology • Solid Tumor