uterus adenocarcinoma

June 12, 2024 -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today presented details on its novel allogeneic blood-derived NK cell therapy (“SNK02”) commercial manufacturing and cryopreservation process by Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen, entitled, “Protecting Patients by Removing Need for Lymphodepletion to Better Preserve Immune Function”. Dr. Song also provided an update on the Company’s initial Phase 1 results using SNK02 to treat patients with advanced refractory solid tumors. Dr. Song’s presentation explored the potential benefits of eliminating pre-treatment lymphodepletion in patients undergoing SNK02 therapy, aiming to safeguard immune function and aid in recovery. Avoiding lymphodepletion before administering cancer treatment can provide many benefits including reduced toxicity, preservation of immune function and potentially enhancing treatment efficacy. 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. Moreover, unpublished Phase 1 SNK02 data were also presented. The Phase 1 clinical trial administered SNK02 intravenously (“IV”) weekly for a total of 8 weeks with a starting dose of 6 x 109 SNK02 cells in patients with advanced refractory solid tumors, without lymphodepletion. The primary endpoint was safety based on adverse events, vitals, laboratory tests and physical exams. Tolerability and maximum tolerated dose were also evaluated. SNK02 was found to be well tolerated as a monotherapy and appears to have some clinical activity against pretreated solid tumors despite the lack of lymphodepletion. Dr. Song commented during the presentation, “As most of the focus of NK cell therapy has been for liquid tumors with lymphodepletion, we have always believed that lymphodepletion could be detrimental to patients with solid tumors especially those being treated with immune checkpoint inhibitors, monoclonal antibodies or bispecific therapies where a robust immune response is essential. We therefore set out to develop a commercial scale manufacturing and cryopreservation process which could yield greater than 100,00 doses of SNK02 (cryopreserved enhanced activated allogeneic NK cells) with the idea that large doses could be delivered without lymphodepletion to potentially overcome any host versus graft reaction. We are pleased to show that, despite developing autoantibodies to sustained repeated dosing of our allogeneic product, SNK02 was safe and treatment appeared to stop the progression of several heavily pretreated solid tumors as a monotherapy. We are excited to further explore the efficacy of SNK02 in combination with immune checkpoint inhibitors and antibodies against solid tumors.” In the Phase 1 SNK02 clinical trial, 6 patients, with advanced refractory solid tumors and an average of 4 prior lines of therapy, were enrolled. The median age was 64 years old (range, 44–71), and 4 were male. The cancer subtypes included 2 colorectal cancers, 1 leiomyosarcoma, 1 angiosarcoma, 1 endometrial adenocarcinoma, and 1 undifferentiated pleomorphic sarcoma. 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. One patient received 18 consecutive weekly doses and another patient received 12 consecutive weekly doses. 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. There was 1 death on study, which was deemed unrelated to the IP. Auto-antibodies appeared to develop around Cycle 5 and appeared to correlate with AEs. There did not appear to be any correlation with KIR mismatch or HLA subtyping with AEs or tumor response. 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. SNK02 is a novel cell-based, donor-derived ex vivo expanded allogeneic NK cell immunotherapeutic drug candidate. NKGen Biotech, Inc. is developing SNK02 for the treatment of a broad range of cancers. NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK NK cell therapeutics. NKGen is headquartered in Santa Ana, California, USA. For more information, please visit www.nkgenbiotech.com. The content above comes from the network. if any infringement, please contact us to modify.

SNK02 has the potential to be a first-in-class cryopreserved allogeneic NK cell therapy for solid tumors that does not require lymphodepletion before administration, which may lead to better overall synergy in future combination regimens with immune checkpoint inhibitors. In this Phase 1 trial, the best objective response of stable disease was demonstrated in 100% of patients that completed 8 treatment cycles of SNK02. SNK02 was well tolerated as a monotherapy and appears to have some clinical activity against pretreated solid tumors despite the lack of lymphodepletion. SANTA ANA, Calif., May 23, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today announced an online publication, titled “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” at the 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. This Phase 1 clinical trial is a multi-center, open-label study evaluating the safety and tolerability of SNK02 in participants with pathologically confirmed solid tumors refractory to standard of care therapy. The study drug, SNK02, is a first-in-kind, cryopreserved allogeneic non-genetically modified NK cell product with significant anti-tumor cytotoxicity and over 90% expression of CD16, NKG2D, NKp46, and DNAM-1, that can be consistently produced on a large commercial scale. SNK02 was administered as an intravenous infusion (IV), weekly for eight weeks in patients with advanced solid tumors. The starting dose was 6x109 SNK02 cells. We hypothesized that higher doses of SNK02 (to overcome autodigestion) could be delivered frequently without the need for lymphodepletion and that it might demonstrate activity against solid tumors that have failed multiple prior standard-of-care treatment options. The primary endpoint was safety based on adverse events (AEs), vitals, laboratory tests, and physical exams. Tolerability of SNK02 and maximum tolerated dose were also evaluated. “Interim data from our Phase 1 clinical study utilizing our second NK cell therapy product, SNK02, demonstrated that the treatment was well-tolerated as a monotherapy in patients with solid tumors refractory to standard of care therapy,” said Paul Y. Song, MD, Chairman and CEO of NKGen. “We are particularly excited because SNK02 has the potential to be a first-in-class cryopreserved allogeneic NK cell therapy for solid tumors that does not require lymphodepletion before administration, which may lead to better overall synergy in future combination regimens especially with immune checkpoint inhibitors where a robust T-cell response is needed. Using our proprietary allogeneic manufacturing and cryopreservation processes, we are capable of producing hundreds of thousands of potential doses of enhanced NK cell therapies from materials collected from a single donor. Thus, our potential to treat a significant number of cancer patients with SNK02 is remarkably high. We are pleased to see such promising Phase 1 trial results for both of our unique cell therapy candidates: autologous SNK01 for neurodegenerative disease and allogeneic SNK02 for cancer.” For additional information on the SNK02 clinical trial, please visit https://www.clinicaltrials.gov/ using the identifier NCT05990920. Highlights from the online publication include: Five patients with advanced refractory solid tumors were enrolled in the trial.Patients had received an average of 4 lines of prior therapy.Median age was 64 (range 44 – 71) and 3 were male.The subtypes were 1 leiomyosarcoma, 1 angiosarcoma, 1 endometrial adenocarcinoma, 1 undifferentiated pleomorphic sarcoma, and 1 colorectal adenocarcinoma.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.There was 1 death on study, which was deemed unrelated to the IP.Auto-antibodies appeared to develop around cycle 5 and appeared to correlate with AEs.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. A copy of the ePublication will be available on the Scientific Publications page of the Company’s website at https://nkgenbiotech.com/. About SNK02 SNK02 is a novel cell-based, donor-derived ex vivo expanded allogeneic natural killer (“NK”) cell, immunotherapeutic drug candidate. NKGen Biotech, Inc. is developing SNK02 for the treatment of a broad range of cancers. About NKGen Biotech NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK NK cell therapeutics. NKGen is headquartered in Santa Ana, California, USA. For more information, please visit www.nkgenbiotech.com. Forward-Looking Statements Statements contained in this press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “could”, “continue”, “expect”, “estimate”, “may”, “plan”, “outlook”, “future” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Because such statements are subject to risks and uncertainties, many of which are outside of the Company’s control, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the Company’s plans and expected timing for developing SNK01, including the expected timing of completing and announcing further results from its ongoing clinical studies; statements regarding the Company’s plans and expected timing for developing SNK02, including the expected timing of completing and announcing further results from its ongoing clinical studies; and the Company’s expected timing for developing its product candidates and potential benefits of its product candidates. Risks that contribute to the uncertain nature of the forward-looking statements include: the Company’s ability to execute its plans and strategies; risks related to performing clinical studies; the risk that initial and interim results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; potential delays in the commencement, enrollment and completion of clinical studies and the reporting of data therefrom; the risk that studies will not be completed as planned; the risk that the abstract will not be published as planned including delays in timing, format, or accessibility; and NKGen’s ability to raise additional funding to complete the development of its product candidates. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in the Company’s filings and reports, which may be accessed for free by visiting the Securities and Exchange Commission’s website at www.sec.gov and on the Company’s website under the subheading “Investors—Financial and Filings”. Investors should take such risks into account and should not rely on forward-looking statements when making investment decisions. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Internal Contact:Denise Chua, MBA, CLS, MT (ASCP)Vice President, Investor Relations and Corporate Communications949-396-6830dchua@nkgenbiotech.com External Contacts:Chris CalabreseManaging DirectorLifeSci Advisors, LLCccalabrese@lifesciadvisors.com Kevin GardnerManaging DirectorLifeSci Advisors, LLCkgardner@lifesciadvisors.com

Study shows ctDNA positivity is the most prognostic factor, demonstrating the potential for Signatera to redefine adjuvant treatment pathways in endometrial cancer AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced a new study published in Gynecologic Oncology validating its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, in endometrial cancer. The full study can be found here. Endometrial cancer (EC) is the most common gynecologic malignancy in the United States. Disease incidence has been rising, but mortality has been rising even faster, potentially due to a higher frequency of aggressive high-risk subtypes of the disease.1-4 More accurate risk stratification is needed to identify those patients who will benefit from therapeutic interventions with curative intent. Current guidelines rely on clinicopathological risk factors to define risk groups and aid in adjuvant treatment decision-making.5,6 However, the decision to administer adjuvant therapy for patients with high-risk and high-intermediate-risk EC remains unclear, creating the need for better diagnostic tools to help determine who is most likely to benefit from treatment.7-10 This real-world study analyzed 267 plasma samples drawn after surgery from 101 patients with EC. The patient cohort was composed of multiple histological subtypes, with patients stratified based on clinicopathological risk factors into high-risk (52%), high-intermediate (22%), low-risk (15%), and other (12%). Key findings include: Patients who tested Signatera MRD-positive at either a single time point or longitudinally experienced significantly higher rates of recurrence than those who remained Signatera-negative (58% and 52%, vs. 6% and 0%, respectively), regardless of mismatch repair (MMR) or p53 status. Signatera MRD status was the only significant risk factor for recurrence when adjusted for clinicopathological risk groups and molecular subgroups such as MMR and p53 status (HR=18.9, p=.001). “This study provides clinical validation of Signatera as a powerful post-surgical biomarker of recurrence risk for patients with endometrial cancer,” said Minetta Liu, MD, chief medical officer of oncology at Natera. “Use of Signatera in clinical workflows may help physicians and patients tailor their adjuvant treatment decisions based on direct evidence of molecular residual disease.” About Signatera Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer (stage IIb and higher) and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 60 peer-reviewed papers. About Natera Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health, and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 180 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. For more information, visit . Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at and . References Temkin SM, Kohn EC, Penberthy L, Cronin KA, Rubinsak L, Dickie LA, et al. Hysterectomy-corrected rates of endometrial cancer among women younger than age 50 in the United States. Cancer Causes Control. 2018;29:427–33. Siegel RL, Miller KD, Fuchs HE, and Jemal A. "Cancer statistics, 2022. CA Cancer J Clin. 2022;72(1):7-33. National Cancer Institute. Surveillance, Epidemiology, and End Results Program. Cancer stat facts: uterine cancer. Accessed February 2, 2024. . Siegenthaler F, Lindemann K, Epstein E, et al. Time to first recurrence, pattern of recurrence, and survival after recurrence in endometrial cancer according to the molecular classification. Gynecol Oncol. 2022;165(2):230-238. Concin N, Matias-Guiu X, Vergote I, et al. ESGO/ESTRO/ESP guidelines for the management of patients with endometrial carcinoma. Int J Gynecol Cancer. 2021;31(1):12-39. Abu-Rustum N, Yashar C, Arend R, et al. Uterine Neoplasms, Version 1.2023, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2023;21(2):181-209. Keys HM, Roberts JA, Brunetto VL, et al. A phase III trial of surgery with or without adjunctive external pelvic radiation therapy in intermediate risk endometrial adenocarcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2004;92(3):744-51. Nout RA, Smit VT, Putter H et al. Vaginal brachytherapy versus pelvic external beam radiotherapy for patients with endometrial cancer of high-intermediate risk (PORTEC-2): an open-label, non-inferiority, randomised trial. Lancet. 2010;375(9717):816-23. Group AS, Kitchener H, Swart AM, Qian Q, Amos C, and Parmar MK. Efficacy of systematic pelvic lymphadenectomy in endometrial cancer (MRC ASTEC trial): a randomised study. Lancet. 2009;373(9658):125-36. de Boer SM, Powell ME, Mileshkin L, et al. Adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): final results of an international, open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2018;19(3):295-309.