Malignant neoplasm of gastro-oesophageal junction

The collaboration exemplifies DDF's commitment to advancing gastrointestinal cancer research and treatment options for patients. FORT LAUDERDALE, Fla., March 19, 2024 /PRNewswire/ -- Debbie's Dream Foundation: Curing Stomach Cancer (DDF) announces an unprecedented collaboration with Memorial Sloan Kettering Cancer Center (MSK) that marks a significant leap forward in the field of gastric cancer research. Through the visionary efforts and support of DDF, a research fellowship grant has been established at MSK under the guidance of Dr. Yelena Janjigian, Chief of Gastrointestinal Oncology Service at MSK. The "Debbie's Dream Foundation Gastric Cancer Investigator" fellowship will focus on patient care, research, and education specifically for esophageal and gastric cancers. The collaboration is a testament to the shared commitment of DDF and MSK to fueling groundbreaking research and providing top-notch cancer care. Continue Reading Debbie's Dream Foundation: Curing Stomach Cancer Dr. Yelena Janjigian, a distinguished member of DDF's Scientific Medical Advisory Board, emphasized the importance of the DDF and MSK's partnership in shaping the future of gastric cancer research. "This fellowship signifies a commitment to excellence in gastroesophageal cancer research. With the support of DDF, we can provide dedicated time and resources to focus on advancing translational studies. This collaboration is pivotal in our collective efforts to better understand and treat esophageal and gastric cancers." Andrea Eidelman, Chief Executive Officer of DDF, expressed her pride in continuing to fund research that propels the organization's mission forward. "At DDF, we are deeply committed to advancing the landscape of gastric cancer research. This partnership with MSK is a significant step towards realizing our vision of a world without stomach cancer. Through the 'Debbie's Dream Foundation Gastric Cancer Investigator fellowship, we aim to make impactful strides in biomarker development, laboratory research, and translational studies in gastroesophageal cancer." DDF plans to contribute nearly $600,000 to fund this initiative over a three-year period, reinforcing the commitment to long-term support for innovative research. MSK will provide regular progress reports, ensuring transparency and accountability throughout the fellowship. Upon completion of the funding, MSK will recognize DDF for its invaluable contribution to advancing cancer research and patient care. Since 2014, DDF, in partnership with the American Association for Cancer Research (AACR), has invested $1.45 million in research grants to pioneering scientists in the United States. The 2023 AACR-Debbie's Dream Foundation Innovation and Discovery Grant recipients include Drs. Eunyoung Choi, Brent Allen Hanks, and Ryan H. Moy are exploring new targets and biomarkers for gastric cancer. Highlighting a significant milestone, DDF also celebrated Dr. Valerie O'Brien's recent discovery, funded by the 2018 Debbie's Dream Foundation-AACR Fellowship, of a precancerous cell type linked to H. pylori infection, offering new insights and therapeutic directions for gastric cancer. For more information about DDF programs and initiatives, please visit . About Debbie's Dream Foundation: Curing Stomach Cancer DDF is a 501(c)(3) non-profit organization dedicated to raising awareness about gastric cancer, advancing research funding, and providing international education and support to patients, families, and caregivers. DDF's ultimate goal is to make the cure for stomach cancer a reality. DDF was founded in 2009 by Debbie Zelman after she was diagnosed with stage IV incurable gastric cancer in 2008 and given only weeks to live. Debbie is considered a pioneer by many for bringing awareness to the plight of stomach cancer patients worldwide, as well as to the lack of federal funding for stomach cancer research. She did all of this while receiving hundreds of rounds of chemo and daily oral treatments. Debbie passed away on December 23, 2017, at 50, almost a decade later. As a result of her leadership, DDF now has a Scientific and Medical Advisory Board of world-renowned doctors and chapters throughout Canada and Germany. DDF strives to continue Debbie's mission to make her dream a reality. To learn more, visit . Media Contact Brittnay Starks, Communications Director Debbie's Dream Foundation: Curing Stomach Cancer (954) 475-1200 [email protected] SOURCE Debbie's Dream Foundation: Curing Stomach Cancer

Peer-Reviewed Research Indicates Whole Genome Biosimulation Holds Promise for Personalized Therapy Selection in Clinical Settings SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Cellworks Group Inc., a leader in Personalized Therapy Decision Support and Precision Drug Development, today announced the results from a real-world study of gastroesophageal cancer which found that Therapy Response Index (TRI) scores generated using the Cellworks Biosimulation Platform predicted overall survival (OS) above and beyond standard clinical factors, including patient age, sex, and tumor-node-metastasis (TNM) staging. The study also showed a significant association between a patient’s TRI score and disease-free survival (DFS) and tumor regression grade (TRG). The peer-reviewed paper, ‘Integration of genomic aberrations to predict clinical outcomes for patients with gastroesophageal adenocarcinoma receiving neoadjuvant chemotherapy,’ is available at ESMO Gastrointestinal Oncology. Despite progress in gastroesophageal cancer therapy, only a small proportion of patients attain long-term survival. Previous precision-based strategies have been constrained by focusing on single biomarker–drug associations. This oversimplified approach to the disease has resulted in a wide spectrum of patient outcomes, with long-term survival rates spanning from 25% to 75% using multi-modality therapy — a combination of chemotherapy, radiation, surgical resection, and adjuvant nivolumab, which has become the standard of care. “The focus for guiding treatment decisions for gastroesophageal patients has centered on specific biomarkers such as HER2, MSI, PD-L1 and CLD18.2,” said Dr. Elizabeth Smyth, Oxford University Hospitals NHS Foundation Trust; and Co-Principal Investigator of the study. “However, further refinement of treatment selection using computational biomarkers might be possible. This study highlights the unique value that Cellworks computational biosimulation can bring to the treatment decision process by utilizing a patient's comprehensive genomic pro biosimulating all possible therapy combinations. This approach could offer a promising avenue for recommending a treatment strategy at an individual level, thereby improving patient outcomes." "The size and complexity of comprehensive genomic panels pose a formidable challenge, making it difficult for oncologists to translate the intricate biology into actionable clinical decisions,” said Dr. Rebecca Fitzgerald, MD, Professor of Cancer Prevention at the University of Cambridge; Director of the Early Cancer Institute; and Co-Principal Investigator of the study. “This study demonstrates that utilizing whole genome sequencing of a patient’s gastroesophageal cancer along with Cellworks personalized biosimulation approach has the potential to highlight when alternative treatment strategies such as fluoropyrimidines, taxanes, anthracyclines or platinum compounds may yield superior outcomes for a specific patient." "The transition from small panel NGS to whole exome and whole genome sequencing brings new insights about each cancer’s complex proteogenomic network,” said Dr. Michael Castro M.D., Oncologist at Beverly Hills Cancer Center; and Chief Medical Officer at Cellworks, Group Inc. “These insights reveal the basis for drug sensitivity and resistance that allows oncologists to select the optimal combination therapy for individual patients and creates the possibility of targeting the sources of therapeutic resistance. The view that genomic information is ‘unactionable’ is transformed by artificial intelligence (AI)-level molecular diagnosis provided by Cellworks’ biosimulation. Most genomic information that can be measured is highly relevant to tumor biology and treatment response but is beyond the grasp of busy clinicians. With Cellworks biosimulation, the oncogene-only approach to precision medicine is already obsolete.” Clinical Study Methods The performance of Cellworks in silico biosimulation and Therapy Response Index (TRI) scores were studied in patients with gastroesophageal adenocarcinoma (OGA) with operable cancers from the UK Oesophageal Cancer Clinical and Molecular Stratification (OCCAMS) International Cancer Genome Consortium study. A total of 270 patients with OGA were selected who had 50x whole genome sequencing carried out on tissue derived from either biopsy or resection within 12 months of treatment. Patients were treated with chemotherapy drugs or regimes according to UK clinical guidelines. Biosimulation was carried out utilizing the Cellworks computational biology model (CBM), which uses both mechanistic and statistical approaches to integrate a patient’s genomic aberrations, revealing signaling pathway dysregulation and variable drug response. Using patient-specific predictions derived from the CBM, a TRI score was used to predict therapeutic overall survival (OS), disease-free survival (DFS) and tumor regression grade (TRG). Results The results of the study revealed that the association of TRI value with overall survival (OS) for gastroesophageal adenocarcinoma patients was significant (P = 0.0012) above and beyond standard clinical factors including patient age, sex, tumor-node-metastasis (TNM) stage and neoadjuvant therapy. The association between TRI values and disease-free survival (DFS) was also significant (P = 0.0288). In addition, the TRI values optimized for tumor regression grade (TRG) displayed a significant association (P = 0.0011). Conclusions This study concluded that TRI scores for gastroesophageal adenocarcinoma patients predict OS and DFS beyond clinical factors. These results highlight the clinical value of employing Cellworks biosimulation for personalized therapy selection and warrant additional clinical evaluation. Cellworks Platform and Therapy Response Index (TRI) The Cellworks Platform biosimulates the impact of specific drug compounds on an individual patient or class of patients using their genomic profile. Multi-omic data from an individual patient or cohort is used as input to the in silico Cellworks Computational Biology Model (CBM) to generate a personalized or cohort-specific disease model. The CBM is a highly curated mechanistic network of 6,000+ human genes, 30,000 molecular species and 600,000 molecular interactions. This model along with associated drug models are used to biosimulate the impact of specific compounds or combinations of drugs on the patient or cohort and produce therapy response predictions, which are statistically modeled to produce a qualitative Therapy Response Index (TRI) score, scaled from 0 (unfavorable outcome) to 100 (favorable outcome) for a specific therapy. The Cellworks CBM has been tested and applied against various clinical datasets with results provided in over 125 presentations and publications with global collaborators. About Cellworks Group Cellworks Group, Inc. is a leader in Personalized Therapy Decision Support and Precision Drug Development. The Cellworks Platform predicts therapy response for individual patients and patient cohorts using a breakthrough Computational Biology Model (CBM) and biosimulation technology. Backed by Artiman Ventures, Bering Capital, Sequoia Capital, UnitedHealth Group and Agilent Ventures, Cellworks has the world’s strongest trans-disciplinary team of molecular biologists, cellular pathway modelers and software engineers working toward a common goal – attacking serious diseases to improve the lives of patients. The company is based in South San Francisco, California with a research and development facility in Bangalore, India. For more information, visit cellworks.life. All trademarks and registered trademarks in this document are the properties of their respective owners.

Dr. Yelena Janjigian, Chief of GI Cancers, Leads Investigator Sponsored Study at Memorial Sloan Kettering Cancer CenterTrial is Supported by Stand Up To Cancer as Part of an Initiative to Find Treatments for the ~70% of Gastroesophageal Cancer (GEC) Patients for Whom Current Treatments Don't WorkRandomized Phase 2 Represents First Novel Combination of Allogeneic Cell Therapy with BOT/BAL Through Collaboration of Agenus and MiNK NEW YORK, Feb. 14, 2024 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases, today announced the first patient dosed in a Phase 2 investigator sponsored study for agenT-797 in second line gastroesophageal cancer, led by Dr. Yelena Janjigian at Memorial Sloan Kettering Cancer Center. The trial builds upon findings from MiNK’s recently published clinical trial (Carneiro et al. 2024 Oncogene) demonstrating that agenT-797 appears to overcome resistance to immune checkpoint inhibitors, with durable disease stabilization and a confirmed response in chemotherapy and anti-PD-1 refractory gastric cancer. “This study is an important step in new treatment combinations to improve outcomes for patients with refractory gastric cancers, an incurable disease with limited response to available therapies,” said Dr. Yelena Janjigian, Chief Gastrointestinal Oncology Service at Memorial Sloan Kettering Cancer Center. "AgenT-797, an off-the-shelf iNKT cell-based therapy, has shown the capacity to target cancerous cells in diseased tissues and is compatible with immune checkpoint inhibitors. This study builds upon the promising outcomes observed with iNKTs in gastric cancer and with botensilimab/balstilimab in GI cancers. By harnessing the immune-enhancing potential of agenT-797, we aspire to improve outcomes for a greater number of patients facing challenging GI cancers." This Phase 2 Study will evaluate the clinical safety and efficacy of the combination of agenT-797 (iNKT cells), botensilimab, a novel fc-enhanced CTLA-4 inhibitor, plus balstilimab (anti-PD-1) with ramucirumab and paclitaxel for patients with previously treated, advanced esophageal, gastric, or gastro-esophageal junction (GEJ) adenocarcinoma. The study aims to enroll around 38 patients with advanced, unresectable, or metastatic forms of these cancers who have experienced disease progression after initial treatment. "We are thrilled to collaborate with GI cancer expert Dr. Yelena Janjigian on this Phase 2 study, furthering the development of agenT-797 in refractory gastric cancer," stated Dr. Jennifer Buell, President and Chief Executive Officer at MiNK. "This study is designed to provide crucial insights into the clinical efficacy of agenT-797, while also assessing its potential synergies with chemotherapy and next-generation immune checkpoint inhibitors, botensilimab and balstilimab. This milestone underscores our unwavering commitment to advancing iNKT cell therapies to address the pressing unmet needs in cancer care and highlights the strength of our collaboration with Agenus to access these novel and exciting combinations to deliver meaningful benefits to our patients." About Botensilimab Botensilimab is Agenus’ investigational multifunctional anti-CTLA-4 immune activator (antibody) designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to "cold" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Approximately 750 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316. About MiNK Therapeutics MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases. MiNK is advancing a pipeline of both native and next generation engineered iNKT programs, with a platform designed to facilitate scalable and reproducible manufacturing for off-the-shelf delivery. The company is headquartered in New York, NY. For more information, visit https://minktherapeutics.com/ or @MiNK_iNKT. Information that may be important to investors will be routinely posted on our website and social media channels. Forward Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the therapeutic and curative potential of agenT-797 and iNKT cells the mechanism of action, potency and safety, interim or top-line data, including statements regarding clinical data of agenT-797 alone and in combination with other therapeutic candidates, for instance, anti-CTLA-4 and anti-PD-1, the anticipated benefits of agenT-797 and clinical development plans and timelines. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These forward-looking statements are subject to risks and uncertainties, including the factors described under the Risk Factors section of the most recent Form 10-K, Form 10-Q and the S-1 Registration Statement filed with the SEC. MiNK cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and MiNK undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Investor Contact917-362-1370investor@minktherapeutics.com Media Contact781-674-4428communications@minktherapeutics.com