Pancreatic Cancer Research Team

SAN FRANCISCO, Feb. 05, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced it will host Part I of a virtual KOL investor event series on Tuesday, February 13, 2024 at 10:30 AM ET. To register, click here. The event will feature Andrew Ko, MD (University of California San Francisco (UCSF), UCSF’s Helen Diller Family Comprehensive Cancer Center) and Vincent Picozzi, MD, MMM (Virginia Mason Digestive Disease and Cancer Institutes, Virginia Mason Medical Center), who will discuss the unmet medical need and current treatment landscape for pancreatic cancer, as well as the clinical development program for pamrevlumab*, a potential first-in-class monoclonal antibody targeting connective tissue growth factor (CTGF) for pancreatic cancer treatment. The event will include information on the mechanism of action of pamrevlumab as well as a review of the pre-clinical and Phase 1/2 data for pamrevlumab and the two ongoing trials: the innovative Precision Promise℠ Phase 2/3 trial being conducted by the Pancreatic Cancer Action Network (PanCAN) for metastatic pancreatic cancer, and the LAPIS Phase 3 trial in locally advanced pancreatic cancer. A live question and answer will follow the formal presentations. The second event in the series, to be scheduled at a later date, will include a review of the development program for FG-3246; a Phase 2 ready CD46 targeting antibody-drug conjugate (ADC) for the treatment of metastatic castration-resistant prostate cancer (mCRPC). This series is intended for investor audiences only. About Andrew Ko, MDAndrew Ko, MD completed his medical training at the Johns Hopkins School of Medicine (Baltimore, MD) and Beth Israel Hospital/Harvard Medical School (Boston, MA) before moving out west to complete his oncology training at Stanford University. He is currently a Professor of Medicine and Associate Chief of the Division of Hematology/Oncology at the University of California San Francisco (UCSF) and a member of UCSF’s Helen Diller Family Comprehensive Cancer Center. His primary clinical and research interests center on gastrointestinal cancers, with a particular emphasis on pancreatic and gastroesophageal malignancies. He has been responsible for developing and leading numerous clinical trials evaluating novel therapeutic strategies for these disease indications (ranging from novel cytotoxics to molecular targeted agents to immunotherapies) supported by industry collaborators, the National Cancer Institute, and various consortia/foundations. His work also entails efforts to identify individual patient/tumor characteristics that influence prognosis and response to specific therapies, including both tissue- and blood-based biomarkers. In addition to his role as Associate Editor for the Journal of Clinical Oncology since 2016, he is currently chair of the NCI’s Pancreatic Cancer Task Force; has served on the scientific program committee, grants committee, and specialty editorial board for the American Society of Clinical Oncology (ASCO); has played a leadership role within the GI Committee of the Alliance for Clinical Trials in Oncology to shepherd new trial concepts in pancreatic cancer through this national cooperative group; and sits on the National Comprehensive Cancer Network Pancreatic Cancer guidelines committee. About Vincent Picozzi, MD, MMMVincent Picozzi, MD, MMM is Director for the Pancreas Center of Excellence, Virginia Mason Digestive Disease and Cancer Institutes, Virginia Mason Medical Center. A summa cum laude, Phi Beta Kappa graduate from Yale University, Dr. Picozzi obtained his MD degree from Stanford University, did his internship and residency at Harvard University (Brigham and Women’s Hospital), and fellowships in hematology and oncology again at Stanford. He also holds a masters degree in medical management Delta Omega, from Tulane University. Dr. Picozzi was an instructor in hematology and oncology at Stanford for two years before joining Virginia Mason, where he has been for the past 38 years. Dr. Picozzi directs an active, comprehensive clinical and translational research program in pancreaticobiliary cancer at Virginia Mason. He has one of the largest pancreaticobiliary oncology practices in the United States. He has published over 150 papers and abstracts, and is currently the principal investigator of 3 registration trials in pancreatic cancer. Dr. Picozzi has been a featured speaker at virtually every major clinical oncologic meeting in the United States, including ASCO (the American Society of Clinical Oncology), ASH (the American Society of Hematology), ASTRO (the American Society of Therapeutic Radiation Oncology), Digestive Diseases Week, AHPBA (The American HepatoPancreaticobiliary Association), ACOS ( the American College of Surgeons), the Best of ASCO, the GI Oncology Symposium and the World Pancreas Symposium. Dr. Picozzi also has held a number of leadership positions with national and regional organizations, including ASCO, ASH, the American College of Surgeons Oncology Group (ACOSOG), the Pancreatic Cancer Action Network (PanCAN) (current board member and formal national chairman), the Pancreas Cancer Research Team (PCRT-Executive Committee), the Washington State Medical Oncology Society (WSMOS- Past President x 2), and the Providence Hospice of Seattle (Executive Board). He is currently the Co-Principal investigator of the Precision Promise Clinical Initiative, sponsored by GCAR, in metastatic pancreatic cancer. About PamrevlumabPamrevlumab is a potential first-in-class antibody being developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF). Pamrevlumab is in clinical development for the treatment of metastatic pancreatic cancer and locally advanced unresectable pancreatic cancer (LAPC). The U.S. Food and Drug Administration has granted Orphan Drug Designation for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC), and Fast Track designation to pamrevlumab for the treatment of patients with LAPC. Pamrevlumab has demonstrated a safety and tolerability profile that has supported ongoing clinical investigation in LAPC and metastatic pancreatic cancer. Pamrevlumab is an investigational drug and not approved for marketing by any regulatory authority. For information about our pamrevlumab studies please visit www.clinicaltrials.gov. About FibroGen FibroGen, Inc. is a biopharmaceutical company focused on accelerating the development of novel therapies at the frontiers of cancer biology. Pamrevlumab, an anti-CTGF fully human monoclonal antibody, is in clinical development for the treatment of metastatic pancreatic cancer and locally advanced unresectable pancreatic cancer (LAPC). Roxadustat (爱瑞卓®, EVRENZO™) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted for review by the China Health Authority. FibroGen recently expanded its research and development portfolio to include antibody-drug conjugate (ADC) and immunoncology product candidates for the treatment of solid tumors. For more information, please visit www.fibrogen.com. Forward-Looking Statements This release contains forward-looking statements regarding FibroGen’s strategy, future plans and prospects, including statements regarding its clinical programs and those of its partner, PanCAN. These forward-looking statements include, but are not limited to, statements regarding the potential and probability of success of FibroGen product candidates, and statements about FibroGen’s plans and objectives and typically are identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. FibroGen’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in FibroGen’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, each as filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and FibroGen undertakes no obligation to update any forward-looking statement in this press release, except as required by law. *Pamrevlumab is an investigational drug and not approved for marketing by any regulatory authority. FibroGen, Inc.Investors:David DeLucia, CFAVice President of Corporate FP&A / Investor Relationsir@fibrogen.com Media:Meichiel KeenanDirector, Investor Relations and Corporate Communicationsmedia@fibrogen.com

A recent publication in "Cancer Discovery" reviewed Germline BRCA-associated pancreatic ductal adenocarcinoma (glBRCA PDAC) spectrum of responses to platinum and PARPi therapy, exploring the genomic and clinical features that may lead to different responses, and investigates the mechanisms of resistance. REHOVOT, ISRAEL / ACCESSWIRE / October 3, 2023 / The publication named "Spectrum of Response to Platinum and PARP Inhibitors in Germline BRCA-Associated Pancreatic Cancer in the Clinical and Preclinical Setting" was led by Dr. Talia Golan, Head of the Pancreatic Cancer Center at Sheba medical center, which is ranked one of the top 10 hospitals in the world by Newsweek, and by Chani Stossel, Ph.D., at the Oncology Institute. Curesponse The research presents clinical outcomes of 125 patients with glBRCA PDAC who were stratified based on the spectrum of response to platinum/PARP inhibition: (i) refractory [overall survival (OS) <6 months], (ii) durable response followed by acquired resistance (OS <36 months), and (iii) long-term responders (OS >36 months). Patient-derived xenografts (PDX) were generated from 25 patients with glBRCA PDAC at different clinical time points. Response to platinum/PARP inhibition in vivo and ex vivo culture (EVOC) was correlated with patients' clinical response. The cResponse assay, developed in collaboration between Curesponse and the Weizmann Institute of Science was used in this research. The assay is now being used in Curesponse laboratories in the UK and in Israel. The cResponse scores (cScore) were compared with the in vivo response for each model and treatment. A significant correlation between EVOC sensitivity to cisplatin and olaparib and in vivo tumor growth was noted (R2 = 0.59, n = 16, P < 0.001). Concordance was observed between EVOC and PDX response in 13/16 models, with a sensitivity of 100% and specificity of 89%. Overall, these results demonstrated a significant correlation between the clinical response to platinum agents and PARPi and the EVOC responses. The cResponse assays offer several advantages, with the main ones being the short turnaround time and the potential of performing several treatment combinations in parallel. The authors summarize the significance of the research being that glBRCA PDAC has a favourable response to platinum/PARP inhibition. However, most patients develop resistance. Such clinical distinction of patients may facilitate more informative treatment decisions. Additional treatment options for this unique subpopulation are needed. They generated model systems in PDXs and an ex vivo system (EVOC) that faithfully recapitulate these specific clinical scenarios as a platform to investigate the mechanisms of resistance for further drug development. "We were very happy to collaborate with Sheba's Pancreatic Cancer Center in this important study. The study demonstrated a strong correlation between the patients' clinical response and the cResponse algorithm score, which signifies the tumor's responsiveness to the tested therapies. The study's findings reinforced our prior clinical validations and showcased the capability of the cResponse algorithm to aid oncologists in selecting the most suitable and effective treatment options for individual patients and their particular cancer," said Dr. Vered Bar, the VP of Research & Development at Curesponse. The cResponse platform combines rapid next-generation sequencing (NGS) with a proprietary functional assay that assesses the response of a cancerous tissue to various drugs and drug combinations while preserving the tumor microenvironment (TME). The combined technology is the first personalized cancer platform that offers patients, oncologists, and pharma partners an empirical test that reflects the response of the patient's tumor to different drugs within two weeks from biopsy. The technology works across numerous therapeutic modalities, including chemotherapy, targeted therapy, and immunotherapy. The cResponse platform is CE marked and performed in an ISO 15189-accredited laboratory setting. The test is reimbursed by private payers in Israel for personalized cancer treatment decision guidance. cResponse will be offered to cancer patients in the UK, EU and the USA in 2024. For further information please contact info@curesponse.tech Contact Information Maoz Perlman Director of Sales & Marketing, Israel info@curesponse.tech Contact Information Guy Neev Chief Executive Officer info@curesponse.tech SOURCE: Curesponse View source version on accesswire.com:

FN Media Group Presents USA News Group News Commentary VANCOUVER, British Columbia, Sept. 26, 2023 /PRNewswire/ -- USA News Group - The seriousness of pancreatic cancer continues to grow, with increasing alarm since The Lancet published an analysis back in April 2023, showing a rising incidence of pancreatic cancer among individuals younger than 55 years. Another study published in JAMA Network Open showed that early-onset cancer in people younger than 50 rose over the last decade, with gastrointestinal cancers seeing the fastest increase. This has led to increased calls from pancreatic cancer organizations such as Pancreatic Cancer Action Network ( PanCAN) for more action in the space, including advocating that the US Congress invest more in cancer research funding now. Among the ongoing efforts that are drawing more attention in the pancreatic cancer space have been the developments coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Merus N.V. (NASDAQ: MRUS), Guardant Health, Inc. (NASDAQ: GH), Medtronic plc (NYSE: MDT), and even NVIDIA Corporation (NASDAQ: NVDA). PanCAN recently followed up their selection of pelareorep—the leading drug candidate of Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC)—for their pivotal Phase 3 trial, by rewarding the drug's developer with its second annual PanCAN Therapeutic Accelerator Award. The award comes with a US$5 million grant to further develop leading-edge treatments. For Oncolytics Biotech, the grant will enable the company to continue the next stage of its research focused on a clinical trial with pelareorep, this time in combination with modified FOLFIRINOX chemotherapy with or without an immune checkpoint inhibitor. "This generous grant will enable early and late-stage patients with pancreatic cancer to potentially benefit from another commonly employed chemotherapy backbone, as FOLFIRINOX and gemcitabine + nab-paclitaxel are the most frequently used chemotherapy standards of care in both the first and second-line setting," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "By teaming up with PanCAN, we believe we may be able to expedite development and provide pancreatic cancer patients with a bespoke immunotherapeutic treatment option." Prior to the award, ONCY successfully raised another US$15 million to continue the advancement of its pelareorep clinical programs in both pancreatic and metastatic breast cancers, with the significant support from an institutional investor. With the injection of another US$5 million from the PanCAN grant, Oncolytics is in an excellent cash runway position. According to their Q2 2023 financial results, on a pro forma basis, including the net proceeds from the public offering, Oncolytics had CAD$42.7 million on June 30, 2023, which should last them into the second half of 2024. "Our core programs in pancreatic and breast cancer are both progressing rapidly towards registrational studies on the back of the impressive clinical data showing the potential of pelareorep as a backbone immunotherapy," said Dr. Coffey. Pelareorep delivered the company a big win near the end of 2022, when the FDA rewarded it with a Fast Track Designation (FTD) for treating advanced or metastatic pancreatic cancer. This came right after an update on ONCY 's GOBLET study, which delivered amazing results, including a 69% objective response rate (ORR) in the first group of patients tested and one even having a rare complete response (CR). "With a five-year survival rate of 12%, pancreatic cancer patients cannot afford to wait for new treatment options," said Julie Fleshman, JD, MBA, President and CEO of PanCAN. "This urgent unmet need was the driving inspiration behind the Precision Promise platform trial, which was designed specifically to identify, accelerate, and de-risk the development of promising pancreatic cancer treatments. We are thrilled to be bringing pelareorep into Precision Promise as a new investigational therapy to study against the current standard of care." Another pancreatic cancer therapy that received a boost from the FDA was Merus N.V. (NASDAQ: MRUS), which, back in early July 2023, received a Breakthrough Therapy Designation for its drug Zeno (zenocutuzumab) for the treatment of patients with advanced, unresectable or metastatic NRG1 fusion pancreatic cancer that has gotten worse with a prior systemic therapy and has no other satisfactory treatment options. "We believe the compelling clinical data for Zeno in NRG1-positive cancer, and Breakthrough Therapy Designation, provide the opportunity to further engage with the FDA to expedite the review of a potential (Biologics License Application) submission," said Dr. Bill Lundberg, President and CEO of Merus. Based on information provided during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, it was found that 34% of patients who underwent treatment with Zeno witnessed a positive response. This response indicated a reduction in tumor size or complete disappearance, with an average response duration of 9.1 months. This data compilation involved 79 patients who were diagnosed with various solid cancers, all of whom had an NRG1 fusion. At the 2023 ASCO GI Annual Meeting there was a demonstration by Guardant Health, Inc. (NASDAQ: GH) of its blood tests for patients with gastrointestinal cancers. Spanning over 10 poster presentations, Guardant shared important updates of its Guardant360® and Guardant Reveal™ blood tests, as well as the GuardantINFORM™ real-world evidence dataset to identify critical biomarkers and acquired co-mutations, track associated treatment patterns and clinical outcomes, and predict disease recurrence from minimal residual disease (MRD) detection. The Guardant360 CDx test was the first blood test to be approved by the FDA for comprehensive genomic profiling for all solid tumors, and it is now FDA-approved as a companion diagnostic test for four targeted therapies in NSCLC and one in advanced breast cancer. While Guardant 's blood tests are making progress, endoscopic ultrasound (EUS) is still considered one of the most useful imaging studies for diagnosing pancreatic cancer, and the technology behind endoscopies is also rapidly progressing. Back in March, Medtronic plc (NYSE: MDT) announced a plan with Cosmo Pharmaceuticals NV and NVIDIA Corporation (NASDAQ: NVDA) to integrate Nvidia 's artificial intelligence technologies into Medtronic's GI Genius intelligent endoscopy module—the first FDA-cleared, AI-assisted colonoscopy tool to help physicians detect polyps that can lead to colorectal cancer. "The possibility for GI Genius to host multiple real-time AI applications is a game-changer for physicians performing gastrointestinal procedures," said Giovanni Di Napoli, president of the Gastrointestinal business at Medtronic. "With the launch of our AI Access™ platform, we are now able to support developers everywhere and accelerate the creation of real-time AI applications. This technology may allow us to offer clinicians expanded access to these tools, potentially improving patient outcomes. We believe that the AI Access platform may be a critical tool for advancing medical AI innovation and improving patient care in the years to come." Article Source: Article Source: USA News Group [email protected] DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). 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