Hepatocellular carcinoma

Genprex Collaborators Publish Positive Preclinical Data with NPRL2 Gene Therapy Utilizing Oncoprex® Delivery System

Retrieved on: 
Tuesday, April 2, 2024
TUSC2, Toxicity, LLC2, Gene, Growth, NSCLC, Diabetes, Risk, Patient, Lung, Neoplasm, Glioma, Mouse, Manuscript, Cancer, Pembrolizumab, NPRL2, Lung cancer, Stomach, BioRxiv, Hepatocellular carcinoma, NK, Natural killer T cell

AUSTIN, Texas, April 2, 2024 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that its research collaborators have published positive preclinical data for the NPRL2 tumor suppressor gene, utilizing the Company's non-viral Oncoprex® Delivery System, in KRAS/STK11 mutant anti-PD1 resistant non-small cell lung cancer (NSCLC) in a humanized mouse model.

Key Points: 
  • Genprex's Oncoprex® Delivery System is a novel non-viral approach that utilizes lipid-based nanoparticles in a lipoplex form to deliver tumor suppressor genes deleted during the course of cancer development.
  • Genprex believes this system allows for delivery of a number of cancer-fighting genes, alone or in combination with other cancer therapies, to combat multiple types of cancer.
  • "These positive preclinical data are very encouraging and support NPRL2 gene therapy as a potential treatment for a sub-group of NSCLC in which patients traditionally are resistant to existing therapies," said Rodney Varner, President, Chairman and Chief Executive Officer at Genprex.
  • In conclusion, researchers reported that NPRL2 gene therapy induces anti-tumor activity through dendritic cell-mediated antigen presentation and cytotoxic immune cell activation.

Harbour BioMed Reports Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 28, 2024
GMG, Patient, Stock exchange, Quality of life, Protein engineering, Bank statement, Investment, Therapy, Research, HBM, Biotechnology, Partnership, ITM, Motherboard, Trial of the century, Neonatal Fc receptor, Safety, PD-L1, ADC, Hepatocellular carcinoma, Boston Children's Hospital, U.S. FDA, Longevity, MSLN, Harbor, Hospital, NK, Engineering, NMPA, AstraZeneca, Biology, Ecosystem, Idea, Pharmaceutical industry

We recorded a significant increase in our revenue, demonstrating the Company's excellent global business development capabilities," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed.

Key Points: 
  • We recorded a significant increase in our revenue, demonstrating the Company's excellent global business development capabilities," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed.
  • Harbour BioMed recorded the profit of US$22.8 million for the year ended 31 December 2023.
  • This is the first time that the Company has recorded a net profit on its annual financial statements.
  • Looking to the future, Harbour BioMed will keep driving business growth and accomplishing its mission through two key pillars, Harbour Therapeutics and Nona Biosciences.

American Liver Foundation Statement on FDA Approval of Resmetirom

Retrieved on: 
Thursday, March 14, 2024
HCC, Liver failure, American Liver Foundation, Fatty liver disease, Liver disease, Disease, Caregiver, Risk, Cirrhosis, Inflammation, Chairperson, Patient, Life, Liver transplantation, Hope, Doctor of Philosophy, MASH, MD, ALF, Pharmacotherapy, Fibrosis, NASH, Hepatology, Hepatocellular carcinoma, NAFLD, FDA, Liver, Food, Pharmaceutical industry

FAIRFIELD, N.J., March 14, 2024 /PRNewswire/ -- Today, the Food and Drug Administration (FDA) granted accelerated approval of a first of its kind drug therapy, resmetirom, for the treatment of nonalcoholic steatohepatitis (NASH) in patients who have progressed to fibrosis. NASH, now called metabolic dysfunction-associated steatohepatitis or MASH, is a dangerously progressive form of nonalcoholic fatty liver disease* (NAFLD) and causes inflammation in the liver and liver damage.

Key Points: 
  • NASH, now called metabolic dysfunction-associated steatohepatitis or MASH, is a dangerously progressive form of nonalcoholic fatty liver disease * (NAFLD) and causes inflammation in the liver and liver damage.
  • "American Liver Foundation applauds the FDA approval of the groundbreaking new drug therapy treatment, resmetirom, for patients with NASH who have progressed to fibrosis," said Lorraine Stiehl , Chief Executive Officer, American Liver Foundation.
  • American Liver Foundation offers many free resources to patients and families affected by liver disease.
  • *Note: The nomenclature for NAFLD and NASH recently changed to metabolic dysfunction-associated liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH) respectively.

TriSalus Life Sciences Receives Approval from the World Health Organization and the American Medical Association’s Adopted Name Council for “Nelitolimod” as the Nonproprietary Drug Name for SD-101

Retrieved on: 
Thursday, March 7, 2024
Research, Medical Devices, Clinical Trials, Health Technology, Biotechnology, Health, Pharmaceutical, Science, Oncology, Liver, International, Neoplasm, Immunotherapy, Hepatocellular carcinoma, USAN, INN, Organization, World Health Organization, Tumor microenvironment, Patient, HCPCS, Cholangiocarcinoma, Publication, WHO, Cancer, Liver disease, Uveal melanoma

“The WHO INN and USAN approval of nelitolimod is an important milestone in the continued progress we are making with our nelitolimod program,” said Mary Szela, Chief Executive Officer and President of TriSalus.

Key Points: 
  • “The WHO INN and USAN approval of nelitolimod is an important milestone in the continued progress we are making with our nelitolimod program,” said Mary Szela, Chief Executive Officer and President of TriSalus.
  • This approach has the potential to enable more durable responses by patients to other immunotherapeutics, thereby facilitating better patient outcomes.
  • Information on nelitolimod will be posted on the USAN website ( www.ama-assn.org/go/usan ) and will be published in the Chemical Abstracts Service and in the U.S. Pharmacopeia.
  • Going forward, TriSalus will use the name in publications and public statements, at conferences and other forums, and in corporate-related materials.

TriSalus Life Sciences Announces Real-World Data Demonstrating the Ability of TriNav® to Successfully Treat Patients with Higher Disease Burden and to Improve Delivery of Therapeutics to Liver Tumors

Retrieved on: 
Thursday, February 29, 2024
Biotechnology, Pharmaceutical, Surgery, Oncology, Health, FDA, Medical Devices, Clinical Trials, Liver, FACS, Neoplasm, Blood, CMS, Immunotherapy, Liver disease, Hepatocellular carcinoma, Liver cancer, Manuscript, TACE, Data, Medicare, Patient, HCPCS, Disease, Clutch (eggs), HCC, Medical imaging

Key findings include that TriNav patients, despite a higher baseline disease burden and clinical complexity, showed overall clinical results comparable to patients with lower disease burden.

Key Points: 
  • Key findings include that TriNav patients, despite a higher baseline disease burden and clinical complexity, showed overall clinical results comparable to patients with lower disease burden.
  • In a matched cohort comparison, TriNav patients had fewer 30-day inpatient visits post-procedure than non-TriNav patients.
  • TriNav TARE patients with liver metastases had fewer clinical complications post-procedure vs. non-TriNav patients in a matched cohort comparison.
  • “This large sample size study underscores the particular benefits of the TriNav device compared to standard drug delivery systems.”

Immune-Onc Therapeutics Announces Clinical Trial Collaboration to Evaluate IO-108 in a Randomized Global Phase 1b/2 Study for First-Line Treatment of Advanced Liver Cancer

Retrieved on: 
Tuesday, February 20, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Bevacizumab, National Comprehensive Cancer Network, Food, Safety, LILRB2, Hepatocellular carcinoma, Therapy, HCC, ILT4, Roche, Patient, Immunotherapy, Cancer, Pharmaceutical industry

Atezolizumab and bevacizumab is the first cancer immunotherapy combination regimen approved by the U.S. Food and Drug Administration for this setting and is the recommended standard of care by the National Comprehensive Cancer Network.

Key Points: 
  • Atezolizumab and bevacizumab is the first cancer immunotherapy combination regimen approved by the U.S. Food and Drug Administration for this setting and is the recommended standard of care by the National Comprehensive Cancer Network.
  • “We are excited to work with Roche to accelerate the development of IO-108,” said Charlene Liao, Ph.D., chief executive officer and board chair of Immune-Onc.
  • “IO-108 has demonstrated clinical activity and an acceptable safety profile across multiple solid tumors as monotherapy and in combination with T cell checkpoint inhibitors.
  • The collaboration marks a significant milestone in establishing IO-108 as the preferred myeloid checkpoint inhibitor for combination with standard of care immunotherapy regimens in solid tumors.”
    Under the collaboration, Roche will sponsor and conduct the global, randomized Phase 1b/2 trial to evaluate the safety, efficacy and pharmacodynamics of IO-108 in combination with atezolizumab and bevacizumab compared to atezolizumab and bevacizumab, the standard of care treatment regimen for advanced liver cancer.

GC Cell and BioCentriq® Execute Process Transfer Agreement in Anticipation of the U.S. entry of Immuncell-LC Inj.

Retrieved on: 
Monday, February 26, 2024
Transfer, Liver, Recurrence, Hepatocellular carcinoma, Risk, CDMO, CIK, Commercial, Odds, Cancer, Patient, Link, Brain, HCC, Mortality, Partnership, Pharmaceutical industry

(Link)

Key Points: 
  • (Link)
    Through this agreement with BioCentriq, GC Cell is accelerating the transfer of Immuncell-LC Inj.
  • YONGIN, South Korea and NEWARK, N.J., Feb. 26, 2024 /PRNewswire/ -- GC Cell , a fully integrated cell therapy pioneer has announced a strategic partnership with BioCentriq , a cell therapy contract development and manufacturing organization (CDMO) and US affiliate of GC Cell.
  • "The Process Transfer Agreement between GC Cell and BioCentriq initiates the groundwork for introducing Immuncell-LC to the U.S. market" said James Park, CEO of GC Cell.
  • "We are thrilled to partner with GC Cell to bring Immuncell-LC, a proven autologous cell therapy to the U.S. Market.

Korea University Researchers Unveil Benefits of Perioperative Radiotherapy for Treating Liver Cancer with High Recurrence Risk

Retrieved on: 
Wednesday, February 7, 2024
OS, Radiation therapy, Rated R, Hepatocellular carcinoma, Survival, Meta-analysis, Patient, HCC, Recurrence, Canadian International Council, Radiation, Disease, Risk, DFS, Neoplasm, Cancer, Liver cancer, Liver, Survival rate, Korea University, Pharmaceutical industry

SEOUL, South Korea, Feb. 7, 2024 /PRNewswire/ -- More than two-thirds of patients with hepatocellular carcinoma (HCC), who receive surgical interventions, experience recurrence owing to lack of an established perioperative treatment. Now, researchers from Korea University have performed a meta-analysis to examine the oncological benefits of administering radiotherapy before or after surgery. The findings suggest that perioperative radiotherapy decreases the chances of recurrence in patients, improving their survival rate.

Key Points: 
  • Researchers have found that radiotherapy during liver cancer surgery reduces chances of recurrence and boosts survival for high-risk patients.
  • Now, researchers from Korea University have performed a meta-analysis to examine the oncological benefits of administering radiotherapy before or after surgery.
  • The findings suggest that perioperative radiotherapy decreases the chances of recurrence in patients, improving their survival rate.
  • This emphasizes the need for an adjuvant treatment like radiotherapy along with surgery for treating HCC patients with a high risk of recurrence.

Can-Fite Expands the Out-Licensing Deal with Ewopharma to Include the Pancreatic Cancer Indication

Retrieved on: 
Tuesday, January 30, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Hepatocellular carcinoma, CANF, Fatty liver disease, Pancreatic cancer, Psoriasis, HCC, CEE, Inflammation, NASH, Eisai, Pharmaceutical industry

to include the pancreatic cancer indication of Can-Fite.

Key Points: 
  • to include the pancreatic cancer indication of Can-Fite.
  • Ewopharma AG exercised its right to expand the distribution agreement to include the indication of pancreatic cancer and the transaction terms of the distribution agreement are applicable to such indication.
  • In addition to Can-Fite, Ewopharma AG has distribution agreements with many leading healthcare companies including Eisai and Biogen.
  • “We are very pleased to expand the distribution agreement with Ewopharma, a leader in pharmaceutical distribution in Central Eastern Europe and Switzerland and include the pancreatic cancer indication.

Rznomics Inc. Secures Orphan Drug Designation from FDA for RZ-001 in Hepatocellular Carcinoma

Retrieved on: 
Friday, February 2, 2024
GBM, RNA, Therapy, Tetrahymena, Patient, Safety, HCC, Mutation, FDA, Marketing, Messenger, MFDS, Reverse transcriptase, Hepatocellular carcinoma, ODD, Pharmaceutical industry

SEONGNAM, South Korea, Feb. 2, 2024 /PRNewswire/ -- Rznomics Inc., a South Korea based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, has received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for RZ-001, for the treatment of patients with Hepatocellular carcinoma (HCC).

Key Points: 
  • SEONGNAM, South Korea, Feb. 2, 2024 /PRNewswire/ -- Rznomics Inc., a South Korea based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, has received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for RZ-001, for the treatment of patients with Hepatocellular carcinoma (HCC).
  • This also may provide access to specialized regulatory assistance from FDA's Office of Orphan Products Development (OOPD).
  • "This FDA Orphan Drug Designation further underlines the potential of our pipeline to expeditiously address the current unmet medical needs of patients with Hepatocellular Carcinoma," said Seong-Wook Lee, CEO and founder of Rznomics.
  • Most recently, Rznomics has entered into an HCC clinical collaboration agreement with F.Hoffmann-La Roche Ltd (Roche) to study RZ-001, in combination with Roche's atezolizumab.