Hepatocellular carcinoma

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

Retrieved on: 
Friday, February 2, 2024

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.

Blue Faery Continues Its Love Your Liver Campaign During Black History Month

Retrieved on: 
Thursday, February 1, 2024

BIRMINGHAM, Ala., Feb. 1, 2024 /PRNewswire/ -- Black/African Americans are 50% more likely to get liver cancer than the general population, and incidence rates are climbing. The Love Your Liver campaign provides community members with convenient opportunities to learn more about their unique liver cancer risks and how to actively manage them. Type 2 diabetes and hepatitis C can both lead to liver cancer, so those in the Black/African American community who currently have or previously had one or both of those diseases are at higher risk for liver cancer. Both type 2 diabetes and hepatitis C are preventable and treatable, so education and early detection are vital to improving survival rates.

Key Points: 
  • Blue Faery is pleased to announce that its annual liver disease and cancer awareness campaign will continue in 2024 during Black History Month.
  • The Love Your Liver campaign provides community members with convenient opportunities to learn more about their unique liver cancer risks and how to actively manage them.
  • Love Your Liver Live, a Black History Month Community Event series, kicks off on February 22, 2024, at 7 p.m.
  • Blue Faery has many educational and advocacy programs, including Love Your Liver, The Truth About Liver Cancer, and You and Liver Cancer.

Biosyngen Announces FDA Fast Track Designation for BST02 in Treatment of Liver Cancer

Retrieved on: 
Thursday, February 1, 2024

SINGAPORE, Feb. 1, 2024 /PRNewswire/ -- Biosyngen is proud to announce that its latest groundbreaking product, BST02, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of all types of liver cancer, including hepatocellular carcinoma and cholangiocarcinoma.

Key Points: 
  • SINGAPORE, Feb. 1, 2024 /PRNewswire/ -- Biosyngen is proud to announce that its latest groundbreaking product, BST02, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of all types of liver cancer, including hepatocellular carcinoma and cholangiocarcinoma.
  • This marks the first TIL cell therapy drug for liver cancer to progress to the clinical stage globally.
  • Furthermore, another product from Biosyngen, BRG01, was granted fast track designation in July 2023.
  • It holds promise for the treatment of all types of liver cancer, offering new hope for patients.

Abpro Announces Filing of Registration Statement on Form S-4 in Connection with Business Combination Agreement with Atlantic Coastal Acquisition Corp. II

Retrieved on: 
Monday, January 22, 2024

Upon the closing of the proposed business combination, the combined company is expected to be named “Abpro Corporation” and to list its common stock on Nasdaq under the new ticker symbol “ABP”.

Key Points: 
  • Upon the closing of the proposed business combination, the combined company is expected to be named “Abpro Corporation” and to list its common stock on Nasdaq under the new ticker symbol “ABP”.
  • The proposed business combination sets Abpro’s implied pre-money equity valuation at $500 million.
  • Consistent with the recent signing of the Business Combination Agreement, the Atlantic Coastal and Abpro boards of directors have approved the proposed business combination, which is expected to be completed in the first half of 2024 subject to, among other things, the approval by Atlantic Coastal and Abpro stockholders, and other customary closing conditions.
  • Financial Group, LLC, is serving as financial advisor to Atlantic Coastal.

Elevar Therapeutics To Present Two Posters From Phase 3 CARES-310 Study at 2024 ASCO Gastrointestinal Cancers Symposium

Retrieved on: 
Thursday, January 18, 2024

ASCO GI will be held Jan. 18-20, 2024, at the Moscone Convention Center (West) in San Francisco, and online.

Key Points: 
  • ASCO GI will be held Jan. 18-20, 2024, at the Moscone Convention Center (West) in San Francisco, and online.
  • Elevar’s poster presentations are:
    Abstract Title: Impact of baseline liver function on survival outcomes in patients with unresectable hepatocellular carcinoma (uHCC) treated with camrelizumab + rivoceranib vs sorafenib: A post hoc analysis of study CARES-310.
  • The results of this post-hoc analysis may have implications for selection of initial and subsequent therapies for uHCC patients.
  • The FDA assigned Prescription Drug User Fee Act (PDUFA) target action dates in May 2024.

Median Technologies Reports 2023 Revenue and Summarizes 2024 Strategic Outlook

Retrieved on: 
Monday, January 29, 2024

Median Technologies (FR0011049824, ALMDT, PEA/SME eligible) announces its 2023 revenue, outlining both its strategic outlook and key milestones for 2024.

Key Points: 
  • Median Technologies (FR0011049824, ALMDT, PEA/SME eligible) announces its 2023 revenue, outlining both its strategic outlook and key milestones for 2024.
  • Fredrik Brag, Chief Executive Officer and Founder of Median Technologies, commented: "In Q4 2023, our iCRO1 business achieved record-high order intake, which increased significantly our backlog.
  • We expect to return to growth in 2024 on the back of a decline in 2023 revenue due to soft order intake in China caused by the Covid lockdowns in 2022 and H1 2023."
  • The Standalone study will be finalized in Q2 2024 and the MRMC study in Q3 2024.

Tvardi Therapeutics Announces Presentation of REVERT LIVER CANCER Phase 2 Clinical Trial Using TTI-101, A Novel STAT3 Inhibitor, at 2024 ASCO Gastrointestinal Cancers Symposium

Retrieved on: 
Thursday, January 18, 2024

Tvardi Therapeutics, Inc., a privately held, clinical-stage biopharmaceutical company focused on the development of STAT3 inhibitors, announced it will present a trials in progress poster at the upcoming 2024 ASCO Gastrointestinal Cancers Symposium on Friday, January 19, 2024, in San Francisco, CA.

Key Points: 
  • Tvardi Therapeutics, Inc., a privately held, clinical-stage biopharmaceutical company focused on the development of STAT3 inhibitors, announced it will present a trials in progress poster at the upcoming 2024 ASCO Gastrointestinal Cancers Symposium on Friday, January 19, 2024, in San Francisco, CA.
  • The poster will highlight the design of the ongoing REVERT LIVER CANCER study, a Phase 1b/2 trial evaluating safety and clinical activity of TTI-101, a novel STAT3 inhibitor, as monotherapy and in combination with standard of care in patients with locally advanced or metastatic, and unresectable hepatocellular carcinoma (HCC).
  • TTI-101 is an orally delivered, small molecule, direct inhibitor of STAT3.
  • For more information about the REVERT LIVER CANCER trial, please visit ClinicalTrials.gov (NCT05440708) .

OSE Immunotherapeutics Highlights Clinical Portfolio Advancements and Provides 2024 Outlook

Retrieved on: 
Friday, January 19, 2024

OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) updates on its clinical portfolio advancements and provides 2024 outlook.

Key Points: 
  • OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) updates on its clinical portfolio advancements and provides 2024 outlook.
  • Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: “The Company has a broad portfolio of 5 products in clinical development with significant advances reached in 2023 and key milestones expected in 2024.
  • Our shared ambition at OSE is to create value by leading our two advanced assets in phase 2 and phase 3 to a clinical inflection point allowing a structuring agreement.
  • Thus, from Q1 2024, the Company could have validated doses and therapeutic regimens to consider the implementation of possible other clinical trials.

Haystack Oncology, developer of Haystack MRD™, and TriSalus Life Sciences collaborate in connection with the clinical development of TriSalus' TLR9 agonist in hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and pancreatic adenocarcinoma

Retrieved on: 
Monday, January 22, 2024

"Haystack MRD's sensitivity enables clinical investigators to closely follow molecular response and measure early evidence of treatment efficacy.

Key Points: 
  • "Haystack MRD's sensitivity enables clinical investigators to closely follow molecular response and measure early evidence of treatment efficacy.
  • Intrahepatic cholangiocarcinoma is cancer that occurs in the parts of the bile ducts that are within the liver.
  • "A significant challenge in the development of immunotherapies for liver and pancreatic tumors is early measurement of response to treatment.
  • "We are thrilled to work with Haystack in pursuit of our mission to develop better therapeutic options for patients with liver and pancreatic tumors."

ASCO GI 2024: Golden Biotech's Antroquinonol Shows Significantly Prolonged Survival in Untreated Metastatic Pancreatic Cancer Patients

Retrieved on: 
Thursday, January 18, 2024

Metastatic Pancreatic Cancer remains a devastating disease with very low survival rate and significant unmet medical needs in terms of treatment options.

Key Points: 
  • Metastatic Pancreatic Cancer remains a devastating disease with very low survival rate and significant unmet medical needs in terms of treatment options.
  • The ASCO Gastrointestinal Cancers Symposium 2024 Committee has selected Golden Biotech's Phase 2 Study, titled "A Phase I/II study of Antroquinonol in combination with Nab-Paclitaxel and Gemcitabine for patients with metastatic pancreatic cancer," for poster presentation.
  • When compared to gemcitabine and other existing first-line therapies for metastatic pancreatic cancer, Antroquinonol in combination with the standard of care exhibited a significant survival advantage.
  • Antroquinonol in combination with the standard of care may provide patients with significantly improved median overall survival and reduced hematological side-effects.