HCC

NiKang Therapeutics Enters into Clinical Trial Collaboration and Supply Agreement to Evaluate NKT2152 in Combination with Standard-of-Care in First-Line Advanced Hepatocellular Carcinoma

Retrieved on: 
Friday, December 8, 2023

This collaboration will utilize Roche’s MORPHEUS-LIVER phase 1b/2 platform for rapid and efficient combination development.

Key Points: 
  • This collaboration will utilize Roche’s MORPHEUS-LIVER phase 1b/2 platform for rapid and efficient combination development.
  • This randomized multi-regional phase 1b/2 trial is intended to evaluate the efficacy and safety of NKT2152 in combination with atezolizumab and bevacizumab versus atezolizumab and bevacizumab in patients with unresectable/advanced HCC not previously treated with systemic therapy.
  • Under the collaboration, Roche will sponsor the study, and each company will supply its respective anti-cancer agent to support the trial.
  • “Based on the compelling scientific rationale and supporting preclinical studies, we have a keen interest in assessing NKT2152 in HCC patients.

Can-Fite Reports Third Quarter 2023 Financial Results and Clinical Update

Retrieved on: 
Thursday, November 30, 2023

(NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced financial results for the nine months ended September 30, 2023.

Key Points: 
  • (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced financial results for the nine months ended September 30, 2023.
  • Financial income, net for the nine months ended September 30, 2023 was $0.38 million compared to financial expense, net of $0.14 million for the same period in 2022.
  • The decrease in financial expense, net was mainly due to revaluation of our short-term investment and increase in interest income from deposits in 2023.
  • The Company's consolidated financial results for the nine months ended September 30, 2023 are presented in accordance with US GAAP Reporting Standards.

Can-Fite: Complete Response and 6.9 Years Overall Survival in a Patient with Advanced Liver Cancer Treated with Namodenoson

Retrieved on: 
Tuesday, November 21, 2023

A patient with advanced HCC that was enrolled in the former Can-Fite Phase II study continues to receive treatment with namodenoson and has now an overall survival of 6.9 years with the disappearance of ascites, normal liver function, and good quality of life and defined as a complete response.

Key Points: 
  • A patient with advanced HCC that was enrolled in the former Can-Fite Phase II study continues to receive treatment with namodenoson and has now an overall survival of 6.9 years with the disappearance of ascites, normal liver function, and good quality of life and defined as a complete response.
  • Namodenoson has Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with the FDA for the treatment of HCC.
  • An interim analysis will be conducted by an Independent Data Monitoring Committee (IDMC) after 50% of enrolled patients are treated.
  • According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year.

FDA Grants Orphan Drug Designation to MAIA Biotechnology for THIO as a Treatment for Glioblastoma

Retrieved on: 
Friday, November 10, 2023

MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA” or the “Company”), a clinical-stage biopharmaceutical company developing telomere-targeting immunotherapies for cancer, announced today that the U.S. Food and Drug Administration (“FDA”) has granted orphan drug designation to its lead asset THIO, a cancer telomere-targeting agent, for the treatment of glioblastoma.

Key Points: 
  • MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA” or the “Company”), a clinical-stage biopharmaceutical company developing telomere-targeting immunotherapies for cancer, announced today that the U.S. Food and Drug Administration (“FDA”) has granted orphan drug designation to its lead asset THIO, a cancer telomere-targeting agent, for the treatment of glioblastoma.
  • This is the third orphan drug designation granted to THIO, following the receipt of orphan drug designations for hepatocellular carcinoma (HCC) and small cell lung cancer (SCLC) in 2022.
  • “We are pleased to receive a third orphan drug designation for THIO, further highlighting FDA’s recognition of THIO’s potential in the treatment of multiple cancer indications, including rare ones such as glioblastoma,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer.
  • “Each year, globally, more than 300,000 people are diagnosed with brain tumors, of which, 25,000 are in the United States.

AbelZeta Pharma Announces Agreement with AstraZeneca to Co-Develop a novel Glypican 3 (GPC3) Armored CAR-T Therapy in China

Retrieved on: 
Thursday, December 7, 2023

C-CAR031 is based on a novel GPC3-targeting CAR-T (AZD5851) designed by AstraZeneca using their transforming growth factor-beta receptor II (TGFβRII) dominant negative armoring discovery platform, and is manufactured by AbelZeta in China.

Key Points: 
  • C-CAR031 is based on a novel GPC3-targeting CAR-T (AZD5851) designed by AstraZeneca using their transforming growth factor-beta receptor II (TGFβRII) dominant negative armoring discovery platform, and is manufactured by AbelZeta in China.
  • Approximately 45% of deaths worldwide from HCC occur in greater China.2
    Under the terms of the agreement, AbelZeta will receive an upfront payment from AstraZeneca for the co-development and commercialization of C-CAR031 in China.
  • AbelZeta is also eligible to receive milestone payments and royalties for the global development of AZD5851, which is being solely developed, manufactured and commercialized by AstraZeneca outside of China.
  • "We are pleased to collaborate with AstraZeneca in pursuing this novel CAR-T treatment for solid tumors," said Tony (Bizuo) Liu, Chairman and CEO of AbelZeta.

NAYA Biosciences and ONK Therapeutics Announce Research Partnership to Advance Combination Therapy of FLEX-NK™ Bispecific Antibodies and Optimally Engineered Off-the-Shelf Natural Killer Cell Therapies

Retrieved on: 
Wednesday, December 6, 2023

Specifically, the partnership will explore the combination of NAYA's GPC3-targeted NY-303 FLEX-NK™ bispecific antibody with ONK's ONKT105, CISH + TGFβR2 double knock-out (KO), sIL-15 knock-in (KI) allogeneic NK cell therapy.

Key Points: 
  • Specifically, the partnership will explore the combination of NAYA's GPC3-targeted NY-303 FLEX-NK™ bispecific antibody with ONK's ONKT105, CISH + TGFβR2 double knock-out (KO), sIL-15 knock-in (KI) allogeneic NK cell therapy.
  • NAYA and ONK plan to assess several combination therapies in preclinical cancer models in 2024 prior to subsequently exploring initiating clinical trials.
  • NAYA's FLEX-NK™ bispecific antibodies are built on a proprietary tetravalent, multifunctional format with flexible linker, facilitating simultaneous binding to different antigens on one or multiple cells.
  • ONK has exclusive, worldwide rights to KO of CISH in NK cells, regardless of the source of the NK cells.

ABK Biomedical announces that its Eye90 microspheres® device has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA)

Retrieved on: 
Tuesday, December 5, 2023

HALIFAX, NS, Dec. 5, 2023 /PRNewswire/ - ABK Biomedical, Inc. , an innovative, medical device company dedicated to the research, development, and commercialization of advanced imageable embolic therapies, announces its Eye90 microspheres device has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).

Key Points: 
  • HALIFAX, NS, Dec. 5, 2023 /PRNewswire/ - ABK Biomedical, Inc. , an innovative, medical device company dedicated to the research, development, and commercialization of advanced imageable embolic therapies, announces its Eye90 microspheres device has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).
  • This designation is for the proposed Eye90 microspheres indication for the treatment of patients living with unresectable Hepatocellular Carcinoma (HCC).
  • "We are pleased with the FDA's decision to grant Breakthrough Device Designation for Eye90 microspheres Y90 radioembolization device.
  • Dr. Aravind Arepally, Chief Medical Officer of ABK Biomedical, stated, "Eye90 microspheres radioembolization marks a significant breakthrough in the treatment of HCC.

Iowa Total Care and the Centene Foundation Announce $2.55 Million Commitment to Central Iowa Shelter & Services

Retrieved on: 
Tuesday, November 28, 2023

DES MOINES, Iowa, Nov. 28, 2023 /PRNewswire/ -- Iowa Total Care, a provider of Medicaid healthcare coverage in Iowa and a wholly owned subsidiary of Centene Corporation (NYSE: CNC), and Centene Foundation, the philanthropic arm of Centene Corporation, today announced a partnership with Central Iowa Shelter & Services (CISS) to create an on-the-ground Housing Command Center (HCC) and a mobile application designed to address certain challenges people and communities face as a result of Social Determinants of Health (SDOH). The HCC is expected to launch in spring of 2025 and will house and support unsheltered individuals in downtown Des Moines, part of CISS' recovery housing complex, with two additional locations in Grinnell and Ottumwa. The app, which is slated to launch in spring of 2024, will offer real-time, action-oriented, person-centered information such as directions to housing, food, medical care, and other resources. By creating a more real-time match of individual and family needs with resources, the app will serve to help address the barriers to health and healthcare for more Iowans.

Key Points: 
  • The app, which is slated to launch in spring of 2024, will offer real-time, action-oriented, person-centered information such as directions to housing, food, medical care, and other resources.
  • Centene Foundation and Iowa Total Care are funding these initiatives and will invest $2.55 million over the course of two years.
  • The mobile app will enable CISS advocates and Iowa Total Care case managers to connect people more effectively to SDOH services.
  • The app will use geolocators to direct people to housing, food, medical care and other resources that deploy the right services in a timely manner.

Medivir announces updated formulation of fostrox, critical to support planned study with accelerated approval intent in second line HCC

Retrieved on: 
Monday, November 27, 2023

The need for new treatments is high and the development of an updated commercial formulation is an additional step towards fostrox becoming a treatment option for HCC patients.

Key Points: 
  • The need for new treatments is high and the development of an updated commercial formulation is an additional step towards fostrox becoming a treatment option for HCC patients.
  • The development efforts have been carried out by Quotient Sciences, Medivir's partner for formulation development and manufacture of drug product.
  • A formulation suitable for commercial manufacture is a critical component in clinical studies with regulatory intent.
  • - "With the plans to initiate a phase 2b study with registrational intent, it is imperative that we use the formulation intended for commercial launch in the study.

Karmanos Cancer Institute first to receive new FDA-approved treatment for advanced liver cancer

Retrieved on: 
Monday, November 13, 2023

DETROIT, Nov. 13, 2023 /PRNewswire/ -- Karmanos Cancer Institute, the largest provider of cancer care and research in Michigan and part of McLaren Health Care, announced today that it will be the first provider in the country to offer patients the new FDA-approved TheraBionic P1 device for the treatment of advanced hepatocellular carcinoma (HCC), the most common type of liver cancer. HCC accounts for approximately 90% of all liver cancers, with average survival rates between 6 and 20 months. The innovative TheraBionic P1 device is a novel at-home treatment that emits low levels of radio-frequency electromagnetic fields that block the growth of tumor cells without affecting healthy tissue. The device is approved for treating patients 18 years of age or older who fail first- and second-line therapies.

Key Points: 
  • HCC accounts for approximately 90% of all liver cancers, with average survival rates between 6 and 20 months.
  • The innovative TheraBionic P1 device is a novel at-home treatment that emits low levels of radio-frequency electromagnetic fields that block the growth of tumor cells without affecting healthy tissue.
  • The device is approved for treating patients 18 years of age or older who fail first- and second-line therapies.
  • "Often, patients with advanced hepatocellular carcinoma who fail first- and second-line therapies have severely impaired liver function, so additional treatment options are limited or nonexistent.