HCC

Elevar Therapeutics to Participate in ASCO 2023 and BIO 2023; New Jersey-based Company Secures State License as It Builds Toward Commercialization

Retrieved on: 
Thursday, June 1, 2023
ACC, BIO, Partnership, Hepatocellular carcinoma, McCormick Place, Biotechnology, NDA, Licensure, TKI, Adenoid cystic carcinoma, Research, ASCO, Organization, American Society of Clinical Oncology, Patient, Annual general meeting, Convention center, Boston Convention and Exhibition Center, PD-1, FDA, Therapy, Regulation of tobacco by the U.S. Food and Drug Administration, Society, HCC, Food, New Drug Application, Pharmaceutical industry

Presentation details are as follows:

Key Points: 
  • Presentation details are as follows:
    Elevar also will attend BIO 2023, to be held June 5-8 at the Boston Convention & Exhibition Center in Boston, as it seeks partnership for global commercialization of rivoceranib.
  • In March, Elevar announced its move to a new corporate headquarters in Fort Lee, New Jersey.
  • It has now obtained its New Jersey Resident State Facility Inspection Report and is a licensed pharmaceutical wholesaler in the state, part of its strategic nationwide state licensing process.
  • We look forward to gaining licensure in every U.S. state as we prepare for commercialization of rivoceranib.”

Can-Fite Reports First Quarter 2023 Financial Results & Provides Clinical Update

Retrieved on: 
Thursday, June 1, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Acumen, Survival rate, Travel, Hepatocellular carcinoma, Pancreatic cancer, Liver cancer, Safety, Survival, American Society of Clinical Oncology, Rabin Medical Center, Journal, Hepatorenal syndrome, Patent, Patient, Liver failure, NYSE, HCC, A3, Disease, Therapy, NASH, Institutional review board, Food, EMA, Pancreas, Ascites, Liver, Cancer, Cirrhosis, FDA, Soroka Medical Center, Hepatic encephalopathy, Liver transplantation, Psoriasis, Fibrosis, Jaundice, CANF, Kidwai Memorial Institute of Oncology, TASE, Decompensation, American Journal of Clinical Oncology, Hepatology, Progression-free survival, Microsoft Access, WNT, ASCO, Green Light, Pivotal, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, Pharmaceutical industry, Medical imaging, Cryptocurrency

(NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory and liver diseases, today announced financial results for the three months ended March 31, 2023.

Key Points: 
  • (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory and liver diseases, today announced financial results for the three months ended March 31, 2023.
  • Safety and efficacy endpoints including objective response, progression-free survival, duration of response, disease control, and overall survival will be monitored.
  • The mechanism of action entails de-regulation of the Wnt signal transduction pathway, a key modulator of pancreatic carcinoma cell growth.
  • The Company's consolidated financial results for the three months ended March 31, 2023 are presented in accordance with US GAAP Reporting Standards.

Omega Therapeutics Presents New Preclinical Data Demonstrating the Potential of Omega Epigenomic Controllers™ to Synergize with Immunotherapies at the ASCO 2023 Annual Meeting

Retrieved on: 
Wednesday, May 31, 2023
Combination, MYC, Doctor of Philosophy, Hepatocellular carcinoma, Consistency, OEC, American Society of Clinical Oncology, Clinical trial, Liver tumor, Omega, NSCLC, Lung cancer, Immunotherapy, Messenger, ASCO, Liver, CD8, CBI, Annual general meeting, TME, Regional Security System, Standard of care, Therapy, IND, PD-L1, Tumor microenvironment, HCC, Society, Vaccine, Pharmaceutical industry

“The enhanced anti-tumor activity demonstrated in these preclinical data strongly support further investigation of MYC-targeting OECs in combination with clinically-validated approaches such as checkpoint blockade immunotherapies.

Key Points: 
  • “The enhanced anti-tumor activity demonstrated in these preclinical data strongly support further investigation of MYC-targeting OECs in combination with clinically-validated approaches such as checkpoint blockade immunotherapies.
  • MYC OECs downregulated expression of PD-L1 protein on the surface of HCC and NSCLC tumor cells in vitro.
  • The combination of MYC OEC and anti-PD-1 or anti-PD-L1 blockade significantly reduced tumor growth in a mouse xenograft liver tumor model compared to single agent treatment.
  • In immune-competent mouse allograft tumor models MYC OEC alone or in combination with CBI conferred anti-tumor immune memory.

Advances of Qilu Pharmaceutical's QL1706 in Clinical Research Presented at ASCO Annual Meeting

Retrieved on: 
Wednesday, May 31, 2023
Abstract, Male, Bevacizumab, Progression-free survival, Platelet, DCR, Overalls, Survival, RECIST, OS, Trae tha Truth, Multimedia, Poster session, Transfection, Immunotherapy, Carboplatin, Antibody, PFS, ASCO, American Society of Clinical Oncology, Proteinuria, ORR, Incidence, Etoposide, ECOG, HCC, PD-1, Smoking, III, Society, SD, Vaccine, Pharmaceutical industry, Part, Safety, Pharmacokinetics, Patient

JINAN, China, May 31, 2023 /PRNewswire/ -- The American Society of Clinical Oncology (ASCO) recently announced the selected abstracts for the prestigious ASCO 2023 Annual Meeting.

Key Points: 
  • JINAN, China, May 31, 2023 /PRNewswire/ -- The American Society of Clinical Oncology (ASCO) recently announced the selected abstracts for the prestigious ASCO 2023 Annual Meeting.
  • Four clinical research abstracts on QL1706 (iparomlimab/tuvonralimab), an innovative bifunctional antibody for immunotherapy, were accepted in the Poster Session.
  • Two of the posters focus on the latest clinical research progress of Qilu Pharmaceutical's QL1706 in extensive-stage small cell lung cancer (ES-SCLC) and advanced hepatocellular carcinoma (HCC).
  • These findings support further investigation of QL1706 plus bevacizumab for first-line treatment of advanced HCC in a phase III clinical trial.

ABK Biomedical Announces FDA IDE Approval for a Multi-Center Pivotal Study of Eye90 microspheres® in Hepatocellular Carcinoma

Retrieved on: 
Tuesday, May 30, 2023
Investigational device exemption, Hepatocellular carcinoma, ABK, Research, Radiation therapy, MD, Patient, NS, Principal, IDE, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Microparticle, HCC, Food, Safety, Medical device, Medical imaging

The pivotal clinical study, Route90, is designed to evaluate the safety and efficacy of Eye90 microspheres in patients living with unresectable Hepatocellular Carcinoma (HCC).

Key Points: 
  • The pivotal clinical study, Route90, is designed to evaluate the safety and efficacy of Eye90 microspheres in patients living with unresectable Hepatocellular Carcinoma (HCC).
  • The Route90 study will evaluate HCC tumors' response rates and duration of response from Eye90 microspheres treatment as co-primary endpoints.
  • "We're motivated to begin this pivotal study and assess the Eye90 microspheres technology in a large well-controlled, well-designed study.
  • Mike Mangano, President, and CEO, ABK Biomedical , said: "FDA approval of this pivotal study is a significant milestone for ABK.

Eisai Delivers New Data and Highlights Continued Progress of Oncology Portfolio and Pipeline at ASCO 2023

Retrieved on: 
Tuesday, May 23, 2023
CREB-binding protein, Carcinoma, Abstract, Senior, CBP, Cancer, Research, Trial of the century, ASCO, American Society of Clinical Oncology, Patient, Physician, Sorafenib, Oncology nursing, Annual general meeting, ADC, Poster, FDA, Survival analysis, Society, HCC, Safety, Nivolumab, Pharmaceutical industry, Eisai

NUTLEY, N.J., May 23, 2023 /PRNewswire/ -- Eisai announced today the presentation of research across various types of cancer from its oncology portfolio and pipeline during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (#ASCO23), which is taking place virtually and in-person in Chicago, Illinois from June 2 to 6.

Key Points: 
  • Eisai entered into a joint development agreement with BlissBio for BB-1701 with option rights for a strategic collaboration in April 2023.
  • A Phase 1/2 clinical study of BB-1701 in the U.S. and China for HER2-expressing solid tumors is currently underway.
  • There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.
  • These abstracts will be made available on Thursday, May 25, 2023 at 5:00 PM EDT.

RZNOMICS Inc. received FDA approval to initiate clinical development of trans-splicing ribozyme-based RNA editing technology in Glioblastoma Multiforme Patients

Retrieved on: 
Friday, May 19, 2023
Therapy, GBM, Alzheimer's disease, Reverse transcriptase, Safety, Retinitis pigmentosa, Mutation, Glioblastoma, RNA, Messenger, U.S. FDA, Patient, Tetrahymena, Retinitis, Toxic Small RNA, Mall of America, IND, HCC, Vaccine

Ribozyme-based RNA editing technology developed by Rznomics has unique features, differentiating it from other nucleic acid-based editing approaches, as follows: (1) A single RNA molecule is catalytically capable of both suppressing target RNA expression and simultaneously expressing a therapeutic RNA.

Key Points: 
  • Ribozyme-based RNA editing technology developed by Rznomics has unique features, differentiating it from other nucleic acid-based editing approaches, as follows: (1) A single RNA molecule is catalytically capable of both suppressing target RNA expression and simultaneously expressing a therapeutic RNA.
  • (2) Safety can be improved by selectively inducing therapeutic RNA expression only in cells/tissues where the target gene is expressed.
  • Through the advanced development phase, I hope Rznomics can provide more new therapeutic options to patients suffering from intractable diseases.
  • In addition to the HCC & GBM, Rznomics is developing ribozyme-based RNA editing treatments for Alzheimer's disease (RZ-003) and inherited retinal dystrophies, called Retinitis pigmentosa (RZ-004).

RZNOMICS Inc. received FDA approval to initiate clinical development of trans-splicing ribozyme-based RNA editing technology in Glioblastoma Multiforme Patients

Retrieved on: 
Friday, May 19, 2023
Therapy, GBM, Alzheimer's disease, Reverse transcriptase, Safety, Retinitis pigmentosa, Mutation, Glioblastoma, RNA, Messenger, U.S. FDA, Patient, Tetrahymena, Retinitis, Toxic Small RNA, Mall of America, IND, HCC, Vaccine

Ribozyme-based RNA editing technology developed by Rznomics has unique features, differentiating it from other nucleic acid-based editing approaches, as follows: (1) A single RNA molecule is catalytically capable of both suppressing target RNA expression and simultaneously expressing a therapeutic RNA.

Key Points: 
  • Ribozyme-based RNA editing technology developed by Rznomics has unique features, differentiating it from other nucleic acid-based editing approaches, as follows: (1) A single RNA molecule is catalytically capable of both suppressing target RNA expression and simultaneously expressing a therapeutic RNA.
  • (2) Safety can be improved by selectively inducing therapeutic RNA expression only in cells/tissues where the target gene is expressed.
  • Through the advanced development phase, I hope Rznomics can provide more new therapeutic options to patients suffering from intractable diseases.
  • In addition to the HCC & GBM, Rznomics is developing ribozyme-based RNA editing treatments for Alzheimer's disease (RZ-003) and inherited retinal dystrophies, called Retinitis pigmentosa (RZ-004).

Replimune Reports Fiscal Fourth Quarter and Year Ended 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, May 18, 2023
Bevacizumab, Radiation, CRC, Skin, Roche, Clinical trial, SCCHN, RP3, SOC, RP1, ASCO, CSCC, Patient, Standard of care, Melanoma, CPS, RP2, BLA, HCC, Nivolumab, Pharmaceutical industry

WOBURN, Mass., May 18, 2023 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of tumor-directed oncolytic immunotherapies, today announced financial results for the fiscal fourth quarter and year ended March 31, 2023 and provided a business update.

Key Points: 
  • R&D Expenses: Research and development expenses were $37.9 million for the fourth quarter and $126.5 million for the fiscal year ended March 31, 2023, as compared to $21.7 million for the fourth quarter and $79.5 million for the fiscal year ended March 31, 2022.
  • Research and development expenses included $2.3 million in stock-based compensation expenses for the fourth quarter and $10.1 million in stock-based compensation expenses for the fiscal year ended March 31, 2023.
  • Selling, general and administrative expenses included $4.6 million in stock-based compensation expenses for the fourth quarter and $18.1 million in stock-based compensation expenses for the fiscal year ended March 31, 2023.
  • Net Loss: Net loss was $49.2 million for the fourth quarter and $174.3 million for the fiscal year ended March 31, 2023, as compared to a net loss of $31.7 million for the fourth quarter and $118.0 million for the fiscal year ended March 31, 2022.

Elevar Therapeutics Submits New Drug Application to FDA for Combination of Rivoceranib and Camrelizumab as First-Line Treatment Option for Unresectable Hepatocellular Carcinoma

Retrieved on: 
Wednesday, May 17, 2023
Hepatocellular carcinoma, Progression-free survival, New Drug Application, NDA, TKI, Liver cancer, Death, Patient, Physician, Sorafenib, PD-1, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, HCC, Food, Pharmaceutical industry

HCC is the most common type of liver cancer and typically has a poor prognosis with a lack of treatment options.

Key Points: 
  • HCC is the most common type of liver cancer and typically has a poor prognosis with a lack of treatment options.
  • “Elevar Therapeutics’ submission of a New Drug Application for the combination of rivoceranib and camrelizumab marks an important milestone in our effort to provide an improved treatment option for patients confronted with uHCC,” said Saeho Chong, chief executive officer of Elevar.
  • With efficacy results generally consistent across all subgroups, the data suggested the combination confers a benefit in a global uHCC population.
  • Elevar is also developing rivoceranib as a monotherapy treatment option for adenoid cystic carcinoma (ACC), and as mono and combination therapies in other tumor cell types.