Hepatocellular carcinoma

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.

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.

Oncorus Reports First Quarter 2023 Financial Results and Provides Business Updates

Retrieved on: 
Monday, May 22, 2023
Interim, Hepatocellular carcinoma, Cancer, Security agreement, Research, RNA, Lung cancer, PwC, Eli Lilly, Genzyme, Acquisition, Investment, Patient, Melanoma, FDA, Loan, Market for corporate control, Renal cell carcinoma, Pharmaceutical industry, Vaccine, Cryptocurrency, IND

On May 9, 2023, Oncorus appointed Alexander Nolte as its interim Chief Financial Officer.

Key Points: 
  • On May 9, 2023, Oncorus appointed Alexander Nolte as its interim Chief Financial Officer.
  • Research and development expenses for the quarter ended March 31, 2023 were $10.6 million compared to $12.5 million for the corresponding quarter in 2022.
  • General and administrative expenses for the quarter ended March 31, 2023 were $4.5 million compared to $5.3 million for the corresponding quarter in 2022.
  • Oncorus expects its cash, cash equivalents and investments, following the full prepayment of its debt capital facility with K2HV in May 2023, to fund its operations into the third quarter of 2023.

KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Demonstrates Long-Term, Durable Survival Benefit Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma

Retrieved on: 
Thursday, May 25, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, Senior, Hepatocellular carcinoma, Pharming, Sunitinib, Survival, Everolimus, RECIST, Head, DO, Cancer, Patient, Stomatitis, Risk, NYSE, Fatigue, Texas Oncology, Diarrhea, Pembrolizumab, FACP, MRK, Research, Lung cancer, Merck & Co., Hypertension, LEAP, HIV disease progression rates, IMDC, Esophageal cancer, Memorial Sloan Kettering Cancer Center, PD-1, Abstract, Death, Safety, Lenvatinib, Overalls, Multimedia, PFS, CR, Stomach, ORR, Acral lentiginous melanoma, IRC, Progression-free survival, RCC, CI, OS, Drug, Trae tha Truth, MSKCC, Hypothyroidism, EDT, ASCO, American Society of Clinical Oncology, Cancer Treatment Centers of America, Physician, Quality of life (healthcare), Annual general meeting, Nausea, Interpretation, Society, Pharmaceutical industry, Dietary supplement, Merck, EU, Eisai

After four years of follow-up, KEYTRUDA plus LENVIMA maintained a clinically meaningful OS benefit versus sunitinib, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]).

Key Points: 
  • After four years of follow-up, KEYTRUDA plus LENVIMA maintained a clinically meaningful OS benefit versus sunitinib, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]).
  • The 24- and 36-month estimated OS rates were 80.4% and 66.4% for KEYTRUDA plus LENVIMA versus 69.6% and 60.2% for sunitinib, respectively.
  • Results from the final pre-specified OS analysis were consistent with the superior results versus sunitinib from the primary OS analysis of the CLEAR/KEYNOTE-581 trial.
  • Grade ≥3 treatment-related adverse events (TRAE) occurred in 74.1% of patients who received KEYTRUDA plus LENVIMA versus 60.3% of patients who received sunitinib.

BeiGene Presentations at the 2023 ASCO Annual Meeting Reinforce Promise Across Oncology Portfolio

Retrieved on: 
Thursday, May 25, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Abstract (summary), Rituximab, Obinutuzumab, BGNE, EU, Doctor of Philosophy, Hepatocellular carcinoma, Lymphoid leukemia, NA, Lenalidomide, OS, Trae tha Truth, Head, Toxicity, Multimedia, BCLC, Lung cancer, ASCO, PLR, Incidence, SSE, OX40, American Society of Clinical Oncology, Patient, Sorafenib, NLR, Annual general meeting, Bone marrow, Abstract, Society, ORR, Tislelizumab, Pharmaceutical industry, Vaccine, Flour, BeiGene

These results include data for BeiGene’s cornerstone therapies, BRUKINSA® (zanubrutinib) and tislelizumab, as well as early results for BeiGene’s OX40 agonist and BCL-2 inhibitor.

Key Points: 
  • These results include data for BeiGene’s cornerstone therapies, BRUKINSA® (zanubrutinib) and tislelizumab, as well as early results for BeiGene’s OX40 agonist and BCL-2 inhibitor.
  • These results will be presented on Monday, June 5, as poster presentations from 8:00-11:00 a.m. CT. (Abstracts #4082 and #4083).
  • BGB-11417 monotherapy also showed promising initial efficacy results in R/R chronic lymphocytic leukemia/small lymphocytic lymphoma, with patients achieving responses at lower dose levels.
  • These results will be presented on Monday, June 5, as a poster presentation from 8:00-11:00 a.m. CT (Abstract #7558).

RayzeBio to Present at Upcoming Medical Conferences

Retrieved on: 
Monday, May 22, 2023
Oncology, Health, Radiology, Research, Science, Pharmaceutical, Biotechnology, Somatostatin, GEP-NET, ASCO, Society of Nuclear Medicine and Molecular Imaging, Hepatocellular carcinoma, IL, SSA, Society, Carcinoma, American Society of Clinical Oncology, Pharmaceutical industry

RayzeBio, Inc., a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, today announced that the Company will be presenting data for its lead clinical program, RYZ101 (Ac225 DOTATATE) at two upcoming medical conferences as well as presentations on preclinical programs.

Key Points: 
  • RayzeBio, Inc., a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, today announced that the Company will be presenting data for its lead clinical program, RYZ101 (Ac225 DOTATATE) at two upcoming medical conferences as well as presentations on preclinical programs.
  • 2023 American Society for Clinical Oncology (ASCO) annual meeting: June 2 - 6 in Chicago, IL
    Title: ACTION-1 phase 1b/3 trial of RYZ101 in somatostatin receptor subtype 2–expressing (SSTR2+) gastroenteropancreatic neuroendocrine tumors (GEP-NET) progressing after 177Lu somatostatin analogue (SSA) therapy: Initial safety analysis.
  • Australian and New Zealand Society of Nuclear Medicine (ANZSNM): May 26 - 28 in Adelaide, Australia
    Title: Anti-tumor activity of RYZ101 in somatostatin receptor-expressing preclinical models of small-cell lung cancer.
  • Title: Novel peptide binder to Glypican-3 for targeted radiopharmaceutical therapy of hepatocellular carcinoma.

Hepion Pharmaceuticals Schedules Conference Call to Review Topline Results from Phase 2 ‘ALTITUDE-NASH’ Liver Function Trial of Rencofilstat

Retrieved on: 
Friday, May 19, 2023
Fatty liver disease, Artificial intelligence, Conditional sentence, HEPA, Hepatocellular carcinoma, Pharmaceutical industry

Hepion is pleased to invite all interested parties to participate in a conference call at 8:30 a.m.

Key Points: 
  • Hepion is pleased to invite all interested parties to participate in a conference call at 8:30 a.m.
  • ET on May 22, during which the ALTITUDE-NASH topline results will be discussed.
  • To participate in this conference call, please dial (800) 715-9871 (U.S.) or (646) 307-1963 (international), conference ID 9439742, approximately 10 minutes prior to the start time.
  • The call will also be broadcast live and archived on the Company's website at www.hepionpharma.com under "Events" in the Investors section.

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.