Brivanib alaninate

Promising Data from Phase 1 Trial with ADP-A2AFP in Liver Cancer at the International Liver Congress Confirm Safety Profile and Demonstrate Potential Benefit for Patients

Retrieved on: 
Friday, August 28, 2020
Medical specialties, Hepatology, Clinical medicine, Cancer, Hepatocellular carcinoma, Brachyury, Tumor markers, Brivanib alaninate

One patient out of four dosed with 5 billion or more cells had a complete response, which was reported previously.

Key Points: 
  • One patient out of four dosed with 5 billion or more cells had a complete response, which was reported previously.
  • The data also demonstrate an acceptable safety profile in patients with hepatocellular carcinoma (HCC).
  • We remain encouraged by the potential of this therapy and we are fully committed to developing ADPA2AFP for people with HCC.
  • Dr. Bruno Sangro of Clinica Universidad de Navarra presented data from Cohort 3 and the expansion phase of the ADP-A2AFP Phase 1 trial during an oral presentation at ILC.

Innovent Announces First Patient Dosed in a Phase 1b Clinical Trial of Sintilimab plus Surufatinib in Advanced Malignancies in China

Retrieved on: 
Thursday, July 9, 2020
Branches of biology, Vascular endothelial growth factor, Macrophage, Angiogenesis, Brivanib alaninate, VEGFR-2 inhibitor

CIBI391A101 is a Phase 1b clinical study conducted in China to evaluate sintilimabplus surufatinib in the treatment of patients with advanced malignancies.

Key Points: 
  • CIBI391A101 is a Phase 1b clinical study conducted in China to evaluate sintilimabplus surufatinib in the treatment of patients with advanced malignancies.
  • The primary objectives of the study are to evaluate the safety, tolerability, and initial anti-tumor efficacy of surufatinib in combination with TYVYT (sintilimab injection).
  • Surufatinib selectively inhibits the tyrosine kinase activity associated with VEGFR and FGFR, which both inhibit angiogenesis and CSF-1R, which regulates tumor-associated macrophages.
  • CIBI391A101 is a Phase 1b clinical study to evaluate the safety, tolerability, and initial anti-tumor efficacy of sintilimabplus surufatinib in patients with advanced malignancies.

The European Commission has Granted Orphan Medicinal Product Designation in the EU for MIV-818

Retrieved on: 
Friday, July 3, 2020
Health, Hepatology, Medicine, Life sciences, Medivir, European Medicines Agency, Hepatocellular carcinoma, Brachyury, Liver cancer, Brivanib alaninate

STOCKHOLM, July 3, 2020 /PRNewswire/ -- Medivir AB (Nasdaq Stockholm: MVIR) today announced that the European Commission, in accordance with the opinion from the European Medicines Agency (EMA), has granted orphan medicinal product designation in the EU for MIV-818 for the treatment of patients with hepatocellular carcinoma (HCC), the most common type of primary liver cancer.

Key Points: 
  • STOCKHOLM, July 3, 2020 /PRNewswire/ -- Medivir AB (Nasdaq Stockholm: MVIR) today announced that the European Commission, in accordance with the opinion from the European Medicines Agency (EMA), has granted orphan medicinal product designation in the EU for MIV-818 for the treatment of patients with hepatocellular carcinoma (HCC), the most common type of primary liver cancer.
  • Orphan Medicinal Product designation provides certain regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10 000 persons in the European Union.
  • This designation can give access to several incentives, including protocol assistance, the EU centralized authorization procedure and reduced regulatory fees and a potential for a 10-year market exclusivity in the EU.
  • HCC represents the fifth most common cancer worldwide but is a rare disease in Europe and the US.

Can-Fite Concludes Successful Meeting with European Medicines Agency (EMA) Regarding Phase III Trial and Registration Plan for Namodenoson in the Treatment of Liver Cancer

Retrieved on: 
Thursday, June 4, 2020
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Medicine, Medical specialties, Clinical medicine, Hepatology, RTT, Hepatocellular carcinoma, Liver cancer, Cirrhosis, Placebo-controlled study, Ramucirumab, Brivanib alaninate, Namodenoson, Can-Fite BioPharma Ltd.

The planned trial, a randomized, double blind, placebo controlled trial, will enroll approximately 450 patients with HCC and underlying CPB7 cirrhosis at multiple centers worldwide.

Key Points: 
  • The planned trial, a randomized, double blind, placebo controlled trial, will enroll approximately 450 patients with HCC and underlying CPB7 cirrhosis at multiple centers worldwide.
  • Patients will be randomized to oral treatment with either Namodenoson 25 mg or matching placebo given twice daily.
  • According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year.
  • Namodenoson is being evaluated as a second line treatment for hepatocellular carcinoma, with a recently completed Phase II trial and planned Phase III trial in this indication.

Innovent Biologics Announced the Results of the Phase 1b Clinical Study of TYVYT® (Sintilimab Injection) in Combination with IBI305 (Bevacizumab Biosimilar) in the Treatment of Advanced Hepatocellular Carcinoma

Retrieved on: 
Monday, June 1, 2020
Medicine, Hepatology, Medical specialties, Clinical medicine, RTT, Hepatocellular carcinoma, Liver cancer, Cancer, Prodrugs, Brivanib alaninate

The study was divided into two parts, the first is a dose escalation phase and the second is a dose expansion phase.

Key Points: 
  • The study was divided into two parts, the first is a dose escalation phase and the second is a dose expansion phase.
  • Professor Zhou Aiping from Cancer Hospital Chinese Academy of Medical Sciences said"Hepatocellular carcinoma is a common malignant tumor in China.
  • This Phase 1b study preliminarily showed positive efficacy and good safety in patients with advanced liver cancer.
  • Under the agreement, Innovent and Lilly are co-developing and commercializing oncology medicines, including TYVYT (sintilimab injection) in China.

Tolero Pharmaceuticals Presents Findings from First Clinical Studies Evaluating Investigational Agents TP-1287 and TP-3654 in Patients with Advanced Solid Tumors at ASCO Virtual Annual Meeting 2020

Retrieved on: 
Friday, May 29, 2020
Organic compounds, Branches of biology, Heterocyclic compounds, Cell Cycle, Cyclin-dependent kinase 9, Proteins, Lactams, Protein kinase inhibitors, Indoles, Brivanib alaninate

TP-1287 is an investigational oral cyclin-dependent kinase 9 (CDK9) inhibitor under evaluation in a Phase 1 study in patients with advanced solid tumors ( NCT03604783 ).

Key Points: 
  • TP-1287 is an investigational oral cyclin-dependent kinase 9 (CDK9) inhibitor under evaluation in a Phase 1 study in patients with advanced solid tumors ( NCT03604783 ).
  • The organizations apply their expertise and collaborate to achieve a common objective - expediting the discovery, development and commercialization of novel treatment options.
  • Any forward-looking statements set forth in this press release speak only as of the date of this press release.
  • "A Phase I, First-in-human, Open-label, Dose escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP 1287 Administered Daily to Patients with Advanced Solid Tumors."

Invitation to Medivir's R&D Day on March 2, 2020

Retrieved on: 
Tuesday, February 25, 2020
Medicine, Medical specialties, Hepatology, Health, RTT, Medivir, Liver cancer, Hepatocellular carcinoma, Cancer, Radiation therapy, Delcath Systems, Brivanib alaninate

It has the potential to become the first liver-targeted, orally administered drug to benefit patients with HCC and other forms of liver cancer.

Key Points: 
  • It has the potential to become the first liver-targeted, orally administered drug to benefit patients with HCC and other forms of liver cancer.
  • A phase I study is ongoing in liver cancer patients.
  • Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high.
  • Collaborations and partnerships are important parts of Medivir's business model and the drug development is conducted either by Medivir or in partnership.

Compugen Announces Phase 1/2 Triple Combination Study to Evaluate COM701 in Combination With Bristol-Myers Squibb's Opdivo® (Nivolumab) and TIGIT Inhibitor

Retrieved on: 
Thursday, February 20, 2020
Drugs, Clinical medicine, Medicine, Bristol-Myers Squibb, Compugen, Antineoplastic drugs, Breakthrough therapy, Monoclonal antibodies, Nivolumab, Programmed cell death protein 1, PD-1 and PD-L1 inhibitors, Brivanib alaninate

Under the existing collaboration with Bristol-Myers Squibb, COM701 is being investigated as a monotherapy and in combination with Opdivoin an ongoing Phase 1 study.

Key Points: 
  • Under the existing collaboration with Bristol-Myers Squibb, COM701 is being investigated as a monotherapy and in combination with Opdivoin an ongoing Phase 1 study.
  • Following the Companies' joint decision to move forward with a triple combination study, Compugen will complete the dose escalation arm of the dual combination of COM701 with Opdivo under its ongoing Phase 1 study.
  • Future studies evaluating COM701 in combination with a PD-1 inhibitor in specific tumor types will be assessed at a later date.
  • The planned open-label Phase 1/2 trial is designed to evaluate the safety, tolerability and antitumor activity of COM701 in combination with Opdivo and BMS-986207.

Can-Fite Submits Liver Cancer Phase III Protocol and Registration Plan to EMA for Namodenoson

Retrieved on: 
Thursday, February 13, 2020
Oncology, FDA, Health, Clinical trials, Pharmaceutical, Biotechnology, Medicine, Medical specialties, Clinical medicine, Hepatology, RTT, Hepatocellular carcinoma, Liver cancer, Hepatitis, Epidemiology of cancer, Brivanib alaninate, Ramucirumab, Namodenoson, Can-Fite BioPharma Ltd.

Having submitted our study design to both U.S. and European regulators, we look forward to initiating this Phase III study.

Key Points: 
  • Having submitted our study design to both U.S. and European regulators, we look forward to initiating this Phase III study.
  • According to the American Cancer Society, in the U.S. liver cancer incidence has tripled since 1980, with an estimated 42,000 cases diagnosed and 32,000 deaths annually.
  • Namodenoson is being evaluated as a second line treatment for hepatocellular carcinoma, with a recently completed Phase II trial and planned Phase III trial in this indication.
  • Can-Fite's liver cancer drug, Namodenoson, recently completed a Phase II trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and is in a Phase II trial for the treatment of non-alcoholic steatohepatitis (NASH).

AVEO Oncology Announces Publication of Phase 1b/2 Study of Tivozanib in Advanced, Inoperable Liver Cancer in the British Journal of Cancer

Retrieved on: 
Wednesday, February 12, 2020
Oncology, Health, FDA, General Health, Clinical trials, Pharmaceutical, Biotechnology, Medicine, Medical specialties, Hepatology, Cancer, Hepatocellular carcinoma, Durvalumab, Brivanib alaninate, Tivozanib, AVEO

The article, titled A multicentre phase 1b/2 study of tivozanib in patients with advanced inoperable hepatocellular carcinoma, is available online first via this link .

Key Points: 
  • The article, titled A multicentre phase 1b/2 study of tivozanib in patients with advanced inoperable hepatocellular carcinoma, is available online first via this link .
  • For the Phase 1b/2 tivozanib study, a total of 27 patients were enrolled.
  • The study sought to evaluate the safety, dosing, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of tivozanib in patients with advanced HCC.
  • I look forward to seeing this potential elucidated in the ongoing DEDUCTIVE study of tivozanib and durvalumab in HCC.