Cholangiocarcinoma

Glenmark, Jiangsu Alphamab Biopharmaceuticals and 3D Medicines announce the signing of a License Agreement for KN035 (Envafolimab) for Multiple Geographies around the World

Retrieved on: 
Thursday, January 25, 2024
Patient, Medication, Emerging market, GSSA, Action Replay, Microsatellite, MSI-H, Chinese, MFS, CIS, Cholangiocarcinoma, UPS, Cancer, License, PD-L1, STS, Lung cancer, Neoplasm, Prevalence, Myxofibrosarcoma, National Medical Products Administration, LTD, NMPA

Jiangsu Alphamab will be responsible of manufacturing KN035 within and outside the Territory.

Key Points: 
  • Jiangsu Alphamab will be responsible of manufacturing KN035 within and outside the Territory.
  • 3D Medicines retains the right to develop and commercialize Envafolimab for any purpose outside the Territory.
  • Under the terms of the agreement, GSSA will receive from Jiangsu Alphamab and 3D Medicines, an exclusive license to develop, register, commercialize, Envafolimab for the oncology indication in the Territory.
  • The Licensors' respective entitlement to the payments (including the upfront payment, milestone payment and the royalty fees) under the License Agreement are subject to the agreements between 3D Medicines and Jiangsu Alphamab.

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
Drug, Bile, Patient, MRD, Cancer, Neoplasm, MD, DNA, Hepatocellular carcinoma, Pancreatic cancer, DGX, Cholangiocarcinoma, Liver cancer, Hay, Quest Diagnostics, TLR9, Liver, Medical imaging

"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."

Eisai Furthers Oncology Research Across Multiple Cancers at ASCO GI and ASCO GU 2024

Retrieved on: 
Tuesday, January 16, 2024
MSD, PRISM, Renal cell carcinoma, Hypoxia, Patient, HCC, Research, Neoplasm, Meta-analysis, Oxidative stress, Rescue coordination centre, RCC, Merck & Co., ASCO, Cell lineage, Everolimus, Society, Pembrolizumab, Headquarters, FGFR2, Deep, Cholangiocarcinoma, Drug discovery, Hepatocellular carcinoma, Cancer, Food, Proteostasis, CBP, Safety, Abstract, Food and Drug Administration, FDA, Inflammation, CREB-binding protein, Biomarker, LEAP, TKI, Merck, Differentiable function, Pharmaceutical industry

TOKYO, Jan 16, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today the presentation of oncology research at two upcoming medical meetings taking place in-person in San Francisco, California and virtually.

Key Points: 
  • TOKYO, Jan 16, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today the presentation of oncology research at two upcoming medical meetings taking place in-person in San Francisco, California and virtually.
  • First, the company will share findings in hepatocellular carcinoma (HCC) and cholangiocarcinoma during the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium (#GI24), which is taking place from January 18-20.
  • Tasurgratinib, for which a marketing authorization application was submitted in Japan in December 2023, is an orally available selective tyrosine kinase inhibitor of FGFR1-3.
  • Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these domains, with the aim of contributing to the cure of cancers.

Independent Research Data On Hepatic Artery Infusion (HAI) Therapy Tp Be Featured At ASCO GI Cancer Symposium

Retrieved on: 
Tuesday, January 16, 2024
Neoplasm, Patient, PST, Research, Local, Pancreas, ASCO, Poster, Rectum, Sidney Kimmel, Johns Hopkins, Cholangiocarcinoma, Hepatic artery proper, HAI, Liver disease, Liver, FDA, Progress, CRC, Colorectal cancer, Physician, Pharmaceutical industry

BOSTON, Jan. 16, 2024 /PRNewswire-PRWeb/ -- Intera Oncology, maker of the only FDA-approved implantable pump for Hepatic Artery Infusion (HAI) therapy, announces independent research on HAI therapy will be presented at the ASCO Gastrointestinal Cancers Symposium (ASCO GI) January 18-20 in San Francisco, California, USA.

Key Points: 
  • BOSTON, Jan. 16, 2024 /PRNewswire-PRWeb/ -- Intera Oncology, maker of the only FDA-approved implantable pump for Hepatic Artery Infusion (HAI) therapy, announces independent research on HAI therapy will be presented at the ASCO Gastrointestinal Cancers Symposium (ASCO GI) January 18-20 in San Francisco, California, USA.
  • Researchers from several top academic medical institutions will present their findings related to HAI therapy through live presentations, oral abstracts, and posters at the symposium.
  • HAI therapy is a powerful treatment for patients with colorectal cancer (CRC) that has spread to the liver and those with intrahepatic cholangiocarcinoma (iCCA).
  • To learn more about evidence supporting the use of HAI therapy, visit Intera Oncology at Exhibitor Booth #4 at #GI24.

Compugen to Receive $10 Million Milestone Payment Following Dosing of First Patient in AstraZeneca Phase 3 Rilvegostomig Trial in Biliary Tract Cancer

Retrieved on: 
Monday, January 8, 2024
Compugen, PD-1, Immunotherapy, TIGIT, Cholangiocarcinoma, Pharmaceutical industry

HOLON, Israel, Jan. 8, 2024 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced that Compugen is entitled to receive a $10 million milestone payment from AstraZeneca (LSE/STO/Nasdaq: AZN), after the first patient was dosed in AstraZeneca's ARTEMIDE-Bil01 trial with rilvegostomig.

Key Points: 
  • HOLON, Israel, Jan. 8, 2024 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced that Compugen is entitled to receive a $10 million milestone payment from AstraZeneca (LSE/STO/Nasdaq: AZN), after the first patient was dosed in AstraZeneca's ARTEMIDE-Bil01 trial with rilvegostomig.
  • Rilvegostomig is a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen's clinical-stage anti-TIGIT antibody, COM902.
  • The ARTEMIDE-Bil01 trial is expected to recruit about 750 subjects in more than 20 countries with biliary tract cancer who will be randomized to receive rilvegostomig or placebo with investigator choice chemotherapy as adjuvant treatment after resection with curative intent.
  • "I am delighted to see the advancement of the rilvegostomig Phase 3 trial by AstraZeneca, a global leader in oncology, which has dosed the first patient triggering a $10 million milestone payment to Compugen," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen.

Eisai Submits Marketing Authorization Application in Japan for Anticancer Agent Tasurgratinib for Biliary Tract Cancer with Fgfr2 Gene Fusion

Retrieved on: 
Tuesday, December 19, 2023
Drug resistance, FGF, Drug discovery, Survival, Tumor microenvironment, FGFR2, FGFR1, Prognosis, Differentiable function, MHLW, Deep, Cholangiocarcinoma, Disease, FGFR, Cancer, Inflammation, Ministry, FGFR3, Proteostasis, Hypoxia, Oxidative stress, Patient, Safety, Eisai

TOKYO, Dec 19, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has submitted a marketing authorization application in Japan for its in-house discovered fibroblast growth factor (FGF) receptor (FGFR1, FGFR2, FGFR3) selective tyrosine kinase inhibitor tasurgratinib succinate (generic name, development code: E7090, "tasurgratinib") for biliary tract cancer with FGFR2 gene fusion.

Key Points: 
  • TOKYO, Dec 19, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has submitted a marketing authorization application in Japan for its in-house discovered fibroblast growth factor (FGF) receptor (FGFR1, FGFR2, FGFR3) selective tyrosine kinase inhibitor tasurgratinib succinate (generic name, development code: E7090, "tasurgratinib") for biliary tract cancer with FGFR2 gene fusion.
  • In Japan, tasurgratinib has received orphan drug designation for a prospective indication for unresectable biliary tract cancer with FGFR2 gene fusion by the Ministry of Health, Labour and Welfare, (MHLW).
  • This application is based on the results of a multicenter, open-label, single-arm clinical phase II trial (Study 201) in Japan and China conducted by Eisai.
  • Study 201 enrolled patients with unresectable biliary tract cancer with FGFR2 gene fusion previously treated with gemcitabine-based combination chemotherapy.

Affimed Announces Positive Data for AFM24 in Combination with the PD-L1 Checkpoint Inhibitor Atezolizumab in Heavily Pre-treated EGFR-Wildtype Non-Small Cell Lung Cancer Patients

Retrieved on: 
Monday, December 11, 2023
Stomach, EST, Hepatocellular carcinoma, RECIST, EGFR, Progression-free survival, Cancer, Pancreatic cancer, Toxicity, Cholangiocarcinoma, Webcast, Patient, Safety, NSCLC, Pharmaceutical industry

The data update as of December 6th, 2023, includes 15 patients from the EGFR-wildtype NSCLC cohort with a median of 2 prior lines of therapy.

Key Points: 
  • The data update as of December 6th, 2023, includes 15 patients from the EGFR-wildtype NSCLC cohort with a median of 2 prior lines of therapy.
  • The combination of AFM24 with atezolizumab showed encouraging signals of clinical activity, including 1 unconfirmed CR, 3 PRs (1 confirmed, 2 unconfirmed) and 7 patients exhibiting SD.
  • Considering the low ORR reported on atezolizumab monotherapy in checkpoint inhibitor-relapsing and refractory patients, Affimed believes the clinical activity observed in AFM24-102 is likely due to the synergy of AFM24 with atezolizumab.
  • AFM24 has demonstrated a positive safety and tolerability profile as both a monotherapy and in combination therapy.

Kymera Therapeutics Presents Interim Results from STAT3 Degrader Phase 1 Clinical Trial at American Society of Hematology Annual Meeting

Retrieved on: 
Monday, December 11, 2023
Patient, STAT3, Montefiore Medical Center, Cholangiocarcinoma, Stomatitis, Neoplasm, Constipation, Tumor microenvironment, PRS, SOCS3, Relapse, Leukemia, Anemia, Fatigue, Nausea, Blood, Carcinoma, Society, Therapy, CTCL, Infrared spectroscopy correlation table, PD, Head, ASH, T-PLL, Cancer, Biomarker, Poster, Peripheral T-cell lymphoma, TPD, Safety, Arthralgia, Cutaneous T-cell lymphoma, PTCL, T-cell prolymphocytic leukemia, Lymphoma, Bone marrow, Pharmaceutical industry

WATERTOWN, Mass., Dec. 10, 2023 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today shared new data from its ongoing KT-333 Phase 1 trial. KT-333, a first-in-class, potent, highly selective, heterobifunctional small molecule degrader of STAT3, demonstrated early signs of antitumor activity at doses that were generally well-tolerated and associated with substantial STAT3 knockdown in blood and tumor. The data were presented at the American Society of Hematology (ASH) 65th Annual Meeting and Exposition taking place from December 9-12, 2023, in San Diego, California.

Key Points: 
  • The data were presented at the American Society of Hematology (ASH) 65th Annual Meeting and Exposition taking place from December 9-12, 2023, in San Diego, California.
  • The poster provides an interim update with a data cut-off as of October 18, 2023.
  • Dr. Aditi Shastri from Montefiore Medical Center and Albert Einstein College of Medicine, a lead investigator in the study, presented the interim Phase 1 findings.
  • Preclinical data demonstrating the potential of STAT3 protein degraders as a therapeutic approach in venetoclax-resistant Acute Myeloid Leukemia was also presented at the meeting.

Ipsen confirms U.S. FDA grants priority review for New Drug Application for elafibranor for the treatment of rare cholestatic liver disease, PBC

Retrieved on: 
Thursday, December 7, 2023
Liver, UDCA, Chapter Two, Woman, FDA, MAA, Fatigue, Nausea, Primary biliary cholangitis, Inflammation, ADR, Patent, Liver disease, Diagnosis, AMF, CHMP, Ascending cholangitis, UCD, Business, ACLF, PDUFA, Itch, Risk, New Drug Application, OA, Common, EASL, MASH, Liver failure, Safety, Ammonia, Elafibranor, Therapy, Epidemiology, History, Patient, Cholangiocarcinoma, Food, Health care, EMA, Ursodeoxycholic acid, MHRA, Cirrhosis, Medicine, NTZ, EVP, Cholestasis, NASH, Research, Diarrhea, Bile, NDA, PBC, Abdominal pain, Clinical trial, European Medicines Agency, IPN, PPAR, P10, CCA, Fibrosis, Pharmaceutical industry

An oral, once-daily dual peroxisome activated receptor alpha/delta (PPAR α,δ) agonist, investigational elafibranor could potentially be the first novel second-line treatment for the rare, cholestatic liver disease, PBC, in nearly a decade.

Key Points: 
  • An oral, once-daily dual peroxisome activated receptor alpha/delta (PPAR α,δ) agonist, investigational elafibranor could potentially be the first novel second-line treatment for the rare, cholestatic liver disease, PBC, in nearly a decade.
  • The trial enrolled 161 patients who were randomized 2:1 to receive either elafibranor 80mg once daily or placebo.
  • ELATIVE also investigated the effect of treatment with elafibranor on pruritus (severe itch), a significant symptom burden amongst people living with PBC.
  • Findings from the secondary endpoint using the PBC Worst Itch NRS score, showed a reduction in pruritis for elafibranor, which was not statistically significant.

RenovoRx Engages Oklahoma University (OU) Health as First Clinical Site in Preparation for the Pivotal Phase III CouGar Clinical Trial in Bile Duct Cancer

Retrieved on: 
Thursday, December 21, 2023
Oncology, Health, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, Associate, Cougar, Wilfrid Sellars, Cholangiocarcinoma, Blood, Hematology, NDA, MD, Radiology, Clinical trial, Glomus tumor, University, Pancreatic cancer, University of Oklahoma, Durvalumab, Interventional radiology, Patient, Safety, Senior, Medical imaging

The CouGar Trial will evaluate RenovoGem in bile duct cancer, specifically unresectable locally advanced extrahepatic cholangiocarcinoma (eCCA).

Key Points: 
  • The CouGar Trial will evaluate RenovoGem in bile duct cancer, specifically unresectable locally advanced extrahepatic cholangiocarcinoma (eCCA).
  • “We are pleased to engage our first clinical site for our second pivotal clinical trial.
  • The CouGar Trial marks an important milestone for RenovoRx as we expand our clinical pipeline for RenovoGem into bile duct cancer, a difficult-to-treat solid tumor cancer,” said Leesa Gentry, Senior Vice President of Clinical Operations at RenovoRx.
  • Oklahoma University (OU) Health is the first clinical site for the CouGar study.