Biliary Tract Cancer Treatment Outlook: A Review on Upcoming Therapies

Los Angeles, USA, May 27, 2021 (GLOBE NEWSWIRE) -- Biliary Tract Cancer Treatment Outlook: A Review on Upcoming Therapies

Although Biliary Tract Cancers are rare with a poor prognosis, the increasing prevalence has increased the demand for combination therapy owing to the better treatment options. The extensive Research and Development by Pharmaceutical companies may primarily contribute to the availability of affordable treatment for Biliary Tract Cancer patients.

DelveInsight’s “Biliary Tract Cancer (BTC) Pipeline Insight” report provides comprehensive insights about 50+ companies and 50+ pipeline drugs in the BTC pipeline landscapes. It comprises Biliary Tract Cancer pipeline drug profiles, including clinical and non-clinical stage products. It also includes the Biliary Tract Cancer therapeutics assessment by product type, stage, route of administration, and molecule type and further highlights the inactive Biliary Tract Cancer pipeline products.    

Some of the key takeaways of the Biliary Tract Cancer Pipeline Report 

• Prominent companies such as Lee's Pharmaceutical, Jiangsu HengRui Medicine, Miracogen, RemeGen, J-Pharma, Hutchison Medipharma, Merck KGaA, AstraZeneca, and others are developing potential drug candidates to boost the Biliary Tract Cancer treatment scenario.
• RC48 is being developed by RemeGen for BTC treatment and is currently in the phase II stage of development.
• In May 2020, the U.S. Food and Drug Administration (FDA) approved Pemazyre (pemigatinib) as the first treatment for adults with certain types of previously treated, advanced cholangiocarcinoma.
• Ivosidenib is an orally available small-molecule inhibitor of mutated cytosolic isocitrate dehydrogenase 1 (IDH1m inhibitor), being developed by Servier for the treatment of Biliary tract cancers. The U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) for TIBSOVO (ivosidenib tablets) as a potential treatment for patients with previously treated IDH1-mutated Cholangiocarcinoma. The sNDA acceptance is supported by data from the ClarIDHy study, the first and only randomized Phase 3 trial for previously treated IDH1-mutated Cholangiocarcinoma.
• Futibatinib (TAS-120), a covalently-binding FGFR inhibitor is an investigational therapy for the treatment of patients with previously treated locally advanced or metastatic Cholangiocarcinoma harbouring FGFR2 gene rearrangements, including gene fusions. In May 2018, the FDA Office of Orphan Drug Development granted futibatinib orphan drug status for the treatment of Cholangiocarcinoma. In April 2021 US FDA has also granted Breakthrough Therapy Designation (BTD) for futibatinib (TAS-120).
• ABTL0812, a first-in-class fully differentiated oral targeted anticancer compound causing cell death by autophagy is being developed and investigated in Preclinical studies by Ability Pharmaceuticals. The drug has received orphan drug designation (ODD) for ABTL0812 from the US Food and Drug Administration (FDA) for the treatment of biliary tract cancer.

Get an overview of pipeline landscape @ Biliary Tract Cancer Clinical Trials Analysis

Biliary Tract Cancer (BTC) is an uncommon and highly fatal malignancy. It is composed of three different main entities:- Gall bladder carcinoma (GBC), intrahepatic cholangiocarcinoma (iCC) and extrahepatic cholangiocarcinoma (eCC), sharing various genetic risk factors and clinical presentation.

Biliary Tract Cancer Emerging Drugs

• TQB2450: Chia Tai Tianqing Pharmaceutical Group

TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has the potential to treat various types of tumors.

Research and Development
Phase III
NCT04809142: Chia Tai Tianqing Pharmaceutical Group initiated a clinical trial in February 2021 titled “A Randomized, Open-label, Parallel Controlled, and Multi-center Phase III Study of TQB2450 Injection Combined with Anlotinib Hydrochloride Capsule Versus Chemotherapy as Second-line Treatment in Subjects with Advanced Biliary Cancer”. The primary objective of this trial is to evaluate the efficacy and safety of TQB2450 combined with anlotinib versus chemotherapy as second-line treatment in subjects with advanced biliary cancer. The trial is anticipated to get completed in February 2023 with an estimated enrollment of 392 participants.

• Envafolimab: 3D Medicines

Envafolimab (KN035) is a novel, single-domain PD-L1 antibody that is administered by subcutaneous injection without the need for an adjuvant. On January 18, 2020, KN035 was granted FDA Orphan Drug Designation (ODD) for the treatment of advanced biliary tract cancer (BTC). On March 30, 2020, Alphamab, 3D Medicines and Simcere reached a three-way strategic collaboration. Alphamab, as the original research party, is responsible for production and quality, 3D Medicines is responsible for global clinical development in the field of oncology, registration and commercialization abroad, and Simcere is responsible for the exclusive commercial promotion of the product in mainland China.

NCT03478488: In April 2018 3D medicine initiated a trial titled “Gemcitabine and Oxaliplatin With or Without KN035 for Biliary Tract Cancer: a Randomised, Open-label, Parallel-group, and Multicenter Phase III Study”. This is a randomized, open-label, parallel-group multi-centre study of Phase 3 study to assess the efficacy and safety of KN035 compared to standard of care (SOC) Gemcitabine-based chemotherapies in the treatment of participants with previously untreated locally advanced or metastatic biliary tract cancer. The company is currently recruiting the participants with an estimated enrollment of 480 participants and is expected to get completed in June 2022.

• RC48-ADC: RemeGen

RC48 was developed to treat HER2 expressing solid tumors. It has a novel antibody with a higher affinity to HER2 compared to standard of care and superior anti-tumour activity compared to other treatments in animal models. RC48 was the first ADC drug approved for human clinical trials in China, and a favourable safety profile has been observed in clinical trials. It is currently being studied in multiple late-stage clinical trials across solid tumour types.

Research and Development
Phase II
NCT04329429: RemeGen in August 2020, initiated “An Open-label, Single-arm, Multi-center, and Phase II Study of RC48-ADC in Subjects with HER2 Overexpressed Locally Advanced or Metastatic Biliary Tract Cancer (BTC) Who Have Failed First-line Chemotherapy”. This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with locally advanced or metastatic HER2 overexpressed biliary tract cancer who have failed first-line chemotherapy. The trial is expected to get completed by December 2022 with expected 57 enrolled participants.

For further information, refer to the detailed report @ Biliary Tract Cancer Pipeline Therapeutics

Scope of Biliary Tract Cancer Pipeline Drug Insight   

• Coverage: Global 
• Major Players: 50+  Key Players
• Prominent Players: Lee's Pharmaceutical, Jiangsu HengRui Medicine, Miracogen, RemeGen, J-Pharma, Hutchison Medipharma, Merck KGaA, AstraZeneca, 3D Medicines, Chia Tai Tianqing Pharmaceutical Group, Eisai Inc., Shanghai Miracogen Inc., Zymeworks Inc., CSPC ZhongQi Pharmaceutical Technology, Threshold Pharmaceuticals, Servier, Basilea Pharmaceutica, Eli Lilly and company, InnoPharmax Inc., Incyte Corporation and many others.  
• Key Drugs Profiles: 50+ Products
• Phases:  
  • Biliary Tract Cancer Therapies Late-stage (Phase III)  
  • BTC Therapies Mid-stage (Phase II)
  • Biliary Tract Cancer Therapies Early-stage (Phase I) 
  • BTC Pre-clinical stage and Discovery candidates    
  • Discontinued and Inactive candidates 
• Mechanism of Action:
  • Natural killer cell stimulants; Programmed cell death-1 ligand-1 inhibitors
  • Macrophage colony-stimulating factor receptor antagonists
  • Amino acid transport system L inhibitors
  • Cell cycle inhibitors; Tubulin polymerisation inhibitors
  • Immunomodulators
  • Programmed cell death-1 ligand-1 inhibitors; T lymphocyte stimulants
• Molecule Types:  
  • Small Molecule
  • Gene Therapy
  • Stem Cell Therapy
• Route of Administration:
  • Intravenous 
  • Inhalation
  • Subcutaneous
  • Oral
• Product Types:
  • Monotherapy
  • Combination
  • Mono/Combination 

Key Questions regarding Current Biliary Tract Cancer Treatment Landscape and Emerging Therapies Answered in the Pipeline Report  

• What are the current options for Biliary Tract Cancer treatment?
• How many companies are developing therapies for the treatment of BTC? 
• How many are Biliary Tract Cancer emerging therapies in the early-stage, mid-stage, and late development stages to treat BTC?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, and significant licensing activities that will impact the Biliary Tract Cancer market? 
• Which are the dormant and discontinued products and the reasons for the same?
• What is the unmet need for current therapies for the treatment of BTC?  
• What are the current novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing Biliary Tract Cancer therapies? 
• What are the critical designations that have been granted for the emerging therapies for BTC? 
• How many patents are granted and pending for the emerging therapies to treat Biliary Tract Cancer?   

Table of Contents

Get a customised pipeline report @ Biliary Tract Cancer Drugs Pipeline Report 

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