K-Pharma speeds up marketing new drugs for bile duct cancer

Handok's U.S. partnering company completes registering patients for the Phase 2/3 trials

Genome & Company and GI Innovation commence clinical trials for their candidate products in combination with Keytruda

Korean pharmaceutical companies are speeding up the development of new drugs for cholangiocarcinoma (also known as bile duct cancer).

 

Handok's partnering company in the United States, Compass Therapeutics, has recently completed registering patients for the Phase 2/3 trials.

 

Once the efficacy of the novel drug is confirmed, Handok plans to apply for approval in South Korea.

 

According to pharmaceutical industry sources on August 16th, Compass Therapeutics has recently completed registering patients for the Phase 2/3 trials in the United States.

 

The trials will evaluate the efficacy of HDB001A(CTX-009) for metastatic or recurrent cholangiocarcinoma and compare the efficacy of HDB001A in combination with paclitaxel to the paclitaxel monotherapy.

 

HDB001A is a novel drug candidate developed by the Korean company ABL Bio.

 

Handok has the domestic distribution rights, and Compass Therapeutics has the global distribution rights.

 

This novel drug candidate is a bispecific antibody targeting Delta-like ligand 4 (Dll4) and vascular endothelial growth factor (VEGF), and it is known to form new blood vessels in the tumor microenvironment.

 

Handok has confirmed the efficacy and safety of HDB001A in the Phase 2 trial conducted in South Korea.

 

The clinical trials evaluated and compared HDB001A in combination with paclitaxel to paclitaxel monotherapy in 24 adult patients with advanced, metastatic, or recurrent cholangiocarcinoma who have received prior treatments.

 

After a median follow-up of 12 months, patients treated with the combination therapy had an objective response rate (ORR) 37.5%, measuring the reduction in tumor sizes.

 

The median overall survival (OS) was 12.5 months.

 

The median duration of response (DOR) was 9.4 months, and the median progress-free period (PFS), duration without progression, was 9.4 months.

 

However, the adverse events of HDB001A plus paclitaxel occurred at the highest rate.

 

Treatment-related adverse events (TRAE) of all Grades, from 1 to 5, were reported in HDB001A plus paclitaxel combination therapy.

 

75% of patients had adverse reactions of over Grade 3.

 

The most common adverse reactions over Grade 3 were neutropenia (50%), hypertension (16.7%), anemia (12.5%), and thrombocytopenia (8.3%).

 

One case of Grade 5 pneumonia was reported.

 

25% of patients had confusion state, pulmonary embolism, and an increase in blood creatinine level.

 

Once Handok confirms the efficacy and stable safety data from the U.S.

 

clinical trial, it will apply for approval in South Korea.

 

Confirming the potential of Keytruda combination therapy…enters the clinical trial Besides Handok, Genome & Company, GI Innovation, and SMT bio are developing novel drugs for cholangiocarcinoma.

 

These companies are conducting clinical trials for Keytruda combination therapies.

 

Korean pharmaceutical companies are conducting clinical trials for their candidate drugs in combination with various immune checkpoint inhibitors, including Keytruda.

Keytruda was approved in April as a first-line treatment of cholangiocarcinoma in South Korea.

 

Genome & Company, GI Innovation, and SMT bio plan to increase the possibility of commercializing their candidate products in combination with an efficacy-confirmed drug.

 

Genome & Company is developing a new candidate product, microbiome-based immune checkpoint GEN-001, in combination with Keytruda for cholangiocarcinoma.

 

Genome & Company aims to improve the efficacy of existing immune checkpoint inhibitors through combination therapy of 'GEN-001' and Keytruda.

 

The company also plans to develop 'GENA-104,' an immune checkpoint inhibitor 'GENA-104' that suppresses novel target CNTN4, for patients who had not benefited from Keytruda targeting PD-L1/PD-1.

 

The Phase 2 trial of GEN-001 for cholangiocarcinoma was approved for changes to the Investigational New Drug (IND) application in June.

 

Genome & Company plans to evaluate the efficacy and safety of three-drug combination therapy, adding FOLFOX (fluorouracil, leucovorin, and oxaliplatin) to the existing GEN001 plus Keytruda combination therapy.

 

Genome & Company confirmed the tolerability and safety of GEN-001 in the Phase 1 trial and determined the recommended dosage for the Phase 2 trial.

 

The trial recently finalized patient treatments.

 

SMT bio is conducting Phase 2b trials for allogenic Natural Killer cells (SMT-NK cells) in combination with Keytruda.

 

The company is evaluating the efficacy of the combination therapy compared to the Keytruda monotherapy.

 

Based on clinical results until now, the combination therapy had a PFS of 4.1 months, which is higher than 1.5 months of the Keytruda monotherapy.

 

It showed improved ORR compared to monotherapy.

 

Last year, the Ministry of Food and Drug Safety (MFDS) acknowledged the effectiveness of SMT-NK cells and approved the therapeutic use of under-trial pharmaceutical for treating patients with cholangiocarcinoma.

 

GI Innovation is conducting a Phase 1 trial in the United States to evaluate the effectiveness of GI-101 in combination with Keytruda.

 

The company aims to secure an indication for treating solid cancers, including cholangiocarcinoma.

 

GI Innovation is also evaluating the marketing possibility of its candidate product in combination with a wide variety of immune checkpoint inhibitors, such as Imfinzi, in addition to Keytruda.