New treatment options for pancreatic cancer arise

Companies busy developing new antibody drugs for pancreatic cancer

Merus’s Bizengri approved in the U.S….shows effect in NRG1 fusion pancreatic cancer and lung cancer

Korean companies also start development of new antibody drugs for pancreatic cancer… Prestige BioPharma starts P1T

New antibody drugs are showing results in pancreatic cancer, a disease area that has been regarded as an incurable disease.

 

Recently, a new bispecific antibody drug from the Dutch company Merus was approved for the treatment of pancreatic cancer in the United States.

 

In clinical trials, the drug has shown therapeutic effects in patients with pancreatic cancer and non-small cell lung cancer.

 

In Korea, efforts to develop new antibody drugs for pancreatic cancer are also underway.

 

Prestige BioPharma, Aptamer Sciences, and ABL Bio have confirmed the potential of antibody drugs in pancreatic cancer.

 

Merus’s HER2·HER3 targeted bispecific antibody secures indications for pancreatic cancer and non-small cell lung cancer

According to industry sources on the 7th, the US FDA approved Merus' bispecific antibody Bizengri for the treatment of pancreatic cancer and non-small cell lung cancer.

 

Bizengri is the first bispecific antibody approved for neuregulin 1 gene (NRG1) fusion lung and pancreatic cancer.

 

The drug received accelerated approval and is subject to further confirmatory clinical trials to determine full approval.

 

Bizengri was first under clinical development as a HER2-targeted antibody but was redirected to simultaneously target the NRG1 gene fusion, a variant of the HER2 and HER3 antibodies, to increase the therapeutic effect.

 

Bizengri’s license was based on a Phase I/II eNRGy study.

 

The study included 30 patients with NRG1-positive pancreatic cancer and 64 patients with non-small cell lung cancer who had failed prior therapy.

 

The mean age of the pancreatic cancer patients was 49 years, and 57% were male.

 

The primary endpoints were overall response rate (ORR) and duration of response (DOR) as determined by Blinded Independent Central Review (BICR).

 

Clinical results showed an ORR of 40% in patients with pancreatic cancer.

 

DOR ranged from a median of 3.7 months to up to 16.6 months.

 

Bizengri showed a strong suit in terms of safety.

 

The most common adverse events occurring after treatment with Bizengri were diarrhea, musculoskeletal pain, fatigue, nausea, constipation, vomiting, and abdominal pain.

 

Adverse reactions occurred in approximately 10% of patients and were generally mild.

 

Merus is recruiting patients to participate in a confirmatory clinical trial for full approval of Bizengri.

 

The company expects Bizengri to be effective in all cancer types driven by NRG1 fusions.

 

Monoclonal antibody, ADC, bispecific antibody for pancreatic cancer

Korean companies are also trying to develop new drugs for pancreatic cancer through antibody drugs.

 

Prestige Biopharma, LigaChem Biosciences, ABL Bio, and Aptamer Sciences are checking the potential of monoclonal antibodies, ADCs, and bispecific antibodies.

 

Pancreatic cancer has one of the lowest survival rates among cancer diseases.

 

According to the National Cancer Center, the 5-year survival rate for pancreatic cancer from 2017 to 2021 is only 15.9%.

 

Due to its organ location, pancreatic cancer has an early detection rate of less than 10%, making it easy to metastasize to surrounding organs.

 

New drugs from various domestic and foreign pharmaceutical companies have tried their hand in this field, but most of them have failed in the clinical trial stage.

 

As such, antibody drugs are emerging as an alternative.

 

Antibody-drug conjugates (ADCs) and multi-antibodies that target 2 or more biomarkers at the same time are actively being tested to conquer intractable diseases.

 

Prestige Biopharma is developing an antibody drug candidate, PBP1510.

 

PBP1510 neutralizes the pancreatic ductal adenocarcinoma overexpression factor PAUF protein, which is a therapeutic target for pancreatic cancer.

 

PBP1510 is currently in Phase I/IIa clinical trials in Spain, the United States, Singapore, and Australia.

 

Through this study, Prestige Biopharma plans to determine the safety and tolerability of PBP1510 in combination with gemcitabine.

 

Aptamer Sciences recently signed a collaboration agreement with Kolon Pharmaceuticals to jointly develop its ADC candidate AST-203.

 

The two companies plan to conduct clinical studies of AST-203 with the goal of securing an indication for pancreatic cancer.

 

Aptamer Sciences and Kolon Pharmaceuticals will jointly develop its ADC candidate AST-203 for pancreatic cancer

AST-203 targets TROP2, a protein mainly expressed in breast, pancreatic, stomach, and lung cancers.

 

The new drug candidate selectively binds to TROP2-positive tumors and penetrates the cell, releasing MMAE, which inhibits cell division, to induce cancer cell death.

 

TROP2 is an intracellular calcium signal transducer involved in cell proliferation and survival.

 

The protein is present in normal cells but tends to be overexpressed in cancer cells and has been linked to drug resistance.

 

The only commercialized drug targeting TROP2 is Gilead's ADC Trodelvy, which is approved for triple-negative breast cancer.

 

In preclinical studies, Aptamer Sciences has shown promise for AST-203 in tumor spheroid (3D aggregates of tumor cells) models.

 

According to the company, AST-203 demonstrated a 6.7-fold higher tumor penetration rate than the existing Trodelvy.

 

ABL Bio is developing bispecific ADCs targeting major solid tumors, including pancreatic, esophageal, colon, and head and neck cancers.

 

Its target antigens are not yet known, but the company says it has shown efficacy compared to single-target ADCs.

 

The company plans to file an IND later next year to test the bispecific ADC in the clinic.