K-Bio to showcase at the ASH 2024

Will unveil accomplishments of anticancer agents·ADC

Aptamer·Hanmi·LigaChem showcase clinical results of their new drug candidate products for blood cancer

Clinical trials for ADC advancing…targeted anticancer agents with new mechanism of action to be presented

Development accomplishments of the Korean pharmaceutical industry's blood cancer treatments will be showcased at an international conference.

 

Hanmi Pharmaceutical, PharosiBio, LigaChem Biosciences, and Aptamer Sciences will present their promising clinical study results, and they are set to join the global stage.

 

PharosiBio and Hanmi Pharmaceutical will present their clinical accomplishment of new drug candidates for acute myeloid leukemia (AML).

 

Aptamer Sciences and LigaChem Biosciences will unveil the competitiveness of their antibody-drug candidate (ADC) platforms.

 

Clinical results of AML will be showcased…new drug discovery platform competitiveness ↑ According to sources on November 23, the American Society of Hematology Annual Meeting and Exposition (ASH 2024) will take place from December 7 to 10 in San Diego, U.S.

 

The American Society of Hematology, the world's largest blood cancer-related academic conference, commences its 66th meeting this year.

 

Hanmi Pharmaceutical will showcase the clinical result of its innovative new drug candidate for AML, 'tuspetinib,' confirming the potential of the drug as a triple combination drug therapy at the ASH 2024.

 

The results will be presented by Hanmi Pharmaceutical's U.S.

 

partnering company, Aptose Biosciences.

 

In 2021, Hanmi Pharmaceutical outlicensed tuspetinib to Canadian pharmaceutical company Aptose Biosciences.

 

Tuspetinib is a new innovative drug targeting key kinases involved in myeloid malignancies.

 

Tuspetinib works in a differentiated pattern.

 

It has been developed as a once-daily administration.

 

It received the fast-track designation pharmaceutical from the U.S.

 

Food and Drug Administration (FDA) last year.

 

Aptose Biosciences is currently investigating the potential of tuspetinib in combination with hypomethylating agents such as BCL2 inhibitor Venetoclax (product name: Venclexta) and azacitidine.

 

Previously, Aptose Biosciences has reported that the combination therapy of tuspetinib and venetoclax in patients with relapsed or refractory AML demonstrated favorable safety profiles and positive drug responses, regardless of prior venetoclax treatment experience.

 

In particular, with tuspetinib administration, no noticeable side effects or typical toxicity responses were observed in medications of the same class.

 

It showed broad activity in all patients with AML who have genetic mutations.

 

Aptose Biosciences will decide on the volume of the triple combination therapy and finish the pilot study by presenting it in the European Hematology Association (EHA) meeting next year.

 

PharosiBio will showcase the Phase 1 trial results of its new drug candidate, 'PHI-101,' for AML.

 

Along with the clinical Phase1b results conducted with PHI-101 160 mg monotherapy, this company is expected to unveil comprehensive clinical data after completing the recruitment of patients.

 

PHI-101 is a targeted cancer agent being developed for treating patients with AML not responding to previous medications or who relapsed due to FLT3 mutation.

 

This new drug candidate product targets the FLT3 gene mutation that occurs in 35% of all patients with AML, inhibiting the growth of cancer cells.

 

In addition to the study of PHI-101 monotherapy, PharosiBio is also conducting clinical trials of combination therapy.

 

The company confirmed the effects of triple combination drug therapy containing PHI-101, Venetoclax, and azacytidine.

 

Venetoclax and azacytidine are used as a first-line treatment for adult patients with AML.

 

In a xenograft animal model, PHI-101 showed a 95% tumor growth inhibition (TGI) when used in combination with Venetoclax.

 

Additionally, when azacitidine was added to the PHI-101+Venetoclax combination therapy, the reported survival period was 53 days.

 

This figure is longer than the 30 days of the control group.

 

PharosiBio plans to investigate the potential of both monotherapy and combination therapy and aim to target all treatment phases.

 

ASH 2023 photo (source=ASH).

Development of ADC for blood cancer is actively conducted LigaChem Biosciences and Aptamer Sciences will report on competitiveness of their ADC platform.

 

ADC is a novel anticancer drug that connects an antibody, which binds to specific antigens on the surface of cancer cells, with a cytotoxic drug linked by a linker.

 

ADCs take advantage of antibodies' selectivity for their targets and the drug's cytotoxic activity to selectively target cancer cells, thereby increasing therapeutic efficacy while minimizing side effects.

 

LigaChem Biosciences will unveil Phase 1 results of CS5001, an ROR1 targeting ADC candidate product under co-development with ABL.

 

ROR1 is a protein that is strongly expressed during fetal development.

 

The clinical trial analyzed the efficacy, pharmacokinetics (PK), and antitumor activity of CS5001 in patients with solid cancer and lymphoma.

 

Based on the presented clinical results, in the first eight dose groups of CS5001, no dose-limiting toxicities (DLT) were observed.

 

Superior safety and expected pharmacokinetics properties were reported, with the maximum tolerated dose (MTD) not being reached.

 

Aptamer Sciences will showcase the study data of 'AST-202,' a new drug candidate product that was selected from utilizing ApDC (Aptamer-Drug Conjugates) in patients with blood cancer.

 

ApDC is a next-generation ADC new drug development platform with its proprietary branched linker-payload technology.

 

Aptamer Sciences has conducted a comparison study comparing ACD Adcetris and AST-202, which are used as conventional blood cancer treatment, and acquired a significant result in tumor-suppressing effects.

 

In a lymphoma model, AST-202 demonstrated superior tumor-suppressing effects than Adcetris, and more than 80% of the AST-202-treated group survived.