Hanmi internationally introduces 7 new drug candidates

including an mRNA anticancer vaccine

Announced in vivo results at AACR... registered 7 abstracts

Introduced in vivo test results about its 4 major anticancer drug candidates

Hanmi Pharmaceutical unveils mRNA cancer vaccine and new targeted anticancer lead compound at AACR2023.

 

(Photo AACR)

Hanmi Pharmaceutical is revealing its messenger ribonucleic acid (mRNA) cancer vaccine and new targeted anticancer lead compounds.

 

The company reinforced its anticancer pipeline by adding next-generation anticancer drug technologies and targets to its existing major anticancer drug pipeline that has been making smooth progress in preclinical trials.

 

According to industry sources on the 2nd, Hanmi Pharmaceutical will be presenting 7 abstracts related to its anticancer pipeline at the American Association for Cancer Research (AACR) Annual Meeting 2023 held in Orlando, Florida from the 14th (local time) to the 19th.

 

At AACR 2023, the company will unveil abstracts about 2 lead compounds in its new anticancer pipeline.

 

One will be about enhancing antitumor activity by inhibiting the YAP/TAZ-TEAD that targets the Hippo pathway, and the other is about an mRNA cancer vaccine.

 

Also, Hanmi Pharmaceutical will be making abstract presentations on how its novel SOS1 inhibitor, HM99462, demonstrates antitumor activity against KRAS-mutant cancers, how its EZH1/2 dual inhibitor HM97662 demonstrates antitumor activity in T-cell lymphoma, the effect of combining use of HM97662 with an immune checkpoint inhibitor, the antitumor effect of its IL-2analog, HM16390, and how BH3120, a bispecific antibody that targets the G-1BB and PD-L1 simultaneously, stimulates T cells in tumor tissue preferred manner.

 

The published abstracts showed that Hanmi’s lead compounds that target the Hippo pathway exhibited dose-dependent growth inhibitory effects in Hippo pathway-altered cancer cell lines.

 

Its safety profile was also confirmed in vitro.

 

Hanmi’s lead compounds that target the Hippo pathway also showed effective tumor growth inhibition activity within tolerable doses in cancer cell xenograft mouse models.

 

The company plans to initiate preclinical studies after establishing a candidate substance for a preclinical study.

 

In addition to the lead compound for the new anticancer drug that targets the Hippo pathway, Hanmi Pharmaceutical also disclosed the results of preclinical studies related to 4 candidates in its major pipeline through abstracts in advance.

 

According to the abstracts, the SOS1 inhibitor HM99462 showed effective tumor growth inhibition activity within tolerable doses when administered alone in cancer cell xenograft mouse models harboring various KRAS mutations.

 

Also, the combination of HM99462 with KRAS G12C or MEK inhibitors led to synergistic anti-tumor activity in both in vitro and in vivo models.

 

HM99462 is currently in IND enabling GLP-toxicity studies and is palnning to initiate a clinical study in early 2024.

 

At the meeting, Hanmi Pharmaceutical also disclosed the antitumor activity of HM97662 in T-cell lymphoma.

 

The enhancer of zeste homology 2 (EZH2) and its homolog EZH1 are types of enzymes known to induce solid cancers like blood cancer.

 

Hanmi confirmed the tumor growth inhibition effect of oral administration of HM97662 in EZH1/2 co-expressed lymphoma cell mouse xenograft model.

 

The company also presented two papers on preclinical studies conducted on its IL-2 analog, HM16390.

 

After administering HM16390 once a week for two weeks in mouse models with melanoma, complete response (CR) was observed in 89% and 100% of the mice at 2.1mg/kg and 8.5 mg/kg, respectively.

 

The median overall survival was also dose-dependently prolonged median overall survival from 15 to 38 days at the dose range of 0.34 to 42 mg/kg.

 

Also, in mouse models with melanoma, the combined use of HM16390 with PD-1 targeted immune checkpoint inhibitors once a week for 4 weeks, CR was increased from 22% with monotherapy to 88% with combination therapy.

 

In addition, Hanmi’s Chinese subsidiary, Beijing Hanmi Pharm disclosed preclinical study results of its bispecific antibody that is designed to target two different targets imultaneously with the Pentambody™ platform.

 

Pentambody is a next-generation, bispecific antibody platform technology that allows one antibody to bind to two different targets simultaneously.

 

Beijing Hanmi Pharm confirmed that BH3120 showed strong antitumor efficacy in multiple tumor models, and that the combination of BH3120 with a PD-1 antagonist showed synergic effects of continuing to activate the T-cells while reducing immune-related side effects.

 

In he toxicology studies conducted so far with cynomolgus monkeys, the No Observed Adverse Effect Level (NOAEL) of BH3120 was determined to be 200 mg/kg.

 

Abstracts of preclinical studies related to mRNA cancer vaccines have not yet been published.

 

The contents that will soon be disclosed are the preclinical results of a clinical study suppressing tumor growth in a KRAS mutant LL/2 mouse model using a multi-target mRNA-based cancer vaccine.

 

Previously, Hanmi Pharmaceutical announced that it had successfully developed its own mRNA platform at the JP Morgan Healthcare Conference 2022 held in January last year.

 

In addition to developing a COVID-19 vaccine, the company has been promoting the application of the mRNA platform in the fields of metabolic diseases, anticancer, cardiovascular and renal diseases, enzyme replacement therapy, etc.