Expanded competitiveness of K-Bio immunotherapies

increasing the possibility of 'big deals'

Aprogen secures development rights for PharmAbcine's PMC-309…the next-generation immunotherapy targeting VISTA

Yuhan·Hanmi·STCube speeds up targeting dual-specific antibodies and new targets…confirming the possibility of combination therapies

Korean pharmaceutical and biotech companies are entering the development of immunotherapies, increasing the possibility of 'big deals' with global pharmaceutical companies.

 

As competition for new drugs targeting next-generation immune checkpoint proteins intensifies, Aprogen has begun developing VISTA targets by securing an antibody candidate from PharmAbcine.

 

Companies such as Yuhan Corp, Hanmi Pharmaceutical, ImmuneOncia, and STCube are also implementing differentiated strategies with new target-based immunotherapies.

 

Aprogen Secures PharmAbcine's Immunotherapy Candidate… 'Free supply agreement for Keytruda'

According to the Financial Supervisory Service's electronic disclosure system on August 23, Aprogen recently secured an exclusive license for the research, development, and commercialization of the immunotherapy candidate PMC-309 through an agreement with PharmAbcine.

 

Aprogen also obtained the rights for its manufacturing and production.

 

The total contract value exceeds 10% of PharmAbcine's consolidated equity capital of KRW 47.7 billion as of last year, and the specific terms are undisclosed.

 

The contract period runs from August 18, 2025, until the expiration of the final valid claim of the licensed patent.

 

PMC-309 works by enhancing T-cell activity by blocking VISTA on the surface of immune T-cells and reducing the immunosuppressive function of myeloid-derived suppressor cells (MDSCs) to normalize the tumor microenvironment.

 

This new drug candidate was discovered through PharmAbcine's fully human antibody library, 'HuPhage,' and specifically targets VISTA, a next-generation target for immunotherapy.

 

A Phase 1 clinical trial of PMC-309 is currently underway in Australia.

 

The Phase 1a part of the trial evaluates safety and pharmacokinetics with monotherapy, starting from low to high doses.

 

The Phase 1b part will verify its combination effect with MSD's 'Keytruda.' MSD signed a free supply agreement for Keytruda with PharmAbcine in 2021, and this arrangement remains in effect for the current trial.

 

The trial's patient enrollment goal is 67, with the first dose administered in November 2023.

 

The expected completion date is 2028.

 

Aprogen expects to see tumor shrinkage signals as early as the low-dose stage and anticipates a more pronounced anti-cancer effect at intermediate doses.

 

Aprogen plans to quickly initiate the Keytruda combination Phase 1b trial once the target signals are confirmed at the intermediate dose, and to pursue early out-licensing to MSD if superior efficacy is proven in the combination therapy.

 

Major Entry into Immunotherapy Market…All-Out Effort for Technology Transfer

New antibody-drug conjugates (ADC)

The immunotherapy development strategy of Korean companies can be summarized as 'signals,' 'speed,' and 'deal-making.' The structure involves securing meaningful response rates and safety data in the early clinical stage and using this as a basis to complete early technology transfers with global partners.

 

This is why Korean companies are pursuing combinations with already commercialized immunotherapies or antibody-drug conjugates (ADCs).

 

This Aprogen-PharmAbcine technology transfer deal is also notable for its collaboration with MSD, which opens the door for early technology transfer to a global pharmaceutical company.

 

The industry is paying close attention to whether a major deal can be made when the clinical response rate, duration of response, and toxicity profile are disclosed.

 

Currently, not only Aprogen and PharmAbcine but also Yuhan Corp, Hanmi Pharmaceutical, STCube, and GI Innovation are developing next-generation immunotherapies.

 

Yuhan Corp recently received approval from the Ministry of Food and Drug Safety for its Phase 1/2 clinical trial plan (IND) for the bispecific antibody immunotherapy candidate 'YH32364.' YH32364 is a new drug candidate that Yuhan Corp in-licensed from ABL Bio in 2018.

 

This trial is the first human dose study for YH32364.

 

Yuhan Corp will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of YH32364 in patients with locally advanced or metastatic solid tumors that have confirmed overexpression of the epidermal growth factor receptor (EGFR).

 

YH32364 is a bispecific antibody immunotherapy candidate that simultaneously targets EGFR and 4-1BB.

 

Yuhan Corp plans to maximize the anti-tumor effect by simultaneously targeting EGFR, a biomarker expressed in major solid tumors like non-small cell lung cancer and colorectal cancer, and 4-1BB, which is involved in T-cell activation.

 

Hanmi Pharmaceutical is conducting a Phase 1 clinical trial for its bispecific antibody immunotherapy candidate, 'BH3120.' BH3120 simultaneously targets PD-L1 and 4-1BB.

 

As PD-L1 is a target where immunotherapies like Keytruda and Opdivo have proven their efficacy, Hanmi Pharmaceutical plans to enhance this effect by adding a 4-1BB protein target.

 

GI Innovation recently changed its U.S.

 

Phase 1/2 clinical trial for the immunotherapy candidate 'GI-102' to a study evaluating its combination therapy with Enhertu.

 

GI-102 is a pipeline that targets CD80 and Interleukin (IL-2) to target tumor and immune cells.

 

It has been engineered to have an even lower binding affinity to the alpha receptor compared to GI-101A.

 

It is known that a high binding affinity to the alpha receptor increases regulatory T-cells, which reduces the anti-cancer effect.

 

GI-102 is also being developed in a subcutaneous (SC) formulation, in addition to the intravenous (IV)formulation.

 

The potential of GI-102 was also confirmed in a monotherapy trial.

 

According to Phase 1/2a data recently disclosed by the company, GI-102 showed an objective response rate (ORR) of 43% in patients with melanoma.

 

When GI-102 was administered, lymphocyte proliferation proceeded smoothly, and no serious drug toxicity was observed in terms of safety.

 

GI Innovation anticipates a more pronounced effect when GI-102 is used in conjunction with Enhertu.

 

The company believes that combining GI-102 with a reduced dose of Enhertu may decrease side effects, such as interstitial lung disease (ILD), which can occur with Enhertu.

 

STCube is set to disclose the clinical results of 'Nelmastobart,' which targets the new biomarker BTN1A1.

 

BTN1A1 is a protein that regulates the immune response to cancer cells by suppressing the activity of immune cells, T-cells.

 

This biomarker is not expressed in normal cells but is strongly expressed in cancer cells, and its expression is mutually exclusive with PD-L1.

 

ST Cube is developing an immunotherapy that targets BTN1A1, which could be a new treatment option for intractable cancers.

 

ST Cube is currently conducting a U.S.

 

and Korean Phase 1b/2 trial of Nelmastobart in combination with paclitaxel for patients with relapsed, refractory, and extensive-stage small cell lung cancer (ES-SCLC).

 

The company is also investigating the potential of a Nelmastobart and capecitabine combination therapy as a third-line or later treatment for metastatic colorectal cancer.

 

TiumBio recently disclosed the Phase 2 clinical trial results for its immunotherapy candidate 'TU2218' in combination with MSD's immunotherapy 'Keytruda.' TU2218 simultaneously blocks the pathways of transforming growth factor-beta (TGF-ß) and VEGF, which are known to inhibit immunotherapy activity, thereby maximizing the efficacy of immunotherapies.

 

The disclosed trial represents the early cohort results from an ongoing study in patients with head and neck cancer and biliary tract cancer.

 

The clinical results showed that the TU2218 + Keytruda combination therapy resulted in a partial response (PR) in 7 out of 11 patients with head and neck cancer, with stable disease (SD) observed in 1 patient.

 

In the biliary tract cancer cohort, 4 out of 23 patients showed PR, and 7 showed SD.

 

ImmuneOncia is conducting clinical trials for its immunotherapy candidate 'IMC-002.' IMC-002 has a mechanism that blocks signals between CD47 on cancer cells and macrophages.

 

The recently disclosed results are the initial findings from an ongoing Phase 1b clinical trial in patients with hepatocellular carcinoma.

 

The trial is evaluating the tolerability and safety of IMC-002 in combination with Lenvima, which is used to treat hepatocellular carcinoma.

 

Among 10 patients who could be assessed for efficacy, the ORR was 30%, and the disease control rate (DCR) was 70%.

 

The median time to progression (TTP) was 8.3 months.