ADC·immunotherapy competitiveness↑…K-bio gains attention

at international conferance

LigaChem Biosciences has confirmed comparable effects of its candidate to Enhertu in a phase 2 gastric cancer trial

Immunotherapy with a new mechanism of action demonstrates potential…synergy with bispecific antibodies

The American Society of Clinical Oncology (ASCO 2024) annual meeting started on May 31st lasting five days in Chicago, U.S.

 

Korea-based biopharmaceutical companies have confirmed clinical achievements in globally trending R&D areas, including antibody-drug conjugates (ADC), immunotherapy for cancer, and bispecific antibodies.

 

LigaChem Biosciences presented clinical data of LCB14, a human epidermal growth factor receptor 2 (HER2)- targeting ADC candidate.

 

LBC14 has been shown to improve primary assessment indexes.

 

ABL Bio confirmed efficacy in various solid cancers and blood cancers, including diffuse large B-cell lymphoma (DLBCL), Hodgkin lymphoma, non-small cell lung cancer (NSCLC), and pancreatic cancer.

 

Additionally, the Korea-based biopharmaceutical industry’s immunotherapy for cancer with a new mechanism of action have shown potential at early stages of clinical trials.

 

It has also shown synergistic effect with bispecific antibodies.

 

LigaChem Biosciences’ ADC shows comparable efficacy to Enhertu At ASCO 2024, LigaChem Biosciences presented the Phase 2 clinical trial result of LCB14, a HER2-targeting ADC candidate.

 

LCB14 is linked via a monomethyl auristatin F (MMAF) agent, unlike most ADC drugs employing topoisomerase inhibitors.

 

MMAF is an anti-tubulin inhibitor that kills cancer cells by inhibiting microtubule formation.

 

Currently, Roche’s Kadcyla Daiichi Sankyo·AstraZeneca’s Enhertu have emerged as HER2-targeting ADCs.

 

These two were approved for the treatment of breast cancer, but only Enhertu was approved gastric cancer.

 

LigaChem Biosciences is confirming the market potential of its candidate for one of Enhertu’s indications, metastatic gastric cancer or gastroesophageal junction cancer.

 

The clinical trial evaluated LCB14’s efficacy in patients with gastric cancer who had received at least two or more previous treatments (16 patients, cohort 1) and who had received at least one treatment (19 patients, cohort 2).

 

Cohort 1 treated with LCB14 had an objective response rate (ORR) of 37.5%, a median progression-free survival (PFS) value of 4.3 months, and an overall survival (OS) of 10.0 months.

 

This result was comparable to the clinical result of DESTINY-Gastric06, evaluating Enhertu’s efficacy, with an ORR of 35.6%, a PFS of 5.7 months, and an OS of 10.2 months.

 

Cohort 2 treated with LCB14 recorded an ORR of 52.6%, a mPFS of 4.4 months, and an OS of 14.6 months.

 

Since LCB14 has shown comparable efficacy to Enhertu in a phase 2 clinical trial, LigaChem Biosciences expects its potential use in treating patients with recurrent solid cancer.

 

ABL Bio has confirmed the efficacy of CS5001, a ROR1-targeting ADC, in a phase 1 clinical trial.

 

ROR1 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.

 

As of January 15, 2024, the drug tolerance and safety of eight doses of CS5001 were analyzed in 17 lymphoma patients and 32 solid cancer patients.

 

In the first eight dose groups of CS5001, no dose-limiting toxicities (DLT) were observed.

 

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

 

Their investigator said, “CS50001 treatment has shown modest drug tolerance without experiencing DLT.

 

Additionally, we observed favorable anticancer activities in various advanced solid cancers and lymphoma.” Achievements in clinical trials of immunotherapy for cancer·bispecific antibodies GI Innovation has confirmed the effectiveness of GI-102, a candidate immunotherapy for cancer.

 

This company is developing GI-102, which acts on CD80 and interleukin (IL)-2.

 

IL-2 is involved in immune cell proliferation and activation, and CD80 blocks CTLA-4, a receptor preventing immune cells from attacking cancer cells.

 

The presented clinical trial results evaluated the safety, drug tolerance, and antitumor activities of GI-102.

 

Korea-based biopharmaceutical companies participated in poster sessions at ASCO 2024, which commenced on May 31.

An ORR of 17.4% was observed in 23 patients (7 skin melanoma patients, 4 NSCLC patients, and 3 ovarian cancer patients).

 

The reported overall ORR was 42.9%, and the disease control rate (DCR) was 85.7%, including three cases of partial response (cPR) confirmed in patients with metastatic skin melanoma who had previously experienced ICB.

 

GI Innovation aims to obtain conditional approval for its GI-102 and is assessing the potential for technology transport.

 

They are also examining the potential of using GI-102 in combination with NK cell therapy, as well as GI-102 monotherapy.

 

The company’s clinical trial results are receiving attention as they strive to make the technology transfer of an immunotherapy candidate by the end of this year.

 

TiumBio presented the interim result of a phase 1b trial involving TU2218, which is under development as bispecific antibodies.

 

TU2218’s underlying mechanism of action involves simultaneously inhibiting transforming growth factor beta (TGF-ß) and vascular endothelial growth factor (VEGF) pathway, which are known to interfere with immunotherapy activation in the body.

 

TiumBio is conducting clinical trials in three clinical institutes in the United States to evaluate the efficacy and safety of TU2218 in combination with the immunotherapy Keytruda in patients with advanced solid cancer.

 

The clinical results showed that out of five patients treated with a daily recommended dose of TU1228 195 mg, two patients had PR, and three patients had SD.

 

The DCR of all treatment groups was 66.7%.

 

The treatment-related adverse events (TRAE) of over Grade 3 were fatigue, increased gamma-glutamyl transpeptidase, and pneumonia.

 

TRAE of Grades 4-5 was not reported.