'Leclaza’s 5 counts of clinical results' to be showcased

at upcoming international conference...new K-made anti-cancer drug

Korean pharma and biotech companies to showcase their results at the 2024 American Society of Clinical Oncology (ASCO 2024) Annual Meeting

Yuhan·Janssen to disclose five counts of Leclaza+Rybrevant combination therapy clinical results

HLB to disclose study results of liver cancer tracking…GI Innovation will showcase its ABL

It has been noted whether new anti-cancer candidates from the pharmaceutical and biotech industry in South Korea will be competitive on a global setting.

 

According to industry sources on April 2nd, various Korean pharmaceutical companies, including Yuhan, HLB, and GI Innovation, will attend the 2024 American Society of Clinical Oncology (ASCO 2024) Annual Meeting, which will take place on 31st for five days in Chicago, United States.

 

The AACR is the world’s largest cancer academic conference, at which 400 companies from 120 countries gather annually to present their latest clinical data.

 

Yuhan-Janssen will disclose their major clinical data of Leclaza+Rybrevant

Leclaza+Rybrevant combination therapy to be presented at ASCO 2024.

Yuhan and its partnering company, Janssen, will present five counts of clinical data results related to Leclaza and Rybrevant combination therapy.

 

Notably, the PALOMA 2,3 trial, which evaluated the effectiveness of the subcutaneous (SC) formulation of Leclaza and Rybrevant, is to be watched.

 

As shifts toward SC formulations gain popularity in anti-cancer immunotherapy, such as Keytruda, Opdivo, and Tecentriq, targeted anti-cancer agents follow suit.

 

Conventional anti-cancer agents are primarily intravenous (IV) therapy, and the administration takes more than one hour.

 

Anti-cancer agents of SC formulation are expected to improve patient convenience since they can significantly reduce the administration duration to within 10 minutes.

 

Phase 3 PALOMA-3 study has evaluated the efficacy and safety of SC formulation Leclaza and Rybrevant therapy compared to IV formulation Leclaza and Rybrevant combination therapy in patients with EGFR positive non-small cell lung cancer (NSCLC) who have failed previous treatments.

 

Furthermore, the Phase 2 PALOMA-2 sutdy evaluated the effectiveness of SC formulation Rybrevant and Leclaza therapy in patients with EGFR-positive NSCLC who have not been treated before.

 

It is to be watched whether the combination therapy of SC formulation can address the concerns regarding infusion-related reactions (IRR) side effects identified in the MARIOSA study.

 

Also, the second analysis results of the Phase 3 MARIPOSA clinical study will be disclosed.

 

These results are from testing the effectiveness of the Rybrevant and Leclaza combination therapy, with interim analysis results for progression-free survival (PFS) and OS previously disclosed in last year’s European Society for Medical Oncology Annual Meeting (ESMO 2023).

 

Results related to high-risk patients with a specific biomarker are anticipated to be presented at this year’s ASCO.

 

This study has evaluated the treatment’s efficacy and safety in comparison to its competitor, Tagrisso by AstraZeneca.

 

Additionally, the clinical results of CHRYSALIS-2 study, evaluating the Leclaza and Rybrevant combination therapy in patients with NSCLC harboring atypical EGFR mutations, will be disclosed.

 

This will be presented by Byoung Chul Cho (Director of the Lung Cancer Center at Yonsei Cancer Hospital), who directed the MARIPOSA research.

 

The clinical results of the Leclaza and Rybrevant combination therapy in patients with EGFR-mutated NSCLC who have CNS diseases will also be disclosed.

 

HLB to disclose additional results of rivoceranib in treating liver cancer…to showcase anti-cancer immunotherapy GI-102

Korean pharma and biotech companies, including GI Innovation, ABL Bio, NeoImmuneTech, and Qurient, to present their results at ASCO 2024.

HLB will present the results of survival duration tracking for liver cancer patients at this conference.

 

Rivoceranib is an oral targeted anti-cancer agent that inhibits vascular endothelial growth factor receptor 2 (VEGFR2), which is involved in tumor angiogenesis.

 

Rivoceranib and camrelizumab combination therapy is currently anticipated to receive approval from the U.S.

 

FDA.

 

In a previously disclosed Phase 3 study of CARES-310, the combination therapy recorded an OS of 22.1 months in patients with liver cancer.

 

The final analysis data of OS will be disclosed at ASCO 2024.

 

GI Innovation will present the Phase 1/2 results of its anti-cancer immunotherapy candidate, GI-102, in metastatic solid cancer.

 

This novel candidate product targets CD80 and interleukin (IL-2), targeting tumors and immune cells.

 

According to interim results from the phase 1/2 clinical trial, GI-102 demonstrated response rates in cancer types unresponsive to conventional anti-cancer immune immunotherapy.

 

Notably, an increase in response rates was observed in melanoma patients who were unresponsive to anti-cancer immunotherapy, with confirmation of proliferation in NK cells and T cells.

 

ABL Bio will present its Phase 1 clinical result of ABL503, a bispecific antibody candidate.

 

ABL503 is a cancer immunotherapy that simultaneously targets PD-1 and 4-1BB.

 

According to the Phase 1 clinical trial result, one instance of complete response (CR) and three instances of partial remission (PR) were confirmed in ovarian cancer patients administered with ABL503.

 

Phase 1 trials of ABL503 are being conducted in 6 agencies in the United States and 3 agencies in South Korea, related to dosage escalation and expansion parts.

 

Once the dosage is determined, the company aims to set the optimal target among solid cancers.

 

NeoImmuneTech will present poster presentations of preclinical data for its NT-I7, an anti-IL-7, in combination with the anti-cancer immunotherapy Keytruda for the treatment of solid cancer.

 

This clinical trial evaluated the efficacy and safety of the combination therapy in 48 patients with pancreatic cancer and 50 patients with microsatellite stable (MSS) colorectal cancers.

 

Qurient will showcase the interim result of the Phase 1 study for the CDK7 inhibitor Q901.

 

Q901 has an underlying mechanism of inhibiting CDK7, a key molecule in regulating the cell cycle.

 

This inhibits DNA damage repairs and increases gene instability, ultimately leading to apoptosis of cancer cells.

 

Qurient is currently conducting a Phase 1/2 trial to evaluate the safety and efficacy of Q901 as a potential anti-cancer treatment in patients with progressive solid cancer.

 

This trial is being conducted in the United States and South Korea.