pharm edaily

[Kim Jinsoo, Edaily Reporter] Radiopharmaceutical developer CellBion surged more than 10% after news broke that its combination trial with Merck’s Keytruda would be expanded. Meanwhile, HLB Therapeutics, which dropped last week following a failed FDA approval, rebounded as investors looked ahead to data from an ophthalmology drug trial.

ABL Bio, on the other hand, saw a slight decline as the release of clinical data for its out-licensed second-line cholangiocarcinoma treatment was delayed.

CellBion stock trend. (KG Zeroin’s MP Doctor)

CellBion Gains on Keytruda Combo Expansion

On March 21, CellBion shares closed at 20,300 won, up 1,850 won or 10.03%, according to KG Zeroin’s MP Doctor (formerly Market Point).

PharmEdaily had earlier published a pay-to-read article titled “CellBion to Expand Combination Trial With Merck… Precursor to FDA Approval”(셀비온, 머크와 병용임상 적용 대상 대폭 확대...‘FDA 허가 전초전 돌입’) The report quickly circulated among paid subscribers and drew strong investor attention.

In February, CellBion signed a clinical trial collaboration and supply agreement with Merck (MSD) to evaluate its PSMA-targeting radiopharmaceutical therapeutic (RPT), 177Lu-DGUL, in combination with the PD-1 antibody Keytruda.

The study is significant in that it combines a radiopharmaceutical with an immune checkpoint inhibitor to offer new hope for prostate cancer patients with limited treatment options.

Merck has shown particular interest in prostate cancer, not only collaborating with CellBion but also running a combination trial of Keytruda and Novartis’ Pluvicto, a radiopharmaceutical for prostate cancer. While Keytruda has secured approvals for more than 20 indications, it still lacks one for prostate cancer.

According to the International Agency for Research on Cancer, prostate cancer accounted for 7.3% of all new cancer cases in 2022, making it the fourth most common after lung (12.4%), breast (11.6%), and colorectal (9.6%) cancers. Market research firm Global Information forecasts that the prostate cancer treatment market will grow from $14.8 billion in 2022 to $28.4 billion by 2030, underscoring Merck’s persistence in the field.

The success of CellBion’s domestic Phase 2 trial will be key to the expanded collaboration. According to an independent image evaluation committee, the overall response rate (ORR) for 177Lu-DGUL in 61 patients was 47.5%, far exceeding Pluvicto’s 29.8% ORR in a Phase 3 trial.

“There will be major changes once we have secured Phase 2 data for Lu-177-DGUL,” said CellBion Vice President Jaemin Park.

HLB Therapeutics Nears Completion of European Trial for RGN-259

HLB Therapeutics rose 7.98% to 8,390 won, recovering to its pre-FDA-rejection level from earlier in March.

The gain is attributed to growing anticipation for Phase 3 data on the ophthalmology drug RGN-259, being developed through U.S. joint venture ReGenTree.

A company representative said at the March 25 shareholder meeting that the European Phase 3 trial for RGN-259 is expected to wrap up by the end of the month.

The trial, known as SEER-3, has been underway since June 2023 at 25 hospitals across Spain, Italy, Poland and Germany. Patient enrollment was completed last month, and dosing is expected to finish by the end of March, potentially enabling a data release in the first half of 2025.

Meanwhile, a separate Phase 3 trial (SEER-2) in the U.S. began in April 2023 and is still recruiting patients to meet its 70-subject target. The primary endpoint is the percentage of patients fully healed four weeks after using the single-dose eye drops. In a prior trial (SEER-1), 6 out of 10 patients in the treatment group fully recovered.

“Since the European trial is progressing faster, we plan to seek market approval there first,” the company said, adding that the U.S. trial is expected to finish in the second half of this year.

ABL Bio Slips on ABL001 Data Delay

Shares of ABL Bio fell as much as 6% early in the day to 32,600 won but recovered to close at 34,750 won, down 2.39%. Over the past week (March 19~26), the stock dropped 15.92%.

The dip followed delays in the release of top-line data from Phase 2/3 trials of CTX-009 (ABL001), a second-line cholangiocarcinoma treatment licensed out to U.S.-based Compass Therapeutics.

Compass previously announced it would share data for the bispecific antibody treatment by the end of Q1. Industry observers had expected a release via abstracts submitted to the American Association for Cancer Research (AACR), but the data was not included. Compass shares also fell 8.65% on March 25.

ABL001 is a bispecific antibody developed by ABL Bio targeting VEGF-A (vascular endothelial growth factor A) and DLL4 (Delta-like ligand 4). It works by inhibiting angiogenesis in tumors, inducing cancer cell death. Compass holds global rights and is conducting the trials in the U.S.

ABL001 received Fast Track designation from the FDA in April 2024. Given that cholangiocarcinoma is a rare disease, the global Phase 2 data may support a new drug application.