Disappointment Spreads Over ABL Bio's Cholangiocarcinoma Trial Results... "Limited Impact on Corporate Value"

ABL Bio: "BBB Shuttle Technology Transfer Discussions Progressing Well... Pipeline Diversification in Place"
DS Investment & Securities: "Grabody-B and Grabody-T Platforms Are the Core Value"

In the phase 2·3 clinical trial of Tovetsemig (ABL001), a candidate treatment for cholangiocarcinoma developed by ABL Bio, the key survival indicator failed to achieve statistical significance. However, the company explained that the impact of this result on corporate value is limited. The securities industry has expressed a similar opinion.

ABL Bio company logo image. ABL Bio

On April 28, ABL Bio announced via its mobile shareholder community, "If ABL001 is approved, it would indeed become an asset that contributes to stable cash flow; however, our corporate value is diversified across various platforms and pipelines, including Grabody-B, Grabody-T, and antibody-drug conjugates (ADC). The current decline in our stock price is excessive."

The company further explained, "Discussions on technology transfer of blood-brain barrier (BBB) shuttle technology with multiple global pharmaceutical firms are progressing smoothly, and talks regarding expanded modalities such as siRNA are also underway." Regarding the U.S. Food and Drug Administration (FDA) application schedule for ABL001, the company stated that "there is no change." It also commented, "The potential impact of the cross-over clinical design on the results was already recognized by the FDA at the time of clinical approval," adding that "the approval process will proceed based on data from the objective response rate (ORR), progression-free survival (PFS), and overall survival (OS)."

The securities sector also shared a similar perspective. Minjeong Kim, a researcher at DS Investment & Securities, noted in a report released that day, "The number of patients in the cholangiocarcinoma market targeted by ABL001 is very small, and the median PFS during the administration period is also short, at about 4.7 months. Since the drug can be administered only for a short time, it lacks commercial viability," assessing that "the value of ABL001 was minimal from the start."

She then summarized the core value of ABL Bio as two platforms. Researcher Kim stated, "The core of ABL Bio's corporate value boils down to two platforms: the BBB shuttle-based Grabody-B platform, starting with ABL301, and the Grabody-T (4-1BB) platform, for which proof of concept (PoC) in humans has been demonstrated with ABL111. I suggest monitoring the results of these pipelines." The final results of the phase 1b clinical trial for ABL111 are expected in the second half of this year.

She was cautious about the possibility of FDA approval. Researcher Kim analyzed, "In the past, when the ORR was announced, the FDA asked Compass Therapeutics for the final OS data from phase 2·3 trials. Since the data failed to achieve statistical superiority, it will not be easy to obtain FDA approval."

She also provided a critical analysis of the cross-over effect cited by the company as the reason for not meeting the OS endpoint. Researcher Kim pointed out that in a post-hoc subgroup analysis, the OS median for the cross-over patient group (12.8 months) was longer than that of the test group that received the study drug from the beginning (8.9 months), explaining, "This leads to the ironic conclusion that Tovetsemig is more suitable as a third-line rather than a second-line therapy." She added, "It is generally very difficult to use post-hoc subgroup data for FDA approval."

Compass Therapeutics, the U.S. company that licensed ABL001 from ABL Bio, released the phase 2·3 clinical results for Tovetsemig the previous day. PFS for the test group was 4.7 months, longer than the control group's 2.6 months, achieving statistical significance. However, OS was 8.9 months for the test group and 9.4 months for the control group, failing to show a significant difference.

Immediately after the clinical trial results were announced, Compass Therapeutics' stock price plunged by more than 60%. On the same morning, ABL Bio's share price also dropped by more than 20% at one point compared to the previous day.

This content was produced with the assistance of AI translation services.