[This Week's Controversy] ABL Bio "Is It a Candidate to Become the Second Alteogen?"

Phase 2/3 Clinical Trial Results for Cholangiocarcinoma Announced on the 1st
Ambiguous Data Leads to Mixed Positive and Negative Evaluations
"The Real Value Lies in the BBB Platform"
Technology Transfer Deal Worth 4 Trillion KRW with GSK Announced on the 7th
Sanofi Phase 1 Trial Results Also in Focus by Mid-Year

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ABL Bio, which has been regarded as one of the 'big three' in new drug research and development alongside Alteogen and Rigachem Bio, saw its stock price fluctuate last week as its most advanced clinical pipeline released ambiguous clinical data. Analysts' opinions were mixed, both positive and negative. However, there was a consensus among securities firms to pay more attention to the follow-up Blood-Brain Barrier (BBB) platform technology under development.

Then, on the 7th, ABL Bio announced that it had signed a technology transfer agreement with the UK-based GlaxoSmithKline (GSK) for the development of new degenerative central nervous system (CNS) disease treatments based on the BBB shuttle platform 'Grabody-B.' The stock price surged to the daily limit.

Leading Domestic Company in Bispecific Antibody Technology

If Alteogen is the top domestic company in formulation conversion platform technology and Rigachem leads in antibody-drug conjugate (ADC) technology, ABL Bio holds leading technology in the field of bispecific antibodies.

Bispecific antibodies are antibodies that can simultaneously recognize two different antigens. Naturally occurring antibodies typically bind to only one target. However, artificially engineered bispecific antibodies can bind to two targets at the same time. For example, one arm of the antibody can recognize cancer cells, while the other arm can recognize immune cells, bringing them together to kill the cancer cells.

In addition to bispecific antibodies, ABL Bio is also developing ADC pipelines, a therapeutic approach that has recently gained global attention.

Disappointing ABL001 Clinical Results

On the 1st (local time), Compass Therapeutics, ABL Bio's technology transfer partner, announced the topline results of the US Phase 2/3 clinical trial combining ABL001 with paclitaxel in patients with cholangiocarcinoma. The key point was that the objective response rate (ORR), an objectively confirmed treatment effect, was 17.1%. Opinions were divided.

Critics pointed to the 37.5% ORR in the Phase 2 trial for cholangiocarcinoma conducted in Korea as a basis. There is an analysis that the US Food and Drug Administration (FDA) may request additional secondary endpoints such as duration of response (DoR), median progression-free survival (mPFS), and median overall survival (mOS). Minjung Kim, an analyst at DS Investment & Securities, evaluated, "Follow-up data is expected to be confirmed in the fourth quarter of this year, but predictions are impossible."

Optimists argued that the ORR was superior to the 5.3% ORR of paclitaxel monotherapy and that there was even one patient who achieved complete remission (CR), meaning the cancer completely disappeared. They also pointed out that the US trial had 111 patients, whereas the Korean trial had only 24, meaning smaller sample sizes can distort data. There is also hope that survival indicators, which will be additional judgment criteria, will improve. Minyong Eom, an analyst at Shinhan Investment Corp., analyzed, "If patient recruitment for Phase 2/3 started on January 9, 2023, and dosing began immediately, there is a possibility of patients surviving more than two years."

Regarding this, the company explained, "We will disclose additional data such as DoR, PFS, and OS within the year, and even if the announcement is slightly delayed beyond December, the review will be completed within six months, so there will be no problem with FDA approval next year." Despite the company's explanation, the stock price fluctuated last week.

'The Real Value is the BBB Platform' Technology Transfer to GSK

There has long been a consensus among securities firms that the technology that will largely determine ABL Bio's stock price direction is the BBB shuttle platform technology 'Grabody-B.' Even analysts who viewed ABL001's future pessimistically evaluated, "The corporate value will be determined by Grabody-B." The most advanced pipeline applying Grabody-B technology is ABL301.

The brain is extremely important in the human body. The BBB blocks the penetration of external substances in various ways. As a result, most drugs cannot cross the BBB, making treatment of brain diseases very difficult. Grabody-B binds to the insulin-like growth factor 1 receptor (IGF1R) on the surface of brain endothelial cells and transports drugs across the BBB into the brain through this receptor.

Previously, in January 2022, ABL Bio signed a joint development and technology transfer agreement worth $1.06 billion with the global pharmaceutical company Sanofi for ABL301, a Parkinson's disease treatment. In October last year, ABL Bio announced the transfer of ABL301 manufacturing technology to Sanofi. Currently, ABL301 is undergoing Phase 1 clinical trials in the US led by ABL Bio, and Sanofi is expected to take over from Phase 2 onward. Minjung Kim, an analyst at DS Investment & Securities, stated, "The Phase 1 clinical trial results of ABL301 are expected to be announced by mid-year."

Recently, in the global market, Roche's Alzheimer's bispecific antibody treatment, Trontinemab, which is an advanced pipeline among BBB shuttles, released positive data, naturally increasing attention on ABL Bio. On the 3rd, Roche announced at the 'Alzheimer's Disease and Parkinson's Disease International Conference 2025 (AD/PD 2025)' positive interim results from Phase 1b/2a clinical trials of Trontinemab based on its own BBB shuttle platform 'Brain Shuttle,' along with plans to enter Phase 3 clinical trials within the year. Besides Roche, companies like BMS, AbbVie, and Eli Lilly have licensed technology and are developing pipelines applying BBB shuttles.

Then, on the 7th, ABL Bio announced that it had transferred the degenerative brain disease treatment development platform Grabody-B to the global pharmaceutical company GSK for ?2.1401 billion (approximately 4.1 trillion KRW). This is the second-largest platform technology transfer deal in history, following Alteogen's $4.7 trillion KRW platform technology transfer to Merck in the US in 2020. ABL Bio is expected to receive a total of ?77.1 million (150 billion KRW) within a month, including upfront payments and short-term milestones. If GSK commercializes the developed drug, ABL Bio will also receive royalties based on an agreed percentage.

This technology transfer is the world's first platform technology transfer based on IGF1R-based BBB shuttle. Most other global pharmaceutical companies base their technology on the transferrin receptor (TfR). Also, as a platform technology transfer, it features unlimited scalability depending on target diseases and specific therapeutic modalities. Sanghoon Lee, CEO of ABL Bio, stated, "Through the commercialization of Grabody-B, we will further solidify ABL Bio's position in the degenerative brain disease treatment market and it will be a great opportunity to expand the applicable modalities of Grabody-B."

ABL Bio will hold an investor relations (IR) meeting on the 9th. The company said it will explain the significance of this contract along with the four growth pillars it presented earlier this year. Various information that will help gauge future stock price trends is expected to be released.