[Edaily Reporter KIM SAE-MI ] Peptron, Inc.(087010)has terminated the technology transfer agreement for “PT302,” a glucagon-like peptide-1 (GLP-1) class diabetes treatment, which it had maintained with Yuhan(000100)for 15 years. PT302 is a pipeline drug that had completed Phase 2 clinical trials but had its further development halted due to diminished market potential following the emergence of competing global products. Attention is focused on the circumstances that led Peptron, Inc. to reclaim exclusive rights to PT302 and secure the clinical data approximately 11 years after the completion of Phase 2 trials.

According to a report by Pharm eDaily, E-Daily’s premium pharmaceutical and biotech content service, on the 19th, Peptron, Inc. mutually terminated its technology transfer agreement for PT302 with Yuhan on March 13. Consequently, it revoked the exclusive license granted to Yuhan and regained exclusive rights to PT302.

Regarding this, Peptron, Inc. stated, “We have secured all clinical data necessary for future global licensing (L/O).” This is interpreted to mean that the company has laid the groundwork to utilize the clinical data for PT302—which had seen no follow-up development for an extended period—for future technology transfers and other purposes.

4 billion won technology transfer agreement, only 1 billion won received… Development stalled at Phase 2 clinical trials

Previously, on February 25, 2011, Peptron, Inc. signed a contract with Yuhan Corporation for the exclusive domestic development and sale of PT302, valued at a total of 4 billion won. Under the agreement, Yuhan Corporation was responsible for domestic clinical trials, regulatory approval, and sales, while Peptron, Inc. was tasked with producing and supplying clinical trial samples and commercial products.

The non-refundable upfront payment was 1 billion won, with additional payments of 1 billion won upon approval for Phase 3 clinical trials, 500 million won upon product approval, and 1.5 billion won upon achieving sales targets. However, since PT302 did not progress beyond Phase 2 clinical trials, the total amount Peptron, Inc. actually received was limited to the 1 billion won upfront payment.

PT302 is an injectable formulation that applies Peptron, Inc.’s long-acting drug delivery platform, “SmartDepot,” to exenatide, a first-generation GLP-1 receptor agonist. It was developed to improve patient convenience by extending the dosing interval compared to conventional exenatide.

Exenatide was commercialized in 2005 when the U.S. Food and Drug Administration (FDA) approved the diabetes treatment “Byetta.” Subsequently, “Byduuran,” which is administered once weekly, was introduced, and follow-up GLP-1 therapies such as liraglutide and semaglutide were launched in quick succession.

Peptron, Inc. also developed PT302 as a long-acting treatment administered once a week or once every two weeks, but the market environment has changed. Peptron, Inc. previously explained that it halted development in 2020 after determining that it would be difficult to secure market viability for PT302 due to the launch of competing products by global pharmaceutical companies.

Currently, the obesity treatment market is dominated by semaglutide and tirzepatide. Exenatide has not been approved as an obesity treatment in the U.S., and its weight-loss effects are considered more limited than those of these products. It is not easy to secure commercial competitiveness simply by extending the dosing interval of PT302.

PT302

Has Demonstrated Blood Glucose Improvement… But Is It Competitive as an Obesity Treatment

? It is worth noting that PT302 has demonstrated blood glucose-lowering effects in previous human clinical trials.

Yuhan Corporation conducted a Phase 2 clinical trial of PT302 in South Korea involving 84 patients with Type 2 diabetes, which was completed in February 2015. The primary endpoint was the change in glycated hemoglobin (HbA1c), and the trial was designed to also evaluate body weight and fasting blood glucose levels.

According to the clinical results disclosed by Peptron, Inc. to Edaily, the change in HbA1c was -0.83 percentage points in the 1 mg once-weekly group, -0.92 percentage points in the 1.6 mg once-weekly group, and -0.88 percentage points in the 2 mg once-every-two-weeks group.

A Peptron, Inc. official explained, “A statistically significant reduction compared to the placebo group was confirmed in all treatment groups.” However, the company did not provide the actual change in the placebo group or specific statistical analysis figures. Detailed analysis results regarding weight loss were also not disclosed.

Therefore, it appears necessary to distinguish between the fact that blood glucose-lowering effects were confirmed in that clinical trial and the drug’s competitiveness as an obesity treatment. Since the extent of PT302’s weight-loss effect has not been confirmed, there are limitations to evaluating its competitiveness against next-generation obesity treatments.

The specific circumstances leading to the suspension of development, despite the efficacy being confirmed in the Phase 2 clinical trial, also remain unclear. Peptron, Inc. stated, “The specific decision-making process regarding follow-up development was an internal matter of the entity leading the development at the time, so it is difficult to explain separately.”

Clinical Data Secured 11 Years Ago… Could It Become a Card for “SmartDepo” Technology Transfer

? Peptron, Inc.’s recovery of the rights to PT302 occurred at a time when the company was pursuing the development of its own obesity treatment and the global commercialization of its SmartDepo platform.

Currently, Peptron, Inc. is developing “PT403,” a semaglutide-based once-monthly obesity treatment, and “PT404,” a tirzepatide-based treatment, among others. On the 7th, the SmartDepo technology evaluation conducted with Eli Lilly over approximately two years concluded. Although no follow-up commercialization agreement was signed at the conclusion of the evaluation, the company is keeping the door open for future collaboration.

Under these circumstances, historical clinical data from PT302 may be utilized as evidence demonstrating the experience of applying SmartDepo technology in humans. However, since PT302, PT403, and PT404 involve different active ingredients, past clinical results cannot be directly used as evidence to validate the efficacy or safety of the current pipeline.

A Peptron, Inc. official stated, “Existing clinical data can be used to support our clinical development experience with long-acting formulation technology,” but added, “Clinical evaluations of individual pipeline candidates are conducted separately during their respective development processes.”

The company took a cautious stance regarding the specific reasons for the contract termination and future commercialization plans. It has not yet been determined whether development of PT302 itself will resume, nor has the company disclosed whether it is actually utilizing this data in technology transfer negotiations with global pharmaceutical companies.

A Peptron, Inc. official stated, “The clinical data we have secured can be utilized in our future technology and business development activities,” but added, “It is difficult to publicly disclose whether we are in discussions with individual global pharmaceutical companies or the specific details of how the data is being used.”