[Edaily Reporter NA EUN-KYUNG ] D&D Pharmatech Inc.(347850)is accelerating negotiations with major global pharmaceutical companies with the goal of exporting the technology for “DD01,” a treatment for metabolic and alcoholic steatohepatitis (MASH), by the end of the year. At the same time, the company has unveiled preclinical results for “DD18,” a next-generation obesity treatment designed to reduce body weight while minimizing the loss of lean body mass, including muscle, and is working to secure new growth engines. The company has also solidified its new drug development and commercialization strategies, including expanding the indications for existing liver fibrosis treatments to include pancreatic cancer and securing investment from its U.S. affiliate.

D&D Pharmatech Inc. unveiled these mid- to long-term development and commercialization strategies at its Research and Development (R&D) Day held on the 3rd at the Grand InterContinental Seoul Parnas in Gangnam-gu, Seoul.

The company’s top commercialization priority is the technology export of DD01, which has completed Phase 2 clinical trials. D&D Pharmatech Inc. recently received the Clinical Study Report (CSR) for DD01. JP Morgan serves as the official partnering advisor. D&D Pharmatech Inc. reiterated that it is currently in technology transfer negotiations with several major global pharmaceutical companies and aims to finalize an agreement by the end of the year. The company plans to present its Phase 2 clinical trial data at the American Association for the Study of Liver Diseases (AASLD) conference on the 8th and hold an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) early next year to discuss the development path toward Phase 3 trials.

Lee Seul-ki, CEO of D&D Pharmatech Inc., explained in her presentation that day, “Even if we secure positive results in Phase 2 clinical trials, it does not mean a technology transfer agreement will be finalized immediately.” “From the perspective of global pharmaceutical companies, they have no choice but to review the matter carefully, as they must invest substantial funds in the subsequent Phase 3 clinical trials and take responsibility for commercialization,” she added. Taking this situation into account, D&D Pharmatech Inc. plans to focus on finalizing a technology transfer agreement by the end of the year while continuing negotiations with multiple global pharmaceutical companies.

Hepatic Fibrosis Treatment TLY012: Expansion into Pancreatic Cancer Treatment Under Review

The candidate drug that garnered new attention at this event is the anti-fibrotic new drug “TLY012.” D&D Pharmatech Inc. revealed the possibility of expanding TLY012—which was initially being developed for hepatic fibrosis, chronic pancreatitis, and systemic sclerosis—to include pancreatic cancer as a target.

TLY012 is a recombinant protein drug that selectively kills myofibroblasts, the cells responsible for fibrosis. It aims to differentiate itself from existing approaches that regulate inflammation or metabolic abnormalities by directly eliminating the cells involved in the progression of fibrosis.

Lee Seul-ki, CEO of D&D Pharmatech Inc., stated, “We have been conducting joint research with the Cancer Center at Brown University School of Medicine for a long time,” adding, “We have confirmed that TLY012 demonstrates very high preclinical efficacy in specific cancer types with severe fibrosis, including pancreatic cancer.”

Pancreatic cancer is a type of cancer characterized by the abundant formation of fibrous stroma around the tumor. Consequently, there is growing interest in whether therapies targeting fibrosis can overcome the limitations of existing anticancer treatments. However, TLY012’s anticancer efficacy has only been confirmed in preclinical studies, and its effectiveness in actual patients has not yet been verified.

D&D Pharmatech Inc. plans to first advance TLY012 into clinical trials as a treatment for liver cirrhosis and then consider expanding its indications. The company aims to begin Phase 1 clinical trials in the first half of next year. The strategy is to confirm safety in Phase 1 and then proceed with full-scale technology transfer starting in the second half of 2028.

CEO Lee explained that researchers at Brown University are showing interest in a clinical study targeting pancreatic cancer patients. He also predicted that it would be possible to design future clinical trials combining treatment and diagnostic imaging using the fibroblast activation protein (FAP)-targeted positron emission tomography (PET) contrast agent currently under development by the company.

When used in combination with semaglutide… more fat was lost while lean body mass was preserved

In the field of obesity treatments, preclinical results for “DD18,” a new UCN2 agonist-based drug, were disclosed. DD18 aims to reduce body weight while minimizing the loss of lean body mass through a mechanism of action different from that of currently marketed glucagon-like peptide (GLP)-1 agonists.

Existing obesity treatments demonstrate significant weight loss effects but have the limitation of reducing lean body mass along with fat. Lean body mass refers to body components other than fat, including muscle, water, and organs.

D&D Pharmatech Inc. announced that, following a 30-day administration of DD18 and semaglutide to obese mice, DD18 alone demonstrated weight loss effects comparable to those of semaglutide.

Of particular note are the changes in body composition. According to the company, while the group treated with semaglutide alone experienced a decrease in lean body mass alongside weight loss, the group treated with DD18 alone showed a tendency for lean body mass to remain stable or increase. This indicates that nearly all of the weight loss in the DD18 group was attributable to a reduction in fat mass.

When semaglutide and DD18 were used in combination, greater reductions in body weight and fat mass were observed compared to semaglutide monotherapy, while the loss of fat-free mass was reduced. This demonstrates the potential to enhance the weight-loss effects of existing GLP-1 therapies while addressing their limitations in terms of body composition.

Director Park explained, “DD18 has weight-loss effects on its own, and when used in combination with incretin-based therapies, additional weight loss can be expected through non-incretin mechanisms.”

D&D Pharmatech Inc. plans to select the final development candidate for DD18 by the end of this year and enter Phase 1 clinical trials in the second half of 2027. The company will also begin actively pursuing technology transfers around the time of entering Phase 1 clinical trials.

Globally, UCN2-based obesity treatments such as “COR-1389” from France’s Corteira Pharmaceuticals, “HM17321” from HanmiPharm(128940), “GUB-UCN2” from Denmark’s Gubra, and “NBIP-2118” from the U.S.-based Neurocrine Biosciences have entered Phase 1 or Phase 1/2 clinical trials. Notably, HanmiPharm licensed HM17321 to Genentech, a subsidiary of Roche, last August in a deal worth up to $2.3 billion (approximately 3 trillion won), while Gubra is validating the drug’s ability to reduce body fat and preserve muscle mass through combination therapy with GLP-1 agonists. The key question moving forward is whether DD18 can demonstrate differentiated weight loss and muscle preservation effects compared to competing candidates in clinical trials.

Neuraly’s Patent Rights Transferred to Headquarters… G-Alpha Seeks Investment from Global Pharmaceutical Companies

D&D Pharmatech Inc. is also reorganizing the business structures of its U.S. subsidiaries and affiliates.

First, the patents related to new drug candidates previously held by its U.S. subsidiary, Neuraly, have been transferred to the parent company, D&D Pharmatech Inc. This marks a shift away from the previous structure, in which the subsidiary independently developed new drugs, toward a model where a domestically listed company with strong fundraising capabilities takes the lead in development. Hong Seong-hun, Vice President of D&D Pharmatech Inc., explained the rationale behind the transfer of the new drug candidate patents, stating, “Since we currently have no plans to list our U.S. subsidiary, we determined it was appropriate for the parent company, D&D Pharmatech Inc.—a publicly listed company capable of raising funds—to take the lead in development.”

He went on to state that the patent rights previously granted to the subsidiary were transferred back to the parent company following an independent third-party valuation.

G-Alpha, an affiliate specializing in radiopharmaceuticals, was also presented as a new growth engine. G-Alpha is a company established in the U.S. by D&D Pharmatech Inc. to separately cultivate a radiopharmaceutical pipeline while the company focuses on the development of new peptide drugs. Global healthcare investment firm OrbiMed and others participated in its establishment.

According to CEO Lee, Z-Alpha has recruited executives and researchers with backgrounds in global pharmaceutical companies and biotech firms, and plans to begin multiple clinical trials in the U.S. in 2027. The company is currently in the final stages of securing follow-on investment, which is expected to involve significant participation from global pharmaceutical companies.

If the funding round is successful, it could boost G-Alpha’s enterprise value and, in turn, increase the value of D&D Pharmatech Inc.’s stake in the company. However, the specific investment amount, investors, and transaction terms have not been disclosed.

CEO Lee emphasized, “While having many promising candidate compounds is clearly a major advantage, we cannot simultaneously allocate sufficient funds and personnel to every program,” adding, “We will constantly evaluate which programs to develop in-house and at what stage to collaborate with global partners to maximize value creation.”