[BizLeader] Kim Sung-jin, CEO of MedPacto, "Key Clinical Results to Materialize Next Year... Pursuing Technology Transfer"

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[Asia Economy Reporter Hyungsoo Park] MedPacto is accelerating the development of therapeutics by receiving large-scale investments from institutional investors. Having gained confidence through clinical trials of one of its major pipelines, 'vactosertib,' MedPacto expects to achieve concrete results next year. Kim Sung-jin, CEO of MedPacto, who has had a busier year than anyone else since the company went public last December, stated, "Many global pharmaceutical companies are showing great interest in vactosertib," adding, "We will strive to create added value and enhance shareholder value by gaining recognition for the high technology of vactosertib."

MedPacto, which was listed on the KOSDAQ market on December 19 last year, achieved considerable results despite the impact of the novel coronavirus disease (COVID-19). Starting with the American Society of Clinical Oncology (ASCO) in May, the company attended numerous conferences including the European Society for Medical Oncology (ESMO) to present clinical results of combination therapy using vactosertib for treating desmoid tumors, gastric cancer, and non-small cell lung cancer. It was confirmed that the therapeutic effect was better when vactosertib was combined with existing treatments compared to monotherapy.

◆ Vactosertib Demonstrates Efficacy in Combination Therapies with Major Anticancer Drugs = MedPacto is conducting a total of 11 combination clinical trials, including investigator-initiated trials, targeting multiple cancer types such as colorectal, gastric, and lung cancers for vactosertib. As the clinical trials proceed as planned, fundraising is also progressing smoothly. Recently, to secure funds for clinical trials aimed at approval for rare and intractable diseases, the company decided to issue convertible preferred stocks (CPS) and convertible bonds (CB). By raising approximately 100 billion KRW through private placement, MedPacto has gained the capacity to conduct combination immuno-oncology clinical trials with plans for commercialization through technology transfer, as well as to independently conduct global Phase 2 clinical trials for desmoid tumors.

Vactosertib inhibits the signaling of transforming growth factor beta 1 (TGF-β1), a tumor growth factor. Normally, TGF-β1 suppresses the proliferation of normal cells, but in cancer cells, mutations prevent it from inhibiting cell growth. Cancer cells excessively produce TGF-β1, which promotes cancer progression.

CEO Kim Sung-jin described vactosertib as "a substance that inhibits the TGF-β1 signaling pathway," explaining, "It helps various anticancer drugs attack cancer cells more effectively and activates immune cells to enhance the cancer cell-killing effect."

He added, "It will establish itself as a next-generation anticancer drug that can be combined with all cancer treatments," emphasizing, "At last month's Society for Immunotherapy of Cancer (SITC) in the U.S., we observed encouraging interim results from the Phase 2a clinical trial of vactosertib combined with Imfinzi in patients with non-small cell lung cancer."

The objective response rate (ORR) for patients with PD-L1 expression of 25% or higher was 57.1%, a remarkable improvement compared to 19.8% with Imfinzi monotherapy.

CEO Kim explained, "Although Imfinzi was not approved as a second-line treatment when administered alone, the likelihood of approval increases with combination therapy," adding, "The median progression-free survival was 4.7 months, which is effective in extending patient survival compared to 1.7 months with Imfinzi monotherapy."

Based on these promising interim clinical results, MedPacto is negotiating technology transfers with global pharmaceutical companies. The company has been invited to the upcoming 'JP Morgan Healthcare Conference' in the U.S. CEO Kim expects that full-scale technology transfer negotiations will proceed based on the numerous clinical data presented so far.

He stated, "We plan to participate in the American Society of Clinical Oncology (ASCO) in the first half of next year," adding, "MedPacto will present clinical results related to colorectal cancer at ASCO and interim results of the first-line treatment clinical trial combining the immuno-oncology drug 'Keytruda' with vactosertib for non-small cell lung cancer at the European Society for Medical Oncology (ESMO)."

The final results of the Phase 2a clinical trial combining vactosertib and Imfinzi for non-small cell lung cancer patients will be disclosed at the U.S. Society for Immunotherapy of Cancer (SITC) in September next year.

◆ Full-Scale Entry into the Rare Disease Market = While progressing with the development schedule of existing therapeutics, MedPacto is also advancing procedures to expand indications for rare cancer types. The company plans to extend the indication of vactosertib combination therapy to rare cancers. The goal is to obtain orphan drug and fast-track designations from the U.S. for desmoid tumors in the first half of next year. Multinational clinical trials will be conducted in Korea, the U.S., and other countries.

CEO Kim said, "Rare and intractable disease therapeutics can receive various benefits during development, including pricing and exclusivity incentives," adding, "Early market approval is possible based on Phase 2 clinical results from a small number of patients, making it a market that the pharmaceutical industry is paying attention to." He also noted, "British pharmaceutical company AstraZeneca acquired U.S. rare disease specialist Alexion for $39 billion (approximately 42 trillion KRW), indicating growing interest in the orphan drug market."

According to a report by the Biotechnology Policy Research Center, the global orphan drug market has grown at an average annual rate of 9% since 2019 and is expected to expand to $223 billion (approximately 262 trillion KRW) by 2024. The Asia-Pacific region is predicted to have an average annual growth rate of 9.9%.

CEO Kim emphasized, "Most of the major ongoing clinical trials will enter their final stages next year," adding, "It is also encouraging that research on rare diseases is yielding results that suggest therapeutic efficacy."

He continued, "MedPacto plans to establish a local subsidiary in the U.S.," forecasting, "As technology transfer of vactosertib becomes more tangible, MedPacto's U.S. subsidiary will serve as a cornerstone for global business."

The U.S. subsidiary will be utilized as a global hub not only for the U.S. but also for multinational approval clinical trials. It is expected to accelerate efforts to obtain orphan drug designation from the U.S. Food and Drug Administration (FDA) for rare diseases such as desmoid tumors.