Innovo Therapeutics Co., Ltd.

2026-05-13 관리자 News Provided by Innovo Therapeutics Inc. May 13, 2026, 08:30 AM KST · Advancing Global Development of INV-008: A First-in-Class Oral 15-PGDH Inhibitor for IBD Designed to Promote Mucosal Healing · Total deal value of up to KRW 662.5 billion, with separate profit sharing in the event of third-party licensing Seoul, May 13, 2026 – Innovo Therapeutics announced today that it has entered into a licensing agreement with Daewoong Pharmaceutical for INV-008, an investigational oral therapy for inflammatory bowel disease (IBD). Under the agreement, the companies aim to accelerate the global development and commercialization of INV-008, with Daewoong leveraging its clinical development and commercialization capabilities to secure an innovative therapeutic asset. The total deal value is up to approximately KRW 662.5 billion, including an upfront payment of KRW 6.5 billion and up to KRW 656.0 billion in development and clinical milestone payments. The agreement also includes a separate profit-sharing arrangement in the event of third-party licensing. Innovo Therapeutics discovered and advanced INV-008 through its proprietary AI-driven drug discovery platform, DeepZema®. Innovo independently carried out the early research process, from novel compound design through lead selection and optimization, to identify a molecule with the desired 15-PGDH inhibitory profile. In preclinical studies, INV-008 demonstrated effects in promoting intestinal mucosal regeneration and reducing inflammation. The program has also shown differentiated drug-like and safety profiles compared with competing compounds, supporting its potential as an innovative therapy for IBD as it advances toward clinical development. Hee-Dong Park, CEO of Innovo Therapeutics, stated: “INV-008 is an innovative therapy designed to go beyond inflammation suppression by promoting intestinal mucosal regeneration, offering a new potential direction for IBD treatment. Through our collaboration with Daewoong Pharmaceutical, we aim to support the accelerated global clinical development and commercialization of INV-008.” Seong-Soo Park, Co-CEO of Daewoong Pharmaceutical, commented: “This agreement represents a strategic partnership that goes beyond a simple technology in-licensing. By working closely with Innovo Therapeutics from the early clinical stage, we aim to advance INV-008 toward global commercialization. We will actively support the clinical development of INV-008 to help establish it as a competitive innovative therapy in the global market.” Innovo Therapeutics has received R&D funding for the INV-008 program from the Korea Drug Development Fund (KDDF, Director Yeong-Min Park) since June 2023 through the National New Drug Development Project, which is promoted by the Ministry of Science and ICT, the Ministry of Trade, Industry and Energy, and the Ministry of Health and Welfare. The company has independently secured non-clinical efficacy and toxicology data for the program. About INV-008: INV-008 is an oral small-molecule therapy targeting 15-PGDH (15-hydroxyprostaglandin dehydrogenase), with a differentiated mechanism of action designed to increase prostaglandin E2 (PGE2) levels in the intestinal mucosa and promote regeneration of damaged tissue. While existing IBD therapies primarily focus on suppressing inflammatory responses, INV-008 is being developed to address both inflammation and tissue repair by supporting intestinal epithelial cell protection and regeneration. This mucosal healing approach has the potential to introduce a new treatment paradigm in IBD, a disease area with substantial unmet medical need. About Innovo Therapeutics: Innovo Therapeutics is a South Korea-based biotechnology company developing small-molecule therapeutics for immune and inflammatory diseases and cancer. Through its proprietary AI platform, DeepZema®, the company continues to efficiently discover new programs and candidate molecules and advance clinical development. Innovo Therapeutics successfully completed a Phase 2 clinical trial in Korea in 2024 for its scar treatment program, INV-001, and has submitted an IND application for a Phase 3 clinical trial. Another IBD therapeutic program, INV-101, received IND clearance from the U.S. FDA for a Phase 2 clinical trial in 2025. Media Contact: Kyungyoun Hong, Innovo Therapeutics Inc. +82-2-6956-8680 kyhong@innovothera.com

Demonstrated strong safety and favorable pharmacokinetics in Phase 1 study A First-in-class oral small molecule modulating immune cell metabolism via glycogen phosphorylase inhibition Once-daily oral administration with high patient convenience Broad development potential in ulcerative colitis and other autoimmune diseases SEOUL, South Korea--(BUSINESS WIRE)--Innovo Therapeutics Inc., a biotech company developing treatments for inflammation, fibrosis, and oncology, today announced the successful completion of a Phase 1 clinical trial for INV-101, a novel oral immuno-metabolic modulator targeting glycogen phosphorylase (GP), in healthy volunteers in the United States. INV-101 selectively controls inflammation by disrupting energy metabolism in hyperactivated immune cells. “INV-101 represents a new therapeutic strategy by modulating immune metabolism rather than suppressing immune responses. These Phase 1 results confirm the strong safety and oral convenience of INV-101." The randomized, double-blind, placebo-controlled study enrolled 48 healthy adult participants and demonstrated an excellent safety and tolerability profile across all dose cohorts, with no serious adverse events (SAEs) or dose-limiting toxicities (DLTs). Pharmacokinetic data also supported once-daily dosing with favorable systemic exposure, suggesting the potential for convenient outpatient administration without the need for routine monitoring. “INV-101 represents a new therapeutic strategy by modulating immune metabolism rather than suppressing immune responses,” said Dr. Hee-Dong Park, CEO of Innovo Therapeutics. “These Phase 1 results confirm the strong safety and oral convenience of INV-101 and serve as a critical foundation for advancing into global Phase 2 trials. We are committed to developing INV-101 as a new treatment option that can offer stable, long-term relief for patients living with autoimmune diseases.” About INV-101 INV-101 is a first-in-class oral small molecule that selectively inhibits glycogen phosphorylase, disrupting the metabolic reprogramming of pro-inflammatory immune cells. This novel mechanism enables targeted suppression of inflammation while preserving systemic immune function. INV-101 has demonstrated target engagement and immune-metabolic modulation in multiple preclinical models. Innovo Therapeutics plans to submit an IND application to the U.S. FDA and initiate a global Phase 2 study in the first half of 2026. The Phase 1 clinical trial of INV-101 was supported by the Korea Drug Development Fund (KDDF). About Innovo Therapeutics Inc. Innovo Therapeutics Inc. is a South Korea–based biotech company focused on the development of small molecule therapies for inflammation, fibrosis, and cancer. The company has built a proprietary AI platform, DeepZema®, to accelerate target identification and compound optimization. Innovo actively pursues global partnerships for clinical development and licensing of its pipeline assets, including INV-101.

SEOUL, South Korea I August 21, 2024 I Innovo Therapeutics Inc. has announced the results of its Phase 2 clinical trial demonstrating the innovative efficacy of INV-001 in scar treatment. The trial involved 77 Korean patients with wounds larger than 3 cm following thyroidectomy, conducted at four general hospitals including Severance Hospital in Seoul. Patients were randomly assigned within 14 days post-surgery to apply INV-001 twice daily for 12 weeks, with efficacy assessed at week 12 using the POSAS (Patient and Observer Scar Assessment Scale). The trial confirmed both the safety and tolerability of INV-001 at both low (0.2%) and high (2%) doses, with no serious adverse events (SAEs) reported. In the group that received the clinical drug at a high (2%) dose for 12 weeks without major protocol violations, a statistically significant difference (p<0.05, ANCOVA; Analysis of Covariance) was observed compared to the placebo, with a 24.5% reduction in scars at week 12, as confirmed through per-protocol set. Key Findings: Professor Won-Jae Lee, the Coordinating Investigator and a plastic surgeon at Yonsei University Severance Hospital, mentioned that this clinical trial is the first globally to confirm the scar suppression effects of HSP47 inhibition. He emphasized that the proven scar reduction effects of INV-001 are highly encouraging. Additionally, he noted that, given the current lack of specialized topical medications for scar suppression, the development of a specialized ointment based on this clinical trial would be welcomed by both clinicians and patients. Dr. Hee Dong Park, a founder and CEO of Innovo Therapeutics, stated that this clinical trial confirmed the safety and efficacy of INV-001, highlighting its potential as a scar treatment. He also noted that its innovative mechanism promises to deliver real value to patients in the scar treatment market. About INV-001: INV-001 inhibits HSP47, a key protein in collagen formation, transport, and extracellular secretion, thereby preventing and treating post-surgical and trauma-induced scars. Results from disease animal models have confirmed that INV-001 effectively inhibits trauma-induced scars without affecting wound healing. About Innovo Therapeutics: Innovo Therapeutics, Inc., headquartered in South Korea, is a biotechnology company primarily focused on developing small molecules for metabolic, inflammatory, and cancer diseases. The company is actively discovering new drug candidates and optimizing research through its AI platform, DeepZema®. SOURCE: Innovo Therapeutics