DWP213388 / Daewoong Pharma, Aditum Bio - LARVOL DELTA

The Safety, Tolerability, PK, and PD of DWP213388 After SAD and MAD Administration in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Daewoong Pharmaceutical Co. LTD. | N=72 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal

Daewoong Pharm Signs License Agreement with US Company (Business Korea) - "Daewoong Pharmaceutical announced that it signed an agreement to license its autoimmune disease drug candidate DWP213388 to Vitalli Bio, a subsidiary of Aditum Bio, a U.S. biotech investment company, at the Korea-U.S. Digital and Bio-health Business Forum held in Boston, the United States, on April 27. Under the agreement, Daewoong Pharmaceutical will transfer the rights to the global development and commercialization of DWP213388 to Vitalli Bio, a subsidiary of Aditum Bio. Some Asian regions, including Korea, are excluded from the agreement. The technology transfer agreement is about DWP213388, a drug candidate in Phase I clinical development, and is valued at USD 477 million (approximately KRW 63.91 billion), including an upfront payment of USD 11 million (approximately KRW 14.7 billion), excluding royalties."

Licensing / partnership • Immunology • Inflammation

Daewoong Pharmaceutical announces a Global License Agreement for DWP213388, a new drug candidate for autoimmune disease with Vitalli Bio (BioSpace) - "Daewoong Pharmaceutical...announced today that it had signed a Global License Agreement for its autoimmune disease drug candidate DWP213388 with Vitalli Bio, a US biotechnology company, on April 28. With this agreement, Daewoong Pharmaceutical will grant exclusive rights for the development and commercialization of DWP213388 in the global market to Vitalli Bio, a portfolio company of Aditum Bio. Daewoong Pharmaceutical will retain rights in some Asian regions including Korea. In return, Daewoong will receive over $10 million in upfront commitments, and the deal is worth up to $477 million. In addition, Vitalli Bio will be granted an option to license earlier stage dual-target inhibitors in development by Daewoong."

Licensing / partnership • Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Psoriasis • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus

Daewoong Pharm secures 50 billion-won R&D fund by selling shares to parent company (Korea Biomedical Review) - "Daewoong Pharmaceutical will sell about 427,000 of its shares to its parent company, Daewoong Co., to secure a research and development fund and invest it in future growth, the company said Wednesday....In addition, Daewoong will use the fund for its various new drug development projects...phase 2 clinical trial for Bersiporocin, treatment for idiopathic pulmonary fibrosis, and phase 1 clinical trial for immunotherapy DWP213388."

Financing • Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Graft versus Host Disease • Idiopathic Pulmonary Fibrosis • Immunology • Psoriasis • Rheumatoid Arthritis • Systemic Lupus Erythematosus

Daewoong Pharmaceutical, possibility of approval in China for ’Nabota’…Raising expectations for new products [Google translation] (eDaily) - "R&D costs in the fourth quarter are expected to increase by 45% year-on-year to KRW 37 billion, and costs have increased due to the phase 2 trial of DWN12088, a PRS inhibitor for idiopathic pulmonary fibrosis, and the phase 1 trial of DWP213388, an autoimmune disease treatment."

Commercial • Graft versus Host Disease • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease

The Safety, Tolerability, PK, and PD of DWP213388 After SAD and MAD Administration in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Daewoong Pharmaceutical Co. LTD.

New P1 trial

Daewoong Pharmaceutical Approval of Phase 1 Clinical Trial to US FDA for Autoimmune Disease New Drug 'DWP213388' [Google translation] (Pharm News) - "Daewoong Pharmaceutical...announced on the 11th that it had received approval from the US FDA for the Phase 1 clinical trial plan (IND) of 'DWP213388', a new drug candidate for autoimmune diseases. Daewoong Pharmaceutical plans to confirm the safety, tolerability, pharmacokinetics and pharmacodynamic characteristics of DWP213388 in the first phase of this clinical trial, and secure the possibility of entering a phase 2 clinical trial for the purpose of exploring efficacy. This phase 1 clinical trial is scheduled to start in the fourth quarter of this year and will be conducted in single and repeated administration to 80 healthy adults."

IND • New P1 trial • Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Psoriasis • Rheumatoid Arthritis • Systemic Lupus Erythematosus

[Exclusive] Daewoong Pharmaceutical applied for Phase 1 clinical trial to FDA for innovative new drug for autoimmune disease [Google translaion] (Money Today) - "According to the pharmaceutical industry...it was confirmed that Daewoong Pharmaceutical recently submitted a Phase 1 clinical trial plan (IND) for 'DWP213388', a new drug candidate for autoimmune disease, to the US Food and Drug Administration (FDA). Accordingly, the FDA will review the safety of new drugs in the submitted clinical trial protocol and decide whether to proceed with local clinical trials for DWP213388. If there is no reason for disqualification, approval for phase 1 clinical trial is expected to be issued within this year."

IND • New P1 trial • Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Psoriasis • Rheumatoid Arthritis • Systemic Lupus Erythematosus