GI Innovation said Thursday that it has dosed the first patient in a global phase 1b/2 clinical trial evaluating its immuno-oncology candidate GI-102 in combination with Johnson & Johnson's experimental cancer drug pasritamig, a first-in-class KLK2xCD3 T-cell engager, in patients with metastatic castration-resistant prostate cancer (mCRPC). Pasritamig is being supplied under a clinical trial collaboration and supply agreement with Janssen Research & Development, a Johnson & Johnson company. The first patient dosing follows GI Innovation's submission of clinical trial applications in Korea and the U.S. in March. The study involves mCRPC patients who have failed standard-of-care treatments. With the first patient now dosed, the Korean biotech company has begun evaluating the potential synergistic effects of GI-102 and pasritamig. https://www.koreabiomed.com/news/articleView.html?idxno=33739

GI Innovation is embarking on the development of next-generation multispecific antibody anticancer drugs incorporating TriOar’s antibody masking technology. The drugs will be designed to act selectively at tumor sites, thereby enhancing anticancer efficacy while reducing potential toxicity to healthy tissues. GI Innovation announced on November 2 that it signed a Memorandum of Understanding (MOU) with TriOar, a company possessing antibody masking platform technology, for the co-development of next-generation masked multispecific antibody-based anticancer drugs. The agreement aims to identify novel anticancer drug candidates by combining GI Innovation’s expertise in multispecific antibodies, T-cell engagers, and fusion proteins with TriOar’s proprietary antibody masking platform, ‘TROCAD.’ Multispecific antibodies and T-cell engagers target cancer cells to trigger immune cell attacks. However, a key development challenge is reducing adverse effects caused by unintended activation in normal tissues. https://www.thebionews.net/news/articleView.html?idxno=29800

GI Innovation said Wednesday that it will present phase 1 trial data on subcutaneous administration of its lead immuno-oncology candidate GI-102 at the ESMO Immuno-Oncology & Advanced Therapies Congress, to be held Dec. 14-16 in London. The poster presentation will cover the safety, tolerability, antitumor activity and immune cell activation observed in patients with advanced solid tumors who received GI-102 by subcutaneous injection. https://www.koreabiomed.com/news/articleView.html?idxno=33644

GI Innovation said Wednesday that the first patient in a Japanese phase 2 trial of its allergy treatment candidate GI-301 is scheduled to receive the drug this month. Under a licensing agreement with Maruho signed in 2023, GI Innovation transferred Japanese development and commercialization rights for GI-301 to Maruho in a deal worth up to 300 billion won ($221 million) at the time. The Korean biotech is entitled to milestone payments tied to development and commercialization, along with royalties on product sales. https://www.koreaherald.com/article/10895842?ref=naver

GI Innovation announced on August 26 that its immuno-oncology candidate, ‘GI-101A (development code),’ has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA). The Fast Track Designation covers the treatment of patients with locally advanced and/or metastatic urothelial carcinoma who have previously received immunotherapy. The FDA grants Fast Track Designation to novel drug candidates expected to offer improved efficacy over existing treatments for serious, life-threatening diseases. https://www.thebionews.net/news/articleView.html?idxno=27579

GI Innovation views the successful Phase 3 clinical trials for melanoma involving personalized messenger ribonucleic acid (mRNA) cancer vaccine candidates developed by Moderna and MSD (Merck & Co.) as a positive signal for its combination development strategy involving ‘GI-102’ (development code), a next-generation interleukin 2 (IL-2)-based immuno-oncology candidate. The company is currently developing GI-102 in combination with Keytruda for patients with stage III–IV metastatic melanoma. https://www.thebionews.net/news/articleView.html?idxno=27412

GI Innovation said Wednesday it and its affiliate GI Longevity have advanced to the finals of the XPRIZE Healthspan competition as their anti-aging therapy has been recognized for its potential therapeutic uses. XPRIZE Healthspan — a seven-year global competition with a total prize pool of $101 million — seeks to develop therapies capable of restoring muscle, cognitive and immune functions in adults aged 50 to 80 by at least 10 years, with a goal of achieving improvements equivalent to 20 years within one year or less. The competition is scheduled to finish in 2030. https://www.koreaherald.com/article/10839082?ref=naver

“The global licensing-out (L/O) process for GI-101A is currently in its final stages. In particular, following the selection of our data as the sole presentation in the ‘Rapid Oral’ session at this year’s ASCO Annual Meeting, interest from potential business development partners has increased significantly, with additional meetings being arranged on-site by global pharmaceutical companies. Market interest has become even more pronounced following the disclosure of the Phase 1 clinical trial results.” Jang Myoung-ho, CEO of GI Innovation, discussed the company’s next-generation immuno-oncology drug candidate ‘GI-101A (f-delicofusp alpha)’ during an interview with on May 30 (local time) at the ‘2026 American Society of Clinical Oncology Annual Meeting (ASCO)’ being held in Chicago, USA. https://www.thebionews.net/news/articleView.html?idxno=25163

GI Innovation said Friday it has received approval from the Ministry of Food and Drug Safety (MFDS) for a phase 2 trial of its investigational drug GI-102 in combination with Keytruda for metastatic melanoma. The study will compare the combination against Keytruda monotherapy in a randomized trial. https://www.koreabiomed.com/news/articleView.html?idxno=31420

GI Innovation announced on April 9 that it plans to present two research findings at the American Association for Cancer Research Annual Meeting (AACR 2026), scheduled to take place in San Diego, USA, from April 17 to 22 (local time). At the conference, GI Innovation will present preclinical findings for ‘GI-128’ (development code), a novel pipeline derived from its proprietary ‘GI-SMART’ platform, along with pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation analysis results for its immuno-oncology candidate ‘GI-102’ (development code). https://www.thebionews.net/news/articleView.html?idxno=23518

GI Innovation announced on April 3 that Phase 1 clinical trial data for its immuno-oncology candidate, ‘GI-101A (development code),’ has been selected for a ‘Rapid Oral Abstract’ presentation at the American Society of Clinical Oncology Annual Meeting (ASCO 2026), widely regarded as the world’s most prestigious oncology conference. ASCO serves as a premier academic forum for the initial disclosure of the latest clinical data in the global oncology field and functions as a key venue for evaluating the clinical value of new therapeutics based on real-world patient data. https://www.thebionews.net/news/articleView.html?idxno=23367

GI Innovation has released modeling data on the dosing strategy for its immuno-oncology candidate, ‘GI-102’ (development code), demonstrating that fixed-dose administration can achieve immune activation effects comparable to those observed with body weight-based dosing. These findings have generated considerable interest, as they highlight the potential to move beyond the weight-based administration method traditionally required for Interleukin-2 (IL-2)-based therapies. https://www.thebionews.net/news/articleView.html?idxno=23000