TU-2218

70.6% Partial Response and 82.4% Disease Control Rate Observed in Interim Phase II Data SEONGNAM, South Korea, Nov. 10, 2025 /PRNewswire/ -- On Friday, 7 November (local time) at the Society for Immunotherapy of Cancer (SITC) 2025 annual meeting, Tiumbio Co., Ltd. (KOSDAQ: 321550), a clinical-stage biopharmaceutical company dedicated to developing novel therapies for rare and intractable diseases, today shared the interim Phase II clinical data for its "first-in-class" Tosposertib (TU2218), a dual inhibitor against TGFβ type I receptor (TGFβRI /ALK5) and VEGFR2. The study evaluated Tosposertib in combination with MSD's Keytruda (pembrolizumab) as a first-line therapy for patients with recurrent/metastatic(r/m) head and neck squamous cell carcinoma (HNSCC). Tosposertib (TU2218) is a highly potent, oral dual inhibitor designed to block the signaling pathways of transforming growth factor-beta (TGF-β) and vascular endothelial growth factor (VEGF), two critical mediators of tumor growth and metastasis. This novel drug candidate was discovered and developed by Tiumbio to enhance the therapeutic efficacy of immune-oncology agents such as Keytruda. Hun-Taek Kim, Ph.D., CEO of Tiumbio, stated "The data presented at SITC mark an important milestone, demonstrating that the strong antitumor activity continues to be sustained with accumulating clinical data and ongoing follow-up." He added, "The combination of Tosposertib (TU2218) and Keytruda has shown meaningful potential and value as an immuno-oncology therapy capable of overcoming the limitations of existing immunotherapies or immunotherapy/chemotherapy combinations in recurrent or metastatic head and neck cancer." The company plans to actively advance patient enrollment for the Tosposertib combination therapy and expand its global clinical trial sites to accelerate the studies required for regulatory approval. Through these efforts, the company aims to provide patients with recurrent or metastatic head and neck cancer earlier access to treatment and, in collaboration with global partners, continue to pursue combination trials and broader indication expansion. Tosposertib (TU2218: TGF-β/VEGF dual inhibitor): Solid Tumors Poster title: Phase 2 trial of TU2218, TGFβ-RI and VEGF-R2 dual inhibitor in combination with Pembrolizumab in patients with head and neck squamous cell carcinoma (HNSCC) Observations in the poster presentation include: As of July 31, 2025 data cutoff date, 27 patients (pts) were enrolled The efficacy-evaluable population consisted of 17 patients who had received prior treatments such as surgery, chemotherapy, or radiotherapy. Response rates overall (N=17): 70.6%, including 9 confirmed partial responses (PRs) and 3 unconfirmed PRs by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. per investigator assessment, including 1L : Response rates overall (N=11) : 72.7% (8/11), including 6 confirmed partial responses (PRs) and 2 unconfirmed PRs 2L+ : Response rates overall (N=6) : 66.7% (4/6), including 3 confirmed partial response (PRs) and 1 unconfirmed PRs Responses observed across PD-L1 levels (CPS 1-19: 66.7% [8/12]; CPS≥20: 80% [4/5]) At the time of data cutoff, 17 patients of the 27 enrolled, remained on treatment. Median follow up of 2.6 months for the 27 patients In 27 patients the combination was well tolerated and no significant overlapping toxicities with pembrolizumab were observed. Treatment-emergent adverse events (TEAEs) were reported in 26 pts Most were Grade (G) 1 or 2 in severity (no G5 were observed) G≥3 TEAEs occurred in 11 patients (40.7%) Most common adverse events included rash and mucositis. No cases of major bleeding or cardiovascular toxicities-safety concerns typically associated with VEGF or TGF-β inhibition- were observed About Tiumbio Co., Ltd. Tiumbio is dedicated to the discovery and development of innovative therapies that alleviate the burden of serious and debilitating disease. Tiumbio's mission is to expand hope and improve the quality of life for people through science. For further information, visit our website at and connect with us on LinkedIn. Contacts: Director Dae-hun Park, Management Office / [email protected] Manager Hyun-kyoung Kim, Future Growth Team / [email protected] SOURCE TiumBio 21% more press release views with Request a Demo

Primary Endpoint Met: Statistically significant reduction in heavy menstrual bleeding achieved in all dosage of Merigolix groups compared to placebo Broader Therapeutic Potential: Positive Phase 2 results in both uterine fibroids and endometriosis could place Merigolix as a strong best-in-class candidate for novel drug approval and global licensing opportunities Multi-Indication Development: Clinical trials are underway for three indications enhancing the asset value-uterine fibroids, endometriosis, and assisted reproductive technology (ART), the latter in collaboration with Hansoh Pharma in China SEONGNAM, South Korea, May 7, 2025 /PRNewswire/ -- TiumBio (KRX: 321550.KQ), a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapeutics for patients with rare and incurable disease, today announced that Merigolix (code name: TU2670, Daewon's code name: DW4902) has successfully met the primary endpoint of reducing heavy menstrual bleeding in a Phase 2 clinical trial for uterine fibroids. In this trial, Merigolix demonstrated statistically significant improvements across all dosage groups compared to placebo in patients with uterine fibroids. Merigolix is an investigational, once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist. Unlike traditional GnRH agonists, which require injection and often lead to an initial hormone surge, Merigolix offers a more patient-friendly oral administration without an initial hormonal flare, providing a faster onset of action and improved treatment adherence. The Phase 2 clinical trial of Merigolix in uterine fibroids was conducted by TiumBio's partner, Daewon Pharmaceutical, and enrolled a total of 71 women diagnosed with uterine fibroids. Participants were randomly assigned to receive high, medium, or low doses of Merigolix, or placebo, administered orally once daily for 12 weeks, followed by a 12-week observation period. The results showed that Merigolix led to statistically significant improvements in heavy menstrual bleeding (HMB)—a validated clinical endpoint—across all dosage groups compared to the placebo. In addition to the primary endpoint, Merigolix demonstrated statistically and clinically meaningful improvements in several key secondary endpoints, including fibroid size reduction, increased hemoglobin levels (indicating improved anemia), and relief of pelvic pain. The safety and tolerability profile of Merigolix was consistent with prior clinical data, with no new safety signs. The mechanism of action of Merigolix can be used in various disorders, including endometriosis, uterine fibroids, ART, precocious puberty, and prostate cancer. Notably, in a separate Phase 2 clinical trial for endometriosis completed in 2024, Merigolix also showed excellent therapeutic efficacy and safety, further reinforcing its potential as a promising new treatment. "We are very excited that Merigolix has demonstrated excellent therapeutic efficacy not only in endometriosis but also in uterine fibroids," said Hun-Taek Kim, Ph.D., MBA, CEO of TiumBio. "successfully achieving both efficacy and safety in Phase 2 significantly increases the probability of regulatory approval and licensing opportunities. We plan to accelerate development and expand into the global uterine fibroid treatment market," he added. "Uterine fibroids are a condition that causes significant suffering for many women, and we believe Merigolix has the potential to become an important new oral treatment that addresses this unmet medical need," said Jonathan In Baek, President of Daewon Pharmaceutical. "We are pleased with the positive results in uterine fibroids and will continue our efforts to provide patients with a convenient and effective new treatment option," he continued. Uterine fibroids are benign tumors that develop in the uterus, primarily affecting women of reproductive age, particularly those in their 30s and older. The condition has a high prevalence rate of approximately 20% among women over the age of 35. The most common symptom is heavy menstrual bleeding, but it can also cause abnormal uterine bleeding, pelvic pain, and anemia. Meanwhile, TiumBio entered into a licensing agreement with Daewon Pharmaceutical in 2019, granting Daewon the rights to develop and commercialize Merigolix in South Korea. About TiumBio Co., Ltd. TiumBio (KRX: 321550.KQ) is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapeutics for patients with rare and incurable diseases. Its mission is to expand the hope and happiness of mankind through our science. TiumBio has three leading pipeline assets: Merigolix (code name: TU2670), TU2218, and TU7710, all in various stages of clinical development. Merigolix is a once-daily, oral GnRH receptor antagonist being developed for the treatment of endometriosis, uterine fibroids, and assisted reproductive technology. TU2218 is a first-in-class oral immune-oncology therapy targeting TGF-β and VEGF pathways to promote response rates in cancer patients when used in combination with immune checkpoint inhibitors. TU7710 is a novel rFVIIa designed to extend its half-life in order to provide more clinical benefits to hemophilia patients with inhibitors. With its expertise in drug development, TiumBio is committed to the discovery and development of innovative treatments to ease the burden of debilitating diseases. For further information, visit our website at and connect with us on LinkedIn. Contacts: Junseok Jang, Head of Corporate Communications & Investor Relations [email protected] Da-ye Song, Manager, Corporate Communications & Investor Relations [email protected] SOURCE TiumBio WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED