ALK5

TiumBio will pursue three indications for the TU2218 combination clinical trial with pembrolizumab TU2218 demonstrated a favorable safety and a synergetic effect with immuno-oncology drugs in preclinical studies BOSTON and SEONGNAM, South Korea, March 11, 2024 /PRNewswire/ -- TiumBio Co., Ltd. (KOSDAQ: 321550), a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapeutics for patients with rare and incurable diseases, announced that it has submitted Investigational New Drug (IND) application to the Korean Ministry of Food and Drug Safe (MFDS) for a Phase 2a study of TU2218, an oral immuno-oncology drug, in late February, 2024 and that preclinical results of TU2218 will be presented at the upcoming 2024 American Association for Cancer Research (AACR) Annual Meeting. TU2218 is a novel oral dual inhibitor targeting transforming growth factor beta receptor 1 (TGFR1) and vascular endothelial growth factor receptor 2 (VEGFR2). TGF-ß and VEGF pathways are known to be factors that interfere with the activity of immuno-oncology drugs, so TU2218 is expected to maximize the efficacy of immuno-oncology drugs by blocking them. TiumBio is currently conducting a Phase 1b clinical trial of TU2218 in combination with Keytruda (pembrolizumab) in advanced solid tumors in the U.S. For the Phase 2a trial, TiumBio has selected indications in biliary tract cancer (BTC), head and neck squamous cell carcinoma (HNSCC), and colorectal cancer (CRC). The study will enroll up to 116 evaluable participants across three cohorts (up to 40 participants for BTC, up to 36 participants for HNSCC, and up to 40 participants for CRC, respectively) and will evaluate the efficacy and safety of TU2218 administered in combination with pembrolizumab. BTC, HNSCC, and CRC have historically shown low treatment response rates to existing therapies. TiumBio expects that the combination of TU2218 and Keytruda will improve response rates in these tumors. Meanwhile, to test the feasibility of various combination options with TU2218, TiumBio conducted in vivo efficacy studies in 4T1, MC39, and CT26 syngeneic tumor models. Results will be presented at the 2024 AACR, taking place from April 5-10 in San Diego, California. The poster abstract highlights the improved efficacy and safety profile of TU2218 in combination with various immuno-oncology drugs. Specifically, the combination of lenvatinib, anti-PD-1 antibody, and TU2218 demonstrated a significant tumor growth inhibition (TGI) of 99% and a complete response (CR) rate of 67% in the CT 26 model, compared to a TGI of 76% and CR of 17% in the control group receiving only lenvatinib and anti-PD-1 antibody. The statistical difference in anti-tumor activity between the two groups was deemed significant (p<0.001). "We believe that the results of this TU2218 triple combination regimen show substantial potential in enhancing anticancer efficacy. We will explore the commercial potential of the combination," said Hun-taek Kim, Ph.D., MBA, Founder and CEO, TiumBio. "The three indications we selected are diseases characterized by high expression of the target protein TGF-beta within the microenvironment, coupled with a significant unmet medical need attributed to low response rates to anti-PD-1 therapies. We will develop TU2218 as a safer and more effective novel drug to increase clinical benefits of the immune checkpoint inhibitors in this area," he added. About TiumBio Co., Ltd. TiumBio (KOSDAQ: 321550) 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 boasts 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 and uterine fibroids in Phase 2 clinical trials. TU2218 is a first-in-class oral immune-oncology therapy targeting TGF-β and VEGF to promote response rates in combination with immune checkpoint inhibitors. TU7710 is a recombinant protein designed to treat people with hemophilia who has 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, Sr. Manager, Corporate Communications & Investor Relations [email protected] Suna Cho, Manager, Corporate Communications & Investor Relations [email protected] SOURCE TiumBio

AGMB-447 is an inhaled lung-restricted small molecule inhibitor of ALK5 GHENT, Belgium--(BUSINESS WIRE)-- Agomab Therapeutics NV (‘Agomab’) today announced that it has dosed the first subject in a first-in-human Phase 1 clinical study of AGMB-447, an inhaled lung-restricted small molecule inhibitor of ALK5 (TGFβRI or ALK5). The study is evaluating AGMB-447 in healthy subjects and in patients with idiopathic pulmonary fibrosis (IPF). The Phase 1 trial includes a Single Ascending Dose (SAD) and a Multiple Ascending Dose (MAD) evaluation of AGMB-447 in healthy subjects, followed by repeated dosing with AGMB-447 in IPF patients over a two-week treatment period. The trial is being conducted in 76 total subjects and patients in the U.K. Primary endpoints will be safety and tolerability. Secondary endpoints will include systemic and local Pharmacokinetics (PK). “Starting clinical development for AGMB-447, our second ALK5 asset to enter the clinic, is exciting and a key milestone for Agomab, as it represents a step forward in providing a potential new treatment option for patients with IPF and other fibrotic lung diseases,” said Andrea Sáez, Chief Development Officer at Agomab Therapeutics. “Thanks to its lung-restricted distribution, AGMB-447 has the potential to potently, yet safely, block TGFβ, a key fibrogenic pathway, selectively in the target tissue.” AGMB-447 is an investigational drug and not approved by any regulatory authority. Its efficacy and safety have not been established. About AGMB-447 AGMB-447 is a small molecule lung-restricted inhibitor of ALK5 (or TGFβRI) for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and other fibrotic respiratory indications. IPF is a devastating disease affecting over 300,000 patients worldwide. IPF is characterized by unregulated production of fibrotic, scar-like tissue that builds up in the scaffolding of the lungs. As a result, the fibrotic lung becomes stiff and hampers the patient’s ability to breathe and reduces the absorption of inhaled oxygen in the blood. Even though some medicinal treatments are available, without a lung transplant, the average survival following diagnosis is only three to five years. TGFβ is a known master regulator of fibrosis in IPF and preliminary clinical data supports targeting the pathway. AGMB-447 is specifically designed to potently and safely inhibit ALK5 in the lung based on rapid metabolism through hydrolysis in plasma to prevent clinically relevant systemic exposure. About Agomab Agomab is focused on achieving disease modification by modulating fibrosis and regeneration in chronic indications such as Fibrostenosing Crohn’s Disease and Idiopathic Pulmonary Fibrosis. We do this by targeting biologically validated pathways – including Transforming Growth Factor β and Hepatocyte Growth Factor - and by applying unique capabilities in organ-restricted small molecules and high affinity antibodies. With a differentiated clinical pipeline across several fibrotic disorders, end-to-end research and development capabilities, a proven BD track-record and a strong investor base, Agomab is building a leading European biopharma company. View source version on businesswire.com: Contacts For Agomab Therapeutics Tim Knotnerus, CEO E-Mail: tim.knotnerus@agomab.com Media Requests for Agomab Dr. Stephanie May or Gretchen Schweitzer Trophic Communications Phone: + 49 171 185 5682 E-Mail: agomab@trophic.eu Source: Agomab Therapeutics NV View this news release online at:

Angelika Jahreis is an industry veteran and currently Senior Vice President and Development Unit Head of Immunology at Novartis Andrea Sáez was previously CSO/COO of Origo Biopharma until the company was acquired by Agomab in 2021 GHENT, Belgium--(BUSINESS WIRE)-- Agomab Therapeutics NV (‘Agomab’), a company developing differentiated programs with disease-modifying potential in fibrotic diseases, announced today the appointment of Angelika Jahreis, MD, PhD, as an independent non-executive director to Agomab’s Board of Directors, while Andrea Sáez, PhD, will join Agomab’s executive leadership team as Chief Development Officer. As part of the next growth phase of the company, Paolo Michieli, PhD, (Founder and formerly Chief Scientific Officer) and Torsten Dreier, PhD, (previously Chief Development Officer) will continue at Agomab as senior advisors and members of the Scientific Advisory Board (SAB). “Angelika’s extensive experience and deep knowledge as a senior drug developer will be of great value to the Board and our company. Additionally, our new CDO Andrea has been a driving force in the development of our clinical pipeline, and I very much look forward to working with her as part of the executive leadership team,” said Tim Knotnerus, Chief Executive Officer at Agomab Therapeutics. “Paolo and Torsten have been key figures in the early phases of the company’s formation as well as its progress to date, and I look forward to working with them both in their new roles as senior advisors and members of the SAB.” “Agomab is building a leading company in the field of fibrotic diseases thanks to their innovative programs targeting ALK5 and MET,” said Angelika Jahreis, non-executive director at Agomab Therapeutics. “Fibrostenosing Crohn’s Disease and Idiopathic Pulmonary Fibrosis are areas of very high unmet medical need and with significant pharma interest.” Andrea Sáez, Chief Development Officer at Agomab Therapeutics, added: “Joining the executive team at this exciting moment of company growth enables me to continue to contribute to the progress of Agomab’s broader pipeline on our trajectory toward serving patients in high need of novel therapies.” Angelika Jahreis is a purpose-driven physician scientist with over 20 years of drug development expertise at Novartis, Gilead, Genentech and Amgen, currently serving as SVP, Development Unit Head of Immunology at Novartis. She earned her MD/PhD from the University of Freiburg, Germany, conducted her postdoctoral research at The Scripps Research Institute in La Jolla and has been honored to serve as a panel member at the FDA JIA Registry and Osteoarthritis Drug Development Workshops. Andrea Sáez was COO/CSO at Origo Biopharma where she led the development of ALK5 inhibitor programs through preclinical and early clinical stages. Following the acquisition of Origo by Agomab in late 2021, she was Head of Portfolio at Agomab and led the development of AGMB-129 into Phase 2 trials. Andrea initiated her academic career with a PhD in Immunology at the Pompeu Fabra University followed by postdoctoral research at Vall d’Hebron Hospital where she published on the therapeutic benefit of TGF-ß inhibitors in cancer. She gained deep understanding of regulatory affairs through supporting various biotechs in CMC, preclinical and clinical regulatory topics in her role as Regulatory Affairs Manager at a leading consultancy firm, after which she became R&D Director at Pangaea Oncology. Prior to joining Origo Biopharma, Andrea was a Senior Associate at Asabys Partners, supporting several biotech investments, including the investment in Origo. About Agomab Agomab is translating a deep expertise in growth factor biology to pioneer and develop novel treatments that aim to resolve fibrosis, repair tissue structure and restore organ function. Combining new scientific insights with robust drug development and a long-term corporate vision, we are building a broad clinical pipeline of differentiated programs with disease modifying potential in fibrotic diseases. View source version on businesswire.com: Contacts For Agomab Therapeutics Tim Knotnerus, CEO E-Mail: tim.knotnerus@agomab.com Media Requests for Agomab Gretchen Schweitzer Trophic Communications Phone: + 49 172 861 8540 E-Mail: agomab@trophic.com Source: Agomab Therapeutics View this news release online at: