1stOncology™: Cancer Intelligence Service – Page 323 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Gyre Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

On March 12, 2026 Gyre Therapeutics (Gyre or the Company) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, reported financial results for the fourth quarter and full year ended December 31, 2025 and provided a business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"2026 is expected to be a pivotal regulatory year for Gyre as we advance Hydronidone toward conditional approval in China following our alignment with China’s CDE," said Ping Zhang, Executive Chairman and Interim Chief Executive Officer of Gyre Therapeutics. "Our planned NDA submission in the first half of 2026 underscores the strength of our Phase 3 data and the constructive progress achieved through regulatory engagement. In addition, we have completed enrollment in our 52-week Phase 3 pirfenidone trial in pneumoconiosis, further strengthening our late-stage respiratory portfolio. We have also incorporated the complete Phase 2 and Phase 3 clinical data from our CHB-associated liver fibrosis program into our U.S. development strategy and expect to submit an IND application in 2026 for MASH-associated liver fibrosis. Finally, we recently announced an agreement to acquire Cullgen, a company with a robust pipeline of degraders, targeting inflammatory diseases and cancers, as well as U.S.-based drug discovery and development capabilities. Collectively, these achievements support the continued advancement of our differentiated pipeline across both China and the United States."

Fourth Quarter 2025 Business Highlights and Upcoming Milestones

Commercial Portfolio

ETUARY (pirfenidone): Generated $106.1 million in sales of ETUARY for the full year ended December 31, 2025, compared to $105.0 million for the same period in 2024.
Etorel (nintedanib ethanesulfonate soft capsules): Launched in June 2025 and generated $4.6 million in sales for the full year ended December 31, 2025.
Contiva (avatrombopag maleate tablets): Launched in March 2025 and generated $5.5 million in sales for the full year ended December 31, 2025.
Pipeline Development Updates

Hydronidone:

In November 2025, Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals) presented positive Phase 3 trial results evaluating Hydronidone for the treatment of liver fibrosis in chronic hepatitis B (CHB)-associated liver fibrosis at The Liver Meeting 2025, the annual meeting of the American Association of the Study of Liver Diseases. The abstract was selected as a Poster of Distinction.
Following the Phase 3 trial results, Gyre Pharmaceuticals completed a Pre-NDA meeting with China’s CDE. Based on the discussions, the CDE indicated that the existing Phase 3 clinical data support a conditional approval filing and potential priority review eligibility, subject to formal acceptance and approval. The Company plans to submit an NDA for conditional approval in the first half of 2026.
In the United States, Gyre Therapeutics plans to conduct a hepatic impairment study under its active U.S. IND application to inform dose selection and enrollment criteria in patients with reduced hepatic function, supporting the Company’s broader U.S. development strategy.
Gyre Therapeutics remains on track to submit an IND application in 2026 with the U.S. Food & Drug Administration for Hydronidone in MASH-associated liver fibrosis, and, subject to IND clearance, initiate a Phase 2 clinical trial.
Pirfenidone:

In the third quarter of 2025, Gyre Pharmaceuticals completed patient enrollment in its 52-week Phase 3 clinical trial evaluating pirfenidone for the treatment of PD. The multicenter, randomized, double-blind, placebo-controlled trial enrolled 272 patients across 18 clinical research centers in China and is designed to assess the efficacy and safety of 52 weeks of pirfenidone treatment in patients with this chronic occupational lung disease characterized by progressive pulmonary fibrosis. The final patient is expected to complete the trial in the third quarter of 2026.
Following approval in March 2025 from China’s National Medical Products Association’s (NMPA) for a clinical trial evaluating pirfenidone in oncology-related pulmonary complications, Gyre Pharmaceuticals plans to initiate an adaptive Phase 2/3 trial in the first half of 2026 in China. This trial will evaluate pirfenidone for radiation-induced lung injury (RILI), including cases complicated by immune-related pneumonitis, at leading oncology centers.
Corporate Updates:

In March 2026, Gyre announced an agreement to acquire Cullgen Inc. (Cullgen), a privately-held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader and degrader antibody conjugate therapies, in an all-stock transaction valued at approximately $300 million. Following the closing of the acquisition, expected in the second quarter of 2026, the new combined entity is expected to be a fully integrated biopharmaceutical company with U.S.- and China-based capabilities spanning from discovery to manufacturing and commercialization and covering multiple therapeutic areas, including inflammatory diseases, cancers, and pain.
Financial Results

Cash Position

As of December 31, 2025, Gyre had cash, cash equivalents, short-term and long-term bank deposits of $75.9 million.

Financial Results for the Three Months Ended December 31, 2025

Revenues: Revenues for the three months ended December 31, 2025 were $37.2 million, compared to $27.9 million for the same period in 2024, representing an increase of $9.3 million, or 33.3% year-over-year. The growth was driven by $1.5 million in Etorel sales and $2.5 million in Contiva sales, as well as a $5.5 million increase in ETUARY sales, partially offset by a $0.2 million decrease in generic drug revenue. The increase in ETUARY sales reflects strengthened commercial execution and the reallocation of marketing resources during the second half of 2025.
Cost of Revenues: For the three months ended December 31, 2025, cost of revenues was $1.7 million, compared to $1.2 million for the same period in 2024. The $0.5 million increase was primarily driven by a $0.4 million increase in stock-based compensation expense, and a $0.1 million increase in cost of sales of Etorel and Contiva.
Selling and Marketing Expense: Selling and marketing expense for the three months ended December 31, 2025 was $23.8 million, compared to $16.9 million for the same period in 2024, representing an increase of $6.9 million, or 40.8% year-over-year. The increase was primarily attributable to expanded commercial activities, including a $2.9 million increase in personnel costs driven by higher sales headcount and commissions, a $2.2 million increase in stock-based compensation expense, a $1.7 million increase in conference and promotional activities, and a $0.1 million increase in travel and other expenses.
Research and Development Expense: For the three months ended December 31, 2025, research and development expense was $4.8 million, compared to $3.7 million for the same period in 2024. The $1.1 million increase was primarily driven by a $0.6 million increase in facilities, depreciation and other expenses, attributable mainly to professional and consulting fees incurred in connection with research and development operations, a $0.3 million increase in pre-clinical research costs, a $0.2 million increase in clinical trial costs and a $0.3 million increase in staff costs which included $0.2 million in stock-based compensation expenses, partially offset by a $0.3 million decrease in materials and utilities expenses.
General and Administrative Expense: For the three months ended December 31, 2025, general and administrative expense was $6.7 million, compared to $5.5 million for the same period in 2024. The $1.2 million increase was primarily driven by a $1.2 million increase in stock-based compensation expense and a $0.8 million increase in functional and administrative department’s personnel expense, partially offset by a $0.6 million decrease in professional service expense, a $0.1 million decrease in depreciation and amortization expense and a $0.1 million decrease in miscellaneous expense.
Income from Operations: For the three months ended December 31, 2025, income from operations was $0.1 million, compared to $0.7 million income from operations for the same period in 2024. The $0.6 million decrease in income from operations was driven primarily by a $9.9 million increase in total operating expenses, partially offset by a $9.3 million increase in revenue.
Net (Loss) Income: For the three months ended December 31, 2025, net loss was $1.4 million, compared to $0.6 million net income for the same period in 2024. The $2.0 million decrease was driven primarily by an increase in income tax expense of $1.1 million, an increase in operating expenses of $9.9 million and a decrease in other income of $0.3 million, partially offset by an increase in revenue of $9.3 million.
Non-GAAP Adjusted Net Income: For the three months ended December 31, 2025, non-GAAP adjusted net income was $4.3 million, compared to $1.1 million for the same period in 2024. The $3.2 million increase was primarily driven by an increase in revenue of $9.3 million partially offset by the increase in operating expenses of $5.8 million and an decrease in other income of $0.3 million.
Financial Results for the Full Year Ended December 31, 2025

Revenues: Revenues for the full year ended December 31, 2025 were $116.6 million, compared to $105.8 million for the same period in 2024, representing an increase of $10.8 million, or 10.2% year-over-year. The growth was driven by $5.5 million in Contiva sales and $4.6 million in Etorel sales, along with a $1.1 million increase in ETUARY sales, partially offset by a $0.4 million decline in generic drug revenue.

Sales of Contiva and Etorel, which commenced commercialization in March 2025 and June 2025, respectively, were primarily driven by the targeted allocation of commercial and marketing resources to support their respective launches during the first half of 2025. The increase in ETUARY sales reflects a strategic realignment of marketing efforts in the third quarter of 2025 to optimize product mix and address evolving market dynamics.
Cost of Revenues: For the full year ended December 31, 2025, cost of revenues was $5.4 million, compared to $3.9 million for the same period in 2024. The $1.5 million increase was primarily driven by a $0.8 million increase in ETUARY’s cost, due to higher plant, property and equipment depreciation from a plant renovation completed in the second half of 2024, a $0.6 million increase in the cost of Contiva and Etorel, in line with the corresponding increase in their sales, and a $0.5 million increase in stock-based compensation expense. These factors were partially offset by a $0.4 million decrease in costs related to generic drugs due to the decrease in sales.
Selling and Marketing Expense: For the full year ended December 31, 2025, selling and marketing expense was $65.2 million, compared to $57.5 million for the same period in 2024. This $7.7 million increase was primarily driven by a $2.5 million increase in conference expenses and promotional expenses, attributable to the launch of additional promotional campaigns in the current year—particularly for the Company’s new products, a $2.6 million increase in staff costs, which was driven by expanded headcount and higher sales commissions, consistent with the corresponding growth in revenue, a $2.3 million increase in stock-based compensation expense and a $0.3 million increase in traveling and other expense.
Research and Development Expense: For the full year ended December 31, 2025, research and development expense was $13.7 million, compared to $12.0 million for the same period in 2024. The $1.7 million increase was attributable to a $1.0 million increase in clinical trial costs, primarily as a result of data analysis costs for Hydronidone, PD and RILI, a $0.4 million increase in staff costs, which included $0.2 million in stock-based compensation expense, a $0.5 million increase in facilities, depreciation and other expenses, attributable mainly to professional and consulting fees incurred in connection with research and development operations, and a $0.4 million increase in pre-clinical research expenses. These expense increases were partially offset by a $0.6 million decrease in materials and utilities expenses.
General and Administrative Expense: For the full year ended December 31, 2025, general and administrative expense was $20.8 million, compared to $16.1 million for the same period in 2024. This $4.7 million increase was primarily driven by a $3.3 million increase in stock-based compensation expense, a $1.3 million increase in functional and administrative department’s personnel expense, and a $0.9 million increase in miscellaneous expense. These cost increases were partially offset by a $0.8 million decrease in professional service expenses.
Income from Operations: For the full year ended December 31, 2025, income from operations was $11.5 million, compared to $16.2 million in income for the same period in 2024. The $4.7 million decrease in income from operations was driven primarily by a $15.5 million increase in total operating expenses, partially offset by a $10.8 million increase in revenue.
Net Income: For the full year ended December 31, 2025, net income was $9.9 million, compared to $17.9 million net income for the same period in 2024. This $8.0 million decrease was driven primarily by the increase in operating expenses of $15.5 million and decrease in change in fair value of warrant liability of $4.5 million, partially offset by an increase in revenue of $10.8 million, an increase in other income of $0.4 million, and a decrease in income tax expense of $0.8 million.
Non-GAAP Adjusted Net Income: For the full year ended December 31, 2025, non-GAAP adjusted net income was $18.9 million, compared to $16.9 million for the same period in 2024. The increase was primarily driven by an increase in revenue of $10.8 million and an increase in other income of $0.4 million partially offset by an increase in operating expenses of $9.2 million.
Full Year 2026 Financial Guidance

For the full year 2026, the Company expects to generate revenues of $100.5 million to $111.0 million, representing a decline of approximately 13.8% to 4.8% compared to 2025.

The Company anticipates that 2026 will be a transition period, during which it plans to prioritize regulatory activities, including preparation for the planned NDA submission of Hydronidone.

In addition, given uncertainties associated with the National Centralized Drug Procurement program and evolving market dynamics, the Company expects to moderate promotional activities for Contiva and Etorel.

Please note the following regarding the total revenue guidance:

Guidance assumes a constant foreign currency exchange rate.
Guidance assumes no significant economic disruption or downturn.

(Press release, Gyre Therapeutics, MAR 12, 2026, View Source [SID1234663527])

Cbio A/S Receives European Regulatory Clearance to Begin First-in-Human Clinical Trial of Next-Generation T-Cell Therapy in late-stage Cervical Cancer

On March 12, 2026 Cbio A/S reported that it has received regulatory clearance to begin a first-in-human Phase I/IIa clinical trial of novoleucel, the company’s next-generation T-cell therapy designed to improve immune cell function in cancer patients potentially leading to a more effective treatment.

The study will enroll up to 20 patients with persistent or recurrent cervical cancer at Karolinska University Hospital in Stockholm, with the first patients expected to be treated within the coming months. Initial safety and translational data are expected by the end of 2026.

The milestone marks Cbio’s transition into clinical development and represents a key value inflection point for the company as it advances its strategy to improve the effectiveness of cell-based therapies in solid tumors.

"The regulatory clearance marks a defining milestone for Cbio," said Ulrik Cordes, Founder and CEO of Cbio. "Patients with recurrent cervical cancer have very limited treatment options once standard therapies fail. We believe that novoleucel has the potential to significantly transform the treatment landscape and are excited to begin evaluating this novel approach in patients."

Cervical cancer remains a major global health challenge, with more than 660,000 new cases diagnosed and 349,000 dying annually worldwide. The new cell-based therapy addresses a high unmet medical need for more effective treatment options.

Novoleucel is a first-in-class therapy designed to address the central challenge in cancer immunotherapy: oxidative stress within the tumor microenvironment that disables immune cells and limits therapeutic efficacy. The T-cells are armored to cope with this stress, increasing resistance to reactive oxygen species and helping preserve their cancer-killing activity inside tumors.

The therapy is based on discoveries from Professor Rolf Kiessling and Stina Wickström’s research group at Karolinska Institute, pioneers in adoptive cell therapy.

"For many years we have studied how oxidative stress suppresses immune cells in tumors," said Rolf Kiessling. "By protecting tumor-reactive T-cells through activation of the Nrf-2 pathway, we aim to improve their persistence and anti-tumor activity. It is very gratifying to see this concept now entering clinical testing."

The therapy will be manufactured at Cbio’s in-house GMP-certified cell therapy production facility in Copenhagen, Denmark, a 1,000 m² production facility dedicated to clinical-grade cell therapy manufacturing.

Cbio is supported by a syndicate of Nordic and international investors and is raising additional capital to support the expansion of the Phase I/IIa clinical program and to further develop its broader cell therapy platform.

"Seeing the program now enter clinical testing is both a proud moment and an important step forward for patients," said Cecilia Hultén, Co-Founder and CFO in Cbio. "The start of the clinical program represents an important value inflection point for the company," said Christian Leroy, board member and investor in Cbio. "We believe Cbio is advancing a compelling approach to improving cell therapies for solid tumors and look forward to following the development of novoleucel."

The ongoing financing will support expansion of the clinical program and the generation of initial safety and translational data expected by the end of 2026.

About the Clinical Trial (EUCT 2024-517594-24)

The Phase I/IIa study will evaluate novoleucel in patients with persistent or recurrent cervical cancer who have progressed after platinum-based chemotherapy and checkpoint inhibitors. The trial will assess safety, feasibility of manufacturing and delivery, persistence of infused T-cells, and early signals of clinical activity.

(Press release, CBio, MAR 12, 2026, View Source [SID1234663526])

Mestag Therapeutics to Present Data on Targeted LTBR Agonist MST-0312 at Cancer Immunotherapy Keystone Symposia

On March 12, 2026 Mestag Therapeutics ("Mestag"), a biotech company harnessing fibroblast immunology for the benefit of patients with inflammatory disease and cancer, reported that it will be presenting a poster at the Cancer Immunotherapy: Basic Mechanisms Informing Clinical Applications & Combinations Keystone Symposia taking place March 15-18, 2026, in Québec City, Canada, titled "MST-0312: FAP-targeted LTBR Agonist Induces High Endothelial Venules, Lymphocyte Infiltration and Tertiary Lymphoid Structures in Solid Tumors."

Poster Details:

Title: MST-0312: FAP-targeted LTBR Agonist Induces High Endothelial Venules, Lymphocyte Infiltration and Tertiary Lymphoid Structures in Solid Tumors
Poster Number: 1037
Date: March 16, 2026
Time: 1:00-3:00 p.m. ET
Session Title: Poster Session 1

About MST-0312
MST-0312 is a first-in-class targeted lymphotoxin beta receptor (LTBR) agonist bispecific antibody designed to induce tertiary lymphoid structures (TLS) and high endothelial venules (HEV) in solid tumors. A remarkable body of clinical evidence correlates the presence of TLS and HEV in tumors with improved response to treatment and patient survival outcomes. It is believed that TLS/HEV formation drives improved access of lymphocytes into tumor tissue, and facilitates local education and activation to tumor antigens. LTBR is the key pathway driving TLS/HEV formation. Preclinical studies show that MST-0312 monotherapy induces strong, dose-dependent anti-tumor responses, including in low-antigen tumors that are typically resistant to immunotherapy. MST-0312 is planned to enter the clinic in 2026 with the initiation of the Phase 1 STARLYS trial, advised by leading cancer experts.

(Press release, Mestag Therapeutics, MAR 12, 2026, View Source [SID1234663525])

Elicio Therapeutics Reports Full Year 2025 Financial Results and Provides Corporate Updates

On March 12, 2026 Elicio Therapeutics, Inc. (Nasdaq: ELTX, "Elicio" or the "Company"), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, reported financial results for the year ended December 31, 2025, and provided recent corporate and clinical updates.

"In 2025, we made meaningful progress advancing ELI-002 7P in KRAS-mutant pancreatic cancer," said Robert Connelly, Chief Executive Officer of Elicio. "We remain focused on completing the Phase 2 AMPLIFY-7P trial and reaching the event-driven primary DFS analysis expected in 1H 2026. We are encouraged by the continued observation of fewer disease progressions and deaths to date than projected in the 2:1 randomized trial, as well as by the durability of T-cell responses and clinical observations reported to date, which reinforce our confidence in ELI-002 7P’s potential to favorably impact outcomes. With capital expected to carry us beyond the anticipated DFS readout, we believe we are well positioned to deliver this important milestone and continue advancing our Amphiphile ("AMP") platform in KRAS-mutant PDAC. We remain highly interested in the potential to expand the development of ELI-002 7P to neoadjuvant and metastatic PDAC and other KRAS+ tumors, with the goal of creating meaningful long-term value for patients and shareholders."

Recent Highlights

In 2025, Elicio continued advancement of the randomized Phase 2 AMPLIFY-7P trial in post-resection mKRAS PDAC, with the event-driven primary DFS analysis remaining on track for an anticipated 1H 2026 readout
In December 2025, Elicio reported evidence of antigen spreading to patient-specific neoantigens beyond mKRAS in the ongoing Phase 2 AMPLIFY-7P trial, demonstrating induction of de novo T cell responses against non-vaccine tumor neoantigens and further supporting the breadth and potential durability of the ELI-002 7P immune response in mKRAS-driven PDAC
In November 2025, Elicio appointed Marc J. Wolfgang as Chief Technology Officer, strengthening the Company’s chemistry, manufacturing, and controls and technical operations capabilities to support late-stage development and potential commercialization readiness

Upcoming Anticipated Milestones for the AMPLIFY-7P Phase 2 Trial

Oral presentation in the Targeted Immunotherapies section at the World Vaccine Congress Washington 2026 (March 30–April 2, 2026; Walter E. Washington Convention Center, Washington, D.C.), scheduled for Wednesday, April 1st at 12:40 PM ET, by Dr. Peter DeMuth, Chief Scientific Officer, highlighting the ELI-002 platform overview, updated Phase 1 2P data (safety, T-cell responses, correlations to tumor biomarkers, RFS and OS), Phase 1 7P data, and Phase 2 AMPLIFY-7P updates (T-cell responses, HLA association and antigen spreading)
ELI-002 to be highlighted by principal investigator Dr. Shubham Pant of The University of Texas MD Anderson Cancer Center (Houston, TX) during his pancreatic cancer presentation in the Advances in Pancreatic Cancer Research and Treatment session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting 2026 (April 17–22, 2026; San Diego, CA), scheduled for Tuesday, April 21st at 12:30 PT
Event-driven primary DFS analysis of the Phase 2 AMPLIFY-7P trial anticipated in 1H 2026
Plans to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration ("FDA") to finalize the Phase 3 trial design for ELI-002 7P in resected mKRAS PDAC following completion of the primary DFS analysis
Finalize the Phase 3 protocol and advance ELI-002 7P toward initiation of a registrational study following the primary DFS endpoint analysis, subject to regulatory alignment.
Continued translational and immunologic data updates from the AMPLIFY 7P program, including additional analyses of antigen spreading and T-cell durability

2025 Financial Results

R&D expense for 2025 was $24.9 million, compared to $33.7 million for 2024. The decrease in R&D expense was primarily related to lower clinical costs as patients progressed into the observation phase of the Phase 2 study of ELI-002 7P.

G&A expense for 2025 was $12.8 million, compared to $11.3 million for 2024.

Net loss for 2025 was $39.5 million, compared to $51.9 million for 2024. Net loss for 2025 includes $1.9 million of non-cash other expense resulting from the change in fair value of the warrant liability. Net loss per share for 2025 was $2.58, compared to $4.25 for 2024.

Cash and cash equivalents as of December 31, 2025, were $18.6 million, compared to $17.6 million as of December 31, 2024.

The Company expects its current cash and cash equivalents and projected at-the-market program proceeds to support operations into Q3 2026, beyond the anticipated AMPLIFY-7P Phase 2 event-driven DFS analysis expected in 1H 2026. The Company raised net proceeds of approximately $4.9 million in Q4 2025 and $6.3 million in Q1 2026 to date, through its established at-the-market program.

(Press release, Elicio Therapeutics, MAR 12, 2026, View Source [SID1234663524])

Meiji Seika Pharma Initiates Phase I Clinical Trial in Australia Evaluating ME3241, an Anti-PD-1 Agonist Antibody Discovered Through Collaborative Research With FBRI

On March 12, 2026 Meiji Seika Pharma Co., Ltd. (Headquarters: Chuo-ku, Tokyo, Japan; President and Representative Director: Toshiaki Nagasato) announced today that it has initiated a Phase I clinical trial of ME3241 (development code), an anti-PD-1 agonist monoclonal antibody discovered through collaborative research with the Foundation for Biomedical Research and Innovation at Kobe (Headquarters: Kobe, Japan; President: Shuh Narumiya; hereinafter "FBRI"). The Phase I clinical trial is designed as a randomized, placebo-controlled, double-blind study, with the objective of evaluating the safety and tolerability of ME3241 following single and multiple dosing, as well as its pharmacokinetics and pharmacodynamics (ClinicalTrials.gov: NCT07422207).

ME3241 was discovered through a collaborative research program led by Program Director Tasuku Honjo, a professor emeritus at Kyoto University. PD-1 is a molecule expressed on activated T cells and other lymphocytes that suppresses immune responses. Through this research, Meiji Seika Pharma and FBRI identified the conditions required to induce immunosuppression by stimulating PD-1 with antibodies, and these findings were published in Science Immunology on January 13, 2023. ME3241 is a unique anti-PD-1 agonist antibody with enhanced PD-1 agonist activity and has the potential to advance clinical development as a therapeutic agent for inflammatory diseases, including autoimmune diseases caused by excessive immune responses.

Meiji Seika Pharma and FBRI will continue to collaborate to advance the development of ME3241 and strive to provide meaningful benefits to patients with autoimmune diseases at the earliest opportunity.

Message from Tasuku Honjo, Program Director, Honorary President, Foundation for Biomedical Research and Innovation at Kobe (FBRI)

The initiation of the Phase I clinical trial of an autoimmune disease therapy by a PD-1 agonist antibody is highly significant, as our finding marks a major milestone in taking a step toward potential therapeutic application for human disease.

This therapeutic approach, which is completely opposite of the widely used cancer therapy employing a PD-1 antagonist antibody, originated from basic research initiated shortly after my appointment as director. After achieving robust results in animal models, we have now reached this clinical stage.

Should safety be confirmed in Phase I, there is strong expectation that the program will progress to Phase II to evaluate efficacy, and subsequently to Phase III with the aim of practical implementation. I am truly delighted by this advancement toward the practical realization of the vision of Kobe Biomedical Innovation Cluster.

Message from Takeshi Naruse, Senior Managing Executive Officer and Head of Research & Development, Meiji Seika Pharma

We have been advancing collaborative research with Professor Tasuku Honjo to discover and develop new drug candidates for inflammatory diseases, an area closely related to Meiji Seika Pharma’s focus on infectious diseases. We are pleased to begin a Phase I clinical trial of ME3241, a unique PD-1 agonist antibody established based on robust foundational research with Professor Honjo and his colleagues. We will expedite the development of ME3241 and strive to deliver it to patients with autoimmune diseases as soon as possible.