Vedolizumab

Portfolio of Oral Selective α4β7 Inhibitors Acquired from EA Pharma, Eisai’s GI Subsidiary Phase 2 Clinical Program in Ulcerative Colitis to Start in First Half of 2025 with Lead Asset Seasoned Executive Team with History of Execution in Inflammatory Bowel Disease Drug Development toJoin Ensho on July 1 Founded by Neena Bitritto-Garg, Veteran Biotech Equity Research Analyst and Former Eisai Staffer MORRIS PLAINS, N.J., June 27, 2024 (GLOBE NEWSWIRE) -- Ensho Therapeutics, Inc., a privately held, clinical-stage biopharmaceutical company focused on developing breakthrough oral therapies for patients with inflammatory diseases, launched today with the announcement that it has acquired a portfolio of oral α4β7 integrin inhibitors through a worldwide exclusive license agreement with EA Pharma Co., Ltd., a subsidiary of Eisai Co., Ltd. Under the terms of the agreement, Ensho has the right to develop, manufacture, and commercialize these assets globally, excluding certain Asian jurisdictions. The two companies jointly announced the exclusive license agreement in a separate press release today. Based on results of an extensive Phase 1 clinical program, Ensho has selected NSHO-101, (also known as EA1080), as its lead drug candidate from the portfolio. The Phase 1 program evaluated single and multiple ascending doses of NSHO-101 in over 180 healthy subjects. Results demonstrated favorable pharmacokinetics (PK) and pharmacodynamics (PD), including target engagement. NSHO-101 was generally safe and well-tolerated in healthy subjects. Results of the Phase 1 program support Ensho’s plans to initiate Phase 2 clinical development in the first half of 2025, starting with ulcerative colitis (UC). Neena Bitritto-Garg, CFA, founder, president and chief executive officer of Ensho, stated, “We are thrilled to acquire this portfolio of oral selective α4β7 integrin inhibitors derived from AJM300, an oral α4 inhibitor that has been approved in Japan for induction therapy in UC. This, along with my history with Eisai and EA Pharma’s impeccable standards for continuous improvement in drug development, led me to found Ensho around this portfolio. We believe NSHO-101 could be a transformational alternative therapy for patients who continue to suffer from IBD despite multiple lines of therapy.” Ensho has recruited a world-class team of executives with decades of experience in inflammatory and gastrointestinal (GI) disease drug development. The team will join Ms. Bitritto-Garg to develop and potentially commercialize these important oral agents for the inflammatory bowel disease (IBD) market. Ms. Bitritto-Garg continued, “I am very pleased to welcome to Ensho our seasoned team of executives, including Bittoo Kanwar, M.D., former chief medical officer of Telavant, which was acquired by Roche last year. The team’s decades of experience in IBD drug development will enable us to not only move quickly, but also smartly, into Phase 2 clinical development with NSHO-101.” Bittoo Kanwar, M.D., stated, “Joining Neena to advance Ensho and its portfolio of promising IBD assets was a tremendously attractive opportunity, given the significant unmet medical needs in IBD, the high potential and validated mechanism of α4β7, and the potential of our novel, oral clinical development candidates to offer differentiated attributes to patients and physicians looking for therapeutic alternatives. In collaboration with our newly formed Ensho team, many of whom have a long history of working together, we look forward to expeditiously advancing our lead asset, NSHO-101, into Phase 2 development early next year.” Ensho Therapeutics was borne out of Ms. Bitritto-Garg’s experience working at Eisai, the parent company of EA Pharma, on business development and in management of the company’s key alliance with Biogen Inc. on Leqembi (lecanemab), which is currently being launched in multiple countries for the treatment of early Alzheimer’s disease. She brings to Ensho nearly a decade’s worth of experience as an equity research analyst covering the biotechnology sector, including the neuroscience and immunology therapeutic areas. Immediately prior to founding Ensho, she led biotech and biopharma equity research strategy at multiple global banks, including at Citigroup Inc., where she was the head of U.S. biotechnology equity research. Ms. Bitritto-Garg is a graduate of the Roy and Diana Vagelos Program in Life Sciences and Management (LSM) at the University of Pennsylvania and holds dual degrees in Biochemistry (B.A.) from the College of Arts and Sciences and Economics (B.S.) with a concentration in finance from Wharton. Seasoned Executives to Join Ensho July 1, 2024Effective July 1, 2024, a seasoned team of executives with decades of experience in the discovery, development, and management of biotechnology companies in the inflammatory disease and IBD space will join Ensho. This team will be led by Bittoo Kanwar, M.D., who will join Ensho as chief executive officer. Andy Whitney, Ph.D. will be named chief scientific officer, Suzanne Vyvoda will act as chief operating officer, and Emily Weng, Sc.D. will join the company as chief data science officer. Neena Bitritto-Garg will continue to oversee the team as founder, president and executive chair of Ensho. Bittoo Kanwar, M.D. Dr. Kanwar will join Ensho as chief executive officer. His strategic development and execution of inflammatory disease programs spans more than two decades and includes roles as chief medical officer of Telavant Holdings, Inc., a Roivant company acquired by Roche in 2023, where he oversaw the clinical development of RVT-3101, an anti-TL1A antibody, in UC; chief medical officer of Applied Molecular Transport, Inc., where he led the company’s IBD-focused clinical development programs; vice president, head of clinical development at Protagonist Therapeutics, Inc., where he also led clinical programs in IBD; and clinical domain lead for IBD at Gilead Sciences, Inc., where he also supported programs in liver fibrosis/NASH, and Hepatitis B and C. Dr. Kanwar was an associate professor at the University of California, San Francisco (UCSF), focused on researching the role of the gut adaptive immune response in both HIV infection and IBD. He holds a B.S. from the University of Minnesota and an M.D. from the University of Iowa. He completed his residency at Rush University Hospitals in Chicago and a fellowship in pediatric gastroenterology at UCSF. Andy Whitney, Ph.D.Dr. Whitney will join Ensho as chief scientific officer. He brings to Ensho over 25 years of experience in drug discovery and development in autoimmune/inflammatory, oncology, and rare diseases. He has led multiple drug discovery projects as senior vice president, head of preclinical development and translational science at Applied Molecular Transport; vice president, biology at BridgeBio Pharma, Inc.; director in Gilead’s inflammation and oncology research group; and was one of the earliest scientists at CGI Pharmaceuticals where he led biology, bioinformatics, and project teams until its acquisition by Gilead. Andy was an NSF postdoctoral fellow at the University of Geneva, Switzerland. He holds an A.B. from Harvard College and a Ph.D. in cell biology from Yale. Suzanne VyvodaMs. Vyvoda will join Ensho as chief operating officer. She brings to Ensho over 20 years of execution and management of drug development and clinical operations programs, including as vice president and head of development operations at Telavant, a Roivant company acquired by Roche in 2023; vice president of development operations and head of clinical operations at Applied Molecular Transport; director of clinical operations at AbbVie Inc.; senior clinical program manager at Gilead and senior manager of clinical operations at BioMarin Pharmaceutical Inc. Suzanne holds a B.S. in sociology and economics from the University of Utah. Emily Weng, Sc.D. Ms. Weng will join Ensho as chief data science officer. She brings to Ensho two decades of expertise in applying statistical and design methods throughout the diverse aspects of research and development programs across broad therapeutics pipelines in biopharmaceutical industry, including immunology and inflammatory diseases. She served as vice president, head of biometrics and data science at Telavant, a Roivant company acquired by Roche in 2023; vice president, head of biometrics at Applied Molecular Transport; senior director, biometrics, and statistical head of respiratory TA at Theravance Biopharma, Inc., and director, biostatistics at Allergan Plc, acquired by AbbVie in 2020. Ms. Weng holds an Sc.D. in cancer biology with a minor in biostatistics and an M.S. in epidemiology from Harvard T.H. Chan School of Public Health. She holds an Executive M.B.A. from the UCLA Anderson School of Management. About Selective a4b7 Integrin Inhibitionα4β7 is a cell surface receptor that helps regulate the migration of immune cells to the intestine and plays a key role in controlling inflammatory responses. It binds to mucosal addressin cell adhesion molecule-1 (MAdCAM-1), which is expressed on intestinal venules and is upregulated in response to inflammation. This interaction helps facilitate the transport of leukocytes and recruitment of effector lymphocytes to the gut mucosa in IBD. Because α4β7 is found primarily in the gut, this localized action provides immune cell inhibition where it is most relevant, potentially minimizing side effects and preserving overall immune cell function. Decades of research validate α4β7 inhibition as an anti-inflammatory mechanism in IBD, which has been further substantiated by the approval of a commercially available antibody, vedolizumab. Yet, there are no approved orally administered α4β7 inhibitors agents for the treatment of IBD. About NSHO-101 (also known as EA1080)NSHO-101 is a novel, oral, selective α4β7 integrin inhibitor designed for the potential treatment of patients with IBD. The Phase 1 clinical program for NSHO-101 evaluated 184 healthy subjects to assess safety, tolerability, food effects, PK and PD of single and multiple ascending doses of NSHO-101. NSHO-101 demonstrated target engagement in this Phase 1 program. There were no appreciable increases in peripheral lymphocytes, suggesting its activity is gut-restricted. NSHO-101 was generally safe and well tolerated. Ensho plans to initiate Phase 2 clinical development of NSHO-101 as a potential treatment for UC in the first half of 2025. About Ensho Therapeutics, Inc.Ensho Therapeutics, Inc. is a privately held, clinical-stage biopharmaceutical company focused on developing breakthrough oral therapies for patients with inflammatory diseases. The company’s initial focus is on a pipeline of oral, selective small molecule inhibitors of lymphocyte homing integrin α4β7 for IBD, a mechanism already validated by a commercially available antibody. Ensho’s assets were acquired from EA Pharma Co., Ltd., a subsidiary of Eisai Co., Ltd., that is focused on gastrointestinal disease. Ensho is preparing to initiate a Phase 2 clinical program in UC with NSHO-101, the lead asset in the company’s pipeline. For additional information on Ensho Therapeutics, Inc., please visit www.enshorx.com. Contacts:Media:Aljanae ReynoldsAreynolds@wheelhouselsa.com Investors: info@enshorx.com

Takeda’s Fruzaqla (fruquintinib) has been approved by the European Commission (EC) to treat adults with previously treated metastatic colorectal cancer (CRC). Patients eligible for the VEGF inhibitor will have received available standard therapies, including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, and anti-VEGF and anti-EGFR agents, and will have progressed on or been intolerant to either trifluridine-tipiracil or regorafenib. CRC, which begins in either the colon or rectum, was the second most common cancer in Europe in 2022, with approximately 538,000 new cases of the disease diagnosed that year. Although early-stage CRC can be surgically resected, Takeda outlined that metastatic CRC “remains an area of high unmet need with poor outcomes and limited treatment options”. The EC’s decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and was based on positive results from the late-stage FRESCO-2 trial, which evaluated Fruzaqla plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated metastatic CRC. The study met all its primary and key secondary efficacy endpoints and demonstrated consistent benefit among patients treated with Fruzaqla regardless of prior therapy type, Takeda said, adding that the drug demonstrated a manageable profile. Teresa Bitetti, president of the global oncology business unit at Takeda, said the approvals marked “an important moment for the colorectal cancer community in the EU”. “We look forward to offering patients a novel treatment option that has a manageable safety profile and can be effective regardless of the prior types of therapies they have received,” she said. Fruzaqla received approval from the US Food and Drug Administration (FDA) in November to treat adults with metastatic CRC who have been previously treated with chemotherapy, an anti-VEGF therapy, and in some cases, an anti-EGFR therapy. The latest authorisation for the therapy comes just two months after Takeda’s Entyvio (vedolizumab) was approved by the FDA for subcutaneous administration in adults with moderately to severely active Crohn’s disease. The company also recently received FDA accelerated approval for the use of its kinase inhibitor Iclusig (ponatinib) in adults who are newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukaemia.