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