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VectivBio

Transforming Lives

Pre-Approval Access Policy

We are conducting clinical studies of an investigational medicine, known as apraglutide, in two serious, rare disorders: Short Bowel Syndrome (SBS) in patients who are dependent on parenteral support and acute Graft Versus Host Disease (GVHD) involving the GI tract, that is failing to respond sufficiently to steroids.

  • In SBS with intestinal failure, patients have insufficient working intestine to meet their nutritional and/or hydration needs and rely on intravenous (IV) nutrition and/or IV hydration. Our pivotal Phase III study has completed enrollment.
  • Acute GVHD (i.e., tends to start within 100 days of an allogeneic stem cell transplant) can impact the GI tract. In around 50% of cases, acute GVHD of the GI tract fails to respond sufficiently to steroids, which can worsen a patient’s prognosis. A Phase II proof-of-concept study has completed enrollment in this patient population.

We remain committed to making apraglutide available as quickly as we can to appropriate patients, following regulatory authority approval, which depends in part on positive data from our clinical studies and the evaluation of these data by regulatory and reimbursement authorities.

Pre-approval access, sometimes known as Expanded Access or Compassionate Use, refers to the provision of an investigational medicine outside of a clinical trial and ahead of regulatory or reimbursement body approval.

At this current time, we believe that participating in clinical studies is the safest way to access our new investigational medicine, under the close monitoring of a specialist clinical research team. Therefore, we do not provide access to apraglutide through Pre-approval Access programs, or outside of clinical studies more generally. This policy may be reviewed and amended in the future.

Details about our clinical studies, including eligibility requirements for participating in ongoing or planned studies are published in public databases such as www.clinicaltrials.gov and www.clinicaltrialsregister.eu.

If you have further questions, please speak with your healthcare provider or contact our Medical Information Team at [email protected].

Luca Santarelli
Luca Santarelli, M.D.
Founder and Chief Executive Officer and Board Member

Dr. Luca Santarelli is the founder, Chief Executive Officer and board member of VectivBio. Dr. Santarelli has more than 20 years of experience in academic and industrial R&D, having led drug programs in the areas of neuroscience, rare diseases, ophthalmology, metabolic and G.I., spanning the value chain from discovery research to commercialization. Most recently, Dr. Santarelli served as Chief Executive Officer and co-founder of Therachon AG. Therachon was focused on the discovery and development of therapeutics for rare pediatric conditions, and was acquired by Pfizer, Inc., in 2019 for $810 million.

Prior to Therachon, he spent 12 years at Roche, most recently serving as the Senior Vice President and Head of Neuroscience, Ophthalmology and Rare Diseases, as well as Small Molecule Research at Roche in Switzerland. In this capacity, he advanced over 20 NMEs to the clinic and various NMEs to registration studies including ocrelizumab in Multiple Sclerosis, gantenerumab in Alzheimer’s disease, balovaptan in Autism, risdiplam in Spinal Muscular Atrophy and faricimab in Diabetic Macular Edema and Age-related Macular Degeneration. During this period, he also catalyzed the creation of Synosia and Clementia, two companies built from Roche’s asset spin-offs, and led the company to multiple in-licensing deals.

Previously, he was a faculty at Columbia University
and a co-founder of BrainCells Inc., a company focused on the discovery of
novel antidepressants that are able to stimulate the growth of new neurons,
with Nobel laureate Eric Kandel, Rene Hen and Fred Gage.

Dr. Santarelli completed his M.D. and Psychiatry
Residency at the University of Turin, Italy, and a postdoctoral fellowship at
Columbia University, focusing on the molecular mechanisms of psychiatric
disorders and adult brain stem cells. His work has been published in high
impact journals including Nature, Science, Nature Neuroscience, Archives of
Neurology and JAMA Psychiatry.

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Claudia D’Augusta
Claudia D’Augusta, Ph.D.
Chief Financial Officer

Dr. Claudia D’Augusta has over 20 years of experience in the field of corporate finance, capital markets and M&A.

She was most recently Chief Financial Officer of Therachon prior to its acquisition by Pfizer in early July 2019. Previously she served as General Manager at TiGenix after its acquisition by Takeda. Prior to this appointment, Claudia was Chief Financial Officer of TiGenix, where she led the company’s IPO on Nasdaq in 2016, served as a member of the Executive Committee and held responsibility for the Finance, Legal and Investor Relations areas. She also served as the Chief Financial Officer of Cellerix and led its merger with TiGenix, a company listed on Euronext. Before joining Cellerix in 2004, Claudia was Finance Director of Aquanima (Santander Group). Previous experiences include Deloitte & Touche in Milan and Apax Partners in Madrid.

Dr. D’Augusta holds a bachelor’s degree in Economics and a Ph.D. in Business Administration from Bocconi University, Italy.

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Christian Meyer
Christian Meyer, M.D., Ph.D.
Chief Operating Officer

Dr. Christian Meyer is the Chief Operating Officer of VectivBio, bringing more than 20 years of international rare disease drug development leadership and entrepreneurship to the company.

Dr. Meyer was part of the founding team of VectivBio, initially acting as its Chief Development Officer, after serving in a similar role at Therachon AG, where he was instrumental in the clinical development of recifercept (TA-46) until its acquisition by Pfizer. Prior to Therachon, he served as Chief Medical Officer at uniQure N.V., where he supported Glybera, the first gene therapy ever approved, and was pivotal in the development of etranacogene dezaparvovec. Preceding his work at uniQure, he held several senior executive positions at Cardoz AB, Symphogen A/S and Zymenex A/S, where he was responsible for building clinical development operations and leading clinical development programs in the rare disease space. Dr. Meyer began his career at Novo Nordisk A/S and held academic and hospital positions before entering the pharmaceutical industry.

Dr. Meyer received his M.D. and Ph.D. in Clinical Cardiology from the University of Copenhagen.

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Omar Khwaja, M.D., Ph.D.
Chief Medical Officer

Dr. Omar Khwaja possesses over 25 years of experience and notable accomplishments in drug development, medicine and academia.

Prior to joining Vectiv, Dr. Khwaja served as Chief Medical Officer and Head of Research and Development at Voyager Therapeutics, a biotechnology company focused on severe neurological diseases. Previously, he was the Global Head of Rare Diseases and Neuroscience Translational Medicine at Roche, where he worked for over eight years. Preceding Dr. Khwaja’s industry experience in drug development, he practiced medicine and taught in academia for over a decade, including as Director of the Clinical Neurogenetics program at Boston Children’s Hospital and as a member of the faculty at Harvard Medical School.

Dr. Khwaja received his M.D. and Ph.D. in Human Molecular Genetics from the University of Cambridge. He is a member of the Royal College of Physicians, serves as the Chief Medical Officer for the Spinal Muscular Atrophy Foundation and is the Chair of the Scientific Advisory Board of the CDKL5 Forum.

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kevin harris
Kevin Harris, MBA
Chief Commercial Officer

Kevin Harris is Chief Commercial Officer of VectivBio with more than 24 years of leadership experience specializing in the launch and management of specialty products.

Prior to VectivBio, Kevin was at Incyte for more than 10 years, most recently as Group Vice President of Global Product Strategy and Strategic Planning. He joined Incyte as the Vice President of Commercial and built and led most of the U.S. commercial functions for the launch of Jakafi®. Previously, Kevin held roles of increasing responsibility at Pfizer, Inc. across the company’s HIV and oncology portfolios. Before that, he served in commercial development and marketing roles at Bristol-Myers Squibb in HIV and oncology. Kevin began his career in management consulting at PRTM and subsequently joined PAREXEL in a marketing and strategy role.

Kevin holds an MBA, with distinction, from Kellogg School of Management at Northwestern University and a B.A. in Biology from Cornell University.

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Scott Applebaum
Chief Legal Officer and Corporate Secretary

Scott Applebaum brings over two decades of legal, regulatory and operational experience in the biopharmaceutical industry to VectivBio.

Prior to joining VectivBio, Mr. Applebaum was the Chief Legal & Compliance Officer and Senior Vice President of Regulatory Affairs at Trevena, where he played a key role in gaining FDA approval for their lead product, Olinvyk®️️️. Previously, he served as President of Context Therapeutics and was General Counsel at Vitae Pharmaceuticals, where he was instrumental in their sale to Allergan. Formerly, he was Chief Legal Officer for Medgenics, a rare genetic disease company. Mr. Applebaum spent 10 years at Shire, where his roles included heading up their global legal group, managing their neuroscience portfolio outside of the United States as SVP of the Neuroscience Business Unit and leading the implementation and execution of the regulatory strategy for all of Shire’s specialty pharmaceutical products worldwide as SVP of Global Regulatory Affairs, Quality Assurance and Compliance. Previously, he was Senior Counsel for medicines and medical imaging at Bristol Myers Squibb.

Prior to his career in the biopharmaceutical industry, Mr. Applebaum was a lawyer at Dechert LLP. He received his J.D. from Stanford Law School and a B.S. in Economics, Finance and Accounting from the University of Pennsylvania.

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Alain Bernard
Alain Bernard, Ph.D.
Chief Technology Officer

Dr. Alain Bernard is Chief Technology Officer of VectivBio and brings more than 30 years of experience in bioprocess development to the company.

Prior to joining VectivBio, Dr. Bernard served as Head of Global Biotech Process Development at R-Pharm and Vice President of Biopharmaceutical Process Sciences at UCB. During the 10 years spent at UCB, he oversaw process development for all new chemical and biological entities. He contributed to launching several biotech and small molecules into commercial phases and lifecycle management of marketed products. Prior to UCB, Dr. Bernard served as Director of Biotech Process Development at Merck Serono where he was responsible for the biotechnology process developments that delivered several improved processes for strategic products. He began his career at Biogen, Geneva, a site that was transitioned to the Glaxo-Wellcome Institute of Molecular Biology.

Dr. Bernard earned his Ph.D. in Biochemical Engineering from a joint program between AgroParisTech in France and the Massachusetts Institute of Technology in the U.S.

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Martine Mazzetti
Martine Mazzetti, MsPharm
Chief of Staff

Martine Mazzetti is Chief of Staff at VectivBio. She brings more than 30 years of experience as a pharmaceutical executive in drug development across multiple therapeutic areas, including orphan diseases.

Most recently, Martine served as Global Head of IMED Project & Portfolio Management at AstraZeneca, a department she was integral in building. Prior to AstraZeneca, she held positions of increasing responsibility at Roche for 20 years including Global Head of Project Management Early Development (pRED). Martine began her career as Regulatory Head for Clinical Nutrition at Salvia (Boehringer Mannheim Group) in Germany later acquired by Clintec (Nestlé-Baxter joint venture) where she successfully led the worldwide registration of new enteral, parenteral products and several medical devices.

Martine Mazzetti studied Biological Engineering at Paris XII and earned her PharmD at the University of Saarbrücken, Germany.

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Nader N. Youssef M.D., MBA, FACG
Senior Vice President, Global Medical Affairs and Patient Partnership

Dr. Nader N. Youssef is SVP, Global Medical Affairs and Patient Partnership at VectivBio. He is a board-certified pediatric gastroenterologist with specialized training in neurogastroenterology focused on intestinal motility and failure disorders

Most recently, Dr. Youssef served as vice president of clinical development at Passage Bio. Prior to that, he was chief medical officer at Nutrinia where he helped secure more than $31M in financing, secured orphan drug designation for a lead product candidate and completed a pivotal phase III trial in premature infants with intestinal malabsorption. Previously he was executive director of GI global clinical development and medical affairs for NPS Pharmaceuticals (acquired by Shire in 2015) which included responsibility for the overall regulatory and development strategy of teduglutide. During his time there, the team secured marketing approval and supported the initial launch for teduglutide in the U.S. (Gattex®) and Europe (Revestive®) for the treatment of adult and pediatric short bowel syndrome. He has held key roles in development at AstraZeneca and was chief medical officer at Electrocore in the past.

Dr. Youssef received a B.S. in finance and international business from New York University Stern School of Business. He earned his M.D. from Ross University School of Medicine and an MBA from University of Pittsburgh Katz School of Business. His residency was completed at Robert Wood Johnson University Hospital and fellowship at Children’s Hospital of Pittsburgh. He has been published in many high impact journals including Gastroenterology and Pediatrics.

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Michael Steininger
Senior Vice President, Head of Human Resources

Michael is Senior Vice President, Head of Human Resources of VectivBio with more than 20 years of HR experience in the pharmaceutical and biotech industry.

Prior to joining VectivBio, Michael was at Roche for 12 years, most recently as Head of Human Resources for the therapeutic areas of Immunology, Infectious Diseases, Ophthalmology, and Therapeutic Modalities within the Research and Early Development Organization.  Michael was responsible to drive the People and Organizational agenda at the research sites across US, Europe, and China and acted as the Management Representation during interaction with association of worker’s councils and social partners on national and international level. He was also responsible for the China People Strategy for the Research and Early Development Organization. During his time at Roche Michael led numerous organizational and cultural transformations on local, regional, and global level, including the integration of several biotech companies into the corporate organization.

Prior to joining Roche, Michael spent 10 years in the Executive Search industry serving clients across the pharmaceutical and biotech industry.

Michael holds a master’s degree in Business Administration and Sports Management from Bayreuth University, Germany.

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Thomas F. Woiwode
Thomas F. Woiwode, Ph.D.
Board Member and Chair

Tom Woiwode, Ph.D. has been with Versant Ventures since 2002, serving as a Venture Partner since 2008 and a Managing Director since 2014.

Dr. Woiwode has served in a number of operating roles over this time, most recently as the Chief Operating Officer of Okairos, a biopharmaceutical company developing genetic vaccines for major infectious diseases. He led the process that culminated in the sale of Okairos to GlaxoSmithKline for $325M. Prior to his role with Okairos, Dr. Woiwode co-founded EuroVentures, a wholly owned biotech incubator within Versant Ventures, and in this role, served as the founding Chief Business Officer for three biotech companies created within Versant: Flexion (public), Synosia (public, merged with BioTie), and Amira (acquired by Bristol-Myers Squibb for up to $475M). Prior to his role as a Venture Partner, Tom was a Principal at Versant Ventures and served on the boards of Antipodean, Metabolex and Saegis. Tom was a research scientist at XenoPort before joining Versant. Tom earned his PhD in Organic Chemistry as an NSF Fellow at Stanford University and graduated summa cum laude with a BA in English and received the Departmental Citation for his B.S. in Chemistry from UC Berkeley. Tom currently serves on the boards of Annapurna, Anokion, Audentes, CRISPR, Gritstone and VectivBio.

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Paul R. Carter
Board Member

Paul R. Carter served in senior executive roles for a decade at Gilead Sciences, most recently as Executive Vice President of Commercial Operations, leading Gilead’s launch and commercialization efforts globally. Previously, he worked for 15 years at GlaxoSmithKline (GSK), where he served in increasingly senior management roles in a number of territories, including as Head of International Business in Asia. Over the past five years, Mr. Carter has been involved with several public and private biopharmaceutical companies as a Board Member and Senior Advisor. He is a Fellow of the Chartered Institute of Management Accountants in the UK and holds a degree in Business Studies from the Ealing School of Business and Management.

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Wouter Joustra
Board Member

Mr. Wouter Joustra has served as a member of our board of directors since December of 2022. Mr. Joustra is currently General Partner at Forbion, a leading European life sciences venture capital firm. At Forbion, Mr. Joustra is responsible for deal origination, general portfolio management and divestment strategies, and focuses on Forbion´s Growth Opportunities Funds, which concentrates on investing in late-stage life sciences companies. Previously, Mr. Joustra was a Senior Trader, as well as Executive Board member of the life sciences franchise at Kempen, a European boutique investment bank. In this role, Mr. Joustra managed Kempen’s trading portfolio, and he was involved in deal structuring and equity capital markets transactions, as well as larger block trades. Until Gyroscope Therapeutics’s acquisition by Novartis for up to $1.5 billion, Mr. Joustra served as a member of Gyroscope Therapeutics’s board of directors. Mr. Joustra is currently on the board of Forbion’s SPAC vehicle, Forbion European Acquisition Corp. (NASDAQ: FRBN), in addition to being a board observer at NewAmsterdam Pharma N.V. (NASDAQ: NAMS). Mr. Joustra holds an M.Sc. in Business Administration from the University of Groningen, and a B.Sc. in International Business and Management from this same university.

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Sandip Kapadia Headshot
Sandip Kapadia, MBA, CPA
Board Member

Sandip Kapadia, MBA, CPA, has served as member of our board of directors since October 2020. Mr. Kapadia brings nearly 25 years of life science industry experience and is currently the Chief Financial Officer for Harmony Biosciences. Previously, Mr. Kapadia was CFO of Intercept Pharmaceuticals from 2016-2021 and held numerous finance leadership positions over 19 years at Novartis and Novartis affiliates in the United States, Switzerland, the Netherlands, and the United Kingdom, including CFO of North America at Novartis’s generic division, Sandoz. Mr Kapadia is currently also a director of Passage Bio and Molecular Partners AG, and previously of Therachon AG. Mr. Kapadia received a B.S. in Accounting from Montclair State University and an M.B.A. from Rutgers University, and is also a U.S. Certified Public Accountant.

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Luca Santarelli
Luca Santarelli, M.D.
Founder and Chief Executive Officer and Board Member

Dr. Luca Santarelli is the founder, Chief Executive Officer, and board member of VectivBio. Dr. Santarelli has more than 20 years of experience in academic and industrial R&D, having led drug programs in the areas of neuroscience, rare diseases, ophthalmology, metabolic and G.I., spanning the value chain from discovery research to commercialization. Most recently, Dr. Santarelli served as Chief Executive Officer and co-founder of Therachon AG. Therachon was focused on the discovery and development of therapeutics for rare pediatric conditions, and was acquired by Pfizer, Inc., in 2019 for $810 million.

Prior to Therachon, he spent 12 years at Roche, most recently serving as the Senior Vice President and Head of Neuroscience, Ophthalmology and Rare Diseases, as well as Small Molecule Research at Roche in Switzerland. In this capacity, he advanced over 20 NMEs to the clinic and various NMEs to registration studies including ocrelizumab in Multiple Sclerosis, gantenerumab in Alzheimer’s disease, balovaptan in Autism, risdiplam in Spinal Muscular Atrophy and faricimab in Diabetic Macular Edema and Age-related Macular Degeneration. During this period, he also catalyzed the creation of Synosia and Clementia, two companies built from Roche’s asset spin-offs, and led the company to multiple in-licensing deals.

Previously, he was a faculty at Columbia University and a co-founder of BrainCells Inc., a company focused on the discovery of novel antidepressants that are able to stimulate the growth of new neurons, with Nobel laureate Eric Kandel, Rene Hen and Fred Gage.

Dr. Santarelli completed his M.D. and Psychiatry Residency at the University of Turin, Italy, and a postdoctoral fellowship at Columbia University, focusing on the molecular mechanisms of psychiatric disorders and adult brain stem cells. His work has been published in high impact journals including Nature, Science, Nature Neuroscience, Archives of Neurology and JAMA Psychiatry.

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Hans Schikan
Hans Schikan
Board Member

Hans Schikan currently serves as Chair of the Board of Directors of Microbiotica (UK) and Complix (BE), in addition to serving on the boards of Pharvaris (NL) and Vicore Pharma (SE). Furthermore, he is a member of the Top Team of the Dutch Top Sector Life Sciences & Health.

Previously, Hans Schikan was the CEO of Prosensa, which used RNA modulating treatments to treat rare diseases such as Duchenne muscular dystrophy. During his time at Prosensa, he oversaw the listing of the company on Nasdaq and the conclusion of an M&A deal with BioMarin for up to $840 million. Prior to that, Hans Schikan held senior positions in Global Marketing and Strategic Development at Genzyme and leadership roles at Organon. Hans Schikan received his Pharm.D. from the University of Utrecht (Netherlands). He previously served on the boards of Wilson Therapeutics (acquired by Alexion), Therachon (acquired by Pfizer), Sobi, Asceneuron, Hansa Biopharma and InteRNA.

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Murray Stewart, DM, FRCP
Board Member

Murray W. Stewart, DM, FRCP, has served as the Chief Medical Officer of Rhythm Pharmaceuticals, a biopharmaceutical company focused on the treatment of rare genetic disorders of obesity, and guided Imcivree® to FDA approval in November 2020. Prior to Rhythm, he was the Head of Research & Development at Novelion Therapeutics, where he oversaw global medical affairs for Juxtapid® and Myalep®, two marketed products for rare metabolic diseases. Previously, Dr. Stewart spent 18 years at GlaxoSmithKline (GSK), serving most recently as Chief Medical Officer, and formerly as Head of Metabolic Pathways and Cardiovascular Therapy and Clinical Head of Biopharm. Preceding his career in drug development, Dr. Stewart was a physician and received his Bachelor of Medicine and Doctor of Medicine from Southampton Medical School. He is a Fellow of the Royal College of Physicians.

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