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Leading the Future of Cancer Treatment with Intelligently Engineered iPSC NK cell and Macrophages

Shoreline Biosciences is developing clinically effective allogeneic, off-the-shelf, targeted, and standardized immunotherapies using intelligently engineered induced Pluripotent Stem Cell (iPSC)-derived NK cells and macrophages for serious diseases. Shoreline’s proprietary cell therapy platform is based on deep expertise in iPSC differentiation methods and genetic programming of the IL-15/CISH pathway for enhanced persistence and tumor killing. In addition, the company aims to restore tissue homeostasis and function by introducing engineered macrophages for  fibrotic and inflammatory pathologies. Shoreline has developed expertise that allows for efficient and cost-effective manufacturing of these cells.

We are committed to scientific and clinical excellence and are passionate about bringing transformative therapies to patients in critical need.

Vision

To create safe, effective, and affordable immunotherapies for the treatment of seriously ill patients

Mission

Through innovative thinking, intelligent design, and tenacity, we strive to discover and develop clinically effective iPSC-derived allogeneic immunotherapies to save lives.

Leadership Team

Kleanthis G. Xanthopoulos, Ph.D.

Co-Founder, Chairman & CEO

Dan S. Kaufman, M.D., Ph.D.

Co-Founder, CSO

STEVEN HOLTZMAN

Co-Founder

William Sandborn, M.D.

Co-Founder & CMO

Vanessa Jacoby

CFO

Mohammad El-Kalay, Ph.D.

Senior VP & Head of CMC

Boyan Litchev, M.D.

Senior VP & Head of GCD

Steven Neben, Ph.D.

VP, Alliance and Project Management

Bjorn Dahle

VP, Smart Manufacturing

Trisha fitzmaurice

Head of People & Culture

Board Members

Kleanthis G. Xanthopoulos, Ph.D.

Co-Founder, Chairman & CEO

Dan S. Kaufman, M.D., Ph.D.

Co-Founder, CSO & Board Member

STEVEN HOLTZMAN

Co-Founder & Board Member

Marios Fotiadis

Board Member

Christopher Fugelsang, Ph.D., J.D.

Board Member

Kimberly J Manhard

Board Member

Science Advisory Board

Travis S. Young

Advisory Board Member

Scott Antonia

Advisory Board Member

SILKE PAUST

Advisory Board Member

Judith Shizuru

Advisory Board Member

Partnered with Advanced Cell Therapy Manufacturing

We are partnered with the Advanced Cell Therapy Laboratory (ACTL) of UC San Diego, a state-of-the-art GMP and GLP facilities that allows us to rapidly drive our innovation. We also leverage an extensive network of leading CMC professionals to guide our manufacturing agenda.

Partners

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Our Proprietary Platform Surpasses What’s Currently Being Done in Cell Therapies

Together let’s push the boundaries of scientific innovation.

Judith Shizuru
ADVISORY BOARD MEMBER

Judith Shizuru is a Professor of Medicine (Blood and Marrow Transplantation [BMT]) and Pediatrics (Stem Cell Transplantation) at Stanford University. Dr. Shizuru is a member of the Stanford BMT faculty, the Stanford Immunology Program, and the Institute for Stem Cell Biology and Regenerative Medicine. Dr. Shizuru received a Bachelor’s degree from Bennington College and an M.D. and Ph.D. from the Stanford University School of Medicine. She trained as a resident in adult internal medicine at the University of California, San Francisco, and in the sub-specialty of hematology at Stanford. Dr. Shizuru has been attending on the Stanford Blood and Marrow Transplantation clinical service since 1997, and she oversees a research laboratory. Her laboratory is focused on understanding the cellular and molecular basis of resistance to engraftment of transplanted allogeneic hematopoietic cells, and the way in which bone marrow grafts modify immune responses including the induction of immune tolerance. Dr. Shizuru has over 150 publications in the fields of immunology and hematopoietic cell transplantation. She is the scientific co-founder of Jasper Therapeutics, Inc, a member of the Board member and Chair of Jasper’s Scientific Advisory Board.

Kimberly J Manhard
Board Member

Kimberly is a biopharmaceutical executive with more than 25 years of drug development, regulatory affairs, quality assurance, pharmacovigilance and pharmaceutical operations experience.

Ms Manhard has served as the Executive Vice President of Drug Development for Heron Therapeutics, Inc. (Heron) since January 2016, after serving as a board director in 2014 and 2015. She rejoined the Heron board in November 2019. Since 2020, Ms Manhard has also served as a board director of Toragen, Inc. (non-public company) and of InhibRx, Inc. (public company), which are focused on the research and development of new treatments for cancer.

From 2008 to 2016, Ms Manhard served as Senior Vice President of Regulatory Affairs and Development Operations at Ardea Biosciences, Inc. (Ardea), a wholly-owned subsidiary of AstraZeneca PLC, and led the US, EU and rest of world registration activities for Zurampic® (lesinurad) for the treatment of hyperuricemia associated with gout. At the time of joining Ardea in 2006, Ms Manhard also oversaw general corporate operations and HIV and Oncology drug development. Prior to joining Ardea, Ms. Manhard was President of her own consultancy firm, Vice President of Regulatory Affairs for Exelixis, Inc. and held multiple regulatory positions at Agouron Pharmaceuticals, Inc., a division of the Warner-Lambert Company, supporting development and commercialization of anticancer and antiviral products, including Viracept® (nelfinavir).

Ms Manhard was also previously with Bristol-Myers Squibb Company in regulatory affairs, responsible for oncology compounds, including Taxol® (paclitaxel) and infectious disease compounds, including Videx® (didanosine) and Zerit® (stavudine). Ms. Manhard began her industry career in clinical research with Eli Lilly and Company and G.H. Besselaar Associates (Covance Inc.). Ms. Manhard is a member of the board of trustees for the Fleet Science Center. She received a B.S. degree in zoology and a B.A. degree in French from the University of Florida.

Dan S. Kaufman, M.D., Ph.D.
Co-Founder, CSO

Dr. Kaufman is a Professor in Department of Medicine, Division of Regenerative Medicine and Director of the Cell Therapy program at the University of California-San Diego (UCSD).

Following undergraduate studies at Stanford University, he completed a combined MD/PhD program at Mayo Clinic and a clinical residency and fellowship in internal medicine and hematology at the University of Wisconsin-Madison.

Dr. Kaufman is practicing clinical work in hematology and blood and marrow transplantation (BMT).

His research focuses on use of human induced pluripotent stem cells (iPSC) to study development of hematopoietic stem/progenitor cells, lymphocytes and other immune cells.

His studies as a post-doctoral fellow were the first to derive blood cells from human pluripotent stem cells.

In addition, His laboratory was the first to produce functional lymphocytes from human pluripotent stem cells.

Dr Kaufman’s laboratory has pioneered strategies including novel NK-specific chimeric antigen receptors and other gene editing approaches that increase NK cell-mediated activity.

Dr. Kaufman also leads the Advanced Cell Therapy Laboratory (ACTL), a GMP facility at UCSD to translate novel cell-based therapies into clinical trials and continues to practice clinical work.

Steven Holtzman
Co-Founder

Steven is the Chair of the boards of Qihan Biotech and Camp4 Biotherapeutics, both private biotechnology companies.

Since January 2020, he has served as a Strategic Advisor to Decibel Therapeutics, where he served as the company’s first president and chief executive officer and a board member from 2016—2020.

Prior to Decibel, from 2011 to 2016 he served as executive vice president, corporate development at Biogen, Inc., where he led eight new drug approvals.

Previously, from 2001 to 2011, Steve was the founder, chief executive officer and board chair of Infinity Pharmaceuticals, Inc., a cancer drug discovery and development company.

He was also, from 1994 to 2001, an early leader and the chief business officer of Millennium Pharmaceuticals, a pioneer in large-scale genetics and genomics.

From 1986 to 1994 he was a co-founder, board member and executive vice president of DNX Corporation, the first transgenic animal company.

He is a member of the board of directors of Molecular Partners, a member of the board of trustees of the Berklee College of Music, and a senior fellow at the Belfer Center for Science and International Affairs at the Harvard Kennedy School.

He was appointed by President Clinton to the National Bioethics Advisory Commission and he also served as a member and vice chair of the board of the Hastings Center for the Life Sciences.

He obtained his undergraduate degree in philosophy from Michigan State University and his graduate degree in philosophy from Oxford University, which he attended as a Rhodes Scholar.

William Sandborn, M.D.
Co-Founder & CMO

Dr. Sandborn joined Shoreline as CMO in April 2021. Dr. Sandborn completed medical school and an internal medicine residency at Loma Linda University in Loma Linda California.

He completed a gastroenterology fellowship at the Mayo Clinic in Rochester, Minnesota in 1993.

From 1993-2010, he was on the faculty of the Mayo Clinic, rising to Professor of Medicine, Vice Chairman of the Division of Gastroenterology and Hepatology, and Associate Dean of Research for Intellectual Property and Industry Relations.

In 2011, he became a tenured Professor of Medicine, Chief of the Division of Gastroenterology, and Director of the Inflammatory Bowel Disease Center at the University of California San Diego.

Dr. Sandborn has published over 851 peer-reviewed articles including articles in the New England Journal of Medicine, Nature, Lancet, JAMA, Annals of Internal Medicine, and Gastroenterology. His h-index is 138.

He is a member of the editorial board for the New England Journal of Medicine. In 2019, he was awarded the Sherman Prize for his work in inflammatory bowel disease. He was a scientific co-founder of Santarus (acquired by Salix Pharmaceuticals in 2013, now Bausch Health), and currently serves as Chair of the Scientific Advisory Board for Prometheus Biosciences.

Vanessa Jacoby
CFO

Ms. Jacoby has extensive experience in the biotechnology and life science sectors, having served as a senior financial executive of several private and public companies.  Prior to joining Shoreline, Ms. Jacoby served as Chief Accounting Officer of Avidity Biosciences, Inc., where she led all corporate finance and planning activities and played a key role in the company’s $300M Initial Public Offering in June 2020 and $100M Series C in October 2019.

Prior to Avidity, Ms. Jacoby was Vice President, Finance at PharmAkea, which was acquired by Galecto in 2019.  Prior to that, she served as a Director of Accounting and Controller at BCI, Inc. and held senior financial roles at Artes Medical and Verenium.  Before joining industry, Ms. Jacoby was an auditor for Ernst & Young.

Ms. Jacoby received her M.B.A. from National University and  B.S. degree in Business Administration from Fundação Armando Alvares Penteado, Sao Paulo, Brazil. She is a certified public accountant with the State of California (inactive).

Marios Fotiadis
Board Member

Marios is an investor specializing in private equity globally with investments representing over $1 billion USD in committed capital.

Marios started his career in investment banking with SG Cowen in New York followed by a move to SG Capital Partners in 1998, where he began his career in private equity. There he focused on investments in growth and venture capital with an emphasis in healthcare and technology companies.

Following that he became the CEO of Achillion Pharmaceuticals Inc (NASDAQ “ACHN”) where he completed a successful turnaround that culminated with an IPO on NASDAQ. Marios moved to Advent International in Boston where he was a partner with a focus on global investments in health care and life sciences.

Subsequently, he became Managing Partner of TVM Capital MENA, where he raised the first private equity fund in the MENA region dedicated to investments in health care and pharmaceuticals.

Since 2012, Marios has been responsible for managing investments of his family office, under Cerus Advisors. He is currently member of the Board of Directors of Stork Capital, an investment management company with offices in Geneva, Switzerland and Dubai.

His responsibilities involve sourcing, closing and managing direct investments in private equity as well as asset allocation and overseeing the selection of managers for the public side of the portfolio. Marios holds a BSc degree cum laude from University of Denver and an MBA from Columbia University in New York.

Christopher Fuglesang, Ph.D., J.D.
Board Member

Dr. Fugelsang is a Co-Founder and Managing Director of Boxer Capital, LLC.

After joining Tavistock Group in 2005, Dr. Fuglesang helped scale Tavistock Group’s public healthcare investing activities with Boxer Capital. Dr. Fuglesang assists in managing the firm’s research team, deal structuring, and securities compliance.

Dr. Fuglesang is a Member of the Board of Directors of CiVi Biopharma, Inc., BCTG Acquisition Corporation (NASDAQ: BCTG) and previously served on Pandion Therapeutics (NASDAQ: PAND) before its acquisition by Merck.

Earlier in his career, Dr. Fuglesang supervised a variety of transactions, including mergers and acquisitions, joint ventures, and other strategic collaborations in the healthcare sector.

Dr. Fuglesang brings with him years of experience in building and developing life science companies, previously founding, and holding board and executive management positions at multiple biotechnology companies.

Dr. Fuglesang holds a Doctorate degree in Chemical Physics from the University of California, Los Angeles, a Juris Doctor degree from the Boston University School of Law, and Bachelor of Science degrees in Chemistry and Physics from the University of California, Los Angeles.

Mohammad El-Kalay, Ph.D.
Senior VP & Head of CMC

Dr. El-Kalay  joined Shoreline in June 2021 as Senior VP and Head of CMC (Chemistry, Manufacturing, and Control).  Dr. El-Kalay has over three decades of experience in global biopharmaceutical operations, including key leadership roles in cell therapy companies where he led the successful translation of several cell therapy candidates into late-stage clinical development, as well as developing a T-cell purging device that was later marketed.

Dr. El-Kalay holds a B.Sc., M.Sc. and Ph.D. from Strathclyde University in Glasgow, UK.

Dr. El-Kalay joins Shoreline from Poseida Therapeutics, where he was VP, Technical Operations and was responsible for developing processes to manufacture their autologous and allogeneic CAR-T cell products. Prior to Poseida, he was SVP, Technical Operations for San Bio, Inc., directing development of manufacturing processes of their gene modified allogeneic mesenchymal stem cells to treat CNS diseases.

Before that, he held senior technical and leadership roles at Sangamo Therapeutics, Stem Cells, Inc., and was Founder, President, and CEO of EyeCyte, an autologous cell therapy company.  He also held senior leadership R&D and Technical Operation roles at MicroIslet, Telos Pharmaceuticals, MorphoGen Pharmaceuticals, Osiris Therapeutics, SyStemix, and Applied ImmuneSciences.

Travis S. Young
Advisory Board member

Dr. Travis Young is the Vice President of Biologics at Calibr, a division of Scripps Research and holds an appointment as Professor of Chemical Biology in the Department of Chemistry at Scripps Research. He received a BS in biochemistry from Boston College and a PhD in chemical biology from The Scripps Research Institute as an ARCS scholar. At Scripps, his work focused on the development of unnatural amino acid incorporation methodologies to improve the properties of therapeutic proteins. This work was foundational for the development of programs in the Calibr pipeline today, including a bispecific antibody for prostate cancer which will enter clinical trials next year. After receiving his PhD, he completed a postdoc at Harvard Medical School with an NIH fellowship, in the department of Biological Chemistry and Molecular Pharmacology with Dr. Christopher T Walsh.

Dr. Young was a member of the founding group of principal investigators at Calibr and serves as the lead investigator on multiple bench-to-bedside antibody and cellular therapy-based programs. Dr. Young maintains a research group focused in the development of novel therapeutics at the interface between protein engineering and synthetic biology. This research spans multiple disease indications including cancer, autoimmune, metabolic disorders, and infectious disease. His work has been highly awarded and received support from the Wellcome Trust, NIH (National Cancer Institute), Department of Defense, Mesothelioma Research foundation, American Cancer Society, among others. His work has resulted in numerous publications and patents with >2250 citations in the past 5 years. Dr. Young has led two programs from concept into first-in-human clinical trials while at Calibr: a bispecific antibody for prostate cancer and a unique switchable CAR-T cell therapy platform for blood cancer.

Bjorn Dahle
VP, Smart Manufacturing

Bjorn Dahle, MBA has extensive experience in various industries in advancing products through manufacturing to sales and marketing. Prior to joining Shoreline, Mr. Dahle was Co-founder and CEO of Inspire Solutions LLC, CEO of VersaCall Technologies and President of KIC, a technology company. Prior to that, he held key executive, global roles at St. Bernardo Softward and MPM. Mr. Dahle holds an MBA in marketing from San Diego State University and a bachelor’s degree in mechanical engineering from Norwegian University of Science and Technology.

Boyan Litchev, M.D.
Senior VP & Head of GCD

Boyan Litchev, MD brings to the company more than two decades of global experience in the pharmaceutical and biotechnology industry, with significant experience in the development of CAR-T, nucleotides (RNA), peptides, small molecules and gene therapies for various diseases.

Dr. Litchev joins Shoreline from Poseida Therapeutics, where he was Head of Clinical Development Oncology and was responsible for leading the company’s CAR-T programs in solid tumors.  Before that, he was Executive Medical Director, Head of Clinical Development Oncology for Halozyme Therapeutics, and Executive Medical Director, RNA-targeted therapies Clinical Development for Akcea Therapeutics, a wholly owned subsidiary of Ionis.  Prior to Akcea, Dr. Litchev worked at Takeda (formerly Shire) where he led clinical development programs in gene therapy and hematology. Dr. Litchev previously held roles of increasing responsibility at Ferring Pharmaceuticals, Syneos Health (INC research), IQVIA (Quintiles) and University of California San Diego. Dr. Litchev is a board-certified physician in Obstetrics and Gynecology. Dr. Litchev received his MD degree from Medical University Plovdiv. Prior to joining the pharmaceutical industry, he has treated patients and conducted clinical research.

Steven Neben, Ph.D.
VP, Alliance and Project Management

Steven Neben, PhD has more than two decades of experience in project and alliance management in the biopharmaceutical industry at both small and large companies. Prior to joining Shoreline, Dr. Neben served as Executive Director, Project and Alliance Management for Regulus Therapeutics where he was responsible for the management of drug discovery and development partnerships with pharmaceutical partners and management of the research stage project portfolio of RNA therapeutic programs. Prior to Regulus, Dr. Neben was Senior Director, Project and Alliance Management at AnaptysBio, Director, Project and Alliance Management at Xoma and principal scientist at Bayer Pharmaceuticals. Dr. Neben holds a BA and PhD from the University of California, Berkeley.

Trisha Fitzmaurice
Head of People & Culture

Mrs. Fitzmaurice is an HR professional with over 8 years’ experience mostly in life science/pharmaceutical companies. Before joining Shoreline, she has held HR roles at Adamis Pharmaceuticals and US Compounding. Mrs. Fitzmaurice holds a Bachelor of Arts degree from Indiana University – Bloomington and a Juris Doctorate from Thomas Jefferson School of Law.

Silke Paust
Advisory Board Member

Research in Dr. Paust’s laboratory at the Scripps Research Institute seeks to elucidate the molecular mechanisms causal to murine and human NK cell-mediated adaptive immunity. Our long-term goal is to use this knowledge to develop novel anti-viral and anti-tumor vaccines or NK cell-based infusion products. Approaches include cell biology, molecular biology, and immunology experiments in mice, humanized mice, and using human specimens.

Scott Antonia
Advisory Board Member

Scott Antonia, MD, PhD, joined the Duke Cancer Institute in 2019, where he directs the DCI Center for Cancer Immunotherapy, and is a member of the Thoracic Oncology disease group as Professor of Medical Oncology. 

After completing his medical oncology training and post-doctoral fellowship in the Flavell Lab at the Yale University School of Medicine, he joined H. Lee Moffitt Cancer Center in 1994. There, he served as chairman of the Department of Thoracic Oncology.

Antonia is recognized as a global leader in the development of immunotherapy for lung cancer. He served as the global principal investigator for the practice-changing Pacific study, which established, as the new global standard of care, anti-PDL1 as consolidative therapy after combined chemo-radiation therapy for locally advanced non-small cell lung cancer. He was also the lead investigator of trials that established the clinical activity of immunotherapy for small cell lung cancer.

For the past 27 years, Antonia has directed a translational research program that’s overall goal is to develop immunotherapeutic strategies for the treatment of cancer patients; using tumor vaccines or adoptive T cell therapies in combination with immunomodulatory strategies designed to thwart the immunosuppressive mechanisms used by tumors to evade T cell mediated rejection. He has extensive experience in conducting early-phase clinical trials testing therapeutic tumor vaccines, adoptive T cell therapies and immunomodulatory antibodies.

Kleanthis G. Xanthopoulos, Ph.D.
Co-Founder, Chairman & CEO

Kleanthis is a serial biotechnology entrepreneur with over two decades of experience in the biotechnology and pharmaceutical research industries as an executive, company founder, chief executive officer, investor and board member.

Dr. Xanthopoulos has founded five companies, introduced three life science companies to NASDAQ and financed and brokered numerous creative strategic alliance and partnership deals with large pharmaceutical partners.

In addition to his role at Shoreline Biosciences, Dr. Xanthopoulos is the Chairman of Stork Capital Life Sciences which focuses on building and investing in innovative biotechnology companies. Dr. Xanthopoulos is a member of the board of directors of IRRAS AB, Connect Biopharma, (NASDAQ: CNTB), Zosano Pharma, Inc., (NASDAQ: ZSAN), and is the co-founder and a member of the board of directors of privately held Sente Inc.

Previously, he served on the boards of LDO sp.a. (Milan, Italy), Odyssey Therapeutics, Anadys Pharmaceuticals and Regulus Therapeutics.

Dr. Xanthopoulos participated in The Human Genome Project as a Section Head of the National Human Genome Research Institute from 1995 to 1997.  Prior to this, he was an Associate Professor at the Karolinska Institute, Stockholm, Sweden. An Onassis Foundation scholar, Dr. Xanthopoulos received his B.Sc. in Biology with honors from Aristotle University of Thessaloniki, Greece, and received both his M.Sc. in Microbiology and Ph.D. in Molecular Biology from the University of Stockholm, Sweden.

Dr. Xanthopoulos has over 45 peer-reviewed publications and several issued patents.