Shoreline Biosciences and BeiGene Announce Strategic Worldwide Collaboration to Develop and Commercialize Genetically Modified Natural Killer (NK) Cell Therapies

SAN DIEGO, CA, CAMBRIDGE, MA & BEIJING, China – June 9, 2021 — Shoreline Biosciences, Inc., a biotechnology company developing intelligently designed allogeneic off-the-shelf, standardized and targeted natural killer (NK) and macrophage cellular immunotherapies derived from induced pluripotent stem cells (iPSC) for cancer and other serious diseases, and BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160), a global biotechnology company, today announced an exclusive worldwide strategic collaboration to develop and commercialize a portfolio of NK-based cell therapeutics with Shoreline’s iPSC NK cell technology and BeiGene’s research and clinical development capabilities for different malignancies.

“BeiGene is a globally recognized biotechnology leader, and we are thrilled to announce our collaboration today,” said Kleanthis G. Xanthopoulos, Ph.D., Shoreline Chairman & CEO. “We look forward to combining our iPSC NK cells with BeiGene’s discovery and clinical development expertise as the parties work to accelerate the development of the next generation of cell therapies for patients around the world.”

Under the terms of the agreement, Shoreline will receive an upfront cash payment of $45 million from BeiGene and will be eligible to receive additional R&D funding, milestone payments and royalties based upon the achievement of certain development, regulatory, and commercial milestones. In the multi-target collaboration, the companies have agreed to work jointly to develop cell therapies for four designated therapeutic targets, with an option to expand the collaboration at a future date. Clinical development will be led by BeiGene globally, with Shoreline responsible for clinical manufacturing. BeiGene will have commercial rights globally, with Shoreline having an option to retain U.S. and Canadian commercialization rights for two targets. In connection with the agreement, BeiGene has an option to acquire an equity stake in Shoreline in its next round of equity financing, subject to specified conditions.

“We are excited to collaborate with Shoreline as BeiGene looks to expand our pipeline of  transformative medicines from small molecule and antibody therapeutics to off-the-shelf cell therapies, a compelling area of research that has been primarily out of reach for many of the world’s patients,” said John V. Oyler, Co-Founder, Chairman, and Chief Executive Officer of BeiGene. “We look forward to collaborating with Shoreline, a leading company in developing iPSC-derived allogeneic cell therapies, as we combine our protein engineering technologies with Shoreline’s standardized NK cell therapy technology. We are hopeful that this combination, along with our clinical development expertise for solid tumor and hematologic malignancies, will bring cell therapies to more patients who need them.”

About Shoreline’s iPSC NK cell technology

Shoreline has developed a proprietary platform focused on iPSC-derived natural killer (NK) cells and macrophages that are optimized with precise and rational genetic reprogramming. The Shoreline NK cell and macrophage-based cell therapies are designed to provide an effective and efficient means for targeting and killing tumors as well as repairing tissue homeostasis. Shoreline’s approach, based on the advantage of its iPSC cell engineering and expansion, is being used to create a streamlined, affordable, and scalable manufacturing process that can deliver cell therapy treatments to patients in a more cost-effective, time-saving manner. Shoreline’s technology is at the forefront of regenerative medicine and is being used to develop potential therapies to treat a wide range of diseases including cancer, inflammatory and genetic diseases.

About BeiGene

BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are committed to expediting the development of our diverse pipeline of novel therapeutics through collaborations or our own internal capabilities, with the aspirational goal of radically improving access to medicines for two billion more people by 2030. BeiGene is a headquarter-less company by design, with a growing global team of approximately 6,000 colleagues across five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal.

BeiGene’s Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding future development and potential commercialization of therapeutic candidates using the licensed technology; potential payments to Shoreline Biosciences; the potential of the licensed technology; and the parties’ commitments and the potential benefits of the collaboration. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene’s ability to achieve commercial success for its marketed products and drug candidates, if approved; BeiGene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene’s reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited operating history and BeiGene’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; the impact of the COVID-19 pandemic on the Company’s clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

Shoreline Biosciences Investor and Media Contact:
Amy Conrad
Juniper Point
(858) 366-3243
amy@juniper-point.com

BeiGene Investor Contact:
Craig West
(857) 302-5189
ir@beigene.com

BeiGene Media Contact:
Liza Heapes or Vivian Ni
(857) 302-5663 or (857) 302-7596
media@beigene.com

SHORELINE BIOSCIENCES APPOINTS KIMBERLY MANHARD TO BOARD OF DIRECTORS

San Diego, Calif., May 19, 2021 – Shoreline Biosciences, Inc. (Shoreline), a biotechnology company developing intelligently designed allogeneic off-the-shelf, standardized and targeted natural killer (NK) and Macrophage cellular immunotherapies derived from induced pluripotent stem cells (iPSC) for cancer and other serious diseases, today announced the appointment of  Kimberly Manhard as a member of the Board of Directors. Ms. Manhard has more than 25 years of experience in drug development, regulatory affairs and pharmaceutical operations, and has been instrumental in the development and approval of eight drugs across multiple therapeutic categories. 

 

“We are very pleased to have such an accomplished drug developer and regulatory expert like Kimberly join our board as we continue to grow Shoreline,” said Kleanthis G. Xanthopoulos, Ph.D., Shoreline Chairman and CEO.  “Kimberly has a diversified background both as an industry executive, and board member who is responsible for delivering eight important commercial drugs to patients.  We are thrilled to welcome Kimberly to our board and look forward to gaining valuable insights as we advance our cell therapy programs toward the clinic and beyond.”

 

“Shoreline has great potential to improve the development of safe, effective and affordable allogeneic cell therapies and carve out a leading position in the dynamic field of immunotherapy,” commented Ms. Manhard. “I am pleased to join such an experienced board and look forward to leveraging my experience to guide Shoreline in the successful development of iPSC-derived allogeneic cell immunotherapies.”

 

Ms. Manhard currently serves as Executive Vice President, Drug Development and director of Heron Therapeutics, where she has played a key role in the development and regulatory approvals of oncology care products Sustol® and Cinvanti® and Zynrelef™ for postoperative pain.  Prior to joining Heron, Ms. Manhard served as the Senior Vice President of Regulatory Affairs and Development Operations at Ardea Biosciences, Inc. (acquired by AstraZeneca), where she was was key to the development and regulatory approval of Zurampic® (lesinurad). Prior to joining Ardea, she 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). She began her career in clinical research with Eli Lilly and Company and G.H. Besselaar Associates (Covance Inc.).  Ms. Manhard also currently serves as a member of the board of directors of InhibRx, Inc. and Shoreline Biosciences and 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.

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Shoreline Biosciences Investor and Media
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Pointamy@juniper-point.com
858-366-3243

 

Shoreline Biosciences Appoints Vanessa L. Jacoby as Chief Financial Officer

Shoreline Biosciences, Inc. (Shoreline), a biotechnology company developing intelligently designed allogeneic off-the-shelf, standardized and targeted natural killer (NK) and Macrophage cellular immunotherapies derived from induced pluripotent stem cells (iPSC) for cancer and other serious diseases, today announced the appointment of Vanessa L. Jacoby as Chief Financial Officer.Ms. Jacoby brings more than twenty years of experience as a financial leader to Shoreline, with a strong background in company building and financial strategy.

“I am pleased to welcome Vanessa to Shoreline as our Chief Financial Officer,”said Kleanthis G. Xanthopoulos, Ph.D., Shoreline Co-Founder and Executive Chairman. “Vanessa’s recent IPO and public markets experience,coupled with a proven track record in building and financing companies through critical phases of growth,will be invaluable to our team as we grow into a domain-dominant cell therapy player.”“I am thrilled to be joining Shoreline at this exciting stage of its development. Shoreline’s vision of developing allogeneic cell therapies has the potential to change the lives of critically ill patients and is a unique and compelling opportunity,” said Ms. Jacoby. “I look forward to utilizing my experience to fulfill Shoreline’s strategic and financial objectives to become a leading cell therapy company.”

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 2020and $100M Series C in October 2019. Prior to Avidity, Ms. Jacoby was Vice President, Finance at Pharm Akea, 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 and she is a certified public accountant with the State of California (inactive). 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.

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Shoreline Biosciences Investor and Media
Contact:
Amy Conrad Juniper
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858-366-3243

Shoreline Biosciences Appoints Co-Founder William Sandborn, M.D. as Chief Medical Officer

Shoreline Biosciences, Inc. (Shoreline),a biotechnology company developing intelligently designed allogeneic off-the-shelf, standardized and targetedcellular immunotherapies derived from induced pluripotent stem cells (iPSC) for cancer and other serious diseases, today announced the appointment of William Sandborn, M.D. as Chief Medical Officer. Dr. Sandborn is a world-renown award winning key opinion leader, inflammatory diseaseclinician, and scientific co-founder of multiple biotechnology companies.

“Bill has been an instrumental part in launching Shoreline as a co-founder and we are thrilled to announce his appointment to our leadership team as Chief Medical Officer,” said Kleanthis G. Xanthopoulos, Ph.D., Shoreline Co-Founder and Executive Chairman. “Bill’s depth and breadth of experience in the immunotherapy space will help us drive our cell therapy programs to the clinic and build a valuable pipeline of allogeneic iPSC-based therapies.”

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. 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 for $2.6B in 2013, now Bausch Health), and currently chairs the Scientific Advisory Board for Prometheus Biosciences, Inc.Dr. Sandborn has published over 849 peer-reviewed articles.

“At Shoreline, we aim to take immunotherapies to the next level by harnessing the cutting-edge science of cell therapy to deliver improved therapeutic options to clinicians and their patients,” added Dr. Sandborn. “I’m very excited to be involved at the ground floor of Shoreline and look forward to translating my clinical and academic expertise into my new role as Chief Medical Officerto create transformative new cell therapies.”

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Shoreline Biosciences Investor and Media
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Amy Conrad Juniper
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858-366-3243

Shoreline Biosciences Announces $43m Financing to Advance Pipeline of Allogeneic Natural Killer and Macrophage Cellular Immunotherapies Derived from Pluripotent Stem Cells

Shoreline Biosciences, Inc. (Shoreline),a biotechnology company developing intelligently designed allogeneic off-the-shelf, standardized and targeted natural killer (NK) and Macrophage cellular immunotherapies derived from induced pluripotent stem cells (iPSC) for cancer and other serious diseases, today announced the completion of a $43M capital raise. The financing was led by Boxer Capital, with participation from BVF Partners L.P., Commodore Capital, Cormorant Capital, Janus Henderson Investors, Logos Capital, Kite,a Gilead company,and Wedbush Healthcare Partners,in addition to Stork Capital, and other investors. In connection with the financing, Christopher Fuglesang, Ph.D., J.D.from Boxer Capital, joined the Shoreline Board of Directors.

The proceeds from the financing will allow Shoreline to accelerate the advancement of its proprietary iPSCplatform focused on developing next generation NKcell and macrophage-cell therapies, while also supporting research efforts to create potent and persistent NK cell-specific Chimeric Antigen Receptors (CARs), switchable CAR-NK cell engagers and macrophage-specific CARs. In addition, Shoreline has entered into a strategic relationship with the Advanced Cell Therapy Laboratory of UC San Diego, a well-recognized manufacturing partner, to secure GMP manufacturing of Shoreline’s cell therapy products.

“We are thrilled to have the support of such outstanding investors who share our vision and commitment to build a differentiated and exciting cell therapy company with the ambition to lead the next wave of allogeneic, off-the-self, targeted and standardized cell therapies,” said Kleanthis G. Xanthopoulos, Ph.D., Shoreline Co-Founder and Executive Chairman. “With this financing, we are well-positioned to drive our programs to the clinic in multiple indications and to build a domain-dominant cell therapy company.”

“We look to invest in companies that are pushing that boundaries of scientific innovation and Shoreline is doing exactly that. Their approach to intelligently designing IPSC-derived cell therapies will help solve many of the current challenges with cell therapies,”said Christopher Fuglesang, Ph.D., J.D., co-founder and Managing Director of Boxer Capital.

Shoreline Biosciences was co-founded by renowned cell therapy expert Dan Kaufman, M.D., Ph.D., and biotech veterans Steven Holtzman, William Sandborn, M.D. and Kleanthis G. Xanthopoulos, Ph.D.


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Contact: Amy Conrad Juniper
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858-366-3243

info@shorelinebio.com
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