Large-Scale Cell and Gene Therapy Contract Development and Manufacturing Organization to Launch in PA

The Center for Breakthrough Medicines expected to relieve the industry’s production constraints, providing patients better access to treatments

(King of Prussia, PA, and New York, NY, January 22, 2020)—The Discovery Labs and Deerfield Management Company have formed The Center for Breakthrough Medicines, a Contract Development and Manufacturing Organization (CDMO) and specialty investment company, to alleviate the critical lack of capacity that is preventing patients from accessing critically needed cell and gene therapies. The CDMO is occupying over 40 percent of The Discovery Labs’ 1.6 million square foot biotech, healthcare and life sciences campus in King of Prussia, PA.

The CDMO provides preclinical through commercial manufacturing of cell and gene therapies and component raw materials. It offers process development, plasmid DNA, viral vectors, cell banking, cell processing, and support testing capabilities all under one roof. The immense $1.1 billion facility will provide instant capacity as the largest known single source for accelerating the delivery and affordability of lifesaving and life-changing therapies from the bench to the patient’s bedside.

The Company has initiated a substantial hiring effort targeting the best and brightest of the life sciences community including, experts in CGMP manufacturing. The Company expects to hire over 2,000 team members within the next 30 months.

The CDMO has retained Nucleus Careers, a cloud-based specialty life sciences human capital recruiting and retention management expert, to buildout the entire team. Nucleus has proprietary recruiting and retention software designed for large scale human capital buildouts of high growth companies.

In addition to developing the world’s largest single-point cell and gene therapy manufacturing facility, The Discovery Labs is establishing THE COLONY which will provide custom built discovery labs, breakthrough funding, sponsored research agreements, housing and relocation for the world’s leading iconic experts in cell and gene therapy.

THE COLONY will seek to work hand in hand with scientists from both academic and pharmaceutical institutions to unlock and expedite groundbreaking therapies.

Marco A. Chacón, Ph.D., Founder of Paragon Bioservices and Chairman of The Discovery Labs states, “musicians, artists, members of religious communities and great thinkers throughout time have formed colonies where freedom of thought and expression combined with unlimited dreams and potential have resulted in the world’s greatest accomplishments. The United States of America is a perfect example.” Dr. Chacón went on to say, “the goal of THE COLONY is to unshackle the potential of the world’s greatest scientific minds.”

The ability for the industry’s greatest scientists to cohabitate, collaborate, cooperate, and communicate via technology and in person will create an exponential therapeutic “X FACTOR.” THE COLONY seeks to unlock institutional barriers prohibiting the world’s greatest scientists from moving at a pace necessary in today’s ever-changing therapeutic revolution. THE COLONY will partner with the institutions where the scientists currently work by providing equity, license fees, and revenue sharing.

“The Center for Breakthrough Medicines will be serving companies from the earliest stages through commercialization. Its exceptional scale and offering will quickly relieve the production bottleneck for advanced therapies by reducing the time, complexity, and cost of commercializing vitally needed gene and cell therapies,” noted Audrey Greenberg, Board Member and Executive Managing Director for The Discovery Labs.

The addition of this end-to-end manufacturing capability is expected to significantly enhance the offerings of The Discovery Labs in an area that has become one of the largest life sciences hubs in the world. Renovations are underway to construct a total of 86 plasmid, viral vector production, universal cell processing, CGMP testing, process development and cell banking suites. The viral vector and cell processing suites will be fully compliant with both U.S. Food and Drug Administration and European Medicines Agency standards. All suites will offer the flexibility to meet client-specific workflows and will be able to adapt quickly to meet demand. The Company is in the process of reserving capacity now for late 2020.

“Today brilliant scientists are advancing an unprecedented number of gene and cell therapy drug candidates. The real tragedy, however, is a scarcity of manufacturing know-how, which is complex and expensive,” said Alex Karnal, Partner and Managing Director of Deerfield Management and a Board Member of the Discovery Labs. “With its visionary business model, it is hoped that The Center for Breakthrough Medicines will help realize the promise of cell and gene therapies in time to treat the many patients who need them.”

The Discovery Labs provides a central campus where the world’s greatest scientists can collaborate on new therapeutic discoveries to eradicate diseases affecting small and large segments of the global population. The Center for Breakthrough Medicines will work with these leaders, life sciences companies, large pharmaceutical companies, and academic and government institutions.

This new manufacturing capability is a transformational addition to The Discovery Labs market offering and dovetails with The Discovery Labs biotech incubator, Unite IQ. Unite IQ offers immediate space to emerging life sciences companies and scientists giving them the ability to grow from startup to enterprise company on one campus. The incubator and accelerator space at Unite IQ provides a comprehensive home for startups with every resource needed to initiate business operations. Unite IQ tenants are expected to utilize the discovery, development, testing, and manufacturing capabilities of the Center for Breakthrough Medicines with seamless forward integration of processes and analytics, and seamless tech transfer from research lab to large scale production

The Emerging Field of Cell and Gene Therapy in Pennsylvania

The demand for clinical and commercial manufacturing capacity is acute and expected to remain that way. The current shortfall in manufacturing for cell and gene therapies is severely underserved with few approved products. There are currently approximately 1,100 advanced therapies in the pipeline pending FDA approval. This will greatly increase highly skilled manufacturing demand. Dr. Peter Marks, Director of the FDA Center for Biologics Evaluation and Research, states, “what keeps me up at night is will we be able to manufacture these on a scale that will allow us to bring the benefit of these therapies to patients?” He further added that “if we can help see cost of goods and ability to manufacture reproducibly improve, I think that’ll be a big thing.” All of this adds up to a supply constrained market that The Center for Breakthrough Medicines aims to help address.

With the potential to treat and even cure disabling, and deadly diseases, gene and cell therapies are ushering in a new era of medicine. These therapies may eventually be able to cure genetic conditions, such as cystic fibrosis, hemophilia A, and a range of cancers. The Philadelphia area has become the epicenter for the flourishing field of gene and cell therapy. Research from CBRE currently ranks the market among the top biotech clusters for medical research and health services. The cluster has become known worldwide as “Cellicon Valley” for its leadership in research and development of this rapidly evolving field. The Discovery Lab’s suburban Philadelphia location offers a talent rich environment due to the area’s preponderance of large pharmaceutical companies and the Philadelphia region’s position boasting the top 10 universities and primary school systems in nation.

Over the past three years, multiple Philadelphia companies have received approvals for major breakthroughs in cell and gene therapy. In 2017, the U.S. FDA approved the first-ever CAR-T cell therapy, Novartis’s Kymriah, which originated at the University of Pennsylvania. Shortly thereafter, the FDA gave landmark approval for the first-ever gene therapy to treat a genetic blindness condition to Spark Therapeutics, a start-up founded by researchers at Children’s Hospital of Philadelphia. These discoveries and others in the pipeline are attracting billions of dollars of venture capital. The Greater Philadelphia Region set a recent record in venture capital financing.

The Discovery Labs Center for Breakthrough Medicines joins more than 25 healthcare, life sciences and tech-enabled companies that already call The Discovery Labs King of Prussia home.

Contact Audrey Greenberg at [email protected] for more information about development services, manufacturing capacity, incubator space or leasing information at the property.

About The Discovery Labs

Part of MLP Ventures, The Discovery Labs is a global provider of world-class cGMP manufacturing, turnkey laboratory solutions, critical materials and office space that support therapeutic products and services to the biotechnology and pharmaceutical industry so that groundbreaking medicines get to the patients that need them. The location in eastern King of Prussia is a prototype for a global rollout of The Discovery Labs, providing Big Pharma, emerging life sciences, consumer and technology companies flexible, end-to-end technical real estate and business infrastructure for the customer’s entire lifecycle from discovery to delivery, including manufacturing capacity. It is the first fully integrated environment that merges technology and life sciences under one roof to drive innovation.

About Deerfield Management

Deerfield is a healthcare investment management firm committed to advancing healthcare through investment, information and philanthropy.

Media Contact:
Tony DeFazio, DeFazio Communications
(o) 484-534-3306 (c) 484-410-1354
[email protected]

Karen Heidelberger, Deerfield Management Company
212-551-1600
[email protected]

Deerfield Leads $34 Million Investment in Lumos Pharma

New York, NY – April 6, 2016- Deerfield Management Company leads a $34 million investment in Lumos Pharma’s Series B financing. The proceeds of the financing will be used to develop LUM-001, Lumos’ lead compound, for the treatment of Creatine Transporter Deficiency (CTD). Funding will also be used to further develop other therapeutics in the company’s pipeline. 

Creatine Transporter Deficiency is a rare defect which causes patients, mostly young boys, to be unable to actively transport creatine across the blood-brain barrier, resulting in delays inexpressive speech and mental development, and also causes these boys to experience behavioral abnormalities, epilepsy and seizures. Due to the clinical presentation, those afflicted with CTD are often misdiagnosed with autism.  This disease is severely debilitating,and the young boys require lifelong care. CTD is the second leading cause of X-linked mental retardation in males after Fragile X Syndrome. LUM-001 is a disease modifying therapy and may significantly alter the development of the defect and symptoms.

“We are proud to be partnering with a pioneer in the orphan disease space to develop a cure for CTD. With the similarities of symptoms with autism often leading to misdiagnosis, and the lack of a current effective therapy, CTD often goes untreated. We believe Lumos has the cutting edge science and technology needed to develop LUM-001 to be the first treatment to help these young boys,” stated Cameron Wheeler, a Principal from Deerfield. 

“We are excited to have Deerfield as a partner in Lumos. We believe Deerfield has the balance, flexibility and skills to help guide us as we move this important cure forward. Deerfield has a strong history in the orphan space and is committed to improving the lives of patients with CTD,” stated Rick Hawkins, CEO of Lumos Pharma.

About Lumos

Lumos Pharma is focused on bringing novel therapies to patients afflicted with unmet medical needs in severe, rare, and genetic diseases. Lumos Pharma is led by an experienced management team withlongstanding experience in the rare disease space. Lumos Pharma’s lead compound is supported by the National Institutes of Health’s Therapeutics for Rare and Neglected Diseases (TRND) program. 

About Deerfield

Deerfield is an investment management firm committed to advancing healthcare through investment, information and philanthropy.

For more information, please visit www.deerfield.com

Contacts

Deerfield Management Company
Karen Heidelberger, 212-692-7140
[email protected]

Lumos Pharma

Deerfield led the $34 million Series B financing in Lumos Pharma. Lumos is an orphan disease company that is focused on bringing novel therapies to patients with unmet medical needs in severe, rare and genetic diseases. Its lead compound, LUM-001, is being developed to treat Creatine Transporter Deficiency (CTD).

Homology

Homology is a genetic medicines company translating proprietary, next generation gene editing and gene therapy technologies into novel treatments for patients with rare diseases. The gene editing platform has the potential to surpass recombinant rates of current editing approaches and leverages naturally occurring genetic mechanisms to treat and correct diseases.

Deerfield Leads Funding in Creation of Akari Therapeutics

Deerfield leads the funding in creation of Akari Therapeutics Plc which is created through the Celsus Therapeutics Plc acquisition of Volution Immuno Pharmaceuticals.

NEW YORK – September 21, 2015 – Deerfield Management Company announced today that it will finance Akari Therapeutics, the new company created through the Celsus Therapeutics Plc (NASDAQ: CLTX) acquisition of Volution Immuno Pharmaceuticals SA. The transaction values the combined company on a fully diluted basis at approximately $150 million.

Akari plans to use the anticipated net proceeds from the private placement for the clinical development of Coversin, Volution’s lead molecule, and for working capital and general corporate purposes. Coversin is under development to treat complement-mediated disorders in several therapeutic areas including hematology, nephrology, and neurology. Complement-mediated disorders are orphan indications and advancement of new options in this area could be life-changing for the individuals living with these diseases.

“We are excited to partner with Akari and believe Coversin has the potential to be a best-in-class C5 inhibitor with a convenient administration profile and distinct advantages in certain indications,” said Jean Kim partner, Deerfield Management. “We believe that Akari has assembled a strong team to develop this asset in a thoughtful and aggressive manner to reach patients and the market quickly.”

“Deerfield is the ideal lead investor for our newly formed company, Akari. Deerfield has a long track record of supporting innovative biotechnology companies and we are encouraged by their confidence in Akari to drive the full potential of our lead asset, Coversin,” said Gur Roshwalb, CEO of Akari. “With this financing, Akari now has enough resources to advance our corporate and clinical goals, while providing us with additional flexibility to pursue opportunities that could further propel the value of the company.”

About Akari Therapeutics Plc

Akari is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases. Akari’s lead drug, Coversin is a second-generation complement inhibitor that acts on complement component-C5, preventing release of C5a and formation of C5b-9 (also known as the membrane attack complex or MAC). C5 inhibition is growing in importance in a range of rare autoimmune diseases related to dysregulation of the complement component of the immune system, including paroxysmal nocturnal hemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), and  Guillain Barré syndrome (GBS).

About Deerfield

Deerfield is an investment management firm committed to advancing healthcare through investment, information and philanthropy.

For more information, please visit www.deerfield.com.

Contacts

Deerfield Management Company
Karen Heidelberger, 212-692-7140
[email protected]

Akari Therapeutics

Akari Therapeutics is a development stage biopharmaceutical company that is developing Coversin for complement-mediated disorders. Deerfield led a $75 million financing to fund the clinical development of Coversin across several therapeutic areas, including hematology, nephrology and neurology.

Deerfield Invests $20 million in Editas Medicine

NEW YORK, NEW YORK – August 10, 2015 – Deerfield Management Company, L.P.’s venture capital fund, Deerfield Healthcare Innovations Fund, L.P, today announced its first therapeutics-based investment by participating, along with Deerfield Private Design Fund III, in providing financing to Editas Medicine.  In total, Deerfield invested $20 million in this early-stage institutional financing.

Editas Medicine is at the forefront ofdeveloping CRISPR/Cas9, a genome-editing technology, which makes it possible to turn off or edit disease-causing genes, potentially leading to a cure. Deerfield’s capital will support the advancement of multiple new therapies into studies which can prove their utility. 

“Gene editing has the potential to cure diseases that currently result in significant disability or death,” said Jim Flynn, managing partner of Deerfield. “Given the dozens of important disease targets where gene editing can play an important role and the transformative effect on lives that these new therapies can offer, Editas Medicine is the ideal initial therapeutic company investment by the Healthcare Innovations Fund.”

“Deerfield’s commitment to changing medical practice through innovative science and thoughtful investing matches our own, and we are privileged to have them as part of our team to help build Editas,” said Katrine Bosley, CEO of Editas Medicine. “Deerfield has a long track record of supporting emerging biotechnology companies and helping them navigate the challenges of bringing important new medicines to patients.”

The Deerfield Healthcare Innovations Fund, which launched in July, focuses on investing in early-stage companies with transformative new healthcare products and services.  All of the fund’s incentive profits go to the Deerfield Partnership Foundation to provide healthcare services for underserved children and promote medical innovation.

About Editas

Editas Medicine is a leading genome editing company and part of a transformational new area of health care – genomic medicine. The Company was founded by pioneers and worldleaders in genome editing bringing specific expertise in CRISPR/Cas9 and TALENs technologies. The Company’s mission is to translate its proprietary technology into novel solutions to treat a broad range of genetically driven diseases.

For more information, visit www.editasmedicine.com

About Deerfield

Deerfield is an investment management firm committed to advancing healthcare through investment, information and philanthropy.

Formore information, please visit www.deerfield.com

Contacts

Deerfield Management Company
Karen Heidelberger, 212-692-7140
[email protected]

Editas

Deerfield invested in the early stage institutional funding and provided a total of $20 million to Editas. Editas is at the forefront of developing CRISPR/Cas9, a genome-editing technology, which makes it possible to turn off or edit disease-causing genes, potentially leading to a cure. The financing will support the advancement of multiple new therapies into studies which can prove their utility.

Rhythm Metabolic

Rhythm Metabolic is a biopharmaceutical company developing peptide therapeutics for the treatment of obesity, including obesity caused by genetic defects in the MC4 pathway and Prader-Willi syndrome.

aTyr Pharma

aTyr Pharma is developing novel therapeutics based on a new class of proteins called Physiocrines. The company’s programs are currently focused on severe, rare diseases characterized by immune dysregulation, for which there are currently limited or no treatment options. aTyr was founded by two leading aminoacyl tRNA synthetase scientists at The Scripps Research Institute. Deerfield participated in a $75M Series E.