Olema Pharmaceuticals

In October 2020, Olema Pharmaceuticals announced a Series C Preferred stock financing of $85 million. The Company is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast and gynecologic cancers.

Reprieve Cardiovascular

In July 2020, Reprieve Cardiovascular completed a Series A round financing of $15 million. Reprieve Cardiovascular is a medical device company focused on automated fluid management technologies for acute heart failure treatment.  

Element Science

In March 2020, Element Science announced that it had raised a $145.6 million Series C financing. The Company is a health technology company pioneering a next-generation digital wearable platform focused on high-risk cardiovascular patients transitioning from the hospital-to-home.

Farapulse

Farapulse is developing catheter-based tools designed to treat atrial fibrillation. The Company aims to advance tissue-selective pulse field ablation therapy on catheter and surgical platforms for both endocardial and epicardial approaches.

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]

Afib treatment advances publish in prominent medical journals

Real-time feature of Acutus’ AcQMap results in improved patient outcomes

A clinical trial investigating Acutus’ AcQMap showed that this novel imaging and mapping system safely guided cardiac ablation resulting in a 12-month freedom from recurrent atrial fibrillation (AFib) in 73 percent of patients with persistent atrial fibrillation.

The results, published in the July 1, 2019 issue of the Journal Circulation: Arrhythmia and Electrophysiology were first reported earlier this year in a late-breaking trial at the 24th Annual AF Symposium in Boston.

Known as UNCOVER-AF, the trial prospectively studied the safety and efficacy of the AcQMap in 127 patients at 13 sites in Europe and Canada – 98 percent of whom achieved a normal heartbeat upon completion of the procedure.

Characterized as an irregular heartbeat, AFib is the most common type of heart arrhythmia and could greatly increase a person’s risk of developing a severe stroke. Cardiac ablation is a procedure that can reduce the risk, yet traditional ablation procedures often fail to achieve long-term absence of AFib, resulting in repeat ablation procedures.

With its precision ultrasound and high definition re-mapping capabilities, AcQMap helps inform physicians in real time who can strive to improve outcomes by checking their work after each ablation.

Adapted from Acutus’ news release: Publication of UNCOVER AF Study in Circulation Demonstrates Impact of Charge Density Mapping During AF Ablation

Acutus has been a Deerfield portfolio company since 2016.  

Farapulse PFA shown as potential alternative to existing ablation procedures

A method of non-thermal field ablation demonstrated safety and efficacy in clinical trials comparing outcomes of the modality to those seen with traditional thermal approaches in patients with paroxysmal atrial fibrillation, or episodic AFib.

The results of the first-in-human trial were reported in an online early version of the manuscript that is slated to publish in the Journal of the American College of Cardiology.

Called pulsed field ablation (PFA), the alternate modality was shown to successfully target heart tissue without damaging adjacent structures like the esophagus or phrenic nerve – a shortcoming of standard ablation therapies, including radiofrequency (via heat) and cryotherapy (by way of freezing).

In 81 patients, 100% of pulmonary veins (PV) were specifically isolated with three minutes of PFA time per patient. Furthermore, long-term remapping procedures demonstrated that the rates of durable PV isolation improved with successive waveform modifications with the most optimized PFA group demonstrating 100% durability.

The rate of primary safety events was low at 1.2%, and with no subsequent primary adverse events during follow-up.

Farapulse has been a Deerfield portfolio company since 2017.

V-Wave scores FDA breakthrough status on its heart failure shunt

V-Wave, Ltd., recently announced that it received the prized FDA Breakthrough Designation for its heart failure shunt. Breakthrough designation is one of the highly sought pre-approval stamps that the FDA can place on a device.

According to the FDA’s website, it is granted when the device “provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions” (than what is currently available). The program aims to provide patients and health care providers with more timely access to medical devices “by speeding up their development, assessment and review,” including prioritized review all the way through to market approval.

V-Wave’s minimally-invasive implanted interatrial shunt for the treatment of patients with severe symptomatic heart failure is designed to regulate left atrial pressure, the primary cause of breathing difficulty and hospitalization due to worsening heart failure.

“In addition to validation of the potential impact of this technology, breakthrough status will facilitate a timely regulatory review and solve a major issue with medical device investments, namely that reimbursement will effectively be secured immediately upon approval,” said Deerfielder, Andrew ElBardissi, MD, who serves on the Company’s board of directors.

The shunt is currently being evaluated in a global, randomized, controlled, double-blinded, 500 patient pivotal Investigational Device Exemption trial called RELIEVE-HF. The study is enrolling advanced heart failure patients with preserved or reduced left ventricular ejection fraction who

remain symptomatic despite the use of guideline directed medical and device therapies.

An ejection fraction is an important measurement of how well the heart is pumping and is used to help classify heart failure and guide treatment. In a healthy heart, the ejection fraction is 50 percent or higher – meaning that more than half of the blood that fills the ventricle is pumped out with each beat.

According to the Centers for Disease Control and Prevention, nearly 6 million adults in the United States have heart failure and about half of these individuals die within 5 years of diagnosis. Heart failure costs the nation an estimated $30.7 billion each year.

Achieving this status means that the device also met at least one of the following FDA criteria:

  1. It represents breakthrough technology;
  2. No approved or cleared alternatives exist;
  3. It offers significant advantages over existing approved or cleared alternatives; and
  4. Availability of this device is in the best interest of patients.

V-Wave, Ltd., a privately held medical device company, has been a Deerfield portfolio company since 2018.

Adapted from company news release: V-WAVE’S INTERATRIAL SHUNT RECEIVES FDA BREAKTHROUGH DEVICE DESIGNATION FOR HEART FAILURE:

https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program

https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142

https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_heart_failure.htm

Neochord

Neochord, Inc. is developing a minimally invasive device that replaces a procedure currently done with open heart surgery to reduce mitral regurgitation. Approximately 200 patients have been treated with this device in Europe (CE Mark achieved) and the company will initiate the US IDE study later this year.

Strata Oncology

In the 2nd quarter of 2018, Deerfield participated in a $26 million Series B financing round for Strata Oncology. The company provides an end-to-end clinical trial platform for precision oncology that expands patient access to precision oncology clinical trials and accelerates clinical trial enrollment.

The company expects to deploy this capital to expand access to precision trials in new hospital systems, fund the FDA approval process for in vitro diagnostics and further develop its technology and analytical capabilities.

InCarda Therapeutics

InCarda Therapeutics is developing a drug/device combination for in-hospital and outpatient treatment of acute atrial fibrillation. By using the pulmonary circulation to deliver drugs to the heart, lower doses and faster cardioversion are likely to occur compared to oral and intravenous therapies. The initial target market will be the in-hospital setting where most patients with atrial fibrillation currently require electrical cardioversion, an invasive and costly procedure.