Florida is currently home to the nation’s second-largest medical device manufacturing industry, second-largest pharmaceuticals manufacturing industry, and the fourth-largest biotech R&D industry, making it a large life sciences hub within the U.S. So, in this article, with more than 2,300 establishments operating within the Florida life sciences industry as a whole, we take a look at five companies helping to drive the state’s biotech scene.
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AIM ImmunoTech is focused on researching and developing therapies to treat multiple types of cancers, immune disorders, and viral diseases. The company’s lead product is a first-in-class investigational drug called Ampligen, which is a double-stranded RNA (dsRNA) and highly selective TLR3 agonist immuno-modulator with broad spectrum activity.
Ampligen is currently being used to treat pancreatic cancer patients in an Early Access Program (EAP) approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center, and AIM has commenced a phase 2 clinical study in locally advanced pancreatic cancer. It was also announced on January 10 that enrollment is now open at Erasmus Medical Center in a phase 1b/2 clinical trial combining Ampligen with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi for the treatment of metastatic pancreatic ductal adenocarcinoma.
Furthermore, Ampligen is approved in Argentina for the treatment of severe chronic fatigue syndrome (CFS), and is currently being evaluated in many aspects of COVID-19 myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and post-COVID conditions.
ImmunityBio is developing next-generation therapies and vaccines that work by bolstering the natural immune system to defeat both cancers and infectious diseases. The company’s range of immunotherapy and cell therapy platforms are intended to drive and sustain an immune response with the goal of creating durable and safe protection against disease.
N-803 (Anktiva) is the company’s lead drug candidate. It is an interleukin-15 superagonist fusion protein that is designed to induce expansion of native NK and CD8+ T-cells without concurrent stimulation of T-regulatory cells. The cytokine interleukin-15 plays a crucial role in the immune system by affecting the development, maintenance, and function of the natural killer (NK) and T cells.
On January 2, the Florida biotech company announced that it had received up to $320 million in royalty financing and equity investment from Oberland Capital. This has provided ImmunityBio with significant financial resources to accelerate its commercialization efforts in anticipation of a potential regulatory approval, as well as to expand its pipeline within the broader urological cancer space. The proceeds will also be used to fund ongoing business operations and clinical trials expanding N-803 indications into multiple solid tumors.
Based in Miami, Florida, Longeveron is a biotech company specializing in the development of cellular therapies for life-threatening and chronic aging-related conditions. The company believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult diseases and conditions associated with aging.
Longeveron’s lead investigational candidate is called Lomecel-B, which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from the bone marrow of young healthy adult donors. The company is currently conducting phase 1 and 2 trials for aging frailty, Alzheimer’s disease, metabolic syndrome, acute respiratory distress syndrome (ARDS), and hypoplastic left heart syndrome (HLHS).
In December 2023, the company announced additional positive clinical data and imaging biomarker results from its phase 2a trial of Lomecel-B in the treatment of mild Alzheimer’s disease. Shortly after, the company also announced that it had closed a $2.36 million registered direct offering.
Focused on developing novel medications targeting cellular motor proteins – which are specialized molecular machines that convert energy into mechanical work inside cells – Myosin Therapeutics’ mission is to address critical unmet medical needs through the development of myosin-targeted therapies that go beyond symptom relief to directly target the root causes of diseases. Currently, its main focus is on developing therapies for central nervous system (CNS) and oncology indications.
One of Myosin’s lead compounds, MT-125, is for the treatment of glioblastoma. In early models, MT-125 has shown that it can simultaneously arrest cancer cell division and migration, and therefore could be a first-in-class therapy. Meanwhile, its other lead compound, MT-110, is for stimulant use disorders, such as meth use disorder and cocaine use disorder.
Last year, the Florida biotech announced that it had supplemented its National Institutes of Health (NIH) funding with a seed funding round to advance the company’s lead programs on glioblastoma and stimulant use disorder. Myosin said that the funding should allow it to reach IND filing for MT-125, as well as advance MT-110 through phase 1 clinical trials.
Psilera believes that nature holds the keys to the future of mental health therapy, as it focuses on combining compounds that already exist in nature with the latest AI screening technology to tailor-make patient-centric neurological therapies.
The company specifically intends to make non-hallucinogenic medications. This is because it believes that by removing the hallucinogenic properties of drugs like LSD, MDMA, and psilocybin (more commonly known as magic mushrooms), it hopes to also remove unpleasant side effects and create more approachable versions of psychedelic neurotherapeutic drugs.
In May 2023, Psilera announced that it had selected its lead clinical candidate, called PSIL-006. The drug was derived from Psilera’s in-house discovery pipeline and has similar characteristics to psilocybin but lacks the hallucinogenic effects. When compared directly in preclinical in vivo studies, PSIL-006 was able to induce rapid and positive behavioral changes representative of alcohol use disorder (AUD), anxiety, depression, and cognitive disorders similar to psilacetin – a psilocybin mimic.
Florida’s biotech scene: A hub of innovation showcasing leading companies
Not only is Florida a leading life sciences hub in itself, but it also has a number of specific hubs within the state, such as Alachua and Jupiter. In fact, at the height of the COVID-19 pandemic in 2020, Alachua’s biotechnology industry contributed more than $1 billion to the local economy, aided by the University of Florida’s business incubator program, which helps drive innovation in the state. Additionally, Momentum Labs was set up in Alachua, specifically providing biotech companies with lab space, business resources, and capital to advance their technologies.
For this reason, many biotech startups are beginning to be set up in Florida. And, although the innovation in the state does not quite yet match up to other major U.S. hubs – such as San Diego, San Francisco, Boston, North Carolina, or New York – several companies do appear to be succeeding in advancing their clinical candidates, as can be seen from the list in this article.