The Bio Report

Zea Biosciences is not a typical contract manufacturing organization. The company uses plants to grow recombinant proteins for biologic therapies. To produce a consistent and predictable product, Zea uses a data-intensive approach and grows plants in clean rooms. The end result is a high-scalable platform that is cost-efficient. We spoke to Jim Wilson, CEO of Zea Biosciences, about the company’s a...

United Biomedical has long been in the business of producing animal vaccines, but in recent years it has turned its attention to developing vaccines for chronic human diseases including neurological diseases, diabetes, and other targets. More recently it has used its vaccine platform to develop a multitope peptide COVID-19 vaccine and spun it out into a division dubbed COVAXX. We spoke to COVAXX c...

CAR-T therapies are an area of great promise for improving outcomes for cancer patients, but the process of preparing cells taken from a patient and genetically modifying them is time consuming and costly. Exuma Biotech believes it can address the cost and time involved in the preparation of these products with its rapid, point-of-care platform technology. We spoke to Greg Frost, chairman and CEO...

The administration of biologics can be challenging because of the sheer volume of product needed to deliver a dose to a patient. It is for this reason that many of these therapies must be infused into a patient, a process that is disruptive, costly, and can take several hours. Halozyme’s Enhanze drug delivery technology has been used by a number of biologics producers to take a therapy that would...

NASH, a form of fatty liver disease, causes progressive damage and can lead to inflammation, fibrosis, and the development of cancer. It has become an increasing health concern as the Western diet has spread throughout the globe. Today it is estimated that as much as 5 percent of the world’s population has NASH with a greater percent of people with the condition in the United States. There is no s...

The complexity of neurodegenerative diseases has made it a challenging area for drug developers. Gene Kinney, CEO of Prothena, has long been involved in the pursuit of therapies for diseases such as Alzheimer’s and believes there has been great progress in understanding and targeting these conditions. In fact, he says we are entering a golden age of neuroscience. We spoke to Kinney about the state...

The U.S. Food and Drug Administration delivered a blow to Pharnext in 2019 when it told the company it should conduct an additional late-stage study of its experimental therapy for the rare neurological condition Charcot-Marie Tooth disease. A manufacturing problem that affected the dose delivered to some patients invalidated one the arms of its study. The company uses artificial intelligence and...

MindMotion GO is a first-of-its-kind mobile neurorehabilitation therapy system that helps people regain motor and task functions through a gamified approach. While the game playing aspects of the technology may help engage patients in activities designed to help them recover from brain injury, the technology is validated by clinical studies and has won regulatory clearance. It should not be confus...

People with the rare and fatal genetic disease spinal muscular atrophy in recent years have seen the approval of an antisense therapy as well as a gene therapy. Genentech has now won U.S. Food and Drug Administration approval for Evrysdi, the first oral, at-home treatment for the condition. We spoke to Levi Garraway, chief medical officer and head of global product development at Genentech, about...

While the revolution in genomics has led to rapid improvements in the cost and speed of sequencing and created new insights into the genetic drivers of health and wellness, proteomics has lagged behind. Being able to capture a comprehensive view of the changing level of proteins in an individual could play a significant role in bringing about an era of precision medicine. SomaLogic is providing a...

The problem of drug resistance isn’t limited to bacteria. It is also a growing concern with fungal species that is causing an increasing need for new agents to combat these microbes. Scynexis is developing the experimental therapy ibrexafungerp, the first of a new class of therapies for serious fungal infections. We spoke to Marco Taglietti, president and CEO of Scynexis, about the problem of drug...

Colorectal cancer is the third most common form of the cancer. While screening is an effective means of preventing it, many people fail to get a colonoscopy because of the invasive nature of the procedure and the preparation and sedation that goes with it. Check-Cap is a clinical-stage company developing C-Scan, the first capsule-based system for preparation-free, colorectal cancer screening. The...

To see the affects of aging all you have to do is look in a mirror and watch the changes over time. Fountain Therapeutics is training its artificial intelligence platform to look at individual cells to detect changes that occur as cells get older and discover therapeutics that target underlying mechanisms of aging. The company believes this will provide new ways to target therapies to treat a rang...

The emergence of immunotherapies has represented a powerful addition to the cancer arsenal, but frequently they fail to deliver benefits to patients. Understanding what therapies will benefit which patients remains a challenge because of the complexity of the immune system. Immunai is applying artificial intelligence to map the immune system and understand its complexities at a granular level to b...

Artificial intelligence is working its way into all aspects of pharmaceutical companies’ operations. While much attention has been given to the role these systems can play in drug discovery, IQVIA sees a significant opportunity to use them to transform the area of regulatory compliance. We spoke to Ronan Brown, senior vice president and head of IQVIA Integrated Global Compliance, about the role AI...

Delivering biologics orally rather than through injection has been an intriguing goal but has proven difficult. Most efforts have focused on finding ways to turn these large protein molecules into formulations where they would not breakdown in the along the digestive tract before they can be absorbed and provide a therapeutic benefit. Rani Therapeutics has taken an unusual tact. Rather than reconc...

Luis Alvarez, a West Point graduate who earned a Ph. D. in bioengineering from MIT, served 20 years in the military including time as an intelligence officer in Iraq. He saw injured soldiers who doctors were able to save, only to later have their limbs amputated because of the inability for injuries to heal properly. The experience led him to develop a means of turning recombinant proteins into a...

Last month, Canadian regulators provided clearance for Appili Therapeutics to begin a phase 2 study of an approved antiviral therapy as a potential preventative treatment against COVID-19 outbreaks. The study will enroll 760 participants who are in long-term care facilities in Ontario. Though others are looking at the drug as a possible treatment for COVID-19, this is the first study to consider i...

The urgency to find treatments for the COVID-19 virus has allowed researchers to set aside institutional bureaucracy and companies to apply their technologies in new ways. One example of this is Scipher Medicine’s collaboration with Northeastern University’s Barabasi Labs, Harvard Medical School, and Network Science Institute. The company is using its artificial intelligence platform to help ident...

As a researcher, Joe Garcia applied functional genomics to understanding genes that contribute to inflammatory disorders such as acute respiratory distress syndrome, or ARDS. As founder and CEO of the biotech company Aqualung Therapeutics, he’s working to advance therapies to hit these novel targets to treat uncheck inflammation with the company’s lead experimental therapeutic candidate targeting...

Bacteriophages have long been used to treat infections. These naturally occurring virus are capable of killing bacteria, but each strain of phage is highly specific. Because of their unique mechanism of action, they provide a potential to address the growing threat posed by multidrug-resistant bacteria, but to treat someone, the right phage must be matched to each patient’s infection. Adaptive Pha...

As a medical student, David Fajgenbaum nearly died from Castleman disease, a rare autoimmune condition. He would suffer recurring bouts that carried him to the brink of death but was able to push the disease into remission by discovering a drug that could be repurposed to treat the disease. Fajgenbaum co-founded the Castleman Disease Collaborative Network and developed a unique approach to researc...

As some jurisdictions move to lift shelter in place orders and seek to restore economic life to normal, there’s growing concerns about the health consequences of moving too fast and the failure to make decisions without adequate testing to guide the process. Fred Brown, president and chief operating officer of the big data health consulting firm Fred Brown Management Consulting, discussed beating...

Targeting the epigenome—the regulators that turn on and off the activity of genes—has long been viewed as a promising way to treat cancer. But despite the promise of this approach, early efforts brought few successes in part because of the broad effects of hitting these targets. Constellation Pharmaceuticals is taking a next-generation approach to epigenetics, targeting what it calls the writer, r...

Acepodia has developed platform technology that allows it to chemically modify or conjugate living cell surfaces. The technology can be applied to any immune cell and any antibody or binding protein, without the use of genetic engineering. The company is working to apply the technology to create a family of cost-effective, off-the-shelf immunotherapies. We spoke to Sonny Hsiao, CEO of Acepodia, ab...