The Bio Report

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 push in that direction with its SomaScan Discovery platform, which can read 5,000 protein measurements in the blood through a single assay. We spoke to Roy Smythe, CEO of SomaLogic, about the role proteins play in health and wellness, the way the company’s technology works, and the opportunity for it to help advance the area of precision medicine.

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 resistant fungal infections, the company’s experimental therapy ibrexafungerp, and why it may provide a new way of treating a range of serious fungal infections.

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 capsule uses ultra-low dose X-ray and wireless communication technologies to generate information on the contours of the inside of the colon as it passes through it. This creates a 3D map that allows physicians to look for polyps and other abnormalities. We spoke to Alex Ovadia, CEO of Check-Cap, about colorectal cancer, why people avoid being screened as they should, and how the company’s C-scan capsule-based system works.

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 range of diseases associated with aging. We spoke to John Dimos, CEO of Fountain, about the company’s AI platform, it’s approach to understanding aging at a cellular level, and how it provides new ways of discovering and developing therapeutics for diseases of aging.

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 better understand its role in health and disease. It is applying what it learns to avoid clinical trial failures, improve combinations of immunotherapies, and guiding future therapeutic development in cancer and a broad range of other conditions. We spoke to Danny Wells, scientific founder of Immunai, about the company’s efforts to map the immune system, the challenges in doing so, and how this has the potential to improve drug development.

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 system can play in improving flagging returns on investment in R&D by allowing regulatory departments to operate more efficiently, breakdown data silos within pharmaceutical companies that hamper performance, and allow companies to focus less on rote work and more on regulatory strategies.

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 reconceiving the biologic, Rani has reconceived the pill itself. The company has developed what it calls a “robotic” pill that carries the therapeutic to the gut where it injects the drug into the wall of the intestines. We spoke to Mir Imran, chairman and CEO Rani Therapeutics, about how the Rani Pill delivers biologics orally, the technology underlying it, and how the company thinks about the opportunities it will pursue.

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 form that allows them to be used as coatings that act like paint and can be applied to implants to promote growth and other benefits. We spoke to Alvarez, founder of Theradaptive, about his journey from the battlefield to the lab, how his company’s platform technology works, and the range of applications to which it may be applied.

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 its potential to prevent outbreaks. We spoke to Armand Balboni, CEO of Appili, about drug, how it works, and its potential to prevent outbreaks of COVID-19 in high-risk populations.

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 identify existing therapies that might be repurposed as treatments for COVID-19. We spoke to Alif Saleh, CEO of Scipher, about the collaboration, the approach Scipher is using to identify drug candidates, and how this might expand on the company’s business strategy.

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 ARDS. We spoke to Garcia about the company’s ARDS therapy, how it works, and why it’s a timely focus given the COVID-19 pandemic.

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 Phage Therapeutics believes it’s found a way to create phage therapies suited to treat patients with drug-resistant infections by building a bank of targeted and genomically-screened bacteriophage and testing individual patient’s bacterial colony against that to determine the appropriate phage to treat them. We spoke to Greg Merril, co-founder and CEO of Adaptive Phage Therapeutics, about the origins of the company, how its technology works, and the regulatory hurdles for producing customized therapies to treat individual patients.

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 research that is now being adopted by other rare disease organizations. He tells his story in his book “Chasing My Cure.” When the COVID-19 outbreak began, Fajgenbaum recognized that the deadliest aspect of the disease—a hyperactive immune response known as a cytokine storm—shared a common link with Castleman disease. He hoped that a researcher would apply his approach to finding a potential drug to repurpose to treat the virus and soon enlisted his own team to do so. We spoke to Fajgenbaum, assistant professor at the Perelman School of Medicine at the University of Pennsylvania and co-founder and executive director of the

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 the COVID-19 pandemic ahead of a piece he’s writing for the fall issue of the Journal of Commercial Biotechnology. Brown offers a few scenarios but believes it will take time for life to return to what it was like. We spoke to Brown about the path to vaccines and therapies, what it will take to move beyond the pandemic, and what we’re learning from this pandemic that will help prepare us for the next one.

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, reader, and eraser classes of epigenetic regulators to modulate gene expression in a highly selective manner. It believes its approach can be used to both induce cancer cell killing, as well as enhance anti-tumor immunity. We spoke to Jigar Raythatha, president and CEO of Constellation Pharmaceuticals, about epigenetics, the company’s approach to developing highly selective therapies that target gene regulators, and its programs in myelofibrosis and prostate cancer.

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, about the company’s platform technology, how it works, and it why it has the potential to change the cost and efficacy of immunotherapies.

One of the challenges to securing the participation of patients in clinical trials can be simple geography. Sanguine Biosciences is seeking to tear down that barrier to participation by using mobile technology to bring clinical trials to patients. The company recently partnered with Vir Biotechnology to complete a COVID-19 clinical study aimed at better understanding the biology of the disease by sending healthcare personnel to collect blood samples from patients at their homes. We spoke to Brain Neman, co-founder and CEO of Sanguine, about it use of digital health technologies, how the company works, and its recent collaboration with Vir Biotechnology for a COVID-19 study.

One of the challenges cell and gene therapies pose is how to control how much and when a desired protein is delivered. Obsidian Therapeutics has developed a platform that allows a small molecule drug to control with precision the timing and level of protein expression from these therapies. We spoke to Paul Wotton, CEO of Obsidian Therapeutics, about the company’s platform technology, how it works, and how it may improve the safety and efficacy of cell and gene therapies.

Patrick Soon-Shiong likes to talk about the “triangle offense,” the activation of a combination of macrophages, natural killer cells, and memory T-cells to battle cancer. He believes the same approach he has been working to train on cancer can be enlisted in the fight against COVID-19, the virus behind today’s global pandemic. We spoke to Soon-Shiong, chairman and CEO of NantKwest, about his approach to immunotherapy, what results he’s seen to date, and why he believes what he’s learned about harnessing the immune system in the fight against cancer can be applied to treating COVID-19.

The COVID-19 pandemic is threatening to stress healthcare systems throughout the world and it is making the development of a vaccine an important part of a strategy to arrest the virus. Though clinical trials for a vaccine are under way, creating a vaccine alone will not be enough. If those efforts are successful, there will be challenges ahead with manufacturing, distributing, and providing equitable access throughout the world. We spoke to Aurélia Nguyen, managing director for vaccines and sustainability for the The Global Alliance for Vaccines and Immunizations about the COVID-19 outbreak, how it may be playing out in different parts of the world, and what was learned from GAVI involvement in previous efforts to develop an ebola vaccine.