The Bio Report

Early detection is a critical means of improving outcomes for cancer patients. When cancer is detected at stage I, patients have a 90 percent chance of survival. By contrast, if cancer is diagnosed at stage IV, patients have just a 5 percent or survival. The use of costly and invasive diagnostic approaches have been a barrier to early detection, but new technology has the potential to change that. Laboratory for Advanced Medicine is developing a simple blood-based test to detect cancer at its earliest stage. We spoke to Ken Chahine, CEO of Laboratory for Advanced Medicine, about the company’s blood-based test, how it works, and how it is prioritizing indications.

As the debate over drug pricing intensifies, biotech investor Peter Kolchinsky is weighing in with a proposed approach to balance access to medicines with the incentive for companies to invest in the development of innovative new therapies. In his new book The Great American Drug Deal, Kolchinsky makes the case for an approach to drug pricing that would ensure that the timely movement of innovative drugs to generic versions while also suggesting mechanisms for cutting the price of therapeutics after patents and exclusivity periods expire when competition fails to arise. We spoke to Kolchinsky about The Great American Drug Deal, his notion of a biotech social contract, and why it’s critical that the industry think differently than it has in the past about approaches to reform drug pricing.

There is growing scientific evidence suggesting that Alzheimer’s disease may be an autoimmune condition. Whether it is or not may be an unsettled issue, but targeting neuroinflammation associated with the disease is viewed by some as a potential therapeutic strategy. INmune Bio is developing an experimental, second-generation, selective TNF inhibitor that targets neuroinflammation. It believes this approach can slow or stop the progression of cognitive and psychiatric symptoms associated with the disease. We spoke to R.J. Tesi, CEO of INmune Bio, about whether Alzheimer’s disease is an autoimmune condition, the role of neuroinflammation in the progress of the disease, and how his company’s experimental therapy differs from existing TNF inhibitors today.

The Gloucester Marine Genomics Institute is seeking to harness biotechnology to discover new therapeutics by studying the DNA of marine life. At the same time, the institute hopes to breathe new life into a 400-year old fishing village that houses it and create new opportunities there. We spoke to Andrea Bodnar, science director at the Gloucester Marine Genomics Institute, about marine biotechnology, the ocean as a source for novel therapeutics, and the institute’s efforts to transform the economy along Cape Ann.

The latest reports on the coronavirus outbreak put the number of infections at nearly 75,000 and deaths at more than 2,100. Against the backdrop of the outbreak, we spoke to Evan Loh, chairman of the Antimicrobials Working Group and CEO of Paratek Pharmaceuticals, about the global changes that are fueling the threat of infectious disease outbreaks, the state of the antimicrobial arsenal, and what needs to be done to spur the development of new agents to combat the rise deadly bugs.

Orchestra BioMed may play at the intersection of drugs and devices, but’s its business strategy is clearly drawn from the biopharmaceutical industry. The company develops its pipeline and then leverages strategic alliances with global partners who can best commercialize its products and maximize their potential. We spoke to David Hochman, CEO of Orchestra BioMed, about the company’s therapeutic devices, the large market opportunities it is targeting, and how it seeks to rewrite the way medtech companies think about partnering.

Psychedelics have long been viewed as having potential to treat a range of mental health disorders including depression, addiction, PTSD, and ADHD. Government policies, though, have long impeded studies of their benefits. Mind Medicine is developing a pipeline of therapies based on psychedelics in the hopes of developing needed medicines for psychiatric conditions. Its lead experimental therapy is an ibogaine-derived molecule for the treatment of opioid addiction. We spoke to Steve Hurst, founder and CEO of MindMed, about the potential for psychedelic-based medicines, what’s known about them to date, and the challenges of working with these substances.

The difficulty in diagnosing Alzheimer’s disease and identifying it at its earliest stages when interventions offer the best opportunity for success, is one of the critical challenges in addressing the neurodegenerative condition. CorTechs Labs has developed quantitative analysis software that allows physicians to analyze brain images to diagnose and monitor patients with the diseases. We spoke to Chris Airriess, CEO of CorTechs, about the difficulty in diagnosing Alzheimer’s disease today, how its technology works, and its efforts to marry its software to genetic data as a way to identify and monitor people who may be at risk of developing the disease.

As people age, the ability of their eyes to focus on objects near to them weakens. The condition, known as presbyopia, affects more than 1.8 billion people worldwide. Though reading glasses provide a solution to the problem, Orasis Pharmaceuticals is developing a corrective eyedrop it says will provide an alternative. We spoke to Elad Kedar, CEO of Orasis, about aging eyes, its experimental eye drop intended to allow people to free themselves from a dependency on reading glasses, and how it works.

Ben Zeskind likens Immuneering’s platform technology to noise-cancelling headphones. Infact, the company’s use of the term “Disease Cancelling Technology” speaks directly to that. The approach, he says, allows the company to build a pipeline of drug candidate that address aspects of disease that have eluded tradition drug development approaches. We spoke Zeskind, CEO of Immuneering, about the company’s evolution from its roots in bioinformatics, its movement into drug development, and how its proprietary platform technology works.

One reason immunotherapies fail is because of the ability to tumors to alter the microenvironment in which they exist and hide themselves from detection by the immune system. In some indications, as few as 20 percent of patients benefit from checkpoint inhibitors. Oncolytics Biotech is developing pelareorep, an immune-oncolytic virus that activates the innate and adaptive immune systems, triggering inflammation in the tumor, and overexpressing checkpoints to increase the number of patients that can benefit from the use of checkpoint inhibitors. We spoke to Matt Coffey, president and CEO of Oncolytics Biotech, about Pelareorep, how it works to treat cancer, and why it can make checkpoint inhibitors more effective.

The brain converts short-term memories into long-term memories through the formation and stabilization of new connections between neurons. Tetra Therapeutics is working to treat cognitive impairment and memory loss from Alzheimer’s disease by developing an experimental therapy intended to stabilize these connections. We spoke to Mark Gurney, CEO of Tetra Therapeutics, about memory loss in Alzheimer’s disease, the company’s experimental therapy to treat the condition, and a recent study he was involved in that suggest TNF inhibitors may provide protection against the condition in patients with autoimmune conditions.

A holiday tradition at The Bio Report is to take a moment to reflect on the year past and look ahead to the new year with Adam Feuerstein, senior writer and national biotech columnist for STAT. We talked to Feuerstein about some of the highs and lows of the year in biotech, a few of the big stories he followed, and the big fourth quarter for biotech stocks. Feuerstein offers us a look at the best and worst CEO of 2019, the upcoming JPMorgan conference, and what to watch in 2020. Last week we released an additional episode of the podcast that featured the Himalayan Cataract Project (https://soundcloud.com/levine-media-group/an-effort-to-eradicate-preventable-blindness), which is working to eradicate preventable blindness throughout the world. There are 18 million people in the developing world who are unable to perform the tasks of daily living because of easily treatable cataracts that can be addressed with a fast and inexpensive procedure. We’re helping raise $100,000 through a GoFundMe Campaign (https://ga

We spend a lot of time on The Bio Report talking about innovation. We are living at a time of great scientific advances that are translating into remarkable therapies that are changing people’s lives. Sometimes, though, the type of innovation needed to address a global health problem has more to do with access and delivery than technology. This was brought home to me when my friend Menghis Bairu, an Eritrean-born physician, life sciences executive, and philanthropist, returned from a recent trip. Menghis had gone to Ethiopia and Eritrea, where he worked with the Himalayan Cataract Project. HCP is working to eradicate curable blindness. There are some 18 million people in the developing world who are unable to perform the tasks of daily living because of easily treatable cataracts that can be addressed with a fast and inexpensive procedure. During a one-week period in these countries, the organization performed nearly 4,500 sight-saving surgeries and provided training to doctors in there. We spoke to Mat

Inhaled insulin has been one of those biotech ideas that have seemed better on paper than in practice. Huge investments have been made to carry these products through challenging development only to end in market flops. Aerami Therapeutics, a company founded by one of the pioneers in the field, is advancing its version of inhaled insulin and building a pipeline of other inhaled biologics behind it We spoke to Anne Whitaker, CEO of Aerami, about its pursuit of inhaled insulin, why she believes the company will be able to avoid the pitfalls others have faced, and the case for delivering insulin and other biologics through the lung with its technology.

In August, Nabriva Therapeutics won U.S. Food and Drug Administration approval for Xenleta for the treatment of community-acquired bacterial pneumonia in adults. It was the first new antibiotic with a novel mechanism of action approved by the FDA in nearly two decades for the condition. We spoke to Ted Schroeder, CEO of Nabriva about Xenleta’s unique mechanism of action, why it may be less prone to the development of resistance, and why policymakers still need to take additional steps to spur development of novel antibiotics.

Healthcare decisions are often flawed because of the limited information on which they are based. But with the growing ability to capture massive amounts of data digitally and apply artificial intelligence to its analysis, there is a growing potential to gain better insights into healthcare and improve patient outcomes. Komodo Health has an ambitious plan to do that with its AI-drive platform that captures 15 million patient encounters with the healthcare system daily to provide a real-time picture of patients and their various encounters. We spoke to Aswin Chandrakantan, chief medical officer and senior vice president of corporate development at Komodo Health, about the changing data landscape, how Big Data has the potential to reshape healthcare decision-making, and what it is enabling everyone from patient groups to payers to do differently.

In the United States, more than 100,000 people are on a transplant waiting list and many other simply do not qualify. In 2009, 25 people per day died while on the waiting list. Transplant procedures are costly and require lifelong use of immunotherapies. BioLife4D is seeking to disrupt organ transplantation with the development of bioprinted hearts produced using a patient’s own cells. The technology also has the potential to have an impact in other areas, such as drug discovery and development. We spoke to Steve Morris, founder and CEO of BioLife4D, about its effort to bioprint a transplantable human heart, a recent milestone it achieved to produce a mini-heart, and the range of challenges it must overcome to make its vision a commercial success.

Sermo describes itself as a “virtual doctors’ lounge” where physicians can express their opinions and interact with other doctors. One of the newer features on the physician-only social network is the ability to crowdsource solutions for difficult cases. We spoke to Erin Fitzgerald, senior vice president of marketing at Sermo, about the social networking platform, how it’s used to solve hard-to-crack cases, and the business model underlying the free service for physicians.

Essential tremors, uncontrollable shaking of the hands, arms, and other parts of the body, have been traditionally treated through drugs or surgery. Cala Health is providing a new option to patients with its wristwatch-like neuromodulation device that uses electrical pulses to stimulate peripheral nerves to treat the condition. We spoke to Renee Ryan, CEO of Cala Health, about the company’s Cala Trio device, the potential for bioelectric medicine to treat a broader range of neurologic, psychiatric, and cardiologic indications; and what it will take to get payers and providers to embrace the technology.