Special Report: Reinventing Biologic Drugs – Part 1

An interview with Brian Finrow, CEO Lumen Bioscience

by Mark Edwards

(Editor’s note: Here we begin a three-part series on how to reinvent biologic drugs to make them available for all, based on an interview with Lumen Bioscience CEO Brian Finrow by Algae Planet Executive Editor Mark Edwards.)

Lumen Bioscience co-founders Brian Finrow, (right) and Jim Roberts, set out to provide a set of affordable medical solutions to millions in need. Their target: currently untreated gut infections and associated inflammation that affect tens of millions annually. These ailments result in significant pain and medical costs as well as millions of premature deaths each year.

C. difficile colitis, Covid-19, and traveler’s diarrhea cause severe gut pain. Painful symptoms are often paired with multiple very expensive hospital stays. For too many people, gut infections reoccur, leading to a downward spiral that can end in death.

E. coli

Most people are familiar with traveler’s diarrhea, often caused by Enterovirulent E. coli (EEC) or Campylobacter. Either may cause diarrhea and other problems in the intestines. Foreign EEC bacteria multiply quickly in the gut and cause a wide range of symptoms including severe bloody diarrhea, nausea, vomiting, stomach cramping, and dehydration. Prolonged events may impose hemorrhagic colitis, hemolytic-uremic syndrome, and other serious gut problems. In developing countries, EEC infections result in death rates of 50%.

Modern medical biologics therapies have been developed, at great expense, for C. difficile colitis and other gut maladies. Biologics are antibody-like proteins, right, designed to chelate and neutralize specific bacterial pathogens. Once the proteins bind with the bacterial pathogens, the body recognizes them as inert and sluffs them off as a waste product.

Biologics are antibody-like proteins

Modern biological protein-based therapeutics are carefully grown and harvested in sterile cell culture. Unfortunately, biological proteins are far too costly for most patients, even in the US. Many people suffer and often die from gut infections every year with no affordable treatment options beyond repeated treatments with broad-spectrum antibiotics.

In our interview, Brian Finrow explained how Lumen Biosciences has designed and built a low-cost, high efficacy antibody-like protein development and manufacturing platform to treat and prevent stomach diseases. No other company in the world had found an affordable biologic solution for the extremely opportunistic threat vector they chose, gut bacteria.

Threat vector

Clostridium difficile bacteria infect and inflame the colon.

Clostridium difficile infection, C-Diff results from disruption of normal healthy bacteria in the colon. C-Diff onset typically occurs from a bacterial illness that requires antibiotic treatment or prophylactic antibiotic treatment prior to surgery. C-Diff can be transmitted from person to person by direct contact or spores. C-Diff often causes severe damage to the colon and may lead to painful disability and death.

C-Diff symptoms include severe watery diarrhea, possibly 10-15 times a day, extreme stomach cramping and pain, rapid heart rate, dehydration, fever and kidney failure. C-Diff attacks the gut as a germ, a bacterium, that causes severe diarrhea and colitis.

Even before Covid-19 appeared, colon inflammation created a cash drain on US hospitals of $7+ billion per year. The human toll and the total societal burden in the US are probably closer to $30 billion per year. Global impact is at least 10 times higher, especially in countries plagued by contaminated water.

Diarrheal diseases are the leading cause of death for children under five. C-Diff and cousin pathogens kill over 800,000 children each year. Diarrheal diseases kill more people than malaria, measles and AIDS combined.

Downward spiral

Highly diverse gut microbiome

The highly diverse gut microbiome consists of trillions of microbes, right, that are both helpful and potentially harmful. In a healthy gut, the microbes coexist peacefully and work symbiotically to break down food into nutrients and to sustain gut stability.

Microbes work together in a manner where both the human body and microbiota benefit. Some are pathogenic and promote disease. In a healthy body, pathogenic and symbiotic microbiota coexist without problems. A disturbance from infectious pathogens, food or water contaminants, or the use of bacteria-destroying antibiotics causes dysbiosis. Dysbiosis stops the normal interactions, disrupts the stable microbiome, and makes the body susceptible to disease.

C-Diff treatment typically uses broad spectrum antibiotics to kill the invading bacteria. Unfortunately, antibiotics are agnostic killers and wipe out both helpful and harmful pathogens. Even when treated with antibiotics, the infection often returns, which results in the downward health spiral (below). Reinfection costs may exceed $35,000 per occurrence, add considerably more hospital time, and increases the probability of death to 7%. Lumen’s medical biologics can stop the C-Diff infection downward spiral.

Downward health spiral

CDC research shows that about 1 in 6 patients who get C-Diff will suffer a reoccurrence in the subsequent 2-8 weeks. One in 11 people over age 65 diagnosed with C-Diff infection die within one month. Over 95% of people suffering from C-Diff today are forced to suffer the consequences because they cannot afford the extraordinary cost of modern biologic medicines.

“Currently, most people suffer from the C-Diff downward spiral because modern biologic medicines are neither available nor affordable. Lumen Bioscience has reinvented biologic medicines in a manner that is affordable and available to all people who are in need,” says Mr. Finrow.

—Reinventing Biologic Drugs: Part 2