LucasPye and IndyGeneUS AI Forge Partnership To Address Drug Development and the African Diaspora

Over the years, minority input in the clinical development of life-saving drugs has been lacking, particularly when it comes to clinical trial participation. That has led to disparities in the efficacy of medications when taken by minority populations. A new partnership between LucasPye BIO and startup IndyGeneUS AI aims to improve that participation.

The partnership pairs Philadelphia-based LucasPye, a contract drug manufacturing company, and IndyGeneUS AI, a genomics company that has developed the largest blockchain encrypted repository of indigenous and diasporic African clinical and multi-omics data. The collaboration vision between the two minority-founded and owned companies was shared during the Health Discovery #ForTheCulture roundtable hosted by BioBuzz.

Yusuf Henriques, founder, and chief executive officer of IndyGeneUS AI said he started the company initially to address the lack of minority inclusion in clinical trials.  Over the course of his career, which included a stint at the U.S. Food and Drug Administration, he saw clinical data for multiple pharmaceutical drug products that came before the regulatory agency for approval. While the drugs were for different disease indications, he said they all lacked participation from a diverse patient population – even for drugs that were primarily aimed at minority patient populations.

The majority of clinical trial participants in the western world are Caucasian males. And while many life-saving drugs have been developed with that formula, Henriques and Tia Lyles-Williams, founder and CEO of biomanufacturing company LucasPye, said those drugs are falling short in minority populations in the United States and particularly on the continent of Africa.  

“The lack of clinical diversity is the root of the problem we are trying to address,” Henriques said.

According to data provided by IndyGeneUS, roughly 3% of genetic data collected across the globe includes people of African descent, while at the same time, people with African ancestry make up approximately 20% of the global population. That 20% population includes some of the most genetically diverse people. A lack of including that diverse population in research limits the capabilities of precision medicine that are aimed at specific genetics, Henriques said.

In order to address this disparity, IndyGeneUS is using state-of-the-art next-generation sequencing technology to generate a whole-genome sequence database. The company’s blockchain technology, which could eventually lead to a type of compensation for participants through increasing the value of the networks, will include one million people from indigenous populations across the African diaspora.

The availability of diverse genetic data will allow for the discovery of novel biomarkers and new drug targets. It will also provide broader safety and efficacy in drug development, Henriques said.

“If you have populations that are not represented in studies, the factors and drivers of disease in those populations won’t be identified, then subsequently you can’t develop diagnostics, then subsequently to that, you can’t develop the therapeutics,” Dr. Bradford Wilson, Chief Scientific Officer of IndyGeneUS said.

Through the genomics project, Dr. Wilmot Allen, IndyGeneUS AI’s Chief Operations Officer, said they will be able to help people on the African continent live longer and safer lives.

“When Africa is stronger from a health perspective, the world is stronger,” Allen said.

Henriques and Lyles-Williams, who originally met as students at Howard University, noted the COVID-19 pandemic highlighted not only how the virus disproportionately impacted black and brown communities in the U.S. but also shone a light on the lack of inclusion in clinical trials. Over the past few years, there have been multiple recognitions of the failures of inclusivity within drug trials and several companies. In 2020, a New England Journal of Medicine report revealed that the racial and ethnic minority groups most negatively impacted by COVID-19 are also the least represented in clinical studies. 

As a result, multiple biopharma companies such as Pfizer, the co-developer of one of the authorized COVID-19 vaccines that have had a presence in Philadelphia, have pledged to increase minority participation in future trials. Pfizer made the pledge after conducting an internal clinical trials participant report that showed a gap of minority patients. Genentech, a subsidiary of pharma giant Roche, which has a presence in Philadelphia, also initiated studies in COVID-19 aimed specifically at minority populations while noting the past lack of clinical inclusion. Johnson & Johnson, among others, has also pledged to improve minority participation within clinical studies.

Lyles-Williams said the partnership between LucasPye and IndyGeneUS can ultimately improve health outcomes for people of African descent. Not only will more precise drugs be able to be developed to treat various diseases, in the long-run, she said the cost of treatment will be more economically affordable for the people of Africa.