CHICAGO – A group of Black-owned biotechnology startups has come together with ambitious plans to sequence African genomes, create a secure data repository for research, make drug development more inclusive, and ultimately, provide compensation to the descendants of Henrietta Lacks.
HelaPlex, a nascent firm planning a coworking space and business accelerator in Philadelphia for life sciences startups and virtual biotech companies, has pledged to invest $30 million in a molecular laboratory for another fledgling company, IndyGeneUS AI, which produces and applies artificial intelligence to genomic data.
Together, HelaPlex and IndyGeneUS — pronounced "indigenous" — expect to sequence thousands of genomes in Africa and in the African diaspora to build a genomic repository they hope will lead to pharmaceuticals and biologics that are less Eurocentric than current offerings. The firms said they expect to pass along a percentage of revenue generated from such drugs to patients who consent to sequencing.
The partners have pledged not only to refrain from using, manufacturing, and selling HeLa cells, but they said that they want to help the Lacks family receive compensation from the patenting and future use of the HeLa line, noting in a statement that they want to "prevent the exploitation of the genetic data that is naturally owned by Africans and people within the African diaspora."
According to HelaPlex founder and CEO Tia Lyles-Williams, "We're arming [the Lacks family] so they can protect themselves and actually be able to generate a little bit of revenue with their participation in the research project that IndyGeneUS is working on."
HelaPlex and IndyGeneUS announced their partnership at a private event in Washington, D.C., in September that was publicly broadcast online Oct. 5, a day after the Lacks family sued Thermo Fisher Scientific over that company's production and marketing of HeLa cells.
"I was really concerned and worried about — now that African genome and the minority genome seems to be the most missing link in order to help move medicine ahead — that [the Black community gets] exploited again," said IndyGeneUS founder and CEO Yusuf Henriques.
Included in the collaboration is LucasPye Bio, a biotherapeutics contract development and manufacturing organization, or CDMO, owned by Lyles-Williams.
The $30 million investment will help IndyGeneUS AI build a 50,000-square-foot lab and purchase at least 12 Illumina NovaSeq 6000 sequencers and at least four Berkeley Lights Beacon optofluidic instruments. IndyGeneUS also plans on building a cloud-based genomic repository for the sequences, encrypted and secured with blockchain technology.
HelaPlex is backed by venture capital, though Lyles-Williams said that she is not ready to disclose the names of the company's investors. She said there may be a crowdfunding effort for both HelaPlex and IndyGeneUS in the future.
Initially, IndyGeneUS plans to create a proprietary genetic repository that maps out the human genome for people of African descent. Sequences will be deidentified and samples collected from patients will not be shared or reused, according to Henriques.
Lyles-Williams said that HelaPlex differs from companies such as BioLabs and LabCentral in that her firm will provide maker space for small-scale manufacturing of drugs, medical devices, and artificial tissue. "[Members] get dedicated project managers, dedicated mentors, and access to investors," she explained.
The HelaPlex program will include education for both entrepreneurs and potential investors. "The investors are taught on how to invest and how to make sure that the asset is viable in life sciences, and companies are taught the commercialization process and how much money and at what point in the commercialization of the clinical development timeline they will need those funds," Lyles-Williams said.
IndyGeneUS hopes to develop drug prototypes at the HelaPlex lab, then run animal and human clinical trials. "Once they get their permission to test in human clinical trials, that asset transfers to my other company, LucasPye Bio," Lyles-Williams said.
"What we've done here … is built a full ecosystem for us to discover drug products that are more favorable to people that are African or of African descent, as well as having a place for them to go to actually be manufactured and taken to the commercial market," she added.
HelaPlex, LucasPye Bio, and IndyGeneUS are boldly forecasting that the repository and early R&D work will allow them to land US government contracts worth $1 billion and to generate $500 million in annual revenues by year three. That projection, of course, is dependent upon the partners finding biomarkers or drug targets, then having successful clinical trials.
Fighting disparities
Henriques is a former US Army Special Forces medic and US Food and Drug Administration official who reviewed postmarket adverse drug reactions.
Lyles-Williams and Henriques met as undergraduates at Howard University more than two decades ago in an introductory genetics class. They followed different career paths, with Lyles-Williams getting involved in biotech research and Henriques first going to the military, then to the FDA, eventually working directly for Janet Woodcock, who was director of the Center for Drug Evaluation and Research and now is acting FDA commissioner.
Henriques later became an entrepreneur, founding, among other companies, TruGenomix — now called Polaris Genomics — which commercialized personalized treatments for post-traumatic stress disorder. The PTSD treatments emerged from work Henriques performed while a health researcher at the US Department of Veterans Affairs in New York.
While TruGenomix went through the Illumina Accelerator program in 2018, Henriques developed a 755-gene panel to test for signs of PTSD. He said that the VA is now considering that panel to help identify veterans at risk for PTSD, anxiety, depression, and bipolar disorder.
When the COVID-19 pandemic emerged in early 2020, Henriques noticed an exacerbation of health disparities between white and Black populations. It was then that the Massachusetts Institute of Technology approached him to create a "hackathon" to address racism in healthcare. The second annual Engineering Health Equity Hackathon will take place next month.
It was at the 2020 event that Henriques decided to launch IndyGeneUS AI to focus on health disparities among the African diaspora, and also reconnected with his former classmate, Lyles-Williams.
"When I was doing the hackathon, it was quite clear that the health disparities that African-Americans are facing are the same ones that Africans on the continent are," Henriques said. "It just made better sense for us to make this a global initiative."
Henriques said that IndyGeneUS has established a subsidiary in Kenya, which has collected and is sequencing about 18,000 samples from Black people with HIV. He suggested that the dataset that emerges from this effort would be "beneficial to a pharma company like Moderna," which has begun a trial of an mRNA-based vaccine for HIV.
Because so much of Africa lacks both sequencing and drug development capacity, IndyGeneUS and LucasPye Bio are looking to build CDMO facilities in South Africa and in an undetermined East African country. IndyGeneUS has also committed to upgrading a lab at the KAVI Institute of Clinical Research at the University of Nairobi; KAVI stands for Kenya AIDS Vaccine Initiative.
Jamaica native Henriques acknowledged the presence of Nigeria-based health technology company 54gene, but said that one company in Nigeria is insufficient to serve the precision medicine needs of a continent of nearly 1.4 billion people. "I think it's time for Africa to start building out their own supply of talent" in biotech, he said.
"The infrastructure needs to be built and that's what Tia and myself are doing is to … create the awareness both here in the US and in Africa for us to make that movement happen," Henriques said.
Standing in the way of progress in Africa is the lack of any real pharmaceutical regulatory framework in countries across the continent, according to Lyles-Williams, allowing a black market in drugs of questionable quality to thrive.
"We need to get that cleaned up so that the patients that need the medicine are getting accurate, sure standards of care," Lyles-Williams said.
At the event broadcast last week, IndyGeneUS, HelaPlex, and additional partners including AfricanAncestry.com launched a website called byusforall.com to support health equity and technological innovation by collecting data from Black, Indigenous, and people of color communities to diversify drug discovery. IndyGeneUS AI also announced the founding of a sister company called IndyGeneUS Health dedicated to fighting racial health disparities on multiple fronts.