The trial, known as ADO2, will utilize OmniScience's recently developed product, Vivo, which uses generative AI to centralize and analyze clinical trial data in real time. Photo omniscience.bio

Houston data science firm OmniScience announced this month that it has partnered with Florida-based INmune Bio (NASDAQ: INMB) on a global Phase 2 Alzheimer’s disease clinical trial.

The trial, known as ADO2, will utilize OmniScience's recently developed product, Vivo, which uses generative AI to centralize and analyze clinical trial data in real time, according to a release. The two companies also partnered during Vivo’s development and recent roll-out.

"OmniScience and INmune Bio share a vision to transform how clinical trial teams engage with data – transforming data into knowledge in real time and informing decisions that increase the probability of success,” Angela Holmes, CEO of OmniScience, says in a statement. “As our partnership moves forward, we’re gaining further insights from the INmune team that we can integrate into Vivo’s roadmap. We look forward to our continued mutual success.”

The ADO2 trial will investigate INmune Bio's clinical-stage biotechnology XPro in patients with mild cognitive impairment or Alzheimer’s disease with brain inflammation, according to its website. Its products are focused on "restoring function in the body's innate immune system to fight disease."

The trial is overenrolled with 208 patients diagnosed with mild Alzheimer’s disease or mild cognitive impairment. The top-line results are expected to be released in Q2 2025.

"A global trial of this size is vast, and Vivo will be critical in our ability to analyze cognitive results,” Tara Lehner, INmune Bio’s vice president of clinical operations, says in the statement. “With genAI provided by Vivo, we can amplify our clinical teams’ capabilities, turning complex data into actionable insights at unprecedented speed, which means we can get answers—and treatments—to patients faster.”

INmune will be able to use OmniScience's Vivo product to unify data from electronic data capture, clinical trial management systems, patient-reported outcomes, clinical outcome assessments, labs, wearables, safety databases and more, according to the statement. The product has been shown to improve data quality and visualizations and reduce the reliance on spreadsheet-based data analysis during clinical trials.

Omniscience was originally founded in 2017, then known as Mercury Data Science. It rebranded and changed its name earlier this year. Holmes was named CEO in 2022.

Omniscience's Vivo product recently won first place in the CNS Summit 2024 Innovation Showcase in Boston and the Blue Whale Ribbon at the inaugural Whale Tank pitch competition during the 2024 Innovation Network Gathering (ING) in West Chester, Pennsylvania.

Coya Therapeutics is looking into how a trendy weight loss drug could complement its Alzheimer’s disease treatment. Photo via Getty Images

Houston therapeutics innovator looks into GLP-1 drugs for Alzheimer’s treatment

drug discovery

Glucagon-like peptide 1, or GLP-1, agonists are all the rage right now thanks to drugs like Ozempic and Wegovy. Though they’re currently being prescribed for diabetes and weight loss, a Houston company reports that it may have found another use for GLP-1s.

Coya Therapeutics, a publicly traded clinical-stage biotechnology company, has filed intellectual property protection for a combination of its proprietary COYA 301 and GLP-1. Coya’s team believes that combining COYA 301, a low-dose interleukin-2 (IL-2) intended to enhance the anti-inflammatory function of regulatory T cells (Tregs), with GLP-1 could be a game-changer in the fight against Alzheimer’s disease.

How does GLP-1 amplify the positive results already noted for COYA 301? The company will soon release phase 2 data for IL-2 in patients with Alzheimer's. Through distinct mechanisms, the pair of drugs could synergistically combat inflammation. That means that neurodegenerative maladies such as Alzheimer’s are just the beginning. The drug combination could also fight autoimmune and metabolic conditions. This isn’t the first combination therapy for Coya — Coya 302 is a pairing of LD IL-2 and CTLA-4 Ig that has also racked up some success in human trials.

According to Coya’s CEO, Howard Berman, “We believe that combination immunotherapy approaches will evolve to play a meaningful role in treating complex immune-based diseases that are driven by a host of pathophysiologic mechanisms.”

He goes on to add that the company has already had success with targeting “multiple, independent, and non-overlapping immune pathways simultaneously” with COYA 302, a combination of COYA 301 and CTLA-4 Ig, commercially known as Abatacept. That pairing is currently being evaluated in numerous neurodegenerative disease models, such as Amyotrophic Lateral Sclerosis (ALS), Alzheimer’s, and Parkinson’s diseases.

“We will continue to expand our portfolio with additional synergistic drug combinations with COYA 301,” Berman adds.

The Belfer family, led by oil tycoon Robert Belfer, had donated an additional $20 million to the Belfer Neurodegeneration Consortium. Photo via mdanderson.org

$20M donation drives neurodegeneration research in Houston

big impact

Neurodegeneration is one of the cruelest ways to age, but one recent donation is invigorating research with the goal of eradicating diseases like Alzheimer’s.

This month, Laurence Belfer announced that his family, led by oil tycoon Robert Belfer, had donated an additional $20 million to the Belfer Neurodegeneration Consortium, a multi-institutional initiative that targets the study and treatment of Alzheimer’s disease.

This latest sum brings the family’s donations to BNDC to $53.5 million over a little more than a decade. The Belfer family’s recent donation will be matched by institutional philanthropic efforts, meaning BNDC will actually be $40 million richer.

BNDC was formed in 2012 to help scientists gain stronger awareness of neurodegenerative disease biology and its potential treatments. It incorporates not only The University of Texas MD Anderson Cancer Center, but also Baylor College of Medicine, Massachusetts Institute of Technology (MIT) and Icahn School of Medicine at Mount Sinai.

It is the BNDC’s lofty objective to develop five new drugs for Alzheimer’s disease and related disorders over the next 10 years, with two treatments to demonstrate clinical efficacy.

“Our goal is ambitious, but having access to the vast clinical trial expertise at MD Anderson ensures our therapeutics can improve the lives of patients everywhere,” BNDC Executive Director Jim Ray says in a press release. “The key elements for success are in place: a powerful research model, a winning collaborative team and a robust translational pipeline, all in the right place at the right time.”

It may seem out of place that this research is happening at MD Anderson, but scientists are delving into the intersection between cancer and neurological disease through the hospital’s Cancer Neuroscience Program.

“Since the consortium was formed, we have made tremendous progress in our understanding of the molecular and genetic basis of neurodegenerative diseases and in translating those findings into effective targeted drugs and diagnostics for patients,” Ray continues. “Yet, we still have more work to do. Alzheimer's disease is already the most expensive disease in the United States. As our population continues to age, addressing quality-of-life issues and other challenges of treating and living with age-associated diseases must become a priority.”

And for the magnanimous Belfer family, it already is.

Houston Methodist's Nantz National Alzheimer Center received a $1 million donation to continue research in neurodegenerative diseases. Photo via Houston Methodist

Houston hospital snags $1M to advance Alzheimer’s research

money moves

Thanks to a recent donation, Houston Methodist is setting up an endowment to support research in neurodegenerative diseases.

Susan and William “Dub” Henning, Jr. have committed to a $1 million gift to Houston Methodist to support Alzheimer’s research at the Nantz National Alzheimer Center at the hospital. This gift will be used to create the Susan and William Henning Jr. Neurodegenerative Research Endowment and in response, a NNAC family room will be named in memory of Dub’s parents, Lena and William Henning.

“Knowing the impact that Alzheimer’s can have not only on patients, but also on the immediate and extended family members experiencing the disease inspired us to support the work being done at the Nantz National Alzheimer Center,” says Dub Henning in a news release. “We want to give hope to families struggling with this disease and contribute to ultimately finding a cure.”

Every year, the NNAC — led by Joseph C. Masdeu — treats thousands of patients looking to prevent Alzheimer’s disease, slow memory loss progression, and improve their quality of life. In 2021 alone, the center provided more than 4,000 patient visits. The fresh funding will allow for Dr. Masdeu's research projects — including more than 26 current studies, 14 in clinical trials and 12 studies to clarify the nature of diseases causing dementia — to continue the important work.

“One of our clinical trials will determine the effects of exercise in preventing deposits of amyloid and tau, two of the proteins that accumulate in the brain of people living with Alzheimer’s disease, and we’re also exploring the role of proper sleep in disease development,” says Masdeu in the release. “Among other studies, we are collaborating with Baylor College of Medicine to define genetic and chemical factors predisposing to the accumulation of amyloid and tau in the brain of people at all stages of the Alzheimer’s spectrum.

"These promising developments would not be possible without the compassion and generosity of community supporters like the Henning family," he continues.

Susan and William “Dub” Henning, Jr. gave a $1 million gift to Houston Methodist. Photo courtesy of Houston Methodist

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Houston space tech startups share latest updates on lunar missions and more

space update

Houston-based space tech companies Axiom Space and Intuitive Machines recently shared updates on innovative projects and missions, each set to launch by 2027.

Axiom Space

Axiom Space, developer of the world’s first commercial space station and other space infrastructure, is gearing up to launch two orbital data center nodes to low-earth orbit by the end of 2025.

The Axiom Space nodes will lay the foundation for space-based cloud computing. Axiom says orbital data centers provide cloud-enabled data storage and processing, artificial intelligence, and machine learning directly to satellites, constellations, and other spacecraft in Earth’s orbit. This innovation will reduce reliance on earth-based systems, enhance wireless mesh networks and improve real-time operation of space-borne assets, according to Axiom.

Axiom has been working on the development of orbital data centers since 2022. The two nodes going into space in 2025 will be part of Kepler Communications’ 10-satellite data relay network, which is scheduled to launch by the end of this year. Axiom Space and Kepler Communications have been collaborating since 2023.

Kam Ghaffarian, co-founder, executive chairman, and CEO of Axiom, says his company already has deals in place with buyers of space-based cloud computing services. Orbital data centers “are integral to Axiom Space’s vision of era-defining space infrastructure, unlocking transformational capabilities and economic growth,” he says.

Axiom Space says it will be able to buy additional payloads on Kepler’s network to boost capacity for orbital data centers. The two companies will team up to provide network and orbital data center services to various customers.

Intuitive Machines

Meanwhile, Intuitive Machines, a space exploration, infrastructure and services company, has picked SpaceX’s Falcon 9 rocket to launch its fourth delivery mission to the moon. The launch will include two lunar data relay satellites for NASA.

Intuitive Machines says its fourth lunar delivery mission is scheduled for 2027. The mission will comprise six NASA commercial lunar payloads, including a European Space Agency drill set designed to search for water at the moon’s south pole.

“Lunar surface delivery and data relay satellites are central to our strategy to commercialize the moon,” Intuitive Machines CEO Steve Altemus says.

The first of five lunar data relay satellites will be included in the company’s third delivery mission to the moon. The fourth mission, featuring two more satellites, will be followed by two other satellite-delivery missions.

Houston doctor aims to revolutionize hearing aid industry with tiny implant

small but mighty

“What is the future of hearing aids?” That’s the question that led to a potential revolution.

“The current hearing aid market and technology is old, and there are little incremental improvements, but really no significant, radical new ideas, and I like to challenge the status quo,” says Dr. Ron Moses, an ENT specialist and surgeon at Houston Methodist.

Moses is the creator of NanoEar, which he calls “the world’s smallest hearing aid.” NanoEar is an implantable device that combines the invisibility of a micro-sized tympanostomy tube with more power—and a superior hearing experience—than the best behind-the-ear hearing aid.

“You put the NanoEar inside of the eardrum in an in-office procedure that takes literally five minutes,” Moses says.

As Moses explains, because of how the human cochlea is formed, its nerves break down over time. It’s simply an inevitability that if we live long enough, we will need hearing aids.

“The question is, ‘Are we going to all be satisfied with what exists?’” he asks.

Moses says that currently, only about 20 percent of patients who need hearing aids have them. That’s because of the combination of the stigma, the expense, and the hassle and discomfort associated with the hearing aids currently available on the market. That leaves 80 percent untapped among a population of 466 million people with hearing impairment, and more to come as our population ages. In a nearly $7 billion global market, that additional 80 percent could mean big money.

Moses initially patented a version of the invention in 2000, but says that it took finding the right team to incorporate as NanoEar. That took place in 2016, when he joined forces with cofounders Michael Moore and Willem Vermaat, now the company’s president and CFO, respectively. Moore is a mechanical engineer, while Vermaat is a “financial guru;” both are repeat entrepreneurs in the biotech space.

Today, NanoEar has nine active patents. The company’s technical advisors include “the genius behind developing the brains in this device,” Chris Salthouse; NASA battery engineer Will West; Dutch physicist and audiologist Joris Dirckx; and Daniel Spitz, a third-generation master watchmaker and the original guitarist for the famed metal band Anthrax.

The NanoEar concept has done proof-of-concept testing on both cadavers at the University of Antwerp and on chinchillas, which are excellent models for human hearing, at Tulane University. As part of the TMC Innovation Institute program in 2017, the NanoEar team met with FDA advisors, who told them that they might be eligible for an expedited pathway to approval.

Thus far, NanoEar has raised about $900,000 to get its nine patents and perform its proof-of-concept experiments. The next step is to build the prototype, but completing it will take $2.75 million of seed funding.

Despite the potential for making global change, Moses has said it’s been challenging to raise funds for his innovation.

“We're hoping to find that group of people or person who may want to hear their children or grandchildren better. They may want to join with others and bring a team of investors to offset that risk, to move this forward, because we already have a world-class team ready to go,” he says.

To that end, NanoEar has partnered with Austin-based Capital Factory to help with their raise. “I have reached out to their entire network and am getting a lot of interest, a lot of interest,” says Moses. “But in the end, of course, we need the money.”

It will likely, quite literally, be a sound investment in the future of how we all hear the next generation.