Celltex is looking into using stem cells to treat COVID-19, and the Houston biotech company just got the green light to go to trials. Photo courtesy of Celltex

A Houston-based biotech company announced last week that it has gotten the approval it was seeking from the U.S. Food and Drug Administration to continue testing its COVID-19 treatment that uses stem cells.

Celltex has received approval from its Investigational New Drug application, or IND, to look into stem cells — specifically Autologous Adipose Tissue-Derived Mesenchymal Stem Cells, or AdMSCs — and their effect on COVID-19 patients.

"The FDA's approval of our IND is not only a critical milestone for Celltex, but also for everyone who has been affected by COVID-19," says David G. Eller, Celltex chairman and CEO. "I am optimistic that our findings will result in favorable outcomes that will improve lives today and for generations to come."

Celltex has been in the stem cell business for nearly a decade and has treated patients with debilitating diseases like multiple sclerosis, Parkinson's, rheumatoid arthritis, and more. Eller says he's been considering how Mesenchymal Stem Cells, or MSCs, could be used amid the pandemic.

"Throughout the entire pandemic, MSCs have shown promise for combatting symptoms and complications associated with COVID-19, and as the nation's leading commercial MSC banking and technology company, Celltex has the unique ability to transition these initial findings into a clinical trial," Eller says.

The FDA clearance will allow for a phase two trial "that will evaluate the safety and prophylactic efficacy of AdMSCs against COVID-19," according to the release. There will be 200 patients across multiple centers that will be involved in the placebo-controlled study.

Celltex offices out of the Galleria area and has laboratory operations of its wholly-owned Mexican subsidiary are located in Hospital Galenia in Cancún, Quintana Roo, Mexico. Last year, Celltex planned an expansion into Saudi Arabia and also has a presence in Europe.

With the Texas Medical Center in their backyard, these Houston biotech companies are creating breakthrough technologies. Getty Images

5 Houston biotech companies taking health care to new levels

The future is now

Houston is the home of the largest medical center in the world, so it comes as no surprise that the Bayou City is also home to breakthrough technologies. Here are five Houston companies developing some of this biotech advancements.

Moleculin Biotech Inc.

Houston-based Moleculin has three different oncology technologies currently in trials. Getty Images

Immunotherapy and personalized medicine get all the headlines lately, but in the fight against cancer, a natural compound created by bees could beat them in winning one battle.

In 2007, chairman and CEO Walter Klemp founded Moleculin Biotech Inc. as a private company. The former CPA had found success in life sciences with a company that sold devices for the treatment of acne. That introduction into the field of medical technology pushed him toward more profound issues than spotty skin.

"Coincidentally, the inventor of that technology had a brother who was a neuro-oncologist at MD Anderson," Klemp recalls.

The since-deceased Dr. Charles Conrad slowly lured Klemp into what he calls the "cancer ecosphere" of MD Anderson. In 2016, the company went public. And it looks like sooner rather than later, it could make major inroads against some of the toughest cancers to beat. Read the full story here.

Cavu Biotherapies

Dr. Colleen O'Connor has adapted immunotherapy treatments to be used in dogs. Courtesy of CAVU Biotherapies

Breakthrough biotech doesn't have to just be for humans. More than three years after its founding, Houston-based veterinary biotech company CAVU Biotherapies' had its first cancer patient: a black Labrador in Pennsylvania diagnosed with B-cell lymphoma.

Dr. Colleen O'Connor, CEO and founder of CAVU Biotherapies, established the company in July 2015 with a goal to help pets live longer post-cancer diagnoses. O'Connor, who earned a PhD in toxicology with a specialty in immunology, has more than a decade of hands-on experience researching cancer treatments.

"Our goal is to scale up and be able to increase our dogs' qualities of life with us," O'Connor said. "We want to keep families intact longer and we want to be able to modernize cancer care for our animals." Read the full story here.

Innovative Biochips

iBiochips, led by founder Lidong Qin, was awarded a $1.5 million grant in September to help develop a new technology that delivers data about the cell's genetic makeup and reports abnormalities. Courtesy of Lidong Qin

Innovative Biochips, a Houston-based biotechnology company, is one step closer to commercializing technology that the company hopes will provide an opportunity for researchers to detect diseases earlier.

The company was founded three years ago by Dr. Lidong Qin, a professor at the Houston Methodist Research Institute's department of nanomedicine. He launched iBiochips as an independent faculty startup that licensed technology from Houston Methodist. Qin says he wanted to engineer and manufacture devices that focus on revolutionizing single-cell isolation and genetic analysis. Read the full story here.

Celltex

Celltex's stem cell technology has received positive results from its multiple sclerosis, Parkinson's, and rheumatoid arthritis patients. Courtesy of Celltex

A Houston stem cell company is making strides in regenerative medicine. Celltex's treatment has been proved effective with its patients. Eighty-three percent of multiple sclerosis patients have reported improvement of symptoms specific to their disease, as have 73 percent of Parkinson's sufferers. But the staggering fact is that 100 percent of 58 respondents with rheumatoid arthritis say they have benefited.

David Eller, chairman, co-founder and CEO of the company, also recently announced the company's expansion to Saudi Arabia. Read the full story here.

Ridgeline Therapeutics

Houston-based Ridgeline Therapeutics isn't going to allow you beat aging, but someday it may well help you to live without muscle loss or diabetes. Getty Images

Stan Watowich pictures a world where elderly people have the same healthy muscles they had at a younger age. Watowich is CEO of Ridgeline Therapeutics, a spin-off company of the University of Texas Medical Branch in Galveston where he is an associate professor of biochemistry and molecular biology, and he wants to make it clear that he is not going to cure aging.

"You and I are still going to get old," he says. "But we have our hopes that as we get old our muscles will stay healthy."

He's talking about the drug candidate, RLT-72484. It has been shown to reactivate muscle stem cells and regenerate skeletal muscle in aged laboratory mice. Read the full story here.


Saudi Arabian representatives met at Houston-based Celltex Therapeutics Corp.'s office earlier this month to finalize a memorandum of understanding. Courtesy of Celltex

Houston biotech company plans expansion into Saudi Arabian market

On the move

A Houston company that uses stem cell technology to treat patients suffering from degenerative diseases is taking its patented technology to another continent.

Celltex Therapeutics Corp. has entered a memorandum of understanding with Saudi Arabia's Research Products Development Company. As a part of the partnership solidified by the MOU, Celltex will open an office in Riyadh, Saudi Arabia, later this year. The new office will aid the commercialization of Celltex's technology and expand the company's presence to Saudi Arabia.

"We are honored to forge a relationship with Saudi Arabia," says David G. Eller, CEO and chairman of Celltex, in a release. "Our collaboration with this first-rate global cohort furthers our commitment to initiating breakthroughs in regenerative medicine, and our presence in Riyadh will further expand our opportunities to improve the quality of life of those in need."

The MOU is a part of the country's effort to diversify the economy that's been dominated by oil and gas, the release says. As a part of Saudi Arabia's National Industrial Development and Logistic Program, Celltex and other United States companies were invited to Riyadh to sign MOUs in January, which resulted in billions of dollars in Saudi investment, per the release.

On February 4, the two parties reconvened at Celltex's office in Houston. The group included top Saudi dignitaries, Abdulmohsen Almajnouni, CEO of RPDC, as well as others.

"We are excited to explore business opportunities with Celltex, a biotechnology company with the innovative proprietary technology, patents and know-how for the cultivation and therapeutic application of stem cells," Almajnouni says in the release.

Celltex currently extracts patients' stem cells at various partner facilities across the United States, but implementation happens at a hospital in Mexico, due to FDA regulations and red tap. However, Eller doesn't foresee this being the process forever.

"We have very good relations with the US FDA," he says in an InnovationMap article. "They are very interested in what we know. Our approach is really is very progressive and we've grown every year."

The company's treatment has been proved effective with its patients. Eighty-three percent of multiple sclerosis patients have reported improvement of symptoms specific to their disease, as have 73 percent of Parkinson's sufferers. But the staggering fact is that 100 percent of 58 respondents with rheumatoid arthritis say they have benefited.

From a locally sourced meal service company to stem cell research and a balance measuring device, this week's innovators are ones to know in the health industry. Courtesy photos

3 Houston health-focused innovators to know this week

Who's who

More and more Americans are focusing on their health, from eating right to experimenting with new treatments or devices. These three Houston innovators are riding the coattails of this health-focused movement with their startups. With advances in technology and the movement only growing faster and faster, you'd better keep your eye on these Houston innovators.

Marla Murphy, founder of The Blonde Pantry

Courtesy of The Blonde Pantry

Marla Murphy didn't feel like she was doing enough to promote health and wellness with her platform, The Blonde Pantry. So, she expanded it to incorporate locally sourced produce and easy-to-make recipes she gets ready every weekend to deliver to her members by Monday.

"It's not about selling meals and moving on, I want this to be a lifestyle company that is really founded and has deep roots in Houston," says Murphy in a InnovationMap story.

Murphy tells InnovationMap that in the next year she hopes to expand into the retail space and find a bigger commercial kitchen to function as their own. She also hopes to partner with companies outside of food and continue to nourish lives in someway.

David Eller, chairman, co-founder and CEO of Celltex

Courtesy of Celltex

Stem cell treatment is personal to David Eller, chairman, co-founder and CEO of Celltex. Eller had the treatment in hopes of resolving pain from a college football injury.

"I would go to work and put four to six Advil in my pocket," Eller says in an InnovationMap story about Celltex's technology. Within months, he stopped needing those pills.

Houston-based Celltex tracks its progress with its patients. Eighty-three percent of multiple sclerosis patients have reported improvement of symptoms specific to their disease, as have 73 percent of Parkinson's sufferers. But the staggering fact is that 100 percent of 58 respondents with rheumatoid arthritis say they have benefited.

Katharine Forth, founder and CEO of Zibrio

Courtesy of Zibrio

Katharine Forth has used a technology she developed with her colleague at NASA to measure balance in astronauts to create a device that any terrestrial human can now use from the comfort of their own homes.

"The machines typically used for balance measurement can be as large as a telephone booth, so we invented a new way to measure postural control using a much smaller mechanism that fit inside a moon boot," Forth says in an InnovationMap article about Zibrio, The Balance Company. Zibrio, The Balance Company.

Zibrio is now a finalist for the 2019 SXSW Pitch in the health and wearables category and will take its balance technology to the stage in March.

Celltex's stem cell technology has received positive results from its multiple sclerosis, Parkinson's, and rheumatoid arthritis patients. Courtesy of Celltex

Houston company uses stem cell technology to treat patients suffering from degenerative diseases

Regeneration nation

The medical community has former governor Rick Perry to thank for a major stride in regenerative medicine.

"He had just gotten elected for the last time and he wanted to leave a legacy. He was tired of people going to Japan or Germany when they needed stem cells," recalls David Eller, chairman, co-founder and CEO of Celltex.

That was 2011, the year that the former president of Dupont Pharmeceuticals-Europe and orthopedic surgeon Dr. Stanley Jones incorporated as Celltex. Perry got the law passed to make it legal to harvest his stem cells, and Jones implanted them while the governor was under the knife for a spinal fusion surgery.

Perry resigned from the Celltex board in 2017, but the truth is, the company no longer needed his clout. Just a year after its debut, the company had in excess of 200 clients, each paying a banking enrollment fee of $6,500. Now, there are close to 1,300.

From research to recovery
Eller is originally from Houston, and he says his hometown is the ideal home base for the company, with its access to the world's largest medical center. The Galleria-area office and lab employ 35 people, with about 50 workers worldwide.

Close to the same time that his friend Perry received his stem cells, Eller also had the treatment in hopes of resolving pain from a college football injury.

"I would go to work and put four to six Advil in my pocket," the CEO recalls.

Within months, all of them remained in his pocket.

But others have had even more dramatic results. Celltex checks in with patients three, six and nine months after their treatments to find out how they're doing. Eighty-three percent of multiple sclerosis patients have reported improvement of symptoms specific to their disease, as have 73 percent of Parkinson's sufferers. But the staggering fact is that 100 percent of 58 respondents with rheumatoid arthritis say they have benefited.

Implementation and the FDA
Celltex's chief scientific officer, Dr. Jane Young, co-authored a study of two severe juvenile rheumatoid arthritis patients whose conditions didn't respond to standard treatments. After trying stem cells, both reported marked improvement in autonomic nervous system and immune function.

Stem cells are gathered through a patient's fat, which can be extracted at any of the 80 facilities around the country that partner with Celltex. The fat is processed at the Houston lab, where processing takes 30 to 35 days.

"We have 15 billion cells in process each day," says Erik Eller, the company's vice president of operations, clarifying that some clients' cells grow faster than others'.

It takes 14 days to come out of cryostasis and leave the lab. From there, the stem cells travel to Hospital Galenia in Cancun, Mexico for implantation, since the FDA categorizes stem cells as a drug if they have expanded as they do at Celltex. That means that a patient cannot use his own stem cells in the United States without a clinical trial. To circumnavigate the red tape, Celltex has simply partnered with the luxurious Mexican hospital.

This is currently the company's biggest challenge, says David Eller, but one he expects to overcome.

"We have very good relations with the US FDA," he says. "They are very interested in what we know. Our approach is really is very progressive and we've grown every year."

Ultimately, Eller hopes to be able to implant stem cells in the United States. But the company's foreign growth is a good start. Celltex is now operating in the Bahamas and is hoping to add Australian extraction facilities sometime this year. They are also in negotiations with a team from Saudi Arabia interested in expanding Celltex to the Middle East.

Other goals for Celltex include improvements both in the realms of sales and revenue and streamlining and improving the safety and efficacy of treatment. Research collaborations with Baylor College of Medicine and Texas A&M will help with the company's medical credibility. This all may help to convince the FDA to allow the Celltex to get a biologics license, the final proof that it is not a drug company. But no matter how it's categorized, Celltex is growing exponentially as its cells.

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Houston immuno-oncology company reaches next FDA milestone, heads to phase 2 trial

green light

A Houston immuno-oncology company has recently made major headway with the FDA, including both a fast track and an orphan drug designation. It will soon start a phase 2 trial of its promising cancer fighting innovation.

Diakonos Oncology was born in 2016, the brainchild of Baylor researchers already hard at work in the realm of dendritic cell vaccines. Drs. Will Decker, Matt Halpert, and Vanaja Konduri partnered with Dan Faust, a Houston businessman and pharmacist, to bring their treatment to the public, says COO Jay Hartenbach.

The name Diakonos means “deacon or servant in Greek,” he explains. “A lot of companies end up focusing on treating a specific disease or cancer and what you end up having is a significant amount of potential but with a lot of tradeoffs and downsides. And so our goal is we need to eliminate the cancer but we can't harm or dramatically malign the patient in doing so.”

How do they do that? Because the therapy catalyzes a natural immune response, it’s the patient’s own body that’s fighting the cancer. Hartenbach credits Decker with the idea of educating dendritic cells to attack cancer, in this case, glioblastoma multiforme (GBM), one of the most aggressive cancers with which doctors and patients are forced to tangle.

“Our bodies are already very good at responding very quickly and aggressively to what it perceives as virally infected cells. And so what Dr. Decker did was basically trick the immune system by infecting these dendritic cells with the cancer specific protein and mRNA,” details Hartenbach.

Jay Hartenbach is the COO of Diakonos Oncology. Photo courtesy of Diakonos Oncology

But GBM isn’t the only cancer on which Diakonos Oncology has its sights set. Other notably stubborn-to-treat cancers that they’re working on include pancreatic cancer and angiosarcoma. The scientists are focused on meeting unmet medical needs, but also realize that treating such cancers would allow for the fastest determination of whether or not the treatment was effective.

The fast track designation, originally received last fall, means that the drug approval time for DOC1021, Diakonos’ glioblastoma vaccine, will be only six months. But Hartenbach highlights an additional boon, the fact that the special designation also allows for more frequent communications with the FDA.

“That’s very helpful for us, right as we're contemplating how to design the upcoming trials. From a business standpoint, it also is incredibly helpful because it provides a third party validation of what we're doing and the results that we're seeing,” he says.

What they’re seeing includes the survival of 13 out of 16 patients from the initial October 2021 enrollment. The three patients who passed away received the lowest dose of DOC1021. Hartenbach says that the remaining patients are thriving, with no serious adverse effects. With a median survival rate of 15 to 21 months, it’s hard to understate the significance of these patients’ success.

Diakonos Oncology is headquartered in Houston, with a staff of 10 in Space City and an additional eight distributed employees. Hartenbach says that the company’s hometown has been instrumental in its success. He mentions that the robust innovation of the Texas Medical Center meant that as the company has grown, there has never been a motivation to leave Houston.

“You're having a lot of both investment and companies actually moving to Houston,” Hartenbach says. “So we’ve been fortunate to have started there. There are bigger traditional biotech hubs, San Diego, Boston, and San Francisco, but Houston really is now putting itself on the map and it's getting a lot of attention.”

One of the companies responsible for that improved reputation? Diakonos Oncology and its promising approach to aggressive cancers.

Houston professor earns competitive NSF award, nearly $700,000 grant

science supported

An assistant professor at Rice University has won one of the highly competitive National Science Foundation's CAREER Awards.

The award grants $670,406 over five years to Amanda Marciel, the William Marsh Rice Trustee Chair of chemical and biomolecular engineering, to continue her research in designing branch elastomers that return to their original shape after being stretched, according to a statement from Rice. The research has applications in stretchable electronics and biomimetic tissues.

“My goal is to create a new paradigm for designing elastomers,” Marciel said in a statement. “The research has four aims: to determine the role of comb polymer topology in forming elastomers, understanding the effects of that topology on elastomer mechanics, characterizing its effects on elastomer structure and increasing the intellectual diversity in soft matter research.”

Marciel, who joined the faculty at Rice in 2019, is one of about 500 researchers to receive the NSF's CAREER Award each year. The award recognizes early-career faculty members who “have the potential to serve as academic role models in research and education and to lead advances in the mission of their department or organization,” according to the NSF.

In addition to supporting Marciel's research, the funds will also go toward creating opportunities in soft matter research for undergraduates and underrepresented scientists. It will establish a new annual symposium called the Texas Soft Matter Meeting, where community college teachers can participate in a soft matter laboratory module and students in the Research Experiences for Undergrads program at Rice will present their summer research.

Recently, Rice also launched the new Rice Synthetic Biology Institute, which aims to strengthen the synthetic biology community across disciplines at the university. It is part of an $82 million investment the university put toward synthetic biology, neuroengineering and physical biology in 2018.

A fellow team or Rice researcher is also working on wearable haptic accessories. A member of the team was recently named to the 2024 cohort of Rice Innovation Fellows. Click here to learn more.