Fannin Innovation Studio's substance use disorder drug will be evaluated by the National Institute of Drug Abuse. Photo via Getty Images

Fannin Innovation Studio, a Houston-based biotech company, is teaming up with a federal agency to test the company’s leading candidate for treatment of substance abuse disorders.

The Addiction Treatment Discovery Program within the National Institute of Drug Abuse will evaluate the drug, known as 11h. Fannin says it’s keeping all intellectual property, proprietary, and commercialization rights for 11h. Fannin’s Goldenrod Therapeutics portfolio startup, founded in 2020, is overseeing development of the drug.

The federal agency’s “active engagement will accelerate our program and provide an additional independent assessment of 11h as we advance it towards clinical development,” Dr. Atul Varadhachary, managing partner at Fannin, says in a news release.

Fannin’s 11h is part of an array of compounds developed by Corey Hopkins, a professor in the Department of Pharmaceutical Sciences at the University of Nebraska Medical Center in Omaha. Fannin licensed 11h in June 2020.

“11h has the potential to significantly supplement [the] current standard of care in a number of substance use disorders, some of which currently lack any approved pharmaceutical treatment options,” says Dr. Dev Chatterjee, managing director at Fannin.

Last year, Varadhachary told InnovationMap that “the one single thing” Houston could do to boost its chances for success in life sciences, particularly in therapeutics, would be to rev up the cultivation of entrepreneurial talent.

“By and large, I don’t think know that this community appreciates how important and how under-resourced that whole people-development piece is,” he says. “It’s not something that comes from taking classes or watching. It comes from doing.”

This week's roundup of Houston innovators includes Emily Reiser of Texas Medical Center Innovation, Atul Varadhachary of Fannin Innovation Studio, and Vicki Knott of Crux OCM. Courtesy photos

3 Houston innovators to know this week

who's who

Editor's note: In this week's roundup of Houston innovators to know, I'm introducing you to two local innovators, as well as one honorary Houstonian, across industries — energy, health care, and more — recently making headlines in Houston innovation.

Emily Reiser, senior manager for innovation community and engagement for Texas Medical Center Innovation

Emily Reiser joins the Houston Innovators Podcast to discuss the latest at TMC Innovation. Photo courtesy of TMC Innovation

Over her past few years at Texas Medical Center Innovation, Emily Reiser has worked with over 1,000 startups. So, it's safe to say she knows what a good pitch looks like and what health tech startups need as far a support from mentors and experts goes.

She shares some of her advice and observations on this week's episode of the Houston Innovators Podcast. She also explains how TMC Innovation is uniquely positioned to advance the best and brightest in life science innovation.

"When we think about how a startup is going to be successful, we think about how they are going to build new partnerships. But we also think about all the people they're going to need to activate and bring them to the next level," Reiser says. "What we do is curate a community of high-value resources that can help these companies elevate to that next level." Click here to read more.

Atul Varadhachary, managing partner of Houston's Fannin Innovation Studio

Atul Varadhachary, managing partner of Fannin Innovation Studio, says that now is the time to invest in life sciences. Photo via fannininnovation.com

Fannin Innovation Studio is hard at work finding, supporting, and accelerating life science innovations, but, according to Managing Partner Atul Varadhachary, the organization can be doing so much more — if only the budget allowed.

Varadhachary makes a case for tripling or even quadrupling the number of participants in Fannin's federally accredited fellowship program. He says this one relatively small investment could push Houston closer to Boston in the life sciences stratosphere.

"I can think of nothing that could give a bigger return on investment for the city," Varadhachary says of expanding Fannin's fellowship program. Click here to read more.

Vicki Knott, co-founder and CEO of Crux OCM

A Canadian software company is expanding its presence in Houston to meet the needs of its clients. Photo courtesy of Crux OCM

For six months of the year, Vicki Knott plans to take up residence in Houston. As the co-founder and CEO of Calgary-based Crux OCM, Knott saw a big opportunity to expand her control room operations automation software business — especially when she nabbed Houston-based Phillips 66 as a client.

Calgary and Houston have a lot in common, Knott says, and she sees a very natural connection to the two regions. Knott plans to work six months of the year in Houston with the local office.

"A lot of the companies that head offices in Houston, they have head offices in Calgary," she says. "If a startup in Houston is getting traction, I think there's a natural movement to start in the Calgary market and vice versa." Click here to read more.

Atul Varadhachary, managing partner of Fannin Innovation Studio, says that now is the time to invest in life sciences. Photo via Getty Images

Innovation studio aims to put Houston on the map for life science startup development

fostering innovation

In a report last year from commercial real estate services company JLL, Boston took the crown for hosting the country's top life sciences ecosystem. Houston ranked 11th.

The difference between Houston and Boston "is not the innovation, it's not the technology, it's not the money. It's that we don't have experienced life sciences entrepreneurs," says Dr. Atul Varadhachary, managing partner of Houston's Fannin Innovation Studio, a for-profit entity that commercializes biotech and medtech concepts.

Fannin has tried to replicate Boston's robust life sciences ecosystem "in a really, really tiny way" via its fellowship program, Varadhachary says. But the reach of the program could be even greater, he believes.

Varadhachary makes a case for tripling or even quadrupling the number of participants in Fannin's federally accredited fellowship program. He says this one relatively small investment could push Houston closer to Boston in the life sciences stratosphere.

Atul Varadhachary is the managing partner of Houston's Fannin Innovation Studio. Photo via fannininnovation.com

To be sure, Houston is no slouch in life sciences. For instance, commercial real estate services company CBRE issued a report last fall ranking Houston second among the country's top emerging clusters for life sciences. But cities like Boston, San Francisco, and San Diego still reign as life sciences royalty in the U.S.

Fannin typically taps five people at a time — folks who've recently earned a master's degree, medical degree or PhD — for a two-year fellowship in life sciences entrepreneurship and commercialization. The initiative is comparable to a post-doctorate program in research or medicine. The Fannin fellows collaborate with therapeutics and medical device companies in the studio's portfolio, gaining hands-on training in facets of business like R&D, intellectual property, regulatory matters, and financing.

Today, five fellows and seven interns work at Fannin. The fellowship program launched in 2006; the internship program started a year earlier. In all, Fannin has welcomed more than 250 fellows and interns. Some of them have gone on to work at Houston organizations such as TMC Innovation, MD Anderson Cancer Center, and the University of Houston.

Varadhachary believes boosting the fellowship headcount to perhaps 15 instead of the current five would be a small price to pay to help elevate Houston's status in life sciences. The full cost of each fellowship is less than $100,000 a year, so bringing aboard another 10 fellows would require an extra annual commitment of under $1 million. That kind of money isn't in Fannin's budget, though.

"I can think of nothing that could give a bigger return on investment for the city," Varadhachary says of expanding Fannin's fellowship program.

More fellows would mean more entrepreneurs equipped to run or start life sciences businesses in Houston, he says. Varadhachary acknowledges the value of efforts like the soon-to-open TMC3 life sciences hub and the recently opened Ion entrepreneurship hub, but he'd like to see more emphasis placed on nurturing people and not just startups.

Varadhachary says the "the one single thing" that Houston could do to increase its probability of success in life sciences, particularly in therapeutics, would be to crank up cultivation of entrepreneurial talent.

"By and large, I don't think know that this community appreciates how important and how under-resourced that whole people-development piece is," he says. "It's not something that comes from taking classes or watching. It comes from doing."

Andrea Letkeman, director of professional development at Fannin, says the fellows initially work one-on-one with a senior executive on projects, then eventually graduate to running their own projects. Fellows also get a close-up look at other projects underway at Fannin.

Varadhachary wants to get Fannin fellows excited "about what we're doing in Houston, and then give them an opportunity to be part of our ecosystem."

Some Fannin fellows have been hired on a full-time basis by the studio, or they've moved into jobs at venture capital firms, life sciences startups, or other players in the ecosystem, according to Letkeman. She says the fellows lend "energy and vibrancy" to Fannin.

"I think that the Fannin model is fairly unique for Houston. There are models that are similar, across the country, to what we do. But there's not enough of them, quite frankly, for the number of people that are interested in these kinds of roles," Letkeman says.

"There is talent that is looking for a way to bridge the gap between academia and real-world commercialization," she adds. "There's just not enough opportunities out there for them."

Re:3D is one of two Houston companies to be recognized by the SBA's technology awards. Photo courtesy of re:3D

2 Houston startups win national technology award from SBA

winner, winner

A couple of Houston startups have something to celebrate. The United States Small Business Administration announced the winners of its Tibbetts Award, which honors small businesses that are at the forefront of technology, and two Houston startups have made the list.

Re:3D, a sustainable 3D printer company, and Raptamer Discovery Group, a biotech company that's focused on therapeutic solutions, were Houston's two representatives in the Tibbetts Award, named after Roland Tibbetts, the founder of the SBIR Program.

"I am incredibly proud that Houston's technology ecosystem cultivates innovative businesses such as re:3D and Raptamer. It is with great honor and privilege that we recognize their accomplishments, and continue to support their efforts," says Tim Jeffcoat, district director of the SBA Houston District Office, in a press release.

Re:3D, which was founded in 2013 by NASA contractors Samantha Snabes and Matthew Fiedler to tackle to challenge of larger scale 3D printing, is no stranger to awards. The company's printer, the GigaBot 3D, recently was recognized as the Company of the Year for 2020 by the Consumer Technology Association. Re:3D also recently completed The Ion Smart and Resilient Cities Accelerator this year, which has really set the 20-person team with offices in Clear Lake and Puerto Rico up for new opportunities in sustainability.

"We're keen to start to explore strategic pilots and partnerships with groups thinking about close-loop economies and sustainable manufacturing," Snabes recently told InnovationMap on the Houston Innovators Podcast.

Raptamer's unique technology is making moves in the biotech industry. The company has created a process that makes high-quality DNA Molecules, called Raptamers™, that can target small molecules, proteins, and whole cells to be used as therapeutic, diagnostic, or research agents. Raptamer is in the portfolio of Houston-based Fannin Innovation Studio, which also won a Tibbetts Award that Fannin Innovation Studio in 2016.

"We are excited by the research and clinical utility of the Raptamer technology, and its broad application across therapeutics and diagnostics including biomarker discovery in several diseases, for which we currently have an SBIR grant," says Dr. Atul Varadhachary, managing partner at Fannin Innovation Studio.

This year, 38 companies were honored online with Tibbetts Awards. Since its inception in 1982, the awards have recognized over 170,000 honorees, according to the release, with over $50 billion in funding to small businesses through the 11 participating federal agencies.

Allterum Therapeutics Inc., a portfolio company of Fannin Innovation Studio, is using the funds to prepare for clinical trials. Photo via Getty Images

Houston biotech startup raises millions to battle pediatric cancer

fresh funds

Allterum Therapeutics Inc. has built a healthy launchpad for clinical trials of an immunotherapy being developed to fight a rare form of pediatric cancer.

The Houston startup recently collected $1.8 million in seed funding through an investor group associated with Houston-based Fannin Innovation Studio, which focuses on commercializing biotech and medtech discoveries. Allterum has also brought aboard pediatric oncologist Dr. Philip Breitfeld as its chief medical officer. And the startup, a Fannin spinout, has received a $2.9 million grant from the Cancer Prevention Research Institute of Texas.

The funding and Breitfeld's expertise will help Allterum prepare for clinical trials of 4A10, a monoclonal antibody therapy for treatment of cancers that "express" the interleukin-7 receptor (IL7R) gene. These cancers include pediatric acute lymphoblastic leukemia (ALL) and some solid-tumor diseases. The U.S. Food and Drug Administration (FDA) has granted "orphan drug" and "rare pediatric disease" designations to Allterum's monoclonal antibody therapy.

If the phrase "monoclonal antibody therapy" sounds familiar, that's because the FDA has authorized emergency use of this therapy for treatment of COVID-19. In early January, the National Institute of Allergy and Infectious Diseases announced the start of a large-scale clinical trial to evaluate monoclonal antibody therapy for treatment of mild and moderate cases of COVID-19.

Fannin Innovation Studio holds exclusive licensing for Allterum's antibody therapy, developed at the National Cancer Institute. Aside from the cancer institute, Allterum's partners in advancing this technology include the Therapeutic Alliance for Children's Leukemia, Baylor College of Medicine, Texas Children's Hospital, Children's Oncology Group, and Leukemia & Lymphoma Society.

Although many pediatric patients with ALL respond well to standard chemotherapy, some patients continue to grapple with the disease. In particular, patients whose T-cell ALL has returned don't have effective standard therapies available to them. Similarly, patients with one type of B-cell ALL may not benefit from current therapies. Allterum's antibody therapy is designed to effectively treat those patients.

Later this year, Allterum plans to seek FDA approval to proceed with concurrent first- and second-phase clinical trials for its immunotherapy, says Dr. Atul Varadhachary, managing partner of Fannin Innovation Studio, and president and CEO of Allterum. The cash Allterum has on hand now will go toward pretrial work. That will include the manufacturing of the antibody therapy by Japan's Fujifilm Diosynth Biotechnologies, which operates a facility in College Station.

"The process of making a monoclonal antibody ready to give to patients is actually quite expensive," says Varadhachary, adding that Allterum will need to raise more money to carry out the clinical trials.

The global market for monoclonal antibody therapies is projected to exceed $350 billion by 2027, Fortune Business Insight says. The continued growth of these products "is expected to be a major driver of overall biopharmaceutical product sales," according to a review published last year in the Journal of Biomedical Science.

One benefit of these antibody therapies, delivered through IV-delivered infusions, is that they tend to cause fewer side effects than chemotherapy drugs, the American Cancer Society says.

"Monoclonal antibodies are laboratory-produced molecules engineered to serve as substitute antibodies that can restore, enhance or mimic the immune system's attack on cancer cells. They are designed to bind to antigens that are generally more numerous on the surface of cancer cells than healthy cells," the Mayo Clinic says.

Varadhachary says that unlike chemotherapy, monoclonal antibody therapy takes aim at specific targets. Therefore, monoclonal antibody therapy typically doesn't broadly harm healthy cells the way chemotherapy does.

Allterum's clinical trials initially will involve children with ALL, he says, but eventually will pivot to children and adults with other kinds of cancer. Varadhachary believes the initial trials may be the first cancer therapy trials to ever start with children.

"Our collaborators are excited about that because, more often than not, the cancer drugs for children are ones that were first developed for adults and then you extend them to children," he says. "We're quite pleased to be able to do something that's going to be important to children."

Pulmotect, a clinical-stage biotechnology company based in Houston, is testing a drug that could be useful in mitigating the threats of the coronavirus, which is currently been recognized as a global health emergency. Getty Images

Houston biotech company is creating a drug that could fight the coronavirus

Med tech

A drug being developed by a Houston biopharmaceutical company eventually could help combat what the World Health Organization has proclaimed a global health emergency.

Experiments conducted by clinical-stage biotechnology company Pulmotect Inc. show its PUL-042 inhaled drug has proven effective in protecting mice against two types of coronavirus: severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). Researchers performed those tests at the University of Texas Medical Branch at Galveston.

In the Galveston experiments, a single inhaled dose of PUL-042 protected lab mice from the SARS virus, and it greatly reduced the amount of virus in their lungs after the mice became infected with SARS or MERS.

"With the risks of virulent coronaviruses and other threats increasing, as shown by the recent outbreak in Wuhan that has already spread from China to other countries including the United States, Pulmotect is optimistic that its immune-stimulating technology could be useful in mitigating the threats of current and emerging pathogens and protecting vulnerable populations," says CEO Dr. Colin Broom in a news release.

The ability of PUL-042 to ward off the newest type of coronavirus, 2019-nCoV, hasn't been tested yet. However, the drug eventually could help prevent the new virus from spreading, says Broom, who joined Pulmotect as CEO last fall. A separate study would be required to evaluate PUL-042 in patients exposed to 2019-nCoV, he says.

"PUL-042 has the potential to prevent and treat respiratory complications in many high-risk patient populations, including those where no effective therapies are currently available, as is the case with the current coronavirus outbreak," Brenton Scott, president and chief operating officer of Pulmotect, says in the release.

Since its discovery in late December 2019 in Wuhan, China, nearly 9,800 people around the world were infected with 2019-nCoV as of January 31, The New York Times reported. Of those people, more than 200 died. On January 30, the World Health Organization (WHO) declared the virus outbreak a global health emergency.

No specific treatment or cure for 2019-nCoV virus is available. This virus is among seven known coronaviruses.

Symptoms of the Wuhan coronavirus include fever, cough, and shortness of breath, according to the U.S. Centers for Disease Control and Prevention (CDC). The virus can cause pneumonia, SARS, kidney failure, or even death, the Virginia Department of Health says.

PUL-042 "would be a great tool to have available for future outbreaks and epidemics, in addition to being used more routinely for more common infections," Broom says.

Fighting coronaviruses is a potential byproduct of PUL-042.

Initially, Pulmotect is focusing development of PUL-042 on the prevention and treatment of respiratory complications suffered by cancer patients with suppressed immune systems. Phase 1 clinical trials already have taken place in the U.S., and Phase 2 clinical trials are scheduled for later this year.

A separate trial of PUL-042 is underway in London. There, the drug is being tested on patients with chronic obstructive pulmonary disease (COPD) who are prone to lung infections. COPD is an inflammatory disease that blocks airflow from the lungs. People with COPD face a heightened risk of conditions like heart disease and lung cancer, the Mayo Clinic says.

Broom says PUL-042 is a few years away from being considered for approval by the U.S. Food and Drug Administration (FDA).

To date, Pulmotect has raised more than $28 million in outside funding. Founded in 2007, Pulmotect emerged from Houston's Fannin Innovation Studio, which nurtures early stage companies in the life sciences sector.

Patents for PUL-042, invented by MD Anderson Cancer Center and Texas A&M University, have been issued in nine countries.

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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.