A Houston health care company received the green light from the FDA to advance a treatment that's targeting a deadly cancer. Photo via Getty Images

The FDA has granted a Houston-based company a Fast Track designation.

Diakonos Oncology Corp. is a clinical-stage immuno-oncology company that has developed a unique dendritic cell vaccine, DOC1021. The vaccine targets glioblastoma multiforme (GBM), the most common and most lethal malignant brain tumor in adults. The aggressive tumors come with a life expectancy of about 15 months following diagnosis. About 7 percent of those diagnosed survive five years, while the 10-year outlook only sees a one-percent survival rate.

“The FDA’s decision acknowledges the potential of this new treatment approach for a very challenging disease,” Diakonos CEO Mike Wicks says in a press release. “Our protocol represents a first for cancer immunotherapy and could be viable for many types of cancers beyond GBM.”

FDA Fast Track designations are intended to expedite the haste with which drugs with early clinical promise are reviewed, likely taking them to market faster.

DOC1021 uses the body’s natural anti-viral immune response to fight GBM. The vaccine mimics viral infection with the patient’s cancer markers. Essentially, DOC1021 uses the body’s own natural ability to detect and eliminate infected cells.

The technology uses dendritic cells, white blood cells that are able to perceive threats, to its advantage. The unique cancer markers are loaded both internally and externally into the immune cells, just as they would simultaneously occur in a viral infection. The individualized treatment is administered through three precise injections that target deep cervical lymph node chains. By dosing this way, the immune responses are directed straight to the central nervous system.

The results have spoken for themselves: All of the patients who have tried the treatment have exceeded survival expectations. And just as importantly, DOC1021 appears to be extremely safe. No serious adverse effects have been reported.

“Because Phase I clinical trials are generally not statistically powered to demonstrate efficacy, detection of a statistically significant efficacy signal is very promising,” says William Decker, associate professor of immunology at Baylor College of Medicine and inventor of the DOC1021 technology.

The Phase 1 open-label trial of DOC1021 (NCT04552886) is currently taking place at both the University of Texas Health Science Center in Houston and at the MD Anderson Cancer Center at Cooper University Health Care in Camden, NJ. The trial is expected to complete this year.

New facility will accelerate investigational treatments in cancer, heart disease, neurological disorders and more. Photo courtesy of Houston Methodist

Houston Methodist opens new cellular therapeutics center

new to hou

Houston Methodist recently opened a new 5,000-square-foot lab that will focus on developing and producing lifesaving treatments through cell therapy, the hospital announced last week.

Named the Ann Kimball & John W. Johnson Center for Cellular Therapeutics after long-time supporters of the hospital, the lab is located in the Houston Methodist Outpatient Center in the Texas Medical Center. The space includes 1710 square feet of cleanroom space, a dedicated quality control laboratory, six production rooms, support spaces and more to help develop new cell therapies and investigational therapeutics.

The combination of the control laboratory and production rooms onsite are anticipated to help the hospital treat patients safely and more efficiently, according to the statement.

Work at the JCCT is slated to benefit medical research throughout Houston Methodist in the fields of cancer, cardiovascular, neurology, organ transplantation, orthopedics and gastroenterology treatment.

The new center is named for Ann Kimball and John W. Johnson, who contributed a gift that will go toward establishing the facility. Photo courtesy of Houston Methodist

According to a statement from the hospital, cell therapy is "one of the most promising treatment options available," with applications in treatment for cancer, heart disease, and neurological diseases like ALS, Alzheimer’s and Parkinson’s. The therapy requires that a patient is implanted with live cells provided by a donor or the patient themselves. These cells can help repair or rejuvenate damaged tissue or cells.

“Many diseases have limited or ineffective therapies, so there is a tremendous need and opportunity to bring transformative and restorative new treatments to patients through cell therapy,” distinguished neurologist Dr Stanley Appel, who will lead the center, said the statement. “Having a cellular therapy laboratory on-site at Houston Methodist has always been a part of our vision. The Johnson family’s generosity and support of this vision will give hope to countless patients battling neurodegenerative diseases and more.”

The Johnsons' gift also created a matching fund that supports cell therapy projects in all specialties at Houston Methodist. At press time, the fund had helped attract 51 donors, including 69-year-old Jack McClanahan, who suffers from ALS and was the first to donate to the center.

"I volunteered for this because I want a younger man or woman with children to have a chance – this is a devastating disease,” McClanahan said in the statement. “If there’s any hope to help others, I just want to be part of it.”

Houston Methodist also announced last month that it will break ground on a $650 million Cypress "smart" hospital this spring. The hospital is slated to incorporate artificial intelligence, big data, and Alexa- and Siri-like voice technology into its treatment plans and design.

A Houston biotech company has raised $38.1 million. Photo by Dwight C. Andrews/Greater Houston Convention and Visitors Bureau

Houston-based cancer and disease bio-venture launches after $38.1M series A

money moves

Sporos Bioventures LLC launched this month after closing a $38.1 million round of series A financing.

The Houston-based biotech company aims to accelerate the development of breakthrough therapies for cancer and immune diseases by sharing resources, capital, access to clinical trial infrastructure, and talent from within its knowledgeable team of biotech executives, entrepreneurs, academic scholars, and investors. The company was launched with four entities: Tvardi Therapeutics, Asylia Therapeutics, Nirogy Therapeutics, and Stellanova Therapeutics.

The most advanced of the four entities, Tvardi, is currently in Phase 1 clinical trial to evaluate it's STAT3 oral inhibitor. It was named a "most promising" life sciences company at the 2020 Texas Life Science Forum, hosted by BioHouston and the Rice Alliance in December. The remaining entities are in the development stages and are focused on cancer, autoimmune disease, fibrosis, and tumor growth, among other conditions.

"Sporos was founded to accelerate the development of new medicines by addressing inefficiencies and risk in the establishment of new biotech companies," Peter Feinberg, Sporos co-founder, said in a statement. "By leveraging our extensive network, including the Texas Medical Center, we first identify transformative scientific opportunities and then deploy our top-tier talent, funding, and operational support to drive these insights into a growing pipeline of first-in-class treatment options."

In conjunction with the launch, Sporos named Michael Wyzga as the company's founding CFO. Wyzga was previously CFO at Genzyme for 12 years and has held various senior-level positions in the industry.

"By strategically deploying valuable resources to young companies that would not typically be supported by top-tier seasoned talent and infrastructure, we believe that we can efficiently bring a diverse set of therapies through clinical development," Wyzga said in a statement. "I am thrilled to join a team with decades of scientific and operational expertise and look forward to guiding our strategic and financial growth."

Wyzga joins a team of seasoned leaders in the biotech and cancer research fields, including Dr. Ronald DePinho, professor of Cancer Biology and past president of MD Anderson, who will serve as the chair of Sporos' Strategic Advisory Council. Jeno Gyuris, a biotech executive in oncology drug discovery and development with more than 25 years of experience, will serve as chief science officer. And Alex Cranberg, an experienced active early-stage biotech investor, serves as director.

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Houston corporate venture leader calls for collaboration across sustainable fuel, innovation community

HOUSTON INNOVATORS PODCAST EPISODE 212

When it comes to the future of aviation — namely, making it more sustainable, a rising tide lifts all boats. Or, in this case, planes.

Andrew Chang, managing director of United Airlines Ventures, explains that working together is the key for advancing sustainable aviation fuel, or SAF. That's why United Airlines started the Sustainable Flight Fund, a $200 million initiative with support from industry leaders, including Air Canada, Boeing, GE Aerospace, JPMorgan Chase, Honeywell, Aramco Ventures, Bank of America, Hawaiian Airlines, JetBlue Ventures, and several others.

"We all recognize that we may compete in our core business, but with the importance of sustainable aviation fuel and given that it's an industry that doesn't exist — you can't compete for something that doesn't exist — let's collaborate and work together to explore technologies that can directly or indirectly support the commercialization and production of sustainable aviation fuel," he says on the Houston Innovators Podcast.

Within United Airline Ventures, Chang's job is to find technology to invest in across the aviation industry spectrum — from SAF to digital technologies that will improve the United customer experience. This means working with startups and other organizations to find the best fit — and, because he's based in Houston, one of United's seven key hubs, this means knowing and interacting with local innovators.

"The knowledge base and the capabilities are here — that's undebatable," Chang says of the Houston innovation ecosystem. "The next step is making sure we're accessing, promoting, collaborating, and learning from one another."

Again, as Chang recognizes, collaboration is key to further developing the ecosystem, "so that we're not trying to solve the same problem in a vacuum," he explains.

United Airlines recently signed an offtake agreement with Cemvita Factory, a Houston biotech startup that's working on SAF. Chang discusses this partnership on the show, as well as explaining how he works with other startups and what he's looking for.

4 Houston life science startups secure over $40M in CPRIT funding

cha-ching

Four Houston bioscience startups have collected nearly $43 million in grants from the Cancer Prevention and Research Institute of Texas (CPRIT).

Here’s a list of the four startups, the amount and purpose of each grant, and some background information about each company.

Stingray Therapeutics

CPRIT grant amount: $13,881,458

Purpose of grant: Clinical trial to evaluate an immunotherapy known as SR-8541A for treatment of advanced or metastatic solid tumors.

Company background: Stingray received a $2 million Small Business Innovation Research (SBIR) award in 2022. In conjunction with the award, Mohan Kaadige, a research associate professor at the Translational Genomics Research Institute, joined Stringray as the principal SR-8541A investigator.

“I … believe we have great potential to alleviate cancer suffering in the near future with this exciting technology,” says Kaadige.

March Biosciences

CPRIT grant amount: $13,358,637

Purpose of grant: Clinical trial to evaluate a T-cell immunotherapy (MB-105) for treatment of certain types of relapsed lymphoma.

Company background: March Biosciences, a Baylor College of Medicine spinout, recently received $4.8 million in funding from Cancer Focus Fund, affiliated with Houston’s MD Anderson Cancer Center.

“The breadth and quality of the support we are receiving from our local partners and institutions underscore Houston’s increasing prominence as a worldwide leader in cancer R&D and clinical research,” says Sarah Hein, co-founder and CEO of March Biosciences.

Mongoose Bio

CPRIT grant amount: $10,621,053

Purpose of grant: Development of T-cell therapies targeting solid-tumor cancer.

Company background: Mongoose founder Cassian Lee, a professor and researcher at MD Anderson, is a CPRIT scholar and a participant in Texas Medical Center Innovation’s 2023 Accelerator for Cancer Therapeutics.

“Mongoose Bio is a first-rate example of the use of CPRIT funds to fund a disruptive cell gene therapy … therapeutic with deep roots and origins in Texas. This innovation will benefit patients with solid tumors not just in Texas but the rest of the world,” says CPRIT.

FixNip

CPRIT grant amount: $4,844,088

Purpose of grant: Clinical study and manufacturing of a silicone implant that creates a soft, natural-looking nipple for women with breast cancer who’ve undergone post-mastectomy breast reconstruction. The clinical study will be done at MD Anderson.

Company background: In conjunction with the CPRIT grant, FixNip is moving its headquarters from Israel to Houston. Austin-based CPRIT became aware of FixNip during a May 2022 trade trip to Israel by the organization’s CEO, Wayne Roberts.

“Loss of nipple projection is the most pervasive problem across all currently existing nipple reconstruction solutions,” says FixNip.

Aside from the grants for the four Houston startups, CPRIT handed out two grants for recruitment of two cancer researchers to Houston:

  • $6 million grant to recruit Dr. Leonido Luznik of Johns Hopkins University to the Baylor College of Medicine. Luznik’s research focuses on allogeneic blood and marrow transplantation (alloBMT), a treatment for blood cancers.
  • $1.99 million grant to recruit Swiss researcher Christina Tringides to Rice University. Tringides is working on a “groundbreaking” treatment for brain tumors, says CPRIT.

Houston entrepreneurs awarded over $30,000 at annual competition

biz plan

An annual pitch competition put on by the city of Houston named its big winners for this year.

The 11th annual Liftoff Houston Startup Business Plan Competition announced its three winners — and each will receive $10,000 in startup money. The winners are:

  • Teria Johnson's e-commerce sweet and savory pies company, Charleston Kitchen
  • Zoey Barker and Mohammadmehdi Mortazavi’s ExoBraced’s ExoBak, a light-weight exoskeleton to help with back pain and prevent injuries from manual workers
  • Giovanni Garza’s Classic Borrego Retail, which offers high-end cowboy boots.

There were nine finalists that were selected from over 100 applicants and competed in Liftoff’s Pitch Day on November 18, where they were ranked on service, product, and innovation after pitching their businesses to a panel of expert judges.

In the event’s 11 years, 33 winners started businesses in the fields of merchandise/retail, software,education, hardware, hospitality, health and wellness, finance, technology,consulting, and logistics. The yearly event is sponsored by Capital One Bank and administered by the Houston Public Library and the Office of Business Opportunity. Liftoff Houston’s results have reflected the diversity of the city.

“The program is especially significant as data collected from recent competitions shows Liftoff Houston made an impact on populations that have been historically marginalized,” says Mayor Sylvester Turner in a news release. “More than 90 percent of participants identified as people of color, more than 70 percent were female, 44 percent had no college degree, and 54 percent earned less than $50,000 a year.”

Runners received $500 each. They are:

  • Francesca Bonaduc’e De Nigris: Intrecci by Francesca collaborates with artisans around the world, to deliver one-of-a-kind handmade rugs.
  • Diana Tudela and Hailee Trombley’s The Goodest Goodbye: a pet aftercare company that uses cutting-edge technology and environmentally conscious efforts.
  • Diane Nguyen’s Flourishing Nexus LLC: a virtual platform that unites health professionals worldwide.

Liftoff Houston – and our finalists – have also made it this far because of our workshop partners, all who have given us the invaluable gift of their time,” says OBO Director Marsha Murray in a news release. “The business, financial, legal and marketing education they have provided has allowed our participants to plan a roadmap to their success, including the creation of viable business plans.”