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.

7 Hills Pharma, an innovative immunotherapy company, was awarded a $13.5 million grant from the Cancer Prevention and Research Institute of Texas. Photo via Getty Images

Houston immunotherapy company to use $13.5M grant to further develop cancer treatments

future of pharma

Between Bangalore and Chennai in the Indian state of Andhra Pradesh, you’ll find the town of Tirupati. It’s home to seven peaks that host a Hindu temple complex devoted to a form of Vishnu, Venkateshvara. It is also the region from which Upendra Marathi originally hails. It’s where his father, and many other family members, attended medical school.

“My father’s first job was to take care of the pilgrims,” recalls Marathi.

It's only natural that his groundbreaking Houston company would be named 7 Hills Pharma.

“That sort of selflessness and giving back, I wanted to embody it in the name of the company,” Marathi says.

Now, 7 Hills Pharma is announcing that last month, it was awarded a $13.5 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT). That’s on top of more than $13 million in NIH grants, making the company the second largest recipient of SBIR/STTR grants in Texas.

Launched in 2016, 7 Hills Pharma is working to develop drugs that can overcome the all-too-common problem of immunotherapy resistance. Thanks to the Nobel Prize-winning work of Jim Allison in the realm of immuno-oncology, the field was “very hot” at the time, says Marathi, particularly in Houston.

So what has 7 Hills developed? Oral small molecules that activate integrins — the receptors that allow cells to bind to one another — allowing for the cell-to-cell interactions that create a successful immune response to immune checkpoint inhibitors such as Yervoy. In other words, they have created capsules that increase the effectiveness of drugs that allow the body’s own immune response to fight cancers.

But that’s not all. Tests have shown that the same discovery, called alintegimod, can also augment the effectiveness of vaccines. The pill, which co-founder and co-inventor Peter Vanderslice calls “a beautiful way to amplify the vaccines,” can potentially be applied to anything from influenza to coronavirus.

Their greatest challenge, says Vanderslice, is the very fact that the technology is so novel.

“Most large pharmas are very risk averse,” he explains. “They only want to do ‘me-too’ kinds of drugs.”

7 Hills Pharma is the third company Marathi, both a PhD and an MBA, has helped to found based on technology he co-invented. Vanderslice is director of the molecular cardiology research laboratories at The Texas Heart Institute.

“It’s very much a homegrown company,” Marathi says.

And a small one, at least for now. Working out of JLabs@TMC, the full-time team is currently just Marathi and Siddhartha De, the senior director of development. Marathi convinced De to transplant himself and his family from India for the purpose of assisting 7 Hills with preparing its drugs for clinical readiness.

The CPRIT funds will allow 7 Hills Pharma to hire several long-time team members full-time and with benefits.

“The bringing of talent and bringing of technology to TMC and what was born at Texas Heart Institute is rather remarkable,” says Rob Bent, the company’s director of operations.

The next step for 7 Hills Pharma is a Phase Ib/IIa clinical trial in patients with treatment-resistant solid tumors. And the team just finalized the deck that will help raise another $10 million to $250 million in the company’s series A. And hopefully sooner rather than later, a new set of medical pilgrims will be thanking 7 Hill Pharma for its care.

A UH professor is fighting cancer with a newly created virus that targets the bad cells and leaves the good ones alone. Photo via Getty Images

University of Houston researchers snag $1.8M to develop cancer-fighting virus

immunotherapy innovation

Viruses attack human cells, and that's usually a bad thing — some Houston researchers have received fresh funding to develop and use the evil powers of viruses for good.

The developing cancer treatment is called oncolytic virotherapy and has risen in popularity among immunotherapy research. The viruses can kill cancer cells while being ineffective to surrounding cells and tissue. Basically, the virus targets the bad guys by "activating an antitumor immune response made of immune cells such as natural killer (NK) cells," according to a news release from the University of Houston.

However exciting this rising OV treatment seems, the early stage development is far from perfect. Shaun Zhang, director of the Center for Nuclear Receptors and Cell Signaling at the University of Houston, is hoping his work will help improve OV treatment and make it more effective.

“We have developed a novel strategy that not only can prevent NK cells from clearing the administered oncolytic virus, but also goes one step further by guiding them to attack tumor cells. We took an entirely different approach to create this oncolytic virotherapy by deleting a region of the gene which has been shown to activate the signaling pathway that enables the virus to replicate in normal cells,” Zhang says in the release.

Zhang, who is also a M.D. Anderson professor in the Department of Biology & Biochemistry, has received a $1.8 million grant from the National Institutes of Health to continue his work.

Zhang and his team are specifically creating a new OV — called FusOn-H2 and based on the Herpes simplex 2 virus.

“Our recent studies showed that arming FusOn-H2 with a chimeric NK engager (C-NK-E) that can engage the infiltrated natural killer cells with tumor cells could significantly enhance the effectiveness of this virotherapy,” he says. “Most importantly, we observed that tumor destruction by the joint effect of the direct oncolysis and the engaged NK cells led to a measurable elicitation of neoantigen-specific antitumor immunity.”

Shaun Zhang is the director of the Center for Nuclear Receptors and Cell Signaling at the University of Houston and M.D. Anderson professor in the Department of Biology & Biochemistry. Image via UH.edu

Houston's Nobel Prize winner, Jim Allison, is the star of Breakthrough, which premieres on Independent Lens at 9 pm Monday, April 27, on PBS, PBS.org, and the PBS Video App. Photo via SXSW.com

Documentary featuring Houston Nobel Prize winner to air on PBS

to-watch list

Not all heroes wear capes. In fact, our current coronavirus heroes are donning face masks as they save lives. One local health care hero has a different disease as his enemy, and you'll soon be able to stream his story.

Dr. James "Jim" Allison won the 2018 Nobel Prize in Physiology or Medicine for his work in battling cancer by treating the immune system — rather than the tumor. Allison, who is the chair of Immunology and executive director of the Immunotherapy Platform at MD Anderson Cancer Center, has quietly and often, singularly, waged war with cancer utilizing this unique approach.

The soft-spoken trailblazer is the subject of an award-winning documentary, Jim Allison: Breakthrough, which will air on PBS and its streaming channels on Monday, April 27 at 9 pm (check local listings for channel information). Lauded as "the most cheering film of the year" by the Washington Post, the film follows Allison's personal journey to defeat cancer, inspired and driven by the disease killed his mother.

Breakthrough is narrated by Woody Harrelson and features music by Willie Nelson, adding a distinct hint of Texana. (The film was a star at 2019's South by Southwest film festival.) The documentary charts Alice, Texas native as he enrolls at the University of Texas, Austin and ultimately, cultivates an interest in T cells and the immune system — and begins to frequent Austin's legendary music scene. Fascinated by the immune system's power to protect the body from disease, Allison's research soon focuses on how it can be used to treat cancer.

Viewers will find Allison charming, humble, and entertaining: the venerable doctor is also an accomplished blues harmonica player. Director Bill Haney weaves Allison's personal story with the medical case of Sharon Belvin, a patient diagnosed with melanoma in 2004 who soon enrolled in Allison's clinical trials. Belvin has since been entirely cancer-free, according to press materials.

"We are facing a global health challenge that knows no boundaries or race or religion, and we are all relying on gifted and passionate scientists and healthcare workers to contain and ultimately beat this thing," said Haney, in a statement. "Jim Allison and the unrelenting scientists like him are my heroes – and I'll bet they become yours!"

Jim Allison: Breakthrough premieres on Independent Lens at 9 pm Monday, April 27, on PBS, PBS.org, and the PBS Video App.

------

This article originally ran on CultureMap.

Houston researchers are hard at work in the lab to progress medical advancements at the bedside. Getty Images

These 3 medical innovations are ones to watch in Houston

Research roundup

Every day, important research is being completed under the roofs of Houston medical institutions. From immunotherapy to complex studies on how a memory is made, Houston researchers are discovering and analyzing important aspects of the future of medicine.

Here are three research projects currently being conducted around town.

University of Houston's potential solution to sickle cell disease

Vassiliy Lubchenko is a University of Houston associate professor of chemistry. Courtesy of UH

For the most part, sickle cells have been a mystery to scientists, but one University of Houston professor has recently reported a new finding on how sickle cells are formed — enlightening the medical community with hopes that better understanding the disease may lead to prevention.

Vassiliy Lubchenko, UH associate professor of chemistry, shared his new finding in Nature Communications. He reports that "droplets of liquid, enriched in hemoglobin, form clusters inside some red blood cells when two hemoglobin molecules form a bond — but only briefly, for one thousandth of a second or so," reads a release from UH.

In sickle cell disease, or anemia, red blood cells are crescent shaped and don't flow as easily through narrow blood vessels. The misshapen cells are caused by abnormal hemoglobin molecules that line up into stiff filaments inside red blood cells. Those filaments grow when the protein forms tiny droplets called mesoscopic.

"Though relatively small in number, the mesoscopic clusters pack a punch," says Lubchenko in the release. "They serve as essential nucleation, or growth, centers for things like sickle cell anemia fibers or protein crystals. The sickle cell fibers are the cause of a debilitating and painful disease, while making protein crystals remains to this day the most important tool for structural biologists."

Lubchenko conclusion is that the key to prevent sickle cell disease is to is to stop the formation of the initial clusters so fibers aren't able to grow out of them.

Baylor College of Medicine's immunotherapy research in breast cancer

science-Digital Composite Image Of Male Scientist Experimenting In Laboratory

Baylor College of Medicine researchers are looking into the complexities of immune cells in breast cancer. Getty Images

Baylor College of Medicine researchers are leading an initiative to figure out the potential effect of immunotherapy on different types of breast cancers. Their report is featured in Nature Cell Biology.

The scientists zoned in on two types of immune cells — neutrophils and macrophages — and they found frequency differed in a way that indicated potential roles in immunotherapy.

"Focusing on neutrophils and macrophages, we investigated whether different tumors had the same immune cell composition and whether seemingly similar immune components played the same role in tumor growth. Importantly, we wanted to find out whether differences in immune cell composition contributed to the tumors' responses to immunotherapy," says Dr. Xiang 'Shawn' Zhang, professor at the Lester and Sue Smith Breast Center and member of the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine, in a news release.

Further exploring the discrepancies between the immune cells and the role they play in tumor growth will help better understand immunotherapy's potential in certain types of breast cancer.

"These findings are just the beginning. They highlight the need to investigate these two cellular types deeper. Under the name 'macrophages' there are many different cellular subtypes and the same stands for neutrophils," Zhang says. "We need to identify at single cell level which subtypes favor and which ones disrupt tumor growth taking also into consideration tumor heterogeneity as both are relevant to therapy."

Rice University, UTHeath, and UH's memory-making study

Researchers from all corners of Houston are diving into how memories are made. Courtesy of Rice University

When you make a memory, your brain cells structurally change. Through a multi-institutional study with researchers from UH, Rice University, and the University of Texas Health Science Center at Houston, we now know more about the way memories are made.

When forming memories, three moving parts work together in the human brain — a binding protein, a structural protein and calcium — to allow for electrical signals to enter neural cells and change the molecular structures in cognition. The scientists compared notes on how on that binding protein works.

The team's study was published in the Proceedings of the National Academy of Sciences. Peter Wolynes, a theoretical physicist at Rice, UH physicist Margaret Cheung, and UTHealth neurobiologist Neal Waxham worked together to understand the complex process memories experience in the process of being made.

"This is one of the most interesting problems in neuroscience: How do short-term chemical changes lead to something long term, like memory?" Waxham says in a release from Rice. "I think one of the most interesting contributions we make is to capture how the system takes changes that happen in milliseconds to seconds and builds something that can outlive the initial signal."

Houston-based Moleculin Biotech now has four different oncology treatment currently in trials. Getty Images

Houston cancer-fighting biotech company introduces its 4th ongoing clinical trial

health report

A Houston-based biotech company has wrapped up enrollment for its most recent clinical trial of its cancer-fighting drug.

Moleculin Biotech Inc. (Nasdaq: MBRX) has launched its fourth ongoing trial — this time focusing on Cutaneous T-Cell Lymphoma, or CTCL, treatment. The company's other three trials include treatment for glioblastoma, an aggressive brain cancer, pancreatic cancer, one of the most virulent killers in oncology, and acute myeloid leukemia, or AML.

To treat these various types of cancers, Moleculin has a several drugs it's in preclinical or clinical trials testing — most biotech companies have only one they focus on. WP1220 is the drug that will be used in this trial for topical CTCL treatment of the cancer's resulting skin lesions.

"We believe there continues to be an unmet need for an improved topical therapy for Stage I-III CTCL skin lesions," says Walter Klemp, Moleculin's chairman and CEO, in a news release, "especially one that may avoid significant unwanted side effects."

WP1220 is what's known as a p-STAT3 inhibitor. STAT3 is a transcription factor that encourages tumor development. Moleculin's technology directly attacks the tumor, but also quiets T Cells, which allows the body's own immune system to fight the cancer itself. Essentially, it works both as chemotherapy and immunotherapy.

"This proof of concept, if successful, could be an important first demonstration of a therapeutic effect in humans from such a p-STAT3 inhibitor," Klemp continues. "We are pleased with how quickly this trial reached full recruitment and we are hopeful to be able to announce results from this trial yet this year."

Klemp founded the company in 2007, and Moleculin went public in 2016. Now, with the company's four clinical trials, Moleculin is even closer to saving lives with its products.

"Notwithstanding the relatively rare nature of CTCL, we believe showing activity with one of our STAT3 inhibitors, within our WP1066 family of molecules, could be an indicator of both the value of p-STAT3 as a target and the potential for our drugs in other cancers where STAT3 is highly activated," Klemp says in the release.

Ad Placement 300x100
Ad Placement 300x600

CultureMap Emails are Awesome

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.”

Texas gas station favorite plugs into partnership for EV chargers

eyes on ev

Buc-ee’s, the beloved Lake Jackson-based chain of convenience stores, has plugged into a partnership with a Mercedes-Benz business unit to install electric vehicle charging stations at Buc-ee’s locations.

Mercedes-Benz HPC North America says it will build EV charging hubs at most Buc-ee’s stores, starting with about 30 hubs by the end of 2024. Some Buc-ee’s hubs already are being set up and are scheduled to begin supplying EV power by the end of this year.

Mercedes-Benz HPC, a subsidiary of the German automaker, is developing a U.S. and Canadian network of EV charging stations. All of the stations will run solely on renewable energy.

“Buc-ee’s values people and partnerships,” Jeff Nadalo, general counsel at Buc-ee’s, says in a news release. “Our new collaboration with Mercedes-Benz HPC North America will continue our traditions of elevated customer convenience and excellent service that have won the hearts, trust, and business of millions in the South for more than 40 years.”

Buc-ee’s — hailed for its squeaky-clean restrooms, abundance of fuel pumps, and unique food — operates 34 supersized convenience stores in Texas and 12 locations in other states. Another seven locations are under construction in Texas, Colorado, Kentucky, Mississippi, and Missouri.

“Mercedes-Benz HPC North America's collaboration with Buc-ee’s represents an important moment in our pursuit of a national charging network that sets a new standard in both convenience and quality,” says Andrew Cornelia, president and CEO of Mercedes-Benz HPC.

“Within a remarkably short period,” Cornelia adds, “we’ve made significant strides towards opening several charging hubs at Buc-ee’s travel centers. Buc-ee’s strategic locations along major travel routes, combined with their commitment to clean and accessible amenities, aligns perfectly with our vision.”

In January 2023, Mercedes-Benz announced plans to install 10,000 EV chargers worldwide, including North America, Europe, and China. Mercedes-Benz drivers will be able to book a charging station from their car, but the network will be available to all motorists.

“The locations and surroundings of the Mercedes-Benz charging hubs will be carefully selected with wider customer needs in mind. Our best possible charging experience will therefore come with food outlets and restrooms situated nearby,” says Mercedes-Benz HPC.

Each hub will feature four to 12 chargers and ultimately as many as 30 chargers.

Mercedes-Benz says more than $1 billion is being invested in the North American charging network, which is set to be completed by 2029 or 2030. The cost will be split between the automaker and solar power producer MN8 Energy, a New York City-based spinoff of banking giant Goldman Sachs.

------

This article originally ran on EnergyCapital.