Houston cell therapy company launches second-phase clinical trial

fighting cancer

March Biosciences is testing its MB-105 cell therapy in a Phase 2 clinical trial for people with difficult-to-treat cancer. Photo via march.bio

A Houston cell therapy company has dosed its first patient in a Phase 2 clinical trial. March Biosciences is testing the efficacy of MB-105, a CD5-targeted CAR-T cell therapy for patients with relapsed or refractory CD5-positive T-cell lymphoma.

Last year, InnovationMap reported that March Biosciences had closed its series A with a $28.4 million raise. Now, the company, co-founded by Sarah Hein, Max Mamonkin and Malcolm Brenner, is ready to enroll a total of 46 patients in its study of people with difficult-to-treat cancer.

The trial will be conducted at cancer centers around the United States, but the first dose took place locally, at The University of Texas MD Anderson Cancer Center. Dr. Swaminathan P. Iyer, a professor in the department of lymphoma/myeloma at MD Anderson, is leading the trial.

“This represents a significant milestone in advancing MB-105 as a potential treatment option for patients with T-cell lymphoma who currently face extremely limited therapeutic choices,” Hein, who serves as CEO, says. “CAR-T therapies have revolutionized the treatment of B-cell lymphomas and leukemias but have not successfully addressed the rarer T-cell lymphomas and leukemias. We are optimistic that this larger trial will further validate MB-105's potential to address the critical unmet needs of these patients and look forward to reporting our first clinical readouts.”

The Phase 1 trial showed promise for MB-105 in terms of both safety and efficacy. That means that potentially concerning side effects, including neurological events and cytokine release above grade 3, were not observed. Those results were published last year, noting lasting remissions.

In January 2025, MB-105 won an orphan drug designation from the FDA. That results in seven years of market exclusivity if the drug is approved, as well as development incentives along the way.

The trial is enrolling its single-arm, two-stage study on ClinicalTrials.gov. For patients with stubborn blood cancers, the drug is providing new hope.

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Researchers from Baylor College of Medicine and the University of Houston have developed a new blood-filtering machine that poses fewer risks to pediatric patients with hyperleukocytosis. Photo courtesy UH.

UH, Baylor researchers make breakthrough with new pediatric leukemia treatment device

childhood cancer

A team of Houston researchers has developed a new microfluidic device aimed at making treatments safer for children with hyperleukocytosis, a life-threatening hematologic emergency often seen in patients with leukemia.

Dr. Fong Lam, an associate professor of pediatrics at Baylor College of Medicine and a pediatric intensive care physician at Texas Children’s Hospital, partnered with Sergey Shevkoplyas, a professor of biomedical engineering at UH, on the device that uses a large number of tiny channels to quickly separate blood cells by size in a process called controlled incremental filtration, according to a news release from UH.

They tested whether performing cell separation with a high-throughput microfluidic device could alleviate the limitations of traditional conventional blood-filtering machines, which pose risks for pediatric patients due to their large extracorporeal volume (ECV), high flow rates and tendency to cause significant platelet loss in the patient. The results of their study, led by Mubasher Iqbal, a Ph.D. candidate in biomedical engineering at UH, were published recently in the journal Nature Communications.

“Continuously and efficiently separating leukocytes from recirculating undiluted whole blood — without device clogging and cell activation or damage — has long been a major challenge in microfluidic cell separation,” Shevkoplyas said in a news release. “Our study is the first to solve this problem.”

Hyperleukocytosis is a condition that develops when the body has an extremely high number of white blood cells, which in many cases is due to leukemia. According to the release, up to 20 percent to 30 percent of patients with acute leukemia develop hyperleukocytosis, and this places them at risk for potentially fatal complications.

The new device utilizes tiny channels—each about the width of a human hair—to efficiently separate blood cells through controlled incremental filtration. According to Lam, the team was excited that the new device could operate at clinically relevant flow rates.

The device successfully removed approximately 85 percent of large leukocytes and 90 percent of leukemic blasts from undiluted human whole blood without causing platelet loss or other adverse effects. It also operates with an ECV that’s about 1/70th of conventional leukapheresis machines, which makes it particularly suitable for infants and small children.

“Overall, our study suggests that microfluidics leukapheresis is safe and effective at selectively removing leukocytes from circulation, with separation performance sufficiently high to ultimately enable safe leukapheresis in children,” Shevkoplyas said in the release.

March Biosciences' oversubscribed raise brought in $28.4 million of financing with Mission BioCapital and 4BIO Capital leading the pack of investors. Photo via Getty Images

Clinical-stage Houston cell therapy company closes $28.4M oversubscribed series A

cha-ching

An emerging biotech company in Houston has closed its series A with outsized success.

March Biosciences' oversubscribed raise brought in $28.4 million of financing with Mission BioCapital and 4BIO Capital leading the pack of investors. The company has now raised more than $51 million in total.

Last year, March Biosciences announced its strategic alliance with CTMC (Cell Therapy Manufacturing Center), a joint venture between MD Anderson Cancer Center and National Resilience. CEO Sarah Hein met her co-founder, Max Mamonkin, at the TMC Accelerator for Cancer Therapeutics. Along with fellow co-founder Malcolm Brenner, March Biosciences launched from the Center for Cell and Gene Therapy (Baylor College of Medicine, Houston Methodist Hospital and Texas Children’s Hospital). Its goal is to fight cancers that have been unresponsive to existing immunotherapies using its lead asset, MB-105.

An autologous CD5-targeted CAR-T cell therapy, MB-105 is currently in phase-1 trials in patients with refractory T-cell lymphoma and leukemia. The treatment is showing signs of being both safe and effective, meriting a phase-2 trial that will begin early next year. The funds raised from the series A will help to finance the Phase 2 clinical development of MB-105 to expand on the existing data with optimized manufacturing processes.

“This oversubscribed financing enables us to advance our first-in-class CAR-T therapy, MB-105, into a Phase 2 trial for T-cell lymphoma – an indication with an exceptionally poor prognosis and few treatment options,” says Hein. “With the support and confidence of our investors, we are not only advancing our lead program but also expanding our pipeline, underscoring our commitment to delivering best-in-class therapies to patients that can change the treatment paradigm for these challenging cancers.”

But that’s not the only exciting news that Hein and her associates have to report. March Biosciences has recently partnered with cell therapy venture studio, Volnay Therapeutics. Led by highly experienced cell therapy development veterans, the March Biosciences team will work to develop a scalable manufacturing process for MB-105 that will lead to commercialization. Volnay co-founder and CEO Stefan Wildt, who held key R&D leadership positions in cell and gene therapy units at Novartis and Takeda, has also joined the board of March Biosciences. The board of directors is also welcoming Cassidy Blundell of Mission BioCapital and Owen Smith of 4BIO Capital.

“The team at March Biosciences is leveraging powerful science and promising clinical data to tackle cancers with significant unmet need,” says Blundell, a partner at Mission BioCapital. “We're excited to support their journey and believe their focused approach with MB-105 could lead to significant breakthroughs in the CAR-T space.”

The Houston-born company, which is a finalist for the 2024 Houston Innovation Awards, continues to accelerate quickly, in part thanks to its home base. After all, existing local investors like TMC Venture Fund also participated in the new raise. As Hein said last year, “Working with partners here in Houston, we have all the pieces and the community rises to the occasion to support you.”

Rice biochemist Natasha Kirienko and MD Anderson physician-scientist Marina Konopleva made the striking discovery. Photo by Jeff Fitlow

Rice and MD Anderson researchers discover exciting new leukemia treatment

big win

Rice University and MD Anderson researchers have just discovered a potential one-two punch that could, they hope, knock out an insidious disease.

A recent study in the journal Leukemia centers on potential new drugs that, with the help of other medications, can thwart leukemia cells.

Specifically, Rice biochemist Natasha Kirienko and MD Anderson physician-scientist Marina Konopleva screened some 45,000 small-molecule compounds to find a few that targeted mitochondria, according to Rice press materials.

In this innovative new study, the team selected eight of the most promising compounds, identified between five and 30 closely related analogs for each, and conducted tens of thousands of tests to systematically determine how toxic each analog was to leukemia cells. This was measured both when administered individually or in combination with existing chemotherapy drugs like doxorubicin, notes a release.

Previously, Kirienko’s lab had shown the eight compounds targeted energy-producing machinery inside cells called mitochondria. Mitochondria, which work nonstop in every living cell, wear out with use. The chosen eight compounds induce mitophagy, which can be described as how cells decommission and recycle deficient and used-up.

Notably, during times of extreme stress, cells can temporarily forgo mitophagy for an emergency energy boost. Previous research has shown leukemia cells have far more damaged mitochondria than healthy cells and are also more sensitive to mitochondrial damage than healthy cells.

Thus, Kirienko and Konopleva reasoned that mitophagy-inducing drugs might weaken leukemia cells and make them more susceptible to chemotherapy. Synergy — using two or more drugs in treatment — is key.

“The point of synergy is that there are concentrations, or dosages, where a single drug doesn't kill,” Kirienko said. “There is no death of healthy cells or cancer cells. But administering those same concentrations in combination can kill a considerable amount of cancer cells and still not affect healthy cells.”

The team tested the toxicity of its mitophagy-inducing compounds and combinations against acute myeloid leukemia (AML) cells, the most commonly diagnosed form of the disease. They then tested the six most effective AML-killing compounds against other forms of leukemia, finding that five were also effective at killing acute lymphoblastic leukemia (ALL) cells and chronic myelogenous leukemia (CML) cells.

Studies found all the mitophagy-inducing drugs caused far less harm to healthy cells.

Finally, the researchers tested one of the most effective mitochondria-targeting compounds, PS127E, using a cutting-edge technique called a patient-derived xenograft (PDX) model. Also referred to as a “mouse clinical trial,” mice are implanted with cancer cells from a leukemia patient. As the cells grow, the mouse is exposed to a drug or combination of drugs as a closer-than-cells test of the treatment’s effect.

Importantly, PDX tests on one compound, PS127E, showed it was effective at killing AML cells in mice, Rice notes, signaling promising news.

“Although this is very promising, we’re still some distance from having a new treatment we can use in the clinic,” Kirienko added. “We still have a lot to discover. For example, we need to better understand how the drugs work in cells. We need to refine the dose we think would be best, and perhaps most importantly, we need to test on a wide variety of AML cancers. AML has a lot of variations, and we need to know which patients are most likely to benefit from this treatment and which are not. Only after we’ve done that work, which may take a few years, would we be able to start testing in humans.”

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This article originally ran on CultureMap.

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4 Houston health tech startups advancing medical innovation

meet the finalists

Houston has been driving medical innovation for decades. And thanks to leading hospitals, cutting-edge research and breakthrough technologies, the region’s healthcare ecosystem continues to improve how patients are diagnosed, treated and cared for.

The Health Tech Business category in our 2025 Houston Innovation Awards will honor an innovative startup within the health and medical technology sectors.

Four forward-thinking businesses have been named finalists for the 2026 award. This year's finalists, selected by our esteemed panel of judges, range from a startup developing miniaturized medical technologies for space to a company using AI to help develop cancer treatment plans.

Read more about these businesses, their innovative founders, and how they're shaping the future of health care below.. The 2026 winners will be announced on InnovationMap.com in mid-November.

Bairitone Health

Bairitone Health is bringing anatomy imaging for sleep apnea to the home environment. The company's platform maps users' anatomy during natural sleep using a facial patch to determine the root cause of airway obstruction. It then offers effective therapies for each patient.

The company was founded in 2022 in the Texas Medical Center's Biodesign program by CEO Meagan Pitcher, CTO Onur Kilic and chief medical officer Britt Cross. It was a member of Activate Houston's inaugural cohort and has participated in numerous accelerators and incubators. The company raised an oversubscribed seed round for $2.4 million earlier this year and received Breakthrough Device Designation from the Food and Drug Administration in April.

InformAI Inc.

InformAI Inc. develops fit-to-purpose AI solutions for the clinical setting. Its RadOncAI product recently received FDA 510(k) clearance. The product uses AI to create a first-pass radiation therapy dose plan for complex head and neck cancers in an effort to eliminate bottlenecks in radiation planning and ultimately cancer treatment. The company has also developed AI products for sinus disease detection and 3D organ reconstruction.

CEO Jim Havelka founded the company in 2017. It is participating in the Mayo Clinic Accelerate Platform. It has raised about $4 million in seed funding and has received numerous non-dilutive grants from the National Science Foundation, the National Institutes of Health and the Cancer Prevention and Research Institute of Texas. The company shared in its application that it plans to launch a Series A fundraising round and submit an FDA 510K application for its organ reconstruction product, Voluquant, by the end of 2026.

Prana Surgical

Prana Surgical is developing a minimally invasive surgical platform for small, hard-to-reach lung nodules that may be cancerous. The company's Prana System cleared U.S. Food and Drug Administration (FDA) approval earlier this year.

Prana Surgical was originally founded as Prana Thoracic in 2022. It has participated in numerous accelerators, including the Texas Medical Center Innovation Accelerator in 2023 and the IGNITE Health accelerator in 2022. It raised $6 million in Series A funding rounds in 2023 and 2024 , with a Series B currently ongoing. The company said in its application that it is currently moving into the next stage of clinical validation and revenue generation in the U.S., in addition to preparing its manufacturing and commercial infrastructure for broader use.

Skybound MedTech

Skybound MedTech develops technologies that aim to address the health risks of long-duration spaceflight. Its compact, miniaturized medical technologies can deliver complex therapies without a physician.

CEO Matthew Kuhn, who previously founded Taurus Vascular, founded Skybound last year. The company emerged from stealth in January after raising a $1.25 million Series A round. It plans to advance its lead dual-use platform into critical preclinical validation in November, the company shared in its application. It is currently raising a $25 million Series A round and is pursuing federal research partnerships with DARPA and ARPA-H.

Generation Park lands new facility to scale xeno-organ production

Organ innovation

Maryland-based United Therapeutics Corp. has opened a new 77,448-square-foot facility to manufacture xeno-organs in Northeast Houston’s growing biotech hub, Generation Park.

The new Houston location is United Therapeutics’ third Designated Pathogen-Free (DPF) site, named for transplant pioneers Dr. Bartley P. Griffith and Dr. Robert A. Montgomery. The company says the new facility will enable it to scale commercial production of its xeno-organs once they receive regulatory approval.

An existing DPF facility in Virginia is supporting clinical trials for the xeno-organs, and a third site in Minnesota will also focus on commercialization with the Houston site, according to the company.

Xeno-organs are organs taken from a non-human animal source and transplanted, implanted or infused into a human recipient.

Currently, United Therapeutics is advancing clinical trials to support a Biologics License Application with the U.S. Food and Drug Administration for its investigational-stage xenotransplantation, UKidney, UThymoKidney and UHeart products. The products all involve working with the genes from humans and pigs.

In 2025, Chron.com reported the company was working to construct an estimated $96 million facility to breed genetically engineered animals. Head of investor relations at United Therapeutics Dewey Steadman told the Houston Business Journal in 2025 that the pigs’ DNA will be edited. In November 2024, a 53-year-old woman in Alabama received a transplanted kidney from UKidney that had 10 gene edits. She had the transplant removed in April 2025, after her body rejected it.

The Dr. Bartley P. Griffith and Dr. Robert A. Montgomery Xenograft Production Facility requires a “strictly controlled, biosecure barrier environment, including air filtration, filtered water, filtered feed supplies, and state-of-the-art decontamination entryways,” according to the company. Being pathogen-free means it includes calibrated air and water conduits to support the transplantability of xenograft products and to prevent contamination. For energy considerations, the building also features solar arrays.

“With our third xenograft production facility now open and clinical trials underway, United Therapeutics is moving closer to its goal of providing transplantable organs to the people who need them,” Martine Rothblatt, chairperson and CEO of United Therapeutics, said in a news release. “It is fitting that this facility is named for Dr. Griffith and Dr. Montgomery, whose first-in-human surgeries turned xenotransplantation from a theoretical possibility into a clinical reality.”

The facility, which wrapped construction in August, is located at 11848 Common Dock Dr. in Generation Park, which will house manufacturing sites for pharmaceutical heavyweights Bristol Myers Squibb and Eli Lilly. Last fall, Eli Lilly tapped Generation Park for its $6.5 billion manufacturing plant, and Bristol Myers Squibb made a $2.3 billion investment in August to bring its state-of-the-art site to the master-planned commercial district.

Elon Musk's SpaceX reports profit as AI and satellite businesses booms

Booming Business

SpaceX reported a bigger quarterly profit than expected on Tuesday, October 20, as its satellite communications and artificial intelligence businesses boomed.

The company, run by Elon Musk, posted a profit for the three months through September 2026 of $4.4 billion, or 35 cents per share, reversing a year-ago loss and easily topping Wall Street's expectations. Revenue soared to $14.6 billion, up 161%.

On a conference call with analysts, Musk suggested a merger with his electric car company Tesla might be in the works, something that has been rumored for months. He said both companies formed “special committees” of independent directors to discuss the issue, though he played down the chances of an imminent deal.

“Some people out there assume that a SpaceX and Tesla merger is a certainty,” he said. “I think that would be overstating it.”

The AI business became SpaceX's largest by revenue in the third quarter, although the Starlink satellite service remains the biggest profit generator.

“They beat across all metrics and the Starlink business looks to be accelerating,” said Dan Ives, an analyst at Yorkville Ives. “This is just what (Wall) Street wanted.”

The stock rose 7.5% in after-hours trading.

Musk also told analysts that for next month's launch of its Starship rocket, SpaceX will attempt to grab both the booster and ship with mechanical arms upon return to base, a key step toward demonstrating it can reuse the massive spacecraft.

“The only way that we can extend consciousness beyond Earth on a sustained basis is with a fully reusable orbital launch vehicle,” Musk said, calling the attempt, if successful, “a massive technology milestone.”

SpaceX hopes to get Starship on a regular launch pattern in preparation for NASA's upcoming lunar missions.

The company already has huge contracts with the federal government, and House Democrats have called for investigations into those contracts and Musk’s work with the Department of Government Efficiency. Musk has spent $276 million since July in support of Republican candidates.

In a filing for its initial public offering in June, SpaceX warned that a change in control of Congress could have a “material and adverse impact on our growth and competitive position.”

Musk recently drew criticism from politicians in Washington after speeds for a military version of SpaceX's satellite communications service were slowed for Ukraine following President Donald Trump's deal to get more diesel oil from Russia amid a push to end the war. The Wall Street Journal reported Tuesday that it was Musk who ordered the slowdown, impeding Ukraine’s use of drones along the front. SpaceX did not immediately respond to an Associated Press request for comment on the Journal story.

Both Trump and Musk have denied responsibility for the slowdown.

As midterm elections near, Musk on Monday promised to give one share of SpaceX to “every kid in America” next year, though he provided no details on how the distribution would be carried out. With communities nationwide protesting the construction of large data centers and concerns about AI safety, AI companies are trying to build goodwill. Anthropic pledged to commit 5% of its shares to a new “public benefit” fund.

SpaceX shares have been under pressure over concerns that the company was spending too much on major projects to compete with rivals such as Anthropic. The company said capital expenditures totaled $19.6 billion last quarter, nearly triple the figure from a year earlier, and it forecast spending would grow to $35 billion to $40 billion in the current quarter.

Shares of SpaceX closed Tuesday at $147.79, down from a peak near $201 after its IPO, which made Musk the world’s first trillionaire at the time. But the share prices for SpaceX and Tesla have since dropped, reducing his net worth to $925 billion, according to Forbes magazine.

Tesla reports third-quarter financial results Wednesday. Last week, Tesla unveiled a new Roadster sports car that in some versions may include thrusters allowing it to briefly fly using SpaceX technology — though experts say anything usable for drivers is a long shot.

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