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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7+ can't-miss Houston business and innovation events in May

where to be

Editor’s note: Houston is living up to its nicknames as Space City and the Energy Capital of the World this month with a lineup of insightful talks, pitch days and industry conferences. Plus, there are opportunities to network over crawfish, learn about brain health and more. Here’s what not to miss and how to register. Please note: this article may be updated to add more events.

May 7 – Ion Block Party and Crawfish Boil

Head to this special edition Block Party, featuring a crawfish cook-off competition among the Ion’s businesses. Competing teams include Transwestern, Microsoft, Rice Alliance, Rice Nexus, South Main Baptist, Per Scholas, Industrious and many others. Taste test crawfish while supplies last, and sip a complimentary drink from Second Draught.

This event is Thursday, May 7, from 4-7 p.m. at the Ion. Register here.

May 12 – Why the Next Decade of Breakthrough Brain Tech Matters For You, and What to Do About It

Hear from Matias Serebrinsky, co-founder and general partner of San Francisco-based PsyMed Ventures, at this talk presented by EO Houston. Serebrinsky will discuss why founders are disproportionately affected by brain health issues and look at breakthrough brain and mental health tech.

This event is Tuesday, May 12, from 11:20 a.m.-1 p.m. at Tony's on Richmond Avenue. Register here.

May 18-19 — Geothermal Transition Summit North America

This two-day summit serves as the meeting point for the geothermal and oil and gas industries and will focus on geothermal energy, including scaling plants and navigating state regulations. The event promises 40 expert speakers, 15 exhibition spaces, and networking opportunities with 250 industry decision makers.

This event begins May 18 at Norris Conference Center. Register here.

May 19 – IOT Innovation Day

IoT Innovation Day will present a series of fast‑paced, 15‑minute tech talks focused on the future of connected devices. These sessions feature insights from founders, engineers, product innovators and industry leaders. Attendees are also invited to sign up to present their own tech talk showcasing their expertise, startup or solution.

This event is Tuesday, May 19, from 10 a.m.-6 p.m. Register here.

May 20-21 — ESF North America

ESF North America returns for its 5th edition, under the theme of “innovation and adaptation.” Attendees will explore how technology, innovation, and collaboration can drive a resilient, competitive refining and chemicals industry.

This event begins May 20 at The Westin Oaks Houston at the Galleria. Register here.

May 21 – AI + Energy Sector Pitch Day

Hear from startups powering the AI boom or using AI to support the energy transition at Greentown's latest installment of its Sector Pitch Day series. Brian Walker, program manager for emerging technologies in the U.S. Department of Energy’s Building Technologies Office, will present the keynote address. Six Greentown startups will present pitches, as well as others from IMPEL, a DOE tech-to-market program, and more. Stick around for a networking happy hour.

This event is Thursday, May 21, from 1:30-6:30 p.m. at the Ion. Register here.

May 28 – NASA Stories at the Ion: A Conversation with NASA’s Artemis II Orion Vehicle Manager Branelle Rodriguez

NASA’s Artemis II Orion Vehicle Manager Branelle Rodriguez will discuss what it took to ready the spacecraft for its mission and return to Earth at this special installment of NASA Stories. Rodriguez will share insights on Orion’s high-speed reentry, the views of the Moon and Earth witnessed by the crew, and what’s next for Orion on NASA’s upcoming Artemis missions in 2027 and 2028. Complimentary breakfast and networking take place before each talk.

This event Thursday, May 28, from 8:30-10 a.m. at the Ion. Register here.

May 28 – NASA Tech Talks: Texas-France Space Hub Business Accelerator Initiative

NASA Tech Talks is partnering with the Rice Space Institute (RSI) this month to host the second cohort of the Texas-France Space Hub in Houston. The hub aims to unite academic institutions and private enterprises to expand commercial space presence in both countries. Startups from the hub will present during the event, followed by drinks and networking at Second Draught.

This event Thursday, May 28, from 6-7 p.m. at the Ion. Register here.

New TMC partnership aims to grow Houston’s biomanufacturing workforce

workforce partnership

Houston is a frontrunner in the race to introduce and manufacture advanced therapeutics to the medical world. A new agreement between the Texas Medical Center (TMC) and San Jacinto College (SJC) aims to speed more experts and their technologies towards the finish line.

Earlier this month, the world's largest medical center and the nation’s second-ranked community college announced their new partnership that will set students on a path towards careers not only in life sciences in general, but also in pharmaceutical and biomanufacturing specifically.

SJC already has programs in those majors—its first graduates are now joining the workforce—but working with TMC will help the college recruit new students, as well as aid in enrollment and participation. Thanks to this collaboration, SJC students will benefit from more experiential learning and be able to transition more smoothly into the next steps in their training.

“Houston is a premier global hub for life sciences and biotechnology, and the talent we need to advance therapeutic drugs, diagnostics, and cell and gene therapy is already here,” William McKeon, the TMC’s president and CEO, said in a news release. “With more companies choosing to establish their headquarters in Houston and the daily breakthroughs happening across the TMC campus, partnering with San Jacinto College is an important step toward sustaining that momentum and unlocking even greater innovation and growth through the promising talent that already exists within our state.”

The partnership is currently slated to last two years, but the institutions have the option to extend after that.

For students, their journey to becoming scientists will likely start with Biopath @ TMC, a program that introduces high school students to biomanufacturing careers and what it takes to pursue one. Since its inception two years ago, the program has worked with more than 2,000 students around Harris County.

“This partnership exemplifies San Jacinto College’s ability to design and deliver programs that align with current workforce demands while opening doors for untapped talent across the Houston region,” Brenda Hellyer, SJC chancellor, said in the release. “TMC is a key industry leader in our region, and San Jacinto College has a unique global curriculum that provides the foundation and skills required for students to succeed and graduates to thrive in meaningful careers that will contribute to the innovation and advancement of the life sciences.”

Thanks to this new collaboration, more of Houston’s biomanufacturing workforce will soon be locally grown.

Houston legacy planning platform secures $2.5M investment, adds to board

fresh funding

Houston-based Paige, a comprehensive life planning and succession software company, has secured a $2.5 million investment to expand the AI-driven tools on its platform.

The funding comes from Alabama-based 22nd State Banking Company, according to a news release. Paige says it will use the funding to expand automation, AI-driven onboarding and self-service tools, as well as add to its sales and customer success teams.

The company was originally founded by CEO Emily Cisek in 2020 as The Postage and rebranded to Paige last year. It helps users navigate and organize end-of-life planning with features like document storage and organization, password management, and funeral and last wishes planning.

“Too many families are left trying to piece together important information during some of the hardest moments of their lives,” Cisek said in the news release. “This investment allows us to accelerate the next phase of growth for Paige by improving the product and expanding support for our members, our financial institution partners and the communities they serve,”

In addition to the funding news, the company also announced that 22nd State Banking CEO and President Steve Smith will join Paige's board of directors.

“We believe banking should be grounded in relationships and built around the real needs of the people and communities we serve. Paige brings something deeply relevant to that mission," Smith added in the release. "It helps families prepare for the future in a practical and meaningful way, and it gives the banking community new pathways to support customers through important life transitions.”

Paige estimates that $124 trillion in assets will change hands through 2048. Yet about 56 percent of Americans do not have an estate plan.

Read more on the topic from Cisek in a recent op-ed here; or listen to InnovationMap's 2021 interview with her here.

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