coronavirus cure?

Houston biotech company gets FDA greenlight to move forward with COVID-19 stem cell treatment

Celltex is looking into using stem cells to treat COVID-19, and the Houston biotech company just got the green light to go to trials. Photo courtesy of Celltex

A Houston-based biotech company announced last week that it has gotten the approval it was seeking from the U.S. Food and Drug Administration to continue testing its COVID-19 treatment that uses stem cells.

Celltex has received approval from its Investigational New Drug application, or IND, to look into stem cells — specifically Autologous Adipose Tissue-Derived Mesenchymal Stem Cells, or AdMSCs — and their effect on COVID-19 patients.

"The FDA's approval of our IND is not only a critical milestone for Celltex, but also for everyone who has been affected by COVID-19," says David G. Eller, Celltex chairman and CEO. "I am optimistic that our findings will result in favorable outcomes that will improve lives today and for generations to come."

Celltex has been in the stem cell business for nearly a decade and has treated patients with debilitating diseases like multiple sclerosis, Parkinson's, rheumatoid arthritis, and more. Eller says he's been considering how Mesenchymal Stem Cells, or MSCs, could be used amid the pandemic.

"Throughout the entire pandemic, MSCs have shown promise for combatting symptoms and complications associated with COVID-19, and as the nation's leading commercial MSC banking and technology company, Celltex has the unique ability to transition these initial findings into a clinical trial," Eller says.

The FDA clearance will allow for a phase two trial "that will evaluate the safety and prophylactic efficacy of AdMSCs against COVID-19," according to the release. There will be 200 patients across multiple centers that will be involved in the placebo-controlled study.

Celltex offices out of the Galleria area and has laboratory operations of its wholly-owned Mexican subsidiary are located in Hospital Galenia in Cancún, Quintana Roo, Mexico. Last year, Celltex planned an expansion into Saudi Arabia and also has a presence in Europe.

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Tvardi Therapeutics Inc. has fresh funds to support its drug's advancement in clinical trials. Photo via Getty Images

A Houston-based clinical-stage biopharmaceutical company has raised millions in its latest round.

Tvardi Therapeutics Inc. closed its $74 million series B funding round led by new investors New York-based Slate Path Capital, Florida-based Palkon Capital, Denver-based ArrowMark Partners, and New York-based 683 Capital, with continued support and participation by existing investors, including Houston-based Sporos Bioventures.

"We are thrilled to move out of stealth mode and partner with this lineup of long-term institutional investors," says Imran Alibhai, CEO at Tvardi. "With this financing we are positioned to advance the clinical development of our small molecule inhibitors of STAT3 into mid-stage trials as well as grow our team."

Through Slate Path Capital's investment, Jamie McNab, partner at the firm, will join Tvardi's board of directors.

"Tvardi is the leader in the field of STAT3 biology and has compelling proof of concept clinical data," McNab says in the release. "I look forward to partnering with the management team to advance Tvardi's mission to develop a new class of breakthrough medicines for cancer, chronic inflammation, and fibrosis."

Tvardi's latest fundraise will go toward supporting the company's products in their mid-stage trials for cancer and fibrosis. According to the release, Tvardi's lead product, TTI-101, is being studied in a Phase 1 trial of patients with advanced solid tumors who have failed all lines of therapy. So far, the drug has been well-received and shown multiple durable radiographic objective responses in the cancer patients treated.

Dr. Keith Flaherty, who is a member of Tvardi's scientific advisory board and professor of medicine at Harvard Medical School, offered his support of the company.

"STAT3 is a compelling and validated target. Beyond its clinical activity, Tvardi's lead molecule, TTI-101, has demonstrated direct downregulation of STAT3 in patients," he says in the release. "As a physician, I am eager to see the potential of Tvardi's molecules in diseases of high unmet medical need where STAT3 is a key driver."

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