Robert Hariri: Affordable Placenta-Based Cell Therapies

Iovance Biotherapeutics has set the price of its newly approved cell therapy, Amtagvi, at $515,000. Similarly, Bristol Myers Squibb’s CAR-T treatment, Breyanzi, which gained FDA approval for additional indications in March, is listed at approximately $487,000. These high prices are a concern for Robert Hariri, a pioneer in regenerative medicine and the CEO of Celularity, who warns that such costs could hinder the widespread adoption of cell therapies.

Hariri, who founded Celularity, a company specializing in stem cells derived from placentas, criticizes the economic feasibility of CAR-T therapies that use patients’ own cells. He argues that these therapies will not become a scalable healthcare solution until they align with economic constraints. Instead, Hariri sees greater potential in therapies derived from donor cells, particularly from placentas, which he describes as “nature’s professional and universal donor.”

Hariri's journey in regenerative medicine began in 2000 when he discovered placental pluripotent stem cells while establishing Anthrogenesis, later acquired by Celgene. His interest in stem cells then expanded to slowing the aging process, leading him to co-found Human Longevity in 2013 with Craig Venter and Peter Diamandis. In 2016, Celgene spun off Celularity, where Hariri now focuses on using placental stem cells to treat various diseases, including cancer and autoimmune conditions. The company is advancing therapies for Crohn’s disease and facioscapulohumeral muscular dystrophy through early-stage trials.

Predicting that cell therapies will soon surpass biologics in treating autoimmune diseases, Hariri laments the industry's rush towards oncology due to the CAR-T revolution, which he believes has slowed progress in other areas.

Apart from his medical ventures, Hariri is also an aerospace entrepreneur and a licensed pilot, with the distinction of having flown with the renowned astronaut Buzz Aldrin.

Hariri emphasizes the necessity of making cell therapy cost-effective. He believes that for these therapies to be meaningful in medicine, they must not only transform patient outcomes but also fit into an already strained healthcare system economically. This conviction has guided his work ever since human embryonic stem cells were discovered in the late 1990s.

During his fellowship at Weill Cornell Medical Center, Hariri saw the potential of these cells in restoring motor function in severely injured patients. However, the use of embryonic stem cells faced ethical opposition and supply quality issues, making commercialization challenging. Hariri then found a more consistent quality in cells derived from postpartum placentas, which also offered an environmentally friendly solution by repurposing what would otherwise be medical waste.

This approach attracted significant attention, including from the Roman Catholic Church, which awarded Hariri the Pontifical Medal for Innovation in 2018. Celularity's placental stem cell technology also received halal certification, facilitating its operations in Muslim-majority regions.

Hariri asserts that medical treatments must align with societal norms to be effectively implemented without resistance. For Celularity, Crohn’s disease was an obvious target for placental-derived treatments, given the observed remission of autoimmune diseases during pregnancy. Their Phase I trial showed promising results in reducing inflammation and fistulas in Crohn’s patients.

Celularity is also developing a therapy for facioscapulohumeral muscular dystrophy, with a Phase I/II study slated to start this year. The company has requested FDA orphan drug designation to accelerate its development.

Despite these advancements, Celularity faces financial challenges, having laid off 188 employees in March 2023 following a significant drop in its stock price. The company executed a reverse stock split to remain listed on Nasdaq. Although the global placental stem cell market is projected to grow significantly, no such therapies have yet received FDA approval.

Hariri envisions placental cells as a key to combating aging, a vision that motivated the creation of Human Longevity. Celularity is also exploring the potential of placental natural killer (NK) cells to eliminate senescent and harmful cells, which could mitigate age-related diseases. Hariri suggests that enhancing the immune system through cell therapy could have widespread health benefits as individuals age.

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