Overcoming the ‘perfect storm’ in regenerative medicine

Celularity founder on weathering the biotech investment downturn, and why he believes cell therapy is the cornerstone of longevity.

In the face of a challenging investment climate, many biotech companies are facing difficult times, and companies developing cell and gene therapies have been particularly affected. While many such companies are still a long way from becoming revenue-generating, regenerative medicine company Celularity is in the fortunate position of being able to support its therapeutics business with income from its range of biomaterials products.

The company, which bases its cellular therapies on cells derived from the human placenta, recently announced that it was expecting purchase orders for its regenerative biomaterials in the order of up to $80 million in 2023 from the Middle East alone. This week, it received its first purchase order, amounting to $45 million.  

Longevity.Technology: Tapping into the therapeutic potential of cells and biomaterials contained in the postpartum placenta, Celularity boasts multiple cell therapy candidates in clinical development, and longevity is a key area of its focus, with programs in autoimmune and degenerative diseases. Celularity’s placental-derived biomaterial products also have longevity applications in areas such as orthopedic disease and regenerative aesthetics. To learn more about how the company is progressing amid troubled times for biotech, we spoke to its founder and CEO, Dr Robert Hariri.

A lot has happened since the last time we spoke with Hariri, and he is quick to acknowledge the investment challenges now facing the field.

“Cellular medicine, which was previously in tremendous favor and heavily invested in, has really taken it on the chin, even to a greater extent than biotech in general,” he says. “The field has been severely devalued in the capital markets and a lot of us are struggling to understand the reasons behind that. It seems that developmental stage technology is particularly affected – businesses that demand access to large amounts of capital at high valuations in order to thrive.”

Overcoming the ‘perfect storm’ in regenerative medicine
Dr Robert Hariri is the founder and CEO of Celularity.

“It’s been a perfect storm of too many companies, limited capital due to risk aversion among technology investors, and the fact that the pathway to commercialization for cellular medicine is perhaps less clear today than it was two to three years ago. But we’re certain that when the market starts to recover, this cellular and regenerative medicine space is going to be attractive again.”

While some richly capitalized companies in regenerative medicine and cell therapy have either filed for bankruptcy or shut down entirely, Hariri says that challenging economic times like this can also present opportunities.

“I’m anxious to see whether the next 12 to 24 months may see efforts to consolidate the industry by putting companies that have either complementary or enabling technologies together to create greater critical mass – greater survivability,” he explains. “This could also help control the high cost of developing cell therapy products. When there are 300 companies in cell therapy, the field is diluted to capital resources, human resources, and infrastructure. But when you combine or find ways to consolidate some of the enterprises, you create efficiency.”

Biomaterials revenues support R&D

The perfect storm in regenerative medicine, says Hariri, has created an environment where cell therapy companies, including Celularity, have had to become capital conservative and whittled down their programs to those with the highest probability of success and potential for fast registration.

“However, what makes us unique is that we are the only company in cellular medicine that has a diversified technology platform grounded in one raw material [postpartum placentas],” says Hariri. “That gives us the ability to be both a commercial stage company as well as a developmental research stage company on the cell therapy side. And so, we’re prepared to weather some of this in ways that a lot of other companies have not been able to.”

As evidenced by its recent announcements in the Middle East, Celularity has been aggressively building on that revenue generating opportunity.

“We recognize there are certain markets that are less sensitive to macroeconomic conditions,” says Hariri. “The Middle East and Asia, for example, have very strong economies, even in this period of global contraction. They’re taking advantage of that to get into technologies where, in the past, they were seen as followers, not leaders. So, I’m very excited about what we’re doing in the Middle East, and about our relationships in Asia.”

Cellular medicine the ‘cornerstone’ of longevity

Celularity’s focus on generating revenue does not mean the company has put its therapeutic work on the back burner. Far from it.

“Cellular medicine is potentially so diversely powerful,” says Hariri. “Cellular products can be used to treat life-threatening diseases like cancer and devastating lifelong diseases like inherited metabolic disorders.”

Hariri says that cellular medicine is an “intuitively logical” approach to treating disease, which holds potential across a wide spectrum of diseases.

“I believe the same targeted CAR-T approach we use in cancer will be used in treating autoimmune diseases, and potentially, even degenerative immunologic diseases,” he says. “I’m also convinced cell therapy could be the most effective tool in the battle against infectious disease. Augmenting the immune system – refining and targeting the immune system against specific infectious agents – is going to be a big area in the future.”

But Hariri also confident that cellular medicine is “the cornerstone to improving our healthspan and our lifespan going forward.”

“The biology is clear: we age, in part, because of the accumulated molecular and cellular defects that occur over time. This accumulation takes the average age of every cell in our body, and slowly increases it to a point that it no longer can accommodate for the biological needs of a of a youthful, active, healthy body.”

Targeting frailty and sarcopenia

Deciding what aspect of longevity to focus on first is a key question for any company in the field. Age-related disease is a vast and diverse area, and companies need to carefully consider the best clinical targets to demonstrate clinically meaningful benefits that could ultimately be leveraged across a range of indications.

“When it comes to longevity and age-related disorders, we believe the best target indication for Celularity is associated with age-related frailty,” says Hariri. “Sarcopenia, the loss of skeletal muscle mass and function, is a component of so many different diseases, including chronic neurologic disease. We know that maintaining healthy lean muscle mass and quality is associated with long life, resistance to cancer, and resistance to cardiovascular disease.”

Celularity has seen, both preclinically and in the clinic, that stem cells derived from the placenta had an effect of improving the quality of muscle tissue.

“Our first observations there were in preclinical models, but then subsequently, in studies of our placental cells being used to treat non healing wounds in patients, where we showed we could improve the quality of muscle by improving circulation to the tissue, and also improve the ability of muscle tissue to recover and build,” says Hariri. “Those observations cemented the potential role for these treatments in sarcopenia – namely age-related sarcopenia. It’s an area we are aggressively going to pursue, because we have a couple of different approaches that we think are going to be important.”

Hariri expects, with a “fair degree of confidence,” that Celularity will have a clinical candidate in frailty by 2024.

“We’re going to look at improving muscle mass and improving muscle function in a target population that has either age-related frailty, or some other source of sarcopenia, whether it be neurogenic, metabolic or inherited,” he says.