Overcoming the ‘perfect storm’ in regenerative medicine

The founder of Celularity shares how he weathered the downturn in biotech investment and why he believes cell therapy is the cornerstone of longevity.

Faced with a challenging investment environment, many biotech companies are facing a difficult situation, with those developing cell and gene therapies being particularly affected. While many of these companies are still a long way from generating revenue, regenerative medicine company Cellularity is fortunately positioned to support its therapeutics business with revenue from its suite of biomaterials products.

The company, which makes cell therapies based on cells derived from human placenta, recently announced that it expects purchase orders for regenerative biomaterials in the Middle East alone to be up to around $80 million in 2023. This week, the company received its first purchase order totaling $45 million.

Longevity.Technology: Leveraging the therapeutic potential of cells and biomaterials contained in the postpartum placenta, Celularity boasts multiple cell therapy candidates in clinical development. Longevity is its focus area, with programs for autoimmune and degenerative diseases. Cellularity’s placenta-derived biomaterial products are also being applied to longevity applications in areas such as orthopedic disease and cosmetic regeneration. To learn more about how the company is progressing during difficult times for biotechnology, we spoke with Founder and CEO Dr. Robert Hariri.

A lot has happened since we last spoke with Hariri, but he is quick to acknowledge the investment challenges facing the sector today.

“Cell medicine, which used to have a huge following and a lot of investment, is having an even bigger impact than biotechnology in general,” he says. “Capital markets have seen a huge drop in the value of this sector, and many of us struggle to understand the reasons behind it. Businesses that require access to large amounts of capital in the US are likely to be particularly affected.”

Overcoming the 'perfect storm' in regenerative medicine
Dr. Robert Hariri is the Founder and CEO of Cellularity.

“It’s a perfect storm of too many companies, with limited capital due to risk aversion by technology investors, and the path to commercialization of cell medicines is probably less clear today than it was a couple of years ago. However, once the market starts to recover, we are confident that the cell and regenerative medicine field will become attractive again.”

While some well-capitalized regenerative medicine and cell therapy companies have filed for bankruptcy or closed entirely, Hariri said the tough economic climate is also an opportunity.

“Over the next 12-24 months, efforts will be made to consolidate the industry by consolidating companies with complementary or viable technologies to create a greater critical mass – greater viability. I’m worried about whether or not,” he explains. “This could also help contain the high cost of developing cell therapy products. With 300 cell therapy companies, the sector is diluted with capital, human resources and infrastructure.” But when you consolidate a few companies or find ways to consolidate, you get efficiency.”

Biomaterials earnings support R&D

Hariri says the perfect storm in regenerative medicine is creating an environment in which cell therapy companies, including Cellularity, are becoming capital conservative and need to narrow their programs down to those with the best chances of success and quick onboarding. said to have produced

“But what makes us unique is that we are the only company in the cell medicine field with a diverse technology platform based on a single raw material.” [postpartum placentas]says Hariri. “This allows us to be both a commercial-stage company and a research-and-development-stage company in terms of cell therapy. We are ready to survive this situation in a way.”

Cellularity has been aggressively building revenue-generating opportunities, as evidenced by recent announcements in the Middle East.

“We recognize that there are certain markets that are less sensitive to macroeconomic conditions,” Hariri said. “The Middle East and Asia, for example, have very strong economies even at this time when the global economy is contracting. So we’re very excited about what we’re doing in the Middle East and our relationship in Asia.”

Cell medicine is the “foundation” of longevity

Celularity’s focus on revenue generation does not mean the company will put therapeutic activity on the back burner. Far from it.

“Cytomedicine is potentially very versatile,” says Hariri. “Cellular products can be used to treat life-threatening diseases such as cancer and devastating lifelong diseases such as inherited metabolic disorders.”

Hariri says cell medicine is an “intuitively logical” approach to treating disease and has potential across a wide range of diseases.

“I believe that the same targeted CAR-T approach that we use for cancer will also be used to treat autoimmune diseases and potentially degenerative immune diseases. I am,” he says. “I also believe that cell therapy may be the most effective tool in fighting infectious diseases. , will be a big field in the future.”

But Hariri also believes that cell medicine is “a foundation for improving future health and longevity.”

“The biology is clear: we age in part due to molecular and cellular defects that accumulate over time. This accumulation increases the average age of all cells in our body.” It slowly increases until it can no longer meet the biological needs of a youthful, active and healthy body.”

Targeting frailty and sarcopenia

Deciding which aspect of longevity to focus on first is a key issue for any company in this space. Age-related diseases are a vast and diverse field, requiring companies to carefully consider optimal clinical goals to ultimately demonstrate clinically meaningful benefits that can be leveraged across a range of indications. .

“When it comes to longevity and age-related disability, we believe that the optimal indication for cellularity is associated with age-related frailty,” says Hariri. “Sarcopenia, the loss of skeletal muscle mass and function, is a component of a great many different diseases, including chronic neurological diseases. We know that it is associated with resistance to cancer and resistance to cardiovascular disease.”

Cellularity has confirmed, both preclinically and clinically, that placenta-derived stem cells are effective in improving muscle tissue quality.

“Our initial observations were made in a preclinical model, but then later in a study of placental cells used to treat non-healing wounds in patients, we found that improving circulation to the tissues improved muscle quality. We’ve shown that it can improve: the ability of muscle tissue to repair and build,” says Hariri. “These observations solidify the potential role of these therapies in sarcopenia, or age-related sarcopenia. Because there are several different possible approaches.”

Hariri is “very confident” that he expects Cellularity to have a clinical candidate for frailty by 2024.

“We intend to investigate improving muscle mass and improving muscle function in a target population with age-related frailty or other causes of sarcopenia, such as neuropathic, metabolic or hereditary.” he says

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