Celularity (CELU) is a public biotechnology company that is leading the next evolution in cellular and regenerative medicine by developing allogeneic cryopreserved off-the-shelf placental-derived cell therapies, including therapeutic programs using mesenchymal-like adherent stromal cells (MLASCs), T-cells engineered with CAR (CAR T-cells), and genetically modified and unmodified natural killer (NK) cells. Pulse 2.0 interviewed Celularity chairperson, CEO, and founder Dr. Robert Hariri to learn more.
Dr. Robert Hariri’s Background
Dr. Hariri completed his undergraduate training at the Columbia University School of Engineering and Applied Sciences and Columbia College and received his M.D. and Ph.D. degrees from Cornell University.
“I was a surgical resident and Fellow in Neurosurgery at The New York Hospital-Cornell Medical Center, and served as an Assistant Professor of Neurosurgery and Associate Research Professor of Surgery at Cornell and Co-director of the Aitken Laboratory in Neurosurgery,” said Dr. Hariri. “Prior to Celularity, I was the founder and CEO of Anthrogenesis Corporation, and after its acquisition by Celgene Corporation, served as CEO of Celgene Cellular Therapeutics. I also co-founded the genomic-based health intelligence company Human Longevity Inc. and have served on numerous public boards, including Cryoport. In 2018, I made the decision to leave Celgene as Celgene spun out Celularity to pursue new avenues of research.”
Formation Of Celularity
How did the idea for Celularity come together? “I have always been very interested in the potential of stem cells, and I often credit my oldest daughter for helping me to arrive at the idea of harvesting placental stem cells. Earlier in my career, I was a surgeon at Cornell University and on call in the ICU. My wife was having her first ultrasound, and I went to the ultrasound suite. I had seen embryos before, but for the first time, I was standing there looking at an early-stage embryo, about 8-12 weeks old, and it dawned on me that although the embryo was the size of a peanut, the placenta was a giant organ. In medical school, we were taught that the placenta was an interface between the developing fetus and the mother. I began exploring and realized the organ wasn’t designed as an interface; it was designed as a bioreactor, literally a cultivation environment. The placenta evolved as this remarkable defense system, and we’re just harnessing some of that natural power,” Dr. Hariri explained. “Part of the inspiration for creating Celularity was to create a focal point to pull together intellectual assets, human capital, and financial resources to harness the power of the placenta so that breakthroughs could be approached with the intensity needed to drive them through the clinical community, the regulatory process, and get products to patients.”
Favorite Memory
What has been Dr. Hariri’s favorite memory working for Celularity so far? “One of my favorite memories is the day our whole company celebrated our listing on the Nasdaq exchange. We originally had planned to ring the closing bell at the exchange in Times Square. Lots of preparation, buses into town, dinner celebrations after, you name it. This was all in the midst of the COVID pandemic. So as our date is closing in, new infections are soaring again due to the Delta variant. Public health officials start tightening restrictions again, and the exchange will no longer allow guests. So instead of ringing the bell, we held a fantastic celebration at our facility in Florham Park, NJ, will all our staff. We popped some champagne and celebrated our new ticker symbol – CELU – and the exciting future that lay ahead of us,” Dr. Hariri reflected.
Challenges Faced
What are some of the challenges Dr. Hariri faced in building Celularity and has the current macroeconomic climate affected the company? “The economic downturn has significantly affected the biotech and medical space, with cell therapy companies hit particularly badly, and Celularity has not been immune to this downturn. However, Celularity is uniquely positioned to weather this difficult market, as it has both the scientific capabilities and the technical infrastructure to bring new products to market,” Dr. Hariri acknowledged. “We recently have signed multiple exclusive territory agreements to distribute our products in more than 100 countries, and we will have additional deals to announce in coming months.”
Core Products
What are Celularity’s core products and features? “Celularity’s core products encompass two main pipelines: biomaterials and cellular therapeutics at various stages of clinical development and commercial application. These pipelines reflect our efforts to harness multiple properties of the placenta to develop placental-derived allogeneic products for indications where demonstrated properties could provide an advantage, both in terms of development (namely, sourcing and proliferation) and potential efficacy (or, affinity),” Dr. Hariri pointed out. “As part of the biomaterials pipeline, we currently market three wound therapy products composed of placental-derived advanced biomaterial products: Interfyl, a decellularized human placental connective tissue matrix (CTM), Biovance, a human amniotic membrane allograft to cover or offer protection from the surrounding environment in soft tissue repair & reconstructive procedures, and Biovance 3L, a human amniotic membrane allograft. We are also developing placental matrix-based products to address bone and tissue healing and degenerative disease needs.”
The success of Celularity’s biomaterial pipeline products offers the company a revenue stream that supports in part the investigational cellular therapeutics focusing on oncology, “inflammaging” (inflammation + aging), autoimmune and infectious diseases. And Celularity recently received encouraging news from the company’s distribution partner the Tamer Group to expect at least $60 million to $80 million in 2023 purchase orders for Celularity’s branded Halal-Certified biomaterial Products. The Tamer Group is a pharmaceutical and medical products distributor and manufacturer based in the Kingdom of Saudi Arabia, representing and partnering with top pharma and medical products companies, also serving the GCC and MEA regions.
Evolution Of Celularity’s Technology
How has Celularity’s technology evolved since launching? “Our knowledge of the placental stem cell multipotent properties has greatly improved since scientists first successfully used umbilical cord blood in children with Fanconi Anemia some 30 years ago. With each merger and acquisition, Celularity’s predecessors LifeBank, Anthrogenesis, then Celgene, benefited from the infusion of technological know-how and ideas to become the pioneering placental stem cell company it is today,” Dr. Hariri replied. “The advances in in-vitro culturing methods allowed us to create a highly scalable in-house GMP manufacturing process to expand and cryopreserve allogeneic, off-the-shelf cell therapy products. Moreover, we are employing recent improvements in gene editing techniques to further modify placental-derived stem cells for improved viability and honing in on therapeutic targets.”
Significant Milestones
What have been some of Celularity’s most significant milestones? “Celularity was founded in 2018 with a vision that the cellular medicines we derive from the placenta will lead to abundant and affordable treatments. We have validated this thesis time and again through our research in infectious and degenerative diseases as well as oncology. Celularity has conducted early-stage studies to determine the safety and efficacy of our proprietary allogeneic, placental-derived, off-the-shelf cell therapy platform for the treatment of aggressive cancers, including glioblastoma and multiple myeloma. Notably, we were the first company in cellular therapy to receive an IND to treat COVID-19, which we used to investigate the application of our post-partum placental-derived cell therapy (CYNK-001),” Dr. Hariri cited. “Finally, in 2021 Celularity went public and is now listed on Nasdaq under the new ticker symbol ‘CELU.’ Since going public, Celularity has investigated the use of its pluripotent stem cells to treat not only aggressive cancers but Crohn’s disease, inflammation, and the effects of aging on the body. In the last three years, Celularity has announced encouraging early-stage clinical findings of trials that examined the efficacy of postpartum placenta stem cell treatment for gastric and gastroesophageal junction (G/GEJ) cancers and AML, Influenza A Virus, and more.”
Differentiation From The Competition
What differentiates Celularity from its competition?
“Celularity is the only cell medicine company with a library of newborn cells derived from cord blood and the placenta that has the ability to produce at scale. While there are many companies investigating the application of stem cells to address a host of ailments and infectious diseases, Celularity is unique in that it’s both a developmental stage company and also a leader in research to validate these claims,” Dr. Hariri affirmed. “Celularity also has a portfolio of marketed biomaterial products that contribute revenue to support its R&D pipeline.”
Future Company Goals
What are some of Celularity’s future company goals?
A recent groundbreaking study in “Cell” has validated HIV can be cured with umbilical cord blood stem cells. The third person ever and the first mixed-race person was cured of HIV using an ‘‘off-the-shelf’’ cord blood graft with the CCR5D32 mutation, natural resistance to HIV observed in Northern European Whites,” Dr. Hariri concluded. “The use of cord blood significantly increases access to stem cell transplantation to patients with ethnic minorities with HIV infection. For years, Celularity has screened, extracted, and expanded cells with this unique mutation, foreseeing future clinical needs and positioning the company as a leading source of these cells for commercial and clinical applications.”
