Celularity is a clinical-stage cell therapeutics company delivering transformative allogeneic cellular therapies derived from the postpartum human placenta. Using proprietary technology in combination with its IMPACT™ platform, Celularity is the only company harnessing the purity and versatility of placental-derived cells to develop and manufacture innovative and highly scalable off-the-shelf treatments for patients with cancer, inflammatory and age-related diseases.
Founded on the pioneering work of Robert Hariri, MD, PhD, in human placenta-derived cellular therapeutics and biomaterials, Celularity is uniquely positioned to harness the potential of most biocreative event on earth: human birth.
In August 2017, Hariri brought Celularity Inc. into the spotlight by announcing a Series A financing with contributions from influential investors, including Celgene Corporation, Sorrento Therapeutics, United Therapeutics Corporation, and Human Longevity, Inc. Six months later in February 2018, the company announced it had raised over $270 million in funding, with contributions from the Genting Group, Tony Robbins, and Dreyfus Family Office, among others.
In early 2018, I first met and interviewed Celularity’s CEO, Dr. Robert Hariri, a pioneer and visionary within the stem cell industry. Over the past year and a half, the company has dramatically accelerated development of its investigational placental derived NK- and T cell-based allogeneic cell therapy programs in oncology.
Today, Celularity’s Placental Cell Derived Natural Killer Cell Therapy (PNK-007) is the only allogeneic, off-the-shelf NK cell therapy being developed from placental hematopoietic stem cells (HSCs) as a treatment option for hematologic cancers and solid tumors. CYNK-001 is a cryopreserved formulation of its PNK-007 cells. As a platform technology company, it is also developing genetically-modified therapies, placental-derived exosomes, and placental-derived adherent cells, among other programs.
For our latest interview, I was invited as a guest to Warren, New Jersey, to visit Dr. Hariri and his team in person, where I experienced the buzzing energy that characterizes the company’s headquarters. In our discussion below, Dr. Hariri and I explore recent changes at Celularity, progress across its clinical programs, and its future directions as we approach 2020.
I hope you enjoy this conversation as much as I did, because Dr. Hariri is not only the CEO of Celularity, but also a high-performance jet pilot, a rocket scientist, a brain surgeon, an inventor, a biomedical scientist, and serial entrepreneur. Previously, he was the Founder and CEO of one of the world’s largest human cellular therapeutics companies, Celgene Cellular Therapeutics, a division of Celgene Corporation. For these reasons and the ones you’ll learn below, Dr. Hariri is distinctively suited to lead Celularity as it introduces a new wave of transformative allogeneic cellular therapies, engineered from the postpartum human placenta.
Interview with Dr. Robert Hariri, CEO of Celularity, Inc.
Cade Hildreth: What is the start-up story of Celularity and what inspired you to create it?
Dr. Robert Hariri: Celularity is the successor company to the Celgene Cellular Therapeutics Division, which was created after the acquisition of a private startup company that I built called Lifebank Anthrogenesis. It’s mission early was to interrogate the postpartum placenta as an ethical, moral, non-controversial source of stem and progenitor cells for the emerging regenerative medicine field.
The cellular medicine world originated with concepts about the biology that we’ve begun to reshape based upon what we know from clinical experience and from extensive primary research, which is that stem cells are not a miniature organ or tissue transplants. Rather, they act as biological response modifiers and secretory sources that help to drive biological processes associated with immunity, immune function, and pro-regenerative processes. In short, they are master orchestrators.
The company that I founded was the first player to recognize that the placenta is an essential source of cells for a variety of logistical and economic reasons. We realized that under the right systems and controls, we could procure these organs at birth, with great attention to quality, as well as exceptional care to the collection of clinical data and medical history data. We could subject them to rigorous quality controls. We could create stringent inclusion and exclusion criteria, and thereby ensure that the finished products entered at such a high quality that we had confidence in how they would exit our manufacturing process. Unless cell therapy begins to approach the standards of small molecules and biologics, it will go the way of other brilliant technologies that are not scalable or deployable, like organ transplantation.
Celularity was fortunate to have originated as a company that Celgene bought to become its Cell Therapy Division. When the business matured to the point that certain clinical-stage assets relevant to Celgene’s oncology portfolio could be focused on within Celgene and the balance could be spun out into an independent company, that gave rise to the origin of Celularity.
As Celgene’s first spin-off company, Celularity is designed to be a nimble, fast-paced execution-oriented business, leveraging all of the unique biologics of the placenta, namely the immunomodulatory behavior and the progenitor behavior in clinical areas that include but are not limited to cancer.
Cade Hildreth: This is a fascinating backstory. While I have had the pleasure of seeing you several times, I haven’t had the opportunity to re-interview you since early 2018. What has changed the most since February 2018 when you announced the launch of the company with $250 million in financing from highly regarded investors, including the Genting Group, Tony Robbins, and the Dreyfus Family Office?
Dr. Robert Hariri: Like any early developmental stage company, the first year is a formative year where you’re establishing operations and infrastructure. As a company that was spun-off of a large company, there were many housekeeping prerequisites to make sure that we could operate independently of any previous Celgene operations. So, we pursued the completion of our clinical trials in acute myeloid leukemia (AML) and multiple myeloma (MM) to prepare for our attention toward our immuno-oncology program, which is our Natural Killer (NK) cell program.
Our PNK program, which stands for “Placental Natural Killer cell,” was originated in our early observation that the placenta had a unique ability to defend against malignant transfer from a mother who had cancer. We recognized that the natural killer cell might play an essential role in that.
Thus, we created a methodology to produce the cells, then “productize” them and leverage them as treatments for specific cancers. As a result of our clinical studies, we saw that not only is the product very well tolerated and quite safe, but the cells retain very significant anticancer activity, which is useful in approaching hematologic malignancies.
Based on the analysis of our data, we are preparing to launch our Phase II studies in these diseases. And in fact, we are thrilled to announce that this past month, the FDA cleared our landmark Investigational New Drug (IND) application for CYNK-001 in patients with glioblastoma multiforme (GBM). This IND represents a significant step toward a potential immunotherapy option that is more accessible and tolerable to patients with glioblastoma multiforme, and to deliver the next-generation of scalable, high quality immunologic approaches for the treatment of devastating cancers.
Cade Hildreth: Fantastic, you have certainly made exciting progress over the past 18 months. I’ve also been extremely interested to ask after your lead products and their stages of development.
Dr. Robert Hariri: Our lead product is an evolution from PNK-007. It’s CYNK, which is our validated cryopreserved version of PNK. The Placental Natural Killer (PNK) cell that was in the original Phase I trial is a fresh product. It hasn’t been cryopreserved. However, for our business model, we want to develop off-the-shelf, long inventory potential, Natural Killer (NK) cells and other placental cells that are fully allogeneic.
Immuno-oncology has come of age with autologous Chimeric Antigen Receptor T-Cell (CAR-T) therapies. It’s a wonderful proof of concept and demonstration of the clinical relevance of that approach. Unfortunately, it doesn’t have the requisite elements to scale the technology and make it economically viable in a comprehensive healthcare system. To date, no more than an estimated 1,000 to 2,000 patients have received CAR-T therapy. It’s a small number. You’d think that upon regulatory approvals, a revolution like this would become far more broadly deployed. It hasn’t been because of the logistic and economic limitations.
For Celularity to have a meaningful impact on cancer, we need an approach that will fit the healthcare system without breaking the bank. Within the current healthcare environment, that is an allogeneic off-the-shelf product.
Cade Hildreth: That makes perfect sense. I believe you also have a pEXO product that is based on placental-derived exosomes. Because the volume of research pertaining to exosomes is expanding exponentially, could you please tell me more about it?
Dr. Robert Hariri: Celularity is considered a startup company. We’re attractive to the finance world as a developmental stage company. We have two decades of experience in everything from the isolation, characterization, and manufacturing of cells from the placenta. Because we do the production ourselves, we very early on identified that as a byproduct of manufacturing and other processing, we produce exosomes. Exosomes are unique because, as non-cellular products, they can be mass-produced and subjected to rigorous quality control standards. In specific setting, they are an ideal companion or substitute for direct cell therapy.
The placenta is nature’s stem cell factory. It’s also nature’s exosome factory. Now, we’ve created methodologies where postpartum, this placenta when subjected to processing, can yield enormous quantities of dose-able exosomes. Once you produce them, you can characterize, quantify, and subject them to release specifications. As a result, you have a therapeutic product with a different regulatory status and profile. With such a unique economic profile, we’ll potentially be able to do many of the therapeutic goals that we would want to achieve with cells, but with a product that is exceptionally convenient to deploy and may have certain advantages in terms of safety and toxicity.
Cade Hildreth: That is a fascinating approach to leveraging a manufacturing byproduct. What is your IMPACT™ Platform and how does it create Celularity’s diverse range of placental-derived cellular products?
Dr. Robert Hariri: Celularity was one of the first companies in cell therapy to recognize that cells are a great product, exosomes are a great product, but the process is also the product. Because the processes are products, controlling the manufacturing, the quality control systems, the release specifications, the packaging, and the clinical delivery, make for an efficient, seamless process that delivers clinical candidates from product candidates.
If possible, it also creates incredible leverage by allowing for a uniform, reliable and reproducible process. The IMPACT™ Platform was designed to give us a predictable pathway from product candidate to clinical candidate and to speed up and create economic efficiency in getting products to patients. Once you get good at producing cells from a particular source material, such as the placenta, all you need to do to change the product, and ultimately the clinical candidate, is to modify an element of the manufacturing. You can keep the “backbone” of manufacturing process stable and introduce only one or two modifications, which is cost-effective because you don’t have to re-engineer your entire process all the time.
The toughest part about producing these products is creating a reliable, predictable manufacturing system that can be subjected to rigorous process development and release controls and then sticking to it. Once it’s built, you enter the raw material into a funnel on one end, and if at the other end, you come out with a clinical-grade product seamlessly across multiple candidates, then your developing costs go down dramatically. Also, the speed to the clinic is much faster. That’s the whole logic behind the IMPACT™ platform.
Cade Hildreth: That makes perfect sense. I heard that Celularity recently signed a long-term lease on a 145,000 sq. ft. advanced cell manufacturing and research facility in Florham Park, New Jersey, to which you’ll be moving your headquarters in 2020. What was the importance of this decision?
Dr. Robert Hariri: Because Celularity is a spin-off of Celgene Corporation, we occupied some legacy Celgene real estate, which we took over. While it has been a beautiful home for our developing company, we are now moving toward late-stage clinical trials, and ultimately, commercialization. Within this context, we recognize the importance of manufacturing and having our R&D co-located with it and other elements of our business.
For this reason, we made the strategic decision to invest in world-class a headquarters in Florham Park, New Jersey, that will co-locate all of our business elements and cover all of our predicted manufacturing and operational needs. An excellent way to think about this is, you won’t be successful if you don’t plan for success. So, you create an organization that is much more likely to get you across the finish line. When you provide the right environment, infrastructure and support, your rather busy teams can focus on the job, instead of their work environment.
For example, Silicon Valley recognizes that the environment in which you put the highest quality people not only speaks to the corporation’s commitment to those folks, but it also yields much higher productivity. That’s the philosophy we had in mind while designing and building this facility.
It is going to be geographically located right between our current two facilities. One is in Cedar Knolls, one is in Warren, and this will be in Florham Park. It’s in an exceptionally lovely environment — a corporate park with a Cancer Center. We’re happy to be close to the Jets Training Center. For football fans, that’s great. It’s also co-located with conference centers in hotels for traveling employees and visitors. It’s got great proximity to highways, so it’s convenient. And, I’m a beneficiary, as it’s very close to an airport that I fly in and out of with high frequency.
Cade Hildreth: Did you ever consider using a third-party contract manufacturing partner (CDMO) or was it always clear that Celularity would control the full manufacturing process for its placental-derived products?
Dr. Robert Hariri: I’ve always believed that controlling manufacturing is not only essential to the security and integrity of your intellectual property (IP), but it’s also the best place to learn and make improvements that will ultimately help to differentiate and distinguish you from your competitors. Because the process is also the product, we wouldn’t want to be paying someone else to learn how to circumvent our IP.
Cade Hildreth: Understood and I appreciate your logic. What is the impact of the team that you have assembled at Celularity, including the role of your Co-Founder, Peter Diamandis?
Dr. Robert Hariri: I feel genuinely privileged to have attracted people like John Sculley, the former CEO of Apple, Dr. Andrew Von Eschenbach, the former commissioner of the FDA, Dr. Andrew Pecora, one of the foremost authorities in Cellular Medicine in Oncology, and my Co-Founder, Peter Diamandis.
These people are not only fully engaged and vested in the company, but they have also been remarkable supporters. They’ve been exceptional mentors and sounding boards for me. They provide such a credible voice on the outside that I think it speaks well for the company. We are even considering broadening the Board of Directors with additional world-class folks. In my experience, the board is either the most significant sponsor and ally to a CEO, or under bad condition, the biggest burden. I’m extremely fortunate in that our board provides extraordinary support for me as the CEO and across the organization, perhaps the best that I’ve ever seen within the industry.
I’m particularly excited, because like many companies, we’re contemplating our future as a public company. There are the times where such individuals – their voice, guidance, and recommendations – will help to set realistic objectives that are not only achievable, but which will be perceived as big value drivers for Celularity. So, I’m incredibly fortunate.
We have who I consider to be the best Chief Science Officer (CSO) within the field, Dr. Xiaokui Zhang. She’s been with me for almost 15 years! She is one of the smartest and best leaders I’ve seen. She is a steady deliverer of high performance and has attracted exceptional team members around her. I’m extremely fortunate to have her.
We’re building the organization with new people in areas like Quality, Regulatory and Legal. As a company that’s so dependent upon its human capital, we have a very strong foundation to build upon.
Cade Hildreth: That’s indeed an impressive team! What are your five-year goals for the company and the clinical timelines for Celularity’s products under development?
Dr. Robert Hariri: We have powerful ambitions around our programs. My five-year objectives are to take our Natural Killer Cell (NK) platform and the cryopreserved CYNK platform forward to registration in at least one liquid tumor in the next five years, and subsequently, to get registration for that platform in solid tumors.
We also have a genetically-modified version of our cryopreserved CYNK product (GM-NK). This product will demonstrate not only our proficiency in amplifying the potency of our cells with genetic modifications, but also confirm that as a platform technology company leveraging post-partum placental cells, that we can be nearly agnostic about the tool sets which get applied. That is, we could potentially pair nearly any cellular methodology with our unrivaled source of cells.
If the winner in this industry will be the company that can produce the most scalable and rapidly produced products with the best economics, Celularity will be very hard to beat.
I also believe that as the targets are validated in other programs and studies, that progress will allow a lot of the heavy lifting to be done for us. Thus, we can come in with a better, faster, and much more economical alternative that uses a much better safety profile and meets the speed-to-scale requirement.
Our Board Member John Sculley speaks to what he thinks is essential, which is a systemic transformation. Our platform and approach represent a true systemic, transformative approach to cellular medicine. I do believe that unless you can create products that meet the scale, the logistics, and financial requirements of a very strained healthcare system, you may never be successful.
As exciting as autologous CAR-T therapy is, what we hear now mostly is concern and dissatisfaction, because of the cost and the overall impact and drain on an already strained healthcare system. The other thing is that the safety profile of these products will factor into clinical selection. For example, a product that might have high efficacy, but be saddled with a toxicity profile or adverse event profile, requiring intensive care or adjunctive therapy. In that case, some clinicians will make choices not to support the technology. In contrast, if you have a product with an excellent safety profile that can be dosed serially over time and can be available as an off-the-shelf product, those advantages will support the selection of that product alternative over existing options.
Cade Hildreth: I wholly agree with that. From your perspective, what contributions will Celularity make to the fields of Cellular and Functional Medicine at large?
Dr. Robert Hariri: I believe that our cellular therapeutic approach is not an isolated strategy in the management of disease, but rather one that is naturally complimentary. The impact we hope to have is that we will be able to work with companies that are advancing novel antibodies, biologics, and small molecules (things like checkpoint inhibitors and so on), because our products work in concert, and in fact, could even potentiate the effects of these other therapeutics.
For the Pharma Industry, we want to be a great partner. Because we are a platform technology company, our natural progression will be to enter into collaborative dialogues to examine the combined benefits of our technology with existing and emerging technologies. We will then look at how the combinatory approach will impact outcomes and the overall cost of care. That’s one way I think we’re going to have an impact. We’re also chasing severe unmet medical needs, harmful diseases with adverse outcomes. We are aiming to take previously untreatable cancers and turn them into treatable, manageable cancers.
In my mind, cell therapy means that you have a tool that can be used to control and ultimately manage a disease over a long period. I believe that cellular medicine is going to have a significant impact on the future of human performance and lifespan. Part of my big dream is to be able to exploit the pro-regenerative and, in some cases, the rejuvenating effect of stem cells to support the biology of aging individuals. There’s a lot of data to support this approach. In some of my earlier work which looked at stem cell levels in organs and tissues as a function of age, there was a clear correlation between age and the number of healthy stem cells. The obvious conclusion one could come to would be to that we need to restore the number and quality of stem cells in order to restore youthful function.
As it turns out, in experiments with animals, that works. You can give animals back stem cells which were collected at birth and those animals will live longer and have better physiologic and anatomic performance. That may be the most effective, efficient way to address the predictable, inevitable changes that occur as we age.
Because cell therapy of this nature, when administered locally or intravenously, has a clear safety profile, one could imagine preserving health and delaying disease and death by simply maintaining a high integrity reservoir of stem cells throughout your life as you age. That’s a straightforward therapeutic approach! I could envision a time when patients will get infusions of stem cells annually or biannually, and we then measure the physiological changes within the individual to track efficacy on per patient basis. For me, that’s a big end game.
Cade Hildreth: That would be incredible, because we are all marching one direction along the time continuum, that is, aging. One of the things that that I’ve noticed about you is that you’re an energetic and passionate leader. What inspires you most about your role as the CEO of Celularity?
Dr. Robert Hariri: This is the hardest job I’ve ever had, and it is the most inspiring and exciting place to be. In some ways, I’m an evangelist, but if I can convince people that what we’re doing here is a noble cause, and that hopefully it will be commercially successful and economically rewarding, the impact it could have on our healthcare system could be systemically transformative.
It could wind up changing the expectations for someone who receives a dire diagnosis. If we can navigate our way into everyday things like age-related degenerative processes, we could reshape the healthcare system. With tools that are far more cost-effective, safer, and better tolerated, we could have a critical impact on the quality of life in contrast to current approaches.
The basis behind immunotherapy for cancer is using the immune system to do its job of defeating cancer or controlling degenerative diseases or immune disorders. Using the immune system to do that is an intuitively logical goal. We all know the impact of treating cancer with the most toxic agents. Even though you can reduce tumor burden and extend the life of patients, you need to look at the whole equation. What does it do to a person’s overall quality of life, their ability to return to work and to return to meaningful, healthy homes? All of that must be taken into consideration. I do believe that cellular therapy is going to be better at this than our conventional approaches.
Cade Hildreth: What types of partners would you like to hear from based on Celularity’s collaborative approach?
Dr. Robert Hariri: Celularity is fortunate to have fascinating dialogues ongoing with some major potential pharmaceutical partners. We have strategic investors from Big Pharma with whom we have quite a close relationship that will lead to many co-development events that will shape our company, as well as the partner company. We’re also open to hearing from any players within the allied industries, including players who are developing cellular engineering tools or genetic engineering tools. We want to talk to companies that are disease-focused and looking for supplemental approaches to inadequately managed diseases.
We’re also open to talking to other peer companies within our field. Cellular therapy is so big and so revolutionary that it’s going to be shaped not just by individual progress and individual companies, but by collaborations. There is no reason why great companies with a similar or parallel mission to what we do can’t one day be an essential partner, or even ultimately, we could all become part of the same company.
I’m a very inclusive person and a big believer that a team often is the best way to achieve a goal. There are several micro small and mid-size companies in the space. You’d be surprised at how different transactions, like mergers and acquisitions between these companies, could create more powerful, efficient, and durable business constructs for getting our patients served. For this reason, when it comes to partnerships, collaborations or licensing agreements, we have an open-door policy and will talk to everybody. I would love people to visit the website (Celularity.com) and also use our social media resources to communicate with us (Twitter: @Celularity; LinkedIn: Celularity, Inc.)
I am a big believer that people today can be informed about day-to-day breakthroughs at their fingertips. I am a follower of yours on LinkedIn and Twitter, and I am fan of those tools because it is bidirectional communication. People can also feel very comfortable reaching out to us via email or calling us.
Cade Hildreth: This has been an incredible honor and I can’t wait to share your corporate and clinical progress with our audience.
Dr. Robert Hariri: Listen, for me this is a real treat. I always enjoy getting to know you and I am a big fan of your work. Thank you as well.
Related: 2018 Interviews with Dr. Robert Hariri
- Robert Hariri – Placental Pioneer Launches Celularity with $250M Cash
- Celularity – Big Bucks, Billionaire Investors, Bold Dreams
Do you have other questions about Celularity? Ask them in the comments below and we’ll share answers.