This is an interview with Patrick Lucy, President and CEO of Lykan Bioscience. Lykan is an innovative cell therapy-focused contract development and manufacturing organization (CDMO) headquartered in Hopkinton, MA. In this interview, we discuss the vision of Lykan Bioscience, its innovative and agile approach to CDMO services, and the company’s future goals. Enjoy!
Cade Hildreth: What was your professional path before you joined Lykan Bioscience?
Patrick Lucy: After spending the first decade of my career in operational roles in biotechnology including Quality Control, Validation and Capital Project Management at Repligen Corporation, Celltech Biologics and Lonza Biologics, I transitioned into business/corporate development. During the 20 years prior to joining Lykan I was the Chief Business Officer at Pfenex Inc. Pfenex was initially incubated within The Dow Chemical Company (Dow) and was eventually spun out of Dow in 2009 creating an independent, venture backed biotechnology company.
I oversaw the evolution of Pfenex’s commercial strategy which evolved over time to expand the reach of the company’s platform technology. After starting as a fee for service process development and technology licensing business, we subsequently evolved into a biosimilar/therapeutic equivalent product developer and then in the final iteration we became an innovative biotechnology company with aspirations to develop nanobody based therapeutics.
In October 2020 Ligand Pharmaceuticals acquired Pfenex for up to $516 million and at that time we had developed a diverse portfolio that included wholly owned products, technology licenses and product development partnerships.
Cade Hildreth: That is an extensive professional background. Out of curiosity, when and why was Lykan formed?
Patrick Lucy: Lykan Bioscience was founded on a vision to revolutionize cell therapy development and manufacturing, to help reach more patients, faster.
With decades of experience in biotechnology and cell therapy, Lykan’s founding team identified an opportunity to positively impact the development and delivery of innovative cell-based therapies. With their experience and learnings in hand, our founding team asked themselves “if we could do it again using what we know now, what would we do differently?” Based on that premise, Lykan Bioscience was born.
Although the vision for Lykan emerged in 2016, the idea became a reality in 2019 when funding was secured from Windrose Health Investors and other seed investors. By 2020, design and construction of the Lykan facility was complete.
Cade Hildreth: What is the significance of the company name “Lykan” and what does it represent to you?
Patrick Lucy: The Lykan name is sourced from the word “Lycan”, which is a mythical creature of Greek-origin that is a wolf-human hybrid. A Lycan is a leader of its pack that is both advanced and adaptive. It is fast, agile, and can rapidly transform itself. It is also known for its regenerative abilities.
Thus, our company name, Lykan Bioscience, is representative of our company’s values and positioning, which are to be agile, responsive, and to consistently provide leadership within the field of cell therapy manufacturing. Specifically, Lykan Bioscience was created to be a CDMO that has differentiated itself from other CDMOs.
Our name reflects our commitment to innovation, leadership, and staying “ahead of the pack”.
While our name and strategic approach were decided as early as 2016, we used them to guide Lykan during each-step of our journey to create the innovative CDMO that we are today.
Cade Hildreth: What was the process and timeline for constructing your current Hopkinton, MA, facility, and how was it financed?
Patrick Lucy: It has been an incredible experience to establish a purpose built, world-class cell therapy manufacturing facility and CDMO business. We began onsite work in December 2019 and completed the facility in August 2020. Our total construction timeline spanned nine months.
The facility construction was financed by our investor, Windrose Health Investors, which is a private equity investment firm.
Cade Hildreth: What is Lykan’s current manufacturing capacity and what types of cell therapy manufacturing can Lykan support?
Patrick Lucy: Lykan Bioscience provides both autologous and allogeneic cell therapy process and analytical development and cGMP clinical and commercial manufacturing making it a full-service cell therapy CDMO.
Through the combination of our operational strategy and proprietary electronic data management system, Lykan enables our partners to deliver their products to patients efficiently, cost-effectively, and with the highest quality. Currently, our manufacturing procedures include but are not limited to cell isolation, cell sorting, cell expansion, washing, volume reduction, in-house cryopreservation storage and irradiation.
With regard to the cell types we can support, we have extensive expertise in the manufacturing of CAR-T cells, iPS cells, regulatory T cells, PBMCs, HSCs, virus-specific T cells, and fibroblasts, as well as other cell types.
Our manufacturing facility consists of an ISO 7 cleanroom core surrounded by ISO 8 transfer corridors with eight independent cGMP processing suites that are capable of simultaneously processing multiple products. We are in the process of adding eight additional cGMP suites, reaching a total of 16 cGMP suites that are all capable of clinical and commercial production. Once complete in Q4 2022, the site will be capable of clinical and commercial manufacturing for the United States and EU.
Cade Hildreth: What types of clients does Lykan serve and what are their common characteristics or needs?
Patrick Lucy: Lykan serves clients who are developing early-to-late stage cell therapy products. We offer integrated solutions that include process development and optimization, analytical development and optimization, clinical and commercial manufacturing, quality and compliance support, and supply chain and logistics.
Currently, our partners range in size from small biotech to large pharma/biotech. The projects we support are both autologous (self-derived) or allogeneic (donor-derived), using different cell types and technologies targeting a wide range of indications.
Our partners have something in common, which is that they need a reliable CDMO partner to provide cGMP capacity. To meet their clinical and commercial needs, they need to outsource processes to an experienced team who has efficient processes and leverages advanced technologies.
Because of our boutique and customer centric approach to partnerships, Lykan is able to meet our partners needs with flexibility, giving each partner unparalleled attention regardless of whether they are a large or small company.
Cade Hildreth: I believe Lykan’s current facility meets FDA regulatory guidelines for US clinical and commercial production, as well as has suites that meet EMEA guidelines for EU commercial production. Based on your location and facility characteristics, what regions can you serve?
Patrick Lucy: Yes, this is correct. Lykan’s facility can support clinical and commercial production for the U.S. and clinical production for the EU. We are in the process of doubling our capacity to 16 suites by adding an additional eight cGMP processing suites. Three of these 8 suites will include commercial production suites that meet EMA requirements.
In addition, the Lykan facility is within 90 miles of four international airports, which provides significant optionality with regard to inbound patient/donor material and outbound product.
As more and more processes use cryopreservation for either or both inbound material and outbound product, we are confident that we can supply North America, as well as Europe, for both autologous and allogeneic products.
Cade Hildreth: What are Lykan’s competitive advantages over other cell therapy CDMOs?
Patrick Lucy: This is a great question because our company is founded around our differentiation and extensive expertise within the cell therapy field, specifically.
First, our team has deep scientific expertise in cell therapy manufacturing. This means we can support autologous and allogeneic products involving a variety of cell types and platforms, including but not limited to CAR-T cells, NK cells, TCR, Treg, TIL, iPS cells, and related cell types.
We also have a purpose-built, state-of-the-art cell therapy manufacturing facility. The 64,000 square foot facility is thoughtfully designed and purpose built for cell therapy production to maximize facility throughput while minimizing manufacturing time and ensuring quality.
We have also implemented best-in-class software solutions that specifically cater to the needs of cell therapy production. This involves integrated software solutions which enable electronic batch records and support real-time monitoring, testing, and release of product as well as management of complex inbound and outbound logistics.
We also have a dedicated process and analytical development laboratory. This innovation laboratory, which spans 1,700 square feet is used to facilitate customer process and analytical development programs as well as innovation initiatives. Those initiatives are focused on next generation technologies and platforms that will positively impact the development, manufacturing and delivery of cell-based therapies.
Lykan also offers a boutique and adaptive approach to partner relationships, which allows our partners to benefit from flexible, customized, and differentiated solutions that support them from technology transfer through to cGMP manufacturing.
Cade Hildreth: Does autologous or allogeneic cell therapy production represent more of your business now and how do you think this will shift over the next 5-10 years?
Patrick Lucy: Lykan supports both autologous and allogeneic products. Currently, the majority of our product pipeline involves autologous therapeutics across a range of cell platforms, including Treg, CAR-T, dendritic cells, MSCs, and other cell types.
We have also included media preparation capacity in our current expansion project (which is currently ongoing and expected to be completed in December 2022) to support allogeneic processes up to 50L scale.
While we believe that autologous based processes will dominate the market over the near-to-mid term, we are building in flexibility to support allogeneic processes.
Cade Hildreth: What trends are you seeing in cell therapy CDMO services and how is Lykan positioned to meet them?
Trends for this upcoming year and beyond in cell therapy CDMO services include overall growth in the industry driven by the unprecedented investment into the sector over the past few years, in 2021 alone over $12B has been invested specifically in cell therapy product development.
The cell and gene therapy sectors are especially likely to see growth, with gains in productivity, scale, and standardization for these therapies increasing over time. Lykan expects and is proactively anticipating this growth. This is why we are actively engaging process solution innovators to assess and deploy their respective technologies in our flexibly designed facility to enable the optimization of partner processes.
Other trends in our sights include increasing pressure from changes in regulations, including drug-price reforms and new guidance from the FDA and EMA. Lykan’s Quality Management System (QMS) and Quality Control (QC) programs have been developed to ensure that our product quality meets both US and EU regulatory standards, while offering the flexibility needed to support manufacturing across all phases of development and commercialization.
We also expect to see changes in automation. Specifically, we anticipate a move toward fully automated cell therapy manufacturing processes that could significantly reduce manual intervention and human errors, thereby supporting robust processes, improving product quality, speeding product delivery, and reducing costs.
Lykan is doing several things to ensure that we are well positioned to help both small and large companies facilitate their end-to-end manufacturing processes. We are building out automated processes and using advanced cloud-based technology for data tracking.
Cade Hildreth: Lykan has attracted an extremely talented and experienced team. What was the process of attracting and aggregating the Lykan team?
Patrick Lucy: Building an organization is similar to building a house. You need clear blueprints, and it starts with having a solid foundation or the house will crumble.
Building the leadership team at Lykan has been a thoughtful process that began with establishing the specific professional experiences required for every role. Our process also specifically details the leadership and management qualities required for each role. We seek a leadership team that has both CDMO and innovative product development experience. This ensures that each member of our leadership team is able to empathize with our partners based on their firsthand drug development experience.
Building successful high-performing teams is an art and it takes time. Each hire is an independent decision and must complement our existing team, share our values and be accretive to our culture. Our interview process includes interview teams where potential candidates’ leadership, management capabilities, work experiences, values, and potential are carefully assessed, debated, and evaluated by the team.
This has created a strong organizational foundation that will enable us to continue building out the company for years to come. Our recruiting and interview process continues to evolve today, as we search for and carefully assess candidates that will add to our organization’s capabilities today—and in the future.
Cade Hildreth: What role has company culture played for Lykan?
Patrick Lucy: This ties into and relates to our team building and talent acquisition approach. Specifically, we strive to develop and maintain a corporate culture that is intentionally inclusive, entrepreneurial, and empowering. We make an ongoing economic and time investment in developing and nurturing our culture. We live everyday by our core values, which are: Innovation, Excellence, Trust and Respect, Teamwork and Integrity.
We value our team and provide a flexible and empowering work environment, a competitive benefits package, and an emphasis on work-life balance. We know our people are the key to our success, so we focus on developing our corporate culture, growth, and ability to reach patients, while simultaneously and authentically embracing diversity, equity and inclusion (DEI) practices.
Of course, Lykan takes great pride in organizational development and training is at the center of this initiative.
Cade Hildreth: What are your five-year goals for Lykan?
Patrick Lucy: Our vision is to be the most highly-regarded and innovative CDMO, so that we can create a healthier world through advanced cell-based therapies that are manufactured with unparalleled quality.
To achieve this vision, our efforts over the next five years will be focused on establishing highly intimate relationships with our partners. We will share a clear understanding of their corporate goals and the relevant timing for achievement, a deep knowledge of their technology platform, their product(s), and the patients they are endeavoring to serve.
Additionally, we will keep our fingers on the pulse of innovation with regard to cell therapy manufacturing platforms and analytical technologies that support the production and testing of these products. In order to be a strong CMC partner, we need to ensure that we can credibly recommend innovative technologies that will enable our partners to develop regulatory compliant, high quality, and cost-effective products that are capable of meeting commercial demand.
Over the next five years, we will have a laser focus on these elements, in addition to continuing to add capacity in advance of demand. I would expect that we add considerably more capacity over the next five years.
Cade Hildreth: What types of partnerships or collaborations does Lykan currently have? What types would you be open to considering?
Patrick Lucy: At the core of the business model, we are a fee-for-service innovative contract development and manufacturing organization (CDMO). We are open to a variety of partnership structures from non-dedicated to dedicated capacity. We welcome adaptive approaches that will allow partners increased access to manufacturing suites as their need’s shift over time.
We are also eager to explore multi-product partnerships wherein Lykan can ensure our partners have sufficient capacity and resources to advance their entire pipeline in line with their overall strategy.