The healthcare industry needs to bring in more effective solutions at affordable prices for all its unsolved questions. Cancer treatment is one of the major focus areas in this. There are various techniques and treatment solutions being devised in this area and a lot more are still under the research stage. CAR-T is one such technique that has shown a lot of potential to combat cancer. Although, it has already been developed, owing to CAR-T’s high costs and complex development procedure, it has not reached all of the population. To rectify this and to find better solutions against cancer, Gracell Biotechnologies is relentlessly working and innovating its way to a highly advanced and better future.
Gracell Biotechnologies is a clinical-stage biotech company with mission to solve CAR-T industry hurdles. The aim to solve the problems like high cost of goods, lengthy and ineffective manufacturing process, lack of off-the-shelf products, and high relapse rate even with the achievement of complete remission for hematological malignancies. Being committed to research and development, it is bringing novel cell therapies with highly cost-effectiveness from the lab to the bedside. Gracell aims to bring best-in-class and affordable cellular medicines to the cancer patients.
Founded in 2017, Gracell has today built a state-of-the-art 44,000 sq. ft. R&D center in Shanghai and 63,000 sq. ft. GMP facility in Suzhou with an additional plant reserved for future commercial needs and advanced multiple IND filings. Currently, the company has over 90 talented FTEs.
A Numero Uno
Wei (William) CAO is the Founder, Chairman, and CEO of Gracell. He is a seasoned front runner with over three decades of experience in biotech and R&D. Before formulating his ideas into Gracell today, he co-founded and was the former CEO of Nasdaq listed CBMG; served at the former senior scientific management positions at Chiron and Affymetrix. William also has over 50 issued patents and applications for advanced cell therapies. He has built Gracell from scratch and has shaped its success with his rich experience. Talking about the company, he says, “Gracell’s mission is to make drugs accessible to ordinary patients. Many of the patients we see now in our clinical studies are not well-off. This mission is what keeps us going through the ups and downs of biotech entrepreneurship.”
The Problem
Chimeric antigen receptor or CAR-T cells are genetically engineered T cells, redirected to bind and kill tumor cells. These T cells, taken from patients’ own (autologous) or healthy donor’s (allogenic) blood, with activation, modification, and expansion, are administered to the patients. Preparation of conventional CAR-T cells can take weeks of processing, with high cost of goods. For patients at late-stage, with very limited life expectancy, long manufacturing time may compromise the medical benefits.
Gracell’s Solutions
Gracell is developing next generation CAR-T for advanced hematological malignancies, including leukemia, lymphoma and myeloma. It has multiple platform technologies and product candidates currently under clinical evaluations.
FasT CAR
FasT CAR is proprietary and patented technology of Gracell. Unlike conventional CAR, FasT CAR production only takes overnight for cell culturing. This results in affordable and highly cost-effective solution for patients. GC007F (anti-CD19), Gracell’s one of the lead program, is redirected to target B cell acute lymphoblastic leukemia (B-ALL). This product of the company has multiple advantages, including younger phenotype, higher proliferation capabilities, less exhaustion, more potent eliminating leukemia malignancies, capability to infiltrate into bone marrow, etc. With all these features, clinical study has further demonstrated its remarkable outcome. Proving the effectiveness of GC007F, on 25th May 2019, 13/13 patients under test achieved complete remission under at least 28 days follow-up, with only mild side effects. Concluding, GC007F has the potential to be best-in-class anti-CD19 CAR-T profile.
UCAR3
Lymphocytes from certain portion of patients cannot be adequately expanded to generate sufficient quality CAR-T cells. With this hurdle in the mind, Gracell is developing its own solution that would provide much better cost economics, mass production per lot, and followed by one-shot release, not specific to each individual patient. UCAR3 will be purely for off-the-shelf use.
UCAR3 technology of Gracell is based on lymphocytes obtained from healthy donors and modified with gene editing to avoid GvHD as well as rejection. Genetic modification also helps protect from host versus graft (HvG) reaction and to enhance UCAR3 T cell persistence and proliferation. The company’s lead program is focused on treatment for T cell malignancies, and it is to enroll patients soon.
In addition to FasT CAR and UCAR3, Gracell has been developing Enhanced CAR-T and Dual CAR-T platform technologies. These are currently under clinical evaluations.
What’s Different?
Among number of other competitors, Gracell is making its own mark and making its presence evident. Gracell has set up strong alliance with top tier hospitals; a network of 18 3A hospitals nationwide and a total 50,000-beds capacity. Additionally, with advances in cellular immunotherapy therapeutics, Gracell has obtained a strong support from the government, with subsidy, tax incentives, and perspective commercial land issuance.
The most important aspect that sets Gracell apart is its capability to expedite product development. This significantly relies on its well-built and highly efficient team, in regard to process and assay development, regulatory compliance, facility engineering, and clinical functions. Moreover, the company does not just rely on in-house R&D activities, it also believes that external partnership can enhance and extend its capabilities and strengths. Gracell has a strong interest in the areas of immuno-oncology and cellular and gene-edited therapeutics that drives clinical unmet needs and is open to co-development and licensing opportunity.
Further Roadmap
Speaking of the CAR-T industry’s problems, William asserts, “The CAR-T industry is still in its infancy and I realized there are still many imperfections with the technology.” He continues, “As a drug developer, we shall be compensating as well as be responsible for those patients who cannot obtain clinical benefits from current standard of care.” Gracell is planning to submit its first filing by the 3rd quarter of 2019 and its new GMP facility will be open to operation by the first quarter of 2020. Additionally, it plans to start IPO within next two-three years. Gracell envisions to become the global leader in cellular cancer immunotherapy.
