With the inauguration of a new state-of-the-art cell therapy lab in early 2022, BeiGene is looking to broaden collaboration and expand its capability in the field of anticancer cell therapy. Founded in 2010, BeiGene, a commercial-stage global biotech company focused on developing cancer treatments, already has three new molecular entities approved in several markets around the world and possesses a diverse pipeline of novel oral small molecules and monoclonal antibodies in varying stages of development. BeiGene only made its first foray into anticancer cell therapy in June 2021, via a collaboration agreement signed with Shoreline Biosciences, a California-based biotech company specializing in natural killer cell therapies.

Charting a New Path in Cell Therapy Development

The cell therapy unit at BeiGene is currently headed by Dr. Alex Huang, Vice President and Head of Cell Therapy, a 20-year industry veteran with experiences in several MNC pharma companies, during which he participated in or oversaw the development of several new anticancer drugs and biomarker-based diagnostics. He strongly believes that cell therapy could be the spearhead to a transforming breakthrough in cancer treatment, not just in hematological oncology, for which most cell therapies are currently approved, but also against solid tumors.

"At BeiGene, it's all about putting patients first," stated Dr. Huang, and this philosophy is deeply embedded throughout the entire R&D process, from improving the efficiency of research and development to reduce treatment costs to designing truly global trials that include both developed and developing countries, making these treatments affordable and accessible to everyone.

Pivoting Longstanding Collaborations to Address New Challenges

The concept of allogeneic CAR-T or other anticancer cell therapy is not new, and a handful of products have advanced to early clinical trials, but challenges such as maintaining the integrity of allogeneic cell cultures, ensuring patient compatibility, and preventing allorejection continue to hold the field back. Despite these challenges, Dr. Huang believes that allogeneic cell therapies developed from iPSC may be able to avoid the problems of patient compatibility and allorejection, while also enabling culture, manufacturing, quality control, and clinical application to become standardized, and even automated to some extent. To this end, BeiGene has been reaching out to longstanding collaborators to explore possibilities and develop R&D strategies going forward.

Recently, a renowned clinical hematologist, Professor Constantine S. Tam, Professor of Hematology at Monash University and Head of the Lymphoma Service at Alfred Hospital Health in Melbourne, Australia, visited the new BeiGene cell therapy lab, and was impressed by how rapidly science is progressing even though it had been in operation for just a short while. In this instance, the industry-renowned "BeiGene Speed" of bringing medicines to patients as quickly as possible was demonstrated.  

About 10 years ago, Professor Tam began to collaborate with BeiGene on conducting clinical trials for the novel BTK inhibitor Brukinsa, which has since been approved in over 65 markets worldwide. It is exciting to see if previous breakthroughs can be replicated and cell therapies that are effective and affordable become a reality for a wider audience.

A Patient-Centered Approach to Ensuring Equitable Treatment Access

Professor Tam was confident that allogeneic cell therapies represented the future. "Currently, there is too much variability in autologous cell therapy," he said. "From the start, the number and quality of cells obtained during the extraction process varies between patients. This can affect subsequent processing and expansion, and eventually, the number of genetically modified cells that each patient receives is different as well. Since each treatment has to be tailored to the condition of each individual patient, the entire process is inefficient, costly, and not really standardized."

As for the potential regulatory hurdles to gaining approval for allogeneic anticancer cell therapies, Professor Tam responded, "If regulatory agencies can accept the level of variability associated with autologous CAR-T, then there is no reason why they would not approve an allogeneic therapy that has standardized production and quality control parameters, standardized dosing, and strong clinical evidence to guide its effective and safe use."

Following autologous CAR-T therapy, a complete response, defined by the absence of all signs of cancer, has been reported in 40-98% of patients. However, this comes with a hefty price tag, with the average cost of care over US$ 600,000, a figure out of reach for most patients. At a time when excessive drug pricing and the high cost of novel cell and gene therapies dominate news headlines, BeiGene's patient-first approach is refreshing, through the successful collaboration with international expert clinicians, BeiGene could spark a revolution in healthcare, enabling equitable access to cutting-edge therapies for patients in need.