Cancer cures are kind of like nuclear fusion: they’ve been 10 years away for the past 60 years. In the world of oncology, victories have often been measured in months of extended life. And while there have been the occasional big wins – think Gleevec for CML – they generally haven’t set the stage for widespread therapeutic improvement.
On the other hand, there’s immunotherapy. Checkpoint inhibitors have shown amazing results in a significant fraction of patients. For those with the right kinds of tumors, these treatments can be the cancer therapy equivalent of winning the lottery. Life science companies are now scrambling to develop diagnostics that will identify which patients are likely respond.
Then there are the next-generation immunotherapies: CAR-T. Market intelligence firm Evaluate just released a CAR-T report and has been disseminating it at BIO 2016. In many ways, CAR-T’s challenges reflect those throughout the industry: funding, trials, manufacturing, approval, payment. Many therapies look great from point A, but it’s the view from point B that pays the rent.
CAR-T treatments are making their way through the pipeline. The report highlights six therapies that may be racing towards approval in the next two years for acute lymphoblastic leukemia (ALL), non-Hodgkin’s lymphoma and diffuse large B-cell lymphoma.
Still, major barriers remain. These therapies are difficult and expensive to manufacture and there’s always the risk of toxicity and/or cancer resistance. Many ALL patients have relapsed within a year. The report notes that companies must also find way to move CAR-T into solid tumors, despite the immunosuppressive microenvironments.
Companies will also have to find new target antigens beyond CD19, which is relatively low-hanging fruit; therefore, everyone is targeting it.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Still, the big players – Juno, Kite and Novartis – are betting big on this potentially lucrative class of treatments. Juno and Kite have attracted major investment based on CAR-T’s abundant promise. Their market caps could take a serious hit if these treatments don’t pan out. Novartis took the plunge, but other big pharma companies are sitting on the sidelines.
At BIO 2016 in San Francisco, a Wednesday afternoon panel is exploring how bispecific antibodies might improve CAR-T therapies, boosting selectivity and reducing side effects. Y-mAbs Therapeutics is also presenting its technology on Thursday.
So where are we with CAR-T? Is it the innovative, transformative, disruptive, paradigm-changing cancer therapy we all hope for, or is it another incremental improvement? We’ll know more in 2017.
