The 3 Important Factors To Consider When Commercializing The CAR-T Therapy

The 3 Important Factors To Consider When Commercializing The CAR-T Therapy

Last month, Novartis’s CAR-T cell therapy CTL-019 has unanimously (10-0) won a recommended approval from FDA advisory committee to treat pediatric, young adult r/r B-cell ALL, marking one big step closer to reaching patients. The vote represents a pivotal milestone for this class of experimental treatment. The FDA is expected to make a final decision on approval by Oct 3rd. The heat for CAR-T therapy has never been hotter.

In this article, I am going to discuss the three most important factors to consider when commercializing a CAR-T therapy, and have especially focused on its complications in China.

  • The uncertainty of CAR-T therapy
  • Its commercialization path
  • The growth of CAR-T market

The Uncertainty of CAR-T Therapy – Safety and Sustainability

In the past few years, CAR-T therapy has taken on a steady upward trend.  Both of its advantage and disadvantage are obvious.  Since its birth, people are thrilled by CAR-T’s exciting potentials – extremely effective and highly personalized, genetic engineered, whole cell therapy. On the flip side, its possible side effects, including immunologic escape, cytokine release syndrome, etc., have also raised serious concerns.

To combat these side effects, a range of approaches are undergoing development.

Novartis, Juno, and Kite are all ramping up their efforts to improve CAR-T’s critical structure through incorporating a switch to open or shut down its tumor killing functions at the right time. Eureka Therapeutics has invented the ARTEMIS platform, in an attempt to discover the next generation targeted immune T cell therapy. Bellicum has developed a CID technology to turn on its “auto suicide” program.

In the wake of next generation technology and the reduction of side effects, the future of CAR-T therapy is promising. Overall, it is considered as a relatively safe therapy with stable efficacies and manageable risks.

How Easy Can A CAR-T Therapy be Commercialized?

How to commercialize CAR-T therapy will continue to be under the heat of discussion in the coming years, especially in the face of a series of strong data delivered by CTL-019 from Novartis and KTE-C19 by Kite, marking the maturation of this type of technology. When it comes to its successful launch, a number of factors need to be taken into a careful consideration. Two of them stand out the most.

First, the ownership of a unique core technology and its associated key intellectual properties.

A product without an independent IP will undoubtedly attract lawsuits down the road. This is especially true in the current pharmaceutical industry environment, where fights over patents have become increasingly intense. Every pharma is striving to hold onto its patents as long as possible, in an effort to prolong its market exclusivity and maximize the revenue, before the generic competition kicks in.

Second, finding the right commercialization path.

Another hard to conquer obstacle before successfully bringing a CAR-T therapy to the market is to find the right commercialization path, which can easily translate the current experimental technology into mass production. Unavoidably, it requires the setting up of a standardized and quality controlled production system, which is able to manage large quantities of CAR-T cell production with minimal biological variances. The good or bad of this step largely predicts whether a CAR-T therapy is set to success or failure post market.

Nowadays, the commercialization path of CAR-T therapy has become increasingly clear in the US; on another note, it is not the same story in China, primarily due to the lack of standardized and mature regulations. However, the future is bright, as CFDA has laid down several new reforms recently, making us confident that the new policies are on the way.

The Market Growth of CAR-T Therapy

Since its birth, CAR-T therapy has been considered as the superstar in the blood cancer sector; its stunning data in leukemia clinical trials has sparkled industrial wide attentions. On the flip side, its performance in solid tumors can only be described as mediocre at the best. However, whether CAR-T therapy can become an independent class of cancer treatment lies largely in its ability to achieve a breakthrough in tackling solid tumors, which represents more than 90% of the oncology market opportunities.

How to improve CAR-T therapy’s efficacy in solid tumors has already become a prevailing question on the mind of industry experts, and we have experience an increasing urgency to answer it, as the field moves ahead. In China, a host of biopharmas is already in the race to become the first one conquering this problem.

So, how will the future of CAR-T therapy market look like?

In America and Europe, we will see two or three top companies, primarily focusing on developing therapies against hot targets, dominate the market; whereas, the rest shares will be divided among others.

In China, we could anticipate seeing a completely different scenery, where a surge of biopharmas dedicating to developing CAR-T therapies will appear, once the CFDA publishes related regulatory policies. In the early stage, it is likely that the market will be shared among everyone. However, with the development of new technology and concentration of power, several biopharmas will stand out from the pack, taking over the majority of the market.

Summary

The future of CAR-T therapy is promising, as it continues to deliver stunning results, particularly in treating blood cancers. Although we have observed various degrees of side effects along the way, overall, the risks are manageable, especially in the wake of a host of methods developed to improve current therapies and reduce associated risks.

To secure an even brighter future, biopharmas need to double down their efforts on building up an automated CAR-T therapy production system with appropriate quality controls. Its success will prime CAR-T therapy for reaching more patients.

China will undoubtedly become one of the hottest CAR-T therapy markets, especially in the face of novel technologies and new regulations.

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