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Within the world of biotech stocks lies the potential to reap massive profits. At the same time though, this space is full of companies who ultimately fail to live up to their ambitions. Because of the tendency for many biotech startups to fail, some investors choose to avoid the space altogether. There is a high level of risk associated with investing in this field, but certain parameters can help in identifying candidates with the potential to give nice returns for investors.
Today, we’ve found a company which utilizes the power of T-cells to battle cancer. Adaptimmune Therapeutics (NASDAQ:ADAP) is a company that seeks to treat cancer by increasing the affinity of T-cell receptors (TCR). The receptors recognize foreign antigens, so utilizing them to combat cancer is a very intriguing method for helping the body fight against disease.
A T-cell is a type of white blood cell that is important for the immune system. It is at the core of adaptive immunity, and the adaptive immune system triggers the body’s response to specific pathogens. Pathogens are microorganisms which can cause diseases such as cancer, so there is a lot of potential in the company’s TCR based platform.
Adaptimmune Therapeutics recently received orphan drug designation from Europe for its NY-ESO SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell therapy for fighting soft tissue sarcoma. The same therapy received orphan status from the US previously. This is a great designation to receive for multiple reasons. For one, orphan drugs are used to treat rare diseases, and there is typically less competition from drug makers fighting against diseases that impact less than 200,000 people. Also, drugs that receive the orphan designation are more likely to be approved by regulatory bodies because of the lack of alternative treatments for patients suffering from certain rare diseases.
Receiving the orphan drug status from Europe comes with a few nice incentives. One of these incentives includes the benefit of receiving scientific advice and protocol assistance from the EMA (European Medicines Agency). This will make it easier for the company’s drug to be approved, since it will be able to interact with an agency that can tell it whether or not it meets the standards required by the EU. Another benefit includes 10 years of market exclusivity in Europe. This means that competitors using similar medicines with the same indication cannot compete with the orphan drug. Although TCR based treatment is limited in the market right now, this will serve as a good cushion for 10 years if the company’s SPEAR T-cell therapy drug gets approved.
A few days ago, Adaptimmune Therapeutics gained access to the EMA’s newly-established Priority Medicines (PRIME) regulatory initiative for the company’s SPEAR T-cell therapy which targets NY-ESO for the treatment of “HLA-A0201, HLA-A0205, or HLA-A0206 allele positive patients with inoperable or metastatic synovial sarcoma…and whose tumor expresses the NY-ESO-1 tumor antigen” (Adaptimune Therapeutics plc). Being integrated into the PRIME initiative will accelerate the review process for its SPEAR T-cell therapy, and this will put the drug on a potential fast-track to getting approved.
Adaptimmune is partnering with GlaxoSmithKline (NYSE:GSK) for the commercialization and development of the NY-ESO T-cell receptor program. The program has yielded impressive proof-of-concept clinical data in solid and hematological cancer. ADAP is looking pretty good from a financial standpoint, as it has over $200 million in cash. With its strong cash balance and partnership, ADAP stock appears to be in a good position with regards to financing research for its drug candidates. Things have been looking up for the company in recent history, and this may suggest that there are better things to come for this company in the future.
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