Emergence Of SYK Inhibitors In Clinical Trials

The advent of immunotherapy has set a development foundation for modern cancer therapies, allowing emergence of novel modalities and targets shaping the future landscape for cancer treatment.

The advent of immunotherapy has set a development foundation for modern cancer therapies, allowing emergence of novel modalities and targets shaping the future landscape for cancer treatment. A previously unidentified target, SYK is presenting as an interesting an attractive therapeutic target. Numerous studies are ongoing which have highlighted that SYK might be an important regulatory molecule involved in pathogenesis for several diseases. Therefore, the possibility of SYK inhibition is being actively explored as a therapeutic approach by the pharmaceutical industry.

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Up until now, there is only one licensed SYK inhibitor drug available in the market, TAVALISSE that has produced clinical response in patients with immune thrombocytopenia (ITP) including those who are refractory to other treatments. Produced by Rigel Pharmaceuticals, the year 2022 observed growing sales for the drugs. During Q2 of 2022, TAVALISSE net product sales were US$18.6 Million, representing the highest net product sales since the launch an increase of 9% compared to the second quarter of 2021, as per Rigel’s quarterly report.

For the third quarter of 2022, Rigel reported US$ 19.2 Million sales in TAVALISSE net product sales which increased by 20% compared to US$ 16.0 Million the third quarter of 2021, as per Rigel’s Quarterly Financial Report. Looking that commercial success of the only approved SYK inhibitor, the pharmaceutical industry aims to present more related treatment option for several other indications. This has encouraged numerous clinical research and development advancements to proceed in the area.

Hutchmed Pharmaceuticals is testing their oral developed SYK inhibitor, Sovleplenib (HMPL-523). Currently, in its phase II/II clinical trials, the company is investigating the safety and preliminary efficacy of the drug in adult patients with warm antibody autoimmune hemolytic anemia. The phase III study aims to confirm the efficacy safety of HMPL-523, a novel, investigational, selective, small molecule inhibitor for oral administration targeting spleen tyrosine kinase (SYK).

The pharmaceutical industry is always keeping up with the emerging and trending targets being identified by vigorous research and development all over the world. Therefore, it is surprising that the market is slowly shifting its focus on the emerging benefit of SYK inhibition. The topic has become attractive in the field and even though the underlying mechanism of SYK inhibitors has not been investigated in larger context.

Kronos Bio Inc currently has two investigational spleen tyrosine kinase (SYK) inhibitors, Entospletinib and Lanraplenib in its clinical pipeline. The preclinical studies from both the drugs represent a promising future outcome and therefore, the company has started enrolling patients in the clinical study for each compound. Lanraplenib is being assessed in a Phase Ib/II study as a potential treatment for patients with relapsed/refractory acute myeloid leukemia in combination with Gilteritinib.

Furthermore, Calithera Biosciences, a clinical stage precision oncology biopharmaceutical company is also investing a SYK inhibitor. The study has initiated patient enrollent in phase II trial evaluating Mivavotinib, a SYK inhibitoe in relapsed/refractory non-GCB diffuse large B-cell lymphoma (DLBCL). The data from the study is expected by the first quarter of 2023.

The market landscape for SYK inhibitors looks flourishing with encouraging and robust clinical pipeline. The market however, still remains limited sixe as there is only one approved drug but with the positive promising results observed in clinical trials, it is not long that the market will see more approvals. With more drugs being in their advanced stages of development, the market for SYK inhibitors is expected to increase at a growing pace. There are several pharmaceuticals targeting this market segment; Alexion Pharmaceuticals, Aptose Biosciences, Archer Pharmaceuticals, Catithera Biosciences, Clevexel Pharma and many others.