It is Incyte’s (INCY) day and Incyte’s forecast about an exciting future for its currently approved product Jakafi and its next generation pipeline products. The firm’s ambitions are high, so its expenses are high, which we believe are required to meet the highly regarded goals. High expenses are cause for instigation of a sell-off – a pattern that we expect will start to eventually fade, unless the expenses are wasted money. Incyte’s expenses are not wasted. The firm’s programs are worth the price paid to develop and the near-term losses are by no means damaging to the firm’s plans and strategies towards the realization of its dreams.
Jakaf, the firm’s approved product, is selling-- and the sales are growing. Incyte’s pipeline is promising; very promising. The pipeline might have added more promise after Incyte entered into a clinical trial collaboration agreement with Merck (MRK) to evaluate the safety and efficacy of the combination of oral indoleamine dioxygenase-1 (IDO1) inhibitor drug INCB24360and Merck’s investigational anti-PD-1 immunotherapy, MK-3475 in a Phase I/II study. The combination is to be given to previously treated patients with metastatic and recurrent non-small cell lung cancer (NSCLC) and other advanced or metastatic cancers.
It is important to note that both drugs belong to a new class of cancer treatments known as immunotherapy drugs that aim at enabling the immune system to fight cancer by inhibiting immune checkpoints. These checkpoints limit the efficacy of the immune system’s cells to reach and eliminate cancers. There is preclinical evidence suggesting that the combination of the two drugs may lead to an enhanced anti-tumor immune response than either agent alone.
Immunotherapy used to be possible only through therapeutic vaccines. Now, the new approach to immunotherapy is gaining tremendous attention from researchers and oncologists as well as from biotech analysts who assess the firms based on their scientific achievements and prospects, not only on their revenues and incomes. There are already some investigational immunotherapeutic products in clinical trials. These products inhibit various immune checkpoints, which makes the immune system successfully use its cells and immunoglobulin to fight diseases. Given the synergistic activity between Incyte’s IDO1 inhibitor INCB24360 and Merck’s anti-PD-1 drug MK-3475, both firms expect the combination would yield a far-reaching efficacy than using each drug alone.
Based on understanding the therapeutic value of IDO1 inhibitor, the President and Chief Executive Officer of Incyte promised to establish additional clinical collaborations with academia and with other oncology firms that have immune checkpoint inhibitors in their pipelines. Incyte and Merck will collaborate on a Phase I/II study to evaluate the safety and efficacy of the combination in previously treated metastatic and recurrent NSCLC, and other advanced or metastatic cancers. The study is expected to begin at any time in the first half of 2014 and will be co-funded by Incyte and Merck and conducted by Incyte.
This is a very important program. Yet, developing INCB24360 as a monotherapy is also very important and very promising. Results from a phase I dose-escalation trial demonstrated that INCB24360 has resulted in greater than 90 percent inhibition of IDO1 activity at well-tolerated doses.
It is important to note that the INCB24360 ability to reduce tumor growth is dependent on a functional immune system - the immune system’s regaining its capability to wipe out cancer cells. This is the main reason for the enthusiasm towards the novel immunotherapy approach and the reason for hailing it by scientists, researchers, oncologists and fair analysts.
INCB24360 is currently in Phase I/II development for metastatic melanoma in combination with ipilimumab and as monotherapy for ovarian cancer.
We will tell you much more about the fascinating Immunotherapy approaches and drugs so you can feel their importance in changing the way cancer is being treated. We will refer to one approved and a few investigational immunotherapeutic drugs. We will also give you more insight about the firm’s announced quarterly financial results and its conference call about this event. Incyte is now a growth firm that is expected to continue growing.
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