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Morning Rounds: Incyte Corp. (INCY) a buy prior to the FDA PDUFA Date


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Pipeline and potential drivers

INCY’s pipeline is very impressive. It consists of 21 compounds, 19 for which they wholly own. Of these, eight are in pivotal stages and data is expected in 2019. Of the eight, four are wholly-owned and two are partnered with NVS/LLY.

INCY pipeline

Jakafi (JAK 1/2) in GvHD

Before we dive in, a little background on GvHD. Allogeneic transplantation of hematopoietic cells is a well-established treatment for hematologic diseases that currently there are no known conventional treatments for. More importantly, there are more than 1 million hematopoietic-cell transplantation have been performed, 40% of which have been known to be allogenic.

Allogenic transplantation comes with significant risk and adverse events. One of the most serious complications is graft-versus-host disease (GvHD), which occurs when immunocompetent T cells in the donated tissue (the graft) recognize the recipient (the host) as foreign.

GvHD seriously compromises tissues and organ’s ability to function leading to eventual organ failure. Acute GvHD typically occurs within the first 100 days post-transplant while the chronic GvHD is within 6 months post-transplant.

Acute GvHD is primarily mediated through T-cells while the chronic GvHD is generated through T- and B-cells. JAK 1 and 2 mediate the signaling pathways that lead to increases in pro-inflammatory cytokines.

INCY has two drugs for the treatment of GvHD. Jakafi which is a JAK 1/2 inhibitor and Itacitinib which is a JAK 1 inhibitor. Both of these drugs are being evaluated in acute and chronic GvHD for which the former is steroid-refractory and latter in the steroid-naive setting.

This brings us to INCY’s Jakafi which is a JAK 1/2 inhibitor. INCY submitted an sNDA for Jakafi as per positive results in REACH1 phase 2 for steroid-refractory acute GvHD. You can expect results from REACH3 phase 3 results for steroid-refractory chronic GvHD in the second half of 2019 and REACH2 phase 3 results for steroid-refractory acute GvHD in 2019.  you can read more about the trial here.

News was released today, stating that the FDA has agreed to extend the review period for sNDA for Jakafi for treatment of patients with acute GvHD in patients with inadequate response to corticosteroids to May 24, 2019.

On a side note – Jakafi is also being evaluated for various other diseases such as blood cancers. For instance, we expect to hear from phase 3 results in essential thrombocytopenia by 2022.

In addition to GvHD, Jakafi’s topical formulation, ruxolitinib, has been proven beneficial in mild-to-moderate atopic dermatitis. It is also being examined in other autoimmune conditions such as hidradenitis suppurativa, an inflammatory follicular skin disease resulting in painful abscesses and lesions.

Itacitinib (JAK 1) in steroid-naive acute GvHD

GRAVITAS-301 phase 3 results in steroid-naive acute GvHD expected this year. We also expect to see results for GRAVITAS-309 phase 3 results for steroid-naive acute GvHD for similar in 2021. Itacitinib has been successful in exhibiting positive proof-of-concept and it is believed that this drug may become the gold standard for treatment of acute GvHD.

To date, the treatment for GvHD consists of corticosteroid regimens. Generally, this results in broad immune suppression of the immune system. Which, essentially increase risk of infections which is one of the leading causes of death in these patients.

Although acute and chronic are slightly different in nature, they are both mediated by T-cells, thus, they can be targeted via JAK inhibition. It is imperative to note that some physicians have noted the use of Jakafi in an off-label method of treatment in steroid-refractory acute GvHD.

There is some excitement around itacitinib. This is attributed to itacitinib promise of a high response rate in steroid-naive GvHD. Additionally, itacitinib’s anti-inflammatory mechanism of action could become a gold standard, with disease-modifying potential and a significant impact to overall survival in the recipients of allogeneic transplants.

There are other driving factors for INCY’s longterm potential. Of those, we highlight the following:
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Author avatar

Dr. Tiam Feridooni

Written by: Dr. Tiam Feridooni MD, PhD, BSc Dr. Feridooni, graduated from Dalhousie Medical School in May, 2018. Prior to enrolling in medical school, he completed his Bachelor of Science with Honours in 2010 in Biochemistry. He then obtained his PhD at Dalhousie University in Pharmacology in 2014, with a focus around regenerative medicine and stem cell transplantation. Dr. Feridooni has been published numerous high impact journals and has also co-authored a few books.

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