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Ignyta Acquisition Puts Spotlight onto Precision Medicine
03:15 EST 25 Dec 2017 | Biotech Watcher
I’ve been away, taking care of some matters that went longer than expected. Even though I am supporting a “free site” for now, I aim to post more often. You are thus seeing two quick posts within hours.
The following is a “one-shot”. I’ve always wanted to write about Ignyta, and its acquisition puts an additional spotlight on precision medicine. I learned about it through a reader (thank you!).
The Skinny
On December 22, 2017, Ignyta (RXDX) announcedits acquisition by Roche for $1.7B. At $27 per share, It is a 74% premium to the RXDX closing price ($15.55) on December 21. The brought an early Xmas present to Ignyta investors.
What is Ignyta?
Founded in 2011, the company is a San Diego based biotech that focuses on precision medicine for treating cancer. Its products are aimed at precise target populations, culled by diagnostic tests, that will most likely benefit from Ignyta’s precision therapeutics. The “DX” in RXDX stands for their proprietary molecular diagnostics, while the “RX” stands for precision medicine.
Why Is This So Important?
In 2017, a milestone for targeted cancer therapeutics was achieved.
While we personally dislike the branding, Ignyta’s focus is timely. The FDA is quick to approve tests that identify patients that will benefit from specific drugs. Furthermore, the FDA recently approved pembrolizumab (Keytruda) for treating tumors with specific features regardless of location. This was a first.
Ignyta’s therapies are aimed at achieving the same status.
Why Ignyta in Particular?
As stated in the announcement:
In the recently announced interim data including patients from the STARTRK-2 trial, in patients with ROS1 fusion-positive advanced NSCLC, entrectinib demonstrated a 78% (25 out of 32; by Investigator) and 69% (22 out of 32; by blinded independent central review, BICR) confirmed objective response rate (ORR). Entrectinib also showed a median duration of response of 28.6 months and median progression free survival of 29.6 months in this population, with 53% of patients remaining on study. Moreover, entrectinib showed 83% (5 out of 6 by BICR) confirmed intracranial ORR in patients with measurable brain metastases.
On December 20, 2017, Ignyta’s rival - Loxo Oncology (LOXO) – started submitting its own anti-TRK drug - larotrectinib - for FDA approval. It hopes to have the next approval for treating cancers with a specific feature, rather than tied to a specific location.
Like Ignyta’s entrectinib, Larotrectinib is a TRK inhibitor.
On November 14, 2017, Loxo announced a global collaboration with Bayer for larotrectinib. It will receive a $400M upfront payment and up to $450M in milestone payments. In the U.S., Loxo and Bayer will share development costs on a 50/50 basis, and later profits on a 50/50 basis. Outside the U.S., Bayer will handle commercialization of larotrectinib and owe double-digit royalties on net sales and sales milestones.
Furthermore, Ignyta isn’t a one-trick pony. It has three drugs in clinical testing, with other candidates in preclinical development. RXDX-105 is currently in a Phase 1b trial and has already shown promising data:
RXDX-105 achieved a preliminary objective response rate of 75% observed in eight RET inhibitor-naive patients with non-KIF5B-RET fusion-positive NSCLC.
Our Thoughts
Beyond Ignyta, we are seeing certain milestones finally being reached. We are seeing targeted therapeutics paired with proprietary diagnostics, as well as FDA approval for treating specific features of the cancer, rather than location. These agents will be approved in a flexible, accelerated fashion.
Although the FDA has sometimes been criticized for moving slowly with new types of therapeutics, it deserves kudos for accommodating these current products.
(At the time this post was written, one or more BioWatch authors held a position in RXDX)
This blog post is from The Biotech Watcher:
Although the FDA has sometimes been criticized for moving slowly with new types of therapeutics, it deserves kudos for accommodating these current products.
(At the time this post was written, one or more BioWatch authors held a position in RXDX)
This blog post is from The Biotech Watcher:
And about us, see http://alanhobbes.blogspot.com/2014/12/welcome-to-my-personal-thoughts-about.htmlOriginal Article: Ignyta Acquisition Puts Spotlight onto Precision Medicine
