July 24, 2017
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – As investors scour the internet for prognosticative information about which biotech stocks to back, one analyst is betting that two small cap oncology companies could demonstrate rallies that last until the end of the year.
Writing in Seeking Alpha, Bret Jensen, the editor of the online publication’s Biotech and Insiders forums, pegged San Diego-based Ignyta (RXDX) and New York-based TG Therapeutics as two stocks to watch. Jensen said both companies are making progress with their respective pipelines and have both reported positive news in recent months.
Since a May 3 low of $6.15, shares of Ignyta have climbed to a high of $11. Share prices have slipped a bit since that June 23 high to this morning’s price of $9.25 per share, as of 10:27 a.m. What sparked the growth of Ignyta’s stock was two bits of strong support from the U.S. Food and Drug Administration. In May, the FDA granted Ignyta’s cancer drug entrectinib a Breakthrough Therapy Designation. “for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumors in adult and pediatric patients who have either progressed following prior therapies or who have no acceptable standard therapies.” Entrectinib is the company’s investigational, orally available, CNS-active tyrosine kinase inhibitor targeting tumors that harbor NTRK1/2/3, ROS1, or ALK gene fusions, according to company data. The drug is currently in Phase II development. Earlier this month, the FDA also granted Orphan Drug designation to entrectinib or “treatment of NTRK fusion-positive solid tumors.” NTRK fusions are molecular alterations that occur in a broad variety of adult and pediatric solid tumor types.
In addition to entrectinib, Jensen also pointed to two other investigational drugs in Ignyta’s pipeline, RXDX-105 and Taledegib. RXDX-105, “an orally available, VEGF-sparing, potent RET inhibitor” is in a Phase Ib trial, Jensen said. Taledegib is a small molecule hedgehog/smoothened inhibitor, he added. Earlier this year, the company said it was exploring strategic options for Taledegib. In March, the company said it entered into an amended and restated license, development and commercialization agreement with Eli Lilly and Company for the Taledegib oncology program.
Since a March spike that saw share prices of TG Therapeutics leap from $5.60 per share to a high of $14.45 per share, company stock has been on a roller coaster ride. Shares of TG Therapeutics are trading at $12.45 as of 10:42 a.m. Since May, the company has had no shortage of positive data due to the strong results it has seen from its Phase III anti-CD20 monoclonal antibody TG-1101 and its triple combination treatment of TGR-1202, TG-1101 and ibrutinib (Imbruvia). In June, the company presented strong data for its Chronic Lymphocytic Leukemia treatment TG-1101 at the American Society of Clinical Oncology. At ASCO, TG Therapeutics said TG-1101 (ublituximab) combined with AbbVie ’s Imbruvica demonstrated an objective response rate of 78 percent in patients with high-risk CLL. TG-1101 works differently than other anti-CD-20 drugs, such as Rituxan. In the case of TG-1101, the drug is designed to target a unique CD-20 molecule that’s found on mature B-cells that makes it such a strong companion drug for Imbruvica.
TG Therapeutics’ triple combination treatment has also seen positive results. Adding the company’s PI3K-delta inhibitor TGR-1202 to the combination of TG-1101 and Imbruvica, the company saw a 100 percent ORR by iwCLL criteria, as well as a high level of complete responses.
