May 5, 2017
By Mark Terry, BioSpace.com Breaking News Staff
The American Society of Clinical Oncology (ASCO) annual meeting is often where biopharma companies release new data on drug trials. With the meeting coming up from June 2-6, Todd Campbell, writing for The Motley Fool, examines three companies that are presenting data he thinks will be catalysts for company stocks.
Based in Cambridge, Mass., Epizyme is focused on oncology by way of novel epigenetic drugs. The company’s lead product candidate is tezemetostat, a first-in-class EZH2 inhibitor being studied in both solid tumors and hematological malignancies as a monotherapy and combination therapy. It is currently in Phase II trials in epithelioid sarcoma, relapsed/refractory diffuse large B-cell lymphoma (DLBCL) with an EZH2-activating mutation, and relapsed/refractory follicular lymphoma, regardless of EZH2 activation.
Epizyme has plans to release data from its Phase II solid-tumor trial at ASCO, as well as discuss non-Hodgkin lymphoma at another conference, the International Conference on Malignant Lymphoma, also held in June.
Campbell writes, “The data reported at these conferences should be watched closely by investors: it will drive discussions Epizyme plans to have with the FDA that will shape a path toward FDA approval. If the results are good, they could help Epizyme clear some hurdles, getting it to market sooner than it would otherwise; that would be good news for investors, given that the company doesn’t currently have any products on the market.”
Epizyme is currently trading for $16.25.
2. NewLink Genetics Corporation
Located in Ames, Iowa, NewLink Genetics Corporation focuses on immuno-oncology. On April 4, the company announced interim results from a Phase II trial of indoximod in combination with checkpoint inhibitors to treat advanced melanoma. In combination with Merck’s Keytruda (pembrolizumab), indoximod showed a 52 percent overall recovery rate (ORR) and a 73 percent disease control rate (DCR).
NewLink is presenting two abstracts at ASCO. One, abstract 105, will involve data from the Phase Ib trial of indoximod and a checkpoint inhibitor, Tecentriq, in advanced or metastatic solid tumors. Abstract 3066 will provide information into indoximod in patients with prostate cancer after being treated with Provenge.
Campbell writes, “Those presentations may help shape views of the role of IDO inhibitors in combination therapy, so they’re important.”
Perhaps more importantly, its releasing data later this year on GDC-0919, which is in collaboration with Roche in solid tumors.
NewLink is currently trading for $16.85.
TG Therapeutics focuses on developing treatments for B-cell cancers and autoimmune diseases. On April 28, it announced preliminary results from an ongoing Phase II trial of TG-1101 (ublituximab) for relapsing forms of multiple sclerosis (RMS). The same drug is also being evaluated in a Phase III trial with AbbVie’s Imbruvica in patients with chronic lymphocytic leukemia (CLL) and high-risk gene mutations.
At ASCO, the company plans to present additional data from its Phase III trial and likely discuss the possibility of accelerated approval by the FDA. Campbell writes, “Because the data presented at ASCO will drive the FDA’s willingness to consider ublituximab’s approval sooner, rather than later, investors will want to tune in to see if ASCO attendees walk away impressed.”
TG Therapeutics is currently trading for $9.70.
