3 Biotechs That Have Investors Grinning at Thanksgiving Dinner This Year
Investors have had a decent year, but some have much to be grateful for this Thanksgiving. The S&P 500 is up about 15 percent year to date, and analysts are projecting that path to the end of the year looks pretty good. Cory Renauer, writing for The Motley Fool, notes three biotech companies that have had particularly good years.
Based in Stamford, Conn., Loxo Oncology develops targeted therapies for cancer. Company stock is up around 142 percent this year. Renauer writes, “Earlier this year, Merck’s Keytruda earned the first FDA approval for a cancer indication that doesn’t specify a body part, and Loxo’s lead candidate is headed down the path the big pharma helped clear. Larotrectinib shrank tumors for a stunning 38 out of 50 patients with a variety of cancers that exhibit one genetic aberration in common, tropomyasin receptor kinase (TRK) fusions.”
And just last week, the company inked a global collaboration deal with Bayer to develop and commercialize larotrectinib and LOXO-195. Under the deal, Loxo will receive a $400 million upfront payment and a potential $450 million in milestone payments after larotrectinib regulatory approvals and commercial sales events and an additional $200 million in milestone payments for LOXO-195.
The company is planning an application for larotrectinib by the end of the year and the FDA already gave it breakthrough designation. That means it’s possible the drug will be approved in late 2018.
Headquartered in San Francisco, Nektar has a broad program for cancer, auto-immune diseases and chronic pain. On Nov 11., with its partner Bristol-Myers Squibb, it announced positive data from the PIVOT-02 Phase I/II trial to evaluate Bristol-Myers’ Opdivo with Nektar’s NKTR-214. The early results were presented at the 2017 Society for Immunotherapy of Cancer (SITC) Annual Meeting.
For the year, Nektar’s stock has gained 250 percent. Earlier in the year, it reported positive results for NKTR-181, a compound that reduces chronic back pain without the “high” that causes opioid addiction. Long-term safety data is expected by the end of the year.
Although the data from the trial with NKTR-214 and Opdivo was small, the addition of NKTR-214 showed a reduction of tumors for three of four advanced lung cancer patients that didn’t express PD-L1, and the combination treatment even pushed one patient into complete remission. More data is necessary, but Renauer believes that if approved as a combo treatment, NKTR-214 could create more than $1 billion in annual sales for Nektar.
Located in Henderson, Nevada, Spectrum is a commercial-stage biotech company with a focus on hematology/oncology. The company’s stock has grown 482 percent this year, largely because of trial data for the company’s poziotinib from 11 patients treated for lung cancer.
Renauer writes, “Spectrum’s poziotinib thrilled investors because it looks like a potential solution to a family of genetic mutations that help tumors resist popular therapies that inhibit epidermal growth factor receptor (EGFR) activity. AstraZeneca launched Tagrisso to help patients overcome one type of EGFR inhibitor resistance just two years ago, and sales of the drug are already on a $1 billion annualized run rate.”
Poziotinib appears to boost Tagrisso’s effectiveness, which has analysts projecting $1 billion in annual sales if it’s approved. However, it’s only in early-stage trials, and there’s a lot that could go wrong between early trials and final approval.
Renauer notes, “Reports of tumor shrinkage among all 11 patients treated should convince the FDA to sign off on a pivotal trial for poziotinib, but it looks like the company isn’t going to wait for a meeting with regulators. Spectrum recently started an 87-patient trial that looks suspiciously similar to studies that have led to accelerated approvals of breakthrough cancer therapies in recent years. If the FDA later decides to allow the new trial to support an application, poziotinib could be ready to launch as soon as the end of next year, although sometime in early 2020 would be reasonable.”