Immunotherapy refers to using the body's own immune system to combat diseases, including cancer. The concept of cancer immunotherapy has made great progress in the last few decades. Remember Dendreon Corp.'s (DNDN) Provenge - a cancer vaccine, which has had tremendous media coverage and political attention? Approved by the FDA in April 2010 to treat prostate cancer, Provenge is the first immunotherapy to win regulatory approval for cancer.
Working on the development of novel immunotherapeutic products to improve cancer treatment options for patients and physicians is NewLink Genetics Corp. (NLNK). For readers who are new to this Ames, Iowa-based biopharmaceutical company, which recently went public, here's a brief overview of its pipeline and what to expect in the coming months...
NewLink's product candidates are based on two immunotherapeutic technologies:
* Proprietary HyperAcute immunotherapy technology, which is designed to stimulate the human immune system and
* Inhibition of indoleamine-(2,3)-dioxygenase, or IDO, pathway technology.
NewLink's lead product candidate is HyperAcute Pancreas, which is being studied in a phase III clinical trial in surgically resected pancreatic cancer patients under a Special Protocol Assessment. The phase III trial for HyperAcute Pancreas cancer immunotherapy was initiated last May and is designed to enroll 700 patients.
As of October 25, 2011, 200 patients were enrolled in the trial and enrollment is expected to be completed in 2013, according to the company. The primary endpoint of the clinical trial is overall survival, with secondary endpoints of disease-free survival, safety, toxicity and immunological responses.
NewLink's other drug candidates, which are based on its proprietary immunotherapy technology are HyperAcute Lung and HyperAcute Melanoma.
HyperAcute Lung is being studied in a combined phase I/II clinical trial for the treatment of advanced non-small cell lung cancer, while HyperAcute Melanoma is being studied in combination with an eight-week course of PEG-Intron, in a phase II clinical trial in 25 patients with advanced melanoma.
The results from the phase II HyperAcute Melanoma trial are expected this year. An interim analysis of patients in the HyperAcute Lung trial demonstrated a median overall survival of 11.3 months, a one-year survival rate of 46% and a favorable safety profile with no dose limiting toxicities, according to NewLink. A phase IIB/III clinical trial of HyperAcute Lung in advanced non-small cell lung cancer, or NSCLC, patients is expected to be initiated in the first half of 2012.
The company's lead investigational drug based on the IDO pathway inhibitor technology is d-1-methyltryptophan, or D-1MT, which is being studied in two phase IB/II clinical trials for metastatic solid tumors.
In one phase IB/II safety and efficacy trial, D-1MT is being studied in combination with an Ad-p53 autologous dendritic cell vaccine for solid malignancies with p53 mutations, such as lung, breast and colon cancers. In the other phase IB/II trial, D-1MT is being tested in combination with Taxotere for patients with advanced stage solid tumors for which Taxotere is the standard-of-care, such as metastatic breast, prostate, ovarian and lung cancers. The preliminary data from the two phase IB/II trials are expected to be announced by the end of 2011.
NewLink went public as recently as November 11, 2011, pricing its shares at $7 each. Given the catalysts lined up for the coming months, NLNK may be worth watching.
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