HyperAcute®-Lung
HyperAcute®-Lung immunotherapy development status & plan
NewLink has completed a Phase 1 study of HyperAcute-Lung cancer vaccine to evaluate the product's safety, and we are currently conducting Phase 2 clinical trials designed to assess its efficacy in Stage IIIB-IV patients with unresectable, recurrent, and either treatment-refractory or metastatic NSCLC. Our results to date in this challenging patient population are very encouraging, and we are increasingly optimistic that HyperAcute-Lung immunotherapy will provide significant clinical benefit to NSCLC patients as part of second-line therapy.
More dramatic results should be expected in earlier staged patients for whom immunotherapies are better suited to produce substantial survival benefits, either as single agents or in combination with traditional therapies. Despite the fact most operable (Stage I and II) NSCLC is resected with curative intent, there is a 30-50% chance of recurrence at three years. We believe administration of HyperAcute-Lung vaccine to these patients in an adjuvant setting may provide a significant clinical benefit in terms of disease-free and overall survival. Likewise, addition of HyperAcute-Lung immunotherapy into current first line treatment regimens could offer another promising drug development path.
About lung cancer
Lung cancer is the second most common tumor type and by far the leading cause of cancer death in the United States among both men and women. Approximately 220,000 people will be diagnosed with lung cancer in the U.S. in 2009, and 160,000 Americans are expected to die from the disease this year. It claims more lives than colon, prostate, lymph, and breast cancers combined.
There are two main types of lung cancer. Small cell carcinoma accounts for approximately 10-15% of disease incidence. NSCLC makes up almost all of the remaining 85-90% of cases (which are further divided into three major subtypes: squamous cell carcinoma, adenocarcinoma, and undifferentiated large cell carcinoma). The combined cure rate for NSCLC patients with Stage IB to IIA disease is approximately 40%. Five year survival rates for patients with Stage IIIB and IV NSCLC are 5% and less than 2%, respectively.
Standard cytotoxic agents used in the treatment of NSCLC are generally associated with a broad range of serious, and often dose limiting, adverse effects. The toxicities that commonly attend cancer chemotherapy have been accepted as largely unavoidable given the dire prospects patients otherwise face. Unfortunately, about half of patients who receive first-line treatment fail their initial therapies, and many of these patients prove unable or unwilling to undergo further, more aggressive therapy due to the harsh effects of the first-line regimens. A desperate need exists for effective medicines with improved toxicity profiles.