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NewLink Genetics takes the stage at ASCO

HyperAcute Pancreas and HyperAcute Lung show positive results in clinical trials
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NewLink Genetics ($NLNK) presented updates on its cancer vaccines, HyperAcute Pancreas (algenpantucel-L) and HyperAcute Lung (tergenpumatucel-L), at the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting.

HyperAcute Pancreas (algenpantucel-L) is based on two allogeneic (non-self) pancreatic cancer tumor cell lines modified to express the gene for alpha (1,3) galactosyl transferase (α-GT), and was given as an intradermal injection in up to 12 treatments over 6 months in the Phase II trials, extended by six maintenance treatments over a further 6 months.

The study presented at ASCO was a Phase II trial in post-surgery high-risk pancreatic cancer patients who received the vaccine along with chemotherapy. Patients treated with the vaccine had better survival at one, two and three years compared with predicted survival if they had only been treated with standard chemotherapy. In some patients, the benefits seemed to increase over time, and in a few patients whose cancer recurred after the study, further chemotherapy put them into remission still ongoing at 6-36 months. The vaccine is now in a Phase III trial.

"We are presenting data from … HyperAcute products at ASCO this year and each of these has generated intriguing data that provide insights into the activity and mechanisms associated with the treatment of patients with HyperAcute immunotherapies," stated Dr. Charles Link, CEO and chief scientific officer of NewLink Genetics. "These observations include survival advantages that improve over time, objective responses, novel immunological findings and chemosensitization."

HyperAcute Lung Cancer (tergenpumatucel-L) is a therapeutic cancer vaccine for the treatment of non-small cell lung cancer (NSCLC), made up of cells from three allogeneic lung tumor cell lines modified to express the gene for α-GT. In the PhaseIb/II study presented at ASCO, people with metastatic or recurrent NSCLC received an injection every two weeks for up to 8 doses. Those who showed an immune response (measured by levels of interferon-gamma) to the vaccine had longer survival, and the overall survival was similar to that seen in other second-line therapies. Monitoring patients for an immune response may be a useful biomarker for the efficacy of the treatment.

"These data suggest an intriguing relationship between a patient's immunological response to tergenpumatucel-L and overall survival," said Dr. John C. Morris of the University of Cincinnati. He added, "[s]urvival of the late stage patients in this study compares favorably with that seen in approved agents and there is emerging data to suggest that patient response to some of these agents may be enhanced by prior treatment with tergenpumatucel-L."

According to analyst Salveen Richter in StreetInsider, "[t]he key value driver [at NewLink] is HyperAcute Pancreas [HAP]--a novel immunotherapy in Phase III clinical trial for surgically-resected pancreatic cancer. A positive Phase II (we recognize it was a single-arm study) in addition to the novel cancer vaccine platform are encouraging as we look toward Phase III data (first interim analysis in late-2012/early-2013E). We model for peak worldwide HAP sales of $850M in 2020, of which $635M is recognized by NLNK."

HyperAcute Pancreas was featured in FierceBiotech's look at key attacks on the disease last year.

- read the poster on HyperAcute Pancreas
- see the press release on HyperAcute PancreasLung
- read the poster on HyperAcute Lung
- see the press release on HyperAcute Lung
- check out the article from StreetInsider

Special Reports: NewLink Genetics - Biotech IPOs of 2011 | HyperAcute Pancreas - Biotech's 5 key attacks on pancreatic cancer

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