Wed, Jun. 8, 11:00 AM
Tue, May 10, 12:47 PM
Tue, May 10, 9:16 AM
Mon, May 9, 6:43 PM
- NewLink Genetics (NASDAQ:NLNK) -32.1% AH after announcing that its investigational immunotherapy for resected pancreatic cancer did not achieve its primary endpoint.
- Patients in one part of the study received the investigational immunotherapy called algenpantucel L along with a standard-of-care treatment, compared with the traditional treatment alone; NLNK says there was no statistical difference between the two groups for overall survival time or for long-term survival.
- Algenpantucel-L was NLNK’s most advanced clinical program using the company’s HyperAcute Cellular Immunotherapy platform.
Mon, May 9, 5:40 PM
Mon, Feb. 29, 8:04 AM
Wed, Feb. 17, 10:07 AM
- Micro cap Inovio Pharmaceuticals (INO +4%) is up in early trading on increased volume in response to its announcement of positive preclinical data for its Zika virus vaccine candidate. In the study, DNA constructs, synthetically generated with the company's SynCon vaccine technology, targeting multiple Zika virus antigens and administered using its CELLECTRA electroporation delivery technology induced robust and durable immune responses. Phase 1 testing is expected to commence before year end.
- Investors seeking to profit from a Zika-stoked up move need to be patient. Regulatory clearance for a vaccine, even with accelerated review, is probably two years away. Drugs to treat infection are further away still.
- Intrexon (XON +6.4%) has seen some recent bullish action (shares doubled from mid-January to early February) in apparent anticipation of the revenue potential of its genetically modified sterile male mosquitoes, OX513A, that produced a 95% reduction in the Aedes aegypti population, the type of mosquito that transmits Zika and Dengue, in a small study in northeast Brazil. Here, again, sobriety is key. The beneficial effects are only temporary (unless the sterile guys are repeatedly released over a wide area, a tall order since mosquitoes only travel ~200 yards so covering a large area would require substantial human and physical resources). Intrexon's pricing leverage will also be constrained because irradiated sterile mosquitoes perform just as effectively and they will be available free-of-charge. Both techniques have similar cost structures, about $400/1M mosquitoes.
- Zika Index: (XON +6.4%)(INO +5.9%)(CERS +1%)(SNY +0.8%)(NLNK -1.8%)
Fri, Jan. 22, 4:49 PM
- Results from a Phase 1b/2 clinical trial assessing NewLink Genetics' (NASDAQ:NLNK) indoximod plus gemcitabine/nab-paclitaxel in patients with metastatic pancreatic cancer showed encouraging durable responses with a delayed pattern and a 42% objective response rate (ORR), including one complete response. The data will be presented today at the 2016 Gastrointestinal Cancers Symposium in San Francisco.
- The results were generated from 12 evaluable patients out of 50 enrolled to date. The target enrollment in the Phase 2 portion is 80. The ORR was 42% (n=5/12) with one complete responder. The small n notwithstanding, this handily beat the 23% ORR in the IMPACT study which established gemcitabine/nab-paclitaxel as the standard of care for metastatic pancreatic cancer.
- Indoximod is an orally available small molecule that inhibits an enzyme called indoleamine 2,3-dioxygenase (IDO), a central regulator of local and systemic immunosuppression that allows tumors to avoid the body's immune response.
- Pancreatic cancer is one of the most resistant to treatment. The one-year survival rate is only 20%, falling to 6% at five years.
- Shares are up 3% after hours on modest volume.
Wed, Jan. 20, 5:39 PM
Nov. 9, 2015, 9:14 AM
Oct. 13, 2015, 9:17 AM
- NewLink Genetics (NASDAQ:NLNK) is 11% premarket on light volume in response to its announcement of a article just published in Cell Reports, titled "Tumor-Expressed IDO Recruits and Activates MDSCs ina Treg-Dependent Manner."
- The article shows that a particular tumor pathway, called indoleamine 2,3-dioxygenase (IDO), is a central regulator of local and systemic immunosuppression and resistance to immunotherapy in melanoma. It also reports that NewLink's indoximod, a small molecule IDO pathway inhibitor, reversed tumor-associated immunosuppression in pre-clinical melanoma models.
- Indoximod is currently in Phase 2 development for breast cancer, prostate cancer, melanoma and glioblastoma multiforme (brain cancer) and in Phase 1b/2 development for pancreatic cancer.
Jul. 31, 2015, 9:19 AM
Jul. 31, 2015, 8:47 AM
- An interim analysis of data from a Phase 3 ring vaccination trial in Guinea shows Merck's (NYSE:MRK) Ebola vaccine candidate, rVSV-ZEBOV, was 100% effective in protecting people from Ebola virus infection within six to 10 days of vaccination (p=0.0036). The preliminary conclusions will be published online today in The Lancet.
- Over 4,000 people have received the vaccine to date. Merck licensed rVSV-ZEBOV from NewLink Genetics (NASDAQ:NLNK) who licensed it from the Public Health Agency of Canada.
- The make the vaccine, a virus similar to the rabies virus called vesicular stomatitis virus is weakened by removing one of its genes which is then replaced with a single Ebola virus gene that, by itself, cannot cause disease.
- Two other trials assessing rVSV-ZEBOV are ongoing: a Phase 3 study, called STRIVE, in Sierra Leone and a Phase 2, called PREVAIL, in Liberia.
- MRK is up a fraction premarket. NLNK is up 9% on light volume.
May 12, 2015, 9:16 AM
May 12, 2015, 8:08 AM
- NewLink Genetics (NASDAQ:NLNK) is off 20% premarket on average volume in apparent response to its announcement after yesterday's close that the Phase 3 trial evaluating algenpantucel-L in pancreatic cancer will continue following the second planned interim data analysis.
- Previously: NewLink on go with algenpantucel-L Phase 3 after 2nd interim analysis (May 11)
May 11, 2015, 5:40 PM
NewLink Genetics Corp. is a biopharmaceutical company focused on discovering, developing and commercializing novel immunotherapeutic products to improve cancer treatment options for patients and physicians. Its portfolio includes biologic and small molecule immunotherapy product candidates... More
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