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NewLink Genetics: Examining Likelihood Of Success In The Impress Trial
- Many investors and commentators have failed to appreciate the risk/reward associated with NewLink's IMPRESS Phase 3 trial for surgically resected pancreatic cancer.
- Analysis presented herein suggests the IMPRESS trial is likely to be a success.
- Median Overall Survival greater than 21 months has not been observed in historical U.S. studies and trials where the percentage of lymph node positive patients is above 65%.
- A substantial pipeline for HyperAcute™ immunotherapy and a synergistic combination with other modalities suggests significant upside for the stock while downside has been limited by two recent lucrative licensing deals.
- The stock has about $10 downside if the trial continues to the final interim analysis and $100+ upside if the trial is stopped.
NewLink Genetics Takes A Shot At Combating Deadly Ebolavirus Infections: Diversification Strategy?
- NewLink Genetics Corp. receives $1 M letter contract from DoD to advance a promising Ebolavirus countermeasure.
- Wholly owned subsidiary BioProtection Systems Corp. leads infectious disease program since 2006.
- NewLink Genetics Corp. investors are getting aware of the so far ‘hidden’ infectious disease program.
- Continuous revenue stream likely for follow-up acquisition/replenishing contracts for infectious disease countermeasures.
- Diversification strategy changes risk assessment of NewLink Genetics Corp. business model; alternative (backup) technologies/strategies are already lined up.
Fri, Jan. 16, 8:54 AM
- A consortia of global research institutions and non-government organizations has been formed to work with Janssen Pharmaceuticals (NYSE:JNJ) to accelerate the development of its Ebola vaccine. The Innovative Medicines Initiative intends to grant more than €100M to fund the development work. The project is delineated into three areas or topics:
- Topic 1: Vaccine development, Phases 1, 2 and 3. Consortia members: Janssen, London School of Hygiene and Tropical Medicine, Oxford University, Insititut National de la Sante et de la Recherche Medicale (INSERM), La Centre Muraz.
- Topic 2: Manufacturing capability: Janssen, Bavarian Nordic A/S, Vibalogics.
- Topic 3: Deployment and compliance of vaccination regimens: Janssen, London School of Hygiene and Tropical Medicine, Grameen Foundation, World Vision of Ireland.
- A recently-started Phase 1 trial is being led by the Oxford Vaccine Group, part of the University of Oxford Department of Paediatrics. Janssen, in partnership with Bavarian Nordic A/S (OTCPK:BVNRY), has produced more than 400K regimens of the prime-boost vaccine for use in large-scale trials that could begin as early as April.
- Ebola vaccine-related tickers: (NASDAQ:NLNK) (NYSE:MRK) (NYSE:GSK)
Dec. 30, 2014, 1:53 AM
- A health-care worker infected with Ebola was admitted to a specialist unit in a Glasgow hospital yesterday after she returned from working with Ebola patients in Sierra Leone.
- She is the second Ebola patient to be treated in the country since the outbreak of the disease and will be transferred to the U.K.’s specialized high-isolation unit at the Royal Free Hospital in London as soon as possible.
- Ebola-related stocks are rising after-hours on the news: Tekmira (NASDAQ:TKMR) +1.7%; BioCryst Pharmaceuticals (NASDAQ:BCRX) +1.2%.
- Other related tickers: Hemipherx BioPharma (NYSEMKT:HEB); Inovio Pharmaceuticals (NASDAQ:INO); NewLink Genetics (NASDAQ:NLNK).
Dec. 22, 2014, 8:44 AM
- The U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) awards a $30M contract to NewLink Genetics (NASDAQ:NLNK) subsidiary BioProtection Systems as the prime contractor to support the development and manufacturing of its rVSV-EBOV (Ebola) vaccine candidate, including a new 330-subject Phase 1b study.
- The investigational vaccine was initially developed by the Public Health Agency of Canada. It is now being advanced by NewLink and Merck (NYSE:MRK).
Dec. 11, 2014, 11:58 AM
- The Global Alliance for Vaccines and Immunisation, Gavi, plans to spend as much as $300M for up to 12 million doses of an Ebola vaccine as soon as the World Health Organization (WHO) recommends one for use. An additional $90M could be used to support countries that introduce the vaccine and to rebuild devastated health systems and restore immunisation services in Ebola-stricken countries.
- Gavi is funded by governments and the Bill & Melinda Gates Foundation.
- Two vaccine candidates are currently being tested in humans in Phase 1 trials. The first trial, assessing Merck (MRK +0.8%) and NewLink Genetics' (NLNK -0.8%) candidate, experienced a hiccup recently when four volunteers complained of joint pain in their hands and feet. The trial is on hold as a precaution, but will restart on January 15 contingent on no further adverse events. The second trial, assessing the combination of GlaxoSmithKline's (GSK +0.4%) monovalent cAd3-EBO Z Ebola vaccine candidate with Bavarian Nordic's MVA-BN Filo booster vaccine, has experienced no adverse events to date.
- Johnson & Johnson (JNJ +0.8%) will begin testing its Ebola vaccine candidate in January and says it will have 250K doses for clinical study by May.
- Previously: Merck-NewLink Ebola vaccine trial interrupted (Dec. 11, 2014)
- Previously: Phase 1 underway for Ebola booster vaccine regimen (Dec. 4, 2014)
- Previously: J&J to begin testing Ebola vaccine in January; expects 250K doses ready by May (Oct. 22, 2014)
Dec. 11, 2014, 9:11 AM
Dec. 11, 2014, 8:08 AM
- The Phase 1 study assessing the safety of the Ebola vaccine candidate from Merck (NYSE:MRK) and NewLink Genetics (NASDAQ:NLNK) has been stopped a week early as a precaution after four volunteers (out of a total of 59) complained of joint pain in their hands and feet. All are being monitored by the medical team. The trial is due to resume on January 5 in as many as 15 volunteers after investigators confirm that the pain symptoms are benign and temporary.
Dec. 5, 2014, 1:57 PM
- As expected, the Biotechnology Industry Organization (BIO) gives a resounding thumbs up in support of adding Ebola to the FDA Priority Review Voucher Program Act. Under the act, developers of a vaccine or treatment for a qualified tropical disease receive a voucher for FDA priority review for another product of its choice.
- Late Wednesday, the U.S. House of Representatives voted unanimously to add Ebola to the Act. Additional refinements to the legislation include making it easier for the Secretary of Health and Human Services to add to the list of qualified diseases, allowing the vouchers to be sold and transferred multiple times and shortening the timeline for notifying the FDA of the intention to use a priority review voucher.
- The changes bring the tropical diseases priority review voucher program more in line with the rare pediatric disease priority review voucher program.
- Ebola-related tickers: (GSK +0.2%)(JNJ +0.5%)(MRK +1%)(NLNK +2.2%)(TKMR -1.4%)(HEB +0.6%)(SRPT -0.8%)(BCRX +0.8%)(CMRX +3.2%)
Dec. 5, 2014, 7:19 AM
- Doctors say that simple intravenous fluid drips could save the lives of many Ebola patients, but they are not being deployed due to a perception that no treatment will work. Many patients are succumbing to extreme dehydration and electrolyte depletion caused by vomiting and diarrhea, according to Ian Roberts of the London School of Hygiene and Tropical Medicine and Anders Perner of Copenhagen University. "Ebola treatment must be more that just a setting for quarantine. Patients will be reluctant to attend treatment centers unless the care they receive...is superior to the care provided by family members."
- The epidemic in West Africa has claimed more than 6,000 lives out of ~17,000 that have been infected. All but 15 of the deaths have occurred in Sierra Leone, Guinea and Liberia.
- ETFs: IRY, IXJ
- Ebola-related tickers: (NYSE:GSK) (NYSE:JNJ) (NYSE:MRK) (NASDAQ:NLNK) (OTCQB:AEMD) (NASDAQ:TKMR) (NYSEMKT:HEB) (NASDAQ:SRPT) (NASDAQ:BCRX)
Dec. 4, 2014, 8:23 AM
- In a Phase 1 trial sponsored by the University of Oxford, 30 healthy volunteers will receive Bavarian Nordic's MVA-BN Filo booster vaccine in combination with the monovalent cAd3-EBO Z Ebola vaccine co-developed by GlaxoSmithKline (NYSE:GSK) and the U.S. National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID). Recent preclinical research suggests that employing an MVA-based booster dose may deliver a more robust and durable immune response to the primary vaccine.
- The study involves 60 healthy adults divided into three cohorts each receiving different doses of the cAd3-EBO Z vaccine. Half of each cohort will also receive the booster dose of MVA-BN Filo.
- The primary endpoint is safety and tolerability. The secondary endpoint is the cellular and humoral immune response. Preliminary results should be available in 1H 2015.
- Both cAd3-EBO Z and MVA-BN Filo have been developed in collaboration with NIAID, which also investigated the prime boost regimen of MVA-BN Filo and Crucell Holland B.V.'s AdVac technology. Crucell is part of J & J (NYSE:JNJ) unit Janssen Pharmaceuticals. Bavarian Nordic and Janssen are collaborating on the development and manufacture of large quantities of their vaccine regimen and intend to start clinical trials shortly.
- Related tickers: (NYSE:MRK) (NASDAQ:NLNK)
Nov. 24, 2014, 9:48 AM
- Merck (MRK -0.7%) enters into an exclusive worldwide license agreement with NewLink Genetics (NLNK +0.5%) to develop and commercialize the latter's investigational rVSV-EBOV (Ebola) vaccine candidate.
- Phase 1 trials are currently underway at Walter Reed Army Institute of Research and the NIAID at the NIH. If successful, the NIH will commence a large, randomized Phase 3 study to evaluate the safety and efficacy of rVSV-EBOV and another investigational Ebola vaccine candidate co-developed by the National Institute of Allergy and Infectious Diseases (NIAID) and GlaxoSmithKline (GSK -0.3%).
- The rVSV-EBOV vaccine was created by scientists at the Public Health Agency of Canada's National Microbiology Laboratory.
Nov. 20, 2014, 11:03 AM
- The Securities and Exchange Commission suspends trading in thinly-traded nano caps Bravo Enterprises (OTCQB:OGNG), Immunotech Labs (OTCPK:IMMB), Myriad Interactive Media (MYRY) and Wholehealth Products (OTCPK:GWPC) citing a lack of publicly available information about the firms' operations.
- The SEC can suspend trading in a stock for 10 days and prohibit broker-dealers from soliciting buyers and sellers until certain reporting requirements are met.
- Ebola Small Cap Index (based on trading behavior): (OTCQB:AEMD -7%)(HEB +1.4%)(TKMR +0.2%)(NLNK +5.4%)(NNVC +2.9%)(INO +5%)(OTCQB:GOVX -2.1%)(SRPT +3.5%)(CMRX -1.3%)(PLX -0.9%)(NSPH -1.4%)(BCRX +0.4%)(LAKE -1.9%)(APT -2.4%)(VSR)(SMED +0.7%)
Nov. 18, 2014, 5:39 PM
Nov. 17, 2014, 12:06 PM
- Nano cap Aethlon Medical (OTCQB:AEMD +29.8%) jumps on massive turnover of 10M shares in response to its report of the successful treatment of a critically-ill Ebola patient in Germany with its Hemopurifier bio-filtration device. In a post-treatment analysis, the device captured 242M Ebola viruses. The patient is expected to make a full recovery.
- The Hemopurifier targets the broad-spectrum elimination of viruses and immunosuppressive proteins from the blood.
- The stock has more than tripled since mid-October when the first treatment with the Hemopurifier was reported.
- Some of the members of the trading behavior-characterized Ebola Small Cap Index have completed their round trips. (HEB +1.2%)(TKMR +5.1%)(NLNK +2.5%)(NNVC -3.8%)(INO -8.5%)(OTCQB:GOVX)(SRPT -0.7%)(CMRX +4.4%)(PLX -1%)(NSPH -0.2%)(BCRX +0.7%)(LAKE +1.3%)(APT +0.2%)(VSR -0.7%)(SMED -2.7%)
Nov. 6, 2014, 7:21 AM
Oct. 28, 2014, 4:10 AM
- The CDC has published new guidelines on healthcare workers who have returned from caring for Ebola patients in Africa following days of disagreements between the federal government and state governors.
- The guidelines recommend that people at high risk of developing Ebola voluntarily isolate themselves from others for 21 days.
- Several states, including New York and New Jersey, still require mandatory quarantines on such people, which has triggered the tensions with the White House.
- Ebola Small-cap Index: HEB, TKMR, NLNK, NNVC, INO, OTCQB:GOVX, SRPT, CMRX, PLX, NSPH, BCRX, LAKE, APT, VSR, SMED.
Oct. 27, 2014, 12:16 PM
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