Cerus Corp.'s Intercept Blood System Progress Report
Mon, Jun. 20, 9:16 AM
Mon, Jun. 20, 6:59 AM
- Cerus (NASDAQ:CERS) enters into a 5-year agreement with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) to support the development of the company's INTERCEPT Blood System for pathogen reduction of red blood cell (RBC) components, including blood-borne pathogens Zika, dengue and chikungunya.
- The contract includes a base period with committed funding of ~$30.8M with subsequent option periods that have could increase the amount to ~$180.5M to support clinical development, regulatory submissions, manufacturing and scale-up activities. Cerus and its partners are responsible for the co-investment of $14.5M.
- The company reported positive results from a European Phase 3 study in RBCs in January 2015 and from a U.S. Phase 2 in December 2014. An application for CE Mark registration should be filed later this year.
- INTERCEPT reduces the risk in transfusion-transmitted infection by inactivating a broad range of viruses, bacteria, spirochetes, parasites and leukocytes in platelet and plasma components. It accomplishes this via the use of a photoactive compound called amotosalen that "docks" between nucleic acid base pairs in the pathogen's DNA. When activated by ultraviolet light, it forms permanent cross-links between the helical strands of DNA that blocks further replication. Plasma and platelets are unaffected since they contain no functional DNA or RNA. The system has been in use in Europe since 2002 and the U.S. since 2014.
- Management will host a conference call this morning at 8:00 am ET to discuss the contract.
- Shares are up 12% premarket on robust volume.
Tue, Mar. 8, 5:46 PM
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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%)
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Dec. 17, 2014, 8:01 AM
- Cerus Corp. (NASDAQ:CERS) is up 23% premarket on moderate volume. After the close yesterday, the company announced that the FDA approved its Intercept Blood System for the preparation of plasma.
- Previously: Cerus +20.3% AH; FDA approves Intercept for plasma (Dec. 16, 2014)
Dec. 16, 2014, 7:21 PM
- Cerus' (NASDAQ:CERS) Intercept plasma system has been "approved for ex vivo preparation of plasma in order to reduce the risk of transfusion-transmitted infection when treating patients requiring therapeutic plasma transfusion."
- Last month, the FDA approved Intercept for treating plasma collected from Ebola survivors for passive immune therapy.
- A CC will be held at 8AM ET tomorrow (webcast).
Dec. 16, 2014, 5:42 PM
Cerus Corp. is a biomedical products company, which is engaged in developing and commercializing the INTERCEPT blood system. It currently markets and sells the INTERCEPT blood system for both platelets and plasma in Europe, the Commonwealth of Independent States, the Middle East and selected... More
Country: United States
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