Lpath, Inc. (LPTN.OB) – Class Leader in Lipidomics-based Antibody Therapeutics in the Blockbuster-Potential Wet AMD Market
Lpath, Inc. and its Immune Y2 technology captured the biotech world’s attention in December 2010 after it announced a partnership with Pfizer (PFE) to develop and potentially market Lpath’s wet AMD drug, iSONEP. Per the agreement, Pfizer provided Lpath with $14 million upfront and Lpath would be eligible to receive development, regulatory and commercial milestone payments that could potentially add up to about $500 million not including the double-digit royalties from the sales of the drug if approved. Lpath announced the receipt of the $14 million in January 2011, setting the tone for the year for this small cap biotech and giving it broader exposure by putting it on many biotech investor watch lists. This agreement at least partially legitimizes Lpath’s Y2 technology and the iSONEP drug specifically as the Big Pharma leader recognizes the drug’s potential. The agreement also gives Pfizer the first right of refusal to Lpath’s cancer drug, ASONEP, which utilizes the same bioactive lipid signaling approach as iSONEP. Biotech traders view the agreement as being a huge positive as Pfizer wouldn’t be investing such a large amount of money or time in such an endeavor without having a great deal of confidence in the technology.
Information on their “top of the class” deserving Immune Y2 technology can be found on the company’s website. Basically, iSONEP itself is a monoclonal antibody targeting Sphingosine 1 Phosphate (S1P). S1P is a bioactive lipid that is a key component of the sphingolipid signaling cascade. In the wet AMD, S1P has been implicated as having many actions that promote inflammation and dysregulated angiogenesis. It additionally supports the survival of multiple cell types including fibroblasts, endothelial and inflammatory cells that participate in the dysfunctional processes of wet AMD and other eye diseases. If this pathway is tied up or neutralized, the angiogenesis, leakiness, scarring and inflammation due to AMD should be effectively eliminated because a larger portion of related factors involved will be targeted, not just those pertaining to the VEGF pathway that EYLEA, Avastin and Lucentis target due to the fact that S1P is linked to the production and activation of the growth factors VEGF, FGF, PDGF MCP-1 IL-6, IL-8 often implicated in the pathogenesis of wet AMD.
Phase 2 trials for iSONEP are already underway. They’re supported by strong phase I data in which the drug was well tolerated in all 15 patients with positive biological effects seen in most patients. The patient set chosen was a difficult one in which several of the patients had failed to respond positively to either Avastin or Lucentis. The drug appeared to stop the abnormal blood vessel growth, reduced the retinal thickness and also controlled the leakiness of the existing vessels, which are trademark effects of the ailment. However, as an added bonus the drug did something that neither Lucentis nor Avastin have shown clinical abilities to do. It mitigated the scarred tissue and inflammation, two key areas that could actually improve vision rather than only stopping its regression. If phase 2 data show comparable results to the phase I data particularly in the areas of vision improvement (2nd phase 2 trial) and in the case of RPE detachment phase 2 trial an improvement is seen in retinal pigment epithelium detachment secondary to wet AMD or polypoidal choroidal vasculopathy (PCV), the company will start generating phenomenal interest by potentially answering a large unmet need in a near-blockbuster market. Pfizer and many biotech investors are already watching the company closely and have already positioned themselves for success in the company. Interim and perhaps even final data obtained in 2012 will be huge catalysts for the company and could justify those decisions.
MFG
Chali
Lpath, Inc. and its Immune Y2 technology captured the biotech world’s attention in December 2010 after it announced a partnership with Pfizer (PFE) to develop and potentially market Lpath’s wet AMD drug, iSONEP. Per the agreement, Pfizer provided Lpath with $14 million upfront and Lpath would be eligible to receive development, regulatory and commercial milestone payments that could potentially add up to about $500 million not including the double-digit royalties from the sales of the drug if approved. Lpath announced the receipt of the $14 million in January 2011, setting the tone for the year for this small cap biotech and giving it broader exposure by putting it on many biotech investor watch lists. This agreement at least partially legitimizes Lpath’s Y2 technology and the iSONEP drug specifically as the Big Pharma leader recognizes the drug’s potential. The agreement also gives Pfizer the first right of refusal to Lpath’s cancer drug, ASONEP, which utilizes the same bioactive lipid signaling approach as iSONEP. Biotech traders view the agreement as being a huge positive as Pfizer wouldn’t be investing such a large amount of money or time in such an endeavor without having a great deal of confidence in the technology.
Information on their “top of the class” deserving Immune Y2 technology can be found on the company’s website. Basically, iSONEP itself is a monoclonal antibody targeting Sphingosine 1 Phosphate (S1P). S1P is a bioactive lipid that is a key component of the sphingolipid signaling cascade. In the wet AMD, S1P has been implicated as having many actions that promote inflammation and dysregulated angiogenesis. It additionally supports the survival of multiple cell types including fibroblasts, endothelial and inflammatory cells that participate in the dysfunctional processes of wet AMD and other eye diseases. If this pathway is tied up or neutralized, the angiogenesis, leakiness, scarring and inflammation due to AMD should be effectively eliminated because a larger portion of related factors involved will be targeted, not just those pertaining to the VEGF pathway that EYLEA, Avastin and Lucentis target due to the fact that S1P is linked to the production and activation of the growth factors VEGF, FGF, PDGF MCP-1 IL-6, IL-8 often implicated in the pathogenesis of wet AMD.
Phase 2 trials for iSONEP are already underway. They’re supported by strong phase I data in which the drug was well tolerated in all 15 patients with positive biological effects seen in most patients. The patient set chosen was a difficult one in which several of the patients had failed to respond positively to either Avastin or Lucentis. The drug appeared to stop the abnormal blood vessel growth, reduced the retinal thickness and also controlled the leakiness of the existing vessels, which are trademark effects of the ailment. However, as an added bonus the drug did something that neither Lucentis nor Avastin have shown clinical abilities to do. It mitigated the scarred tissue and inflammation, two key areas that could actually improve vision rather than only stopping its regression. If phase 2 data show comparable results to the phase I data particularly in the areas of vision improvement (2nd phase 2 trial) and in the case of RPE detachment phase 2 trial an improvement is seen in retinal pigment epithelium detachment secondary to wet AMD or polypoidal choroidal vasculopathy (PCV), the company will start generating phenomenal interest by potentially answering a large unmet need in a near-blockbuster market. Pfizer and many biotech investors are already watching the company closely and have already positioned themselves for success in the company. Interim and perhaps even final data obtained in 2012 will be huge catalysts for the company and could justify those decisions.
MFG
Chali