mercredi 21 octobre 2015

Neovacs : Jason McCarthy annonce un objectif de cours strastosphérique

Sometimes a rifle shot can only stop a single target and is not enough to stop a herd. Similarly, a single monoclonal antibody (MAb) can only stop one arm of the immune system. You need the power of a shotgun to stop multiple branches of autoimmune diseases in its tracks. Neovacs' Kinoid vaccine technology is a polyclonal antibody ("shotgun") approach to autoimmune diseases, including systemic lupus erythematosis (SLE), or lupus. 

• The key to treating SLE is the cytokine INFα (interferon alpha), but this comes in 13 flavors. MAbs may halt a few INFαs, leaving the others to compensate. A shotgun approach, however, covers all 13 isotypes. INF-Kinoids (INF-K) are the SLE shotgun. Phase I/II data has shown that INF-K neutralizes all INFα and shuts off INFα-controlled inflammatory genes. A phase IIb proof of concept (POC) study (n=166) is underway in Europe and phase II studies in the U.S. and China should initiate in early 2016.

• Bottom line. It’s all upside from here, in our opinion. As a result of the prior TNF-K failure in rheumatoid arthritis (RA), Neovacs’ valuation has been punished. We see this as a strategic advantage for investors, as the focus should now be on INFα in SLE, a completely different cytokine (apples vs. oranges). Early data has been promising, and Neovacs has seen biomarkers in SLE that it didn't see in RA, giving more visibility and increasing the probability of success, in our view. If the technology works in SLE, INF-K could be the next Humira, and big pharma partners may be wanted. Details 

• Kinoid technology: active immunotherapy. Cytokines are like mediators of the immune system and can be overexpressed or abnormally released in autoimmune diseases, cancer, and allergies. Blockbuster anti-cytokine MAbs targeting cytokines (such as Humira, Remcade, and Avastin) are given as passive immunotherapy and have shown efficacy, but they have limits — most specifically, the development of resistance. Kinoids avoid this problem by fusing inactivated cytokines with the immunogenic protein KLH (keyhole limpet hemocyanin). Kinoids (like INFα-K) are injected into the patient as an active immunotherapy that induces a polyclonal antibody immune response against the endogenous cytokine driving the disease. Kinoids allow the patient's immune system to generate a response and avoid the development of drug resistance. In addition, they're far cheaper to produce. 

• INFα-K in SLE: Visibility increases the probability of success. Where is POC in SLE? What target? What endpoint? These questions have yet to be answered, resulting in SLE existing in a graveyard of failed drugs. However, we now know that SLE is driven by INFα, and it’s the master regulator of the inflammatory genes being turned on and causing tissue damage in SLE. In other words, INFα — and thus, SLE — has a "gene signature" and can be measured. The INFα-K phase I/II study showed that polyclonal Abs neutralize all subtypes of INFα, and the gene signature goes negative; it shuts off. Neovacs now has a target (INFα), a population (mild-mod SLE, INFα-gene-signature positive), and endpoints (immunogenicity, biomarkers, and improved SLE activity score). Most importantly, the company has visibility: the gene signature that may be a predictor of disease activity. As a result, we believe that Neovacs’ probability of success increases in the ongoing and upcoming phase II trials. POC data could come by 1Q17. 

• Valuation. Our model assumes an INFα-K launch in 2020 in Europe, the U.S., and China. We discount back 30% in our free cash flow, discounted EPS, and sum-of-the-parts models, which are equally weighted to derive a €4 price target.

Source :

AMF. Actionnaire Néovacs le 21.10.2015