ABX464: More impressive anti-inflammatory data
Data presented at the United European Gastroenterology Conference ("UEG") further support the impact of Abivax's ABX464 on ulcerative colitis ("UC"). While response to biologic therapies such as anti-TNFs often wains with time and alternatives including JAK inhibitors are associated with serious safety issues, 12-month Phase 2a extension endoscopic data indicate sustained and improving clinical remission with ABX464 in 75% of patients observed. Matched by improvements in both Mayo Score and faecal calprotectin, these impressive results provide confidence for the on-going confirmatory Phase 2b trial as well as potential in Crohn's disease and rheumatoid arthritis ("RA"). These data provide an even stronger basis for a licensing / development deal expected by mid 2020E in a > $70bn market. We reiterate and maintain both our OUTPERFORM recommendation and €31.30 target price.
22 Oct 19
Financing provides strong endorsement
The €12m investment by a leading healthcare investor (Sofinnova Partners), is a strong endorsement of Abivax and anti-inflammatory ABX464 in particular. As highlighted in our recent report (25th June 2019), clinical data to date suggests that ABX464 could take a meaningful share of the $70bn anti-inflammatory market. The unmet potential of the inflammatory market is well illustrated by the recently announced $5.1bn deal between Gilead Sciences Inc. and Galapagos NV. With future financing expected from partnering. the Sofinova investment adds to our confidence for Abivax securing a major licensing deal over the the next 12 months. Now funded until Q2/2020E, we believe the ABX464 data provide a strong basis for licensing to provide development funding thereafter. We reiterate both our OUTPERFORM and €31.30 target price.
16 Jul 19
Ready to deal with inflammation
Focussed on identification and exploitation of regulators of immunity and inflammation, Abivax has two major products in clinical trials. With Phase 2a efficacy on a par with recently approved tofacitinib, ABX464 shows sustained benefit in ulcerative colitis ("UC") without the safety concerns of JAK or anti-TNF drugs. Moving into confirmatory Phase 2b for UC and Phase 2a in Crohn's and rheumatoid arthritis ("RA"), ABX464 promises a meaningful share of the $70bn anti-inflammatory market and a substantial licensing agreement by 2020E. Entering Phase 1/2, ABX196 is a powerful activator of iNKT cells with with potential to extend the benefits of PD-1 / PD-L1 immune checkpoint inhibitors ("ICI"). Sustained by ICIs iNKT cells act directly on cancer cells as well as promote the anti-tumour activity of key ICI-activated cells; a strong rational for synergy. Funded until Q1/2020E, we believe the ABX464 data provide a strong basis for licensing to provide development funding thereafter. We reiterate our OUTPERFORM and increase our TP to €31.30 (from €28.80).
25 Jun 19
ABX464: sustained safety and benefit in inflammatory bowel
Data presented at the ECCO (European Crohn's and Colitis Organisation) support the potential of Abivax's ABX464 in ulcerative colitis ("UC") While response to biologic therapies such as anti-TNF often wains with time and alternatives including JAK inhibitors are associated with serious safety issues, six month Phase 2a extension data indicate safety and progressive improvements from ABX464 in key UC disease markers, including Mayo Score and faecal calprotectin over the eight months since the original trial began. We are optimistic that clinical studies planned for 2019E should confirm the UC results and may suggest efficacy in Crohn's Disease and rheumatoid arthritis ("RA"). There appears a firm basis for a licensing / development deal expected during 2019E in a > $70bn market. We reiterate and maintain both our OUTPERFORM recommendation and €28.80 target price.
11 Mar 19
Getting a brake in inflammation
With proof-of-concept trials in ulcerative colitis ("UC") suggesting efficacy on a par Abivax's ABX464 looks a real alternative to approved therapies. A new class of oral drug releasing a natural inflammatory brake, ABX464 could alleviate the treatment failures and possibly safety issues of existing drugs. This would open a significant opportunity in a > $70bn market. We are optimistic that clinical studies planned for 2019E should confirm the UC results and may suggest efficacy in Crohn's Disease and rheumatoid arthritis ("RA"). There appears a firm basis for a licensing / development deal expected during 2019E. We reiterate our OUTPERFORM recommendation and increase our target price ("TP") to €28.80 (from €19.50 / share).
22 Jan 19
Remarkable data opens door to $15bn IBD market
Phase 2a ulcerative colitis ("UC") data indicates real promise for the ABX-464 in the $15bn inflammatory bowel disease ("IBD") market. A small early stage trial, positive read-out on all key parameters suggests real benefits from this oral once a day drug for patients seeking to avoid repeated intravenous infusions or at worst surgical bowel removal. Already showing promise in the depletion of latent HIV reservoirs, these new data should significantly de-risk the drug's path to market potentially opening the door to an even larger opportunity in inflammatory disease. We reiterate both our OUTPERFORM recommendation and €19.50 target price.
06 Sep 18
ABX464 reduces HIV DNA in latent viral gut reservoir
Data released from the second cohort of the ABX-464-005 trial indicates that ABX-464 can reduce the latent HIV reservoir in gut as well as in peripheral blood in patients receiving anti-retroviral therapy. Compared to the first trial cohort, these data suggest that the drug is safe when used over a longer period (3 months vs. 28 days) and has an impact on multiple latent viral reservoirs in HIV-infected patients; even when u sed at a third of the dose (50mg/day vs. 150mg/day). While full data from the trial is not expected until late Q3 / early Q4 2018E, these preliminary data should be seen as encouraging, suggesting that the trial should form a strong platform for movement into a Phase 2b study. We reiterate our OUTPERFORM recommendation and €19.50 target price.
03 Jul 18
HIV: Draining the reservoir; cooling the flame
While retroviral therapy now sees patients survive into their seventies, latent residual infection still condemns the HIV-infected to life time therapy, chronic health problems and shortened lives. Compelling preclinical data now supported by two Phase II human trials indicate that Abivax's ABX464 could be the first drug to drain the latent HIV reservoir. With its novel mode of action ("MoA"), the drug may not only act to reduce or even eradicate residual infection untouched by existing antiretrovirals, but also provide relief from the inflammation that blights the lives of patients with HIV as well as other major unrelated diseases such as inflammatory bowel disease ("IBD"). ABX464 has potential as an HIV curative therapy or as adjunct to existing treatments. Risk adjusted modelling suggests fair values for curative and adjunctive scenarios of €28.5 and €16.3 / share, rising to €48 and €27 respectively should on-going clinical trials in HIV and IBD yield positive results during 2018.
05 Oct 17