Anergis has returned to investors for another tranche of cash to finance clinical development of its birch pollen allergy product. The extension, which brings the total raised in the Series B round to CHF 30 million ($31 million), stretches Anergis' financial runway out beyond generation of the Phase IIb data it foresees forming the basis of partnership talks.
Anergis CEO Vincent Charlon
Lausanne, Switzerland-based Anergis raised the majority of the Series B round in December 2014, at which time it pulled in CHF 14.5 million from Sunstone Capital, BioMedInvest, Renaissance PME and WJFS and converted an earlier CHF 8 million loan. The round, which was added to in an unpublicized CHF 2 million extension around one year ago, enabled Anergis to gear up for a 450-person Phase IIb trial it sees as having the statistical power to contribute data to regulatory approval filings down the line.
With the Phase IIb study set to start in the fall, Anergis has moved to secure its longer-term future by tapping existing investors for more money. "We are now adding 5 million in order to have the means to go beyond the results of that trial," Anergis CEO Vincent Charlon told FierceBiotech. Charlon expects to have data from the Phase IIb trial in the third quarter of 2017, at which time, if everything goes according to plan, Anergis will be one Phase III study away from approval on both sides of the Atlantic.
The case in support of the birch allergy product extends beyond the planned Phase IIb and III trials. "We have clinical data over more than one season in conditions of natural exposure," Charlon said. "That is really what is expected by authorities to approve products." Anergis now has evidence of immune memory dating back four years. The process of inducing an antibody response, which starts by administering a mix of long synthetic peptides in the two months leading up to the allergy season, appears to be supported by natural reactivation of the immune memory in subsequent years.
Such data have enabled Anergis to raise the money and start to think about how it can take its lead candidate through what is left of clinical development. "At this point in time, we believe that we will seek a partner to reach approval," Charlon said. Discussions about a possible deal are expected to ramp up once Anergis has data from the upcoming trial.
- read the statement (PDF)