Selecta Biosciences ($SELB) expects to get Phase II data for its lead candidate with the $70 million it just raised in an IPO. The trial is slated to start next half.
But Selecta cautioned that it has already had three serious adverse events in Phase I testing for its lead, for which final data are due next half. Two of these adverse events have been classified as possibly related to the study drug, SEL-212.
The bulk of the cash raised in the IPO will go to completing a combined Phase I/II program for SEL-212, which includes two Phase I trials and a Phase II trial to test the gout candidates’ ability to control uric acid levels and to mitigate the formation of anti-drug antibodies (ADAs).
The biodegradeable nanoparticle drug delivery company has already spent more than $121 million since it was founded in 2007. Existing investors boosted the offering in the current tough IPO market environment by committing to invest up to $40 million in the IPO.
Selecta investors include Polaris Venture Partners (10.4% post-IPO stake), Flagship Ventures (9.8%), RusNano (8%) and OrbiMed (7.4%).
Drug delivery pioneer and MIT professor Robert Langer is a Selecta co-founder; he also sits on the company board, but was slated to resign upon the IPO alongside two other board members to establish an independent board in compliance with Nasdaq rules, the company said. Another Langer nanoparticle biotech, Bind Therapeutics ($BIND) declared bankruptcy earlier this year.
The premise of Selecta is to use its synthetic vaccine particle (SVP) tech to modulate the immune system to treat diseases with biologic therapies—that can themselves trigger an undesired immune response. This includes ADAs, which the immune system produces in response to biologic therapy.
“SVP technology encapsulates an immunomodulator in biodegradable nanoparticles to induce antigen-specific immune tolerance to mitigate the formation of ADAs in response to life-sustaining biologic drugs,” the company noted in its IPO filing.
SEL-212 is comprised of a combination of a biodegradable nanoparticle that encapsulates the immunomodulatory rapamycin, which is a small molecule approved for the prevention of organ rejection in kidney transplant patient. It also includes the co-administration of pegsiticase, Selecta’s pegylated uricase, for the treatment of refractory and chronic tophaceous gout that’s intended to reduce ADA formation.
At June 3, Selecta had enrolled 70 patients in the Phase Ia and Phase Ib trials who received either SEL-212 (SVP-Rapamycin and pegsiticase), SVP-Rapamycin alone or pegsiticase. The three reported adverse events in these trials include a case of atrial fibrillation in a 62 year-old man that was treated and from which he recovered. That was found not to be related to pegsiticase.
The other two cases were found to be possibly related to the study drug. They include a patient with a rash followed by joint pain that resolved with treatment using steroids, analgesics, anti-nausea medications and topical antihistamine cream, as well as the most recent case of a patient on the highest dose that was reported on June 15 with stomatitis. This included the formation of mouth sores and inflammation that resulted in rapid weight loss; it is also a common adverse reaction to rapamycin.
Beyond the lead candidate, Selecta has a four other programs it hopes to advance into the clinic: a gene therapy for an autosomal recessive metabolic disorder that it expects to submit an IND for by the end of 2017 and a gene therapy for x-linked metabolic disorder that it plans to submit an IND for in 2018.
In addition, it has a trio of discovery stage programs in food allergy, celiac disease and Type 1 diabetes that are partnered with Sanofi ($SNY) and a fourth in malaria that’s partnered with the Bill and Melinda Gates Foundation.
The IPO offering priced at $14, the low end of its anticipated range. In response, Selecta bumped up the number of shares sold to 5 million, from the previous 4.25 million.
- here is the SEC filing
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