About Us

OVERVIEW

Calixa Therapeutics, Inc is a privately-held biopharmaceutical company focused on develop-ment of a novel cephalosporin to address the expanding problem of multi-drug resistant organisms ("bad bugs"). Treatment for resistant gram negative bacteria, especially Pseudomonas aeruginosa, is recognized as an unmet medical need by the infectious disease community.

Calixa's lead product, CXA-101, is an IV formulation of a novel cephalosporin that has excellent potency especially against multi-drug resistant Pseudomonas which differentiates it from other cephalosporins. No similar drug is known to be in development. Calixa plans to combine this product with a beta-lactamase inhibitor (BLI); the combination product (CXA-201) will have potential to become first-line coverage for gram negative organisms in serious infections in hospitalized patients. The projected NDA for the IV product is targeted for 2013. Peak revenues from IV and inhaled products are projected to be >$700M. The IP position is strong with composition of matter patent protection until 2023

DEVELOPMENT STATUS

The IND for CXA-101 was filed in June 2008 and two Phase 1 studies were successfully completed in January 2009. The safety profile was excellent and PK profile was predictable. A Phase 2 proof-of-concept study will start in the second quarter of 2009. The development of this product will be merged with the development of a product that combines CXA-101 with a beta-lactamase inhibitor (BLI). This combination product (CXA-201) will have an enhanced spectrum of activity and increased clinical utility as first-line coverage for gram negative organisms suspected in serious infections in hospitalized patients. In addition to the IV products, the same cephalosporin is being evaluated for inhaled administration (CXA-301) in cystic fibrosis to address multi-drug resistance (including to tobramycin) in Pseudomonas aeruginosa.

HISTORY

Calixa was cofounded in 2007 by Drs. Eckard Weber and James Ge. Calixa successfully acquired the global (ex-Asia) development rights for FR264205 from Astellas Pharma Inc. Calixa quickly assembled a management team with extensive recent experience in the clinical development of anti-infectives. We raised a $30 million Series A round from three highly respected venture capital firms: Domain Associates, Canaan Partners and Frazier Healthcare Ventures.

BUSINESS STRATEGY

Calixa's business strategy is to in-license, develop and commercialize proprietary novel anti-infective drugs with superior efficacy and safety to address important unmet medical needs. The team will:

  • Leverage our team's successful track record to move drug candidates efficiently through clinical proof-of-concept phase.
  • Define a development and regulatory strategy for each compound to enable successful, global filings.
  • Efficiently manage resources to meet corporate milestones and build company infrastructure to support development and commercialization of products in specialty markets in the US.
  • Actively explore in-license opportunities to expand our pipeline.
  • Strengthen our intellectual property.
  • Seek a strategic partner to support a robust development program for each compound in order to maximize the value of the asset.