Our Products

Pipeline

Product Pipeline

We believe that Adnectins™ and PROfusion™ provide us with the opportunity to build a unique pipeline of best-in-class targeted biologics in multiple therapeutic areas.

Our research strategy is to create Adnectin-based product candidates that address antibody-validated targets and are superior to existing drugs on the market or in development -- there are at least 170 antibody products approved or in the clinic.

As a result, we believe we are able to build and develop products in a capital efficient manner due to lower biology and chemistry risks and a clearer clinical and regulatory development path.

Our first Adnectin, Angiocept™, is an antagonist of the VEGFR-2 pathway and is in clinical development in the United States. In addition, we are also pursuing several other research programs in a variety of therapeutic areas.

Adnectin Clinical Strategy and Development

As the first in a new class of targeted biologics, a key component of our clinical strategy for the development of Angiocept was to utilize the phase 1 development to demonstrate a number of key product attributes of the Adnectin class, including:

  • Favorable Adnectin safety and tolerability profile, as demonstrated by:
    • No observed off-target activity associated after single or repeated doses
    • No significant acute infusion reactions after single or repeated doses
    • Demonstrated acceptable safety profile in three-month animal toxicology studies to support phase 2 development
  • Favorable Adnectin immunogenicity profile, as demonstrated by:
    • Consistent biological activity for up to several months after repeated weekly doses indicating no significant antibody-induced neutralization in patients
    • Consistent drug levels after several months of repeated weekly injections indicating no significant antibody-induced clearance
    • No clinically significant immune response after several months of repeated weekly treatment
    • No immunogenic response detected to Adnectin backbone
  • Favorable Adnectin pharmacokinetic profile, as demonstrated by:
    • Support of weekly to every-other-week dosing
    • Inter and intra-patient drug level consistency over time for ease of dosing
    • Predictable drug exposure between dose levels

The results to date from our ongoing phase 1 clinical trial indicate a favorable clinical profile consistent with all our phase 1 strategic objectives for the Adnectin class.

Angiocept's Mechanism of Action

Angiocept is a highly potent, specific and complete VEGFR-2 pathway antagonist. It inhibits tumor angiogenesis, the formation of new blood vessels in tumors, which is vital to the progression of tumor growth.

The VEGFR-2 pathway is composed of its receptor and its multiple activating proteins: VEGF-A, VEGF-C and VEGF-D. It has been shown that binding of one of these proteins to human VEGFR-2 stimulates the growth of the cells that form new blood vessels, and studies of clinical samples from cancer patients demonstrate that human VEGF-A, VEGF-C and VEGF-D are over-expressed in tumor tissue or plasma.

Anti-angiogenic drugs that block the formation of these new blood vessels have emerged as an important new drug category in the treatment of cancer. Cancer cells secrete a variety of protein activators or growth factors that bind to receptors and promote angiogenesis. We believe that the most important pathway in this process is the VEGFR-2 pathway.

We believe that Angiocept is the only pure antagonist of all protein activators in the VEGFR-2 pathway and is specific for the VEGFR-2 receptor, thus potentially avoiding off-target side effects. It is also the smallest anti-angiogenic biologic, which may potentially improve tissue distribution. Therefore, we believe Angiocept has a number of properties that may create the opportunity for a best-in-class antiangiogenic treatment.

Angiocept Clinical Development

Phase 1: We are conducting our phase 1 clinical trial of Angiocept in the United States in oncology patients.

Our phase 1 clinical trial results to date are consistent with the mechanism that Angiocept is acting as an antagonist to its intended target, human VEGFR-2. In addition, our phase 1 clinical trial allowed us to identify a well-tolerated and pharmacologically active dose of Angiocept, which we plan to use in our first phase 2 clinical trial.

Phase 2: We are planning multiple phase 2 clinical trials in oncology to establish the potentially broad applicability of Angiocept. We have initiated a multicenter Phase 2 clinical study of Angiocept in patients with recurrent glioblastoma multiforme (GBM), the most common and aggressive type of primary brain tumor.