SEATTLE, WA, USA I December 10, 2012 I ALLOZYNE, Inc., a clinical-stage biotech focused on autoimmune diseases and cancer, announced the results from a preclinical study characterizing one of its next generation proofofconcept (POC) antibody drug conjugates (ADCs). This ADC exhibits potent cell killing against Her2+ breast cancer cells in vivo. A significant reduction in tumor size was observed after a single administration.  

This POC ADC was comprised of a monoclonal antibody targeting Her2/neu attached by a cleavable linker to a potent synthetic drug payload using ALLOZYNE’s proprietary Biocipher™ technology. After attachment of a smallmolecule conjugate to the antibody, there was no significant loss of binding affinity or compromised PK profile when compared to that of the parental antibody.

Stability of the linker is one of the most important considerations for ADCs given that poor linker stability can lead to negative safety implications in the clinic as in the case of first generation products such as Mylotarg™, which was later withdrawn from the market due to adverse safety events.   ALLOZYNE’s ADCs remained stable in human serum at 37 degrees C for at least one month and demonstrate significantly reduced aggregation compared to their parental antibodies.  

ALLOZYNE’s protein engineering platform enables the creation of engineered antibodies known as “AzAbs” that are based on monoclonal antibodies (mAbs) and contain sitespecifically incorporated azide nonnatural amino acids (NNAAs). The azide NNAAs can be incorporated at virtually any position within the antibody and serve as a functional handle that is uniquely reactive during a bioconjugation reaction. This unique reactivity ensures that the linkertoxin conjugate is attached at the site of the azide NNAA only and at no other locations on the AzAb. These fundamental components of ALLOZYNE’s technology are compatible with virtually all linker and toxin types.

“By precisely controlling both the site and number of linkertoxin conjugates we have the potential to increase the safety profile of this rapidly expanding new class of cancer therapeutics and possibly also increase efficacy as well. This is a key advantage of our ADCs and something that represents a significant challenge for the current approaches”, stated Ms. Meenu Chhabra, President & CEO of ALLOZYNE.

About ADCs

ADCs are antibodybased therapeutics armed with a destructive small molecule payload. The antibody ensures that the payload is delivered specifically to a specific cancer cell type, much like a homing missile for cancer cells. Upon reaching its target, it is brought inside the cancer cell where its payload is released and the cancer cell is destroyed, sparing the surrounding healthy cells.

According to DATAMONITOR, ADCs currently represent the fastest growing category of targeted cancer therapeutics with the first therapies being approved recently in 2010. ADCs represent a class of next generation therapeutics that are expected to supplant many of the existing monoclonal antibodies currently used to treat various forms of cancer given their increased effectiveness at treating the disease that has been observed in late stage clinical trials.  

About ALLOZYNE

ALLOZYNE is a biopharmaceutical company creating a pipeline of novel protein therapeutic product candidates to treat cancer, autoimmune and inflammatory diseases. ALLOZYNE’s current product development efforts are based on its proprietary Biocipher™ technology platforms which enable the union of biological protein engineering and medicinal chemistry in order to create novel and enhanced protein therapeutics.

The technology underlying ALLOZYNE’s Biocipher™ platforms is comprised of three components:  

• the ability to sitespecifically modify the amino acid sequence of any protein;  

the ability to insert stable chemical hinges into these modified sites within the protein; and  

• the utilization of these hinges to attach bioconjugates such as polymers, toxic drugs, and antibodies.    

ALLOZYNE’s mission is to leverage its platform technologies to develop bestinclass and firstinclass product candidates customized to optimize safety, efficacy, dosing convenience and drug characteristics that ALLOZYNE believes may lead to enhanced patient compliance and disease modification.

SOURCE: Allozyne