LADD is Aduro's proprietary platform of live, attenuated double-deleted Listeria monocytogenes strains that have been engineered to express tumor-associated antigens to induce an innate immune response and tumor-specific T cell-mediated immunity. Personalized LADD, or pLADD, is a second generation LADD technology that is being designed for individualized, patient-specific immunotherapy. The pLADD approach leverages the immune activating activity of the Listeria bacterial vector in combination with neoantigens, or the tumor markers specific to an individual’s cancer, which are derived from the patient’s own unique tumor cells. Once administered, pLADD therapies are expected to mobilize the immune system through first an immediate recognition of the presence of Listeria as being foreign and then second a specific and customized immune attack on cells containing the tumor neoantigens presented by pLADD. An Investigational New Drug (IND) application has been accepted, and a Phase 1 trial evaluating the safety and immunogenicity of pLADD in patients with advanced gastro-intestinal cancers is planned.
“There is tremendous excitement in the oncology field to develop personalized therapies as the next new wave in immunotherapy to specifically customize treatment for each patient based on neoantigens that are unique to a patient’s tumor,” said
The pLADD technology platform is well-suited to maximize the potential benefit of personalized therapy through the ability to engineer the therapy with multiple tumor-specific neoantigens, as well as to leverage an efficient small-scale manufacturing process in its production.
To create a patient-specific pLADD therapy, a physician begins by removing tumor cells from the patient. These cells are analyzed in order to molecularly characterize (sequence) the tumor, including any mutations that are unique to the patient’s own tumor cells. Predictive algorithms for antigen processing are run to identify pertinent tumor antigens. Aduro then creates a LADD strain that includes the patient-specific neoantigens for administration.
Preclinical Data with pLADD
Preclinical data showed that pLADD induced a robust immune response, including broad innate immune responses involving cytokines, chemokines, natural killer, and gamma delta T cells, as well as antigen-specific adaptive T cell responses (CD8+ and CD4+). In preclinical models, pLADD remodeled the tumor microenvironment, whereby an increase in infiltration of neutrophils, T cells and dendritic cells was observed. The combination of pLADD with an anti-PD-1 led to a sustained immune response and significant prolongation of survival in these models.
Detailed preclinical data will be presented by Aduro scientist
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, the potential for pLADD and our other technology platforms, plans, timing and the availability of results of our clinical trials, our ability to resume new patient enrollment in LADD clinical trials and the potential for eventual regulatory approval of our product candidates. In some cases, you can identify these statements by forward-looking words such as “may,” “will,” “continue,” “anticipate,” “intend,” “could,” “project,” “expect” or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our history of net operating losses and uncertainty regarding our ability to achieve profitability, our ability to develop and commercialize our product candidates, our ability to use and expand our technology platforms to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our inability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, our reliance on third parties, and our ability to obtain and adequately protect intellectual property rights for our product candidates. We discuss many of these risks in greater detail under the heading “Risk Factors” contained in our quarterly report on Form 10-Q for the quarter ended September 30, 2016, which is on file with the Securities and Exchange Commission. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
Sylvia WheelerSVP, Corporate Affairs 510 809 9264 Media Contact: Susan Lehner510 809 2137 email@example.com