HER2 vaccine, AE37 Sample Clauses

HER2 vaccine, AE37. The HER2/neu proto-oncogene is a tumor associated antigen that has been investigated in many types of cancers including breast, prostate, and ovarian. HER2/neu codes for a 185kD trans-membrane protein in the epidermal growth factor receptor family which is found to be over- expressed in 20-30% of breast cancers and has also been correlated with more aggressive tumor behavior (Slamon 1989). It has been shown to be expressed in an additional 50% of breast cancers at low to intermediate levels. AE37 is a fifteen amino-acid peptide from the HER2 protein to which the four amino-acid sequence LRMK has been added, it is produced by a solid-phase peptide synthesis. The peptide sequence is AC-LRMK-GVGSPYVSRLLGICL-NH2. Studies have demonstrated that the AE37 peptide stimulates a robust helper T-cell response leading to effective cytotoxic T lymphocyte (CTL) activity against tumors expressing even low levels of HER2 regardless of HLA status. AE37 is a hybrid Ii-Key/HER2 peptide. Ii-Key hybrids have been shown to display >250 times potency in terms of T-cell stimulation in vitro compared to the unmodified naturally-occurring peptide. AE37 has been shown to be recognized both by CD4+ T helper cells as well as CD8+ CTLs (HER2 Hybrid Peptide AE37 IB). Antigen Express has developed a novel method for dramatically increasing antigen-specific stimulation of T helper cells. This involves the addition of a small portion of the major histocompatibility complex (MHC) class II-associated Ii protein (termed Ii-Key) to class II epitopes (Xxx 2000). The Ii-Key segment of the Ii protein was found to bind to an allosteric site on MHC class II molecules, thereby facilitating the direct charging of a vaccine peptide into the antigenic peptide-binding site of MHC class II molecules (Sotiriadou 2007). The resulting Ii- Key/antigenic epitope hybrid displays up to 250 times greater potency in vitro compared to the unmodified class II epitope (Sotiriadou 2007). Studies have shown that Ii-Key hybrid peptides derived from a variety of disease-related antigens more potently activate CD4+ T helper cells in vivo as well as in vitro when compared to epitope only peptides. The consequence of this increased yet specific T helper cell stimulation is more robust CTL activation and the production of immunological memory.
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  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

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