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Selecta Biosciences Announces Publication in Nature Nanotechnology Describing Novel Approach for Improving the Efficacy and Safety Profile of Biologic Drugs
- Published results from preclinical studies show the potential of Selecta’s proprietary SVP-Rapamycin (SEL-110) immune therapy to improve the efficacy and safety of biologic therapeutics
- The data support Selecta’s lead clinical program, showing Selecta’s SVP-Rapamycin (SEL-110) induces antigen-specific immune tolerance and prevents the formation of anti-drug antibodies (ADAs) to biologic drugs, including pegsiticase (for gout) and adalimumab (for rheumatoid arthritis)
“Undesired immune responses affect both the efficacy and safety of marketed biologic therapies and the development of otherwise promising new technologies. Selecta’s SVP platform positions the company to enhance biologic therapy and to advance a pipeline of proprietary products that meet the therapeutic needs of patients with rare and serious diseases,” said
In the Nature Nanotechnology journal article,
Data presented in the journal article support the Company’s clinical lead program in gout, showing that intravenous co-administration of tolerogenic nanoparticles with pegylated uricase inhibited the formation of ADAs in mice and nonhuman primates and normalized serum uric acid levels in uricase-deficient mice. Underscoring the broad potential of the approach, results additionally show that subcutaneous co-administration of nanoparticles with adalimumab durably inhibited ADAs, resulting in normalized pharmacokinetics of the anti-TNFα antibody and protection against arthritis in TNFα transgenic mice.
In the published research, the induction of specific immune tolerance by SVP-Rapamycin (SEL-110) versus chronic immune suppression is supported by the findings that: (1) antigen must be co-administered at the time of SVP-Rapamycin (SEL-110) treatment; (2) immune tolerance is durable to many challenges of antigen alone; (3) animals tolerized to a specific antigen are capable of responding to an unrelated antigen, meaning that SVP-Rapamycin (SEL-110) does not induce a broad immune suppression; and (4) activation of naïve T cells is inhibited when adoptively transferred into previously tolerized mice. In contrast, daily administration of free rapamycin, at five times the total weekly rapamycin dose as that administered in the SVP-Rapamycin, was observed to transiently suppress the immune response, but did not induce durable immunological tolerance.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the potential utility of SVP-Rapamycin (SEL-110) immune therapy to enable repeat dosing and to enhance gene therapy treatment for rare and serious diseases and the potential of SVP-Rapamycin.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding, which may not be available; our limited operating history; the impact on our operations and financial flexibility of the restrictive covenants of our indebtedness; limitations on our ability to use our net operating loss and research and development tax credit carryforwards; the unpredictable nature of our development efforts for marketable drugs; the unproven approach to antigen-specific immune therapies; the lengthy, expensive and uncertain process of clinical drug development; potential delays in enrollment of patients, which could affect the receipt of necessary regulatory approvals; potential delays in regulatory approval, which would impact the ability to commercialize our product candidates and affect our ability to generate revenue; our inability to obtain orphan drug designation or breakthrough therapy designation for our product candidates; our reliance on third parties to manufacture our product candidates and to conduct our clinical trials; our inability to maintain our existing collaborations; our lack of experience in manufacturing our product candidates; failure to achieve market acceptance in the medical community; our inability to establish effective sales, marketing and distribution capabilities; potential competition with respect to our product candidates; failure to obtain marketing approval internationally; post-marketing restrictions or withdrawal from the market; anti-kickback, fraud, abuse, and other healthcare laws and regulations exposing us to potential criminal sanctions; negative public opinion and increased regulatory scrutiny of gene therapy and genetic research; our inability to adequately protect our proprietary technology; changes in
These and other important factors discussed under the caption “Risk Factors” in our final prospectus filed with the
Kathryn MorrisThe Yates Network +1-845-635-9828 firstname.lastname@example.org Investor Contact: Stephanie AscherStern Investor Relations, Inc. +1-212-362-1200 email@example.com