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SAN FRANCISCO, June 12, 2017 (GLOBE NEWSWIRE) -- In a late-breaking abstract at the 77th American Diabetes Association meeting in San Diego, ProLynx LLC announced a novel drug delivery system to support once-monthly subcutaneous (SC) administration of a GLP-1 receptor agonist (GLP-1RA) called PLX039 for the treatment of Type 2 diabetes (T2D). The work will be published in ACS Chemical Biology. GLP-1RAs have emerged as an important standard-of-care drug class for the treatment of Type 2 diabetes and are projected to command a $12 Bill market by 2024. These agonists auto-regulate blood glucose concentration, have anti-obesity effects, and may reduce risks for adverse cardiovascular events in patients with T2D. Currently, there are three once- or twice- daily and three once-weekly GLP-1RAs approved by the FDA; an additional once-weekly agonist and a long-acting osmotic pump delivery system are in late stage trials.  Yet, poor medication adherence and persistence remain as major factors leading to failure of glycemic control in almost 50% of T2D patients. Now, ProLynx has used its half-life extension platform to develop a monthly-administered GLP-1RA. Compared to weekly-administered agonists, obvious benefits are believed to include greater patient convenience, compliance and persistence. Daniel Santi, co-founder and President of ProLynx, said: “This is the first GLP-1RA that does not require huge doses of a drug meant for weekly administration to maintain therapeutic levels over a monthly period.” Santi added: “PLX039 should find a dose-interval sweet-spot with its once-monthly administration. Some patients will find that a once-weekly dosing interval is too short, and will not want to have a long-acting osmotic pump implanted; for these patients, the once monthly GLP-1 receptor agonist PLX039 should be just right.” In the ProLynx half-life extension platform, a drug is tethered to hydrogel microspheres by a self-cleaving linker that is pre-programmed to release the drug at a pre-determined rate. After SC injection, the drug is slowly released from the microsphere depot into the systemic circulation. ProLynx attached their peptidic GLP-1RA – a stabilized analog of exenatide – to its hydrogel microspheres. After SC injection to rodents the GLP-1RA showed a serum half-life of one month. Monthly injections of the formulation in diabetic rats showed identical glucoregulatory effects as continuously infused exenatide, and simulation of the pharmacokinetics indicate it should serve well as a once-a-month treatment for T2D in humans. About ProLynx. ProLynx LLC is a privately held biotechnology company developing proprietary drug delivery systems for half-life extension of proteins, peptides and small molecules. The company is seeking to apply its technology to extend half-lives of drug candidates of pharmaceutical companies, and to improve properties of off-patent therapeutics. ProLynx has a monthly GLP-1 receptor agonist and a subcutaneous long-acting octreotide in its pre-clinical portfolio, and a PEG~SN-38 in Phase 1 clinical trials. The company is located in San Francisco, CA. Further information about the company may be found at  www.ProLynxllc.com.


SAN FRANCISCO, June 12, 2017 (GLOBE NEWSWIRE) -- In a late-breaking abstract at the 77th American Diabetes Association meeting in San Diego, ProLynx LLC announced a novel drug delivery system to support once-monthly subcutaneous (SC) administration of a GLP-1 receptor agonist (GLP-1RA) called PLX039 for the treatment of Type 2 diabetes (T2D). The work will be published in ACS Chemical Biology. GLP-1RAs have emerged as an important standard-of-care drug class for the treatment of Type 2 diabetes and are projected to command a $12 Bill market by 2024. These agonists auto-regulate blood glucose concentration, have anti-obesity effects, and may reduce risks for adverse cardiovascular events in patients with T2D. Currently, there are three once- or twice- daily and three once-weekly GLP-1RAs approved by the FDA; an additional once-weekly agonist and a long-acting osmotic pump delivery system are in late stage trials.  Yet, poor medication adherence and persistence remain as major factors leading to failure of glycemic control in almost 50% of T2D patients. Now, ProLynx has used its half-life extension platform to develop a monthly-administered GLP-1RA. Compared to weekly-administered agonists, obvious benefits are believed to include greater patient convenience, compliance and persistence. Daniel Santi, co-founder and President of ProLynx, said: “This is the first GLP-1RA that does not require huge doses of a drug meant for weekly administration to maintain therapeutic levels over a monthly period.” Santi added: “PLX039 should find a dose-interval sweet-spot with its once-monthly administration. Some patients will find that a once-weekly dosing interval is too short, and will not want to have a long-acting osmotic pump implanted; for these patients, the once monthly GLP-1 receptor agonist PLX039 should be just right.” In the ProLynx half-life extension platform, a drug is tethered to hydrogel microspheres by a self-cleaving linker that is pre-programmed to release the drug at a pre-determined rate. After SC injection, the drug is slowly released from the microsphere depot into the systemic circulation. ProLynx attached their peptidic GLP-1RA – a stabilized analog of exenatide – to its hydrogel microspheres. After SC injection to rodents the GLP-1RA showed a serum half-life of one month. Monthly injections of the formulation in diabetic rats showed identical glucoregulatory effects as continuously infused exenatide, and simulation of the pharmacokinetics indicate it should serve well as a once-a-month treatment for T2D in humans. About ProLynx. ProLynx LLC is a privately held biotechnology company developing proprietary drug delivery systems for half-life extension of proteins, peptides and small molecules. The company is seeking to apply its technology to extend half-lives of drug candidates of pharmaceutical companies, and to improve properties of off-patent therapeutics. ProLynx has a monthly GLP-1 receptor agonist and a subcutaneous long-acting octreotide in its pre-clinical portfolio, and a PEG~SN-38 in Phase 1 clinical trials. The company is located in San Francisco, CA. Further information about the company may be found at  www.ProLynxllc.com.


SAN FRANCISCO, June 12, 2017 (GLOBE NEWSWIRE) -- In a late-breaking abstract at the 77th American Diabetes Association meeting in San Diego, ProLynx LLC announced a novel drug delivery system to support once-monthly subcutaneous (SC) administration of a GLP-1 receptor agonist (GLP-1RA) called PLX039 for the treatment of Type 2 diabetes (T2D). The work will be published in ACS Chemical Biology. GLP-1RAs have emerged as an important standard-of-care drug class for the treatment of Type 2 diabetes and are projected to command a $12 Bill market by 2024. These agonists auto-regulate blood glucose concentration, have anti-obesity effects, and may reduce risks for adverse cardiovascular events in patients with T2D. Currently, there are three once- or twice- daily and three once-weekly GLP-1RAs approved by the FDA; an additional once-weekly agonist and a long-acting osmotic pump delivery system are in late stage trials.  Yet, poor medication adherence and persistence remain as major factors leading to failure of glycemic control in almost 50% of T2D patients. Now, ProLynx has used its half-life extension platform to develop a monthly-administered GLP-1RA. Compared to weekly-administered agonists, obvious benefits are believed to include greater patient convenience, compliance and persistence. Daniel Santi, co-founder and President of ProLynx, said: “This is the first GLP-1RA that does not require huge doses of a drug meant for weekly administration to maintain therapeutic levels over a monthly period.” Santi added: “PLX039 should find a dose-interval sweet-spot with its once-monthly administration. Some patients will find that a once-weekly dosing interval is too short, and will not want to have a long-acting osmotic pump implanted; for these patients, the once monthly GLP-1 receptor agonist PLX039 should be just right.” In the ProLynx half-life extension platform, a drug is tethered to hydrogel microspheres by a self-cleaving linker that is pre-programmed to release the drug at a pre-determined rate. After SC injection, the drug is slowly released from the microsphere depot into the systemic circulation. ProLynx attached their peptidic GLP-1RA – a stabilized analog of exenatide – to its hydrogel microspheres. After SC injection to rodents the GLP-1RA showed a serum half-life of one month. Monthly injections of the formulation in diabetic rats showed identical glucoregulatory effects as continuously infused exenatide, and simulation of the pharmacokinetics indicate it should serve well as a once-a-month treatment for T2D in humans. About ProLynx. ProLynx LLC is a privately held biotechnology company developing proprietary drug delivery systems for half-life extension of proteins, peptides and small molecules. The company is seeking to apply its technology to extend half-lives of drug candidates of pharmaceutical companies, and to improve properties of off-patent therapeutics. ProLynx has a monthly GLP-1 receptor agonist and a subcutaneous long-acting octreotide in its pre-clinical portfolio, and a PEG~SN-38 in Phase 1 clinical trials. The company is located in San Francisco, CA. Further information about the company may be found at  www.ProLynxllc.com.


SAN FRANCISCO, June 12, 2017 (GLOBE NEWSWIRE) -- In a late-breaking abstract at the 77th American Diabetes Association meeting in San Diego, ProLynx LLC announced a novel drug delivery system to support once-monthly subcutaneous (SC) administration of a GLP-1 receptor agonist (GLP-1RA) called PLX039 for the treatment of Type 2 diabetes (T2D). The work will be published in ACS Chemical Biology. GLP-1RAs have emerged as an important standard-of-care drug class for the treatment of Type 2 diabetes and are projected to command a $12 Bill market by 2024. These agonists auto-regulate blood glucose concentration, have anti-obesity effects, and may reduce risks for adverse cardiovascular events in patients with T2D. Currently, there are three once- or twice- daily and three once-weekly GLP-1RAs approved by the FDA; an additional once-weekly agonist and a long-acting osmotic pump delivery system are in late stage trials.  Yet, poor medication adherence and persistence remain as major factors leading to failure of glycemic control in almost 50% of T2D patients. Now, ProLynx has used its half-life extension platform to develop a monthly-administered GLP-1RA. Compared to weekly-administered agonists, obvious benefits are believed to include greater patient convenience, compliance and persistence. Daniel Santi, co-founder and President of ProLynx, said: “This is the first GLP-1RA that does not require huge doses of a drug meant for weekly administration to maintain therapeutic levels over a monthly period.” Santi added: “PLX039 should find a dose-interval sweet-spot with its once-monthly administration. Some patients will find that a once-weekly dosing interval is too short, and will not want to have a long-acting osmotic pump implanted; for these patients, the once monthly GLP-1 receptor agonist PLX039 should be just right.” In the ProLynx half-life extension platform, a drug is tethered to hydrogel microspheres by a self-cleaving linker that is pre-programmed to release the drug at a pre-determined rate. After SC injection, the drug is slowly released from the microsphere depot into the systemic circulation. ProLynx attached their peptidic GLP-1RA – a stabilized analog of exenatide – to its hydrogel microspheres. After SC injection to rodents the GLP-1RA showed a serum half-life of one month. Monthly injections of the formulation in diabetic rats showed identical glucoregulatory effects as continuously infused exenatide, and simulation of the pharmacokinetics indicate it should serve well as a once-a-month treatment for T2D in humans. About ProLynx. ProLynx LLC is a privately held biotechnology company developing proprietary drug delivery systems for half-life extension of proteins, peptides and small molecules. The company is seeking to apply its technology to extend half-lives of drug candidates of pharmaceutical companies, and to improve properties of off-patent therapeutics. ProLynx has a monthly GLP-1 receptor agonist and a subcutaneous long-acting octreotide in its pre-clinical portfolio, and a PEG~SN-38 in Phase 1 clinical trials. The company is located in San Francisco, CA. Further information about the company may be found at  www.ProLynxllc.com.


SAN FRANCISCO, June 12, 2017 (GLOBE NEWSWIRE) -- In a late-breaking abstract at the 77th American Diabetes Association meeting in San Diego, ProLynx LLC announced a novel drug delivery system to support once-monthly subcutaneous (SC) administration of a GLP-1 receptor agonist (GLP-1RA) called PLX039 for the treatment of Type 2 diabetes (T2D). The work will be published in ACS Chemical Biology. GLP-1RAs have emerged as an important standard-of-care drug class for the treatment of Type 2 diabetes and are projected to command a $12 Bill market by 2024. These agonists auto-regulate blood glucose concentration, have anti-obesity effects, and may reduce risks for adverse cardiovascular events in patients with T2D. Currently, there are three once- or twice- daily and three once-weekly GLP-1RAs approved by the FDA; an additional once-weekly agonist and a long-acting osmotic pump delivery system are in late stage trials.  Yet, poor medication adherence and persistence remain as major factors leading to failure of glycemic control in almost 50% of T2D patients. Now, ProLynx has used its half-life extension platform to develop a monthly-administered GLP-1RA. Compared to weekly-administered agonists, obvious benefits are believed to include greater patient convenience, compliance and persistence. Daniel Santi, co-founder and President of ProLynx, said: “This is the first GLP-1RA that does not require huge doses of a drug meant for weekly administration to maintain therapeutic levels over a monthly period.” Santi added: “PLX039 should find a dose-interval sweet-spot with its once-monthly administration. Some patients will find that a once-weekly dosing interval is too short, and will not want to have a long-acting osmotic pump implanted; for these patients, the once monthly GLP-1 receptor agonist PLX039 should be just right.” In the ProLynx half-life extension platform, a drug is tethered to hydrogel microspheres by a self-cleaving linker that is pre-programmed to release the drug at a pre-determined rate. After SC injection, the drug is slowly released from the microsphere depot into the systemic circulation. ProLynx attached their peptidic GLP-1RA – a stabilized analog of exenatide – to its hydrogel microspheres. After SC injection to rodents the GLP-1RA showed a serum half-life of one month. Monthly injections of the formulation in diabetic rats showed identical glucoregulatory effects as continuously infused exenatide, and simulation of the pharmacokinetics indicate it should serve well as a once-a-month treatment for T2D in humans. About ProLynx. ProLynx LLC is a privately held biotechnology company developing proprietary drug delivery systems for half-life extension of proteins, peptides and small molecules. The company is seeking to apply its technology to extend half-lives of drug candidates of pharmaceutical companies, and to improve properties of off-patent therapeutics. ProLynx has a monthly GLP-1 receptor agonist and a subcutaneous long-acting octreotide in its pre-clinical portfolio, and a PEG~SN-38 in Phase 1 clinical trials. The company is located in San Francisco, CA. Further information about the company may be found at  www.ProLynxllc.com.


News Article | May 31, 2017
Site: globenewswire.com

SAN FRANCISCO, May 30, 2017 (GLOBE NEWSWIRE) -- ProLynx LLC today announced that the United States Patent and Trademark Office has issued US Patent 9,649,385 entitled “Hydrogels with Biodegradable Crosslinking”. The patent broadly covers the use of ProLynx’s ß-eliminative linkers to control the in vivo bio-degradation rate of hydrogels used for drug delivery. Previously, patents were issued on the use of these linkers to control release of drugs tethered to these hydrogel carriers. The recently issued patent is part of a growing intellectual property portfolio that now includes six issued US patents and five pending US applications, along with 11 issued ex-US patents and corresponding international applications. These patents and applications cover ProLynx proprietary linkers and their use in various applications, including soluble and insoluble conjugates generally as well as specific examples of the technology. "This patent is an important component of ProLynx's intellectual property portfolio since it extends the utility of our beta-eliminative linkers to controlling the in vivo residence times of our hydrogel microsphere drug carriers," said co-founder and President Daniel V. Santi, M.D., Ph.D. "The technology allows us to balance the rates of drug release and carrier degradation such that after the drug is released, the carrier dissipates, dissolves and eliminates." ProLynx LLC is a privately held biotechnology company developing proprietary drug delivery systems for half-life extension of proteins, peptides and small molecules. The company is seeking to apply its technology to extend half-lives of drug candidates of pharmaceutical companies, and to improve properties of off-patent therapeutics. ProLynx has a monthly GLP-1 receptor agonist and a subcutaneous long-acting octreotide in its pre-clinical portfolio, and a PEG~SN-38 in Phase 1 clinical trials. The company is located in San Francisco, CA. Further information about the company and its capabilities may be found at http://www.prolynxllc.com.


News Article | May 31, 2017
Site: globenewswire.com

SAN FRANCISCO, May 30, 2017 (GLOBE NEWSWIRE) -- ProLynx LLC today announced that the United States Patent and Trademark Office has issued US Patent 9,649,385 entitled “Hydrogels with Biodegradable Crosslinking”. The patent broadly covers the use of ProLynx’s ß-eliminative linkers to control the in vivo bio-degradation rate of hydrogels used for drug delivery. Previously, patents were issued on the use of these linkers to control release of drugs tethered to these hydrogel carriers. The recently issued patent is part of a growing intellectual property portfolio that now includes six issued US patents and five pending US applications, along with 11 issued ex-US patents and corresponding international applications. These patents and applications cover ProLynx proprietary linkers and their use in various applications, including soluble and insoluble conjugates generally as well as specific examples of the technology. "This patent is an important component of ProLynx's intellectual property portfolio since it extends the utility of our beta-eliminative linkers to controlling the in vivo residence times of our hydrogel microsphere drug carriers," said co-founder and President Daniel V. Santi, M.D., Ph.D. "The technology allows us to balance the rates of drug release and carrier degradation such that after the drug is released, the carrier dissipates, dissolves and eliminates." ProLynx LLC is a privately held biotechnology company developing proprietary drug delivery systems for half-life extension of proteins, peptides and small molecules. The company is seeking to apply its technology to extend half-lives of drug candidates of pharmaceutical companies, and to improve properties of off-patent therapeutics. ProLynx has a monthly GLP-1 receptor agonist and a subcutaneous long-acting octreotide in its pre-clinical portfolio, and a PEG~SN-38 in Phase 1 clinical trials. The company is located in San Francisco, CA. Further information about the company and its capabilities may be found at http://www.prolynxllc.com.


News Article | May 31, 2017
Site: globenewswire.com

SAN FRANCISCO, May 30, 2017 (GLOBE NEWSWIRE) -- ProLynx LLC today announced that the United States Patent and Trademark Office has issued US Patent 9,649,385 entitled “Hydrogels with Biodegradable Crosslinking”. The patent broadly covers the use of ProLynx’s ß-eliminative linkers to control the in vivo bio-degradation rate of hydrogels used for drug delivery. Previously, patents were issued on the use of these linkers to control release of drugs tethered to these hydrogel carriers. The recently issued patent is part of a growing intellectual property portfolio that now includes six issued US patents and five pending US applications, along with 11 issued ex-US patents and corresponding international applications. These patents and applications cover ProLynx proprietary linkers and their use in various applications, including soluble and insoluble conjugates generally as well as specific examples of the technology. "This patent is an important component of ProLynx's intellectual property portfolio since it extends the utility of our beta-eliminative linkers to controlling the in vivo residence times of our hydrogel microsphere drug carriers," said co-founder and President Daniel V. Santi, M.D., Ph.D. "The technology allows us to balance the rates of drug release and carrier degradation such that after the drug is released, the carrier dissipates, dissolves and eliminates." ProLynx LLC is a privately held biotechnology company developing proprietary drug delivery systems for half-life extension of proteins, peptides and small molecules. The company is seeking to apply its technology to extend half-lives of drug candidates of pharmaceutical companies, and to improve properties of off-patent therapeutics. ProLynx has a monthly GLP-1 receptor agonist and a subcutaneous long-acting octreotide in its pre-clinical portfolio, and a PEG~SN-38 in Phase 1 clinical trials. The company is located in San Francisco, CA. Further information about the company and its capabilities may be found at http://www.prolynxllc.com.


News Article | May 31, 2017
Site: globenewswire.com

SAN FRANCISCO, May 30, 2017 (GLOBE NEWSWIRE) -- ProLynx LLC today announced that the United States Patent and Trademark Office has issued US Patent 9,649,385 entitled “Hydrogels with Biodegradable Crosslinking”. The patent broadly covers the use of ProLynx’s ß-eliminative linkers to control the in vivo bio-degradation rate of hydrogels used for drug delivery. Previously, patents were issued on the use of these linkers to control release of drugs tethered to these hydrogel carriers. The recently issued patent is part of a growing intellectual property portfolio that now includes six issued US patents and five pending US applications, along with 11 issued ex-US patents and corresponding international applications. These patents and applications cover ProLynx proprietary linkers and their use in various applications, including soluble and insoluble conjugates generally as well as specific examples of the technology. "This patent is an important component of ProLynx's intellectual property portfolio since it extends the utility of our beta-eliminative linkers to controlling the in vivo residence times of our hydrogel microsphere drug carriers," said co-founder and President Daniel V. Santi, M.D., Ph.D. "The technology allows us to balance the rates of drug release and carrier degradation such that after the drug is released, the carrier dissipates, dissolves and eliminates." ProLynx LLC is a privately held biotechnology company developing proprietary drug delivery systems for half-life extension of proteins, peptides and small molecules. The company is seeking to apply its technology to extend half-lives of drug candidates of pharmaceutical companies, and to improve properties of off-patent therapeutics. ProLynx has a monthly GLP-1 receptor agonist and a subcutaneous long-acting octreotide in its pre-clinical portfolio, and a PEG~SN-38 in Phase 1 clinical trials. The company is located in San Francisco, CA. Further information about the company and its capabilities may be found at http://www.prolynxllc.com.


Santi D.V.,ProLynx | Schneider E.L.,ProLynx | Ashley G.W.,ProLynx
Journal of Medicinal Chemistry | Year: 2014

We have recently reported a chemical approach for half-life extension that utilizes β-eliminative linkers to attach amine-containing drugs or prodrugs to macromolecules. The linkers release free drug or prodrug over periods ranging from a few hours to over 1 year. We adapted these linkers for use with phenol-containing drugs. Here, we prepared PEG conjugates of the irinotecan (CPT-11) active metabolite SN-38 via a phenyl ether that release the drug with predictable long half-lives. Pharmacokinetic studies in the rat indicate that, in contrast to other SN-38 prodrugs, the slowly released SN-38 shows a very low Cmax, is kept above target concentrations for extended periods, and forms very little SN-38 glucuronide (the precursor of enterotoxic SN-38). The low SN-38 glucuronide is attributed to low hepatic uptake of SN-38. These macromolecular prodrugs have unique pharmacokinetic profiles that may translate to less intestinal toxicity and interpatient variability than the SN-38 prodrugs thus far studied. © 2014 American Chemical Society.

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