Last update 21 Nov 2024

Pegadricase

Last update 21 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Enzyme

Synonyms

Pegsitacase, Pegsiticase

+ [3]

Target

Uric acid

Mechanism

Uric acid stimulants

Therapeutic Areas

Immune System DiseasesCongenital DisordersEndocrinology and Metabolic Disease+ [4]

Active Indication

Tumor Lysis SyndromeAutoimmune DiseasesNeoplasms+ [2]

Inactive Indication-

Originator Organization

Polaris Inc.

Active Organization

Shenyang Sunshine Pharmaceuticals Co., Ltd.

EnzymeRx LLC

Selecta Biosciences, Inc.

+ [2]

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

RegulationOrphan Drug (US)

Gene Sequence

Sequence Code 24143

Source: *****

Clinical Trials associated with Pegadricase

CTR20233654 / RecruitingPhase 1

注射用聚乙二醇化重组假丝酵母尿酸氧化酶在中国健康成年受试者中不同预处理条件下单次给药、剂量递增、随机双盲的安全耐受性研究

[Translation] A single-dose, dose-escalation, randomized, double-blind safety and tolerability study of PEGylated recombinant Candida uricase for injection in healthy Chinese adult subjects under different pretreatment conditions

通过在中国成年健康受试者中进行单次给药、剂量递增的研究，评估在不同预处理条件下，健康人体对SSS11的安全性和耐受性。

[Translation]

A single-dose, dose-escalation study was conducted in healthy adult Chinese subjects to evaluate the safety and tolerability of SSS11 in healthy humans under different pretreatment conditions.

Start Date07 Dec 2023

Sponsor / Collaborator

Shenyang Sunshine Pharmaceuticals Co., Ltd.

CTR20232891 / RecruitingPhase 1

注射用聚乙二醇化重组假丝酵母尿酸氧化酶在痛风和高尿酸血症患者中多次给药、剂量递增、随机双盲、安慰剂对照的安全性、耐受性、药代动力学和初步药效学研究

[Translation] A multiple-dose, dose-escalation, randomized, double-blind, placebo-controlled safety, tolerability, pharmacokinetics, and preliminary pharmacodynamics study of pegylated recombinant Candida uricase for injection in patients with gout and hyperuricemia

主要目的评价在痛风和高尿酸血症患者中多次给予注射用聚乙二醇化重组假丝酵母尿酸氧化酶（试验药物代号：SSS11）的安全性和耐受性。次要目的评价在痛风和高尿酸血症患者中多次给予SSS11的药代动力学特征；评价在痛风和高尿酸血症患者中多次给予SSS11的药效学特征；评价在痛风和高尿酸血症患者中多次给予SSS11的免疫原性特征。

[Translation]

Primary objective To evaluate the safety and tolerability of multiple administrations of PEGylated recombinant Candida uricase for injection (investigational drug code: SSS11) in patients with gout and hyperuricemia. Secondary objectives To evaluate the pharmacokinetic characteristics of multiple administrations of SSS11 in patients with gout and hyperuricemia; To evaluate the pharmacodynamic characteristics of multiple administrations of SSS11 in patients with gout and hyperuricemia; To evaluate the immunogenicity characteristics of multiple administrations of SSS11 in patients with gout and hyperuricemia.

Start Date27 Nov 2023

Sponsor / Collaborator

Shenyang Sunshine Pharmaceuticals Co., Ltd.

NCT06629376 / RecruitingPhase 1

Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacological Studies of SSS11 in Patients With Gout and Hyperuricemia After Multiple Administrations, Dose Escalation, Randomized Double-blind, Placebo-controlled Trials

This is a safety, tolerability, pharmacokinetics, and preliminary pharmacological study of multiple administration, dose escalation, randomized double-blind, placebo-controlled.The main purpose of this experiment is to evaluate the safety and tolerability of multiple injections of PEGylated recombinant Candida urate oxidase (test drug code: SSS11) in patients with gout and hyperuricemia.The experimental period includes a screening period of 4 weeks, a treatment period of 4 or 8 weeks, and an observation period of 4 weeks。

Start Date20 Nov 2023

Sponsor / Collaborator

Shenyang Sunshine Pharmaceuticals Co., Ltd.

100 Clinical Results associated with Pegadricase

100 Translational Medicine associated with Pegadricase

100 Patents (Medical) associated with Pegadricase

Literatures (Medical) associated with Pegadricase

02 Apr 2024·Rheumatology

The COMPARE head-to-head, randomized controlled trial of SEL-212 (pegadricase plus rapamycin-containing nanoparticle, ImmTOR™) versus pegloticase for refractory gout

Article

Author: Traber, Peter G ; Kivitz, Alan J ; Keenan, Robert T ; Strand, Vibeke ; Khanna, Puja P ; Choi, Hyon K ; Terkeltaub, Robert ; DeHaan, Wesley ; Azeem, Rehan ; Baraf, Herbert S B ; Dalbeth, Nicola

AbstractObjectivesSerum urate (SU) lowering with PEGylated uricases in gout can reduce flares and tophi. However, treatment-emergent anti-drug antibodies adversely affect safety and efficacy and the currently approved PEGylated uricase pegloticase requires twice-monthly infusions. Investigational SEL-212 therapy aims to promote uricase-specific tolerance via monthly sequential infusions of a proprietary rapamycin-containing nanoparticle (ImmTOR) and pegadricase.MethodsCOMPARE was a randomized, phase 2, open-label trial of SEL-212 vs pegloticase in adults with refractory gout. SEL-212 [ImmTOR (0.15 mg/kg) and pegadricase (0.2 mg/kg)] was infused monthly or pegloticase (8 mg) twice monthly for 6 months. The primary endpoint was the proportion of participants with SU <6 mg/dl for ≥80% of the time during 3 and 6 months. Secondary outcomes were mean SU, gout flares, number of tender and/or swollen joints and safety.ResultsDuring months 3 and 6 combined, numerically more participants achieved and maintained a SU <6 mg/dl for ≥80% of the time with SEL-212 vs pegloticase (53.0% vs 46.0%, P = 0.181). The percentage reductions in SU levels were statistically greater during months 3 and 6 with SEL-212 vs pegloticase (−73.79% and −47.96%, P = 0.0161). Reductions in gout flare incidence and number of tender and/or swollen joints were comparable between treatments. There were numerical differences between the most common treatment-related adverse events of interest with SEL-212 and pegloticase: gout flares (60.2% vs 50.6%), infections (25.3% vs 18.4%) and infusion-related reactions (15.7% vs 11.5%), respectively. Stomatitis (and related terms) was experienced by eight participants (9.6%) with SEL-212 and none with pegloticase. Stomatitis, a known event for rapamycin, was associated with ImmTOR only.ConclusionsSEL-212 efficacy and tolerability were comparable to pegloticase in refractory gout. This was associated with a substantial reduction in treatment burden with SEL-212 due to decreased infusion frequency vs pegloticase.Clinical trial registrationNCT03905512.

01 Aug 2023·Rheumatology and therapy

Phase 2 Dose-Finding Study in Patients with Gout Using SEL-212, a Novel PEGylated Uricase (SEL-037) Combined with Tolerogenic Nanoparticles (SEL-110).

Article

Author: Traber, Peter G ; Kivitz, Alan ; Rhodes, Sheri ; Azeem, Rehan ; Kishimoto, Takashi K ; Nicolaou, Savvas ; Choi, Hyon ; Park, Justin ; Johnston, Lloyd ; Leung, Sheldon S ; Inshaw, Jamie ; Sands, Earl ; DeHaan, Wesley

INTRODUCTIONSEL-212 is a developmental treatment for uncontrolled gout characterized by serum uric acid (sUA) levels ≥ 6 mg/dl despite treatment. It comprises a novel PEGylated uricase (SEL-037; also called pegadricase) co-administered with tolerogenic nanoparticles containing sirolimus (rapamycin) (SEL-110; also called ImmTOR^®), which mitigates the formation of anti-drug antibodies (ADAs) against uricase and SEL-037 (PEGylated uricase), thereby enabling sustained sUA control (sUA < 6 mg/dl). The aim of this study was to identify appropriate dosing for SEL-037 and SEL-110 for use in phase 3 clinical trials.METHODSThis open-label phase 2 study was conducted in adults with symptomatic gout and sUA ≥ 6 mg/dl. Participants received five monthly infusions of SEL-037 (0.2 or 0.4 mg/kg) alone or in combination with three or five monthly infusions of SEL-110 (0.05-0.15 mg/kg). Safety, tolerability, sUA, ADAs, and tophi were monitored for 6 months.RESULTSA total of 152 adults completed the study. SEL-037 alone resulted in rapid sUA reductions that were not sustained beyond 30 days in most participants due to ADA formation and loss of uricase activity. Levels of ADAs decreased with increasing doses of SEL-110 up to 0.1 mg/kg, with anti-uricase titers < 1080 correlating with sustained sUA control and reductions in tophi. Overall, 66% of evaluable participants achieved sUA control at week 20 following five monthly doses of SEL-037 0.2 mg/kg + SEL-110 0.1-0.15 mg/kg, whereas only 26% achieved sUA control at week 20 when SEL-110 was withdrawn after week 12. Compared to other dose combinations, SEL-037 0.2 mg/kg + SEL-110 0.15 mg/kg achieved the greatest sUA control at week 12 and was well-tolerated with no safety concerns.CONCLUSIONResults provide continued support for the use of multiple monthly administrations of SEL-037 0.2 mg/kg + SEL-110 0.1-0.15 mg/kg in clinical trials for SEL-212.TRIAL REGISTRATIONClinicalTrials.gov identifier, NCT02959918.

01 Sep 2002·The Journal of rheumatology

Uricase formulated with polyethylene glycol (uricase-PEG 20): biochemical rationale and preclinical studies.

Article

Author: Ensor, C Mark ; Clark, Mike A ; Bomalaski, John S ; Holtsberg, Frederick W

OBJECTIVEHumans have a non-sense codon inserted into the 5 prime end of the open reading frame of urate oxidase, and thus express an enzymatically inactive fragment of this enzyme; and consequently are unable to metabolize uric acid into allantoin and are prone to develop hyperuricemia and gout. Various urate oxidases (uricase) from mammals and microorganisms have been administered to humans with hyperuricemia and gout. Although successful in lowering plasma uric acid, these therapies have had limited application due to undesirable biochemical properties of the enzymes used, the short circulating half-life, and inherent antigenicity of these preparations.METHODSWe compared urate oxidase from a variety of sources for specific enzyme activity, pH optimum, affinity, and retention of enzyme activity under physiological conditions. A variety of polyethylene glycols (PEG) were tested to formulate uricase.RESULTSUrate oxidase from Candida utilis had more favorable enzymatic properties and PEG of 20,000 MW (termed uricase-PEG 20) had greatly reduced antigenicity and increased circulating half-life as compared to those previously described.CONCLUSIONIt is anticipated that uricase-PEG 20 may have utility as a treatment for hyperuricemia and gout.

News (Medical) associated with Pegadricase

07 Nov 2024

·www.globenewswire.com

Sobi to present new data across its immunology portfolio at the ACR Convergence 2024

WALTHAM, Mass., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), today announced the presentation of four abstracts that highlights data from its immunology portfolio at the ACR Convergence 2024 taking place in Washington, D.C. from November 14–19, 2024. Sobi’s commitment to delivering innovative treatments for people living with immunological diseases is seen in global studies spanning multiple disorders: Results from two Phase 3 trials evaluating the effect on patient-reported outcomes in patients with chronic refractory gout treated with SEL-212.Initial data on the effect of anti-drug antibodies on serum uric acid (sUA) reduction and safety in response to treatment with SEL-212.DISSOLVE 1 Phase 3 study: Results of a post hoc analysis of sustained sUA reduction and safety of SEL-212 in patients with chronic refractory gout living in the United States.Results from a Phase 3 Study and a pooled analysis of two prospective trials evaluating efficacy and safety of emapalumab in patients with Macrophage Activation Syndrome in Still’s disease. Key Sobi data to be presented at ACR Convergence 2024 Chronic Refractory GoutSEL-212Improvements in Patient-Reported Outcomes After Treatment with SEL-212 in Adults with Refractory Gout: Results from Two Randomized Phase 3 TrialsSession: Patient Outcomes, Preferences, & Attitudes Poster ISaturday, November 16; 10:30 AM - 12:30 PMImpact of Anti-drug Antibodies on the Efficacy of SEL-212 in Patients with Chronic Gout Refractory to Conventional TherapySafety and Efficacy of SEL-212 in the US and ex-US Subgroups: Results from the Phase 3 DISSOLVE StudiesSession: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster IIIMonday, November 18; 10:30 AM - 12:30 PM Macrophage Activation SyndromeEmapalumabEfficacy and Safety of Emapalumab in Children and Adults with Macrophage Activation Syndrome (MAS) in Still’s disease: Results from a Phase 3 Study and a Pooled Analysis of Two Prospective TrialsLate-Breaking AbstractsNovember 19; Session Time: 8:00 AM - 9:30 AM; Presentation Time: 9:00 AM - 9:15 AM All abstracts can be accessed via the official ACR Convergence website. ContactsFor details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media, click here. About SEL-212SEL-212 is being developed as a novel once-monthly combination medicine that integrates targeted immunomodulation with uricase-based therapy and is being investigated for the treatment of chronic refractory gout . SEL-212 consists of pegadricase, a proprietary pegylated uricase, co-administered with nanoencapsulated sirolimus. About Chronic Refractory GoutGout is the most common form of inflammatory arthritis with more than 8.3 million people in the United States having been diagnosed with gout, which is caused by high levels of uric acid in the body that accumulate around the joints and other tissues and can result in flares that cause intense pain. Approximately 160,000 people in the United States suffer from chronic refractory gout (CRG), where patients are resistant to conventional medicines and symptoms are more persistent. CRG is a painful and debilitating condition in people with persistent raised serum uric acid (sUA) levels, which may result in several flares per year and the development of nodular masses of uric acid crystals known as tophi. About emapalumab-lzsgEmapalumab-lzsg is a fully human, anti-IFNγ monoclonal antibody that binds free and receptor-bound IFNγ, neutralizing its biological activity. In the US, emapalumab-lzsg is indicated for pediatric (newborn and older) and adult primary hemophagocytic lymphohistiocytosis (HLH) patients with refractory, recurrent or progressive disease, or intolerance to conventional HLH therapy. Emapalumab-lzsg is the first and only medicine approved in the US for primary HLH, a rare syndrome of hyperinflammation that usually occurs within the first year of life and can rapidly become fatal unless diagnosed and treated. The FDA approval in 2018 was based on data from the phase 2/3 studies (NCT01818492 and NCT02069899).For the treatment of HLH, Emapalumab is indicated for administration through twice per week until hematopoietic stem cell transplantation (HSCT). The efficacy and safety of emapalumab are currently being evaluated. Emapalumab is currently under investigation (phase 3) in patients with MAS in Still’s disease or systemic lupus erythematosus (SLE) (EMERALD; NCT05001737). U.S. Indication for Gamifant® (emapalumab-lzsg)Gamifant® (emapalumab-lzsg) is an interferon gamma (IFNγ)–blocking antibody indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent, or progressive disease or intolerance with conventional HLH therapy. Important Safety InformationInfectionsBefore initiating Gamifant, patients should be evaluated for infection, including latent tuberculosis (TB). Prophylaxis for TB should be administered to patients who are at risk for TB or known to have a positive purified protein derivative (PPD) test result or positive IFNγ release assay. During Gamifant treatment, patients should be monitored for TB, adenovirus, Epstein-Barr virus (EBV), and cytomegalovirus (CMV) every 2 weeks and as clinically indicated. Patients should be administered prophylaxis for herpes zoster, Pneumocystis jirovecii, and fungal infections prior to Gamifant administration. Increased Risk of Infection With Use of Live VaccinesDo not administer live or live attenuated vaccines to patients receiving Gamifant and for at least 4 weeks after the last dose of Gamifant. The safety of immunization with live vaccines during or following Gamifant therapy has not been studied. Infusion-Related ReactionsInfusion-related reactions, including drug eruption, pyrexia, rash, erythema, and hyperhidrosis, were reported with Gamifant treatment in 27% of patients. In one-third of these patients, the infusion-related reaction occurred during the first infusion. Adverse ReactionsIn the pivotal trial, the most commonly reported adverse reactions (≥10%) for Gamifant included infection (56%), hypertension (41%), infusion-related reactions (27%), pyrexia (24%), hypokalemia (15%), constipation (15%), rash (12%), abdominal pain (12%), CMV infection (12%), diarrhea (12%), lymphocytosis (12%), cough (12%), irritability (12%), tachycardia (12%), and tachypnea (12%). Additional selected adverse reactions (all grades) that were reported in less than 10% of patients treated with Gamifant included vomiting, acute kidney injury, asthenia, bradycardia, dyspnea, gastrointestinal hemorrhage, epistaxis, and peripheral edema. Please see the full Prescribing Information for Gamifant. About Sobi North AmericaAs the North American affiliate of international biopharmaceutical company Sobi, the Sobi North America team is committed to Sobi’s vision of being a leader in providing innovative treatments that transform lives for individuals with rare diseases. Our product portfolio includes multiple approved treatments focused on immunology, hematology and specialty care. With U.S. headquarters in the Boston area, Canadian headquarters in the Toronto area, and field sales, medical and market access representatives spanning North America, our growing team has a proven track record of commercial excellence. More information is available at https://www.sobi.com/usa or at www.sobi.com. About Sobi®Sobi is a specialized international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of hematology, immunology and specialty care, Sobi has approximately 1,800 employees across Europe, North America, the Middle East, Asia and Australia. In 2023, revenue amounted to SEK 22.1 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com, LinkedIn and YouTube. Brian Castellibrian.castelli@sobi.com

Phase 3Clinical ResultDrug ApprovalImmunotherapyVaccine

02 Jul 2024

·www.prnewswire.com

Sobi initiates rolling biologics license application to FDA for SEL-212 for the potential treatment of chronic refractory gout

STOCKHOLM, July 2, 2024 /PRNewswire/ -- Sobi ® today announced the initiation of a rolling Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for SEL-212. The submission is based on the results of the DISSOLVE I and II pivotal studies. SEL-212 is an innovative biologic therapy in development for the treatment of chronic refractory gout, a debilitating condition characterised by the persistent and painful buildup of urate crystals in the joints. This significant milestone follows the FDA's Fast Track designation of SEL-212 in March 2024, underscoring the urgent need for new treatment options for patients with chronic refractory gout. The FDA's Fast Track program is intended to facilitate the development and expedite the review of medicines that treat serious conditions and fill an unmet medical need. "We are very pleased to initiate the rolling submission of the BLA for SEL-212, bringing Sobi one step closer to providing a potential new, effective treatment option for patients with chronic refractory gout," said Lydia Abad-Franch, MD, MBA, Head of Research, Development, and Medical Affairs, and Chief Medical Officer at Sobi. "The Fast Track designation confirms the previously released SEL-212 phase 3 clinical data, highlighting the significant need for innovative therapies in this space and reinforcing our commitment to transforming the lives of patients with rare diseases." SEL-212 is a novel investigational combination medicine designed to reduce serum urate (SU) levels in people with chronic refractory gout, potentially reducing harmful tissue urate deposits which can lead to gout flares and joint deformity when left untreated. Sobi licensed SEL-212 from Selecta Biosciences (now Cartesian Therapeutics) in June 2020 and is responsible for development, regulatory and commercial activities in all markets outside of China. About SEL-212 SEL-212 is a novel investigational combination medicine designed to reduce serum urate (SU) levels in people with chronic refractory gout, potentially reducing harmful tissue urate deposits which when left untreated can lead to debilitating gout flares and joint deformity. SEL-212 consists of pegadricase, Selecta's proprietary pegylated uricase, co-administered with ImmTOR™, designed to mitigate the formation of anti-drug antibodies (ADAs). ADAs develop due to unwanted immune responses to biologic medicines, reducing their efficacy and tolerability, which remains an issue across multiple therapeutic modalities and disease states including chronic refractory gout. About Chronic refractory gout Gout is the most common form of inflammatory arthritis with more than 8.3 million people in the United States having been diagnosed with gout, which is caused by high levels of uric acid in the body that accumulate around the joints and other tissues and can result in flares that cause intense pain. Approximately 200,000 people in the United States suffer from chronic gout refractory to conventional medicines, a painful and debilitating condition in people with SU levels above 6 mg/dL and therefore have several flares per year and can develop nodular masses of uric acid crystals known as tophi. Elevated SU levels have been associated with diseases of the heart, vascular system, metabolism, kidney and joints. About Cartesian Therapeutics Cartesian Therapeutics is a clinical-stage company pioneering mRNA cell therapies for the treatment of autoimmune diseases. The Company's lead asset, Descartes-08, is a potential first-in-class mRNA CAR-T in phase 2b clinical development for patients with generalised myasthenia gravis. Additional phase 2 studies are planned in systemic lupus erythematosus under an allowed IND, as well as basket trials in additional autoimmune indications. The Company's clinical-stage pipeline also includes Descartes-15, a next-generation, autologous anti-BCMA mRNA CAR-T. About Sobi® Sobi® is a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of haematology, immunology, and specialty care. Sobi has approximately 1,800 employees across Europe, North America, the Middle East, Asia, and Australia. In 2023, revenue amounted to SEK 22.1 billion. Sobi's share (STO: SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn. For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here. This information was brought to you by Cision The following files are available for download:

Phase 2Phase 3Fast Track

31 Oct 2023

·www.globenewswire.com

Selecta Announces Transition of Manufacturing and Clinical Operations of ImmTOR for SEL-212 to Commercialization Partner Sobi

WATERTOWN, Mass., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR™ platform to develop tolerogenic therapies for autoimmune diseases and gene therapies, today announced that it has entered into an agreement to transition the manufacturing and development rights and remaining clinical operations of ImmTOR for SEL-212 to its development and commercialization partner, Swedish Orphan Biovitrum AB (publ.) (Sobi). As of November 6, 2023, Sobi will assume responsibility for the manufacturing and commercial supply of ImmTOR for SEL-212. SEL-212, a combination of Selecta’s ImmTOR immune tolerance platform and a therapeutic uricase enzyme (pegadricase), is in development for the treatment of chronic refractory gout. A Biologics License Application (BLA) submission for SEL-212 remains on track for the first half of 2024. In connection with this transition, 15 Selecta employees currently supporting ImmTOR manufacturing and clinical development activities for SEL-212 are expected to become employees of Sobi. In addition, Peter G. Traber, M.D., Chief Medical Officer of Selecta, will begin serving as a consultant to Sobi, helping to oversee the clinical and regulatory activities associated with SEL-212. Dr. Traber will also continue to serve in his role as Chief Medical Officer at Selecta on a part-time basis. “We believe transitioning our manufacturing operations to Sobi will further streamline our organization, consistent with our announced strategic objective to optimize the value of our SEL-212 royalty stream for stockholders,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Selecta. “Leveraging ImmTOR, the only immune tolerance platform with positive Phase 3 data, we firmly believe that SEL-212 has strong potential to address this significant unmet need and exceed $700 million in peak sales in the U.S." Sobi licensed SEL-212 from Selecta in June 2020 and is responsible for development, regulatory and commercial activities in all markets outside of China. Selecta was originally responsible for ImmTOR manufacturing. Selecta is eligible to receive up to $615.0 million in remaining regulatory and commercial milestone payments and tiered double-digit royalties on net sales of SEL-212. About Selecta Biosciences, Inc.Selecta Biosciences Inc. (NASDAQ: SELB) is a clinical stage biotechnology company leveraging its ImmTOR™ platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses. With a proven ability to induce tolerance to highly immunogenic proteins, ImmTOR has the potential to amplify the efficacy of biologic therapies, including redosing of life-saving gene therapies, as well as restore the body’s natural self-tolerance in autoimmune diseases. Selecta has several proprietary and partnered programs in its pipeline focused on enzyme therapies, gene therapies, and autoimmune diseases. Selecta Biosciences is headquartered in the Greater Boston area. For more information, please visit www.selectabio.com. Selecta Forward-Looking StatementsAny statements in this press release about the future expectations, plans and prospects of Selecta Biosciences, Inc. (the “Company”), including without limitation, statements regarding the Company’s strategic prioritization of SEL-212 and its collaborations with Sobi and Astellas, the Company’s plans regarding the transition of manufacturing and clinical operations for SEL-212 to Sobi, the Company’s plans to maximize the value of its pipeline through potential licensing and corporate development activities, the unique proprietary technology platform of the Company and its partners, the potential of ImmTOR to enable re-dosing of therapies and to mitigate immunogenicity, the potential of ImmTOR and the Company’s product pipeline to treat chronic refractory gout, MMA, liver diseases, other autoimmune diseases, or any other disease, the anticipated timing or the outcome of ongoing and planned clinical trials, studies and data readouts, the anticipated timing or the outcome of the FDA’s review of the Company’s regulatory filings, the Company’s and its partners’ ability to conduct its and their clinical trials and preclinical studies, the timing or making of any regulatory filings, the anticipated timing or outcome of selection of developmental product candidates, the ability of the Company to consummate any expected agreements and licenses, the potential treatment applications of product candidates utilizing the ImmTOR platform in areas such as gene therapy, gout and autoimmune disease, the ability of the Company and its partners where applicable to develop gene therapy products using ImmTOR, the novelty of treatment paradigms that the Company is able to develop, the potential of any therapies developed by the Company to fulfill unmet medical needs, the Company’s plan to apply its ImmTOR technology platform to a range of biologics for rare and orphan genetic diseases, the potential of the ImmTOR technology platform generally, the Company’s ability to grow and maintain its strategic partnerships, and enrollment in the Company's clinical trials and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including proof of concept trials, including uncertain outcomes, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a particular clinical trial will be predictive of the final results of that trial and whether results of early clinical trials will be indicative of the results of later clinical trials, the ability to predict results of studies performed on human beings based on results of studies performed on non-human subjects, the unproven approach of the Company’s ImmTOR technology, potential delays in enrollment of patients, undesirable side effects of the Company’s product candidates, its reliance on third parties to manufacture its product candidates and to conduct its clinical trials, the Company’s inability to maintain its existing or future collaborations, licenses or contractual relationships, its inability to protect its proprietary technology and intellectual property, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, the Company’s recurring losses from operations and negative cash flows, substantial fluctuation in the price of the Company’s common stock, risks related to geopolitical conflicts and pandemics and other important factors discussed in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and in other filings that the Company makes with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any intention to update any forward-looking statements included in this press release, except as required by law. For Investors and Media:Blaine DavisChief Financial Officerbdavis@selectabio.com

Phase 3License out/inGene Therapy

100 Deals associated with Pegadricase

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KEGG	Wiki	ATC	Drug Bank
D10077	-	-	DB15129

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Tumor Lysis Syndrome	Phase 2	-	Polaris Inc.	-
Tumor Lysis Syndrome	Phase 2	-	EnzymeRx LLC	-
Tumor Lysis Syndrome	Phase 2	-	Selecta Biosciences, Inc.	-
Autoimmune Diseases	Phase 1	CN	3SBio, Inc.	30 Jan 2022
Neoplasms	Phase 1	CN	Shenyang Sunshine Pharmaceuticals Co., Ltd.	22 Oct 2019
Gout	Discovery	US	Selecta Biosciences, Inc.	01 Oct 2016
Hyperuricemia	Discovery	US	Selecta Biosciences, Inc.	01 Oct 2016

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SEL-212 (EULAR2019)	Phase 2	Gout	152	SEL-212 (0.1 mg/kg ImmTOR + 0.2 mg/kg pegadricase)	fwmnymwlpo(xnkznpaoxk) = All evaluable patients receiving 0.1 or 0.15 mg/kg ImmTOR administered with 0.2 mg/kg pegadricase who achieved three months of SUA control maintained SUA control in months four and five of combination treatment rlwffohrod (copndtpgcc ) View more	-	12 Jun 2019
				SEL-212 (0.15 mg/kg ImmTOR + 0.2 mg/kg pegadricase)
FOCIS2017	Phase 2	-	38	SEL-212 (SVP-R + pegsiticase)	wtmpmzonck(fyaeywffqn) = ylvraoemdf artiitzhcc (fycuqqtsqy )	Positive	14 Jun 2017
				Pegsiticase alone	wtmpmzonck(fyaeywffqn) = tvkulnstfd artiitzhcc (fycuqqtsqy )

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Clinical Trial

Identify the latest clinical trials across global registries.

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Approval

Accelerate your research with the latest regulatory approval information.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis