Th purpose of this study is to determine whether ADI-PEG20 (PEGylated arginine deiminase), an arginine catabolizing enzyme preparation, improves insulin sensitivity, mitochondrial respiration, and energy utilization in adolescents with prediabetes.

Start Date01 Jul 2024

Sponsor / Collaborator

Washington University School of Medicine

[+1]

NCT05813327 / RecruitingPhase 1/2IIT

A Phase I/II Trial of Neoadjuvant ADI-PEG 20 in Combination With Ifosfamide and Radiotherapy in Soft Tissue Sarcoma (STS)

In this study, patients with soft tissue sarcoma (STS) will receive ADI-PEG 20 and ifosfamide in combination with radiation as neoadjuvant therapy. In phase I of the study, up to 5 dose levels will be tested to find the recommended phase II dose (RP2D), after which patients enrolling to phase II will be treated at that dose level to assess efficacy.

Start Date14 Mar 2024

Sponsor / Collaborator

Washington University School of Medicine

[+1]

NCT06085729 / RecruitingPhase 1/2IIT

Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)

To find the best dose of ADI-PEG20 that can be given in combination with carboplatin and cabazitaxel to patients with AVPC.

Start Date29 Feb 2024

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

100 Clinical Results associated with Pegargiminase

100 Translational Medicine associated with Pegargiminase

100 Patents (Medical) associated with Pegargiminase

163

Literatures (Medical) associated with Pegargiminase

15 Aug 2023·Clinical cancer research : an official journal of the American Association for Cancer Research

Discovery and Targeting of a Noncanonical Mechanism of Sarcoma Resistance to ADI-PEG20 Mediated by the Microenvironment.

Article

Author: Hu, Zhixian ; White, Eileen P ; Dehner, Carina A ; Lin, Zongtao ; Shoghi, Kooresh I ; Kremer, Jeff C ; Chrisinger, John S A ; Garcia, Benjamin A ; Brashears, Caitlyn B ; Oyama, Toshinao ; Bomalaski, John S ; Baker, Adriana ; Rogers, Leonard C ; Fettig, Nicole ; Van Tine, Brian A ; Bastos, Alliny C S ; Zhou, Dong

PURPOSE:

Many cancers lack argininosuccinate synthetase 1 (ASS1), the rate-limiting enzyme of arginine biosynthesis. This deficiency causes arginine auxotrophy, targetable by extracellular arginine-degrading enzymes such as ADI-PEG20. Long-term tumor resistance has thus far been attributed solely to ASS1 reexpression. This study examines the role of ASS1 silencing on tumor growth and initiation and identifies a noncanonical mechanism of resistance, aiming to improve clinical responses to ADI-PEG20.

EXPERIMENTAL DESIGN:

Tumor initiation and growth rates were measured for a spontaneous Ass1 knockout (KO) murine sarcoma model. Tumor cell lines were generated, and resistance to arginine deprivation therapy was studied in vitro and in vivo.

RESULTS:

Conditional Ass1 KO affected neither tumor initiation nor growth rates in a sarcoma model, contradicting the prevalent idea that ASS1 silencing confers a proliferative advantage. Ass1 KO cells grew robustly through arginine starvation in vivo, while ADI-PEG20 remained completely lethal in vitro, evidence that pointed toward a novel mechanism of resistance mediated by the microenvironment. Coculture with Ass1-competent fibroblasts rescued growth through macropinocytosis of vesicles and/or cell fragments, followed by recycling of protein-bound arginine through autophagy/lysosomal degradation. Inhibition of either macropinocytosis or autophagy/lysosomal degradation abrogated this growth support effect in vitro and in vivo.

CONCLUSIONS:

Noncanonical, ASS1-independent tumor resistance to ADI-PEG20 is driven by the microenvironment. This mechanism can be targeted by either the macropinocytosis inhibitor imipramine or the autophagy inhibitor chloroquine. These safe, widely available drugs should be added to current clinical trials to overcome microenvironmental arginine support of tumors and improve patient outcomes.

01 Jun 2023·Pharmacological reports : PR

A role for macrophages under cytokine control in mediating resistance to ADI-PEG20 (pegargiminase) in ASS1-deficient mesothelioma

Article

Author: Szlosarek, Peter W ; Cutts, Rosalind ; Sheaff, Michael ; Chelala, Claude ; Balkwill, Frances ; Feng, Shenghui ; Ghazaly, Essam ; Berry, Joe Scott ; Phillips, Melissa M ; Steele, Jeremy ; Pavlyk, Iuliia ; Nattress, Callum ; Carpentier, Josephine ; Bomalaski, John ; Hallden, Gunnel ; Allen, Michael

Abstract:

Background:

Pegylated arginine deiminase (ADI-PEG20; pegargiminase) depletes arginine and improves survival outcomes for patients with argininosuccinate synthetase 1 (ASS1)-deficient malignant pleural mesothelioma (MPM). Optimisation of ADI-PEG20-based therapy will require a deeper understanding of resistance mechanisms, including those mediated by the tumor microenvironment. Here, we sought to reverse translate increased tumoral macrophage infiltration in patients with ASS1-deficient MPM relapsing on pegargiminase therapy.

Methods:

Macrophage-MPM tumor cell line (2591, MSTO, JU77) co-cultures treated with ADI-PEG20 were analyzed by flow cytometry. Microarray experiments of gene expression profiling were performed in ADI-PEG20-treated MPM tumor cells, and macrophage-relevant genetic “hits” were validated by qPCR, ELISA, and LC/MS. Cytokine and argininosuccinate analyses were performed using plasma from pegargiminase-treated patients with MPM.

Results:

We identified that ASS1-expressing macrophages promoted viability of ADI-PEG20-treated ASS1-negative MPM cell lines. Microarray gene expression data revealed a dominant CXCR2-dependent chemotactic signature and co-expression of VEGF-A and IL-1α in ADI-PEG20-treated MPM cell lines. We confirmed that ASS1 in macrophages was IL-1α-inducible and that the argininosuccinate concentration doubled in the cell supernatant sufficient to restore MPM cell viability under co-culture conditions with ADI-PEG20. For further validation, we detected elevated plasma VEGF-A and CXCR2-dependent cytokines, and increased argininosuccinate in patients with MPM progressing on ADI-PEG20. Finally, liposomal clodronate depleted ADI-PEG20-driven macrophage infiltration and suppressed growth significantly in the MSTO xenograft murine model.

Conclusions:

Collectively, our data indicate that ADI-PEG20-inducible cytokines orchestrate argininosuccinate fuelling of ASS1-deficient mesothelioma by macrophages. This novel stromal-mediated resistance pathway may be leveraged to optimize arginine deprivation therapy for mesothelioma and related arginine-dependent cancers.

01 May 2023·Molecular cancer research : MCR

BAP1 Loss Is Associated with Higher ASS1 Expression in Epithelioid Mesothelioma: Implications for Therapeutic Stratification

Article

Author: Marciniak, Stefan J. ; Butt, Zohra ; Szlosarek, Peter W. ; Shaw, Liam ; Rassl, Doris M. ; Kenyani, Jenna ; Jackson, Richard ; Tripari, Martina ; Goate, Zoe ; Grosman, Rudi ; Sacco, Joseph J. ; Coulson, Judy M. ; Querques, Francesca ; Barnett, Sarah E. ; Lian, Lu-Yun ; Silva, Luisa C.

Abstract:

The nuclear deubiquitylase BRCA1-associated protein 1 (BAP1) is frequently inactivated in malignant pleural mesothelioma (MPM) and germline BAP1 mutation predisposes to cancers including MPM. To explore the influence on cell physiology and drug sensitivity, we sequentially edited a predisposition mutation (w-) and a promoter trap (KO) into human mesothelial cells. BAP1w-/KO MeT5A cells express less BAP1 protein and phenocopy key aspects of BAP1 loss in MPM. Stable isotope labeling with amino acids in cell culture–mass spectrometry revealed evidence of metabolic adaptation, with concomitant alteration of cellular metabolites. In MeT5A, BAP1 deficiency reduces glycolytic enzyme levels but increases enzymes involved in the tricarboxylic acid cycle and anaplerotic pathways. Notably both argininosuccinate synthase 1 (ASS1), essential for cellular synthesis of arginine, and its substrate aspartate, are elevated in BAP1w-/KO MeT5A cells. Likewise, ASS1 expression is higher in BAP1-altered MPM cell lines, and inversely correlates with BAP1 in The Cancer Genome Atlas MESO dataset. Elevated ASS1 is also evident by IHC staining in epithelioid MPM lacking nuclear BAP1 expression, with improved survival among patients with BAP1-negative/ASS1-expressing tumors. Alterations in arginine metabolism may sensitize cells to metabolic drugs and we find that BAP1-negative/ASS1-expressing MPM cell lines are more sensitive to ASS1 inhibition, although not to inhibition of purine synthesis by mizoribine. Importantly, BAP1w-/KO MeT5A become desensitized to arginine deprivation by pegylated arginine deiminase (ADI-PEG20), phenocopying BAP1-negative/ASS1-expressing MPM cell lines.

Implications::

Our data reveal an interrelationship between BAP1 and arginine metabolism, providing a potential means of identifying patients with epithelioid MPM likely to benefit from ADI-PEG20.

News (Medical) associated with Pegargiminase

29 May 2024

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BESREMi® (Ropeginterferon alfa-2B) Shows Greatest Benefit Among Cytoreductive Therapies in Lowering Symptomatic Burden of Polycythemia Vera (PV): Real-World Analysis Published at ASCO

Seventy-five percent of BESREMi patients experienced reduction in severe PV symptoms Medical chart review supports importance of symptomatic burden in real-world treatment of PV and clinical utility of cytoreductive therapies compared to phlebotomy alone BURLINGTON, Mass.--(BUSINESS WIRE)-- PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, announced today results from a real-world data review published in the Journal of Clinical Oncology supplement (abstract # e18530) for the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting Proceedings. The retrospective medical chart review demonstrates the potential for cytoreductive therapies (CTs) to impact the burden of illness of polycythemia vera (PV) in patients, with ropeginterferon alfa-2B (marketed as BESREMi®) showing the greatest percentage reduction (when compared to other CTs) in patients seen with severe PV symptoms. This review included patients receiving phlebotomy alone (n=103) and each of the following cytoreductive therapies with or without concomitant phlebotomy: hydroxyurea (n=165), ruxolitinib (n=115), peginterferon alfa-2a (n=44) and ropeginterferon alfa-2b (n=45). From their initial presentation to their most recent visit, healthcare providers observed a reduction in the number of patients with severe symptoms across all CTs, with the greatest reduction in severe symptoms seen in ropeginterferon alfa-2b patients, with a reduction from 12 to 3 patients reporting severe symptoms (75%). They observed a reduction for hydroxyurea from 7 to 4 patients (43%); in ruxolitinib from11 to 6 patients (45%), and in peginterferon alfa-2a from12 to 8 patients (33%). Among patients treated with phlebotomy alone, the top reasons physicians indicated they would initiate cytoreductive therapy would be worsening of symptoms (32%), increased frequency of phlebotomy (29%) or difficulty to control hematocrit (24%). “PV is a chronic and life-threatening myeloproliferative neoplasm associated with significant clinical, economic and patient burden,” said Adan Sosa, Pharm.D., Director of Health Economics and Outcomes Research at PharmaEssentia. “When phlebotomy fails, the top reason healthcare providers indicated they would initiate cytoreductive therapy for PV patients is worsening of symptoms – an insight that supports the importance of symptomatic burden in PV treatment, beyond hematologic response. As healthcare providers work towards best practice PV care, this review supports the importance of BESREMi as a therapeutic option that demonstrates clinical efficacy and may impact the symptomatic burden of illness for patients.” In 2023, the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) were updated to include BESREMi as the only preferred therapeutic option for the treatment of adults with both high- and low-risk polycythemia vera, regardless of treatment history. In this review, 63% of patients were identified as high risk (>60 y/o with history of thrombosis). “Polycythemia vera is a chronic blood disorder which is now recognized as a type of cancer. Physicians have focused on the patient’s blood counts and molecular results to make treatment decisions, and these real-world data reinforce that, for patients, symptoms matter,” said Robert B. Geller, M.D., Head of Medical at PharmaEssentia USA. “We hope these results provide additional evidence regarding the meaningful clinical value of BESREMi for patients with this myeloproliferative neoplasm, as well as encourage treating physicians to consider early and optimal cytoreductive interventions for appropriate PV patients.” More About this Review This medical chart review took place from October to December 2023 and included a total of 420 unique charts of U.S. adult patients with a confirmed diagnosis of PV in the prior 12 months, from 125 healthcare providers representing academic, community and private practice settings. Data were collected at three points in time, initial presentation of PV, diagnosis and at the most recent HCP visit; additionally, healthcare professional rationale on treatment decision-making was captured. About Polycythemia Vera (PV) Polycythemia vera (PV) is a cancer originating from a disease-initiating stem cell in the bone marrow resulting in a chronic increase of red blood cells, white blood cells, and platelets. PV may result in cardiovascular complications such as thrombosis and embolism, and often transforms to secondary myelofibrosis or leukemia. While the molecular mechanism underlying PV is still subject of intense research, current results point to a set of acquired mutations, the most important being a mutant form of JAK2.1 About BESREMi® (ropeginterferon alfa-2b-njft) BESREMi is an innovative monopegylated, long-acting interferon. With its unique pegylation technology, BESREMi has a long duration of activity in the body and is aimed to be administered once every two weeks (or every four weeks with hematological stability for at least one year), allowing flexible dosing that helps meet the individual needs of patients. BESREMi has orphan drug designation for the treatment of polycythemia vera (PV) in adults in the United States. The product was approved by the European Medicines Agency (EMA) in 2019, by the US Food and Drug Administration (FDA) in 2021, and has recently received approval in Taiwan and South Korea. The drug candidate was invented by PharmaEssentia and is manufactured in the company’s Taichung plant, which was cGMP certified by TFDA in 2017 and by EMA in January 2018. PharmaEssentia retains full global intellectual property rights for the product in all indications. BESREMi was approved with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infectious disorders. Please see full Prescribing Information, including Boxed Warning. Indication BESREMi is indicated for the treatment of adults with polycythemia vera. Important Safety Information WARNING: RISK OF SERIOUS DISORDERS Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping therapy. CONTRAINDICATIONS Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation, or suicide attempt Hypersensitivity to interferons including interferon alfa-2b or any of the inactive ingredients of BESREMi. Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment History or presence of active serious or untreated autoimmune disease Immunosuppressed transplant recipients WARNINGS AND PRECAUTIONS Depression and Suicide: Life-threatening or fatal neuropsychiatric reactions have occurred in patients receiving interferon alfa-2b products, including BESREMi. These reactions may occur in patients with and without previous psychiatric illness. Other central nervous system effects, including suicidal ideation, attempted suicide, aggression, bipolar disorder, mania and confusion have been observed with other interferon alfa products. Closely monitor patients for any symptoms of psychiatric disorders and consider psychiatric consultation and treatment if such symptoms emerge. If psychiatric symptoms worsen, it is recommended to discontinue BESREMi therapy. Endocrine Toxicity: These toxicities may include worsening hypothyroidism and hyperthyroidism. Do not use BESREMi in patients with active serious or untreated endocrine disorders associated with autoimmune disease. Evaluate thyroid function in patients who develop symptoms suggestive of thyroid disease during BESREMi therapy. Discontinue BESREMi in patients who develop endocrine disorders that cannot be adequately managed during treatment with BESREMi. Cardiovascular Toxicity: Toxicities may include cardiomyopathy, myocardial infarction, atrial fibrillation and coronary artery ischemia. Patients with a history of cardiovascular disorders should be closely monitored for cardiovascular toxicity during BESREMi therapy. Avoid use of BESREMi in patients with severe or unstable cardiovascular disease, (e.g., uncontrolled hypertension, congestive heart failure (≥ NYHA class 2), serious cardiac arrhythmia, significant coronary artery stenosis, unstable angina) or recent stroke or myocardial infarction. Decreased Peripheral Blood Counts: These toxicities may include thrombocytopenia (increasing the risk of bleeding), anemia, and leukopenia (increasing the risk of infection). Monitor complete blood counts at baseline, during titration and every 3-6 months during the maintenance phase. Monitor patients for signs and symptoms of infection or bleeding. Hypersensitivity Reactions: Toxicities may include serious, acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis). If such reactions occur, discontinue BESREMi and institute appropriate medical therapy immediately. Transient rashes may not necessitate interruption of treatment. Pancreatitis: Pancreatitis has occurred in 2.2% of patients receiving BESREMi. Symptoms may include nausea, vomiting, upper abdominal pain, bloating, and fever. Patients may experience elevated lipase, amylase, white blood cell count, or altered renal/hepatic function. Interrupt BESREMi treatment in patients with possible pancreatitis and evaluate promptly. Consider discontinuation of BESREMi in patients with confirmed pancreatitis. Colitis: Fatal and serious ulcerative or hemorrhagic/ischemic colitis have occurred in patients receiving interferon alfa products, some cases starting as early as 12 weeks after start of treatment. Symptoms may include abdominal pain, bloody diarrhea, and fever. Discontinue BESREMi in patients who develop these signs or symptoms. Colitis may resolve within 1 to 3 weeks of stopping treatment. Pulmonary Toxicity: Pulmonary toxicity may manifest as dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, pulmonary hypertension, and sarcoidosis. Some events have resulted in respiratory failure or death. Discontinue BESREMi in patients who develop pulmonary infiltrates or pulmonary function impairment. Ophthalmologic Toxicity: These toxicities may include severe eye disorders such as retinopathy, retinal hemorrhage, retinal exudates, retinal detachment and retinal artery or vein occlusion which may result in blindness. During BESREMi therapy, 23% of patients were identified with an eye disorder. Eyes disorders ≥5% included cataract (6%) and dry eye (5%). Advise patients to have eye examinations before and during BESREMi therapy, specifically in those patients with a retinopathy-associated disease such as diabetes mellitus or hypertension. Evaluate eye symptoms promptly. Discontinue BESREMi in patients who develop new or worsening eye disorders. Hyperlipidemia: Elevated triglycerides may result in pancreatitis. Monitor serum triglycerides before BESREMi treatment and intermittently during therapy and manage when elevated. Consider discontinuation of BESREMi in patients with persistently, markedly elevated triglycerides. Hepatotoxicity: These toxicities may include increases in serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT) and bilirubin. Liver enzyme elevations have also been reported in patients after long-term BESREMi therapy. Monitor liver enzymes and hepatic function at baseline and during BESREMi treatment. Discontinue BESREMi in patients who develop evidence of hepatic decompensation (characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome or variceal hemorrhage) during treatment. Renal Toxicity: Monitor serum creatinine at baseline and during therapy. Avoid use of BESREMi in patients with eGFR <30 mL/min. Discontinue BESREMi if severe renal impairment develops during treatment. Dental and Periodontal Toxicity: These toxicities may include dental and periodontal disorders, which may lead to loss of teeth. In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with BESREMi. Patients should have good oral hygiene and regular dental examinations. Dermatologic Toxicity: These toxicities have included skin rash, pruritus, alopecia, erythema, psoriasis, xeroderma, dermatitis acneiform, hyperkeratosis, and hyperhidrosis. Consider discontinuation of BESREMi if clinically significant dermatologic toxicity occurs. Driving and Operating Machinery: BESREMi may impact the ability to drive and use machinery. Patients should not drive or use heavy machinery until they know how BESREMi affects their abilities. Patients who experience dizziness, somnolence or hallucination during BESREMi therapy should avoid driving or using machinery. Embryo-Fetal Toxicity: Based on the mechanism of action, BESREMi can cause fetal harm when administered to a pregnant woman. Pregnancy testing is recommended in females of reproductive potential prior to treatment with BESREMi. Advise females of reproductive potential to use an effective method of contraception during treatment with BESREMi and for at least 8 weeks after the final dose. ADVERSE REACTIONS The most common adverse reactions reported in > 40% of patients in the PEGINVERA study (n=51) were influenza-like illness, arthralgia, fatigue, pruritis, nasopharyngitis, and musculoskeletal pain. In the pooled safety population (n=178), the most common adverse reactions greater than 10%, were liver enzyme elevations (20%), leukopenia (20%), thrombocytopenia (19%), arthralgia (13%), fatigue (12%), myalgia (11%), and influenza-like illness (11%). DRUG INTERACTIONS Patients on BESREMi who are receiving concomitant drugs which are CYP450 substrates with a narrow therapeutic index should be monitored to inform the need for dosage modification for these concomitant drugs. Avoid use with myelosuppressive agents and monitor patients receiving the combination for effects of excessive myelosuppression. Avoid use with narcotics, hypnotics or sedatives and monitor patients receiving the combination for effects of excessive CNS toxicity. USE IN SPECIFIC POPULATIONS Pregnancy: Based on mechanism of action and the role of interferon alfa in pregnancy and fetal development, BESREMi may cause fetal harm and should be assumed to have abortifacient potential when administered to a pregnant woman. There are adverse effects on maternal and fetal outcomes associated with polycythemia vera in pregnancy. Advise pregnant women of the potential risk to a fetus. Lactation: There are no data on the presence of BESREMi in human or animal milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed children from BESREMi, advise women not to breastfeed during treatment and for 8 weeks after the final dose. Females of Reproductive Potential: BESREMi may cause embryo-fetal harm when administered to a pregnant woman. Pregnancy testing prior to BESREMi treatment is recommended for females of reproductive potential. Advise female patients of reproductive potential to use effective contraception during treatment with BESREMi and for at least 8 weeks after the final dose. Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Geriatric Use: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other therapy. About PharmaEssentia PharmaEssentia (TPEx: 6446), headquartered in Taipei, Taiwan, is a global and rapidly growing biopharmaceutical innovator. Leveraging deep expertise and proven scientific principles, PharmaEssentia aims to deliver effective new biologics for challenging diseases in the areas of hematology, oncology, and immunology with one approved product and a diversifying pipeline. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today PharmaEssentia is expanding its global presence with operations in the U.S., Japan, China, and Korea, along with a world-class biologics production facility in Taichung, Taiwan. For more information about PharmaEssentia USA, visit the website, LinkedIn or Twitter. Forward Looking Statement This press release may contain forward looking statements, including statements regarding the clinical benefits to be derived from ropeginterferon alfa-2b, the commercial opportunity and competitive positioning, new indications or labeling for ropeginterferon alfa-2b, and business prospects for ropeginterferon alfa-2b. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and similar legislation and regulations under Taiwanese law. These forward-looking statements are based on management expectations and assumptions as of the date of this press release, and actual results may differ materially from those in these forward looking statements as a result of various factors. These factors include whether BESREMi is successfully commercialized and adopted by physicians and patients, the extent to which reimbursement is available for BESREMi, and the ability to receive FDA and other regulatory approvals for additional indications for BESREMi. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. © 2024 PharmaEssentia Corporation. All rights reserved. PharmaEssentia, the PharmaEssentia logo, and BESREMi are trademarks or registered trademarks of PharmaEssentia Corporation. 1 Cerquozzi S, Tefferi A. Blast transformation and fibrotic progression in polycythemia vera and essential thrombocythemia: a literature review of incidence and risk factors. Blood Cancer J. 2015;5, e366; DOI:10.1038/bcj.2015.95

Clinical ResultDrug ApprovalOrphan DrugASCOClinical Study

22 May 2024

·www.biospace.com

Gilead to Present Latest Research Across Key Liver Disease Indications at the European Association for the Study of the Liver Congress 2024

– Key Findings from PBC, HDV, HCV, HBV and MASH/Fibrosis Studies Affirm Commitment to Drive Life-changing Science in Liver Disease – FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced new research to be presented at the European Association for the Study of the Liver (EASL) Congress, June 5-8, 2024 in Milan, Italy. Key findings from more than 25 abstracts will include: Interim results for two years from the ASSURE study which evaluate the long-term efficacy and safety pro investigational seladelpar for the treatment of primary biliary cholangitis (PBC); Results of a pooled analysis, showcasing the effects of tenofovir-based antiviral therapy in reducing long-term incidence of primary liver cancer in people living with chronic hepatitis B (HBV); Final results of the Phase 2b MYR204 study evaluating the efficacy and safety of Hepcludex® (bulevirtide) in combination with pegylated interferon alfa-2a (PegIFN) in patients with compensated chronic hepatitis delta virus (HDV); and A late breaker presentation on the final results from the pivotal MYR301 Phase 3 study evaluating the efficacy and safety of bulevirtide as monotherapy. “These data underline Gilead’s commitment to drive life-changing science and create healthier futures for people living with liver disease. We look forward to presenting our latest research at EASL, as we strive to deliver novel medicines to populations with high unmet medical need,” said Frank Duff, MD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. “The breadth of our data being presented across viral and inflammatory liver diseases, speaks to our commitment to driving positive change at every step of a person’s journey. Transforming lives goes beyond treatment, and our research, innovation and partnerships span initial awareness and education, through to screening, diagnosis, path to care and ongoing management to address current unmet needs.” To drive efforts in supporting the World Health Organization’s (WHO) goal to eliminate viral hepatitis as a public health threat by 2030, Gilead will also present real-world data in hepatitis C (HCV) and launch a national HCV awareness program in Italy to raise awareness of the disease. In collaboration with EASL, Gilead will launch “Epatite C Mettiamoci un Punto” (Hepatitis C Let’s Put a Stop to it) in Milan to raise awareness about the disease and encourage people to get tested for HCV through EASL’s “Love Your Liver” Campaign. Advancing Treatment options in PBC New data demonstrating the long-term efficacy and safety pro investigational seladelpar for the treatment of primary biliary cholangitis (PBC) will be presented at EASL. These include the first interim data from the Phase 3 open-label ASSURE study that includes people who received a second year of seladelpar treatment following their initial participation in the Phase 3 RESPONSE study. The study also includes patients with insufficient response to first-line PBC treatment, ursodeoxycholic acid (UDCA). These data evaluate the composite biochemical response (alkaline phosphatase (ALP) < 1.67x upper limit of normal (ULN), ALP decrease ≥ 15%, and total bilirubin ≤ ULN) and ALP normalization, as well as pruritus for seladelpar in the treatment of PBC which is a rare, chronic, cholestatic liver disease mainly affecting women (1 in 1,000 women over the age of 40 or about 130,000 total people in the U.S.) that impairs liver function and quality of life. The most common early symptoms of PBC are pruritus (itching) and fatigue, which can be debilitating for some patients. Progression of PBC is associated with an increased risk of liver-related mortality. Key Findings in HDV At the EASL Congress, Gilead will present 13 abstracts in HDV, including the Week 144 (48 Weeks off-treatment) results of the Phase 2b MYR204 study of bulevirtide with or without peginterferon alfa-2a (PegIFN) in people with chronic HDV and compensated liver disease (GS-002), and results from the pivotal Phase 3 MYR301 study assessing the efficacy and safety of bulevirtide as monotherapy as a late-breaker presentation (LB-309). Further highlighting Gilead as a leader in HDV research, a sub-analysis of the MYR204 study (OS-122) evaluating intrahepatic virological outcomes 24 Weeks off-treatment will be presented. A pooled analysis of the MYR203, MYR204 and MYR301 studies (TOP-400) discussing the impact of nucleos(t)ide analogues alongside bulevirtide 48 Weeks off-treatment will also be shared as an oral presentation. These data evaluate the efficacy pro bulevirtide for people living with HDV, which is considered the most severe form of viral hepatitis due to rapid disease progression towards liver failure, liver cancer and liver-related death. Key Abstracts at EASL 2024: ID Abstract Title PBC OS-019 Efficacy and safety of seladelpar in patients with primary biliary cholangitis and compensated liver cirrhosis in the open-label, long-term ASSURE safety study: interim results THU-098 Appraising gain of an extended 2-year placebo-controlled trial in primary biliary cholangitis: challenges for evaluating clinical outcomes SAT-175 PPAR-delta activation with seladelpar regulates cholangiocyte inflammation THU-119 Seladelpar treatment increases fatty acid beta-oxidation and serum carnitine levels in patients with primary biliary cholangitis consistent with increased expression of the carnitine transporter OCTN2 and the mitochondrial carnitine shuttle SAT-177 Assessment of PPAR-delta target engagement in mouse liver assessed by single nuclei sequencing following a single oral dose of seladelpar LB-283 Long-term efficacy and safety of open-label seladelpar treatment in patients with primary biliary cholangitis (PBC): interim results for 2 years from the ASSURE study HDV GS-002 48-week off-therapy efficacy and safety of bulevirtide in combination with pegylated interferon alfa-2a in patients with chronic hepatitis delta: Final results from MYR204 LB-309 Efficacy and safety of 144 weeks of bulevirtide 2 mg or 10 mg monotherapy from the ongoing Phase 3 study, MYR301 TOP-400 Impact of bulevirtide given with or without nucleos(t)ide analogues on 48-week virologic outcomes in patients with chronic hepatitis delta virus infection WED-395 Undetectable hepatitis delta virus RNA at the end of treatment with bulevirtide and pegylated interferon alpha-2a is an important predictor of 48 weeks sustained virologic response in chronic hepatitis delta OS-122 Bulevirtide in combination with pegylated interferon alfa-2a shows a sustained off-treatment response in the liver FRI-435 Serological and nucleic acid testing laboratory screening rates for hepatitis delta virus among adult patients in the United States HCV THU-374 Description of age, sex, and characteristics of hepatitis C patients in the SVR10K study: a real-world SOF/VEL analysis performed across five global regions WED-498 Impact of direct acting antiviral market access policy barriers and restrictions for Hepatitis C patients: a database analysis of claims from states with and without Medicaid restrictions WED-447 Age at incident cirrhosis in individuals with hepatitis C virus infection: a US administrative claims analysis HBV WED-397 Tenofovir-based antiviral therapy reduces long-term incidence of hepatocellular carcinoma in chronic hepatitis B patients FRI-390 Off-treatment outcomes after discontinuing tenofovir-based treatment in hepatitis B e antigen-positive and hepatitis B e antigen-negative patients with chronic hepatitis B virus MASH/Fibrosis TOP-264 Paired assessment of Enhanced Liver Fibrosis (ELF) and Fibrosis-4 (FIB-4) scores is associated with an elevated risk of liver-related clinical events in patients with advanced fibrosis due to metabolic dysfunction-associated steatohepatitis (MASH) For more information, including a complete list of abstract titles being presented at the meeting, please visit the EASL website. In July 2023, the European Commission (EC) granted full Marketing Authorization (MA) for bulevirtide 2 mg for the treatment of adults with chronic HDV and compensated liver disease. Bulevirtide was initially granted conditional MA from the EC in July 2020 to provide access to people living with HDV urgent access to treatment. Bulevirtide also received full MA in Great Britian in August 2023 and in Switzerland in February 2024. In the U.S. and outside of the European Economic Area, bulevirtide is an investigational agent that is not approved for any use. In these regions, health authorities have not established the safety and efficacy of bulevirtide. Bulevirtide 10 mg is an investigational product and has not been approved anywhere globally. Seladelpar is an investigational compound and is not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority; its safety and efficacy have not been established. About PBC PBC is a rare, chronic inflammatory liver disease primarily affecting women (1 in 1,000 women over the age of 40 or about 130,000 total people in the US). PBC is characterized by impaired bile flow (known as cholestasis) and the accumulation of toxic bile acids in the liver, leading to inflammation and destruction of the bile ducts within the liver and causing increased levels of ALP, ALT, and GGT, enzymes found primarily in the liver, as well as total bilirubin. The most common early symptoms of PBC are pruritus (itching) and fatigue, which can be debilitating for some patients. Progression of PBC is associated with an increased risk of liver-related mortality. About HDV HDV is considered the most aggressive or severe form of viral hepatitis, associated with more rapid progression towards liver-related death and liver cancer in people with hepatitis B (HBV). On average, HDV progresses to cirrhosis within 5 years and to liver cancer within 10 years. Nearly 5% of people who have a chronic infection with HBV are estimated to have HDV, equating to 12-15 million people worldwide. The prevalence of HDV infection is largely underestimated due to lack of universal testing of HBV-positive individuals for HDV. About Gilead Sciences in Liver Disease For decades, Gilead has pioneered the way forward to improve the lives of people living with liver disease around the world. We have helped transform hepatitis C from a chronic condition into one that can be cured for millions of people. For people living with hepatitis B or D, our focus on advancing our medicines drives hope that today’s research will turn into tomorrow’s cures. Beyond viral hepatitis, we’re working to deliver advanced treatments for people living with primary biliary cirrhosis (PBC). But our commitment doesn’t stop there. Through our ground-breaking science and collaborative partnerships, we strive to create healthier futures for everyone living with liver disease. We are committed to a future without liver disease. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials or studies, including those involving Hepcludex (bulevirtide) and seladelpar; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that the FDA and other regulatory authorities may not approve bulevirtide for the treatment of HDV and/or seladelpar for the treatment of PBC, and the risk that any such approvals, if granted, may be subject to significant limitations on use; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Hepcludex, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company’s website at , follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Phase 2Clinical ResultDrug ApprovalPhase 3Breakthrough Therapy

05 Mar 2024

·www.prnewswire.com

ADI Announces U.S. FDA 510(k) Clearance and the Commercial Launch of Sensinel by Analog Devices™ Cardiopulmonary Management (CPM) System

Enabling closer remote patient monitoring and reduced healthcare costs WILMINGTON, Mass., March 5, 2024 /PRNewswire/ -- Analog Devices, Inc. (Nasdaq: ADI) today announced U.S. Food and Drug Administration (FDA) 510(k) clearance and the commercial launch of the Sensinel ™ Cardiopulmonary Management (CPM) System. The compact wearable device is a non-invasive, remote management system that captures cardiopulmonary measurements for chronic disease management such as heart failure. It is the first FDA clearance the company has received in its 59-year history. Continue Reading ADI Announces U.S. FDA 510(k) Clearance and the Commercial Launch of Sensinel by Analog Devices™ Cardiopulmonary Management (CPM) System "Since our founding, ADI has focused on accelerating breakthroughs that enrich lives through innovative products," said Patrick O'Doherty, Senior Vice President of Digital Healthcare at ADI. "By combining our wearable vital signs sensing and signal processing technology with cardiologist-inspired algorithms to precisely determine a congestive heart failure patient's daily state of health, we developed the Sensinel CPM System. This innovative service-based product has the potential to open up several billion dollars of green-field market opportunity for ADI while improving patient care, streamlining clinician workflows, and reducing healthcare cost." More than 6 million Americans are living with heart failure today, and this number is estimated to rise to nearly 8 million by 2030.¹ Heart failure currently costs Americans approximately $30 billion each year, and this is expected to rise to almost $70 billion by 2030.¹ Approximately 80% of those costs are due to hospitalization.¹ Other prior solutions measuring similar parameters have shown the ability to reduce hospital admissions. However, oftentimes these solutions are either invasive and/or do not provide sensitive and specific enough data to make a meaningful clinical impact. This data is critical to allow the care team to predict an event early enough in advance to potentially avoid a costly hospitalization for the patient. The Sensinel CPM System is the next-generation solution for management of cardiopulmonary diseases like heart failure. It is equipped with a set of physiological indicators to help care teams better manage chronic conditions early and remotely, as well as in a precise manner. Patients self-apply ADI's Sensinel CPM Wearable which they only wear for three to five minutes in a home care setting. The device then captures data about their cardiopulmonary health. This data is automatically uploaded to ADI's Sensinel CPM Cloud Platform using a cellular link (without the need for a patient-supplied Internet connection) and is then further analyzed using ADI's Sensinel CPM Intelligent Algorithms in the cloud. "Early detection of physiological changes is critical for clinicians to prevent a heart failure hospitalization," said Dr. Sean Pinney, Chief of Cardiology at Mount Sinai Morningside in New York City. "ADI's Sensinel CPM System is a highly accurate, reproducible, and reliable solution to help improve predictive care." "When managing chronic conditions like heart failure, it is critical to adjust treatment early to get the condition under control without the need for hospitalization. Other existing non-invasive solutions are not specific enough to provide the data a clinician needs to be effective for early intervention," said Dr. Venu Gopinathan, ADI Fellow and Managing Director of Medical Products at ADI. "Our new cardiopulmonary system is designed to fit seamlessly into the workflow of care and perform a variety of physiological measurements that allow care teams to make early clinical decisions, without subjecting them to information overload." ADI's Sensinel CPM System is now commercially available. For more information, visit . About Sensinel by Analog Devices™ Sensinel by Analog Devices – a brand new wearable healthcare line – aims to fundamentally transform how chronic disease is managed to promote quality of life in an affordable manner. The first product, the Sensinel CPM System, is a non-invasive, at-home solution that captures cardiopulmonary measurements for chronic disease management such as heart failure. Analog Devices, Inc., the company behind Sensinel, is a global semiconductor leader with more than 50 years of expertise in the healthcare industry, particularly within sensing, measuring, computing, connecting, and powering to accelerate human breakthroughs that enrich lives and the world. About Analog Devices, Inc. Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world. With revenue of more than $12 billion in FY23 and approximately 26,000 people globally working alongside 125,000 global customers, ADI ensures today's innovators stay Ahead of What's Possible. Learn more at and on LinkedIn and Twitter (X). All trademarks and registered trademarks are the property of their respective owners. Forward-Looking Statements This press release contains forward-looking statements, which address a variety of subjects including, for example, statements regarding applications, benefits and growth opportunities related to Sensinel or other healthcare wearables; and other future events. Statements that are not historical facts, including statements about our beliefs, plans and expectations, are forward-looking statements. Such statements are based on our current expectations and are subject to a number of factors and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements. The following important factors and uncertainties, among others, could cause actual results to differ materially from those described in these forward-looking statements: the effects of business, economic, political, legal and regulatory uncertainty or conflicts upon our global operations; changes in demand for semiconductors and the related changes in demand and supply for our products; manufacturing delays, product availability and supply chain disruptions; our future liquidity, capital needs and capital expenditures; our development of technologies and research and development investments; our ability to compete successfully in the markets in which we operate; changes in our estimates of our expected tax rates based on current tax law; adverse results in litigation matters; the risk that we will be unable to retain and hire key personnel; security breaches or other cyber incidents; unanticipated difficulties or expenditures relating to integrating Maxim Integrated Products, Inc. ("Maxim"); uncertainty as to the long-term value of our common stock; and the risk that expected benefits, synergies and growth prospects of acquisitions, including those from our acquisition of Maxim, may not be fully achieved in a timely manner, or at all. For additional information about factors that could cause actual results to differ materially from those described in the forward-looking statements, please refer to our filings with the Securities and Exchange Commission, including the risk factors contained in our most recent Annual Report on Form 10-K. Forward-looking statements represent management's current expectations and are inherently uncertain. Except as required by law, we do not undertake any obligation to update forward-looking statements made by us to reflect subsequent events or circumstances. References 1. American Heart Association. Understand your risk for heart failure. American Heart Association website. Published May 9, 2017. Updated June 13, 2023. Accessed March 5, 2024. CONTACT: Ferda Millan Global PR and External Communications Analog Devices [email protected] (408) 373-1854 Michael Lucarelli Vice President, Investor Relations and FP&A Analog Devices [email protected] (781) 461-3282 SOURCE Analog Devices, Inc.

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100 Deals associated with Pegargiminase

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Indication	Highest Phase	Country/Location	Organization	Date
Malignant Pleural Mesothelioma	NDA/BLA	US	Polaris Group	18 Nov 2023
Unresectable Hepatocellular Carcinoma	Phase 3	TW	Polaris Group	14 Mar 2022
Unresectable Hepatocellular Carcinoma	Phase 3	VN	Polaris Group	14 Mar 2022
Liver Cancer	Phase 3	US	Polaris Pharmaceuticals, Inc.	30 Jan 2022
Glioblastoma	Phase 3	US	Polaris Group	30 Jul 2019
Glioblastoma	Phase 3	AU	Polaris Group	30 Jul 2019
Glioblastoma	Phase 3	CA	Polaris Group	30 Jul 2019
Glioblastoma	Phase 3	FR	Polaris Group	30 Jul 2019
Glioblastoma	Phase 3	DE	Polaris Group	30 Jul 2019
Glioblastoma	Phase 3	CH	Polaris Group	30 Jul 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02709512 (ATOMIC-meso , NEWS) Manual	Phase 3	Malignant Pleural Mesothelioma	249	ADI-PEG20+chemotherapy	rqypedxqlc(picadzhcge) = ADI-PEG20, with traditional chemotherapy -- increased the median survival of participants by 1.6 months, and quadrupled the survival at 36 months, compared to placebo-chemotherapy. tnohyvbitq (bdkabphwlj )	Positive	15 Feb 2024
				Placebo+chemotherapy
NCT02709512 (ATOMIC-Meso, Pubmed)	Phase 2/3	Malignant Pleural Mesothelioma First line arginine-auxotrophic tumor	249	Pegargiminase	qdgylxdjmw(sirbhgfznh) = with pegargiminase occurred in 36 patients (28.8%) and with placebo in 21 patients (16.9%); drug hypersensitivity and skin reactions occurred in the experimental arm in 3 patients (2.4%) and 2 patients (1.6%), respectively, and none in the placebo arm zextcwturn (fjykunqdtu ) View more	Positive	15 Feb 2024
				Placebo
NCT02709512 (ADI-PEG 20 \| ATOMIC \| ATOMIC-meso \| ATOMIC-meso , CTgov)	Phase 2/3	Malignant Pleural Mesothelioma	249	ADI-PEG 20 plus Pem Platinum (Drug: ADI-PEG 20 Plus Pem Platinum)	adenemylkj(yxixssmzfm) = djxfgsiqjf sekhkperoi (owogjwieba, ylngwkoqse - nlhwjmungy) View more	-	04 Oct 2023
				Placebo plus Pem Platinum (Drug: Placebo Plus Pem Platinum)	adenemylkj(yxixssmzfm) = gbtnxmzutv sekhkperoi (owogjwieba, gbcdrmgylr - uezfddmfnf) View more
NCT02709512 (ATOMIC-meso, AACR2023) Manual	Phase 2/3	Malignant Pleural Mesothelioma	249	pegargiminase+chemotherapy	pywsmwoyom(chkmxrcfks) = dzmejptmcf ksvzhvdawm (pdafmtqqvv, 7.9 - 11.8) View more	Positive	14 Apr 2023
				placebo+chemotherapy	pywsmwoyom(chkmxrcfks) = myxiakxhdb ksvzhvdawm (pdafmtqqvv, 6.1 - 9.5) View more
NCT04587830 (ASCO2022) Manual	Phase 1	Glioblastoma First line	26	ADI-PEG 20+temozolomide+radiation	bngobtpigb(cnahohzuop) = jhhtihyhby sywkottxqd (crjddyljjd )	Positive	02 Jun 2022
NCT01948843 (Pubmed \| Cancer Med) Manual	Phase 1	Metastatic Solid Tumor	15	ADI-PEG 20+Doxorubicin	dfpfoornvz(pzevdqwfef) = hrixvpgoeo vfrkrejiie (jrwdfufacx ) View more	Positive	28 Nov 2021
NCT02029690 (ADI-PEG20, Pubmed \| Cancer Med) Manual	Phase 1	Non-squamous non-small cell lung cancer ASS1 Deficient Expression	21	pemetrexed+cisplatin+pegargiminase	quhdntxvqs(fkplzgrqvq) = aiswhivmtx bccjcbnyul (amckkwdqhc, 2.9 - 4.8) View more	Positive	01 Oct 2021
NCT02102022 (Pubmed \| Cancer) Manual	Phase 2	Advanced Hepatocellular Carcinoma	140	5-fluorouracil+leucovorin+oxaliplatin+Pegylated arginine deiminase	jvfdqlovwy(oscyalsrul) = qywheiqypp esnkwayujd (nsxgvmltml, 5.0 - 15.4) View more	Negative	20 Aug 2021
NCT03254732 (Pubmed \| Oncoimmunology) Manual	Phase 1	Solid tumor	25	pembrolizumab+ADI-PEG 20	sjoljfwyrh(owkbvdugyr) = neutropenia npxntqotur (dksfmclycg )	Positive	12 Jul 2021
NCT03449901 (ASCO2021) Manual	Phase 2	Sarcoma Second line	75	gemcitabine+docetaxel+pegylated arginine deiminase (gemcitabine 600mg/m2)	aoexxrkhlo(jqvpylnlqu) = lbboecqvtr xajzkwompp (ekfknpedgz ) View more	Positive	20 May 2021
				gemcitabine+docetaxel+pegylated arginine deiminase (leiomyosarcoma (LMS))	aoexxrkhlo(jqvpylnlqu) = aliydxcmoo xajzkwompp (ekfknpedgz ) View more

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