Peptide R&D news / live registry feed

Ang2 and TAT targeting of leptomeningeal disease by the intravenous and intrathecal routes: a comparative analysis

Leptomeningeal disease (LD) refers to the metastasis of cells to the leptomeningeal membranes in the central nervous system (CNS), and it is a deadly complication of several different types of cancer, including breast cancer (BC) and pediatric medulloblastoma (MB). Angiopep-2 …

Distinct Mechanisms for Inhibition of SARS-CoV-2 Main Protease: Dimerization Promoted by Peptidomimetic Inhibitors and Disrupted by Ebselen

The SARS-CoV-2 main protease (Mpro) is a key target for antiviral drugs. Given its conserved sequence across coronaviruses and essential role in viral replication, numerous inhibitors have been developed to target its active site. Mpro exists in equilibrium between the active …

CD1b-specific T cells are transcriptionally closer to conventional CD4 T cells than to innate-like NKT and MAIT cells

Unconventional T cells recognize non-peptide antigens presented by molecules other than the major histocompatibility complex (MHC) proteins. Among unconventional T cells, natural killer T (NKT) cells, which recognize CD1d-lipid complexes, mucosal-associated invariant T (MAIT) …

Integral Synthesis and Clearance Analysis via DIA (ISDia) Reveals Diverse Protein Abundance Regulation during Endoplasmic Reticulum Stress

Endoplasmic Reticulum (ER) stress disrupts protein homeostasis, driving cellular responses critical for survival, development and disease. However, systematic proteome-wide analyses of protein synthesis and clearance during ER stress remain limited. In this study, we developed…

The conserved β-hairpin of the SUI1 domain is a dual-function structural module governing translation initiation and ribosome recycling in yeast

Most eukaryotic mRNAs encode a single functional polypeptide. Following translation termination, both the large and small ribosomal subunits are typically released from the mRNA by ribosome recycling factors. However, after translating short upstream open reading frames (uORFs…

Single-atom inhibition of oncogenic drivers through cysteine coordination

Small-molecule inhibitors rely on molecular recognition within suitable binding pockets, leaving many disease-associated proteins difficult to target. Here, we introduce the concept of a single-atom inhibitor in which gold (Au) engages critical cysteine residues of oncogenic d…

Disease-linked mutations in hnRNPA2B1 accelerate condensate maturation and promote amyloid aggregation

Heterogeneous nuclear ribonucleoprotein A2B1 (hnRNPA2B1) is a multifunctional RNA-binding protein that undergoes liquid-liquid phase separation (LLPS), contributing to the assembly of membraneless organelles across different cellular contexts. However, dysregulated phase separ…

Structural basis of endogenous lipid recognition and G protein selectivity in GPR119

G protein-coupled receptors (GPCRs) often engage multiple intracellular transducers, yet the structural basis by which endogenous ligands influence G protein selectivity remains poorly understood. GPR119 is a lipid-activated receptor expressed in pancreatic {beta}-cells and en…

A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)

Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic. * HR positive (HR+) means the cancer cells have protei…

Effect of an Intraoperative Polynucleotide Injection on Scar Quality After Thyroidectomy and Parathyroidectomy

The goal of this clinical trial is to learn whether a single polynucleotide injection can improve scar quality after thyroid or parathyroid surgery in adults. It will also assess the safety of the injection. The main questions this study aims to answer are the following: Does …

A Long-term Extension Study of Ustekinumab in Pediatric Participants

The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab

A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease

The purpose of this study is to assess whether JNJ-64042056 affects the spread and build up of tau (a protein in brain) when compared with placebo, using brain scan (tau PET) to determine results from specific areas of the brain.

Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma

This randomized phase II trial studies how well rituximab and combination chemotherapy with or without lenalidomide work in treating patients with newly diagnosed stage II-IV diffuse large B cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the abilit…

A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers

The purpose of this study is to determine the putative recommended phase 2 dose(s) (RP2Ds) and best way to take (optimal route of administration) JNJ-89402638 and to determine the safety of JNJ-89402638 at the RP2D(s) in participants with metastatic colorectal cancer (mCRC) an…

Technology Interventions for Youth Alcohol Use

The purpose of this study is to evaluate the effects of two programs to prevent/reduce alcohol misuse among youth primary care patients. Depending on their study condition, youth will receive a brief web-based computer program or the web program + 8 weeks of supportive text me…

Study of Lung Proteins in Patients With Pneumonia

This study will examine the different types of proteins present in the lungs of patients with pneumonia to explore the causes of different types of the disease. Pneumonia is a condition that causes lung inflammation AND is often caused by an infection. It is usually diagnosed …

A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Fosmanogepix) for the potential treatment of candidemia and/or invasive candidiasis, a life-threatening fungal infection caused by several species of yeast called Candida.…

Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment

This phase III trial compares the effect of adding cetuximab to pembrolizumab versus pembrolizumab alone in treating patients with head and neck squamous cell carcinoma (HNSCC) that has come back after a period of improvement (recurrent) and/or that has spread from where it fi…

A Clinical Trial Evaluating TQF3250 Capsules in Patients With Type 2 Diabetes Mellitus and Overweight/Obesity

This is a multicenter, randomized, double-blind, placebo-controlled Phase 1b clinical study designed to evaluate the safety, tolerability, pharmacokinetic profiles and preliminary efficacy of multiple oral doses of TQF3250 capsules in trial subjects with type 2 diabetes mellit…

Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET)

Background: A neuroendocrine tumor is a rare type of tumor. It comes from body cells called neuroendocrine cells. Sometimes, these tumors develop in the gastrointestinal tract and pancreas. Researchers want to find out if a combination of drugs can shrink these tumors. Objecti…

Pembrolizumab With Liver-Directed or Peptide Receptor Radionuclide Therapy for Neuroendocrine Tumors and Liver Metastases

This pilot phase II trial studies how effective pembrolizumab and liver-directed therapy or peptide receptor radionuclide therapy are at treating patients with well-differentiated neuroendocrine tumors and symptomatic and/or progressive tumors that have spread to the liver (li…

Water Deprivation Protocol

Background: \- One area in which obese and lean individuals may be different is how their bodies handle water balance and thirst. Studies done in animals suggest that individuals with greater body fat may tolerate periods without water better than lean animals. Other research …

Phase 1 Study of Ibrutinib and Immuno-Chemotherapy Using Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib,Rituximab (TEDDI-R) in Primary CNS Lymphoma

BACKGROUND: * Primary CNS lymphoma (PCNSL) is a rare subtype of diffuse large B-cell lymphoma. * The outcome for patients with this diagnosis is significantly worse than for that of systemic DLBCL. Most treatment approaches in the past have included high dose methotrexate and …

An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS

The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT) results in an improvement of metastasis-free survi…

Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)

DESTINY-Gastric03 will investigate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of trastuzumab deruxtecan (T-DXd) alone or in combination with chemotherapy and/or immunotherapy in HER2-expressing advanced/metastatic gastric/gas…

A Phase Ib/II Clinical Study of LBL-024 Combination Therapy in Patients With Metastatic Colorectal Carcinoma

This study is an open-label, multi-center Phase Ib/II clinical trial evaluating the safety and efficacy of LBL-024 in combination with other drugs for the treatment of metastatic colorectal carcinoma (mCRC), aiming to evaluate the safety and efficacy of LBL-024 in combination …

A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Other Agents in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208)

The purpose of this study is to evaluate the safety, tolerability, and efficacy of Pumitamig alone or in combination with other agents in participants with advanced Renal Cell Carcinoma (RCC)

The Use of 124-I-PET/CT Whole Body and Lesional Dosimetry in Differentiated Thyroid Cancer

Study rationale High risk patients with differentiated thyroid cancer (DTC) require therapy with 131 I under thyroid stimulating hormone (TSH) stimulation. There are two methods of TSH stimulation endogenous by thyroid hormone withdrawal (THW) leading to hypothyroidism and exo…

Phase 2 Trial of BMF-219 in Participants With Type 1 Diabetes Mellitus

Phase 2 Trial of BMF-219 in Participants with Type 1 Diabetes Mellitus.

Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor

This randomized phase III trial studies octreotide acetate and recombinant interferon alfa-2b to see how well it works compared to octreotide acetate and bevacizumab in treating patients with high-risk neuroendocrine tumors that have spread to other places in the body (metasta…

Phase I/IIa Dose Finding Study of Triplet Regimen of Relatlimab Ipilimumab and NIvolumab in First Line Therapy of Metastatic Melanoma (TRINITY)

To determine the recommended Phase IIa dose (RP2D) of the triplet combination. To determine the safety and efficacy of the combination at the RP2D.

Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer

This randomized phase III trial studies carboplatin given together with paclitaxel with or without bevacizumab to see how well it works compared with oxaliplatin given together with capecitabine with or without bevacizumab as first-line therapy in treating patients with newly …

N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma

The purpose of this study is to find out whether N10 chemotherapy is a safe and effective treatment for children with high-risk neuroblastoma.

EA2176: Phase 3 Clinical Trial of Carboplatin and Paclitaxel +/- Nivolumab in Metastatic Anal Cancer Patients

This phase 3 trial compares the addition of nivolumab to chemotherapy (carboplatin and paclitaxel) versus usual treatment (chemotherapy alone) for the treatment of anal cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, s…

Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)

Researchers are looking for new ways to treat people with endometrial cancer (EC) who have previously received treatment with platinum based therapy (a type of chemotherapy) and immunotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. This clinica…

Combinatorial Therapy to Induce an HIV Remission

Combination approaches will almost certainly be required to generate durable control of HIV in the absence of antiretroviral therapy (a "remission"). In this study, 20 individuals will receive a combination regimen administered during ART and then undergo an analytic treatment…

Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)

This ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain…

Gastrointestinal Dopamine Decarboxylase and Levodopa Pharmacokinetics

The main treatment for Parkinson's disease is a medication called levodopa. Levodopa has to be absorbed from the gut and travel to the brain to work, but a naturally occurring enzyme in the lining of the stomach, called dopamine decarboxylase (AADC), can break some of it down …

The Neural Impact Score benchmarks drugs in Multi-Region Brain Organoids

Only about 10 percent of drugs that clear animal testing succeed in humans, and central nervous system programs carry an even steeper translational gap. Human-relevant NAMs are gaining global regulatory and funding support, creating an urgent need for interpretable preclinical…

MHC II-expressing bone marrow megakaryocytes are noncanonical antigen presenting cells and activate CD4+ T cells ex vivo

While professional antigen-presenting cells drive adaptive immunity, atypical cell types can fulfill this role in the bone marrow. Megakaryocytes (MKs) are canonically recognized for platelet production, but recent studies indicate functional heterogeneity and immune potential…

Addition of 2', 3' cis-dialdehydes, 2', 3' cis-diols and phosphoryl groups to the 3' end of oligonucleotides using periodate-oxidized nucleoside triphosphates and terminal deoxynucleotidyl transferase

We present a simple and efficient way to add cis dialdehydes, phosphoryl groups, or cis diols to the 3 prime end of oligonucleotides using periodate oxidized nucleotides (oNTPs) and terminal deoxynucleotidyl transferase (TdT). The 3 prime end cis dialdehyde-modified oligos are…

LemonCatcher Acidic Pull-Down Enables Selective In-Cell Hydrogen-Deuterium Exchange Mass Spectrometry

Proteins are dynamic molecules which sensitively adapt according to their environment. Hydrogen-Deuterium eXchange Mass Spectrometry (HDX-MS) provides unique insights into protein conformational processes. However, existing methodology cannot selectively enrich proteins post-l…

Multi-Peptide Prompting Enables In-Context Learning in Protein Language

Protein language models (PLMs) are trained primarily on individual protein sequences, yet many peptide-discovery problems require inference from only a small number of labeled examples. Here, we show that single-sequence PLMs can perform in-context peptide learning without gra…

A New Enzyme Family Catalyzing Methyllanthionine Sulfoxide Formation in Anti-phage Lanthipeptides

Lanthipeptides are one of the largest classes of ribosomally synthesized and post-translationally modified peptides (RiPPs). The coi biosynthetic gene cluster (BGC) from Streptomyces coelicolor A3(2) encodes a canonical class I lanthipeptide dehydratase (CoiB) and cyclase (Coi…

BDNF-related brain-liver communication in metabolic syndrome: implications for anxiety and depression

Metabolic syndrome is frequently accompanied by anxiety and depression, suggesting interactions between metabolic dysfunction and affective regulation. Brain-derived neurotrophic factor (BDNF) and its high-affinity receptor tropomyosin receptor kinase B (TrkB) are involved in …

Diagnostic accuracy of plasma p-tau217 against amyloid PET: A meta-analysis of technical platform variability and ratio versus single marker comparisons

To systematically evaluate the diagnostic accuracy of plasma phosphorylated tau 217 (p-tau217) for detecting amyloid pathology in Alzheimer's disease (AD), compare performance across different technical platforms, and assess the incremental diagnostic value of the p-tau217/Aβ4…

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

This phase III trial compares the effectiveness of rituximab to mosunetuzumab in treating patients with follicular lymphoma with a low tumor burden. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) an…

Growth Hormone Administration and the Human Immune System

Background: \- In elderly individuals, an age-associated decline in the immune system s ability to function is believed to contribute to increased incidence of infection, autoimmune disorders, and cancer. This decline in immune system function may be related to the decline in …

Cryoablation+Ipilimumab+Nivolumab in Melanoma

The aim of this study is to find out whether the combination of two approved drugs, ipilimumab and nivolumab, in combination with cryoablation are safe and effective for participants who have an unresectable melanoma that is resistant, or is growing, after receiving immunother…

RC48 in Combination With AK104 and Bevacizumab in OCCC

Disitamab vedotin (RC48) in combination with AK104 (PD-1/CTLA-4 bispecific) and bevacizumab for the treatment of recurrent and persistent clear cell ovarian cancer: a single-arm, phase II, multicenter study (DAB OCC study)

Effectiveness of Zidovudine vs. Zidovudine Plus Alpha Interferon vs. Interferon for Treatment of HIV

This study will compare the effectiveness of zidovudine (AZT) alone vs. zidovudine plus interferon (IFN) vs. interferon alone in reducing HIV viral load, lessening immune system deterioration, and increasing the time to development of the first opportunistic infection in HIV-i…

A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)

The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab. Researchers want to know if giving intismeran autogene and pembrolizumab after surgery can hel…

Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Locoregionally Advanced Head and Neck Cancer Who Cannot Take Cisplatin

This phase II/III trial studies how well radiation therapy works with durvalumab or cetuximab in treating patients with head and neck cancer that has spread to a local and/or regional area of the body who cannot take cisplatin. Radiation therapy uses high energy x-rays to kill…

Base-Edited Hematopoietic Stem/Progenitor Cell Gene Therapy for Treatment of CXCR4-WHIM

Background: Warts, hypogammaglobulinemia, infections and myelokathexis syndrome (WHIMs) is a rare disorder that affects the immune system. People with WHIMs can have severe infections all over their body. WHIMs is caused by a mutation in the CXCR4 gene. Treatment with drugs ca…

177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer

Background: Oncocytic (Hurthle cell) thyroid cancer (HTC) is a rare disease with few treatment options. Researchers are developing a radioactive drug that targets a protein that appears in high numbers on HTC cancer cells. Objective: To test a radioactive drug (177LuDOTA-EB-TA…

Measuring Circulating Tumor Deoxyribonucleic Acid Tumor Fraction to Guide Early 177Lu-PSMA-617 Treatment Discontinuation in Patients With Metastatic Castration-Resistant Prostate Cancer, DYNAMO Trial

This clinical trial studies whether measuring circulating tumor deoxyribonucleic acid (ctDNA) tumor fraction (TF) can be used to help guide the early stopping (discontinuation) of lutetium Lu 177 vipivotide tetraxetan (177Lu-PSMA-617) in patients with castration-resistant pros…

Human Experimental Models of Pain (HEMP)

This pilot study will test an innovative way to establish how pain medicines provide analgesia in healthy adults. The study uses a group of short, controlled pain tests to look at different types of pain responses in the body. The main goal is to find out if this testing appro…

Cardiac Morphology and Function in Individuals With Autonomic Dysreflexia

This case-control study aims to investigate left ventricular remodeling in individuals with chronic spinal cord injury or disease (SCI/D) (≥10 years) and autonomic dysreflexia (AD) who have no prior cardiovascular history. The primary objective is to compare cardiac changes be…

Testing the Addition of Venetoclax or Gemtuzumab Ozogamicin (GO) to Usual Treatment Regimen (Cytarabine and Daunorubicin, "7+3") for Core Binding Factor Acute Myeloid Leukemia (CBF-AML) to Improve Response (A MYELOMATCH Treatment Trial)

This phase II MYELOMATCH treatment trial compares the effect of venetoclax to gemtuzumab ozogamicin, when given with cytarabine and daunorubicin ("7+3" regimen), for the treatment of patients with core binding factor acute myeloid leukemia (CBF-AML). Venetoclax is in a class o…

Testing the Addition of the Immune Therapy Drugs, Tocilizumab and Atezolizumab, to Radiation Therapy for Recurrent Glioblastoma

This phase II trial studies the best dose and effect of tocilizumab in combination with atezolizumab and stereotactic radiation therapy in treating glioblastoma patients whose tumor has come back after initial treatment (recurrent). Tocilizumab is a monoclonal antibody that bi…

Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)

This is a Phase I/II non-randomized clinical trial of ex vivo hematopoietic stem cell (HSC) gene transfer treatment for X-linked severe combined immunodeficiency (XSCID, also known as SCID-X1) using a self-inactivating lentiviral vector incorporating additional features to imp…

Testing RG1-VLP Vaccine to Prevent HPV-related Cancers

This phase I trial tests the safety, side effects, and best dose of RG1-virus-like particle (VLP) in preventing human papillomavirus (HPV)-related cancers in women. RG1-VLP is a vaccine that aims to protect against rare HPV types not targeted by currently approved HPV vaccines…

HSK42360-Na Tablets Combined With Cetuximab With or Without Chemotherapy in BRAF V600-Mutant Metastatic Colorectal Cancer

This is a Phase I/II, single-arm, open-label, multi-center study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HSK42360-Na tablets combined with cetuximab with or without chemotherapy in patients with BRAF V600-mutant metastatic colorectal…

A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Folate Receptor Alpha (FRα)Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of neoadjuvant carboplatin and mirvetuximab soravtansine in participants with folate receptor alpha (FRα) -expressing …

IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors

Background: Myeloid cells are a type of immune cell found in most tumors. Interleukin 12 (IL-12) is a protein that helps the immune system kill tumor cells. Researchers want to know if myeloid cells that have been genetically engineered to produce IL-12 (IL-12 GEMys) can activ…

Rollover Study for Participants Who Have Been Treated With and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other Study Treatments

The purpose of this study is to allow continued access to opnurasib (JDQ443) to participants who are benefitting from treatment with opnurasib as a single agent or in combination with other study treatments in pre-defined Novartis-sponsored opnurasib studies and to continue to…

Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer

This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. Immunotherapy with…

Haploidentical Transplant for People With Chronic Granulomatous Disease (CGD) Using Alemtuzumab, Busulfan and TBI With Post-Transplant Cyclophosphamide

Background: CGD causes infections and inflammation. The only cure currently is a bone marrow transplant. Most often a perfectly matched bone marrow donor is used. Researchers want to see if they can lower the risks of using a mismatched donor. Objectives: To see if it is safe …

An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab

Background: Crohn s disease (CD) is an inflammatory bowel disease. It causes inflammation of the gut. Symptoms may include diarrhea, abdominal pain, fatigue, weight loss and malnutrition. CD has no cure, but symptoms can sometimes be controlled with medicine. Researchers want …

An Open Label, Randomized Study of Neoadjuvant Nivolumab and Chemotherapy, With or Without Sub-ablative Stereotactic Body Radiation Therapy, for Resectable Stage IIA to IIIB Non-small Cell Lung Cancer

An open label, randomized study of neoadjuvant nivolumab and chemotherapy, with or without sub-ablative stereotactic body radiation therapy, for resectable stage IIA to IIIB non-small cell lung cancer

CD4 CAR+ ZFN-modified T Cells in HIV Therapy

This research study is being carried out to study a new way to possibly treat HIV. As part of this study, doctors will take some of your own white blood cells, called T-cells, and modify them so that they can identify and target your HIV cells. The purpose of the study is to e…

Testing Nivolumab and Ipilimumab With Short-Course Radiation in Locally Advanced Rectal Cancer

This phase II trial investigates the effect of nivolumab and ipilimumab when given together with short-course radiation therapy in treating patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced). Immunotherapy with monoclonal antibodies,…

Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia

This phase II trial studies how well clofarabine and melphalan before a donor stem cell transplant works in treating patients with a decrease in or disappearance of signs and symptoms of myelodysplasia or acute leukemia (disease is in remission), or chronic myelomonocytic leuk…

GLP-1R Actions on Muscle and the Skeleton

The GRAMS study objectives are to assess the musculoskeletal changes that occur after weight loss using GLP-1 based therapy. A lifestyle intervention with diet and exercise is included to assess any mitigating effects are provided, versus a control group with regular exercise …

A Mammalian High-Throughput Screen for AI-Designed Peptide-Guided Protein Degraders

Targeted protein degradation (TPD) offers a route to eliminate disease-driving proteins that remain inaccessible to conventional inhibitors. However, degrader discovery remains low-throughput, labor-intensive, and dependent on randomized libraries or non-human display systems,…

Inhibiting nociceptor endocytosis reduces MIA-induced osteoarthritic pain behavior

Introduction: Osteoarthritis (OA) is a degenerative joint condition characterized by chronic pain and the need for pain management. Locally targeting the endocytotic AP2 complex in nociceptors presents a potential strategy for providing sustained pain relief in individuals wit…

Composition-controlled artificial collagen shows opposing roles of collagen-binding integrins and discoidin domain receptors in neuronal differentiation of PC12 cells

Collagen, a major component of the extracellular matrix, regulates cellular behaviors, such as adhesion, differentiation, and angiogenesis. These functions are mediated by interactions between specific amino acid motifs within the collagen triple-helical structure and collagen…

Assessing the translation of AI-prioritized genome-derived peptide fragments into validated antimicrobial candidates

The emergence of antibiotic-resistant pathogens such as Staphylococcus aureus demands accelerated antimicrobial discovery strategies. Artificial intelligence (AI) enables large-scale inference of candidate antimicrobial peptides (AMPs), yet experimental validation remains esse…

Donor-derived CD8+CD122+ Tregs generated in mixed donor chimeric NOD mice suppress autoreactive T cells

The establishment of mixed hematopoietic chimerism is a promising way to induce immune tolerance for islet replacement therapy and to treat the underlying autoimmunity in type 1 diabetes (T1D). Mixed chimerism not only promotes effective thymic negative selection of autoreacti…

Phase-resolved transcriptomic bottlenecks in peptide cancer vaccine response

Background: Peptide cancer vaccines can elicit antigen-specific immunity, but peripheral immunogenicity often does not translate into durable tumor control. Methods: We analyzed transcriptomic profiles across three public human peptide-vaccine cohorts: C1/GSE278476, a MUC1 plu…

FDA — Supplement approved · Efficacy: ZEPBOUND (ELI LILLY AND CO)

Active ingredient(s): TIRZEPATIDE. Marketed as ZEPBOUND, ZEPBOUND KWIKPEN, ZEPBOUND (AUTOINJECTOR). Application NDA217806.

Roche outlays $2.3bn for Hanmi’s non-GLP-1 obesity candidate

The licensing deal marks a diversification of Roche’s obesity pipeline as it seeks entry into the lucrative market.

Roche commits $750m to double Oregon-based US manufacturing capacity

Roche's Oregon fill-finish site will produce both autoinjectors and pre-filled syringes – serving its pipeline and portfolio.

FDA recall (Class II) — SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injectio

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Recalling firm: Apollo Care, LLC.

FDA recall (Class II) — SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Recalling firm: Apollo Care, LLC.

FDA recall (Class II) — SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Onl

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Recalling firm: Apollo Care, LLC.

FDA recall (Class II) — SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Recalling firm: Apollo Care, LLC.

FDA recall (Class II) — SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 M

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Recalling firm: Apollo Care, LLC.

FDA recall (Class II) — SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Recalling firm: Apollo Care, LLC.

FDA recall (Class II) — SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Recalling firm: Apollo Care, LLC.

FDA recall (Class II) — SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Onl

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Recalling firm: Apollo Care, LLC.

FDA recall (Class II) — SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Recalling firm: Apollo Care, LLC.

Amylyx readies approval push after GLP-1 inhibitor halves blood sugar crashes in ph. 3 win

Amylyx Pharmaceuticals’ $35 million bet on the GLP-1 receptor antagonist avexitide appears to have paid off, with the molecule cutting the number of dangerous blood sugar crashes by more than half in patients with a rare endocrine disease.

EMA validates Pfizer and Valneva’s Lyme disease vaccine

The EMA has validated the MAA from Pfizer and Valneva for their Lyme disease vaccine candidate, PF-07307405.

Eli Lilly cracks down on illicit weight loss drug trade with US lawsuits

Eli Lilly is suing several US companies that are allegedly selling illegal versions of its weight loss candidate, retatrutide.

Lyophilisation is growing in pharma, but technical challenges persist

Lyophilisation solves several challenges in pharmaceutical supply chains while introducing new ones to fill-finish processes.

Scholar Rock ditches Novo’s legacy Catalent plant in FDA refiling of SMA drug

Scholar Rock has dropped Novo Nordisk’s troubled Catalent facility as a contract manufacturer in its FDA refiling for apitegromab, a spinal muscular atrophy candidate, after a recent inspection of the plant was classified as “Official Action Indicated.”

Novo Nordisk’s CFO on the oral Wegovy rollout and beyond

Novo Nordisk CFO Karsten Munk Knudsen joins “The Top Line” to discuss oral Wegovy’s rollout, the company’s raised outlook, why he’s still optimistic about CagriSema and more.