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Clinical Trial News

GeneCentric Secures $8M Series C to Commercialize RNA-Based Liquid Biopsy Platform

  • GeneCentric Therapeutics closed an $8 million Series C financing round led by Hatteras Venture Partners to commercialize its GenomicsNext platform, which combines gene expression analysis with DNA variant detection in liquid biopsies.
  • The company's ExpressCT technology enables measurement of gene expression from circulating tumor DNA, addressing limitations of current liquid biopsy assays that focus solely on DNA mutations.
  • GenomicsNext is expected to launch commercially in 2025 as a research tool for biopharmaceutical companies, with funding providing runway through 2026.

Avalo Therapeutics Appoints Rita Jain to Board as AVTX-009 Phase 2 Trial for Hidradenitis Suppurativa Progresses

Monoclonal Antibody
  • Avalo Therapeutics has appointed Rita Jain, M.D., a rheumatologist with over two decades of biopharmaceutical leadership experience, to its Board of Directors.
  • The appointment comes as the company advances AVTX-009, a high-affinity anti-IL-1β monoclonal antibody, through a Phase 2 LOTUS trial for hidradenitis suppurativa.
  • Dr. Jain previously served as Chief Medical Officer at ChemoCentryx, where she advanced Tavneos (avacopan), a first-in-class treatment for ANCA-associated vasculitis.
  • The Phase 2 LOTUS trial results for hidradenitis suppurativa are expected to read out in the middle of next year.

Kaiser Permanente Launches FDA-Approved Gene Therapy Program for Pediatric Sickle Cell Disease

FDA ApprovalRare Disease
  • Kaiser Permanente Southern California will launch an FDA-approved gene therapy program for pediatric sickle cell disease patients through a partnership with Downey Medical Center and City of Hope.
  • The program will serve approximately 220 children aged 12 and above currently treated by Kaiser Permanente, with the first patient scheduled for treatment this summer.
  • The gene therapy process involves extracting stem cells from the patient's blood, modifying them in a laboratory, and reinfusing them to provide a cure without requiring donor matching.
  • This treatment addresses a critical unmet need, as sickle cell disease affects approximately 100,000 Americans and reduces life expectancy by more than 20 years compared to the national average.

Haploidentical Bone Marrow Transplantation in Sickle Cell Patients (BMTCTN1507)

NCT03263559CompletedPhase 2
Medical College of Wisconsin
Posted 10/3/2017

FDA Approves Tafasitamab Triple Combination for Relapsed/Refractory Follicular Lymphoma

Drug ApprovalMonoclonal Antibody
  • The FDA has approved tafasitamab-cxix (Monjuvi) in combination with lenalidomide and rituximab for adult patients with relapsed or refractory follicular lymphoma.
  • The phase 3 inMIND trial demonstrated a median progression-free survival of 22.4 months with the tafasitamab combination versus 13.9 months with placebo plus lenalidomide and rituximab.
  • This approval provides the first CD19- and CD20-targeted immunotherapy combination for this patient population, offering a chemotherapy-free treatment option.
  • Serious adverse effects were reported in 33% of patients receiving tafasitamab, with serious infections occurring in 24% of patients.

Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC

NCT03395197Active, Not RecruitingPhase 3
Pfizer
Posted 12/18/2017

Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome

NCT04401748Active, Not RecruitingPhase 3
AbbVie
Posted 9/10/2020

A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.

NCT04680052Active, Not RecruitingPhase 3
Incyte Corporation
Posted 4/15/2021

Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL

NCT02399085CompletedPhase 2
MorphoSys AG
Posted 3/29/2016

Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

NCT02598661Active, Not RecruitingPhase 2
Geron Corporation
Posted 1/12/2016

Tafasitamab and Zanubrutinib for the Treatment of Patients With Newly Diagnosed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, TaZA CLL Study

NCT05718869RecruitingPhase 2
City of Hope Medical Center
Posted 5/18/2023

MInimal Residual Disease Adapted Strategy

NCT04934475Active, Not RecruitingPhase 3
Intergroupe Francophone du Myelome
Posted 12/8/2021

Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders

NCT06434363RecruitingPhase 1
M.D. Anderson Cancer Center
Posted 7/31/2024

A Study Evaluating Venetoclax in Combination With Azacitidine in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

NCT02942290Active, Not RecruitingPhase 1
AbbVie
Posted 1/12/2017

Eccogene Initiates Phase 1b Trial of Novel Oral GLP-1 Receptor Agonist AZD5004/ECC5004 in China

  • Eccogene has dosed the first patient in a Phase 1b clinical trial of AZD5004/ECC5004, an investigational oral small molecule GLP-1 receptor agonist, in China.
  • The drug is being developed for type 2 diabetes and obesity or overweight with at least one comorbidity, designed as a convenient once-daily oral therapy with no food-related restrictions.
  • AstraZeneca is currently conducting two global Phase 2b trials (VISTA and SOLSTICE) to evaluate the drug's efficacy and safety in obesity and type 2 diabetes patients.
  • The China trial represents a key milestone to support local regulatory requirements, with Eccogene retaining co-development and co-commercialization rights in the region.

Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus.

NCT06579105Active, Not RecruitingPhase 2
AstraZeneca
Posted 10/8/2024

Effects of AZD5004 in Adults Who Are Living With Obesity or Overweight With at Least 1 Weight-related Comorbidity

NCT06579092Active, Not RecruitingPhase 2
AstraZeneca
Posted 10/8/2024

Dapagliflozin Combination Therapy Shows Promise for Adolescents with Type 1 Diabetes in Clinical Trial

Precision Medicine
  • A multicenter clinical trial found that dapagliflozin combined with insulin reduced kidney disease risk and improved health outcomes in 98 adolescents with type 1 diabetes over 16 weeks.
  • The combination therapy demonstrated significant improvements including 8.8 ml/min reduction in glomerular filtration rate, 0.47% decrease in HbA1c, and 2.8 kg weight reduction compared to placebo.
  • Results showed similar safety profiles between treatment groups with only one mild case of diabetic ketoacidosis in the dapagliflozin group, suggesting the therapy could inform new early intervention strategies.
  • The study addresses a critical gap in adolescent diabetes research, as this age group is often underrepresented in clinical trials despite facing unique challenges with hormonal changes and treatment management.

Adolescent Type 1 Diabetes Treatment With SGLT2i for hyperglycEMia & hyPerfilTration Trial

NCT04333823Active, Not RecruitingPhase 3
The Hospital for Sick Children
Posted 12/11/2020

Johnson & Johnson Expands Tecnis Odyssey IOL to Europe, Middle East, and Canada Following US Success

  • Johnson & Johnson has launched the Tecnis Odyssey IOL in Europe, the Middle East, and Canada, expanding access to its presbyopia-correcting intraocular lens technology.
  • The full visual range IOL demonstrates strong patient satisfaction rates, with 94% of patients satisfied with overall vision without glasses and 96% satisfied with smartphone reading.
  • Clinical data shows the Tecnis Odyssey IOL provides two times better contrast in low lighting compared to PanOptix and minimizes night vision disturbances.
  • The launch follows the IOL's successful US introduction in October 2024, where it became the fastest-growing presbyopia-correcting IOL in the market.

Camurus' CAM2029 Shows Significant Liver Volume Reduction in Phase 2b Trial for Rare Polycystic Liver Disease

Rare DiseaseOrphan Drug
  • Camurus' POSITANO Phase 2b study demonstrates that CAM2029 significantly reduces liver volume by 4.3% and liver cyst volume by 8.7% compared to placebo in patients with polycystic liver disease.
  • The 12-month randomized trial enrolled 71 participants and met its primary endpoint with statistical significance, while also showing improvements in disease symptoms and patient-reported outcomes.
  • CAM2029 was well tolerated with a safety profile consistent with approved somatostatin receptor ligands, and Camurus plans to discuss Phase 3 study design with regulatory authorities.
  • The treatment addresses a significant unmet medical need for approximately 37,000 patients in the US and EU who currently have no approved pharmacological treatment options.

A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD

NCT05281328Active, Not RecruitingPhase 2
Camurus AB
Posted 6/28/2022

TOLREMO Therapeutics Strengthens Leadership with Key Appointments as TT125-802 Shows Clinical Promise

  • TOLREMO therapeutics has appointed Alessandra Cesano, MD, PhD, to its Board of Directors and named Florian D. Vogl, MD, PhD, as Chief Medical Officer to strengthen leadership capabilities.
  • The leadership changes follow promising clinical data presentation at ASCO 2025, where TT125-802 demonstrated significant clinical activity as the first CBP/p300 inhibitor to show efficacy in solid tumors.
  • TT125-802 showed rapid, deep and durable objective responses in KRAS-G12C and EGFR-mutant non-small cell lung cancer with a best-in-class safety profile without thrombocytopenia.
  • The company plans to initiate clinical trials evaluating TT125-802 in combination with targeted therapies for advanced tumor indications including EGFR- and KRAS-mutated lung cancer and multiple myeloma.

BrightSpring's Onco360 Pharmacy Selected as National Partner for Three New Cancer and Rare Disease Therapies

OncologyRare DiseaseDrug ApprovalTargeted Therapy
  • BrightSpring Health Services announced that its specialty pharmacy Onco360 has been selected as the national pharmacy partner for three newly approved therapies targeting advanced cancers and rare genetic disorders.
  • The partnership includes GOMEKLI for neurofibromatosis type 1 patients with plexiform neurofibromas, AVMAPKI FAKZYNJA CO-PACK for KRAS-mutated recurrent low-grade serous ovarian cancer, and IBTROZI for ROS1-positive non-small cell lung cancer.
  • Onco360 will provide comprehensive patient support including access, education, data management, and expert clinical guidance for these innovative treatments across all 50 states.

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