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Clinical Trial News

iMDx Digital PCR Platform Shows Equivalent Performance to NGS in Kidney Transplant Rejection Testing

  • iMDx's digital PCR-based GraftAssureIQ test demonstrated equivalent donor-derived cell-free DNA measurements compared to next-generation sequencing platforms in a head-to-head study of 96 kidney transplant recipients.
  • The University Hospital Heidelberg study represents the first direct comparison of two commercially available dd-cfDNA test kits based on single nucleotide polymorphisms, with digital PCR showing improved analytical sensitivity for detecting low-quantity dd-cfDNA.
  • Results support iMDx's preparation for commercial launch following expected regulatory approval next year, targeting the estimated $1 billion transplant rejection testing market.
  • Extended study data will be presented at the European Society of Organ Transplantation Congress in London from June 29 to July 2, 2025.

Bio-Techne Partners with USP to Enhance Quality Standards for Monoclonal Antibody and Gene Therapy Development

Monoclonal Antibody
  • Bio-Techne Corporation announced a distribution agreement with the U.S. Pharmacopeia (USP) to sell monoclonal antibody and AAV reference standards alongside its analytical solutions globally.
  • The collaboration addresses critical quality challenges in biotherapeutic development, particularly as more than 160 antibody therapies have been approved worldwide and biosimilar competition increases.
  • Gene therapy represents one of the fastest-growing biopharmaceutical sectors, offering cures for previously incurable genetic diseases despite facing development challenges including low yields and analytical complexities.
  • The partnership combines USP's well-characterized reference standards with Bio-Techne's MauriceFlex analytical system to provide integrated characterization solutions for complex biologics from development through product release.

OutSee Secures £1.8M Seed Funding to Advance AI-Powered Genomics Platform for Drug Discovery

AIDrug Discovery
  • Cambridge-based OutSee raised £1.8M in seed funding led by Ahren Innovation Capital to advance its proprietary AI platform Nomaly for predictive genomics drug discovery.
  • The company's Nomaly technology uses hypothesis-free modeling to predict disease and phenotype directly from single genomes, enabling target discovery from smaller datasets previously considered too complex to interpret.
  • OutSee plans to expand its in-house target pipeline focusing on CNS disorders, rare diseases, and metabolic conditions while establishing partnerships with major pharmaceutical and biotech companies.
  • The funding builds on over £500K in Innovate UK grants and partnerships with Genomics England and FinnGen, positioning the company to transform therapeutic target identification.

Sterotherapeutics Doses First Patient in Phase 2 Trial of ST-002 for Cushing's Syndrome

Orphan DrugRare Disease
  • Sterotherapeutics has successfully dosed the first patient in its Phase 2 clinical trial evaluating ST-002 for Cushing's Syndrome treatment.
  • The multicenter European study aims to assess safety, efficacy, and tolerability of ST-002 in patients with this rare endocrine condition caused by chronic excess cortisol exposure.
  • ST-002 has received FDA Orphan Drug Designation and addresses a significant unmet medical need, as no universally effective treatment currently exists for Cushing's Syndrome.
  • The trial will evaluate complications including diabetes and MASLD using magnetic resonance imaging and targeted measurements across multiple European sites.

Bayer Extends 16-Year Research Partnership with Tsinghua University for Three More Years

Drug DiscoveryOncology
  • Bayer and Tsinghua University have extended their strategic research collaboration by three additional years, building on a 16-year partnership that has produced over 70 joint research projects and more than 10 publications in top international journals.
  • The extended agreement focuses on joint research targeting oncology, cardiovascular and renal diseases, neurology, rare diseases, and immunology, reinforcing Bayer's commitment to healthcare innovation in China's rapidly evolving pharmaceutical market.
  • The partnership has established a benchmark for collaboration between multinational pharmaceutical companies and Chinese academic institutions, with Bayer conducting more than 80% of its major multi-center clinical trials in China.
  • Bayer's broader China strategy includes two global R&D centers, four production facilities, and the recent launch of Bayer Co.Lab China, which aims to incubate 10-15 biotech startups focusing on cutting-edge therapeutic innovations.

Revolution Medicines Secures $2 Billion Funding Deal with Royalty Pharma for RAS Cancer Drug Development

Targeted TherapyOncology
  • Revolution Medicines partnered with Royalty Pharma on a $2 billion flexible funding agreement to support global development and commercialization of its RAS(ON) inhibitor portfolio for cancer treatment.
  • The funding comprises up to $1.25 billion in synthetic royalty monetization on daraxonrasib sales and up to $750 million in corporate debt, with $1.25 billion available at the company's discretion.
  • Revolution Medicines retains full strategic control of product development and commercialization while removing its cash runway guidance, enabling independent global operations.
  • The agreement includes milestone-based payments tied to FDA approval and sales targets, with royalty rates decreasing as sales increase and reaching zero above $8 billion annually.

BrightGene's Dual GLP-1R/GIPR Agonist BGM0504 Shows Superior Efficacy to Semaglutide in Phase 2 Diabetes Trial

  • BrightGene's dual GLP-1R/GIPR agonist BGM0504 demonstrated superior HbA1c reduction compared to semaglutide in a Phase 2 type 2 diabetes study, with the 15mg dose achieving -2.48% reduction versus -1.43% for semaglutide at Week 12.
  • The Phase 2 obesity study showed significant weight reductions ranging from -10.77% to -19.78% with BGM0504 treatment, along with meaningful improvements in waist circumference and blood pressure parameters.
  • Preclinical data for BGM1812, a novel amylin analog, revealed 1.8× and 2.2× increased receptor activation compared to petrelintide, with potential for once-weekly oral administration and synergistic effects when combined with dual agonists.

Sonrai Analytics Partners with Plectonic Biotech to Advance AI-Driven Logic-Gated Antibody Cancer Immunotherapies

AIPrecision Medicine
  • Belfast-based AI specialist Sonrai Analytics has partnered with German biotech Plectonic Biotech to accelerate development of logic-gated antibody immunotherapy technology across multiple cancer types.
  • The collaboration will leverage Sonrai's AI-driven multi-modal approach integrating single-cell RNA sequencing with proteomic mass spectrometry to identify ultra-specific antigen combinations for tumor targeting.
  • Plectonic's proprietary Logibody technology acts as a molecular switch that triggers antibody-mediated immune responses only in the presence of specific tumor antigens, aiming to increase treatment precision while reducing toxicity.
  • The partnership combines Sonrai's advanced data science capabilities with Plectonic's DNA nanotechnology to fast-track development and accelerate the path to clinical trials.

Glenmark Launches Tevimbra, First Immuno-Oncology Drug in India for Lung and Esophageal Cancer Treatment

Monoclonal AntibodyDrug ApprovalOncology
  • Glenmark Pharmaceuticals has launched Tevimbra (tislelizumab), marking the company's first entry into immuno-oncology in India following CDSCO approval.
  • The anti-PD-1 monoclonal antibody is indicated for first-line treatment of locally advanced or metastatic NSCLC in combination with chemotherapy and second-line treatment as monotherapy.
  • Tevimbra is already approved in 46 countries including the US and EU, with over 1.5 million patients treated globally and worldwide sales of $625 million in 2024.
  • The drug targets NSCLC, which represents over 80% of lung cancer cases, and ESCC, the most common esophageal cancer subtype in India.

Zambon Secures Chinese Approval for Intravenous Fluimucil Following Successful Phase 3 Trial

Drug Approval
  • Zambon has received Chinese regulatory approval and launched the intravenous formulation of Fluimucil (N-acetylcysteine) for treating respiratory diseases with excessive mucus secretion.
  • A pivotal Phase 3 trial involving 333 patients across 28 Chinese hospitals demonstrated that IV Fluimucil was significantly superior to placebo and non-inferior to ambroxol in reducing sputum viscosity.
  • The approval follows a robust local clinical development program including Phase 1 and Phase 3 studies that confirmed the drug's safety, tolerability, and efficacy profile.
  • The launch marks Zambon's expansion in the Chinese market and celebrates the 60th anniversary of the Fluimucil molecule.

A Study to Evaluate Pharmacokinetics, Safety and Tolerability of Single and Multiple Intravenous Doses of N-acetylcysteine (NAC) in Chinese Healthy Volunteers

NCT03881163CompletedPhase 1
Zambon SpA
Posted 11/11/2019

A Clinical Trial to Compare the Efficacy and Safety of 1-week Treatment of Intravenous N-acetylcysteine (NAC) 600 mg Twice Daily, Ambroxol Hydrochloride 30 mg Twice Daily and Placebo as Expectorant Therapies in Adult Chinese Patients With Respiratory Tract Diseases and Abnormal Mucus Secretions

NCT03843541CompletedPhase 3
Zambon SpA
Posted 6/25/2019

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