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Clinical Trial News

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

CSPC Pharmaceutical Secures NMPA Approval for Dupixent in COPD, Marking First Biologic Treatment for China's 65 Million Patients

Drug ApprovalMonoclonal Antibody
  • CSPC Pharmaceutical Group received NMPA approval for Dupixent (dupilumab) on September 27, 2024, making it the first biologic therapy for chronic obstructive pulmonary disease in China's market of 65 million diagnosed patients.
  • Phase 3 trials BOREAS and NOTUS demonstrated that Dupixent achieved 30-34% reductions in COPD exacerbations and significant improvements in lung function and quality of life for patients with type 2 inflammation-driven disease.
  • The approval positions CSPC as exclusive partner for Dupixent in China through collaboration with Regeneron and Sanofi, targeting a $15 billion COPD market where 80% of patients experience repeated exacerbations despite standard therapies.
  • CSPC's strategic approach includes developing a dupilumab biosimilar for atopic dermatitis while leveraging the established COPD franchise, creating cross-promotional opportunities within China's rapidly growing biologics sector.

Lundbeck's Lu AG13909 Receives Orphan Drug Designation for Congenital Adrenal Hyperplasia Treatment

Monoclonal AntibodyRare Disease
  • Lundbeck received orphan drug designation from both the FDA and EMA for Lu AG13909, a novel humanized monoclonal antibody targeting ACTH for congenital adrenal hyperplasia treatment.
  • The first-in-class anti-ACTH antibody represents an innovative therapeutic approach for CAH, a rare genetic disorder affecting approximately 1 in 14,000-18,000 live births worldwide.
  • An expanded Phase I/II clinical trial is currently enrolling adults with classic CAH across North America and seven European countries, with monthly intravenous dosing.
  • Animal studies demonstrated significant and durable reductions in corticosterone/cortisol and aldosterone levels with no adverse effects after six months of treatment.

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