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Clinical Trial News

Rakovina Therapeutics and NanoPalm Form Joint Venture to Advance AI-Discovered Cancer Drug kt-3283

AIOncology
  • Rakovina Therapeutics and Saudi-based NanoPalm have signed a non-binding Letter of Intent to form a joint venture focused on developing AI-discovered oncology therapeutics using advanced lipid nanoparticle delivery systems.
  • The collaboration will initially focus on kt-3283, a dual PARP-HDAC inhibitor that has demonstrated enhanced cytotoxicity in preclinical models of Ewing sarcoma, breast cancer, and ovarian cancer compared to currently approved inhibitors.
  • The joint venture will be domiciled in Saudi Arabia with global development rights, combining Rakovina's AI-powered drug discovery platform with NanoPalm's precision patterned lipid nanoparticle technology.
  • This partnership represents the first pLNP-oncology-focused biotech venture co-founded in Saudi Arabia, aligning with the Kingdom's National Biotechnology Strategy for local biotech development.

Bayer Partners with Kumquat Biosciences in $1.3 Billion Deal to Develop KRAS G12D Inhibitor for Hard-to-Treat Cancers

Targeted Therapy
  • Bayer and Kumquat Biosciences announced an exclusive global license and collaboration worth up to $1.3 billion to develop a KRAS G12D inhibitor targeting pancreatic, colorectal, and lung cancers.
  • The KRAS G12D mutation is found in 37% of pancreatic ductal adenocarcinoma cases, 13% of colorectal cancers, and 4% of non-small cell lung cancers, yet lacks effective treatment options despite occurring in nearly 25% of human cancers.
  • Kumquat received FDA clearance for its investigational new drug in July 2025 and will complete Phase Ia studies, while Bayer handles subsequent development and commercialization activities.
  • The collaboration addresses a critical unmet medical need in pancreatic cancer, which has a five-year survival rate of less than 10% and is projected to see a 95.4% increase in new cases by 2050.

A Study of ASP3082 in Adults With Advanced Solid Tumors

NCT05382559RecruitingPhase 1
Astellas Pharma Inc
Posted 6/8/2022

Study of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation

NCT05737706TerminatedPhase 1
Mirati Therapeutics Inc.
Posted 3/6/2023

Lupin Partners with Sandoz to Commercialize Ranibizumab Biosimilar Across Multiple Global Markets

Monoclonal Antibody
  • Lupin Limited has entered into a strategic partnership with Sandoz Group AG to commercialize its biosimilar ranibizumab across the European Union, Switzerland, Norway, Australia, Hong Kong, Vietnam, and Malaysia.
  • Under the agreement, Sandoz will handle commercialization while Lupin maintains responsibility for manufacturing and regulatory submissions, with Sandoz holding exclusive marketing rights in most markets except France, Australia, Vietnam, and Malaysia.
  • The biosimilar ranibizumab targets multiple retinal conditions including neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion-related macular edema.
  • A separate agreement grants Sandoz sole commercialization rights for the biosimilar in Canada, expanding the partnership's global reach for this VEGF-A inhibitor therapy.

Pfizer's Padcev-Keytruda Combination Shows Significant Survival Benefit in Muscle-Invasive Bladder Cancer Trial

  • Pfizer's Padcev combined with Merck's Keytruda significantly improved event-free survival and overall survival in muscle-invasive bladder cancer patients when administered before and after surgery compared to surgery alone.
  • The interim results from an ongoing late-stage trial demonstrate the practice-changing potential of this combination therapy in earlier stages of bladder cancer treatment.
  • Muscle-invasive bladder cancer accounts for about 25% of all newly diagnosed bladder cancers and represents a particularly aggressive form with high risk of spreading.
  • Pfizer plans to discuss the trial results with global health authorities for potential regulatory filings, building on Padcev's existing FDA approval for metastatic urothelial cancer.

Amphastar Pharmaceuticals Expands Pipeline with $453 Million Licensing Deal for Three Novel Peptide Therapeutics

Oncology
  • Amphastar Pharmaceuticals has entered into an exclusive licensing agreement with Nanjing Anji Biotechnology for three proprietary peptide therapeutics targeting oncology and ophthalmology indications in the US and Canada.
  • The deal includes an endogenous peptide for cancer growth suppression, a peptide-docetaxel conjugate designed to reduce toxicity, and an anti-VEGFR peptide eye drop for wet age-related macular degeneration.
  • The agreement involves $6 million in upfront payments and potential milestone payments totaling up to $453 million, with 5% royalties on net sales capped at $60 million per product.
  • The licensing terms extend for ten years from first commercial sale with potential extension for an additional decade, strengthening Amphastar's proprietary peptide pipeline.

PureTech Health Launches Celea Therapeutics to Advance Phase 3-Ready IPF Treatment

Rare Disease
  • PureTech Health has launched Celea Therapeutics as a new subsidiary focused on respiratory diseases, with deupirfenidone (LYT-100) as its lead Phase 3-ready candidate for idiopathic pulmonary fibrosis.
  • Former Teva North America CEO Sven Dethlefs will lead Celea, bringing over 25 years of pharmaceutical experience including successful launches of deuterated medicines like AUSTEDO.
  • Deupirfenidone demonstrated potential to stabilize lung function decline over 26 weeks in Phase 2b trials while maintaining favorable safety and tolerability compared to current IPF treatments.
  • The company plans to initiate Phase 3 testing by the end of Q3 2025 following FDA discussions and is seeking external funding for development through commercialization.

LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

NCT05321420Active, Not RecruitingPhase 2
PureTech
Posted 7/22/2022

Panthera Biopartners Secures Major Investment from LDC to Expand UK's Largest Clinical Trial SMO Network

  • Panthera Biopartners, the UK's largest Site Management Organisation for commercial clinical trials, has secured investment from private equity firm LDC to accelerate expansion plans.
  • The company achieved remarkable growth with revenue increasing by more than 200% since 2022, while serving eight of the 12 largest pharmaceutical companies.
  • In 2024, Panthera was the top global recruiter in four international clinical studies and had the first patient recruited in nine trials globally or within the UK.
  • The investment will support expansion into Europe, increase clinical sites beyond the current six UK locations, and enhance technology capabilities for trial delivery.

MMJ BioPharma Files Emergency Motion to DEA as Trump Signals Openness to Medical Cannabis

Orphan Drug
  • MMJ BioPharma Cultivation filed an emergency motion to DEA Administrator Terry Cole seeking immediate approval of its seven-year-delayed application to manufacture pharmaceutical-grade cannabis for FDA clinical trials.
  • The company holds FDA Orphan Drug Designations and has filed Investigational New Drug applications for cannabis-based treatments targeting Huntington's disease and Multiple Sclerosis.
  • President Trump acknowledged the medical benefits of marijuana and announced a reclassification decision could come within the next few weeks.
  • MMJ's GMP-compliant approach aligns with federal law and operates separately from the recreational cannabis industry, addressing the balance between public safety and legitimate medical need.

Fosun Pharma Secures $645 Million Global Licensing Deal for Novel DPP-1 Inhibitor XH-S004

  • Fosun Pharma has signed a licensing agreement with Expedition Therapeutics for XH-S004, a novel oral DPP-1 inhibitor, worth up to $645 million in total payments.
  • XH-S004 is currently in Phase II trials for non-cystic fibrosis bronchiectasis and Phase 1b trials for COPD, representing the first small molecule oral inhibitor with this mechanism of action.
  • The drug targets neutrophilic inflammation by inhibiting DPP-1 and associated neutrophil serine proteases, addressing significant unmet medical needs in chronic respiratory diseases.
  • Expedition will gain global development and commercialization rights outside of China, Hong Kong, and Macau, with Fosun retaining rights in these territories.

Sana Biotechnology Reports Breakthrough in Type 1 Diabetes Cell Therapy with 6-Month Clinical Data

CAR-T
  • Sana Biotechnology presented positive 6-month clinical results showing hypoimmune-modified pancreatic islet cells survived and functioned without immunosuppression in type 1 diabetes patients.
  • The New England Journal of Medicine published the company's 12-week clinical results, demonstrating stable C-peptide production and successful immune evasion.
  • The company raised $105 million in new capital and expects to file investigational new drug applications for SC451 and SG299 as early as 2026.
  • Clinical data from ongoing GLEAM and VIVID trials evaluating allogeneic CAR T cell therapies are expected to be reported in 2025.

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