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Alvotech Secures Japanese Approval for Three Biosimilars Including First Global Golimumab Biosimilar

Drug ApprovalMonoclonal AntibodyOncology
  • Alvotech's partner Fuji Pharma received Japanese regulatory approval for three biosimilars: AVT03 (denosumab), AVT05 (golimumab), and AVT06 (aflibercept) from the Ministry of Health, Labor and Welfare.
  • AVT05 represents the first golimumab biosimilar approved for sale in major global markets, marking a significant milestone in biosimilar development.
  • The approvals expand treatment access for multiple conditions including bone lesions, rheumatoid arthritis, and various eye disorders in the Japanese market.
  • This achievement builds on Alvotech and Fuji Pharma's successful partnership, which previously launched Japan's first Stelara biosimilar in May 2024.

Advanced Drug Delivery Technologies Drive Biotech Innovation as Nanomedicine Market Approaches $430 Billion

Oncology
  • The global nanomedicine market is projected to grow from approximately $245 billion in 2023 to over $430 billion by 2028, driven by increasing adoption in oncology, neurology, and regenerative medicine.
  • Four biotech companies are advancing cutting-edge delivery platforms: Medicus Pharma's microneedle patches for skin cancer, Nanobiotix's radioenhancing nanoparticles, Avidity's antibody-oligonucleotide conjugates for rare diseases, and Arrowhead's multi-tissue RNA interference platform.
  • These next-generation delivery systems address traditional limitations of oral, intravenous, and subcutaneous administration by improving therapeutic precision, reducing side effects, and enabling targeted drug delivery to previously inaccessible tissues.
  • Multiple companies have achieved significant clinical milestones, including FDA Fast Track designations, European CE marks, and positive Phase 2 trial results, positioning the sector for potential commercial breakthroughs.

Immuto Scientific Secures $8M Funding and Daiichi Sankyo Partnership to Advance AI-Driven Cancer Target Discovery

AIOncology
  • Immuto Scientific closed an oversubscribed $8 million Seed 2 financing round led by DYDX to advance its AI-enabled structural surfaceomics platform for drug discovery.
  • The company announced a collaboration with Daiichi Sankyo to discover new cancer-specific cell-surface targets in solid tumors using proprietary structural proteomics technology.
  • Immuto's platform identifies disease-specific surface protein conformations invisible to conventional omics approaches, potentially enabling development of first-in-class therapies with improved selectivity.
  • The funding will support advancement of the company's internal oncology pipeline toward IND-enabling studies and platform expansion into immunology and inflammation.

Portuguese Startup Mondego Bio Secures Series A Funding to Develop Novel PTPN2 Inhibitors for Cancer Immunotherapy

Oncology
  • Mondego Bio, a Portuguese biotech startup, has secured Series A funding led by Biovance Capital Partners alongside OrbiMed and Torrey Pines Investment to develop PTPN2 inhibitors for cancer treatment.
  • The company is developing best-in-class protein tyrosine phosphatase non-receptor type 2 (PTPN2) inhibitors that could improve cancer immunotherapy efficacy with enhanced safety profiles.
  • PTPN2 functions as a critical negative regulator of the JAK-STAT pathway, and its inhibition represents a potential therapeutic strategy to enhance interferon-gamma signaling in cancer immunotherapy.
  • This investment marks the inaugural funding from Biovance Capital Fund I, which manages €57 million to support early-stage drug development companies across Europe.

Rgenta Therapeutics Receives FDA Orphan Drug Designation for RGT-61159 in Adenoid Cystic Carcinoma Treatment

OncologyRare Disease
  • The FDA has granted Orphan Drug Designation to RGT-61159, an oral small molecule inhibitor targeting the MYB oncogene through RNA splicing modulation for adenoid cystic carcinoma treatment.
  • RGT-61159 is currently being evaluated in a Phase 1a/b clinical trial for patients with advanced relapsed or refractory adenoid cystic carcinoma or colorectal cancer.
  • The designation provides significant regulatory benefits including tax credits, fee waivers, and seven years of market exclusivity if approved.
  • Adenoid cystic carcinoma affects approximately 11,000 people in the US and has limited treatment options, with MYB overexpression found in over 90% of cases.

Study of Safety and Efficacy of RGT-61159 in Adults with Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)

NCT06462183RecruitingPhase 1
Rgenta Therapeutics Inc
Posted 8/19/2024

GSK Commits $30 Billion U.S. Investment to Advance Respiratory and Cancer Medicine Manufacturing

OncologyAI
  • GSK announced a $30 billion investment across the United States over five years, focusing on research and development and supply chain infrastructure to strengthen life sciences capabilities.
  • The investment includes $1.2 billion for advanced manufacturing facilities and AI technologies, featuring a new biologics flex factory in Pennsylvania targeting respiratory diseases and cancer treatments.
  • Construction of the Upper Merion facility will commence in 2026, designed to produce next-generation medicines for COPD, asthma, and various cancer types including hematological and solid tumors.
  • The initiative will create hundreds of highly skilled jobs and positions the U.S. as GSK's top global location for clinical trials and research studies over the next five years.

UTR Therapeutics Publishes Preclinical Data for First-in-Class c-MYC RNA Therapeutic UTRxM1-18

Oncology
  • UTR Therapeutics published peer-reviewed preclinical data in Frontiers in Pharmacology demonstrating UTRxM1-18 achieved 100% complete pathological responses and significant metastasis inhibition in pancreatic cancer models.
  • The first-in-class RNA therapeutic directly destabilizes c-MYC mRNA through engineered 3'UTR elements and is delivered via proprietary iron-oxide nanocages with a serum half-life exceeding 24 hours.
  • The company filed an IND submission with the FDA in May 2025 and plans to initiate Phase 1 trials in patients with advanced c-MYC-driven tumors pending regulatory approval.
  • UTRxM1-18 demonstrated a favorable safety profile with no significant systemic toxicities across preclinical studies, supporting its therapeutic window for targeting the previously "undruggable" c-MYC protein.

FDA Grants Fast Track Designation to CRB-701 ADC for Recurrent Head and Neck Cancer

Oncology
  • The FDA has granted fast track designation to CRB-701, a next-generation antibody-drug conjugate targeting Nectin-4, for patients with recurrent or metastatic head and neck squamous cell carcinoma who have progressed after platinum-based chemotherapy and anti-PD(L)-1 therapy.
  • Early data from an ongoing phase 1/2 trial showed promising efficacy with a 57% objective response rate and 86% disease control rate among head and neck cancer patients who underwent response evaluations.
  • This marks the second fast track designation for CRB-701, following a previous designation for relapsed or refractory metastatic cervical cancer in 2024.
  • The designation is supported by data from the ongoing phase 1/2 study evaluating CRB-701 in solid tumors with high Nectin-4 expression, with results to be presented at the 2025 ESMO Congress.

A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors

NCT06265727RecruitingPhase 1
Corbus Pharmaceuticals Inc.
Posted 4/1/2024

Lilly Commits $5 Billion to Virginia Manufacturing Facility for Bioconjugate and ADC Production

Monoclonal AntibodyOncology
  • Eli Lilly announces plans to build a $5 billion manufacturing facility in Virginia's Goochland County, marking the company's first dedicated bioconjugate platform and monoclonal antibody production site.
  • The facility will focus on manufacturing antibody-drug conjugates (ADCs) and active pharmaceutical ingredients for cancer, autoimmune, and other advanced therapies.
  • The project will create 650 high-paying manufacturing jobs and 1,800 construction positions, representing the first of four new U.S. manufacturing sites Lilly plans to announce this year.
  • Expected completion within five years, the facility is part of Lilly's $50 billion U.S. capital expansion commitment since 2020 and will incorporate advanced technologies including AI and machine learning.

Henlius Biotech in Advanced Licensing Talks with J&J and Roche for Experimental Cancer Drug

Oncology
  • Shanghai Henlius Biotech is negotiating with pharmaceutical giants Johnson & Johnson and Roche to sell rights to an experimental cancer drug.
  • The potential agreement could generate at least several hundred million dollars upfront for the Fosun subsidiary, with additional milestone payments based on drug performance.
  • Negotiations remain ongoing as Henlius seeks to maximize the deal value while discussions with multiple multinational pharmaceutical companies continue.

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