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German Radiopharmaceutical Biotech ITM Secures $262.5M Debt Financing to Advance Cancer Treatment Technologies

Oncology
  • ITM Isotope Technologies Munich SE, a German radiopharmaceutical biotech company, has announced a major debt financing agreement worth $262.5 million.
  • The funding will support the company's development of radiopharmaceutical technologies aimed at shaping the future of cancer treatment.
  • This significant investment highlights the growing interest in radiopharmaceutical approaches for oncology applications.
  • The financing represents a substantial capital injection for the German biotech sector and radiopharmaceutical development.

Pimicotinib Achieves 54% Response Rate in Phase 3 Trial for Rare Joint Tumor

Rare DiseaseOncology
  • Pimicotinib demonstrated a statistically significant 54.0% objective response rate versus 3.2% for placebo in the global Phase 3 MANEUVER trial for tenosynovial giant cell tumor.
  • The CSF-1R inhibitor met all five secondary endpoints, showing clinically meaningful improvements in pain, stiffness, range of motion, and physical function.
  • Nearly two-thirds of patients experienced at least 50% reduction in tumor volume, with treatment well-tolerated and low discontinuation rates.
  • Results represent the highest response rate achieved to date with systemic therapy for TGCT, with regulatory submissions planned to begin this year.

Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)

NCT05804045Active, Not RecruitingPhase 3
Abbisko Therapeutics Co, Ltd
Posted 4/27/2023

Portal Access Secures $7M Series A to Advance Next-Generation Chemotherapy Port Through FDA Approval

OncologyFDA Approval
  • Portal Access, Inc. closed a $7 million Series A financing round with over 80% led by U.S. physician investors to support FDA approval of its Flexi-Port™ SLF-TANL™ device.
  • The novel subcutaneous port features self-tunneling technology designed to simplify vascular access for oncology patients and enable bedside or outpatient placement.
  • Despite being standard of care, nearly half of cancer patients do not receive chemo-ports due to various delays, highlighting the unmet need this device aims to address.
  • The company plans 510(k) submission in July 2025 with anticipated U.S. market launch in early 2026.

Apotex Launches First Generic Nilotinib in US with 180-Day Market Exclusivity

Oncology
  • Apotex Corp. announced the launch of nilotinib capsules, the first generic version of Tasigna® in the United States, with 180 days of market exclusivity.
  • The kinase inhibitor is indicated for treating Philadelphia chromosome positive chronic myeloid leukemia in adults and children aged 1 year and older.
  • The generic launch aims to improve patient access to this critical leukemia treatment by providing a more affordable alternative to the brand-name medication.
  • Nilotinib demonstrates higher efficacy compared with other available treatments for patients with resistance or intolerance to prior therapy.

Phanes Therapeutics Doses First Patient with Anti-CD73 Antibody Mavrostobart in Combination Therapy Trial

Monoclonal AntibodyOncology
  • Phanes Therapeutics has dosed the first patient in a clinical study evaluating mavrostobart (PT199), an anti-CD73 monoclonal antibody, in combination with chemotherapy.
  • Mavrostobart demonstrates complete inhibition of both soluble and membrane-bound CD73 enzyme activities without hook effect at higher concentrations, addressing limitations of current CD73 inhibitors.
  • The multi-center Phase I/II MORNINGSTAR study is evaluating mavrostobart's safety, tolerability, pharmacokinetics and preliminary efficacy alone and in combination with PD-1 inhibitors or chemotherapy.
  • The company is leveraging proprietary technology platforms to develop novel biologics addressing unmet medical needs in cancer treatment.

Dose Escalation/Expansion Study of Mavrostobart (PT199), an Anti-CD73 MAb, Administered Alone and in Combination with a PD-1 Inhibitor or Chemotherapy (the MORNINGSTAR Study)

NCT05431270RecruitingPhase 1
Phanes Therapeutics
Posted 8/11/2022

ADC Market in NSCLC Projected to Reach $3.9 Billion by 2032, Led by AstraZeneca's Datroway

OncologyTargeted Therapy
  • The antibody-drug conjugate (ADC) market in non-small-cell lung cancer is projected to grow at a 6.8% CAGR across seven major markets and exceed $3.9 billion by 2032.
  • AstraZeneca and Daiichi Sankyo's Datroway is expected to dominate the market with over 32.6% market share, generating more than $1.2 billion by 2032.
  • The ADC pipeline in NSCLC remains active with 29 ongoing Phase III trials, as companies increasingly focus on first-line and early disease settings.
  • Manufacturing capacity expansions by Lonza and AstraZeneca are underway to meet rising ADC demand, with facilities expected operational by 2028-2029.

World ADC San Diego Conference Highlights Growing Industry Focus on Antibody-Drug Conjugates

OncologyDrug Approval
  • The 15th World ADC San Diego conference (November 4-7, 2024) represents the industry's largest and most comprehensive ADC-focused forum, featuring 120+ speakers across six development tracks.
  • Recent ADC breakthroughs include Enhertu's tumor-agnostic accelerated approval and practice-changing combination results from PADCEV, driving unprecedented industry attention.
  • Major pharmaceutical companies including Pfizer, AbbVie, J&J, Merck, and others have engaged in billion-dollar ADC partnerships and acquisitions, positioning ADCs at the forefront of oncology R&D.
  • The conference addresses end-to-end ADC development challenges from discovery to manufacturing, reflecting the field's evolution toward front-line cancer treatments.

Chengdu UCELLO Biotech's UC101 Becomes First Allogeneic Universal CAR-T Therapy to Receive FDA IND Approval

CAR-TOncology
  • Chengdu UCELLO Biotech's CD19-targeted allogeneic universal CAR-T therapy UC101 received FDA IND approval on January 11, 2025, marking a historic milestone as the first such product worldwide.
  • The therapy represents a significant advancement in CAR-T technology by utilizing allogeneic universal T cells rather than patient-specific autologous cells, potentially reducing manufacturing time and costs.
  • Challenge IM provided critical ultrafiltration technology and automated cross-flow filtration systems to support UC101's manufacturing processes, demonstrating the importance of specialized bioprocessing equipment in cell therapy development.

Onco-Innovations Initiates Manufacturing of PNKP Inhibitor for Preclinical Testing

OncologyTargeted Therapy
  • Onco-Innovations has partnered with Dalton Pharma Services to begin manufacturing 50 grams of their proprietary PNKP inhibitor A83B4C63 for preclinical testing.
  • The nanoparticle-formulated inhibitor previously demonstrated significant survival benefits in colorectal cancer models, extending median survival from 23 to 60 days in PTEN-deficient mice.
  • This manufacturing milestone represents a critical transition from early research to production scale-up, supporting the company's planned IND submission to the FDA this year.

Eli Lilly Acquires Scorpion's Cancer Drug STX-478 in $2.5 Billion Deal

Targeted TherapyOncology
  • Eli Lilly has entered into a $2.5 billion agreement to acquire STX-478, an experimental oral PI3K alpha inhibitor from Scorpion Therapeutics for breast cancer and other solid tumors.
  • STX-478 is currently in phase 1/2 trials for hormone receptor-positive, HER2-negative breast cancer and could potentially address 30%-40% of people with HR-positive breast cancer.
  • The deal includes an upfront payment plus regulatory and commercial milestones, while Scorpion will spin off its remaining pipeline assets into a new independent company.
  • This acquisition expands Lilly's oncology portfolio following its $8 billion Loxo Oncology acquisition in 2019 and represents the company's renewed focus on PI3K inhibitors after abandoning LOXO-783 last year.

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