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FDA's ODAC to Review Four Cancer Drugs in May Meeting

Oncology
  • The FDA has scheduled a two-day meeting of its Oncologic Drugs Advisory Committee (ODAC) in May to review four different cancer therapies.
  • The ODAC meeting represents a significant regulatory milestone for the cancer drugs under review, potentially impacting their approval pathways and availability to patients.
  • Following the oncology reviews, the FDA's Vaccines and Related Biological Products Advisory Committee will evaluate COVID-19 vaccine formulations for the 2025-2026 season.

Algorae Pharmaceuticals Partners with Peter MacCallum Cancer Centre to Validate AI-Predicted Drug Combinations

AIDrug DiscoveryOncology
  • Algorae Pharmaceuticals has partnered with the Victorian Centre for Functional Genomics at Peter MacCallum Cancer Centre to validate AI-predicted drug synergies using high-throughput screening technology.
  • The collaboration will test 24 drug candidates, including 21 AI-generated compounds, across four cancer cell lines: glioblastoma, pancreatic ductal adenocarcinoma, invasive breast carcinoma, and prostate carcinoma.
  • Full dataset from the screening program is expected within six months, with successful validation potentially accelerating regulatory pathways and creating opportunities for pharmaceutical partnerships.

China's Rising Influence in Global Drug Development: Bridging Studies Transform US Clinical Research

Oncology
  • China has emerged as a significant player in global drug development, accounting for 23% of global drug candidates in 2024, creating new pathways for translational research in the US.
  • Chinese biotech companies can progress from launch to first-in-human data in just 18 months compared to several years in the US, raising questions about transcontinental applicability of clinical data.
  • Innovative "bridging studies" are becoming crucial for demonstrating the translatability of China-developed drugs to Western populations, requiring diverse patient enrollment and pharmacokinetic similarities across ethnic groups.

A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy (Carboplatin- Etoposide) in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

NCT04063163Unknown StatusPhase 3
Shanghai Henlius Biotech
Posted 9/12/2019

To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC

NCT05468489RecruitingPhase 3
Shanghai Henlius Biotech
Posted 11/18/2022

A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors

NCT06115642RecruitingPhase 1
Shanghai Henlius Biotech
Posted 11/24/2023

A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy (Carboplatin-Nanoparticle Albumin Bound (Nab) Paclitaxel) in Patients With Stage IIIB/IIIC or IV NSCLC

NCT04033354Active, Not RecruitingPhase 3
Shanghai Henlius Biotech
Posted 8/14/2019

A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)

NCT06907615RecruitingPhase 2
Shanghai Henlius Biotech
Posted 6/9/2025

TuHURA Biosciences Initiates Phase 1b/2a Trial of IFx-Hu2.0 for Deep-Seated Merkel Cell Carcinoma

OncologyRare Disease
  • TuHURA Biosciences has launched a phase 1b/2a trial evaluating IFx-Hu2.0 combined with pembrolizumab in patients with noncutaneous Merkel cell carcinoma of unknown primary origin.
  • The study targets up to 30% of MCC patients who present without primary skin lesions, focusing on deep-seated tumors in liver, lungs, or retroperitoneum.
  • IFx-Hu2.0 is designed to overcome primary resistance to checkpoint inhibitors and has shown systemic antitumor immune responses in previous trials.
  • Initial data from the 9-patient multicenter trial are expected in late 2025 or early 2026, with potential expansion to other cancer types if successful.

Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma

NCT06947928Not Yet RecruitingPhase 2
TuHURA Biosciences, Inc.
Posted 6/30/2025

IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Advanced Or Metastatic Merkel Cell Carcinoma (MCC)

NCT06940440Not Yet RecruitingPhase 1
TuHURA Biosciences, Inc.
Posted 4/30/2025

Mana.bio Unveils AI-Driven Advances in RNA Delivery at ASGCT 2025

AIOncology
  • Mana.bio presented three posters at ASGCT 2025 showcasing their machine learning platform for designing lipid nanoparticles with improved safety and tissue specificity for RNA therapeutics.
  • The company demonstrated significant progress in developing precision RNA therapies targeting T-cells and lung tissue, addressing key challenges in extra-hepatic RNA delivery.
  • By combining public and laboratory-generated data, Mana.bio's AI models can predict critical LNP attributes including physiochemical properties, tissue specificity, and in-vivo safety profiles.

Targeted Radiopharmaceuticals Summit Returns to Europe and US as Industry Momentum Builds

Targeted TherapyOncology
  • The 6th Targeted Radiopharmaceuticals Summit Europe will take place in Amsterdam on December 3-5, featuring 40+ speakers across pre-clinical and clinical tracks as radiopharmaceutical innovation accelerates.
  • Major pharmaceutical companies including Novartis, Eli Lilly, AstraZeneca, and Bayer are driving industry growth through billion-dollar collaborations and clinical advancements in novel radiopharmaceutical targets.
  • The 4th Targeted Radiopharmaceuticals Summit US returns to San Diego in July, bringing together 275+ global stakeholders to address key challenges in isotope supply, manufacturing, and clinical translation.

FDA Advisory Committee Discusses Columvi Combination for Relapsed or Refractory DLBCL

Oncology
  • Genentech's Columvi (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin demonstrated a 41% reduction in risk of death for patients with relapsed or refractory diffuse large B-cell lymphoma in the Phase III STARGLO study.
  • The FDA Oncologic Drugs Advisory Committee met to discuss the supplemental Biologics License Application for this combination therapy, focusing on the applicability of global trial results to U.S. patients.
  • If approved, this first-of-its-kind bispecific antibody combination could provide a much-needed, off-the-shelf, fixed-duration treatment option for transplant-ineligible patients who currently face poor prognosis.

A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

NCT04408638Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 2/23/2021

An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma

NCT06047080RecruitingPhase 3
Hoffmann-La Roche
Posted 9/18/2023

Molecular Profiling Reduces Radiotherapy Need in Early-Stage Endometrial Cancer

Precision MedicineOncology
  • The PORTEC-4a trial demonstrated that molecular profiling safely reduced radiotherapy need in 46% of women with high-intermediate risk endometrial cancer while maintaining excellent cancer control.
  • Patients with unfavorable molecular profiles who received intensive pelvic radiotherapy showed significantly better outcomes with an 8.4% recurrence rate compared to 30.5% in standard treatment groups.
  • This precision medicine approach represents a major advancement in personalized endometrial cancer treatment, allowing clinicians to tailor therapy based on individual tumor biology and risk profiles.

Hovione and Firstgene Partner to Develop Novel Gene Therapy for Liver Cancer

Oncology
  • Hovione and Firstgene Life Sciences have established a strategic collaboration to develop a tissue-specific gene therapy targeting hepatocellular carcinoma, the most common type of liver cancer and third leading cause of cancer-related deaths worldwide.
  • The partnership leverages Hovione's proprietary virus-like particle platform technology, which enables highly specific delivery of genetic material to target tissues while minimizing off-target effects common in conventional gene therapies.
  • This collaboration represents Xlife Sciences AG's strategic entry into the gene therapy market, expanding its portfolio into high-potential therapeutic areas while addressing a significant unmet medical need for the approximately 900,000 new HCC cases diagnosed annually.

RenovoRx Secures New U.S. Patent for TAMP Therapy Platform, Strengthening IP Portfolio for Targeted Cancer Treatment

OncologyTargeted Therapy
  • RenovoRx received U.S. patent NO. 12,290,564 for "Methods for Treating Tumors," expanding protection of its Trans-Arterial Micro-Perfusion (TAMP) therapy platform through November 2037.
  • The patent covers novel methods for local drug delivery near tumors using the company's FDA-cleared RenovoCath device, marking the ninth U.S. patent in RenovoRx's growing intellectual property portfolio.
  • This patent strengthens commercial protection for RenovoCath as the company scales commercialization efforts and advances its Phase III TIGeR-PaC trial evaluating intra-arterial gemcitabine for locally advanced pancreatic cancer.
  • RenovoRx now holds 19 issued patents and 12 pending patents, providing robust IP protection as the company began generating revenue from RenovoCath device sales in December 2024.

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