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Jaguar Health Advances Canalevia-CA1 Field Study for Canine Cancer Treatment as Company Pursues Full FDA Approval

Drug ApprovalOncology
  • Jaguar Health has established the first study site for its field study of Canalevia-CA1, the FDA conditionally approved prescription drug for treating chemotherapy-induced diarrhea in dogs.
  • The company is pursuing two parallel goals: obtaining full FDA approval for CID treatment and expanding crofelemer's indication to treat general, non-infectious diarrhea in dogs.
  • Approximately 1 in 4 dogs develop cancer during their lifetime, with roughly 6 million new cancer diagnoses made in dogs annually in the U.S.
  • Jaguar is actively seeking partnerships to fund development and commercialization of crofelemer for general canine diarrhea treatment, representing a significant unmet medical need.

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.

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.

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

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

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.

JNJ-1900 Shows Promise in Phase 1 Trial for Advanced Pancreatic Cancer

Oncology
  • JNJ-1900 (NBTXR3) demonstrated favorable safety and feasibility in a Phase 1 trial involving 22 patients with locally advanced or borderline resectable pancreatic cancer.
  • The trial showed encouraging efficacy with a median overall survival of 23 months from diagnosis, compared to 19.2 months with standard care in a historical review.
  • Exploratory biomarker analyses revealed CA19-9 normalization in 59% of patients, associated with improved survival, and increased circulating tumor mutational burden in 40% of patients.

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