Iovance Biotherapeutics

GT Biopharma Advances GTB-3650 Phase 1 Trial to Second Cohort Following Promising Immune Activation Signals

3 days ago

• GT Biopharma has successfully completed dosing in the first cohort of its Phase 1 trial for GTB-3650, a second-generation TriKE immunotherapy, with no safety or tolerability issues observed. • Both patients in Cohort 1 demonstrated early biological signs of immune activation, including increased natural killer cell activity and expansion, supporting the therapy's mechanism of action. • The trial, which will evaluate approximately 14 patients across seven dose cohorts, aims to treat relapsed or refractory CD33-expressing hematologic malignancies through enhanced NK cell-mediated cancer destruction.

Selected TIL Therapy Combined with Pembrolizumab Shows Promising Results for Metastatic Gastrointestinal Cancers

2 months ago

• NIH researchers report that a new form of tumor infiltrating lymphocyte (TIL) therapy combined with pembrolizumab achieved 23.5% objective response rate in patients with metastatic gastrointestinal cancers, compared to 7.7% with selected TILs alone. • The clinical trial included 91 heavily pretreated patients with various gastrointestinal cancers, demonstrating efficacy across multiple tumor types including colon, rectal, pancreatic, and bile duct cancers. • Response durations ranged from 4 months to 3.5 years in the combination therapy group, offering new hope for extending cell-based immunotherapies to common solid tumors that have historically been resistant to such approaches.

Promising Pipeline for Soft Tissue Sarcoma Treatment Expands with 130+ Therapies in Development

2 months ago

• Global soft tissue sarcoma pipeline constitutes 125+ companies developing 130+ treatment therapies, with significant progress in clinical trials across various stages of development. • FDA grants Orphan Drug Designation to Actuate Therapeutics' elraglusib for soft tissue sarcoma treatment, highlighting its potential to address unmet needs in this rare cancer. • Novel approaches include tumor-targeting antibody-cytokine fusion proteins, intratumoral administration techniques, and GSK-3β inhibition, offering hope for improved outcomes in this challenging disease.

Iovance Biotherapeutics Continues Expansion with Nearly 300 New Stock Option Grants to Support TIL Therapy Development

2 months ago

• Iovance Biotherapeutics granted inducement stock options covering 297,600 shares to fifty new employees on April 17, 2025, following similar grants of 308,710 shares to forty-three employees in March. • The company is expanding its workforce to support the commercialization of Amtagvi, the first FDA-approved T-cell therapy for a solid tumor indication, and further development of its tumor infiltrating lymphocyte (TIL) platform. • Each stock option has a three-year vesting period with an exercise price of $3.06 per share, reflecting Iovance's strategic investment in human capital to advance its cancer immunotherapy pipeline.

B-Cell Lymphoma Pipeline Expands with 300+ Therapies in Development for 2025

2 months ago

• DelveInsight's latest report reveals a robust B-cell lymphoma pipeline with over 295 companies developing 300+ therapies, highlighting significant industry investment in this area. • Several major pharmaceutical companies including BeiGene, Celgene, Hoffmann-La Roche, and Allogene Therapeutics have initiated pivotal late-stage clinical trials for novel B-cell lymphoma treatments in March 2025. • Emerging therapies include CAR-T cell approaches, bispecific antibodies, and novel targeted agents, with many incorporating dual-targeting mechanisms to overcome resistance seen with single-target therapies.

FDA Approves ORLYNVAH™: First New Oral Treatment for Uncomplicated UTIs in 25 Years

3 months ago

• Iterum Therapeutics receives FDA approval for ORLYNVAH™, marking the first branded uncomplicated UTI treatment to enter the U.S. market in over 25 years and the first oral penem antibiotic approved in the country. • The drug demonstrates significant potential against multi-drug resistant pathogens, specifically targeting Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis in adult women with limited treatment options. • Iterum reports $24.1 million in cash reserves as of December 2024, with funding projected to sustain operations into the second half of 2025 while pursuing pre-commercialization activities.

TIL Therapy and Novel Combinations Advance Melanoma Treatment

5 months ago

• Lifileucel (Amtagvi), a tumor-derived autologous T-cell immunotherapy, received FDA accelerated approval for unresectable or metastatic melanoma after PD-1 inhibitor treatment. • Studies show lifileucel, alone or with pembrolizumab, yields objective response rates of 31.5% to 65.2% in advanced melanoma, even after multiple prior therapies. • IBI363, a PD-1, IL-2α bispecific antibody, demonstrates promising disease control and objective response rates in melanoma patients who have progressed on PD-1 inhibitors. • Personalized cancer vaccine mRNA-4157 (V940) combined with pembrolizumab significantly reduces the risk of disease recurrence in resected stage IIIB to IV melanoma.