Antag Therapeutics receives FDA clearance for AT-7687 IND application
- Antag Therapeutics' IND application for AT-7687 has been accepted by the FDA.
- The Phase I trial will assess safety, tolerability, and pharmacokinetics in healthy lean and obese subjects.
- AT-7687 will be tested as a monotherapy and in combination with semaglutide.
- Preclinical studies show AT-7687 aids weight loss and improves lipid profiles without gastrointestinal side effects.
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CDE grants breakthrough therapy designation to LBL-024 for extrapulmonary neuroendocrine carcinoma
- The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation to LBL-024.
- LBL-024 is a bispecific antibody targeting PD-L1 and 4-1BB, developed by Leads Biolabs for advanced extrapulmonary neuroendocrine carcinoma (EP-NEC).
- Clinical data shows LBL-024 more than doubles the Objective Response Rate (ORR) and Overall Survival (OS) compared to existing treatments.
- Leads Biolabs plans to pursue global clinical development of LBL-024 to offer more effective treatment options for EP-NEC patients.
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Clearside Biomedical announces positive topline results from ODYSSEY Phase 2b trial of suprachoroidal CLS-AX in wet AMD
- The ODYSSEY Phase 2b trial of CLS-AX for wet AMD achieved all primary and secondary outcomes.
- CLS-AX maintained stable visual acuity and anatomical control over 9 months with a positive safety profile.
- 67% of participants did not require additional treatment up to 6 months, reducing treatment burden by 84%.
- The trial supports advancing CLS-AX into Phase 3 development for a flexible maintenance dosing regimen.
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Ocugen announces removal of clinical hold on investigational new drug application for OCU200 phase 1 clinical trial
- The FDA has lifted the clinical hold on Ocugen's investigational new drug application for OCU200, a treatment for diabetic macular edema (DME).
- OCU200 is a recombinant fusion protein targeting the integrin pathway, potentially benefiting DME patients, including those non-responsive to current therapies.
- The phase 1 trial is a multicenter, open-label, dose-ranging study with a focus on safety and includes a combination cohort with anti-VEGF.
- Ocugen plans to explore additional indications for OCU200, such as diabetic retinopathy and wet age-related macular degeneration.
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Pierre Fabre and Scorpion Therapeutics dose first patient in phase I/II trial for NSCLC treatment
- Pierre Fabre Laboratories and Scorpion Therapeutics have initiated a Phase I/II trial for PFL-241/STX-241, targeting EGFR mutations in NSCLC.
- The trial is open-label and multi-center, focusing on safety, tolerability, pharmacokinetics, and preliminary efficacy.
- PFL-241/STX-241 is designed to inhibit the C797S mutation, a resistance mechanism in NSCLC patients.
- No approved treatments currently exist for patients with this 'double mutant' EGFR NSCLC.
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Aurigene oncology announces promising results of phase 1 study for CAR-T cell therapy
- Aurigene Oncology Limited reported Phase 1 results for Ribrecabtagene autoleucel (DRL-1801) in relapsed/refractory multiple myeloma.
- All 8 patients in the study achieved clinical response, with 62.5% achieving stringent complete response.
- No high-grade events of Cytokine Release Syndrome (CRS) or neurotoxicity were observed.
- The Drugs Controller General of India (DCGI) approved the commencement of Phase 2 of the trial.
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KaliVir Immunotherapeutics doses first patient in phase 1/1b trial of VET3-TGI for incurable, advanced, solid tumors
- KaliVir Immunotherapeutics has initiated the STEALTH-001 study, dosing the first patient with VET3-TGI.
- VET3-TGI is an oncolytic immunotherapy targeting tumor cells and delivering immune-stimulatory transgenes.
- The trial involves dose escalation to find the maximum tolerated dose for monotherapy and combination with checkpoint inhibitors.
- Expansion cohorts will evaluate safety and efficacy in patients with advanced, unresectable, or metastatic solid tumors.
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Viatris announces positive top-line results from phase 3 study of Effexor in Japanese adults with generalized anxiety disorder
- Phase 3 study in Japan showed Effexor met primary and all secondary efficacy endpoints for treating generalized anxiety disorder (GAD).
- Effexor was well tolerated with low discontinuation rates and no serious treatment emergent adverse events.
- The study involved 357 Japanese outpatients, using a randomized, double-blind, placebo-controlled design over 8 weeks.
- Viatris plans to submit to the Pharmaceuticals and Medical Devices Agency (PMDA) in 2025 and present full results at a future medical congress.
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Kiromic BioPharma reports favorable ongoing clinical results from deltacel-01 trial
- Kiromic BioPharma reports positive results from the Deltacel-01 Phase 1 trial for patients with stage 4 metastatic NSCLC.
- Patient 4 showed a 5.3% reduction in tumor size at six months, while Patient 6 maintained stable disease at two months.
- The trial's median progression-free survival has increased to 6 months, indicating potential to delay disease progression.
- Deltacel-01 trial involves gamma delta T-cell therapy combined with low-dose radiotherapy, focusing on safety and efficacy.
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