October 16, 2024 - 🧬 [nGram] Today’s Neurology Scoop: Novocure's Optune Lua® FDA Approval, BrainScope's Alzheimer's Breakthrough

1. FDA approves Novocure’s Optune Lua for metastatic non-small cell lung cancer

   • The FDA has approved Optune Lua for use with PD-1/PD-L1 inhibitors or docetaxel in treating metastatic non-small cell lung cancer (mNSCLC).
   • The approval is based on the Phase 3 LUNAR study, which showed a 3.3-month extension in median overall survival for patients using Optune Lua.
   • Optune Lua is a portable device that uses tumor treating fields (TTFields) to target cancer cells, offering a non-invasive treatment option.
   • Next steps include potential further regulatory actions in other geographies.
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2. UroGen announces FDA acceptance of its new drug application for UGN-102

   • UroGen Pharma's NDA for UGN-102, a treatment for low-grade intermediate-risk non-muscle invasive bladder cancer, has been accepted by the FDA.
   • The FDA has set a PDUFA goal date of June 13, 2025, for a decision on the approval of UGN-102.
   • The NDA is supported by data from the Phase 3 ENVISION trial, which showed a 79.6% complete response rate at three months.
   • If approved, UGN-102 could address a U.S. market valued at approximately $5 billion.
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3. Bioversys completes phase 2 trial for BV100 in VABP

   • BioVersys completed the last patient visit in the Phase 2 trial of BV100 for ventilator-associated bacterial pneumonia (VABP).
   • The trial showed BV100 is generally safe, well-tolerated, and effective against CRAB infections.
   • A global Phase 3 registration trial is planned for the second half of 2025.
   • Strategic investment from GIBF will support the launch of BV100's clinical program in China.
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4. HUTCHMED announces positive results from SAVANNAH Phase II trial for lung cancer treatment

   • The SAVANNAH Phase II trial showed that the combination of TAGRISSO (osimertinib) and ORPATHYS (savolitinib) achieved a high objective response rate in patients with EGFR-mutated NSCLC with high MET overexpression/amplification.
   • The trial targeted patients whose disease progressed on TAGRISSO, addressing MET-driven resistance, a common issue in EGFR-targeted therapies.
   • The combination therapy has received Fast Track designation from the US FDA and will be further assessed in the global SAFFRON Phase III trial.
   • The safety profile of the combination was consistent with known data, and no new safety signals were identified.
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5. Akeso reports positive results from phase 3 study of cadonilimab in cervical cancer

   • Akeso Biopharma announced positive results from the Phase 3 COMPASSION-16 study of cadonilimab in cervical cancer.
   • The study evaluated cadonilimab with or without chemotherapy and bevacizumab, showing significant improvement in progression-free survival (PFS) and overall survival (OS).
   • In the intention-to-treat population, the cadonilimab regimen showed a median PFS of 12.7 months versus 8.1 months for the control group.
   • The study highlights cadonilimab's potential to address unmet needs in cervical cancer treatment, regardless of PD-L1 expression levels.
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6. OKYO Pharma starts phase 2 trial for neuropathic corneal pain

   • OKYO Pharma has initiated a Phase 2 trial for OK-101 to treat neuropathic corneal pain (NCP), a condition with no FDA-approved treatments.
   • The trial is a 12-week, randomized, placebo-controlled study involving 48 patients, focusing on pain relief measured by the Visual Analog Scale.
   • OK-101 previously showed significant pain relief in a Phase 2 trial for dry eye disease and demonstrated efficacy in pre-clinical models of NCP.
   • The trial is led by Dr. Pedram Hamrah at Tufts Medical Center, aiming to evaluate OK-101's potential benefits in NCP patients.
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7. Ventyx Biosciences presents new 52-week results from the phase 2 trial of VTX002 in ulcerative colitis at UEG Week 2024

   • Ventyx Biosciences shared 52-week data from the phase 2 trial of tamuzimod in ulcerative colitis at UEG Week 2024.
   • The trial showed high rates of clinical and endoscopic remission among long-term extension completers.
   • Tamuzimod is positioned as a potential best-in-class oral therapy for ulcerative colitis.
   • Slides from the presentation will be available on Ventyx's website.
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8. Brainscope completes proof-of-concept for early Alzheimer’s prediction biomarker

   • BrainScope has successfully completed the proof-of-concept phase for a novel EEG-based biomarker to predict early onset of Alzheimer’s disease.
   • The study involved a multi-year longitudinal investigation using EEG data from elderly individuals with memory complaints.
   • Distinctive EEG profiles were identified, differentiating those who showed no change, declined to mild cognitive impairment, or converted to dementia.
   • The next phase will focus on validating this biomarker, which could revolutionize early diagnosis and treatment of Alzheimer’s.
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9. Ikerian announces series B funding first close of USD 8M led by Sanoptis

   • Ikerian secured USD 8M in Series B funding, led by Sanoptis, with participation from existing investors.
   • A strategic commercial agreement with Sanoptis aims to expand RetinAI Discovery in Europe.
   • Funds will enhance AI models, Discovery CONNECT, and expand into neurodegenerative and rare diseases.
   • Deployment of Discovery CONNECT is planned for Q1 2025, enhancing data connectivity in healthcare.
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