Abdera Therapeutics receives FDA orphan drug designation for ABD-147
- ABD-147 is a precision radiopharmaceutical biologic therapy targeting DLL3 on neuroendocrine tumors.
- The FDA's Orphan Drug Designation provides incentives like tax credits, user fee exemptions, and potential market exclusivity.
- Abdera plans to initiate a Phase 1 clinical trial in 2024 for patients with SCLC or LCNEC who previously received platinum-based therapy.
- ABD-147 also received Fast Track designation for treating extensive stage small cell lung cancer (ES-SCLC).
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Akeso to present data from 13 clinical studies at ESMO 2024
- Akeso will showcase results from 13 clinical studies on its internally developed antibodies at ESMO Congress 2024.
- Featured antibodies include cadonilimab, ivonescimab, ligufalimab, and penpulimab.
- Studies cover various cancers such as colorectal, breast, head and neck, liver, and more.
- Ivonescimab's combination with ligufalimab will be presented for the first time.
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Ribometrix to present data supporting potential of eIF4E program in KRAS mutant non-small cell lung cancer at ESMO 2024
- Ribometrix will present data on its eIF4E program at the ESMO Congress in Barcelona, Spain, from September 13-17, 2024.
- The presentation will cover in vitro and in vivo studies of RBX-6610, a small molecule eIF4E inhibitor, for treating KRASG12C mutant NSCLC.
- RBX-6610 monotherapy showed anti-proliferative effects in KRASG12C mutant tumor cell lines, including those with acquired resistance.
- RBX-6610 combined with KRAS inhibitors resulted in significant tumor regression and re-sensitized resistant tumor cells to KRAS inhibitors.
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Gilead to present new Trodelvy data at the IASLC 2024 World Conference on Lung Cancer
- Gilead will present new data from its lung cancer clinical development program at the IASLC 2024 World Conference on Lung Cancer.
- Key presentations include initial results from the EVOKE-02 study in previously untreated advanced or metastatic non-small cell lung cancer (mNSCLC).
- Subgroup analysis from the EVOKE-01 study shows overall survival improvement in second-line mNSCLC patients.
- Updated data from the TROPiCS-03 study demonstrate promising activity in extensive stage small cell lung cancer (ES-SCLC).
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Bayer to present new prostate cancer data and continued oncology portfolio research at ESMO 2024
- Bayer will present new oncology data at ESMO 2024, including results from the Phase III ARANOTE trial on NUBEQA (darolutamide) plus ADT in mHSPC patients.
- Late-breaking results from the EORTC's Phase III PEACE-III study on XOFIGO (radium-223 dichloride) in combination with enzalutamide for mCRPC will be presented.
- Updated analysis from the SCOUT and NAVIGATE studies on VITRAKVI (larotrectinib) in TRK fusion cancer patients will be highlighted.
- Trial in Progress (TiP) data from the Phase III SOHO-2 trial on BAY 2927088 for NSCLC with HER2-activating mutations will be presented.
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NextPoint Therapeutics announces first-in-class T cell engager NPX372 as new drug candidate targeting B7-H7 in solid tumors
- NextPoint Therapeutics unveils NPX372, a novel T cell engager targeting the B7-H7 axis in solid tumors.
- B7-H7 is an immunomodulatory receptor upregulated in various solid tumors, making it a unique target for tumor-directed therapies.
- NPX372 is a CD3 bispecific antibody that redirects T cell-mediated cytotoxicity toward B7-H7-positive tumors.
- Preclinical data show NPX372's potent anti-tumor responses and favorable safety profile, with no indication of cytokine release syndrome.
- NextPoint is advancing the Investigational New Drug (IND) application for NPX372.
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Ocuphire Pharma initiates VEGA-3 phase 3 trial evaluating phentolamine ophthalmic solution 0.75% for presbyopia
- Ocuphire Pharma has started the VEGA-3 Phase 3 trial for Phentolamine Ophthalmic Solution 0.75% to treat presbyopia.
- The trial is a randomized, double-masked, placebo-controlled study involving 545 participants.
- Participants will receive one drop of the solution or placebo each evening, with the primary endpoint being a 15-letter improvement in near visual acuity.
- Top-line data from the VEGA-3 trial is expected in the first half of 2025.
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Aurinia announces first participant dosed in AUR200 single ascending dose trial
- Aurinia Pharmaceuticals has dosed the first participant in a Phase 1a single ascending dose (SAD) study of AUR200.
- The study will assess safety, tolerability, pharmacokinetics, and biomarker changes in healthy volunteers.
- Data from the study is expected in the first half of 2025.
- AUR200 targets BAFF and APRIL, cytokines involved in B-cell survival and differentiation, and is intended for autoimmune diseases with high unmet needs.
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Crestone announces positive data from phase 2 clinical trial of CRS3123 for C. difficile infections
- Crestone reported positive topline results from the Phase 2 trial of CRS3123 in patients with Clostridioides difficile infection (CDI).
- Clinical cure rates at day 12 were 97% for CRS3123 and 93% for vancomycin, with no clinical failures.
- CDI recurrence rates at day 40 were significantly lower for CRS3123 (4%) compared to vancomycin (23%).
- The National Institute of Allergy and Infectious Diseases (NIAID) has provided $4.5 million in new funding for further studies based on these results.
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Cyclo Therapeutics presents encouraging preliminary safety data from ongoing pivotal phase 3 study and substudy for the treatment of Niemann-Pick disease type C1
- Cyclo Therapeutics presented positive preliminary data from its ongoing pivotal Phase 3 study (TransportNPC™) and substudy evaluating Trappsol® Cyclo™ for Niemann-Pick Disease Type C1 (NPC1).
- The TransportNPCâ„¢ study, which completed enrollment in May 2024, is the most comprehensive controlled pivotal study for NPC1, involving 104 patients.
- The substudy, focusing on newborns to 3-year-olds, aims to evaluate Trappsol® Cyclo™'s ability to target visceral aspects of NPC1.
- Safety data showed 625 adverse events, with 80% being mild, and no patients withdrawing due to safety concerns.
- Topline data from the 48-week interim analysis is anticipated in H1 2025, with potential marketing applications to follow if data meets statistical significance.
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