Weekly Pipeline Highlights: Anti-inflammatory Monoclonal Antibody Shows Rapid Efficacy in Asthma and COPD; Targeted Radiopharmaceutical for Solid Tumors Clears FDA IND
Aktis Oncology
Developer of Novel Targeted Radiopharmaceuticals
Enveda
Small Molecule Therapy Developer
2. Aktis Oncology Announces FDA Approval of IND Application for Targeted Radiotherapy AKY-2519, Allowing Entry into Phase 1b Clinical Trial
Rademikibart: Announcement of Preliminary Data from Phase 1 Clinical Trial
Connect Biopharma Announces Positive Topline Results from Phase 1 Study of Next-Generation Anti-Interleukin-4 Receptor Alpha (IL-4Rα) Antibody RademikibartRademikibart is a fully human monoclonal antibody targeting IL-4Rα, which inhibits the Th2 inflammatory pathway by blocking the functions of IL-4 and IL-13.Aiming to treat Th2-related inflammatory diseases such as atopic dermatitis, asthma, and chronic obstructive pulmonary disease.
Study data show that asthma and COPD patients who received a single 300 mg, 2-minute intravenous push of rademikibart,Forced Expiratory Volume in 1 Second (FEV1) improves rapidly, with many patients experiencing an FEV1 improvement of ≥200 mL within 15 minutes after administration.This rapid improvement provides clinical confirmation of the unique bronchodilatory benefits of rademikibart observed preclinically. Additionally,The patient maintained an average FEV1 improvement of approximately 200-400 mL on Day 29.The drug was generally well tolerated, with no serious or severe adverse events reported, and no patients discontinued the medication as a result.
AKY-2519: IND Application Granted FDA Approval
Aktis Oncology Announces FDA Approval of IND Application for AKY-2519, Allowing Entry into Phase 1b Clinical TrialAKY-2519 is a mini-protein radiolabeled conjugate targeting B7-H3, designed to deliver the potent isotope actinium-225.（actinium-225）Selectively delivered to tumors expressing the target, B7-H3 is expressed in various solid tumors such as prostate cancer and lung cancer.This is the second microprotein radioconjugate discovered by Aktis using its proprietary platform to enter clinical stage. Its leading drug, AKY-1189 targeting Nectin-4, is currently recruiting patients in a phase 1b clinical trial.
ENV-294: Release of Phase 1b Clinical Trial Data
Enveda Announces Positive Results from Phase 1b Clinical Trial of ENV-294, a Potential “First-in-Class” Once-Daily Oral Treatment, in Patients with Moderate-to-Severe Atopic Dermatitis (AD). This open-label study enrolled nine adult patients who had previously received systemic treatments. All patients received once-daily oral dosing of 800 mg ENV-294 for 28 days, followed by a 14-day observation period after discontinuation.
The study showed rapid and deep clinical remission.By Day 42, the Eczema Area and Severity Index (EASI) had decreased by an average of 85%, with efficacy observed as early as Day 8. All patients (100%) achieved EASI-50, 78% reached EASI-75, and 56% attained EASI-90, with continued improvement even after discontinuation of the drug.In terms of safety, the drug demonstrated good tolerability, with no serious adverse events reported and no patients discontinuing the medication as a result.
PALI-2108: Announcement of Phase 1b Clinical Trial Data
Palisade Bio Announces Positive Topline Data from Phase 1b Clinical Trial of PALI-2108 for the Treatment of Fibrostenotic Crohn's Disease (FSCD)PALI-2108 is a PDE4 inhibitor prodrug that can be locally activated at disease sites such as ulcerative colitis and FSCD, significantly increasing the concentration of PDE4 inhibitors in lesion tissues while reducing systemic exposure, thereby decreasing adverse effects like diarrhea commonly associated with traditional PDE4 inhibitors.
This Phase 1b study demonstrated encouraging early efficacy signals in five patients. The data shows,The Simple Endoscopic Score for Crohn's Disease (SES-CD) decreased by 47.5%, with 40% of patients achieving endoscopic remission.In terms of safety, the drug demonstrated good safety and tolerability during the two-week treatment period, with no serious adverse events reported. Additionally, pharmacokinetic and pharmacodynamic data support its once-daily oral dosing regimen. Based on these positive results, the company plans to advance PALI-2108 into a Phase 2 clinical trial for moderate to severe Crohn's disease.
[1] Aktis Oncology Announces FDA Clearance of Investigational New Drug Applications for AKY-2519 and Provides Business Updates and Full Year 2025 Financial Results. Retrieved March 31, 2026, from https://www.globenewswire.com/news-release/2026/03/30/3264994/0/en/Aktis-Oncology-Announces-FDA-Clearance-of-Investigational-New-Drug-Applications-for-AKY-2519-and-Provides-Business-Updates-and-Full-Year-2025-Financial-Results.html
[2] Ultragenyx Announces FDA Clearance of Investigational New Drug (IND) Application for UX016, a Sialic Acid Prodrug for the Treatment of GNE Myopathy. Retrieved March 31, 2026, from https://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-announces-fda-clearance-investigational-new-drug-1
[3] Connect Biopharma Announces Positive Topline Data from its Phase 1 Study of Intravenous (IV) Rademikibart in Patients with Asthma or COPD. Retrieved March 31, 2026, from https://www.globenewswire.com/news-release/2026/03/30/3264480/0/en/Connect-Biopharma-Announces-Positive-Topline-Data-from-its-Phase-1-Study-of-Intravenous-IV-Rademikibart-in-Patients-with-Asthma-or-COPD.html
[4] Palisade Bio Reports Positive PALI-2108 Phase 1b Clinical Data. Retrieved March 31, 2026, from https://palisadebio.com/palisade-bio-reports-positive-topline-data-from-phase-1b-clinical-study-of-pali-2108-in-fibrostenotic-crohns-disease/
[5] Bambusa Therapeutics Presented Positive Results from the Phase 1 Multiple Ascending Dose Trial of BBT001 at the 2026 American Academy of Dermatology (AAD) Annual Meeting. Retrieved April 2, 2026, from https://www.prnewswire.com/news-releases/bambusa-therapeutics-presented-positive-results-from-the-phase-1-multiple-ascending-dose-trial-of-bbt001-at-the-2026-american-academy-of-dermatology-aad-annual-meeting-302731280.html
[6] Enveda Reports Positive Results for ENV-294 in a Phase 1b Clinical Trial of Patients with Moderate-to-Severe Atopic Dermatitis. Retrieved April 2, 2026, from https://www.businesswire.com/news/home/20260331510616/en/Enveda-Reports-Positive-Results-for-ENV-294-in-a-Phase-1b-Clinical-Trial-of-Patients-with-Moderate-to-Severe-Atopic-Dermatitis
[7] Tonix Pharmaceuticals Announces Presentation of Phase 1 Data and Outlines Planned Adaptive Phase 2 Field Study of TNX-4800 for the Prevention of Lyme Disease, at the World Vaccine Congress Washington 2026. Retrieved April 2, 2026, from https://www.globenewswire.com/news-release/2026/03/31/3265326/28908/en/Tonix-Pharmaceuticals-Announces-Presentation-of-Phase-1-Data-and-Outlines-Planned-Adaptive-Phase-2-Field-Study-of-TNX-4800-for-the-Prevention-of-Lyme-Disease-at-the-World-Vaccine-C.html
[8] Neutrolis Announces Positive First-in-Human Phase 1a Results from LIBERATE-I Trial of NTR-1011, a First-in-Class DNASE1L3 Fusion Protein. Retrieved April 2, 2026, from https://www.globenewswire.com/news-release/2026/04/02/3267224/0/en/Neutrolis-Announces-Positive-First-in-Human-Phase-1a-Results-from-LIBERATE-I-Trial-of-NTR-1011-a-First-in-Class-DNASE1L3-Fusion-Protein.html
[9] Alltrna Announces Approval to Initiate First-in-Human Clinical Trial of AP003, the First tRNA Therapeutic to Enter Clinical Trials. Retrieved April 2, 2026, from https://www.prnewswire.com/news-releases/alltrna-announces-approval-to-initiate-first-in-human-clinical-trial-of-ap003-the-first-trna-therapeutic-to-enter-clinical-trials-302728901.html
[10] Avacta announces first patient treated in Phase 1 FOCUS-01 trial of FAP-Exd (AVA6103) – a sustained-release pre|CISION® exatecan peptide drug conjugate. Retrieved April 2, 2026, from https://avacta.com/avacta-announces-first-patient-treated-in-phase-1-focus-01-trial-of-fap-exd-ava6103-a-sustained-release-precision-exatecan-peptide-drug-conjugate/
[11] Pelthos Therapeutics Announces First Patient Dosed in Phase 1b/2a Clinical Trial of CT2000 in Eye Pain. Retrieved April 2, 2026, from https://www.globenewswire.com/news-release/2026/03/31/3265510/0/en/Pelthos-Therapeutics-Announces-First-Patient-Dosed-in-Phase-1b-2a-Clinical-Trial-of-CT2000-in-Eye-Pain.html
[12] Delonix Bioworks Announces Initiation of Phase 1 First-in-Human Clinical Trial of a Next-Generation MenB OMV Vaccine DX-104. Retrieved April 2, 2026, from https://www.prnewswire.com/news-releases/delonix-bioworks-announces-initiation-of-phase-1-first-in-human-clinical-trial-of-a-next-generation-menb-omv-vaccine-dx-104-302728529.html
[13] BioLineRx Announces Initiation of Phase 1/2a Study of GLIX1 for the Treatment of Glioblastoma (GBM). Retrieved April 2, 2026, from https://www.prnewswire.com/news-releases/biolinerx-announces-initiation-of-phase-12a-study-of-glix1-for-the-treatment-of-glioblastoma-gbm-302725980.html
[14] Adcytherix Doses First Patient in Phase 1 Trial of ADCX-020 and Strengthens Leadership to Support Next Phase of Growth. Retrieved April 2, 2026, from https://www.adcytherix.com/post/adcytherix-doses-first-patient-in-phase-1-trial-of-adcx-020-and-strengthens-leadership-to-support-ne
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