Clinical Trial Update

Antengene Doses First Patient in ATG-201 Phase I Autoimmune Trial

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Antengene Doses First Patient in ATG-201 Phase I Autoimmune Trial

Shanghai – November 06, 2026 -- Antengene Corporation Limited (SEHK: 6996.HK) has dosed the first patient in China in the Phase I ATTRACT study of ATG-201, its CD19 x CD3 bispecific T-cell engager (TCE) for adult patients with B cell-mediated autoimmune diseases. UCB holds worldwide exclusive rights to develop, manufacture and commercialize the asset.

UCB holds global rights while Antengene runs Phase I in China and Australia

Under the agreement, UCB also gains access to the manufacturing technology associated with ATG-201. Antengene remains responsible for conducting the Phase I trials in China and Australia.

The Australian arm has cleared its regulatory steps. ATG-201 has obtained approval from the Human Research Ethics Committee (HREC) and completed the Clinical Trial Notification (CTN) process with the Therapeutic Goods Administration (TGA).

Karyopharm Lands Two ASH 2026 Orals for Selinexor in Myelofibrosis

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Karyopharm Lands Two ASH 2026 Orals for Selinexor in Myelofibrosis

Newton, Mass. – November 04, 2026 -- Karyopharm Therapeutics (Nasdaq: KPTI) will present Week 48 data from its Phase 3 SENTRY trial and early monotherapy data from its Phase 2 SENTRY-2 trial in two oral sessions at ASH 2026, giving selinexor two oral slots in myelofibrosis. A third abstract, from the STOMP trial in multiple myeloma, was selected for a poster.

SENTRY Week 48 data go on stage December 13

The SENTRY presentation (publication number 526) is scheduled for December 13, 2026, from 10:15 a.m. to 10:30 a.m. CT. It will cover updated results for selinexor plus ruxolitinib in JAK inhibitor-naïve myelofibrosis. Chief Medical Officer Reshma Rangwala said the data show ongoing benefit through week 48.

Cambiotics Enrolls First Patient in 70-Firefighter PFAS Probiotic Trial

Copenhagen – November 03, 2026 -- Cambiotics ApS has enrolled the first participant in its first human clinical trial, testing whether its probiotic strain 46-SL1 changes serum PFAS concentrations in 70 firefighters with prior occupational exposure.

Crossover trial runs 2 x 12 weeks in Chicago

The study is randomised, double-blind and placebo-controlled. Atlantia Clinical Trials is conducting it in Chicago, Illinois (NCT07846371). Researchers are also assessing safety, tolerability and fecal microbiome changes. 46-SL1 is being developed as a dietary supplement.

Dr. Stacey Boetto of Atlantia Clinical Trials is the Principal Investigator.

Nuvation Bio to Present Four Safusidenib Posters at SNO 2026

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Nuvation Bio to Present Four Safusidenib Posters at SNO 2026

NEW YORK – November 02, 2026 -- Nuvation Bio (NYSE: NUVB) will present four posters on safusidenib, its investigational mutant IDH1 inhibitor, at the Society for Neuro-Oncology (SNO) Annual Meeting in Philadelphia on November 12-15, 2026. One poster carries updated long-term Phase 2 J201 results that go beyond the topline data the company announced in July 2026.

Three trial-in-progress posters cover ongoing safusidenib studies

The other three posters give overviews of ongoing safusidenib trials. Nuvation Bio will staff Booth #126 at the meeting and plans to post the materials in the Publications section of its website after the presentations.

CEO David Hung said patients with IDH1-mutant glioma are often diagnosed in their 30s and 40s and need targeted treatments with "durable responses."

Zhimeng Completes 255-Patient Enrollment in Pivotal ALS Trial

Shanghai – October 31, 2026 -- Shanghai Zhimeng Biopharma has completed enrollment of 255 patients in the pivotal Phase 2/3 trial of CB03-154 for amyotrophic lateral sclerosis (ALS), moving the potassium channel opener toward topline data and a possible new drug application in China.

Trial runs at 15 Chinese centers with a Week 39 primary endpoint

The study is led by Professor Fan Dongsheng of the 3rd Affiliated Hospital of Peking University and spans 15 clinical research centers in Mainland China. Its primary efficacy endpoint is the change from baseline in ALSFRS-R score at Week 39. China's Center for Drug Evaluation (CDE) cleared the Phase 2/3 study in July 2025. The U.S. FDA granted CB03-154 Orphan Drug Designation in October 2023.

Phrontline's TJ101 Shows 6/8 Responses in Urothelial Cancer

SHANGHAI – October 30, 2026 -- Phrontline Biopharma reported partial responses in six of eight response-evaluable urothelial carcinoma patients (75%) treated with its bispecific antibody-drug conjugate (ADC) TJ101, and has dosed the first patient in a Phase Ib trial.

TJ101 produces responses in patients previously treated with EV and pembrolizumab

The data were presented at the ESMO Congress 2026 in Madrid on October 23, 2026. Responders included patients previously treated with enfortumab vedotin (EV) and pembrolizumab. The results are preliminary and come from a small patient group. The company itself cautions that such findings may not predict outcomes in later studies.

Eisai to present five-year lecanemab Clarity AD data at CTAD 2026

Stockholm – October 30, 2026 -- Eisai will present five years of Clarity AD data on lecanemab (Leqembi) at the Clinical Trials on Alzheimer's Disease (CTAD) conference in Boston, November 16-19, 2026, according to its partner BioArctic AB (Nasdaq Stockholm: BIOA B). The dataset spans the core and long-term extension phases and is one of the longest follow-up sets reported to date for an approved anti-amyloid Alzheimer's therapy.

LEADER study tests lecanemab in US clinical practice three years after approval

A symposium on Wednesday, November 18, 11:00-11:40 AM ET, will cover the retrospective, multicenter LEADER study. The study draws on real-world data from different types of US treatment centers, three years after FDA approval.

Three analyses are scheduled: utilization and outcomes from initiation through maintenance therapy, sex-based outcomes, and at-home subcutaneous administration.

Atrium Doses First Patient in Phase 1/2 ATR 1072 PRKAG2 Trial

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Atrium Doses First Patient in Phase 1/2 ATR 1072 PRKAG2 Trial

San Diego – October 29, 2026 -- Atrium Therapeutics (Nasdaq: RNA) has dosed the first patient in Corventis, a Phase 1/2 trial of ATR 1072 in PRKAG2 syndrome, and expects initial proof-of-concept data in the second half of 2027.

Corventis will enroll about 37 participants in two parts

The open-label, multicenter study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of ATR 1072. Part A uses multiple ascending dose cohorts to characterize safety and support dose selection. Part B is a single-arm expansion cohort at the recommended Phase 2 dose, assessing efficacy trends in cardiac structure and function.

The primary endpoint is the incidence of treatment-emergent adverse events. Secondary and exploratory endpoints include PRKAG2 mRNA reduction, siRNA tissue concentrations and plasma pharmacokinetics.

Solid Biosciences Doses First Patient in FALCON Gene Therapy Trial

Global – October 27, 2026 -- Solid Biosciences has dosed the first participant in FALCON, a Phase 1b trial of SGT-212, its investigational gene therapy for Friedreich's ataxia (FA), and expects to release an initial data update in the second half of 2026, subject to patient enrollment.

FALCON tests a dual-route gene therapy in adults aged 18-40

FALCON is an open-label, dose-finding study designed to evaluate the safety and tolerability of SGT-212 in people aged 18-40 living with FA. Solid describes the approach as novel and first-in-class. It is the first-in-human study of SGT-212.

Intradentate nucleus infusion precedes intravenous delivery

Each participant receives an intradentate nucleus (IDN) infusion targeting the cerebellar dentate nuclei, followed by an intravenous (IV) infusion. Solid says the dual routes are intended to address the neurologic, cardiac and systemic manifestations of FA.

Servier Doses First Patients in Pivotal Emi-Le ACC Cohort

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Servier Doses First Patients in Pivotal Emi-Le ACC Cohort

Boston – October 19, 2026 -- Servier has dosed the first patients in EMBLEM-1, the pivotal Phase 2 cohort of its Phase 1/2 study of Emiltatug Ledadotin (Emi-Le) in aggressive adenoid cystic carcinoma (ACC), a cancer with no FDA-approved systemic treatment.

Emi-Le is an investigational antibody drug conjugate (ADC) directed against B7-H4. The cohort is enrolling under trial identifier NCT05377996.

EMBLEM-1 uses objective response rate per RECIST 1.1 as its primary endpoint

The trial will measure the percentage of patients who achieve a best overall response of confirmed complete response or partial response. It will also evaluate the safety of Emi-Le in ACC.