clinical_trial_update

Cambridge, Mass. – September 13, 2026 -- Marengo Therapeutics has completed enrollment in the monotherapy cohorts of its Phase 1/2 STARt-001 trial evaluating invikafusp alfa across eight distinct PD-1-resistant tumor types, with updated results selected for an oral presentation at the ESMO 2026 Congress in Madrid, October 23-27.

Trial enrollment closes across eight PD-1-resistant tumor types

The monotherapy cohorts covered patients with MSS colorectal cancer, PD-L1-negative non-small cell lung cancer and triple-negative breast cancer, among others resistant to checkpoint blockade. Enrollment continues in standard-of-care combination cohorts, while the company plans to name lead indications for focused development alongside the ESMO data release.

San Francisco – September 13, 2026 -- Cionic reported that the first 60 participants in its TRANSFORM study showed an average 26% improvement in health-related quality of life after one month, using the standardized EQ-5D-5L instrument across all five measured dimensions.

Cionic launches 12-month study tracking 1,000 adults with upper motor neuron conditions

The TRANSFORM study follows 1,000 adults with multiple sclerosis, stroke, spinal cord injury, cerebral palsy, and related conditions over 12 months, collecting quality-of-life data through six surveys administered via the Cionic mobile app at onboarding and at one, three, six, nine, and 12 months. The primary endpoint, EQ-5D-5L, measures mobility, self-care, usual activities, pain, and anxiety/depression, while secondary measures track spasticity, urinary incontinence, and fatigue.

South San Francisco, Calif. – September 12, 2026 -- IDEAYA Biosciences and Servier have dosed the first patient in OptimUM-11, a global Phase 3 trial testing darovasertib combined with crizotinib as adjuvant therapy for primary uveal melanoma, targeting a disease segment with no approved systemic treatment options.

Trial design pairs oral PKC and cMET inhibitors for high-risk patients post-local therapy

OptimUM-11 will enroll approximately 450 patients who have completed local therapy for primary uveal melanoma and face elevated risk of metastatic recurrence. Patients will be randomized 1:1 to receive darovasertib plus crizotinib for 12 months or to observation, regardless of HLA status. The primary endpoint is relapse-free survival.

Shanghai – September 11, 2026 -- CorrectSequence Therapeutics (Correctseq) reported that its transformer Base Editor (tBE) therapy CS-101/CS-206 achieved full transfusion independence or elimination of vaso-occlusive crises (VOC) in four new patients from Nigeria, Laos, Malaysia and Pakistan, expanding on earlier results in five Chinese patients who all reached transfusion independence. The findings, published September 7, 2026 in Cell Stem Cell, cover patients with sickle cell disease (SCD) and transfusion-dependent beta-thalassemia (TDT) carrying distinct genotypes, including βS/βS, β0/βE, and two β0/β0 variants.

San Diego – September 09, 2026 -- Inhibrx Biosciences, Inc. (Nasdaq: INBX) will webcast primary endpoint results from the randomized, controlled Phase 2 portion of its HexAgon study on Tuesday, September 8, 2026 at 5:00 a.m. Pacific Time.

Phase 2 data will compare INBRX-106 combination therapy against pembrolizumab alone

The study evaluates INBRX-106, a hexavalent OX40 agonist, combined with pembrolizumab against pembrolizumab monotherapy as a control arm. The trial enrolled first-line, treatment-naïve patients with PD-L1 positive (CPS ≥ 20) metastatic or unresectable recurrent Head and Neck Squamous Cell Carcinoma (HNSCC).

Carlsbad – September 08, 2026 -- Tyra Biosciences, Inc. (Nasdaq: TYRA) will disclose initial clinical results from its SURF302 Phase 2 study of oral dabogratinib in intermediate risk non-muscle invasive bladder cancer (IR NMIBC) during a conference call scheduled for September 9, 2026, at 8:00 am ET.

Tyra sets September 9 call to unveil first SURF302 data

The clinical-stage biotech confirmed the call and webcast will present initial efficacy and safety data from the ongoing SURF302 trial, marking the first public disclosure of results for dabogratinib in this bladder cancer indication.

Dabogratinib targets FGFR3-driven tumors as lead pipeline asset

Dabogratinib is Tyra's lead precision medicine candidate, developed as a potential first-in-class selective FGFR3 inhibitor. Beyond IR NMIBC, the company is advancing the drug for low-grade upper tract urothelial cancer (LG-UTUC) and achondroplasia (ACH).

Valby, Denmark – September 07, 2026 -- Lundbeck will present preclinical data at the European Epilepsy Congress in Athens showing its investigational drug bexicaserin simultaneously increases inhibitory and decreases excitatory neuronal activity in hippocampal brain tissue, a dual mechanism the company says supports broad-spectrum antiseizure potential across multiple epilepsy types.

Preclinical study links dual mode of action to broader seizure control

CARY, N.C. -- September 01, 2026 -- Veloxis Pharmaceuticals dosed the first participant on Aug. 31, 2026, in its Phase 2 RENGEVITY-201 trial testing pegrizeprument, an investigational immunosuppressive drug, against tacrolimus in kidney transplant recipients. The Cary, North Carolina-based company, a unit of Asahi Kasei Corporation, will enroll up to 120 de novo kidney transplant patients across multiple sites in the randomized, partially blinded study registered as NCT07290777. Patients will receive one of two pegrizeprument doses or tacrolimus, each layered on top of rATG, corticosteroids and mycophenolate maintenance therapy.