Clinical Trials

Cambridge, Mass. – October 02, 2026 -- Marengo Therapeutics will present interim results from its STARt-002 trial combining invikafusp alfa with Gilead's TRODELVY (sacituzumab govitecan-hziy) at the Society for Immunotherapy of Cancer's 41st Annual Meeting in Phoenix, Arizona, November 4-8, 2026.

STARt-002 pairs a T-cell agonist with an antibody-drug conjugate for the first time in clinical testing

The Phase 1b/2 study tests invikafusp alfa, a Vβ6-selective dual T-cell agonist, alongside TRODELVY's TROP2-directed cytotoxic payload delivery. Marengo's Chief Medical Officer Kevin Chin said the ADC is designed to release tumor antigens and inflame the tumor microenvironment, priming less immunogenic tumors for T-cell-mediated responses that invikafusp alfa can then amplify.

Hong Kong – – October 02, 2026 -- Ascletis Pharma Inc. (HKEX: 1672) presented preclinical data showing its ASC36_35FDC injectable combination drove a 24.8% body-weight reduction in a diet-induced obesity rat model on Day 14, outperforming two competitor co-formulations tested under identical dosing conditions.

The data were unveiled in a short oral discussion at the 62nd European Association for the Study of Diabetes (EASD) Annual Meeting, held September 28–October 2, 2026, in Milan, Italy.

Valby – October 02, 2026 -- H. Lundbeck A/S will present late-breaking Phase III data on its multiple system atrophy (MSA) drug candidate amlenetug alongside new Parkinson's disease pipeline results at the International Congress of Parkinson's Disease and Movement Disorders (MDS) 2026 in Seoul, South Korea, running October 4-8.

MASCOT trial enrolled 401 participants across a global Phase III program

The late-breaking oral presentation will detail baseline characteristics of participants in MASCOT (NCT06706622), Lundbeck's ongoing Phase III trial of amlenetug in MSA. The trial enrolled 401 participants with clinically probable or established MSA, covering both MSA-C and MSA-P subtypes, across sites in North America, Europe, Asia and Australia. The double-blind treatment period runs 72 weeks, comparing high- and low-dose amlenetug against placebo, with results expected in Q3 2027.

San Francisco – September 29, 2026 -- Innovent Biologics reported an 84.6% overall response rate for its trispecific antibody IBI3003 at the recommended Phase 2 dose in heavily pretreated multiple myeloma patients, data presented in an oral session at the 23rd International Myeloma Society Annual Meeting 2026.

Trial identifies 360 μg/kg as the optimal dose after testing three dose levels

Among 26 patients treated at 360 μg/kg with a median follow-up of 7.57 months, median progression-free survival has not yet been reached. The cohort produced 11 stringent complete responses, 4 very good partial responses, and 7 partial responses. Response rates climbed to 94.7% among 19 patients who had received only 2 to 4 prior lines of therapy, and 92.3% among 13 patients without extramedullary disease.

Hong Kong – – September 29, 2026 -- Ascletis Pharma Inc. (HKEX: 1672) reported a 48.9% placebo-adjusted reduction in psoriasis area and severity index (PASI) scores from a 28-day U.S. proof-of-concept trial of ASC50, an oral small molecule IL-17A inhibitor positioned as a needle-free alternative to injectable antibody therapies for plaque psoriasis.

Once-daily 200 mg dosing matched published efficacy benchmarks for injectable IL-17A antibody secukinumab

The randomized, double-blind, placebo-controlled Phase I study (NCT07024602) enrolled mild-to-moderate plaque psoriasis patients who received once-daily 200 mg oral ASC50 for 28 days. Ascletis said the PASI reduction was comparable to published secukinumab data, though the comparison was not conducted head-to-head.

Hong Kong – September 28, 2026 -- Akeso, Inc. (9926.HK) has enrolled the first patient in COMPASSION-37, a global Phase III head-to-head trial testing its bispecific antibody cadonilimab against nivolumab as first-line treatment for HER2-negative advanced gastric and gastroesophageal junction (G/GEJ) adenocarcinoma.

Trial pits cadonilimab plus chemotherapy against nivolumab-based standard of care

The multicenter study compares cadonilimab combined with chemotherapy to chemotherapy with or without nivolumab in previously untreated, unresectable or metastatic G/GEJ patients. It is co-led by Dr. Yelena Y. Janjigian of Memorial Sloan Kettering Cancer Center, Professor Markus Möhler of Johannes Gutenberg University Mainz, and Professors Jiafu Ji and Lin Shen of Peking University Cancer Hospital. Janjigian, Möhler and Shen were investigators on the earlier CheckMate 649 trial, which established nivolumab plus chemotherapy as a global first-line standard.

Barcelona – September 24, 2026 -- Daewoong Pharmaceutical has completed enrollment of 104 idiopathic pulmonary fibrosis (IPF) patients in its global Phase 2 trial of Bersiporocin (DWN12088), with top-line results now expected in the first half of 2027.

Trial spans South Korea and the US with balanced enrollment

Of the 104 patients, 55 (52.9%) were enrolled in South Korea and 49 (47.1%) in the United States. The company presented full baseline patient characteristics at the European Respiratory Society (ERS) Congress 2026 in Barcelona on September 6, following interim data shared earlier at KATRDIC 2025.

Tokyo – September 24, 2026 -- Astellas Pharma Inc. (TSE: 4503) has dosed the first patient in a Phase 3 study evaluating setidegrasib, an investigational KRAS G12D-targeted protein degrader, against docetaxel in previously treated non-small cell lung cancer (NSCLC) patients carrying the KRAS G12D mutation.

Trial targets patients who progressed on chemotherapy and checkpoint inhibitors

The randomized, open-label study will enroll approximately 356 patients across multiple countries whose locally advanced or metastatic NSCLC has progressed after platinum-based chemotherapy and checkpoint inhibitor therapy. Dual primary endpoints are progression-free survival, assessed by blinded independent central review, and overall survival.

Toronto – September 24, 2026 -- Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) has hit its 110-patient enrollment target for the pivotal Phase III MAVERIC trial ahead of its end-of-September guidance, and will now expand recruitment to as many as 150 patients.

Blinded review shows fewer recurrences than expected in pericarditis trial

A blinded review of patients randomized 1:1 to CardiolRxTM or placebo found a lower-than-anticipated rate of pericarditis recurrence, according to Cardiol. The MAVERIC Steering Committee recommended the enrollment increase to capture enough clinical events for a statistically robust efficacy read.

President and CEO David Elsley said the company is not aware of any change in routine clinical practice that would explain the reduced recurrence rate, calling the finding encouraging.

Suzhou, China – September 24, 2026 -- Innovent Biologics (HKEX: 01801) will present late-breaking Phase 3 data for its CLDN18.2-targeting antibody-drug conjugate IBI343/TAK-921 at the 2026 European Society for Medical Oncology (ESMO) Annual Meeting in Madrid, running October 23-27.

Phase 3 gastric cancer trial secures late-breaking oral slot

Results from the registrational G-HOPE-001 study, comparing Arcotatug Tavetecan against treatment of physician's choice in previously treated advanced gastric or gastroesophageal junction adenocarcinoma, will be delivered as a late-breaking abstract (LBA77) during the October 23 proffered paper session. Dr. Kohei Shitara of Chiba, Japan, will present the first interim analysis of the randomized, open-label trial.