The global, randomized Phase 3 PEAK study compared bezuclastinib plus sunitinib against sunitinib monotherapy in patients with imatinib-resistant or intolerant GIST. As of September 30, 2025, the data cutoff, the combination demonstrated a 50% reduction in the risk of disease progression or death compared to the standard of care (HR = 0.50, 95% CI: 0.39–0.65). Results confirmed an mPFS of 16.5 months for the combination versus 9.2 months for sunitinib alone, with an unprecedented ORR of 46% compared to 26%. At the time of reporting, overall survival (OS) data remain immature, but the average treatment duration for the bezuclastinib arm is projected to exceed 19 months.
Domain Therapeutics Doses First Patients in Phase I/II Trial of DT-7012 Targeting CCR8 in Solid Tumors
Domain Therapeutics has announced that the first patients have been dosed in its Phase I/II DOMISOL clinical study evaluating DT-7012, a differentiated Treg-depleting anti-CCR8 monoclonal antibody, for the treatment of advanced solid tumors.
The DOMISOL study is an open-label, first-in-human trial focusing on the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of DT-7012. The trial is being conducted in Australia (NCT06819735).
DT-7012 is designed to address a critical limitation of current cancer treatments, such as immune checkpoint inhibitors (ICIs), namely the immunosuppressive effect of regulatory T cells (Tregs) within the tumor microenvironment (TME). DT-7012 targets CCR8, a receptor predominantly expressed on these intratumoral Tregs.
Domain Therapeutics highlights DT-7012’s unique, differentiated properties, stating it offers unprecedented selectivity in depleting these immunosuppressive Tregs via potent ADCC and ADCP mechanisms while simultaneously improving overall immune function. It is designed to maintain depletion efficiency even in challenging, CCL1-rich TMEs, positioning it as a potentially groundbreaking solution to overcome immune resistance in patients with limited options.
This marks DT-7012 as Domain’s second fully proprietary asset to enter the clinic, underscoring the company’s ability to translate cutting-edge G Protein-Coupled Receptor (GPCR) biology into differentiated products. Domain Therapeutics specializes in targeting GPCRs, a crucial, yet often challenging, class of drug targets, for immuno-oncology and inflammatory diseases. The acquisition of this asset by Pfizer earlier this month, as previously reported, demonstrates the high market interest in this therapeutic area.
Anaptys Reports Phase 2 Study of Rosnilimab in Moderate-to-Severe Ulcerative Colitis Failed to Achieve Primary or Secondary Endpoints at Week 12
AnaptysBio, Inc. reported that its investigational therapy rosnilimab was safe and well-tolerated but did not achieve the primary efficacy endpoint, mean change from baseline in the modified Mayo Score (mMS), or key secondary endpoints, including clinical response and remission at Week 12, in a global Phase 2 trial for moderate-to-severe ulcerative colitis. Placebo response rates were consistent with historical data. As a result, the company will discontinue the UC trial, leading to estimated cost savings of at least $10 million.
The Phase 2 randomized, double-blind, placebo-controlled, multicenter trial assessed rosnilimab’s safety and efficacy in 136 UC patients across the U.S. and Europe. Participants had a mean baseline mMS of 6.7 and had previously experienced inadequate response, loss of response, or intolerance to at least one conventional or advanced therapy. Around 50% had prior exposure to advanced treatments, and 62% had a Mayo Endoscopic Subscore (MES) of 3, indicating severe disease activity. Patients were randomized to receive 400 mg SC every four weeks (Q4W), 800 mg SC every two weeks (Q2W), or placebo.
At Week 12, rosnilimab showed no efficacy advantage over placebo, with clinical remission achieved by 7% of patients in both dosing groups and endoscopic remission achieved by 5% and 4%, respectively. Although early data indicated some improvement in remission rates between Weeks 12 and 24, the results at Week 24 did not meet the six-month target benchmarks.
Consistent with findings from the rheumatoid arthritis Phase 2b trial, biomarker analyses demonstrated ~90% depletion of pathogenic T cells at Week 12, which was sustained through Week 24. During the treatment extension period (TEP), patients transitioned to a 400 mg every 8 weeks (Q8W) regimen and maintained these reductions up to Week 50. Moreover, PD-1+ T cells in colonic tissue were significantly depleted at Week 12, mirroring effects observed in synovial tissue from the RA study, with similar reductions across both induction doses, indicating maximal pharmacologic activity was achieved at 400 mg Q4W.
Evoke Pharma Enters into Definitive Agreement to Be Acquired by QOL Medical
Evoke Pharma, Inc., a specialty pharmaceutical company, and QOL Medical, LLC, a privately held biopharmaceutical company, have entered a definitive agreement for QOL Medical to acquire Evoke for $11.00 per share in cash. The transaction, structured as a tender offer, has been unanimously approved by both Boards and is expected to close by the end of 2025.
The purchase price of $11.00 per share represents a significant premium of 139.7% to Evoke’s closing share price on November 3, 2025. This valuation reflects the strategic importance of Evoke’s commercial product, GIMOTI (metoclopramide) nasal spray.
GIMOTI is the first and only FDA-approved nasal spray formulation of metoclopramide indicated for the treatment of acute and recurrent diabetic gastroparesis in adults. Diabetic gastroparesis is a debilitating gastrointestinal disorder where gastric emptying is delayed, which can compromise the absorption of oral medications.
QOL Medical CEO Derick Cooper noted the acquisition is a natural extension of their capabilities, strengthening their existing GI portfolio and establishing them as a leader in specialty gastrointestinal care. Evoke CEO Matt D’Onofrio stated that QOL Medical is an ideal partner due to its strong commercial GI experience and commitment to continuity for the underserved diabetic gastroparesis community.
The transaction is not subject to a financing condition and will be funded by QOL Medical using cash on hand. GIMOTI carries a Boxed Warning for Tardive Dyskinesia, a serious and often irreversible movement disorder, and treatment duration should be avoided for longer than 12 weeks.
Eledon Presents Phase 2 BESTOW Trial Results for Tegoprubart in Kidney Transplant Rejection Prevention at ASN Kidney Week 2025
Eledon Pharmaceuticals presented positive Phase 2 BESTOW trial results for tegoprubart, an anti-CD40L antibody, for preventing organ rejection in de novo kidney transplant patients at the ASN Kidney Week 2025 Annual Meeting. The 12-month, randomized, head-to-head study compared tegoprubart-based immunosuppression (n = 63) with standard-of-care tacrolimus (n = 64).
While the primary endpoint, change in eGFR at 12 months, did not reach statistical significance, the mean eGFR for tegoprubart was numerically higher, representing what Eledon believes is the highest reported mean eGFR in this setting. Subgroup analyses showed particularly high eGFRs for tegoprubart in living-related donor and high-KDPI recipient groups.
The key finding was tegoprubart’s differentiated and superior safety profile, which successfully avoided the chronic toxicities associated with tacrolimus:
- Metabolic: New-onset diabetes after transplantation (NODAT) was significantly lower versus tacrolimus.
- Neurologic: Tremor incidence was markedly lower.
- Renal Recovery: Delayed graft function (DGF) occurred less often and required shorter dialysis time.
- Infections: Sepsis/bacteremia was also lower in the tegoprubart arm.
Regarding efficacy, the drug met the FDA-recognized composite efficacy failure endpoint (death, graft loss, and acute rejection), demonstrating non-inferiority to tacrolimus. Based on these results, which highlight strong maintenance of renal function and substantially reduced long-term toxicities, Eledon plans to advance tegoprubart into Phase 3 development.
