SAN DIEGO, May 28, 2026
Phanes Therapeutics announced updated positive Phase 2 clinical trial results for spevatamig (PT886) in combination with gemcitabine and nab-paclitaxel (GnP) as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The investigational therapy, a first-in-class anti-CLDN18.2/CD47 bispecific antibody, demonstrated promising efficacy and a manageable safety profile in one of the most aggressive and difficult-to-treat solid tumors. The updated findings support continued development of spevatamig and strengthen its potential as a novel immunotherapy option for pancreatic cancer patients with limited treatment alternatives.
Spevatamig Combination Achieves Promising Response Rates
Clinical results showed that patients treated with 2 mg/kg weekly spevatamig plus GnP achieved an objective response rate (ORR) of 52.4% and a disease control rate (DCR) of 90.5%, comparing favorably with outcomes reported in historical pivotal studies of standard chemotherapy. More than 90% of patients enrolled at this dose level had de novo metastatic disease, reflecting a patient population similar to those included in Phase 3 frontline pancreatic cancer trials.
Investigators also reported a median progression-free survival (mPFS) of 7.3 months and a median overall survival (mOS) of 14.7 months among U.S. patients, with a median follow-up duration of 14.7 months. The company noted that efficacy data from the ongoing 3 mg/kg cohort continue to mature and may support selection of the optimal dose for future registrational studies.
Novel Innate Immunity Enhancer Targets “Cold” Tumors
Advertisement
Spevatamig belongs to a new class of immuno-oncology therapies known as Innate Immunity Enhancers (I2Es). Unlike traditional immune checkpoint inhibitors that activate T cells, spevatamig is designed to stimulate macrophages and dendritic cells to recognize and eliminate cancer cells. This mechanism may offer a significant advantage in “cold tumors” such as pancreatic cancer, which historically demonstrate poor responses to checkpoint inhibitors.
The antibody simultaneously targets CLDN18.2, a tumor-associated antigen, and CD47, a key immune evasion signal used by cancer cells. According to Phanes, the optimized CD47-binding component helps reduce hematologic toxicity while improving gastrointestinal tolerability, with more than 190 patients treated globally across monotherapy and combination studies.
Phase 3 Development Plans Advance Following Positive Results
The company believes the updated Phase 2 findings provide a strong rationale for advancing spevatamig into a randomized Phase 3 clinical trial in first-line metastatic pancreatic cancer. Spevatamig has already received both FDA Orphan Drug Designation and Fast Track Designation for pancreatic cancer, highlighting its potential to address a significant unmet medical need.
Phanes is also evaluating the therapy in additional cancer indications and has established a clinical collaboration with Merck & Co. to investigate spevatamig in combination with Pembrolizumab. With enrollment continuing in the higher-dose cohort and additional efficacy data expected later in 2026, the company aims to rapidly progress spevatamig toward late-stage development and potential commercialization.
Source: Phanes Therapeutics press release
