spevatamig (PT886) / Phanes Therap - LARVOL DELTA

Phase 1/2 study of spevatamig (PT886) in combination with gemcitabine plus nab-paclitaxel (GnP) in frontline (1L) treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). (ASCO-GI 2026) - P1/2 | "Overall, spevatamig + GnP is well tolerated, with no significant additive toxicity to GnP. Spevatamig + GnP showed promising efficacy when compared with published studies of GnP in 1L mPDAC, suggesting that spevatamig + GnP may provide additional clinical benefit to patients."

Combination therapy • Metastases • P1/2 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • CLDN18

Spevatamig (PT886), a claudin 18.2 (CLDN18.2)/CD47 bispecific antibody, in combination with gemcitabine plus nab-paclitaxel (GnP) in frontline (1L) treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). (ASCO 2026) - P1/2 | "Overall, spevatamig 2 mg/kg QW or 3 mg/kg QW + GnP is well tolerated, with no significant additive toxicity compared to the adverse event profile anticipated with GnP alone. The additional efficacy data from patients treated at the 2 mg/kg QW spevatamig + GnP dose level continues to demonstrate promise when compared to pivotal trials of GnP in 1L mPDAC; enrollment into the 3 mg/kg QW spevatamig + GnP dose level is ongoing with maturing efficacy data. These two dose levels exhibit good combinability with chemotherapy and can be assessed in future combination studies with novel targeted therapies such as KRAS inhibitors."

Bispecific • Combination therapy • Metastases • Oncology • Pancreatic Ductal Adenocarcinoma • CLDN18 • KRAS

Spevatamig, a bispecific antibody targeting Claudin 18.2 and CD47, as a monotherapy or in combination with chemotherapy as a second-line treatment for biliary tract cancer (BTC) (ESMO 2026) - No abstract available

Bispecific • Clinical • Combination therapy • Monotherapy • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor • CLDN18

Phanes Therapeutics Receives FDA Fast Track Designation for Spevatamig in Advanced and Metastatic Biliary Tract Carcinoma (PRNewswire) - "Spevatamig is currently in Phase 2 studies for the treatment of multiple forms of gastrointestinal cancers."

Fast track • Biliary Tract Cancer

Phanes Therapeutics, Inc…has expanded their clinical trial collaboration with Merck…to study spevatamig in combination with Merck's anti-PD-1 therapy, KEYTRUDA (pembrolizumab), and chemotherapy in 1L BTC. (PRNewswire)

Licensing / partnership • Biliary Tract Cancer

PT886 For Treatment of Patients With Metastatic/Advanced Gastric, Gastroesophageal Junction and Pancreatic Adenocarcinoma (the TWINPEAK Study) (clinicaltrials.gov) - P1/2 | N=114 | Recruiting | Sponsor: Phanes Therapeutics | N=72 ➔ 114

Enrollment change • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CLDN18

Phanes Therapeutics Announces Completion of Enrollment in Phase 2 Clinical Trial of Spevatamig in Combination with Chemotherapy for the Frontline Treatment of Metastatic Pancreatic Ductal Adenocarcinoma (PRNewswire) - "Two dose levels of spevatamig in combination with standard of care chemotherapy are being evaluated as frontline (1L) treatment for metastatic pancreatic ductal adenocarcinoma (PDAC) in the Phase 2 study....Topline results from the PDAC Phase 2 study are expected by 2026 year-end."

Enrollment status • P2 data • Pancreatic Ductal Adenocarcinoma

Phanes Therapeutics Announces Updated Phase 2 Clinical Trial Results of Spevatamig (PT886) in Combination with Chemotherapy in Frontline Treatment of Metastatic PDAC at the 2026 ASCO Annual Meeting (PRNewswire) - "The full poster presentation will be held on Saturday, May 30....2 mg/kg QW spevatamig + GnP showed promising efficacy (52.4% ORR, 90.5% DCR) when compared with the GnP arm in pivotal trials in 1L mPDAC; importantly, more than 90% of patients at this dose level had de novo metastatic disease....Median progression-free survival (mPFS) was 7.3 months, and median overall survival (mOS) was 14.7 months in US patients, where the median follow up time is 14.7 months. The efficacy data for 3 mg/kg spevatamig + GnP is still maturing....'The enrollment at the 3 mg/kg dose level is progressing rapidly and we hope to see efficacy data in the second half of 2026. We could be Phase 3 ready shortly after that'."

P2 data • Trial status • Pancreatic Ductal Adenocarcinoma

Resolved hematological toxicities associated with anti-CD47 agents using a bispecific design involving an optimized anti-CD47 arm: A clinical proof of concept study (AACR 2026) - "In spevatamig + pembrolizumab combination therapy (N=14), hematological AEs were similar to spevatamig monotherapy, with no neutropenia, only 1 patient experiencing Grade 1 thrombocytopenia, and anemia predominantly Grade 1/2. These clinical data are consistent with preclinical studies in dose range-finding studies in non-human primates. Our findings demonstrate that by adopting a bispecific design with one optimized anti-CD47 arm, CD47 can be safely targeted, enabling the opportunity to assess clinical efficacy of the molecule for patients with advanced malignancies."

Bispecific • Clinical • Oncology • CD47 • CLDN18 • SIRPA

Pharmacokinetics of spevatamig (PT886), a bispecific antibody targeting CLDN18.2 and CD47, in patients with advanced gastrointestinal cancers as monotherapy or combination therapy (AACR 2026) - "A total of 61 patients were included in this PK study: 31 patients with advanced GI cancers in spevatamig monotherapy dose escalation (0.1 mg/kg QW to 9 mg/kg Q2W) in a phase 1 trial, and 30 patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) treated with spevatamig in combination with gemcitabine plus nab-paclitaxel (GnP) in a phase 2 trial, where 2 mg/kg once-weekly (QW), 3 mg/kg QW and other exploratory regimens were tested. In conclusion, model-based simulations indicate that spevatamig exhibits dose-dependent, increase in exposures either in monotherapy or combinations at two statistically distinct potentially efficacious dose levels. Combinations with GnP did not alter spevatamig exposure at 2 mg/kg QW or 3 mg/kg QW; overall, spevatamig exhibited PK characteristics suitable for combinatorial clinical development."

Bispecific • Clinical • Combination therapy • Metastases • Monotherapy • PK/PD data • Gastrointestinal Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CLDN18

Reducing nausea and vomiting while maintaining the full potential for efficacy with spevatamig, a CLDN18.2xCD47 bispecific antibody (AACR 2026) - "In 35 patients, spevatamig was combined with gemcitabine + nab-paclitaxel (GnP) at dose levels (or weekly equivalent doses) from 2 mg/kg QW to 4 mg/kg QW, to assess safety, tolerability and efficacy in first-line (1L) pancreatic ductal adenocarcinoma (PDAC). Although the nausea rate is higher, all the events were effectively managed with no N/V related dose reductions or treatment discontinuation. The bispecific design of spevatamig, which contains an anti-Claudin 18.2 arm and an anti-CD47 arm, reduced the overall risk of N/V associated with CLDN18.2 targeting at potentially efficacious doses, enabling combinability with GnP for 1L PDAC and treatment adherence that may lead to better efficacy outcomes compared to chemotherapy."

Bispecific • Clinical • Biliary Cancer • Biliary Tract Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • CD47 • CLDN18

Phanes Therapeutics…announced that they will present updated Phase 2 results of spevatamig (PT886) in combination with chemotherapy in frontline (1L) treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) at the American Society of Clinical Oncology (ASCO) Annual Meeting (PRNewswire)

P2 data • Pancreatic Ductal Adenocarcinoma

Phanes Therapeutics announces dose expansion in clinical study of spevatamig in combination with chemotherapy for treatment of biliary tract cancer (PRNewswire) - "As of March 2026, more than 160 patients globally have been dosed with spevatamig collectively in monotherapy and combination therapy settings."

Trial status • Biliary Tract Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Pancreatic Ductal Adenocarcinoma

Phanes Therapeutics...announced that they will present three posters from their ongoing Phase 2 clinical trial with spevatamig (PT886), a first-in-class bispecific antibody targeting CLDN18.2 and CD47, at the American Association for Cancer Research (AACR) held on April 17-22 in San Diego, CA. (PRNewswire) - "All three posters will be presented under the Phase II and Phase III Clinical Trials Session."

P2 data • Biliary Tract Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Pancreatic Ductal Adenocarcinoma

Phanes Therapeutics Announces Positive Phase 2 Results of Spevatamig (PT886) in Combination with Chemotherapy in Frontline (1L) Treatment of Metastatic PDAC at ASCO GI 2026 (PRNewswire) - "As of December 12, 2025, 107 patients have been treated with spevatamig in the US collectively in monotherapy and combination settings. Of these patients, 42 with 1L mPDAC have been treated with spevatamig + GnP across several dosing regimens....In the 2 mg/kg QW spevatamig + GnP 1L mPDAC dosing regimen (n=15), the DCR was 93% and the ORR was 40% (6/15 achieved partial response, with 1 patient pending confirmation). The median progression-free survival (mPFS) was 7.3 months with a 6-month PFS rate of 59%. The median overall survival (mOS) was 13.2 months and still maturing while 6-month OS rate was 93%. Responses were observed across CLDN18.2 scores ≥ 10% (≥ 2+ staining)."

P2 data • Pancreatic Ductal Adenocarcinoma

Phanes Therapeutics to Present Phase 1/2 Study Results of Spevatamig (PT886) in Combination with Chemotherapy in Frontline (1L) Treatment of Metastatic PDAC at ASCO GI 2026 (PRNewswire)

P1/2 data • Pancreatic Ductal Adenocarcinoma

Phanes Therapeutics announces first biliary tract carcinoma (BTC) patient dosed in clinical study of spevatamig in combination with chemotherapy (PRNewswire)

Trial status • Biliary Tract Cancer

Spevatamig (PT886) as Monotherapy or in Combination With Chemo and/or ICI, for the Treatment of Patients With Advanced Gastric, Gastroesophageal Junction, Pancreatic Ductal or Biliary Tract Carcinomas (the TWINPEAK Study) (clinicaltrials.gov) - P1/2 | N=258 | Recruiting | Sponsor: Phanes Therapeutics | N=135 ➔ 258

Checkpoint inhibition • Enrollment change • Monotherapy • Biliary Cancer • Biliary Tract Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

PT886 for Treatment of Patients with Metastatic/Advanced Gastric, Gastroesophageal Junction and Pancreatic Adenocarcinoma (the TWINPEAK Study) (clinicaltrials.gov) - P1/2 | N=135 | Recruiting | Sponsor: Phanes Therapeutics | Trial completion date: Apr 2026 ➔ Apr 2028 | Trial primary completion date: Dec 2025 ➔ Dec 2027

Checkpoint inhibition • Combination therapy • Metastases • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CLDN18

Phanes Therapeutics Announces First Patient Dosed in Clinical Study of PT886 in Combination with KEYTRUDA (pembrolizumab) (PRNewswire) - "Phanes Therapeutics...announced today that the first patient has been dosed in the clinical study of PT886 in combination with Merck's anti-PD-1 therapy, KEYTRUDA (pembrolizumab). The dosing was conducted in a cohort of gastric and gastroesophageal junction cancers....The multi-center Phase I/II clinical trial of PT886 (NCT05482893), known as the TWINPEAK study, is currently evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT886 in patients with locally advanced or metastatic gastric, gastroesophageal junction and pancreatic cancers."

Trial status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

TWINPEAK phase I/II study, PT886 a bispecific antibody targeting claudin 18.2 and CD47 in combination with chemotherapy and/or pembrolizumab in gastric/GEJ-carcinomas or PDAC (ESMO 2024) - P1/2 | "In addition, patients that have progressed under zolbetuximab may still express CLDN18.2, benefiting from re-introduction of a CLDN18.2 targeted therapy with a differentiated mechanism of action such as the bispecific approach with CD47 (Cohort 5). Endpoints for further development include ORR, safety, OS and biomarkers. The study is adaptive and may further expand with an increase in sample size and additional cohorts."

Combination therapy • P1/2 data • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • CD47 • CLDN18

Phanes Therapeutics Announces First Patient Dosed in Clinical Study of PT886 in Combination with Chemotherapy (PRNewswire) - "Phanes Therapeutics...announced today that the first patient has been dosed in the clinical study of PT886 in combination with chemotherapy. Dosing has been completed in two cohorts: one for first-line treatment of pancreatic cancers and another for second-line treatment of gastric, gastroesophageal junction cancers....The multi-center Phase I/II clinical trial of PT886 (NCT05482893), known as the TWINPEAK study, is currently evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT886 in patients with locally advanced or metastatic gastric, gastroesophageal junction and pancreatic cancers that have progressed after all available standard therapy or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate."

Trial status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Pancreatic Cancer

Phanes Therapeutics’ PT886 granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma by the FDA (PRNewswire) - "Phanes Therapeutics, Inc...announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PT886 for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma....The multi-center Phase I clinical trial of PT886 (NCT05482893), known as the TWINPEAK study, is currently evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT886 in patients with locally advanced or metastatic gastric, gastroesophageal junction and pancreatic cancers..."

Fast track designation • Trial status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

PT886 For Treatment of Patients With Metastatic/Advanced Gastric, Gastroesophageal Junction and Pancreatic Adenocarcinoma (the TWINPEAK Study) (clinicaltrials.gov) - P1/2 | N=72 | Recruiting | Sponsor: Phanes Therapeutics | Phase classification: P1 ➔ P1/2 | Trial completion date: Apr 2024 ➔ Apr 2026 | Trial primary completion date: Nov 2023 ➔ Dec 2025

Combination therapy • Metastases • Phase classification • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CLDN18

Phanes Therapeutics, Inc. Announces Clinical Trial Collaboration and Supply Agreement with Merck to Evaluate PT886 in Combination with KEYTRUDA (pembrolizumab) (PRNewswire) - "Phanes Therapeutics, Inc...announced...that it has entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study PT886, its first-in-class bispecific antibody targeting claudin 18.2 and CD47, in combination with Merck's anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab), in patients with claudin 18.2 positive gastric or gastroesophageal junction (GEJ) adenocarcinomas...Phanes is currently enrolling patients in a multi-center Phase I clinical trial of PT886 in the U.S...in patients with locally advanced or metastatic gastric, GEJ, or pancreatic cancer..."

Enrollment open • Licensing / partnership • Gastroesophageal Junction Adenocarcinoma • Pancreatic Cancer