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 | "Clinical Trial Registration Number: NCT05482893 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Combination therapy • Metastases • P1/2 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • 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=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

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

Phanes Therapeutics Announces the Establishment of Oncology Clinical Advisory Board (PRNewswire) - "Phanes Therapeutics, Inc...today announced that it has formed a Clinical Advisory Board (CAB) to enhance the development of its three clinical stage programs: PT199 for solid tumors, PT886 for gastric, gastroesophageal junction and pancreatic adenocarcinomas, and PT217 for small cell lung cancer and other neuroendocrine cancers....Members of Phanes' Clinical Advisory Board: Tony Mok..."

Commercial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor

Phanes Therapeutics Announces the Establishment of Oncology Clinical Advisory Board (PRNewswire) - "Phanes Therapeutics, Inc...today announced that it has formed a Clinical Advisory Board (CAB) to enhance the development of its three clinical stage programs: PT199 for solid tumors, PT886 for gastric, gastroesophageal junction and pancreatic adenocarcinomas, and PT217 for small cell lung cancer and other neuroendocrine cancers."

Commercial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor

Phanes Therapeutics Announces First Patient Dosed in Phase 1 Study of PT886 for Advanced Gastric, Gastroesophageal Junction and Pancreatic Adenocarcinomas (PRNewswire) - "Phanes Therapeutics...announced today that the first patient has been dosed in the phase 1 clinical study (NCT05482893) of PT886, a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47 for the treatment of gastric, gastroesophageal junction and pancreatic adenocarcinomas....The multi-center Phase I clinical trial of PT886 is 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 Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

A phase I, first-in-human, open-label, dose escalation and expansion study of PT886 in adult patients with advanced gastric, gastroesophageal junction, and pancreatic adenocarcinomas. (ASCO-GI 2023) - P1, P2 | "Preliminary safety and efficacy data are anticipated in the second quarter of 2023. Clinical trial information: NCT02178241."

Clinical • IO biomarker • Metastases • P1 data • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • CD47 • CLDN18 • SIRPA

PT886 For Treatment of Patients With Advanced Gastric, Gastroesophageal Junction and Pancreatic Adenocarcinomas (clinicaltrials.gov) - P1 | N=58 | Recruiting | Sponsor: Phanes Therapeutics | Not yet recruiting ➔ Recruiting | Trial completion date: Jan 2024 ➔ Apr 2024 | Initiation date: Aug 2022 ➔ Nov 2022 | Trial primary completion date: Aug 2023 ➔ Nov 2023

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CLDN18

PT886 For Treatment of Patients With Advanced Gastric, Gastroesophageal Junction and Pancreatic Adenocarcinomas (clinicaltrials.gov) - P1 | N=58 | Not yet recruiting | Sponsor: Phanes Therapeutics

New P1 trial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CLDN18

Phanes Therapeutics' anti-CD47 antibody patent granted in the US (PRNewswire) - "Phanes Therapeutics...announced today that the U.S. Patent and Trademark Office (USPTO) has granted the patent (Patent No. US 11,401,329) of its anti-CD47 antibodies. The patent relates to the invention of anti-CD47 monoclonal antibodies and bispecific antibodies comprising an anti-CD47 arm, including PT886, an anti-claudin18.2/anti-CD47 bispecific antibody being developed for gastric and pancreatic cancers, and PT217, an anti-DLL3/anti-CD47 bispecific antibody being developed for the treatment of small cell lung cancer."

Patent • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer

Phanes Therapeutics' PT886 granted Orphan Drug Designation for the treatment of pancreatic cancer by the FDA (PRNewswire) - "Phanes Therapeutics, Inc...announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to PT886 for the treatment of pancreatic cancer."

Orphan drug • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

Phanes Therapeutics announces FDA IND clearance for PT886, an anti-claudin18.2/anti-CD47 bispecific antibody being developed for patients with gastric, gastroesophageal junction, and pancreatic cancers (PRNewswire) - "Phanes Therapeutics...announced today that it has received clearance from the US Food and Drug Administration to commence Phase I studies with PT886, its anti-claudin18.2/anti-CD47 bispecific antibody being developed for patients with gastric, gastroesophageal junction (GEJ) and pancreatic cancers....'We have built a strong pipeline in immuno-oncology by leveraging our proprietary technology platforms and expect to file one additional IND with PT217, an anti-DLL3/anti-CD47 bispecific antibody for the potential treatment of small cell lung cancer and other neuroendocrine cancers'."

IND • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer

Phanes Therapeutics revealed manufacturing validation of its bispecific technology platforms PACbody and SPECpair at AACR 2022 (PRNewswire) - "Phanes Therapeutics, Inc...revealed that the company has completed the manufacturing scale production of a bispecific antibody constructed with its PACbody™ and SPECpair™ technologies....The lead molecule is PT886...being studied for pancreatic and gastric cancers, with a target IND filing date in Q2 2022....In addition to the PT886 poster, Phanes presented two other posters at AACR 2022 on PT199, an anti-CD73 mAb with a differentiated mechanism of action, and PT217, an anti-DLL3/anti-CD47 bispecific antibody, respectively."

Commercial • IND • Preclinical • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

PT886, an anti-claudin18.2/anti-CD47 bispecific antibody constructed with the PACbodyTM and SPECpairTM technology platforms, exhibits robust anti-tumor activity in a pancreatic cancer xenograft model (AACR 2022) - "These data support the proof of concept of the PACbody™ and SPECpair™ technology platforms and demonstrate the unique profile of our anti-CD47 arm that’s suitable for the bispecific antibody approach. PT886 is a first-in-class anti-CLDN18.2/anti-CD47 bispecific antibody with native IgG-like structure and phase 1 clinical trial is planned for the first quarter of 2022."

Preclinical • Gastric Cancer • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Pancreatic Cancer • Solid Tumor • CD47 • CLDN18 • CLDN8 • SIRPA

Phanes Therapeutics Announces Three Upcoming Presentations at the 2022 American Association for Cancer Research (AACR) Annual Meeting (PRNewswire) - "Phanes Therapeutics...announced today that three posters featuring its IND-enabling stage molecules will be presented at the upcoming 2022 American Association for Cancer Research (AACR 2022) Annual Meeting....'These are the first three lead molecules that are planned to enter Phase 1 clinical studies this year. More first-in-class bispecific antibody programs will follow from our pipeline after we file three INDs in 2022'....'The posters will showcase our deep science and how the preclinical data packages support our clinical development plans'."

IND • Preclinical • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor