peluntamig (PT217) / Phanes Therap - LARVOL DELTA

An open-label, multicenter, phase 1/2 study of peluntamig (PT217), an anti-DLL3/anti-CD47 bispecific antibody, in patients with DLL3-expressing cancers such as SCLC, LCNEC and EP-NEC (SKYBRIDGE study). (ASCO 2025) - P1/2 | "Patients will receive peluntamig and SOC paclitaxel...Patients will receive peluntamig + CE + atezolizumab...Patients will be backfilled to DLT-cleared dose levels to further evaluate safety, tolerability, PK and efficacy. Potentially active cohorts will be further investigated in dose randomization studies in Part B. (NCT05652686.)"

Clinical • IO biomarker • P1/2 data • Endocrine Cancer • Genito-urinary Cancer • Large Cell Carcinoma • Lung Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • CD47 • DLL3

Phanes Therapeutics announces first patient dosed in clinical study of peluntamig in combination with atezolizumab (PRNewswire) - "Phanes Therapeutics...announced today that the first patient has been dosed in the clinical study of peluntamig in combination with Roche's anti-PD-L1 monoclonal antibody atezolizumab (TECENTRIQ)....The multi-center Phase I/II clinical trial of peluntamig (NCT05652686), known as the SKYBRIDGE study, is currently evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of peluntamig in patients with advanced or refractory cancers expressing DLL3."

Trial status • Solid Tumor

Phanes Therapeutics Announces First Patient Dosed in Clinical Study of Peluntamig (PT217) in Combination with Chemotherapy (PRNewswire) - "Phanes Therapeutics, Inc...announced today that the first patient has been dosed in the clinical study of peluntamig (PT217) in combination with chemotherapy."

Trial status • Lung Cancer • Neuroendocrine Tumor • Prostate Cancer • Small Cell Lung Cancer

Phanes Therapeutics’ PT217 granted Fast Track Designation by the FDA for NEPC (PRNewswire) - "Phanes Therapeutics, Inc...announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PT217 for the treatment of patients with metastatic de novo or treatment-emergent neuroendocrine prostate cancer (NEPC)....The multi-center Phase I/II clinical trial of PT217 (NCT05652686), known as the SKYBRIDGE study, is currently evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of PT217 in patients with advanced or refractory cancers expressing DLL3. A Phase I clinical trial of PT217 is also ongoing in China (CTR20242720)."

Fast track • Neuroendocrine Tumor • Prostate Cancer

A Study of PT217 in Patients with Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study) (clinicaltrials.gov) - P1/2 | N=203 | Recruiting | Sponsor: Phanes Therapeutics | N=61 ➔ 203 | Trial completion date: Jun 2025 ➔ Aug 2028 | Trial primary completion date: Jan 2025 ➔ Dec 2027

Checkpoint inhibition • Enrollment change • Trial completion date • Trial primary completion date • Endocrine Cancer • Genito-urinary Cancer • Large Cell Carcinoma • Lung Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • DLL3 • EGFR

SKYBRIDGE study: An open-label, multicenter, dose escalation and dose expansion phase I/II study of PT217 as a monotherapy and in combination with an atezolizumab, in patients with SCLC, LCNEC and EP-NEC known to express DLL3 (ESMO 2024) - P1/2 | "In addition, a cohort in frontline SCLC will combine PT217 with Atezolizumab as a maintenance therapy after completion of platinum-based chemotherapy and Atezolizumab induction. The study is adaptive and based upon emerging data an increase in sample size and additional cohorts may be added."

Clinical • Combination therapy • IO biomarker • Monotherapy • P1/2 data • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • CD47 • DLL3

Phanes Therapeutics' PT217 receives Orphan Drug Designation for Neuroendocrine Carcinoma from the FDA (PRNewswire) - "Phanes Therapeutics, Inc...announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to PT217 for the treatment of neuroendocrine carcinoma (NEC)."

Orphan drug • Neuroendocrine Tumor • Oncology • Solid Tumor

A Study of PT217 in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study) (clinicaltrials.gov) - P1/2 | N=61 | Recruiting | Sponsor: Phanes Therapeutics | Phase classification: P1 ➔ P1/2

Phase classification • Endocrine Cancer • Genito-urinary Cancer • Lung Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • DLL3 • EGFR

Phanes Therapeutics, Inc. Announces Clinical Supply Agreement with Roche to Evaluate PT217 in Combination with an anti-PD-L1 Therapy (PRNewswire) - "Phanes Therapeutics...announced today that it has entered into a clinical supply agreement with Roche to study PT217, its first-in-class bispecific antibody targeting DLL3 and CD47, in combination with Roche's anti-PD-L1 therapy, atezolizumab, in patients with small cell lung cancer (SCLC), large cell neuroendocrine carcinoma of the lung (LCNEC) and extrapulmonary neuroendocrine carcinomas (EP-NECs)....Phanes is currently enrolling patients in a multi-center Phase I clinical trial of PT217. The Phase I clinical trial (NCT05652686), known as the SKYBRIDGE study."

Enrollment status • Licensing / partnership • Neuroendocrine Tumor • Small Cell Lung Cancer

Phanes Therapeutics' PT217 granted Fast Track Designation by the FDA (PRNewswire) - "Phanes Therapeutics...announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PT217 for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression following platinum chemotherapy with or without a checkpoint inhibitor....The multi-center Phase I clinical trial of PT217 (NCT05652686), known as the SKYBRIDGE study, is currently evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of PT217 in patients with advanced or refractory cancers expressing DLL3."

Fast track designation • Trial status • Neuroendocrine Tumor • Small Cell Lung 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 PT217 for Small Cell Lung Cancer and Other Neuroendocrine Cancers Expressing DLL3 (PRNewswire) - "Phanes Therapeutics, Inc...announced today that the first patient has been dosed in the Phase 1 clinical study...of PT217, a first-in-class native IgG-like bispecific antibody (bsAb) targeting DLL3 and CD47 for the treatment of small cell lung cancer and other neuroendocrine tumors....The multi-center Phase I clinical trial of PT217 is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT217 in patients with unresectable or small cell lung cancer (SCLC), large cell neuroendocrine cancer (LCNEC), neuroendocrine prostate cancer (NEPC) and gastroenteropancreatic neuroendocrine carcinoma (GEP-NEC) 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 • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer

A Phase 1 Study of PT217 in Patients With Advanced Refractory Cancers Expressing DLL3 (clinicaltrials.gov) - P1 | N=58 | Recruiting | Sponsor: Phanes Therapeutics | Not yet recruiting ➔ Recruiting | Initiation date: Jan 2023 ➔ Jun 2023

Enrollment open • Metastases • Trial initiation date • Endocrine Cancer • Genito-urinary Cancer • Lung Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • DLL3 • EGFR

A Phase 1 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of PT217 in Patients With Advanced Refractory Cancers Expressing DLL3 (clinicaltrials.gov) - P1 | N=58 | Not yet recruiting | Sponsor: Phanes Therapeutics

New P1 trial • Endocrine Cancer • Genito-urinary Cancer • Lung Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • DLL3 • EGFR

Phanes Therapeutics announces FDA IND clearance for PT217, an anti-DLL3/anti-CD47 bispecific antibody being developed for patients with small cell lung cancer and other neuroendocrine cancers (PRNewswire) - "Phanes Therapeutics, Inc...announced today that it has received clearance from the US Food and Drug Administration (FDA) to commence Phase I studies with PT217, its anti-Delta-like ligand 3 (DLL3)/anti-Cluster of differentiation 47 (CD47) bispecific antibody being developed for patients with small cell lung cancer (SCLC) and other neuroendocrine cancers....The Phase I study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of PT217 in subjects with advanced or refractory cancers. Patients with the following tumor types will be eligible for screening: unresectable SCLC, large cell neuroendocrine cancer (LCNEC), neuroendocrine prostate cancer (NEPC) and gastroenteropancreatic neuroendocrine tumors (GEP-NET)."

IND • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor

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

"#PhanesTherapeutics #PT217 receives #OrphanDrug Designation for #SmallCellLungCancer from the #FDA https://t.co/hYfyNxM99z" (@1stOncology)

FDA event • Orphan drug • Lung Cancer • Oncology • Solid Tumor

Phanes Therapeutics' PT217 receives Orphan Drug Designation for small cell lung cancer from the FDA (PRNewswire) - "Phanes Therapeutics, Inc...announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to PT217 for the treatment of small cell lung cancer (SCLC)."

Orphan drug • Lung Cancer • Oncology • Small Cell Lung 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

PT217, an anti-DLL3/anti-CD47 bispecific antibody, exhibits anti-tumor activity through novel mechanisms of action (AACR 2022) - "Furthermore, PT217 exhibits regular mAb-like manufacturability in process development and CMC. We expect to initiate a phase 1 trial to target SCLC in the first half of 2022."

IO biomarker • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • CD47 • DLL3 • 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

MAPT R406W increases tau T217 phosphorylation in absence of amyloid pathology. (PubMed, Ann Clin Transl Neurol) - "MAPT R406W is a tau mutation that leads to 3R+4R tauopathy similar to AD, but without amyloid neuropathology. These findings suggest that change in CSF pT217/T217 ratio is not specific to AD and might reflect common downstream tau pathophysiology common to 3R+4R tauopathies."

Journal • Alzheimer's Disease • Amyloidosis • CNS Disorders • Dementia • Frontotemporal Lobar Degeneration • Immunology • Movement Disorders • Progressive Supranuclear Palsy

[VIRTUAL] Clustering Biomarkers in Dominantly Inherited Alzheimer’s Disease (AAIC 2021) - " Cross sectional clinical and neuropsychological evaluation (Clinical Dementia Rating (CDR), Geriatric Depression Scale (GDS), Mini-Mental State Exam (MMSE)), structural magnetic resonance imaging (AD cortical signature), amyloid measures (amyloid positron emission tomography (PET) and CSF Aβ42 and 40), tau measures (CSF total tau and phosphorylated tau isoforms pT181, pT205, pT202, and pT217), and neurodegeneration measures (fluorodeoxyglucose (FDG) PET, serum NFL, CSF neurogranin, SNAP-25, VILLIP-1) and neuroinflammation (CSF YKL-40) were acquired in 130 mutation carriers (MC) and 79 non-carriers (NC) from the Dominantly Inherited Alzheimer Network observational study (Table 1)... Understanding the relationships biomarkers have with each other, as well as understanding which biomarkers are most reflective of disease processes, is vital for patient care and clinical trials. In this study, we have identified groups of biomarkers that are most similar to each other, as..."

Biomarker • Alzheimer's Disease • CNS Disorders • Dementia • Depression • Geriatric Disorders • Immunology • Inflammation • Psychiatry • Amyloid PET • CHI3L1 • CSF Aβ42 • CSF Neurogranin • CSF T-tau • FDG PET • MRI