PY314 / ImageneBio, Foundery Biosciences - LARVOL DELTA

Myeloid targeting antibodies PY159 and PY314 for platinum-resistant ovarian cancer. (PubMed, J Immunother Cancer) - "Both PY159 and PY314 were well tolerated, with an acceptable safety profile, as both single agents and in combination with pembrolizumab. Both agents warrant further investigation in heavily pretreated PROC."

Journal • Musculoskeletal Pain • Oncology • Ovarian Cancer • Solid Tumor

Foundery Immune Studio, LLC Acquires Rights to a Suite of Next-Generation Clinical Stage Immunotherapies (PRNewswire) - " Foundery Immune Studio, LLC...announced today its acquisition of worldwide rights for three clinical-stage immune tuning therapies from Ikena Oncology, Inc...Antibodies PY314 and PY159, targeting TREM2 and TREM1, respectively, completed Phase 1 trials and were well tolerated. Both antibodies demonstrated promising pharmacodynamic effects alone and in combination with pembrolizumab. The third program targeting MARCO, PY265, is Investigational New Drug (IND)-ready."

Commercial • Non Small Cell Lung Cancer • Ovarian Cancer

Dr Beckermann on the Investigation of PY314 Plus Pembrolizumab in ccRCC (OncLive) - "Kathryn Beckermann, MD, PhD, discusses the treatment of PY314 in combination with pembrolizumab in patients with clear cell renal cell carcinoma."

Video • Renal Cell Carcinoma

Dr Beckermann on the Investigation of PY314 Plus Pembrolizumab in ccRCC (OncLive) - P1a/1b | N=288 | NCT04691375 | Sponsor: Pionyr Immunotherapeutics Inc. | "Kathryn Beckermann, MD, PhD, genitourinary medical oncologist, assistant professor, medicine, Division of Hematology and Oncology, Department of Medicine, Vanderbilt University Medical Center, discusses the background of and outcomes observed in a phase 1a/1b study (NCT04691375) of PY314 in combination with pembrolizumab (Keytruda) in patients with clear cell renal cell carcinoma (ccRCC)....Investigators observed limited efficacy with the combination in this trial, she continues. Within this highly refractory patient population, only 1 patient achieved a partial response, and several patients experienced stable disease, Beckermann reports, adding that the median progression-free survival was 1.4 months. However, the primary end point of the study was met, with the combination deemed safe and tolerable, she explains."

P1 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

A phase 1b open-label study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of py314 in combination with pembrolizumab in patients with advanced renal cell carcinoma. (PubMed, Invest New Drugs) - P1a/1b | "The median PFS was 1.4 months (95% CI 1.2- 3.8). The combination of PY314 and pembrolizumab was safe, but the limited anti-tumor effect observed suggests that TREM2 targeting in conjunction with PD-1 blockade may not overcome resistance to prior CPI. Further investigation is warranted to determine if improved efficacy can be achieved in IO-naïve settings. Trial Registration: NCT04691375."

Combination therapy • Journal • Metastases • P1 data • PK/PD data • Fatigue • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Evaluation of Myeloid Targeting Agents, PY159 and PY314, in Two Dose Expansion Phase 1b Trials in Platinum-Resistant Ovarian Cancer (ESMO-IO 2023) - P1a/1b | "Conclusions Both PY159 and PY314 were well tolerated, with an acceptable safety profile, as a single agent and in combination with pembrolizumab. Both agents warrant further investigation in heavily pretreated PROC."

P1 data • Oncology • Ovarian Cancer • Solid Tumor

A Study of PY314 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b | N=288 | Active, not recruiting | Sponsor: Pionyr Immunotherapeutics Inc. | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Hormone Receptor Breast Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PD-1 • PD-L1 • TREM2

Pionyr Immunotherapeutics and Gilead Change Exclusive Option Agreement (Businesswire) - "Pionyr Immunotherapeutics, Inc...announced that Pionyr and Gilead Sciences, Inc...have mutually agreed to change their 2020 exclusive option agreements....As part of this agreement, Gilead waives its exclusive option to acquire Pionyr. Pionyr will be responsible for ongoing development of its pipeline, which includes PY159, PY314 and PY265. The company has the resources to advance its pipeline for the next two years. Within that timeframe, Pionyr will continue enrollment in Phase 1b expansion cohorts for both PY159 and PY314 in the refractory setting and is planning to add new frontline cohorts for both candidates. Pionyr has also completed IND-enabling studies for PY265 and will be ready to file an IND for that program in 2023."

IND • Licensing / partnership • Trial status • Oncology • Solid Tumor

A phase 1a dose-escalation study of PY314, a TREM2 (Triggering Receptor Expressed on Macrophages 2) targeting monoclonal antibody. (ASCO 2022) - "PY314 was well tolerated and has an excellent safety profile both as a single agent and in combination with pembrolizumab. A recommended dose for expansion was derived and enrollment in five prespecified cancers is ongoing."

P1 data • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • HER2 Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer • HER-2

Pionyr Immunotherapeutics’ Phase 1a Study of TREM2-targeting Antibody PY314 for the Treatment of Solid Tumors Featured at ASCO 2022 (Businesswire) - "Pionyr Immunotherapeutics, Inc...announced today that PY314, a monoclonal antibody targeting TREM2 (triggering receptor expressed on macrophages 2), was safe and well-tolerated in a Phase 1a dose-escalation study as a single agent and in combination with pembrolizumab at its label-approved dose. A maximum tolerated dose (MTD) was not observed over the range of PY314 doses tested and a dose for study expansion was recommended based on an analysis of clinical data (including PK exposure) in the context of supportive preclinical data models. The study will be featured in a poster presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 3-7 virtually and in Chicago."

P1 data • Oncology • Solid Tumor

Pionyr Immunotherapeutics Presents on Third Myeloid-Directed Therapeutic Program at Keystone Symposium (PRNewswire) - '"Our lead programs, PY314 (anti-TREM2) and PY159 (anti-TREM1), are currently in the clinic, and PY265 is on track to complete IND-enabling studies and enter the clinic in 2023.'"

IND • Oncology

Pionyr Immunotherapeutics Doses First Patient in Phase 1b Expansion Study of PY314 (PRNewswire) - "Pionyr Immunotherapeutics...announced today that the first patient has been dosed in Phase 1b expansion studies investigating PY314 in patients with solid tumors....This Phase 1b portion of the study follows Pionyr's Phase 1a dose escalation trial which evaluated the safety and tolerability of PY314 alone and in combination with pembrolizumab in multiple solid tumors. The multi-centered, US-based Phase 1a study has completed enrollment and determined a recommended Phase 1b dose for expansion."

Trial status • Oncology • Solid Tumor

A Study of PY314 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b; N=276; Recruiting; Sponsor: Pionyr Immunotherapeutics Inc.; Trial completion date: Oct 2022 ➔ Oct 2023; Trial primary completion date: Oct 2022 ➔ Oct 2023

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Breast Cancer • Colon Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Kidney Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PD-L1

Pionyr and Abcam extend partnership to evaluate TREM2-expressing cells in cancer patients (PRNewswire) - “Today Pionyr Immunotherapeutics, Inc…and Abcam…announced the extension of their collaboration with a new commercial licensing agreement to support the progression of PY314, the first to the clinic of Pionyr's compounds….Pionyr's Phase 1 clinical study will recruit patients with predefined tumor types where macrophages expressing TREM2 in the tumor microenvironment are most likely implicated as a driver of resistant metastatic disease. Under the terms of the agreement, Pionyr will evaluate Abcam's anti-TREM2 antibody to detect the presence of TREM2-expressing macrophages in tumor biopsy samples from patients enrolled in the first-in-human study.”

Licensing / partnership • Oncology • Solid Tumor

PIONYR Immunotherapeutics Initiates Phase 1 Clinical Study Of PY314 (PRNewswire) - "Pionyr Immunotherapeutics...announced the initiation of a Phase 1 clinical study investigating PY314 in patients with solid tumors...The Phase 1 study will enroll patients at multiple academic centers in the US and will evaluate PY314 as both a single agent and in combination with an approved checkpoint inhibitor."

New P1 trial • Oncology • Solid Tumor

Gilead Sciences Secures Exclusive Option to Acquire Pionyr Immunotherapeutics (Businesswire) - "Gilead Sciences, Inc…announced today that for $275 million the company will acquire a 49.9 percent equity interest in Pionyr Immunotherapeutics Inc…and an exclusive option to purchase the remainder of Pionyr. Under the agreement, Pionyr’s shareholders may receive up to an additional $1.47 billion in option exercise fees and future milestone payments…Pionyr plans to file investigational new drug (IND) applications with the U.S. Food and Drug Administration for both PY314 and PY159 in the third quarter of this year….Gilead may exercise its exclusive option upon completion of Phase 1b studies for PY314 and PY159, or at an earlier time if Gilead chooses to do so, for a $315 million option exercise fee and up to $1.15 billion in potential future milestone payment."

IND • M&A • Oncology • Solid Tumor