CAM-H2 / Precirix - LARVOL DELTA

Patient Case Study - HER2+ Breast Cancer Patient with Brain Metastasis, Treated in a Phase 1/2 Study with the HER2-Directed Radiopharmaceutical, CAM-H2 (EANM 2024) - "She underwent a mastectomy and received systemic anti-cancer treatments including Tucatinib, Emtanzine-Trastuzumab, Trastuzumab, and Capectabine. Patient 001-001's case demonstrates the challenges associated with advanced HER2+ breast cancer with brain metastasis. CAM-H2 therapy showed encouraging imaging results without obvious clinical benefit. This was the first patient treated in the dose escalation part of the study and the patient received a total of 100mCi of the investigational product."

Case study • Clinical • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Dose Escalation Study to Evaluate Safety, Dosimetry, and PD of the HER2-Directed Radioligand CAM-H2 in Patients With Advanced HER2+ Breast, Gastric, GEJ, and Other HER2+ Solid Tumors (trial ID: NCT04467515) (SNMMI 2024) - P1/2 | "CAM-H2 demonstrated an acceptable safety profile at 50 mCi, 100 mCi and 150 mCi. Based on the dosimetry data gathered, bone marrow could be the dose limiting organ although we have not seen significant clinical signs of haematological toxicity. It is possible that bone marrow values may be artificially high due to spill over from the neighbouring kidney uptake as measurements are taken from the lumbar spine."

Clinical • Metastases • Cough • Gastric Cancer • Gastrointestinal Cancer • Hematological Disorders • Oncology • Pain • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Thrombocytopenia • HER-2

A Study to Evaluate Safety, Tolerability, Dosimetry, and Preliminary Efficacy of the HER2 Directed Radioligand CAM-H2 in Patients With Advanced/Metastatic HER2-Positive Breast, Gastric, and Gastro-Esophageal Junction (GEJ) Cancer (clinicaltrials.gov) - P1/2 | N=13 | Terminated | Sponsor: Precirix | Active, not recruiting ➔ Terminated; Per Strategic Sponsor decision

Metastases • Trial termination • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Tom Plitz commences role as Chief Executive Officer of Precirix (Precirix Press Release) - "Precirix...today announces that Tom Plitz has been appointed CEO of the company. Former CEO, Ruth Devenyns, will remain in an advisory role for the next month to ensure a smooth transition. The company is furthermore reinforcing its team of experts and received additional financial support from its investors to drive CAM-FAP towards the clinic and define the clinical development plan of CAM-H2."

Financing • Breast Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

A Study to Evaluate Safety, Tolerability, Dosimetry, and Preliminary Efficacy of the HER2 Directed Radioligand CAM-H2 in Patients With Advanced/Metastatic HER2-Positive Breast, Gastric, and Gastro-Esophageal Junction (GEJ) Cancer (clinicaltrials.gov) - P1/2 | N=13 | Active, not recruiting | Sponsor: Precirix | Recruiting ➔ Active, not recruiting | N=70 ➔ 13 | Trial completion date: Jan 2025 ➔ Jan 2024 | Trial primary completion date: Jan 2025 ➔ Dec 2023

Enrollment change • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Precirix raises EUR 80m in Series B to advance its pipeline of precision radiopharmaceuticals (PRNewswire) - "Precirix NV...announces the closing of a EUR 80m Series B financing round led by new investors INKEF Capital, Jeito Capital and Forbion as co-leads....The proceeds of this financing round will fund the development and expansion of Precirix's pipeline. More specifically, the company will advance CAM-H2 through its ongoing Phase I/II study, and plans to bring additional novel radiopharmaceuticals to the clinic. Precirix will also focus on further strengthening the platform, using its potential to generate new product candidates, linkers and CMC processes."

Financing • Breast Cancer • Gastric Cancer • Oncology • Solid Tumor

Precirix Dosed First Patients in Phase I/II Clinical Study Evaluating CAM-H2 in HER2-Positive Metastatic Cancernd update tracker (Businesswire) - "Precirix NV...announces that it has dosed the first patients in its Phase I/II clinical study of CAM-H2 for the treatment of HER2-positive metastatic cancer. This is a major milestone in the company’s development of its lead therapeutic asset....The Phase I/II clinical study will allow inclusion of patients with brain metastases, a population in dire need of effective therapies, and will enroll a total of appr. 70 patients."

Trial status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology

A Study to Evaluate Safety, Tolerability, Dosimetry, and Preliminary Efficacy of the HER2 Directed Radioligand CAM-H2 in Patients With Advanced/Metastatic HER2-Positive Breast, Gastric, and Gastro-Esophageal Junction (GEJ) Cancer (clinicaltrials.gov) - P1/2; N=70; Not yet recruiting; Sponsor: Camel-IDS NV; Initiation date: Sep 2020 ➔ Feb 2021

Clinical • Trial initiation date • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

A Study to Evaluate Safety, Tolerability, Dosimetry, and Preliminary Efficacy of the HER2 Directed Radioligand CAM-H2 in Patients With Advanced/Metastatic HER2-Positive Breast, Gastric, and Gastro-Esophageal Junction (GEJ) Cancer (clinicaltrials.gov) - P1/2; N=70; Not yet recruiting; Sponsor: Camel-IDS NV

Clinical • New P1/2 trial • Breast Cancer • Chronic Kidney Disease • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor