AMP-224 / AstraZeneca, GSK - LARVOL DELTA

A pilot study of AMP-224—a PD-1 inhibitor—in combination with stereotactic body radiation therapy (SBRT) in patients with metastatic colorectal cancer (ASCO-GI 2015) - Abstract #TPS788; P=NA, N=NA; "The objectives are to determine the safety, tolerability and feasibility of AMP-224 in combination with stereotactic body radiation therapy (SBRT) to metastatic hepatic metastasis in patients with advanced colorectal cancer."

Clinical protocol • Colorectal Cancer • Oncology

A Pilot Study of the PD-1 Targeting Agent AMP-224 Used With Low-Dose Cyclophosphamide and Stereotactic Body Radiation Therapy in Patients With Metastatic Colorectal Cancer. (PubMed, Clin Colorectal Cancer) - "AMP-224 in combination with SBRT and low-dose cyclophosphamide was well tolerated, however, no significant clinical benefit was observed in patients with mCRC."

Clinical • Journal • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Clinical and pharmacodynamic (PD) results of a phase I trial with AMP-224 (B7-DC Fc) that binds to the PD-1 receptor (ASCO 2013) - Presentation time: Monday, Jun 3, 8:00 AM - 11:45 AM; Abstract #3044; P1, N=42; Sponsor: Amplimmune; NCT01352884; "31% of baseline tumors were B7-H1+. Several PD readouts in the periphery showed reductions in PD-1HIcells and emergence of a functional T cell response (increases in IFNg+, TNFa+, IL-2+ CD4 and CD8 T cells) in individual patients where partial response, stable disease, and mixed responses were seen."

P1 data • Oncology

Phase I study of safety, tolerability, pharmacokinetics, and pharmacodynamics of AMP-224 (B7-DC Fc fusion protein) in a regimen containing cyclophosphamide (CTX) in patients with advanced solid tumors (AACR 2013) - Abstract#: LB-193; P1, N=42; Sponsor: Amplimmune; NCT01352884; "Two dose-limiting toxicities were observed, 1 each at 10 mg/kg (infusion reaction) and 30 mg/kg (flu-like symptoms). Infusion reactions were common (61%) across all doses but manageable with pre-medications. Common treatment-related adverse events (all grades) were chills (54%), fatigue (34%) flushing (34%), nausea (32%), vomiting (29%), fever (27%), and headache (22%). No drug-related inflammatory adverse events were identified."

Adverse events • P1 data • Oncology

MedImmune strengthens immune-mediated cancer therapy portfolio with acquisition of Amplimmune (AstraZeneca International Press Release) - "AstraZeneca...announced that MedImmune...has entered into a definitive agreement to acquire Amplimmune...acquisition will bolster MedImmune’s oncology pipeline by obtaining multiple early-stage assets for its immune-mediated cancer therapy (IMT-C) portfolio, including AMP-514...with the aim of an investigational new drug (IND) filing before the end of 2013....The proposed transaction is subject to customary regulatory approvals and is expected to close in the third quarter of 2013...Amplimmune has rapidly developed three biologic product candidates: AMP-224 is in Phase 1b trials in cancer; AMP-110 for autoimmune diseases in partnership with Daiichi Sankyo; and AMP-514 for cancer."

Anticipated IND • M&A • Oncology

MedImmune completes acquisition of Amplimmune (AstraZeneca Press Release) - "AstraZeneca...announced that on 4 October MedImmune...completed its acquisition of Amplimmune...the acquisition bolsters MedImmune’s oncology pipeline by obtaining multiple early-stage assets for its immune-mediated cancer therapy (IMT-C) portfolio, including AMP-514...MedImmune acquired 100 per cent of Amplimmune’s shares for an initial consideration of $225 million and deferred consideration of up to $275 million based on reaching predetermined development milestones."

M&A • Oncology

A pilot study of AMP-224, a PD-L2 Fc fusion protein, in combination with stereotactic body radiation therapy (SBRT) in patients with metastatic colorectal cancer (ASCO-GI 2016) - P1, N=17; NCT02298946; "AMP-224 in combination with SBRT to site of colorectal hepatic metastases is safe and feasible. Preliminarily no objective responses have been seen. Full clinical and correlative data including post-therapeutic radiated and non-radiated tumor biopsies will be presented."

P1 data • Colorectal Cancer • Oncology