Date: 2015-02-04
Type of information: Publication of results in a medical journal
phase: 1-2a
Announcement: publication of results in Haematologica
Company: Patrys (Australia)
Product: PAT-SM6 (recombinant human monoclonal IgM antibody targeting glucose-regulated protein 78)
Action
mechanism: monoclonal antibody. PAT-SM6 is a natural human IgM antibody which has been shown to have potent anti-cancer properties in a large number of laboratory and animal studies. More specifically, Patrys has screened PAT-SM6 against more than 200 tumours from individual patients with various cancers, and the product binds to over 90% of the tumours screened regardless of cancer type, patient age, gender or disease stage. Patrys has filed patent applications to cover the PAT-SM6 antibody molecule, disease target and the mechanism of action. PAT-SM6 has been granted orphan drug status in Europe and the USA for multiple myeloma.
Disease: multiple myeloma
Therapeutic area: Cancer - Oncology
Country: Germany
Trial
details: This open-label, single-centre, Phase I, multi-dose escalating study is investigating the safety and preliminary efficacy of an i.v. infusion of the anti-GRP78 monoclonal IgM antibody PAT-SM6 in patients with relapsed or refractory multiple myeloma. (NCT01727778)
Latest
news: * On February 4, 2015, Patrys announced that results from the PAT-SM6 Phase I/IIa, open-label study in patients with refractory or relapsed multiple myeloma(MM), have been published in a peerreviewed journal Haematologica. The article is currently available online and will be included in an upcoming print edition of the journal. The article provides a summary of the results of the clinical study conducted in twelve heavily pretreated MM patients that received four escalating doses of PAT-SM6, over a period of two weeks, via intravenous infusions at 0.3, 1, 3, and 6 mg/kg doses. Safety and tolerability, the primary objectives of this study, have been successfully supported with all doses administered found to be safe, well tolerated and the maximum tolerated dose (MTD) not reached. Four out of twelve patients (33.3 %) had stable disease after PAT-SM6 treatment across the dose cohorts 1, 3 and 6 mg/kg according to the International Myeloma Working Group (IMWG) criteria. The data is comparable to other antibodies under clinical development for the treatment of MM. Treatment of relapsed-refractory MM continues to present a therapeutic challenge, prompting a continued search for additional therapeutic options. The trial results are also important because they reflect in vivo activity in a difficult-to-treat patient population. Targeting GRP78, which is responsible for resistance in many cancers, highlights the prospective role of PAT-SM6 in combination with the existing therapies to overcome tumour resistance. The favorable safety profiles of PAT-SM6 make it a likely candidate for possible synergistic results in combination with other therapies while maintaining low toxicity. The publication also includes supplementary data on an interesting observation made during the course of the trial regarding immune mechanisms of PAT-SM6 and its possible role in overcoming tumour resistance. (GRP78-Directed Immunotherapy In Relapsed Or Refractory Multiple Myeloma- Results From A Phase 1 Trial With Monoclonal IgM Antibody PAT-SM6. Leo Rasche, Johannes Duell, Inês C. Castro, Valentina Dubljevic, Manik Chatterjee, Stefan Knop, Frank Hensel, Andreas Rosenwald, Hermann Einsele, Max S. Topp, Stephanie Brändlein. Haematologica January 2015 Doi:10.3324/haematol.2014.117945)
