Polaris Group’s ADI‑PEG 20 Shows Promising Clinical Activity in NSCLC When Combined with Standard First Line Chemotherapy Regimen

On January 10, 2018 Polaris Group reported that the combination of its lead therapeutic ADI‑PEG 20 (pegylated arginine deiminase) with the standard first-line chemotherapy cisplatin + pemetrexed doublet (PemCis) has shown promising clinical activity in an ongoing phase 1 study cohort of non-squamous non-small cell lung carcinoma (NSCLC) patients (Press release, Polaris Pharmaceuticals, JAN 10, 2018, View Source [SID1234526281]). The results will be presented by Dr. Peter Szlosarek from Barts Cancer Institute, London, at the fifth AACR (Free AACR Whitepaper)-IASLC International Joint Conference in San Diego.

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Twenty-one chemo-naïve NSCLC patients were enrolled in the single-arm, open label study to assess the safety and preliminary activity of ADI+PemCis. The treatment was well tolerated, and demonstrated robust tumor responses. Ten patients (47.6%) had a partial response, and 8 patients (38.1%) had stable disease for a disease control rate of 85.7%.

"We are excited to see that ADI+ PemCis demonstrated robust anti-tumor activity in the chemo-naïve NSCLC patients," said John Bomalaski, M.D., Executive Vice President, Medical Affairs at Polaris Pharmaceuticals, Inc. "There have been many exciting developments for NSCLC treatment in the past few years, especially in the area of immunooncology. We are planning new clinical studies that would combine ADI‑PEG 20 with standard chemotherapy as well as immunooncology therapy to maximize treatment effect for cancer patients."

About ADI-PEG 20

ADI‑PEG 20 is a biologic being developed by Polaris Group to treat cancers carrying a major metabolic defect that renders them unable to internally synthesize arginine. Because arginine is essential for protein synthesis and survival of cells, these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI‑PEG 20 is designed to deplete the external supply of arginine, causing arginine-dependent cancer cells to die while leaving the patient’s normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine-dependency and can potentially be treated with ADI‑PEG 20.

LIDDS: NanoZolid® with immune-stimulating agent confirms efficacy in an additional cancer model

On January 10, 2018 LIDDS reported that it has successfully completed another preclinical study in mice assessing the feasibility of using the NanoZolid drug delivery technology for intratumoral immunotherapy (Press release, Lidds, JAN 10, 2018, https://www.globenewswire.com/news-release/2018/01/10/1286736/0/en/LIDDS-NanoZolid-with-immune-stimulating-agent-confirms-efficacy-in-an-additional-cancer-model.html [SID1234555920]). Clear anti-tumor effects have been observed in another cancer model in mice where significant decreases in tumor growth was demonstrated.

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LIDDS has several projects ongoing that focus on assessing the feasibility of using the NanoZolid-technology for local or intratumoral immunotherapy. These studies aim at a local intratumoral delivery of an immune-stimulatory agent.

The confirmed anti-tumor effect of an immune-stimulating agent formulated using the NanoZolid-technology in two independent cancer models in mice, will trigger the initiation of follow-on studies. The possibility that local immune-stimulation using the NanoZolid-technology will increase the effects of systemic immunotherapy will be investigated. Results are expected during the next four months.

A locally delivered immunotherapy has the potential to act either as a monotherapy or in combination with systemic immunotherapies e.g. checkpoint inhibitors. Successful combination treatments could significantly increase the response rates and efficacy rates of current immunotherapies. As immuno-oncology is the fastest growing area in oncology, reaching a market size over 100 billion USD by 2022, these results should be of great interest to pharmaceutical companies seeking new combination modalities to increase the response rate and efficacy of their immunotherapy drugs.

A recent review article in the highly ranked journal Annals of Oncology highlights the unique opportunity of intratumoral treatments to increase the efficacy of immunotherapy while reducing the potential side-effects, View Source

Immunotherapy for the treatment of cancer aims to activate and utilize the body’s own immune system to recognize and attack tumors and cancer cells and is today the most promising area of cancer research.

Corporate Presentation 36th Annual J.P. Morgan Heathcare conference

On January 10, 2018 PTC Therapeutics presented at the 36th Annual J.P. Morgan Healthcare Conference (Presentation, PTC Therapeutics, JAN 10, 2018, View Source [SID1234523051]).

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RADIOMEDIX AND AREVA MED ANNOUNCE INITIATION OF PHASE 1 CLINICAL TRIAL OF ALPHAMEDIX(TM), A TARGETED ALPHA THERAPY FOR PATIENTS WITH NEUROENDOCRINE TUMORS

On January 10, 2018 RadioMedix Inc. and AREVA Med reported the initiation in the United States of Phase I trial for AlphaMedixTM in patients with somatostatin receptor positive neuroendocrine tumors (Press release, RadioMedix, JAN 10, 2018, View Source [SID1234525019]). AlphaMedixTM is composed of a somatostatin (SST) analogue radiolabeled with 212Pb, an isotope used for Targeted Alpha-emitter Therapy (TAT).

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"Targeted Alpha-emitter Therapy (TAT) is the wave of the future in nuclear oncology and has a tremendous potential to treat patients with NET and overcome some of the limitations of current Peptide Receptor Radionuclide Therapy (PRRT)" said Dr. Ebrahim S. Delpassand, Chairman and CEO of RadioMedix, sponsor of the trial.

"Building on compelling preclinical results, I trust that this study with the combination of our excellent research and clinical teams and AREVA Med’s expertise in 212Pb-labeled radiotherapeutics development, will mark an important milestone in TAT" added Dr. Izabela Tworowska, CSO of RadioMedix.

This open-label, dose escalation study’s objective is to determine safety, bio-distribution, and preliminary effectiveness of 212Pb-AR-RMX in adult patients with differentiated NETs. Patients will be enrolled at Excel Diagnostic and Nuclear Oncology Center (Houston, TX).

"Excel Diagnostics and Nuclear Oncology Center (EDNOC) was the first institution in the United States to conduct a clinical trial using Lu-177 DOTATATE PRRT, making this therapy available to NET patients. EDNOC in continuation of its tradition, will be the first center to pioneer TAT in the U.S." added Dr. Delpassand, Medical Director of EDNOC.

"AREVA Med has for many years been focused on setting up a reliable production of 212Pb and developing therapeutics using this promising isotope. Our collaboration with RadioMedix and this Phase 1 trial is an important accomplishment as we believe that 212Pb-based therapies will have a significant impact on difficult to treat tumors. In this context, AlphaMedixTM could prove to be particularly appropriate for patients suffering from NETs and go beyond limitations of existing treatments" said Julien Dodet, AREVA Med’s CEO.

Intrexon Corporation Presentation, dated January 10, 2018.

On January 10, 2018 Intrexon Corporation presented Presentation, dated January 10, 2018 (Presentation, Intrexon, JAN 10, 2018, View Source [SID1234523050]).

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