On January 10, 2018 Immix Biopharma, Inc., reported that it has received Human Research Ethics Committee (IRB) approval to begin a Phase 1/2a Open-Label, Dose-Escalation/Dose-Expansion Safety, Tolerability and Pharmacokinetic Study of IMX-110 in Participants with Advanced Solid Tumors ( View Source ) (Press release, Immix Biopharma, JAN 10, 2018, View Source [SID1234523373]).

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In preclinical studies, Immix flagship platform candidate Imx-110 demonstrated efficacy against pancreatic, gliobastoma, triple negative breast, colorectal, multiple myeloma and ovarian cancer models. Preclinical data from a syngeneic KPC pancreatic cancer model demonstrated not only a marked reduction in tumor size, but also a wholesale rearrangement of the immune system and tumor microenvironment with near complete disappearance of regulatory T and endothelial cells from tumor foci with simultaneous tumor infiltration by CD8 lymphocytes post-treatment.

This cross-tumor efficacy in diverse models is a testament to the far-reaching potential of the approach employed by Immix. "By creating a combination therapy which attacks the root drivers of cancer’s evolutionary adaptability and resistance to any therapy, we have the chance to really change the paradigm of chasing tumor adaptations and provide meaningful benefit to cancer patients," shares CEO and co-founder Ilya Rachman, MD, PhD, MBA.

Imx-110 is a first-in-class combination therapy designed to inhibit cancer resistance and evolvability, while inducing apoptosis. Imx-110 contains NF-kB/Stat3/pan-tyrosine kinase inhibitor curcumin combined with a small amount of doxorubicin, encased in a nano-sized delivery system for optimal tumor penetration. The nanoparticle is tunable in that it can be bound to various targeting moieties – delivering even more payload to tumors or other cell populations of interest, if needed.

The study’s Principal Investigator Professor de Souza shared, "We are excited to be able to partner with Immix in conducting this first-in-human study with a promising novel nanoparticle. I look forward to seeing what it can do in cancers that are traditionally difficult to treat." To stay updated on the latest clinical results or for queries, please contact:

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

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On January 10, 2018 Delcath Systems, Inc. (OTCQB:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that it has concluded a modification agreement with the U.S. Food and Drug Administration (FDA) for its Phase 3 clinical trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) to treat patients with hepatic dominant ocular melanoma (The FOCUS Trial). The modification agreement revises the FOCUS trial’s eligibility criteria to permit a greater extent of extra-hepatic disease by removing the size restriction, number and location of extra-hepatic lesions, in conjunction with a treatment plan for the extra-hepatic metastases.

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Commenting on the announcement, Jennifer K. Simpson, Ph.D., President and CEO of Delcath Systems, "We requested this protocol modification to improve patient access to this important clinical trial for appropriately selected and managed patients. In an ultra-orphan indication like ocular melanoma, striking the appropriate balance between eligibility criteria and patient access can be a challenge. We are pleased that the FDA agreed to this modification, and hope that once approved by the institutional review boards of our participating clinical trial sites, that this modification will help accelerate enrollment in this registrational trial."

PHP Therapy with Melphalan/HDS was developed by Delcath Systems as a targeted, whole organ therapy for the liver. It is commercially available as a device in Europe, where it is marketed as CHEMOSAT. The system has not been approved by the U.S. Food and Drug Administration, and is undergoing Phase 3 clinical testing in the U.S. as an investigational product.

Abstract #202913

Clinical significance of high expression of a specific solute carrier transporter in HCC (Abstracts, GenoScience, JAN 10, 2018, View Source [SID1234523060]).

Patricia Gifu, Sonia Brun, Guanxiong Wang, Firas Bassissi, Claude Caron de Fromentel, Philippe Merle, Philippe Halfon; Cancer Research Center of Lyon, Lyon, France; Genoscience Pharma, Marseille, France; Service d’Hepatogastroentérologie, Hôpital de la Croix Rousse, Lyon, France

Background: Hepatocellular carcinoma (HCC) is the third cause of cancer-related death. GNS561 (Genoscience Pharma, France) is a small molecule inducing apoptosis by lysosome inhibition and caspase activation. GNS561 has high hepatotropism and anti-tumorigenic capacity on tumor bulk and cancer stem cells. Its main target is a specific solute carrier transporter (SLCt). We describe here the clinical relevance of the overexpression of SLCt in HCC patients.

Methods: The expression of SLCt was investigated by iQRT-PCR in surgically resected HCC tumors (T) and the matched non-tumor (NT) liver tissues (n = 180) as well as healthy livers (HL) devoid of chronic or acute disease (n = 10). Pearson’s chi-squared test was employed for significant correlation tests while univariate and multivariate survival analysis were performed by Cox proportional hazard ratio (HR) method.

Results: SLCt was overexpressed in 40.5% of T and 30.3% of NT as compared to HL. High SLCt in T was associated with microvascular emboli (p = 0.034) and expression of the cancer stem cell markers Sox2 (p = 0.025) and CD133 (p = 0.034). High SLCt in NT correlated with cirrhosis (p = 0.009) and presence of satellite nodules (p < 0.001). Univariate analysis showed association between high SLCt in T and shortened overall survival (OS) (HR = 1.08, p = 0.020), lower progression-free survival (PFS) (HR = 1.76, p = 0.006) as well as early recurrence-free survival (ERFS) (within 2 years post-surgery) (HR = 1.88, p = 0.008). In multivariate analysis, high SLCt tended to be an independent factor for OS, and this was strongly significant for PFS and ERFS. High SLCt in NT, is quite a poor outcome factor on late recurrence-free survival (HR = 2.33, p = 0.056) together with cirrhosis in univariate analysis, but remained dependent of cirrhosis in multivariate analysis. Late recurrence is linked to the intrinsic tumorigenic status of the liver.

Conclusions: Overexpression of the SLCt in HCC tumors is associated to stemness features and appears as a poor outcome factor impacting on early recurrence. Further, SLCt in NT is associated with development of de-novo HCC. Validation cohorts and prospective assessments are needed to define high SLCt as a potential biomarker of HCC stemness and patient outcome.

On January 10, 2018 Abbvie presented JP Morgan Conference presentation (Presentation, AbbVie, JAN 10, 2018, View Source;t=1 [SID1234523053]).

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