On January 11, 2018 Rgenix, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and antibody cancer therapeutics, reported the publication of clinical and pre-clinical results by research collaborators at Rgenix and The Rockefeller University (Press release, Rgenix, JAN 11, 2018, View Source [SID1234523092]). The results of the collaboration, published in the January 11 online issue of Cell, reveal that the Liver-X Receptor/Apolipoprotein E (LXR/ApoE) pathway regulates anti-tumor immunity via effects on myeloid-derived suppressor cells (MDSCs).

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Rgenix Announces Publication In Cell Demonstrating Activation of LXR/ApoE with RGX-104 Enhances Antitumor Immunity

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MDSCs are an immunosuppressive cell population that have been found to be circulating at high levels in cancer patients who are also commonly found to be non-responders to immunotherapy. RGX-104 was able to deplete MDSCs both in cancer patients participating in the dose escalation portion of the Phase 1a/b trial and in mice. This resulted in robust activation of relevant T cell populations in both settings.

"We are pleased to have this opportunity to share our latest research results in Cell that illustrate the effects our first-in-class RGX-104 compound has on one of the key cells that are responsible for suppressing the immune response in cancer patients," said Masoud Tavazoie, M.D., Ph.D., and Chief Executive Officer and co-founder of Rgenix. "We believe RGX-104 represents a novel strategy for stimulating anti-tumor immunity, and this data cements this belief and furthers our resolve to continue developing this compound both as monotherapy as well as in combination with checkpoint inhibitor therapy."

Sohail Tavazoie, M.D., Ph.D., Leon Hess Associate Professor and Head of Elizabeth and Vincent Meyer Laboratory of Systems Cancer Biology at the Rockefeller University who was the senior-author of the study as well as co-founder of Rgenix, added: "The data our research has generated at this stage is exciting and supports our perspective that RGX-104 has the potential to modulate the immune response in a broad array of cancers. We will continue to progress in our research and our pursuit of unique treatments for patients affected by cancers with a high unmet medical need."

The paper, titled "LXR/ApoE Activation Restricts Innate Immune Suppression in Cancer", was published today and is available online.

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 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary immunotherapy cancer vaccine technology and targeted cancer therapies, reported the latest follow-up data from the Company’s Phase 1a trial of ProscaVax for prostate cancer (Press release, OncBioMune Pharmaceuticals, JAN 10, 2018, View Source [SID1234523118]). ProscaVax is OncBioMune’s novel immunotherapeutic cancer vaccine consisting of a combination of prostate cancer associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).

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In the trial, 20 hormone-naïve and hormone-independent recurrent prostate cancer patients with increasing PSA were treated with six intradermal injections of ProscaVax.

The latest data shows:

14 of 20 (70%) patients have increased PSA Doubling Time (PSADT – the time for serum PSA to double its value and a key metric of disease progression) post-initiation of ProscaVax immunotherapy. This demonstrates a slowing of tumor growth at a minimum of 31 weeks post-initiation of ProscaVax immunotherapy.
15 of 18 patients have increased immunity to PSA at 31 weeks post-initiation of ProscaVax immunotherapy.
Of the 20 patients that completed ProscaVax immunotherapy, 4 patients have shown disease progression at 31 weeks and one patient has chosen to withdraw from the study after week 19 without progression and entered another clinical trial.
As a subset, of the four patients that demonstrated disease progression at 31 weeks, 3 did not have an increase in their PSADT.
"This data continues to build upon an impressive data set from the study indicating that ProscaVax is inhibiting prostate cancer progression in patients that have failed today’s standard therapies. There is a body of evidence in relapsed and advanced prostate cancer patients that slowing the velocity of PSA increase and therefore increasing PSA doubling time has a significant impact on improving prognoses," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "In my view, not only would a therapy that can increase PSADT in a majority of patients obviously be extremely valuable in the therapeutic sense, but there is the possibility that monitoring PSADT can help identify patients that may require additional more aggressive treatment regimens due to inability to decrease PSA velocity. We look forward to mid-stage studies to better understand the clinical benefit of ProscaVax and the opportunity to improve clinical care in this area of unmet medical need."

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

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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: