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 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 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the MD Anderson Cancer Center ("MD Anderson"), reported it has expanded the Company’s development pipeline for the treatment of acute myeloid leukemia ("AML") with an immuno-stimulating STAT3 inhibitor (Press release, Moleculin, JAN 10, 2018, View Source [SID1234523052]).

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"Leading experts in the treatment of AML, Dr. Jorge Cortes and Dr. Sanjay Awasthi have now asked us to expand our clinical research to include WP1066, our immuno-stimulating agent and STAT3 inhibitor, to increase therapeutic options for AML patients," commented Walter Klemp, Chairman and CEO of Moleculin. "This would potentially be complementary and synergistic with Annamycin and existing first line treatments and could position us as a leader in the advancement of leukemia treatments."

Dr. Sanjay Awasthi, Professor of the Department of Internal Medicine, Division of Hematology & Oncology, Texas Tech University Health Sciences Center and Medical Director, Southwest Cancer Center Lubbock, Texas, added, "The apparent ability in pre-clinical trials of WP1066 to stimulate the patient’s natural immune response and simultaneously inducing tumor cell death by inhibiting the activated form of STAT3 is highly promising and unique. Importantly, based on current scientific findings, such properties should be extremely valuable in developing improved treatments for AML patients and expanding their therapeutic options.

"We are clearly excited to see what Moleculin’s Annamycin can do for relapsed or refractory AML patients in the Company’s recently launched clinical trial," continued Dr. Awasthi, "thus given the potential for an even broader arsenal of AML drugs, we are encouraging Moleculin to expand their AML clinical research to include this novel immuno-stimulating STAT3 inhibitor drug candidate."

Another noted AML expert, Dr. Jorge Cortes, is also encouraging Moleculin’s clinical expansion, commenting: "AML appears to be associated with a significant increase in the activation of STAT3 and many of us in the AML clinical community have been eager to test the ability of a STAT3 inhibitor to treat AML patients. Part of the difficulty in pursuing this path has been finding a safe and effective STAT3 inhibitor and, if successful, WP1066 may have finally opened this pathway."

Mr. Klemp concluded: "Of course, our first priority will be to demonstrate single agent activity in both Annamycin and WP1066, but we see exploring the potential for synergistic effect as a longer-term opportunity as well."

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.

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.