On April 3, 2018 Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) (”Diffusion” or ”the Company”), a clinical-stage biotechnology company focused on extending the life expectancy of cancer patients, reported that management will present an overview of the Company and recent advancements of its lead product candidate, trans sodium crocetinate (TSC), at The MicroCap Conference to be held on April 9th and 10th at the Essex House in New York City (Press release, Diffusion Pharmaceuticals, APR 3, 2018, View Source;T=&Y=&D=&FID=1500109269&iid=4649065#new_tab [SID1234525201]).

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The presentation is scheduled for Monday, April 9, 2018 at 3:30 p.m. Eastern time.

To listen to the presentation live, investors may visit the investor relations section of Diffusion Pharmaceuticals’ website at www.diffusionpharma.com. An archived webcast of the presentation will also be available on the Company’s website for a period of time.

On April 3, 2018 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that interim data from its Phase 2 study of prexigebersen in combination with low-dose cytarabine (LDAC) (BP1001-201) for the treatment of acute myeloid leukemia (AML) has demonstrated that the combination therapy continues to be well-tolerated and has shown early anti-leukemic activity in nearly 50% of evaluable AML patients including four patients with complete remission and four with stable disease to date in this study (Press release, Bio-Path Holdings, APR 3, 2018, View Source [SID1234525173]).

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The open-label Phase 2 study is evaluating the efficacy and safety of prexigebersen in conjunction with LDAC, a therapeutic regimen well established in treatment of AML patients who cannot or elect not to be treated with more intensive chemotherapy. The primary objective of the study is to determine whether the combination of prexigebersen and LDAC provides greater efficacy than what would be expected with LDAC alone in this de novo patient population. The study had a pre-determined decision point at 19 evaluable patients in which the study would be terminated if less than 5 patients responded and the study would be expanded to 54 patients if five or more patients responded.

The interim analysis was performed on 17 evaluable patients instead of 19, since criteria to move to the next steps in the study had been met. Of the 17 evaluable patients, there were four patients who achieved complete responses, one patient who achieved a morphologic leukemia free state, two patients who had significantly reduced bone marrow blasts and four patients with stable disease. In total, 47% of the evaluable patients showed some form of response, including stable disease, to the combination treatment. The average age of patients in the study was 73.5 years old.

Based on the recommendations of the principal investigators of the study, the Company is amending the protocol to change the dosing schedule to that used in the Phase 1b study in relapsed and refractory AML patients in which a higher dose of prexigerbesen was administered prior to LDAC treatment starting at day 10 versus LDAC treatment starting on day four as was the case in the BP1001-201 study to date. In addition, the investigators endorse the inclusion of a decitabine cohort based on relatively new and positive data with this compound.

"We are very pleased with these encouraging interim data as they demonstrate the potential for the combination of prexigerbesen and LDAC to effectively treat these de novo AML patients. These early results are encouraging when you consider that the complete response rate in elderly AML patients greater than 65 years of age on LDAC alone have been estimated (Lin Journal of Clinical Oncology Abstract) to be only 10%1," noted Peter H. Nielsen, chief executive officer of Bio-Path. "We look forward to advancing the planned protocol amendments as we expect they will provide even better results for these patients suffering with AML. If successful, it will provide for approvals in the U.S. and Europe for both combination therapies."

On April 3, 2018 Esanex, Inc., a clinical stage company developing Heat Shock Protein inhibitors for the treatment of cancer, reported that it will present data at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place in Chicago from April 14 – April 18 (Press release, Esanex, APR 3, 2018, View Source [SID1234525168]). Data on Esanex’s pre-clinical studies of SNX-2112, the active form of SNX-5422, will be presented in a poster in the Experimental and Molecular Therapeutics track, in session PO.IM02.03 – Immune Mechanisms Invoked by Therapies 1.

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Poster Presentation Details:

Title: Transcriptomics analysis of SNX-2112 on immune and mitochondrial genes
Abstract No: 2758
Poster Board Number: 20
Date/Time: Monday, Apr 16, 2018 1:00 PM – 5:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 33

About SNX-5422
SNX-5422 is a chemically unique, orally active Hsp90 inhibitor that has provided durable clinical responses in open label trials in non-small cell lung cancer (NSCLC) and neuroendocrine tumors (NET). The potential of SNX-5422 in hematologic cancers is currently being explored in a chronic lymphocytic leukemia (CLL) open label clinical trial (clinicaltrials.gov ID#NCT02973399). With approximately 200 patients treated to date, SNX-5422 has a well-established safety profile that supports studying it in combination with existing approved drugs in a variety of clinical settings.

On April 3, 2018 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported that it will present complete data from the Phase 2 clinical trial of efgartigimod (ARGX-113) in myasthenia gravis at the 2018 American Academy of Neurology (AAN) Annual Meeting in Los Angeles, CA (Press release, argenx, APR 3, 2018, http://www.argenx.com/en-GB/news-internal/argenx-to-present-complete-data-from-the-phase-2-clinical-trial-of-efgartigimod-argx-113-in-myasthenia-gravis-at-the-american-academy-of-neurology-annual-meeting/30178/ [SID1234525166]).

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Details on the presentation are as follows:

Date & Time: Tuesday, April 24, 2018, 9:15 a.m. – 11:30 a.m. PT

Presentation Title: A double-blind placebo-controlled study to evaluate the safety and efficacy of
FcRn-antagonist efgartigimod (ARGX-113) in generalized myasthenia gravis

Investor Event and Webcast Information

argenx will host an investor event on Tuesday, April 24, 2018, beginning at 1:00 p.m. PT in Los Angeles to discuss the complete efgartigimod clinical data presented at AAN earlier that day. The event will be webcast live and can be accessed on the argenx website www.argenx.com or by clicking here.

About efgartigimod

Efgartigimod (ARGX-113) is an investigational therapy for IgG-mediated autoimmune diseases and was designed to exploit the natural interaction between IgG antibodies and the recycling receptor FcRn. ARGX-113 is the Fc-portion of an antibody that has been modified by the argenx proprietary ABDEG technology to increase its affinity for FcRn beyond that of normal IgG antibodies. As a result, ARGX-113 blocks antibody recycling through FcRn binding and leads to fast depletion of the autoimmune disease-causing IgG autoantibodies. The development work on ARGX-113 is done in close collaboration with Prof. E. Sally Ward (University of Texas Southwestern Medical and Texas A&M University Health Science Center, a part of Texas A&M University (TAMHSC)).

On April 3, 2018 Reata Pharmaceuticals, Inc. (Nasdaq:RETA) (Reata or Company), a clinical-stage biopharmaceutical company, reported the upcoming presentation of preclinical data for its novel RORγt inverse agonist RTA 1701 at the Annual Meeting of the American Association of Immunologists in Austin, Texas on May 6-7, 2018 (Press release, Reata Pharmaceuticals, APR 3, 2018, View Source;p=RssLanding&cat=news&id=2340738 [SID1234525163]). RTA 1701 is the lead product candidate from Reata’s proprietary series of RORγt inverse agonists for the potential treatment of a broad range of autoimmune, inflammatory, and fibrotic diseases. RTA 1701 is an orally-bioavailable, RORγt-selective, inverse agonist that demonstrates strong efficacy in rodent disease models. RTA 1701 potently suppresses production of IL-17A, a clinically important cytokine, in human immune cells and when dosed orally to non-human primates.

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Reata will present key preclinical data characterizing RTA 1701 in the following sessions:

Dulubova et al., "RTA 1701 is an orally-bioavailable, potent, and selective RORγt inhibitor that suppresses Th17 differentiation in vitro and is efficacious in mouse models of autoimmune disease." May 6, 2:30 pm CT.
Reisman et al., "RTA 1701 is an oral RORγt inhibitor that suppresses the IL-17A response in non-human primates." May 7, 2:30 pm CT.
"Our data with RTA 1701, and especially our primate proof-of-concept experiments, are highly encouraging," said Keith Ward, Ph.D., Reata’s Chief Development Officer. "We believe that a high, unmet need remains for patients with autoimmune and inflammatory disorders, and that RTA 1701 represents a promising small molecule development candidate in these indications." RTA 1701 was discovered by Reata, who holds global rights for the asset.

Reata plans to continue the development of RTA 1701 with a first-in-human study in 2018 that includes evaluation of IL-17A suppression with initial results expected by 1H19.

About RORγt

RORγt is the key transcription factor that orchestrates the differentiation of Th17 cells and drives production of key pro-inflammatory cytokines, including IL-17A. Aberrant IL-17A signaling has been implicated in many diseases, including chronic inflammatory and autoimmune diseases such as rheumatoid arthritis, psoriasis, inflammatory bowel disease, multiple sclerosis, and many others. Therefore, suppression of activity of RORγt via an inverse agonist such as RTA 1701 has the potential for broad activity across multiple therapeutic areas of high, unmet medical need.