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.

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 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 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 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or the "Company"), reported that provides an operational update on the Company’s ongoing development activities for its lead product candidates, eftilagimod alpha ("efti" or "IMP321"), and IMP761, along with partner updates (Press release, Immutep, APR 3, 2018, View Source [SID1234525802]).

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Efti Clinical Update

The first two out of six patients of the additional cohort of the Company’s TACTI-mel (Two ACTive Immunotherapeutics in melanoma) Phase I clinical trial in Australia have commenced their treatment. This follows the recruitment of all 18 patients in the initial three cohorts of TACTI-mel and the subsequent expansion of the trial to include an additional cohort of six patients in February 2018. The TACTI-mel trial evaluates the combination of efti and anti-PD-1 therapy KEYTRUDA (pembrolizumab) in unresectable or metastatic melanoma patients, with the additional cohort receiving 30mg of efti in combination with pembrolizumab starting at cycle one of pembrolizumab. The Company plans to present data from the TACTI-mel trial in the middle of this calendar year.

In the AIPAC (Active Immunotherapy PAClitaxel) clinical trial, 33 out of a planned 34 clinical sites across Belgium, the Netherlands, Poland, Hungary, United Kingdom, France and Germany are now actively recruiting and treating patients. The trial evaluates efti in combination with paclitaxel in metastatic breast cancer. The study remains on track to be to be fully recruited with 226 patients in Q3 of calendar year 2018; first Progression Free Survival data are expected in calendar year 2019.

Six patients have now been recruited for the investigator-initiated Phase I clinical trial INSIGHT, which is being conducted in Frankfurt, Germany. These patients are receiving escalating doses of efti either via local (intratumoral) or loco-regional (intraperitoneal) injection. The objective of the study is to determine the recommended dose for each administration route for an intended Phase II clinical trial.

Following the Company’s announcement on 12 March 2018 of its collaboration and supply agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada), through a subsidiary, to evaluate the combination of Immutep’s lead immunotherapy product candidate, efti with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), Immutep is preparing to start its new clinical trial program TACTI-002 (Two ACTive Immunotherapies) in the second half of calendar 2018. This new trial will evaluate the combination of efti with KEYTRUDA in patients with advanced non-small cell lung cancer, head and neck cancer, or ovarian cancer. The Company plans to file the respective Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) in the first half of calendar 2018.

IMP761 Update

Immutep’s IMP761 (a LAG-3-specific antibody with unique agonistic properties) is currently being tested in vivo in animal models. IMP761 is the first known therapeutic agonist LAG-3 antibody. To our knowledge, no other company has developed a therapeutic agonist antibody to one of the three main immune checkpoint molecules, namely CTLA-4, PD-1 and LAG-3, as an immuno-suppressive drug for auto-immune diseases.

Efti Partnering Update

EOC Pharma

Immutep’s Chinese partner for efti, EOC Pharma, an oncology focused affiliate of Eddingpharm, received approval for the IND status in China and is expected to start clinical development in China with efti in H1 2018.

CYTLIMIC

Immutep is also pleased to report that its partner CYTLIMIC has started a Phase I clinical trial for adjuvant immunotherapy at the Yamaguchi University Graduate School of Medicine in Japan. The study is the second that will test CYTLIMIC’s cancer peptide vaccine in combination with efti.