On June 20, 2018 Aminex Therapeutics, Inc., a clinical-stage drug development company focused on advancing a novel cancer immunotherapy, reported it received clearance from the Food and Drug Administration to initiate the first Phase 1 clinical trial of its immuno-oncology drug candidate AMXT 1501, a small molecule polyamine uptake inhibitor, and the approved drug DiFluoroMethylOrnithine (DFMO, eflornithine), a polyamine synthesis inhibitor (Press release, Aminex Therapeutics, JUN 20, 2018, View Source [SID1234527410]). This immunotherapy treatment will be evaluated in patients with a broad range of advanced solid tumor cancers.

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The open label, multicenter, dose-escalation trial will evaluate the safety and tolerability of AMXT 1501 alone, and in combination with DFMO, in more than 50 patients with advanced solid tumors. The trial will include a dose-ranging stage followed by an expansion phase. Evaluation of pharmacokinetics, pharmacodynamics and clinical response rates will be assessed. The trial is listed on the NIH clinical trial registry www.clinicaltrials.gov (Identifier: NCT03536728). NEXT Oncology of San Antonio, Texas is the first of four clinical sites planned for this trial. The first cancer patient received an initial dose on June 12, 2018.

"Initiating this first trial of our unique immunotherapy approach represents a significant milestone for Aminex Therapeutics. We are extremely excited to begin clinical evaluation of this investigational therapy that has demonstrated significant promise in many preclinical studies involving multiple animal solid tumor cancer models," said Jim Skaggs, Chief Executive Officer and Chairman of the Board of Aminex Therapeutics. "The primary goal of this trial is to determine the safety and appropriate dosage of AMXT 1501 and DFMO in combination. Efficacy indications will also be assessed. We are also pleased to announce the closure of a $10 million series B financing to support our clinical development efforts."

Aminex Therapeutics’ immunotherapy approach combines the company’s oral, small molecule polyamine uptake inhibitor, AMXT 1501, with the off-patent polyamine synthesis inhibitor, DFMO, approved for African sleeping sickness. AMXT 1501 is designed to work in conjunction with DFMO to constrain the production and uptake of polyamines – molecules found in high concentrations in cancer cells and linked to immune system suppression. Reducing polyamines and, in turn, decreasing myeloid-derived suppressor cells in the tumor microenvironment, allows for activation of the immune system to attack solid tumors. In preclinical studies involving multiple cancer models, AMXT 1501 + DFMO has been shown to be especially effective against cancers driven by MYC and RAS, two major oncogenes known to promote the development of many types of solid tumor cancers.

Aminex Therapeutics, which is led by an experienced management team, board of directors and scientific advisory board, announced the strengthening of its leadership team with the earlier appointments of Roger Ulrich, Ph.D. to its Board of Directors and Stephen B. Baylin, M.D., as member of the Scientific Advisory Board and clinical advisor. Dr. Ulrich is a founder of Calistoga Pharmaceuticals and formerly with Acerta Pharma, Merck, Abbott Laboratories and The Upjohn Company. He currently serves as director for Acerta Pharma, Remedy Pharmaceuticals and is a Senior Advisor to Frazier Healthcare Partners. Dr. Baylin is Virginia and D.K. Ludwig Professor of Oncology and Medicine, Co-Director of the Cancer Biology Division and Associate Director for Research Programs of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

On June 20, 2018 SillaJen, Inc., (KOSDAQ:215600), a clinical-stage, biotherapeutics company focused on the development of oncolytic immunotherapy products for cancer, reported the first patient has been enrolled in REN026, the Phase 1b clinical trial of Pexa-Vec (pexastimogene devacirepvec) in combination with cemiplimab (REGN2810) for the treatment of renal cell cancer (RCC) (Press release, SillaJen, JUN 20, 2018, View Source [SID1234527430]). The first patient was enrolled in the United States, with expansion to sites in South Korea and Australia anticipated over the coming weeks.

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SillaJen is collaborating with Regeneron to evaluate Pexa-Vec, SillaJen’s lead clinical candidate, in combination with Regeneron’s cemiplimab, an anti-PD1 monoclonal antibody. The aim of the trial is to assess the safety and efficacy of the combination in patients with unresectable or metastatic renal cell carcinoma. The study will also investigate the immune modulating potential of Pexa-Vec given concurrently with checkpoint inhibitor therapy by evaluating multiple blood and tissue biomarkers.

"Given the initial activity seen with Pexa-Vec monotherapy and the potential of oncolytic viruses to enhance anti-tumor immunity, combining Pexa-Vec with cemiplimab is quite rational and has the promise to build upon the activity of checkpoint inhibitor therapy alone in RCC. This trial will not only assess the clinical activity of the two agents but allow us to assess in more depth the changes elicited in anti-tumor immunity following treatment by examining peripheral blood and tumor samples. This will give us proof of concept data that will help us expand this approach to other tumor types," stated James Burke, M.D., chief medical officer at SillaJen.

About Pexa-Vec and the SOLVE Platform
Pexa-Vec is the most advanced product candidate from SillaJen’s proprietary SOLVE (Selective Oncolytic Vaccinia Engineering) platform. The vaccinia strain backbone of Pexa-Vec has been used safely in millions of people as part of a worldwide vaccination program, and over 300 cancer patients have been treated with Pexa-Vec to date. Pexa-Vec was engineered to target common genetic defects in cancer cells by deleting their thymidine kinase (TK) gene, thus making Pexa-Vec dependent on the cellular TK expressed at persistently high levels in cancer cells. Pexa-Vec is also engineered to express granulocyte-macrophage colony stimulating factor (GM-CSF) protein. GM-CSF complements the cancer cell lysis of the product candidate, leading to a cascade of events resulting in tumor necrosis, tumor vasculature shutdown and sustained anti-tumoral immune attack. Pexa-Vec has been shown to be effective when delivered both intratumorally and systemically by intravenous administration. Pexastimogene devacirepvec (Pexa-Vec) is currently being evaluated in a worldwide Phase 3 clinical trial for advanced primary liver cancer, and more information can be found at: View Source

On June 20, 2018 ERYTECH Pharma (Euronext Paris:ERYP) (Nasdaq:ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that Chief Executive Officer, Gil Beyen, will present at the JMP Securities Life Science Conference, June 20, 2018 at The St. Regis, New York, in New York City (Press release, ERYtech Pharma, JUN 20, 2018, View Source;p=RssLanding&cat=news&id=2355228 [SID1234527399]).

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Conference Details:

– Conference: JMP Securities Life Science Conference

– Date: June 20, 2018

– Presentation Time: 9:00 AM EDT / 3:00 CET

On June 20, 2018 Abbott (NYSE: ABT) reported that it will announce its second-quarter 2018 financial results on Wednesday, July 18, 2018, before the market opens (Press release, Abbott, JUN 20, 2018, View Source [SID1234527401]).

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The announcement will be followed by a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern), and will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the call will be available later that day.

On June 20, 2018 Atossa Genetics Inc. (ATOS) ("Atossa" or the "Company"), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, reported that it has completed dosing and clinical visits in its Phase 1 study of its proprietary topical Endoxifen in men (Press release, Atossa Genetics, JUN 20, 2018, View Source [SID1234527402]).

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"We are now proceeding to the final stages of this study, which are to complete analysis of blood samples and then collect and analyze the data," commented Steve Quay, Ph.D., M.D., President and CEO of Atossa. "We expect to report preliminary results from the study in the next quarter," added Dr. Quay.

The objectives of the placebo-controlled, repeat dose study of 24 healthy male volunteers are to assess the pharmacokinetics of a proprietary topical Endoxifen dosage form over 28 days, as well as to assess safety and tolerability.

Atossa is developing topical Endoxifen for a condition in men called gynecomastia, which is male breast enlargement. According to the Mayo Clinic, 25% of men in the U.S. between the ages of 50-69, or approximately 10 million men, suffer from gynecomastia. It is the most common male breast disorder and is caused by a hormone imbalance where testosterone is low compared to estrogen. For example, in prostate cancer treatment, testosterone is suppressed with androgen deprivation therapy resulting is higher estrogen levels that usually triggers gynecomastia. One recent study indicates that up to 90% of men taking androgen deprivation therapy suffer from gynecomastia and breast pain (Handoo Rhee, et al., October 18, 2014, BJU International). There is no FDA-approved pharmaceutical to treat gynecomastia. Current therapeutic approaches in these patients include the daily use of oral estrogen-suppressing medications and prophylactic breast bud irradiation which is often repeated.

Atossa’s Proprietary Endoxifen

Endoxifen is an active metabolite of tamoxifen. Tamoxifen is an FDA-approved drug to prevent new breast cancer as well as recurrent breast cancer in breast cancer patients. Tamoxifen itself must be broken down by the liver into active compounds (metabolites), of which Endoxifen is the most active. Many patients taking tamoxifen, however, do not properly metabolize tamoxifen into therapeutic levels of Endoxifen.

Atossa has completed a comprehensive Phase 1 clinical study using both a topical and an oral formulation of Endoxifen in women. Results from the topical arm of the Phase 1 study in women indicated that the topical formulation was safe, well tolerated and that topical Endoxifen crossed the skin barrier in a dose-dependent fashion.

Topical Endoxifen Opportunities

In addition to gynecomastia, Atossa is also developing its proprietary topical Endoxifen to reduce Mammographic Breast Density (MBD), which has been shown in studies conducted by others to be an independent risk factor for developing breast cancer. To date, 34 U.S. states have enacted laws requiring that findings of MBD be communicated to the patient. And according to the National Cancer Institute, approximately 10 million women in the U.S. have high breast density (BI-RADS level C or D with "D" being the highest). Although oral tamoxifen has been shown to reduce MBD, the benefit-risk ratio is generally not acceptable to most patients. For example, it is estimated that only ~ 2% of women at high-risk of developing breast cancer, including those with MBD, take oral tamoxifen to prevent breast cancer because of the risks of, or actual side-effects of, oral tamoxifen. There is no FDA-approved treatment for MBD.

Atossa is planning a Phase 2 study of its topical Endoxifen in women with MBD. The study will be conducted at Stockholm South General Hospital in Sweden and will be led by principal investigator Dr. Per Hall, MD, Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet.

The primary endpoint of this study is to determine if topical Endoxifen administration results in an individual change in MBD, which will be measured after three and six months. Secondary endpoints are safety and tolerability. The objective of the study is to determine the effect size on MBD between the placebo and active groups, which will permit sample size calculations in a future Phase III study. Enrollment is anticipated to be completed by the end of 2018.