On August 21, 2018 Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that the first patient has been enrolled under the amended protocol for its registration trial in ocular melanoma liver metastases (Press release, Delcath Systems, AUG 21, 2018, View Source;p=RssLanding&cat=news&id=2364273 [SID1234529754]). Stanford University Medical Center is the first trial site to enroll a patient under the amended protocol.

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The trial, A Single-arm, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients with Hepatic-Dominant Ocular Melanoma (The FOCUS Trial), will enroll a minimum of 80 patients with ocular melanoma metastatic to the liver. Patients previously enrolled in the Melphalan/HDS arm of the trial under the prior randomized protocol will continue to be treated and evaluated as part of the amended trial.

"We are very pleased that the team at Stanford were able to begin enrolling patients in the amended trial so quickly," said Jennifer K. Simpson, PhD, MSN, CRNP, President and Chief Executive Officer of Delcath Systems. "We look forward to rolling out the amended protocol to additional centers in the coming months and are working hard to achieve our goal of completing trial enrollment by the end of the first half of 2019."

On August 21, 2018 Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company focused on identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology and immunology, reported a publication in the journal Cancer Research (Press release, Aclaris Therapeutics, AUG 21, 2018, View Source [SID1234529011]).

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The title of the article is: "Inhibition of the stromal p38MAPK/MK2 pathway limits breast cancer metastases and chemotherapy-induced bone loss."

ATI-450, an investigational drug, is a selective inhibitor of p38 mitogen-activated protein kinase-activated protein kinase 2 (p38MAPK/MK2) interface and an attractive candidate for stromal-targeted therapy. Levels of p38MAPKα expressed by a tumor and the surrounding stromal cells correlate with poor prognosis. In addition, p38MAPK signaling plays a key role in regulating osteoclast differentiation. In this paper, mouse models were utilized to explore the stromal inhibition of p38MAPK/MK2 pathway with oral ATI-450 in limiting breast cancer metastasis and protecting against bone loss, a major comorbidity of breast cancer.

Key Preclinical findings:

Pharmacologically targeting the stromal p38MAPK/MK2 pathway limits breast cancer metastasis, preserves bone quality, and extends survival.
The role of the stromal compartment in tumor progression is strongly illustrated in breast cancer bone metastases, where the stromal compartment supports tumor growth, albeit through poorly defined mechanisms.
p38MAPKα is frequently expressed in tumor cells and surrounding stromal cells, and its expression levels correlate with poor prognosis. This observation led the authors to investigate whether inhibiting the p38MAPKα pathway could reduce breast cancer metastases in a clinically relevant model.
Orally administered ATI-450 limited outgrowth of metastatic breast cancer cells in the bone and visceral organs.
This effect was primarily mediated by p38MAPKα-MK2 pathway inhibition within the stromal compartment. Beyond limiting metastatic tumor growth, ATI-450 reduced tumor-associated and chemotherapy-induced bone loss, a serious comorbidity that greatly diminishes quality of life for cancer patients.
These data: a) support a central role for stromal-derived factors in tumor progression; and (b) identify the p38MAPK-MK2 pathway as a promising therapeutic target for treating metastatic disease and preventing chemotherapy- and tumor-induced bone loss.
Several studies have shown that the stroma plays a significant role in tumor progression, thereby establishing a rationale for developing stroma-targeted anti-tumor therapies. The findings of Dr. Stewart and her colleagues suggest that stromal-targeted therapies have the potential to provide durable responses, help circumvent drug resistance, and synergize with tumor-targeted therapies.

This study was carried out by the laboratory of Sheila Stewart, Ph.D., at the Washington University School of Medicine in St. Louis in collaboration with Aclaris Therapeutics, Inc.

The article is available at View Source and will appear in print form in the future.

On August 21, 2018 Humanigen, Inc presented the Investor Presentation (Presentation, Humanigen, AUG 21, 2018, View Source [SID1234529049]).

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On August 21, 2018 Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported that the Company will participate in the following upcoming investment conferences (Press release, Inovio, AUG 21, 2018, View Source [SID1234529012]):

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Rodman and Renshaw 20th Annual Global Investment Conference, sponsored by H.C. Wainwright & Co., LLC
Presentation
Dr. J. Joseph Kim, President & CEO
September 5, 2018, 10:25 AM ET
New York, NY

Citi’s 13th Annual Biotech Conference
1×1 meetings only
September 6, 2018
Boston, MA

Cantor Fitzgerald 2018 Global Healthcare Conference
Presentation
Dr. J. Joseph Kim, President & CEO
October 2, 2018, 10:55 AM ET
New York, NY

Live and archived versions of the presentations will be available through the Inovio Investor Relations Events page at View Source

On August 21, 2018 Imago BioSciences, a clinical-stage pharmaceutical company developing novel anti-cancer therapies, reported that the Phase 1/2a clinical trial of IMG-7289 for the treatment of high-risk acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) has fully enrolled at 45 patients (Press release, Imago BioSciences, AUG 21, 2018, View Source [SID1234529013]). This study assessed the safety, pharmacokinetics, pharmacodynamics and anti-neoplastic activity of IMG-7289, an inhibitor of the epigenetic enzyme lysine-specific demethylase 1.

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"We are extremely grateful to have worked with terrific investigators and staff that enrolled and cared for a population of patients in great need of therapeutic options," said Hugh Young Rienhoff, Jr. M.D., Imago’s Chief Executive Officer. "This study generated a wealth of knowledge about the pharmacokinetics, pharmacodynamics, and safety profile of our LSD1 inhibitor IMG-7289 as a single agent and in combination with ATRA. This study provides very clear guidance on how to use IMG-7289 at a variety of doses and in a variety of indications."

Upon the successful completion of the Phase 1 multiple ascending dose portion of the trial assessing IMG-7289 as a single agent, the study progressed into the Phase 2a expansion arm which evaluated the combination treatment regimen of IMG-7289 plus ATRA for extended dosing durations. Treatment of the final 2a expansion cohort remains ongoing.

About IMG-7289

IMG-7289 is a small molecule developed by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme regulating cytokine expression and shown to be vital in sustaining self-renewal in cancer stem/progenitor cells, particularly neoplastic bone marrow cells. In non-clinical studies, IMG-7289 demonstrated robust in vivo anti-tumor efficacy across a range of myeloid malignancies and models of myeloproliferative neoplasms as a single agent and in combination with other therapeutic agents. IMG-7289 also shows activity against solid tumors in combination with other agents in non-clinical models. IMG-7289 is an investigational agent currently being evaluated in a second Phase 1/2a clinical trial in high-risk myelofibrosis patients aged 18 or older is currently enrolling patients in both United States and Australia. (www.clinicaltrials.gov Identifier NCT03136185).