On August 21, 2018 Sensei Biotherapeutics, Inc., a privately-held biopharmaceutical company developing immuno-oncology therapies that teach the immune system to recognize and attack cancer, reported the appointment of Ildiko Csiki, M.D., Ph.D., as Chief Medical Officer (Press release, Sensei Biotherapeutics, AUG 21, 2018, View Source [SID1234529015]). Dr. Csiki brings nearly two decades of leadership experience in oncology drug development and research, most recently serving as Vice of President of Immuno-Oncology Clinical Development at Inovio Pharmaceuticals.

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"It is with great excitement that we welcome such an accomplished oncologist and clinical leader to Sensei. Ildiko brings an outstanding intellect, expertise and passion for patients to our team," said John Celebi, CEO of Sensei Biotherapeutics. "She is joining Sensei at a time when we are taking bold steps in discovering and developing the next generation of cancer immunotherapies, and we look forward to her contributions to building our oncology drug development capabilities and developing the clinical strategies for SNS-301 and the other programs in our pipeline."

Dr. Csiki joins Sensei at a pivotal time with promising clinical data from the Phase I trial of its lead drug candidate SNS-301 expected in the fall of 2018, and the continued development of its proprietary SPIRIT drug development platform that is generating a pipeline of innovative immuno-oncology therapies.

"I am excited to join Sensei and have the opportunity to play a leadership role in advancing innovative immuno-oncology drug candidates and bring new medicines to cancer patients," said Ildiko Csiki, CMO of Sensei Biotherapeutics "Our SPIRIT platform offers an innovative mechanism for detecting and eliminating cancer. I am eager to move forward with the clinical program for Sensei’s lead drug candidate, SNS-301, as well as creating the clinical strategy for the company’s pipeline of immuno-oncology therapies with the potential to have a profound impact for cancer patients."

In her most recent role, Dr. Csiki served as Vice of President of Immuno-Oncology Clinical Development at Inovio Pharmaceuticals where she led the advancement of Inovio’s DNA-based cancer immunotherapies based on T cell immunotherapeutic vaccines, including responsibility for overseeing clinical programs, clinical strategy, medical monitoring and regulatory submissions. Previously, Dr. Csiki was a Senior Director of Oncology Clinical Development at Merck, as a clinical development lead for pembrolizumab (Keytruda), and she was Director of Clinical Development at GSK focused on a lymphoma and other oncology programs. Before that, Dr. Csiki was an Assistant Professor in the Perelman Cancer Center at the University of Pennsylvania where she had an active clinical practice and a translational science laboratory focused on thoracic malignancies. She holds an M.D. and Ph.D. from Vanderbilt University School of Medicine. Her postdoctoral training included an internship in Internal Medicine and residency in radiation oncology at Vanderbilt and subsequently, a Holman Pathway Research Fellowship.

On August 21, 2018 Ichor Medical Systems, Inc. (Ichor) reported that its investigational TriGrid Delivery System (TriGrid) is being utilized in a Phase 1b/2 clinical trial to administer GX-188E, an investigational therapeutic HPV DNA vaccine developed by Genexine, Inc (Press release, Ichor Medical Systems, AUG 21, 2018, View Source [SID1234529014])., in patients with human papilloma virus (HPV)-induced advanced non-resectable cervical cancer, in combination with an anti-PD-1 therapy (NCT03444376).

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Cervical cancer is the fourth most common cancer affecting women worldwide and is almost always caused by infection with HPV. Preventative vaccines for cervical cancer are ineffective in women who are already infected with HPV, and despite advances in screening and HPV vaccination, a significant number of women develop advanced disease. Although chemotherapy is the standard first-line treatment for advanced cervical cancer, the prognosis remains poor and effective second line options are still needed.

Ichor’s patented TriGrid Delivery System uses electroporation to open pathways into cells to facilitate entry of a DNA vaccine into its intracellular site of action. The TriGrid has been utilized in >25 clinical studies, including randomized comparative studies demonstrating that administration of DNA vaccines with the TriGrid device significantly enhanced immune responses to the vaccines compared to conventional injection. A Phase 1 study using the TriGrid to deliver GX-188E in patients with high grade cervical intraepithelial neoplasia (CIN), a precancerous stage of cervical cancer, showed promising results with GX-188E demonstrating the ability to induce a tumor-specific immune response with evidence of lesion clearance (Nat Commun. 2014 Oct 30; 5: 5317).

Immuno-oncology is a rapidly evolving field of medicine designed to improve the ability of a patient’s immune system to detect and destroy tumors. The study has been initiated in Korea with plans to enroll up to 46 patients and was recently announced by Genexine.

Robert Bernard, Ichor Founder and CEO, stated, "Ichor’s TriGrid Delivery System is a platform technology used by an increasing number of Ichor partners for clinical delivery of their DNA vaccines where T-cell generation is a critical aspect of the prescribed immunotherapy. We are pleased through our Genexine partnership to expand TriGrid’s use into additional areas of immuno-oncology around the world."

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).

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 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.