argenx announces that AbbVie has exercised its exclusive option to license ARGX-115, a novel immuno-oncology antibody

On August 22, 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 the exercise by AbbVie of its exclusive license option to develop and commercialize ARGX-115, an antibody targeting the novel immuno-oncology target glycoprotein A repetitions predominant (GARP) (Press release, argenx, AUG 22, 2018, View Source [SID1234529025]).

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"We are very excited by AbbVie’s decision to exercise its option to license and develop ARGX-115, given its compelling track record in oncology. We are proud of the work that this milestone represents for argenx—both in efficiently advancing a premier Innovative Access Program candidate to clinical development and in facilitating wider recognition of the important research out of the de Duve Institute / Université Catholique de Louvain around this first-in-class target," said Tim Van Hauwermeiren, Chief Executive Officer of argenx. "Our Innovative Access Program remains a strategic priority for us, capitalizing on the combined strengths of the argenx antibody platform and the deep disease biology expertise at research institutions. We continue to seek out cutting-edge research and targets while advancing our current collaborations, all with the potential to broaden our pipeline and demonstrate our discipline as a strategic partner."

"Immuno-oncology is one of AbbVie’s key focus areas in our mission to discover and develop medicines that drive transformational improvements in cancer treatment," said Tom Hudson, M.D., Vice President, Oncology Early Discovery and Development, AbbVie. "Our collaboration with argenx over the past two years has been productive, and we look forward to continue working together to fuel scientific progress for patients."

argenx and AbbVie entered into an option and license agreement for ARGX-115 in April 2016. With the option exercise announced today, AbbVie obtains a worldwide, exclusive license to develop and commercialize ARGX-115-based products. argenx is now eligible to potentially receive development, regulatory and commercial milestone payments of up to $625 million, as well as tiered royalties on ARGX-115-based product sales, if approved. argenx also has the right to co-promote ARGX-115-based products in the EU and Swiss Economic Area.

About ARGX-115

ARGX-115 employs argenx’s SIMPLE Antibody technology and binds specifically to the protein glycoprotein A repetitions predominant (GARP), which plays a key role in the regulation of production and release of active transforming growth factor beta (TGF-β). ARGX-115 is believed to selectively limit the immunosuppressive activity of activated regulatory T-cells (Tregs), thereby stimulating the immune system to attack cancer cells. While the normal function of Tregs is to suppress certain compartments of the immune system to prevent self-directed immune responses through the release of active TGF-β, Tregs can also prevent the immune system from recognizing and suppressing pathogenic cells including cancer cells.

argenx believes the selective inhibition of TGF-β release by Tregs is potentially superior to systemic inhibition of TGF-β activity or depletion of Tregs and may give rise to therapeutic products with an improved safety profile.

ARGX-115 was discovered under argenx’s Innovative Access Program with the de Duve Institute / Université Catholique de Louvain / WELBIO and exclusively licensed under a research and option agreement in 2013.

About the Innovative Access Program (IAP)

Through the IAP, argenx collaborates closely with academic centers of excellence and emerging biotechnology companies, bringing cutting-edge antibody discovery technologies to the heart of novel target research. The extraordinary diversity of the immune repertoires comprising its SIMPLE Antibody Platform streamlines target validation, transforming novel protein discoveries into next generation therapeutic antibody programs.

Halozyme Therapeutics To Participate In Upcoming Investor Conferences

On August 22, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that it will participate in two upcoming investor conferences (Press release, Halozyme, AUG 22, 2018, View Source [SID1234529026]).

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Dr. Helen Torley, president and chief executive officer of Halozyme, will participate in Citigroup’s 13th Annual Biotech Conference in Boston on Wednesday, September 5, 2018. Dr. Torley will represent Halozyme on a panel titled "Targeted Therapies Oncology – Aiming for the Bull’s Eye" at the conference.

On Thursday, September 6, 2018, Dr. Torley will present an overview of the company at the 2018 Wells Fargo Securities Healthcare Conference in Boston at 1:20 p.m. ET / 10:20 a.m. PT. A live audio webcast of the presentation will be available in the "Investors" section of Halozyme’s website at www.halozyme.com with an archived replay available for 90 days following the event.

Aclaris Therapeutics Announces ATI-450 (MK2 pathway Inhibitor) publication in the Journal Cancer Research

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.

Investor Presentation dated August 21, 2018

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

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Inovio Pharmaceuticals to Participate in Upcoming Investment Conferences

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