Jounce Therapeutics to Present Nonclinical Translational Data at the 2018 American Association for Cancer Research (AACR) Annual Meeting

On April 12, 2018 Jounce Therapeutics, Inc. (NASDAQ:JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers for patient enrichment, reported that its nonclinical translational data will be presented in two posters at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, Illinois from April 14-18, 2018 (Press release, Jounce Therapeutics, APR 12, 2018, View Source;p=RssLanding&cat=news&id=2342263 [SID1234525282]).

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"The data presented at AACR (Free AACR Whitepaper) for gastric cancer and triple negative breast cancer provides an example of the way in which we use the Jounce Translational Science Platform to interrogate the cellular microenvironment within the tumor to explore potential biomarkers. These data, focused on our ICOS agonist antibody program, JTX-2011, help inform our clinical development strategy," said Deborah Law, D. Phil., chief scientific officer of Jounce Therapeutics.

Details on the posters are as follows:

Genomics based studies of gastric tumors identify ICOS as potential target for therapeutic intervention
Session Title: Immune Checkpoints 1
Location: McCormick Place South, Exhibit Hall A, Poster Section 31
Date and Time: Monday Apr 16, 2018 from 8:00 AM – 12:00 PM CT
Poster Board Number: 10; Permanent Abstract Number: 1685

Integrated genomics and histology based studies of triple negative breast cancer identify ICOS as potential target for therapeutic intervention
Session Title: Immune Checkpoints 1
Location: McCormick Place South, Exhibit Hall A, Poster Section 31
Date and Time: Monday Apr 16, 2018 from 8:00 AM – 12:00 PM CT
Poster Board Number: 3; Permanent Abstract Number: 1678

The posters will be available on the "Investors and Media" section of the Jounce Therapeutics website at www.jouncetx.com.

About JTX-2011
Jounce’s lead product candidate, JTX-2011, is a monoclonal antibody that binds to and activates ICOS, a protein on the surface of certain T cells. Preclinical data support that JTX-2011 may have a dual mechanism of action that stimulates anti-tumor T effector cells, and also reduces the immunosuppressive T regulatory cells in the tumor microenvironment. The company is developing JTX-2011 to treat solid tumors as a single agent and in combination with other therapies.

AACR 2018: GamaMabs Pharma to present new data on expression of Anti-Müllerian Hormone type II Receptor in non-gynecological cancers and on first ADC candidate targeting AMHRII

On April 12, 2018 GamaMabs Pharma, a biotechnology company developing optimized therapeutic antibodies targeting AMHRII for the treatment of cancer, reported the presentation of two posters on its AMHRII program at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, taking place from April 14 to 18 in Chicago, USA (Press release, GamaMabs Pharma, APR 12, 2018, View Source [SID1234525281]).

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The results of extensive investigations show AMHRII expression in a majority of tumor samples in a wide range of non-gynecological tumors such as colorectal and lung cancers, hepatocarcinoma or renal cell carcinoma. Moreover internalization capabilities and selective distribution of the target have been utilized to design a first AMHR2 based ADC approach.

The presentation details are as follows:
• Title: Anti-Müllerian Hormone type II Receptor (AMHRII) found expressed in
human non-gynecological solid tumors, suggesting potential broader applications
for anti-AMHRII-based therapy
o Abstract number: 774
o Date and time: April 15, 2018, 1pm – 5pm (CT)
o Session category/title: Experimental and Molecular Therapeutics
o Location: Section 36

• Title: Anti-Müllerian hormone type II receptor (AMHRII), a cancer target for
GM103, a novel antibody-drug conjugate (ADC)
o Abstract number: 1779
o Date and time: April 16, 2018, 8am – 12pm (CT)
o Session category/title: Therapeutic Antibodies, including Engineered
Antibodies 1
o Location: Section 34

The studies were performed with GamaMabs’ partners, including the Curie Institute (Paris, France), the Gustave Roussy Institute (Villejuif, France), Massachusetts General Hospitals (Boston, USA), the Léon Bérard Cancer Center (Lyon, France), Nantes University Hospital (France), the Montpellier Cancer Research Institute (France), Abzena (UK) and the Helsinki University Hospital (Finland).

"We are happy to be able to share such groundbreaking data on AMHRII expression, unveiling its potential as a novel target in a wide range of solid tumors," said Jean-François Prost, VP R&D at GamaMabs. "The results with GM103 clearly show, as a proof of concept, that AMHRII is also a suitable target for treating AMHRII-positive solid tumors with an ADC."

"We are committed to expanding our development plans beyond gynecological cancers, in particular for our lead program GM102," said Stéphane Degove, CEO at GamaMabs. A copy of the above referenced abstracts can be viewed online through the AACR (Free AACR Whitepaper) meeting website. Following the presentation, the data presented will be available on the Publications page of GamaMabs’ website.

FLX Bio to Highlight New Preclinical Data from CCR4 and USP7 Programs at the American Academy For Cancer Research (AACR) Annual Meeting

On April 12, 2018 FLX Bio, Inc., a biopharmaceutical company focused on the discovery and development of oral small-molecule drugs to activate the immune system, reported that preclinical data supporting two of the company’s oncology programs will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting to be held April 14 through April 18, 2018 in Chicago, IL (Press release, FLX Bio, APR 12, 2018, View Source [SID1234525280]).

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"The data that will be presented at AACR (Free AACR Whitepaper) provides important validation for the clinical development strategy of FLX475, our novel CCR4 antagonist, as well as support for further development of our USP7 inhibitors. We now have preclinical data validating that tumors positive for the Epstein-Barr Virus (EBV+) may be an ideal target for FLX475. We believe that pairing a biomarker-based patient selection protocol with both single agent and combination studies of FLX475 supports our precision medicine strategy for clinical development," said Dirk G. Brockstedt, Ph.D., Senior Vice President of Biology for FLX Bio. "In addition, the data presented on our USP7 inhibitors validate the robust mechanisms of action for an anti-cancer response and support further preclinical and clinical development."

Presentation Title (Abstract #4752): EBV-Associated Tumors Increase Regulatory T Cell Recruitment via CCR4 Ligand Expression and are a Promising Indication for Treatment with Small Molecule CCR4 Inhibitors
On Tuesday, April 17, Gene Cutler, Ph.D. and Oezcan Talay, Ph.D., both of FLX Bio will present data demonstrating that tumors that test positive for Epstein-Barr Virus (EBV+) show increased expression of CCL22 and CCL17, the two ligands of the CCR4 receptor on regulatory T cells. EBV+ tumors produce high levels of CCL22 and CCL17, which recruit regulatory T cells to the site of the tumor, thereby suppressing the immune response to allow the tumor to grow unchecked. EBV+ tumors include nasopharyngeal carcinoma, a proportion of classical Hodgkin’s Lymphoma and gastric carcinoma. The data show that expression of the EBV gene LMP1 in human EBV+ B cells drives expression of CCL22. This expression drives the recruitment of regulatory T cells, a reaction that was blocked with a small-molecule CCR4 antagonist, potentially providing a new therapeutic treatment for patients with EBV+ cancers. The data demonstrate that patients with EBV+ tumors may be particularly responsive to treatment with FLX475, FLX Bio’s lead CCR4
antagonist.

Presentation Title (Abstract #2915): Discovery and Optimization of Potent and Selective
Inhibitors of USP7 to Enhance Anti-Tumor Immunity and Target Tumor Growth
On Monday, April 16, Yamini Ohol, Ph.D., of FLX Bio will present data demonstrating in vitro and in vivo data for a series of potent, highly-selective bioavailable small molecule inhibitors of USP7. USP7 is a deubiquitinase that regulates the levels of multiple proteins involved in cancer progression and the immune response. The preclinical results demonstrate that FLX Bio’s USP7 inhibitors activate p53 in cell-based assays, kill tumor cells and activate the immune system, indicating that these small molecule compounds may provide benefit as anti-cancer therapeutics via multiple mechanisms of action.

About FLX475
FLX475 is a best-in-class oral, small molecule antagonist of CCR4. In preclinical studies, FLX475 inhibited tumor growth and increased tumor regression as a single agent. In addition, FLX475 enhanced the antitumor effects of various checkpoint inhibitors including anti-PD-L1 and anti- CTLA4 antibodies as well as immune agonists such as anti-4-1BB. FLX475 also has the potential to enhance cell-based immunotherapies such as CAR-T and cancer vaccines. Unlike antibodies to CCR4, FLX475 selectively blocks the recruitment of regulatory T cells to the tumor site and does not deplete cells beneficial to an anti-tumor response or regulatory T cells in healthy tissue such as blood, spleen and skin cells. In addition to the study ongoing in healthy volunteers, FLX Bio intends to initiate a clinical trial of FLX475 alone and in combination with a checkpoint inhibitor in patients with cancer, including patients with EBV+ tumors, in 2018.

About USP7
Ubiquitin specific protease 7 (USP7) impacts several important cancer pathways, changing the levels of oncogenes and tumor suppressors including p53 and modulating the immune system through targets such as Tip60 and FoxP3. USP7 is an enzyme that removes a tag called ubiquitin from proteins and stabilizes the levels of those proteins in the cell. For example, through the stabilization of MDM2, USP7 causes p53 levels to go down, thus allowing cancer cells to proliferate. FLX Bio has also shown that key aspects of inflammatory responses are modulated by its small-molecule USP7 inhibitors – an effect that may be beneficial to targeting cancers. FLX Bio expects to select a preclinical USP7 inhibitor this year

argenx to receive third preclinical milestone payment from collaboration with LEO Pharma



On April 12, 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 achievement of its third preclinical milestone from its collaboration with LEO Pharma, following the approval of the clinical trial application (CTA) filing for ARGX-112 (Press release, argenx, APR 12, 2018, View Source [SID1234525279]).

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"This milestone showcases the productivity of our collaboration with LEO Pharma, marking the final step before ARGX-112 may enter clinical development. It triggers the third of three success-based preclinical milestone payments under this collaboration. We are convinced of the potential of ARGX-112 to address unmet needs in inflammatory skin diseases and are excited to see the program approved for clinical development," commented Tim Van Hauwermeiren, CEO at argenx.

In May 2015, argenx entered into a research collaboration and exclusive license option agreement with LEO Pharma to develop and commercialize ARGX-112, a novel antibody discovered by argenx using its SIMPLE Antibody technology. During the collaboration term, argenx successfully concluded all ARGX-112 research and development activities required for the first filing by LEO Pharma of a CTA.

As part of the agreement, argenx has granted LEO Pharma an exclusive option to obtain a worldwide, exclusive license to the ARGX-112 program, to develop and commercialize licensed products for inflammatory skin disorders. In addition to the upfront and preclinical milestone payments, argenx may receive further regulatory and clinical milestone payments up to approximately €100mm as well as royalties on net sales of any product.

Alexion to Report First Quarter 2018 Results on Thursday, April 26, 2018

On April 12, 2018 Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) reported that the Company will report its financial results for the first quarter ended March 31, 2018 on Thursday, April 26, 2018 before the US financial markets open (Press release, Alexion, APR 12, 2018, View Source [SID1234525278]). Following the release of the financial results, Alexion management will conduct a conference call and audio webcast on Thursday, April 26, 2018, at 10:00 a.m. Eastern Time (ET).

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To participate in this conference call, dial 888-394-8218 (USA) or 323-701-0225 (International), passcode 1013806 shortly before 10:00 a.m. ET. A replay of the call will be available from 1:00 p.m. ET through a limited time thereafter. The replay number is 888-203-1112 (USA) or 719-457-0820 (International), passcode 1013806. The audio webcast can be accessed on the Investor page of View Source