A Phase 2 Study to Assess the Safety and Efficacy of Umbralisib (TGR-1202) in Patients with Chronic Lymphocytic Leukemia (CLL) who are Intolerant to Prior BTK or PI3Kδ Inhibitor Therapy

On June 18, 2019 TG Therapeutics Presented the corporate presentation (Presentation, TG Therapeutics, JUN 18, 2019, View Source [SID1234537862]).

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Corporate Presentation

On June 16, 2019 Xenetic Biosciences presented the Corporate Presentation (Presentation, Xenetic Biosciences, JUN 18, 2019, View Source [SID1234537827]).

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Vivoryon Therapeutics mandates goetzpartners as strategic business development advisor for expansion of its innovative QPCTL technology into immuno-oncology  

On June 18, 2019 Vivoryon Therapeutics AG, (Euronext Amsterdam: currently PBD, to be changed to VVY, ISIN: DE0007921835), a clinical stage precision medicine company focused on bringing first-in-class therapies to patients suffering from age-related diseases, and goetzpartners, an independent advisory firm for strategy, M&A and transformation, reported their collaboration to explore the expansion of Vivoryon’s proprietary platform based on its Glutaminyl-peptide cyclotransferase-like protein (QPCTL) technology into the field of immuno-oncology (Press release, Vivoryon Therapeutics, JUN 18, 2019, View Source [SID1234537421]). In this context goetzpartners has been mandated as the exclusive strategic business development advisor of Vivoryon Therapeutics.

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Vivoryon’s lead molecule, PQ912, is currently in clinical stage development for Alzheimer’s Disease (AD) and is a first-in-class, highly specific and potent inhibitor of Glutaminyl cyclases (QPCT and QPCTL). New research has shown that small molecule Glutaminyl cyclase inhibitors could also represent an attractive approach for myeloid immune checkpoint control.

Consequently, Vivoryon’s next platform project focuses on immune checkpoint inhibition and the Glutaminyl-peptide cyclotransferase-like protein (QPCTL). QPCTL is a posttranslational modifying enzyme that is essential for the pyroglutamate formation on CD47, a crucial signaling protein in immune response to cancer. Inhibitors of QPCTL, like PQ912 and other small molecule compounds protected under Vivoryon’s patents, have been shown to silence the checkpoint signal from the CD47/SIRPa axis, and thus are offering a novel strategy to augment the efficacy of anti-tumor antibody therapies. Based on Vivoryon’s data, PQ912 could readily be advanced into clinical Phase I studies in cancer. In addition, Vivoryon Therapeutics owns a broader set of highly promising QPCTL inhibitor compounds in advanced preclinical stages of development.

"When weighing our options on how to move forward our QPCTL technology into the field of immuno-oncology, we wanted to make sure we did everything possible to bring scientific excellence for the benefit of patients to other indications. Understanding this responsibility, we decided to seek out industry leaders in business development consulting who understood our strategic needs and could provide us with the support necessary to unlock the full potential of our platform by partnering with major pharma players. For this reason, we look forward to working with goetzpartners, who have robust business experience and the expertise to guide us through this process" said Dr. Ulrich Dauer, CEO of Vivoryon Therapeutics.

"We are proud to have been selected by Vivoryon Therapeutics as their strategic advisors," said Ulrich Kinzel, Managing Director at goetzpartners, "The Company is a technology leader with their patented proprietary Glutaminyl Cyclase inhibition platform, and it is an exciting opportunity for us to connect them with the right partner to explore its full potential."

For more information, please contact:

Vivoryon Therapeutics AG
Dr. Ulrich Dauer, CEO
Email: [email protected]

goetzpartners Corporate Finance GmbH
Ulrich Kinzel
Tel: +49 (0) 89 29 07 25 125

MC Services AG
Anne Hennecke, Susanne Kutter
Tel: +49 (0) 211 529 252 27
Email: [email protected]

IDERA PHARMACEUTICALS TO PRESENT AT THE 2019 JMP SECURITIES LIFE SCIENCES CONFERENCE

On June 18, 2019 Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) reported that the company will present at the 2019 JMP Securities Life Sciences Conference on Thursday, June 20, 2019 at 1:30 p.m. Eastern Time at the St. Regis Hotel in New York City (Press release, Idera Pharmaceuticals, JUN 18, 2019, View Source [SID1234537165]).

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A live audio webcast of Idera’s presentation will be accessible in the Investors and Media section of Idera’s website at View Source An archived version will also be available on the company’s website after the event for 90 days.

Jounce Therapeutics Initiates Phase 2 EMERGE Study of Vopratelimab in Combination with Ipilimumab in Patients with Non-Small Cell Lung Cancer or Urothelial Cancer

On June 18, 2019 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that it has initiated dosing in the Phase 2 EMERGE clinical trial of its lead product candidate, vopratelimab, in combination with ipilimumab in patients with non-small cell lung cancer (NSCLC) or urothelial cancer who have progressed on or after PD-1/PD-L1 inhibitor therapies (Press release, Jounce Therapeutics, JUN 18, 2019, View Source [SID1234537158]). These patient populations represent a rapidly growing area of unmet need as PD-1 inhibitors move into earlier lines of therapy, with few options and no established standard of care for patients who progress after a PD-1/PD-L1 inhibitor.

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"The Phase 2 EMERGE clinical trial of vopratelimab and ipilimumab builds upon the original science from our founders as well as the reverse translational subset analysis from patients who benefitted in our ICONIC trial versus those who did not. Vopratelimab treatment resulted in the emergence of ICOS hi CD4 T effector cells in the peripheral blood and emergence of these cells was associated with response and improvements in progression free survival and overall survival, as presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting," said Beth Trehu, M.D., chief medical officer of Jounce Therapeutics. "Ipilimumab is known to induce a population of ICOS hi CD4 T cells, making it a scientifically logical combination partner for vopratelimab in the EMERGE study, as we have shown vopratelimab stimulates, expands and sustains ICOS hi CD4 T cells. We are pleased to have begun enrollment in the EMERGE clinical trial and expect to report preliminary efficacy data in 2020."

About the Phase 2 EMERGE Clinical Trial
The Phase 2 EMERGE clinical trial is an open-label, multi-center study to evaluate the efficacy of vopratelimab in combination with ipilimumab. In the initial stage, Jounce expects to enroll approximately 40 patients with NSCLC and approximately 40 patients with urothelial cancer. The primary endpoint is overall response rate (ORR) and secondary endpoints include safety, duration of response, progression free survival (PFS) and overall survival (OS). Additional important assessments will include close monitoring of ICOS hi CD4 T cell emergence, and a range of other biomarkers, including exploratory assessment of potential predictive biomarkers. Jounce expects to report preliminary efficacy and biomarker relationships to clinical outcomes on up to 80 patients in 2020.

Patients and physicians interested in the Phase 2 EMERGE trial can contact [email protected]. For more information on this trial, please visit View Source (Identifier: NCT03989362).

About Vopratelimab
Jounce’s lead product candidate, vopratelimab (formerly JTX-2011), is a clinical-stage monoclonal antibody that binds to and activates ICOS, the Inducible T cell CO­Stimulator, a protein on the surface of certain T cells commonly found in many solid tumors. Vopratelimab was assessed in a Phase 1/2 clinical trial that we refer to as ICONIC. In the initial Phase 1/2 portion of ICONIC, vopratelimab was found to be safe and well-tolerated, both alone and in combination with nivolumab, an anti-PD-1 antibody. At the June 2018 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), we reported Response Evaluation Criteria in Solid Tumors, or RECIST, responses and other tumor reductions as determined by investigator assessment that were associated with an ICOS pharmacodynamic biomarker. We subsequently reported that these responses were durable, lasting six or more months and that all responders, as determined by investigator assessments, remained on study for more than one year. ICONIC also included dose-escalation Phase 1 portions to assess vopratelimab in combination with pembrolizumab, an anti-PD-1 antibody, and in combination with ipilimumab, an antibody that binds to CTLA-4 on certain T cells. This Phase 1 portion established the safety of vopratelimab in combination with each of ipilimumab and pembrolizumab.