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Immutep Announces Data from Ongoing TACTI-mel Phase I Clinical Trial in Unresectable or Metastatic Melanoma

On May 17, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported more mature data relating to Part B of its ongoing phase I TACTI-mel clinical study of the Company’s lead product candidate, eftilagimod alpha ("efti" or "IMP321") in patients with melanoma (Press release, Immutep, MAY 17, 2019, View Source [SID1234536468]). The data will be presented at the World Advanced Therapies & Regenerative Medicine Congress & Expo 2019 in London on May 17, 2019 by Dr Frédéric Triebel, Chief Scientific Officer and Chief Medical Officer of Immutep.

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The ongoing TACTI-mel trial evaluates the combination of efti with anti-PD-1 therapy KEYTRUDA (pembrolizumab) in 24 patients with unresectable or metastatic melanoma. It is a multi-center, open label clinical trial that involves four cohorts of six patients, each cohort testing different dosages of efti, including 1 milligram (mg), 6 mg and 30 mg, in combination with pembrolizumab. Part B of the study includes a cohort of 6 patients at 30 mg of efti in combination with pembrolizumab, starting at cycle 1, day 1 and with a treatment duration of 12 months.

Consistent with previous data reported at 6 months of combination treatment (March 2019), patients in Part B continue to report positive results in terms of tumour reductions after 9 months of treatment. 4 patients are continuing to receive treatment. No new safety data or data from Part A of the study have been reported. The key findings from Part B are:

Part B (starting day 1 cycle 1

of pembro therapy)

N=6

Overall Response Rate (ORR)

50%
Disease Control Rate (DCR)

66%
The full presentation slides from the World Advanced Therapies & Regenerative Medicine Congress & Expo 2019 can be accessed via Immutep’s website at www.immutep.com.

About the TACTI-mel clinical trial

The ongoing TACTI-mel (Two ACTive Immunotherapies in melanoma) Phase I clinical trial is a multicenter, open-label study evaluating the combination of eftilagimod alpha ("efti") with pembrolizumab, in unresectable or metastatic melanoma patients that have had either a suboptimal response or had disease progression with pembrolizumab monotherapy (clinicaltrials.gov identifier NCT 02676869).

Johnson & Johnson to Participate in Bernstein’s 35th Annual Strategic Decisions Conference

On May 17, 2019 Johnson & Johnson (NYSE: JNJ) reported that it will participate in Bernstein’s 35th Annual Strategic Decisions Conference on Thursday, May 30, at the Grand Hyatt, New York (Press release, Johnson & Johnson, MAY 17, 2019, View Source;johnson-to-participate-in-bernsteins-35th-annual-strategic-decisions-conference-300852402.html [SID1234536464]). Alex Gorsky, Chairman and Chief Executive Officer, will represent the Company in a session scheduled at 12:00 p.m. (Eastern Time).

This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.

A webcast replay will be available approximately two hours after the live webcast.

Aurinia Pharmaceuticals to Present at the RBC Capital Markets Global Healthcare Conference

On May 17, 2019 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (the "Company") reported that Mr. Peter Greenleaf, Chief Executive Officer, will present a corporate overview at the RBC Capital Markets Global Healthcare Conference on Wednesday, May 22, 2019 at 6:30am PT (9:30am ET) in New York, NY (Press release, Aurinia Pharmaceuticals, MAY 17, 2019, View Source [SID1234536463]).

The presentation will be webcast live and can be accessed via the investor section of the Aurinia website, www.auriniapharma.com. A replay of the presentation will also be archived on the Company website following the event.

MEDIGENE TO PRESENT INTERIM DATA ANALYSIS FROM PHASE I/II DC-VACCINE TRIAL AT THE EHA CONFERENCE 2019

On May 17, 2019 Medigene AG (FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, reported that it will present data from the interim analysis of the ongoing Phase I / II clinical trial with Medigene’s DC vaccine during the annual congress of the European Hematology Association (EHA) (Free EHA Whitepaper) taking place from 13 – 16 June in Amsterdam (Press release, MediGene, MAY 17, 2019, View Source [SID1234536462]).

Medigene will present a poster on June 15 from 17:30-19:00 entitled "Interim Analysis of a WT-1 and PRAME ` Fast-DC´ vaccine shows safety as active immunotherapy for the prevention of AML relapse".

For the full abstract of the poster, please follow this link:
View Source
or View Source

Ligand Licenses VER250840 to Cumulus Oncology

On May 17, 2019 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported the signing of a license agreement granting Cumulus Oncology exclusive worldwide rights to develop and commercialize VER250840, a novel, oral, selective, preclinical Chk1 Kinase Inhibitor discovered using Ligand’s Vernalis Design Platform (VDP) (Press release, Ligand, MAY 17, 2019, View Source [SID1234536461]). Under the terms of the agreement, Ligand will receive an upfront license fee, and is eligible to receive over $76 million of milestone payments and tiered royalties in the mid-to-high single digit range, depending on revenue. In addition, Ligand is eligible to receive an additional fee, payable in cash or Cumulus equity, upon Cumulus achieving specified financing-related events.

"We are pleased to be partnered with Cumulus to continue to advance the development of this important kinase target," said John Higgins, Chief Executive Officer of Ligand. "Since Ligand’s acquisition of Vernalis in October of last year, the business in Cambridge has been successfully integrated and is significantly contributing to the advancement of Ligand’s Shots-on-Goal business model. VDP consists of a team of accomplished scientists servicing the needs of partners to design molecules addressing highly-challenging targets, and we expect additional partnered programs to result from their efforts over the coming months and years."

About VER250840

VER250840 is a novel oral, selective Chk1 kinase inhibitor discovered using the Vernalis Design Platform (VDP). Chk1 is an important target within the DNA Damage Response (DDR) network and has been shown to play a key role in maintaining genomic integrity of cancer cells. Inhibition of Chk1 blocks cell cycle arrest and DNA repair, forcing cancer cells to undergo cell division with substantial DNA damage that results in their death. In both in vitro and in vivo preclinical studies, VER250840 has demonstrated an ability to target Chk1 in a range of different tumor types, as a single agent and in combination with several different cytotoxic agents. The clinical utility of DDR inhibitors for the treatment of cancer has recently been validated by the approval of inhibitors of Poly (ADP-ribose) polymerase (PARP). The opportunity to select patients most likely to respond to Chk1 inhibitors exists.

About the Vernalis Design Platform (VDP)

Vernalis (R&D) Limited is a Ligand subsidiary based in Cambridge, UK, and is a world leader in structure-guided drug discovery. The Vernalis Design Platform (VDP) integrates protein structure determination and engineering, fragment screening and molecular modeling, with medicinal chemistry, to enable success in novel drug discovery programs against highly-challenging targets. A key element to the success of VDP is establishing a robust platform for drug discovery for each target to validate hit identification using multiple proprietary assay and biophysical systems. Vernalis has collaborations across many therapeutic areas, including oncology, CNS, anti-infectives and inflammation, with global partners and a heritage of successful internal drug discovery in oncology and anti-infectives.