Bristol-Myers Squibb and Illumina Announce Strategic Collaboration to Develop and Commercialize Companion Diagnostics for Bristol-Myers Squibb’s Oncology Immunotherapies

On April 13, 2018 Bristol-Myers Squibb Company (NYSE: BMY) and Illumina, Inc. (NASDAQ: ILMN) reported a collaboration that will utilize Illumina’s next-generation sequencing (NGS) technology to develop and globally commercialize in-vitro diagnostic (IVD) assays in support of Bristol-Myers Squibb’s oncology portfolio (Press release, Bristol-Myers Squibb, APR 13, 2018, View Source [SID1234525302]). The companies plan to develop a diagnostic version of the Illumina TruSight Oncology 500 assay to measure potentially predictive genomic biomarkers, including Tumor Mutation Burden (TMB). Illumina’s TruSight Oncology 500 assay is being developed to detect most of the known biomarkers for oncology therapeutics, including TMB and Microsatellite Instability for immunotherapies.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Through our deep understanding of cancer biology and emerging research, we recognize the importance for physicians to know each patient’s biomarker status to help fight their cancer in a more personalized way," said Saurabh Saha, M.D., Ph.D., Senior Vice President, Global Head of Translational Medicine, Bristol-Myers Squibb. "We are excited to partner with Illumina to pursue development of diagnostics that can help predict which patients will have the potential to benefit most from our immunotherapies."

"The identification of biomarkers for targeted therapies is emerging as a key part of a cancer patient’s journey, from treatment selection through response monitoring and allows physicians to follow the evolution of a patient’s tumor over time," said Garret Hampton, Ph.D., Executive Vice President of Clinical Genomics at Illumina. "Next-generation sequencing assays, such as a companion diagnostic (CDx) version of TruSight Oncology 500, are ideally suited to the comprehensive interrogation of a patient’s cancer. With BMS’ leading position in immunotherapy development, we see tremendous promise in this partnership to co-develop next-generation sequencing-based diagnostics that can identify effective therapeutic combinations and provide global access to these targeted drugs."

Cancer immunotherapy works by helping the immune system mount an anti-cancer response, a process that depends in part on the recognition of cancer-specific proteins called neoantigens. Bristol-Myers Squibb’s clinical development program includes 24 clinical-stage molecules designed to target different immune system pathways across more than 50 types of cancers, and through its translational capabilities, has identified a number of potentially predictive biomarkers, including PD-L1, TMB, MSI-H/dMMR and LAG-3.

Incyte to Report First Quarter Financial Results

On April 13, 2018 Incyte Corporation (Nasdaq:INCY) reported that it has scheduled its first quarter 2018 financial results conference call and webcast for 8:00 a.m. ET on Tuesday, May 1, 2018 (Press release, Incyte, APR 13, 2018, View Source;p=RssLanding&cat=news&id=2342471 [SID1234525296]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The schedule for the press release and conference call/webcast is as follows:


Q1 2018 Press Release:

May 1, 2018 at 7:00 a.m. ET

Q1 2018 Conference Call:

May 1, 2018 at 8:00 a.m. ET

Domestic Dial-In Number:

877-407-3042

International Dial-In Number:

201-389-0864

Conference ID Number:

13678858

If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for the U.S. is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference ID number 13678858.

The live webcast with slides can be accessed at www.incyte.com under For Investors, Events and Presentations and will be available for replay for 30 days.

VAXIMM Announces Presentations at Upcoming Industry and Scientific Events

On April 13, 2018 VAXIMM AG, a Swiss/German biotech company focused on developing oral T-cell immunotherapies, reported that the Company will participate in several upcoming events in the second quarter of 2018 (Press release, Vaximm, APR 13, 2018, View Source [SID1234525295]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

AACR (American Association for Cancer Research) Annual Meeting 2018 April 14 – 18, 2018 Chicago, IL, USA

Poster #733 / 18: "Modulating T cell immunity in tumors by targeting PD‑L1 and neoantigens using a live attenuated oral Salmonella platform"
Poster Session: Vaccines 1
Sunday, April 15th, 1:00 PM – 5:00 PM

The poster summarizes the immunogenicity and anti-leukemia efficacy of VAXIMM’s oral T‑cell immunotherapy candidate VXM10 encoding variants of the murine PD-L1 protein. The animal study also describes the systemic immunogenicity of Salmonella-based polyepitope oral vaccines, supporting the design of Salmonella-based neoantigen vaccines.

The abstract is available here.

European Neoantigen Summit 2018
April 24 – 26, 2018
Amsterdam, The Netherlands

Presentation: "Fast and Cost-Effective Oral Delivery Technology of Personalized T-Cell Vaccines Based on a Live Attenuated Bacteria Platform"
Thursday, April 26th, 11:15 AM CEST

Dr. Heinz Lubenau, Chief Operating Officer of VAXIMM, will present the Company’s platform technology based on first-in-class oral T-cell activators using modified attenuated bacteria that can be readily adapted to target a wide range of cancer-related antigens.

Dr. Lubenau also will participate in the panel, "Advancing Manufacturing Practices for Personalized Cancer Vaccines" taking place on Thursday, April 26th at 2:45 PM CEST.

Bio€quity Europe
May 14 – 16, 2018
Ghent, Belgium

Dr. Lubenau will give a corporate presentation on Tuesday, May 15th at 11:40 AM CEST.

Annual Results for the year ended December 31, 2017

On April 13, 2018 Kiadis Pharma N.V. ("Kiadis Pharma" or the "Company") (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing a T-cell immunotherapy product candidate designed to reduce Graft versus Host Disease (GVHD) and relapse after hematopoietic stem cell transplantations (HSCT), reported its audited 2017 Annual Results for the year ended December 31, 2017, which have been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the European Union (Press release, Kiadis, APR 13, 2018, View Source [SID1234525293]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Operating highlights (including post reporting period)

In April 2017, based on the positive results from the Phase 2 ‘007’ trial, filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for approval of lead program ATIR101 as an adjunctive treatment in haploidentical (genetically half-matched) hematological stem-cell transplantations for adult patients with malignant disease.
In September 2017, received the Regenerative Medicine Advanced Therapy (RMAT) designation from the US FDA for ATIR101. The RMAT pathway is equivalent to the Breakthrough Therapy designation that allows companies, such as Kiadis Pharma, that are developing regenerative medicine therapies to interact with the US FDA more frequently. During 2017 only 12 companies obtained an RMAT designation.
In December 2017, enrolled first patient in a Phase 3 trial of ATIR101 with participating sites in the US, Canada and Europe.
In December 2017, secured access to build in-house manufacturing capabilities with an agreement to lease an existing state of the art commercial manufacturing facility. This includes process development and quality control laboratories, as well as office space.
Strengthened Kiadis organization and Supervisory Board with key people who have a successful track record in developing and commercializing innovative products, including Mr. Arthur Lahr as CEO, Mr. Jan Feijen as COO, Dr. Andrew Sandler as CMO and Dr. Karl Hård as Head of Investor Relations. Dr. Otto Schwarz, former COO of Actelion and Mr. Subhanu Saxena, former Head of Global Product Strategy at Novartis and CEO of Cipla, are proposed as new Supervisory Board members.
In March 2018, submitted responses to the EMA’s list of questions, potentially allowing to obtain an opinion from the EMA as early as the fourth quarter of 2018. If positive, this would enable a conditional marketing approval from the European Commission in the first quarter of 2019, with potential launch in selected countries in Europe starting in the second half of 2019.
Financial highlights (including post reporting period)

Significantly strengthened cash position, raised more than EUR 60 million in equity and debt since June 2017.
The cash position increased to EUR 29.6 million at year-end 2017 compared to EUR 14.6 million at the end of 2016. This is mainly due to cash received from share offerings less the cash used in operating activities in 2017. Cash position was EUR 47.7 million at end of March 2018.
Operating loss increased to EUR 16.1 million in 2017 from a loss of EUR 11.4 million in 2016.
Operating expenses increased by EUR 4.7 million compared to last year as the number of employees increased from

Commenting on the financial results, Arthur Lahr, CEO of Kiadis Pharma, said: "We can look back at 2017 as a truly transformational year and are well on our way turning Kiadis Pharma into a Phase 3 clinical and commercial stage company. I am very proud of what the entire Kiadis Pharma team achieved. We are on track to obtain a CHMP opinion in the fourth quarter of 2018 for our lead program ATIR101. If positive, this would enable an approval from the European Commission in the first quarter of 2019, with potential launch in selected countries in Europe starting in the second half of 2019.

"I wish to thank our employees, partners and shareholders for their support and confidence. ATIR101 has the potential to address a very significant unmet need in transplantation, reducing relapse and Graft versus Host Disease. We look forward to continue this journey together to achieve our vision to become a fully integrated biopharmaceutical company and improve the lives of patients suffering from
serious diseases."

Conference call and presentation
The Kiadis management will host a conference call for analysts and investors today, Friday April 13, 2018 at 2:00pm CEST / 1:00pm BST / 8:00am EDT. To participate in the conference call, please call one of the following numbers ten minutes prior to commencement of the call:

A question and answer session will follow the presentation of the results. The presentation may be accessed by visiting View Source

For more information, please contact:

Kiadis Pharma:
Karl Hård, Head of IR & Communications
Tel. +31 (0) 611 096 298
[email protected]

Optimum Strategic Communications:
London: Mary Clark, Supriya Mathur, Hollie Vile
Tel: +44 (0) 203 714 1789
Amsterdam: David Brilleslijper
Tel: +31 (0) 610 942 514
[email protected]

Bloom Burton & Co. Healthcare Investor Conference

On April 12, 2018 Triumvira reported that it will be presenting at the Bloom Burton & Co. Healthcare Investor Conference on May 2 and 3, 2018 at the Sheraton Centre Toronto Hotel in Toronto, ON., Canada (Press release, Triumvira Immunologics, APR 12, 2018, View Source [SID1234525820]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This year, BBHIC will host approximately 60 of Canada’s premier publicly-traded and venture-backed private companies together with the most promising pre-venture companies in the healthcare industry. Our agenda includes company presentations, keynote sessions and panel discussions by industry leaders.