On May 30, 2018 GeneCentric Therapeutics reported that it will present the first data on the application of its proprietary Cancer Subtyping Platform (CSP) to bladder cancer and its potential utility to provide drug response biomarkers for the disease (Press release, GeneCentric Therapeutics, MAY 30, 2018, View Source [SID1234526958]). The gene expression subtyping data will be presented in a poster session at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, IL on June 2, 2018.

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"Gene expression subtypes of bladder cancer have shown considerable potential as drug response biomarkers," said Dr. Myla Lai-Goldman, CEO/Founder of GeneCentric and senior author on the study. "However, to date subtype signatures have required data on several thousand genes, limiting their use to research settings. This research demonstrates that by applying our CSP platform, subtypes can be generated with a 60-gene signature Cancer Profiler, opening the door to broad use in drug development and ultimately, clinical practice." She noted that with an estimated 81,190 new bladder cancer cases in the US and 17,240 deaths, and the emergence of promising immuno and targeted therapies, there is a significant need for biomarkers predictive of drug response.

The studies, conducted by GeneCentric scientists in collaboration with researchers at the University of North Carolina Chapel Hill’s Lineberger Cancer Center, assigned four gene expression subtypes based on approximately 2700 genes from 408 bladder cancer patients in The Cancer Genome Atlas (TCGA). The researchers then developed a subtype signature based on 60 genes and tested the 60-gene set in two additional data sets.

Analysis of the gene signatures suggested additional study of their potential as therapeutic biomarkers independently as well as in combination with other molecular features. For example, subtypes showed differences in the expression profiles of genes that are promising therapeutic targets in bladder cancer, such as FGFR3 and ERBB2. The differences were consistent across multiple data sets. Bladder cancer subtypes also showed variability in immune profiles that is likely to inform the response to immunotherapy. Subtypes were also found to be significantly prognostic for Stage 2 and 3 bladder cancer.

Details of the presentation are as follows:

Title: "Bladder Cancer Gene Expression Subtypes (60 gene signature) Defines Prognosis, Differential Immune Response and Biomarker Associations."
Abstract Number: 4538

Date: June 2, 2018
Time: 8:30AM-11:30AM
Location: Hall A
Presenter: Greg Mayhew, PhD, Director, Bioinformatics, GeneCentric Therapeutics

On May 30, 2018 Nordic Nanovector ASA (OSE: NANO) reported its results for the first quarter 2018 (Press release, Nordic Nanovector, MAY 30, 2018, View Source [SID1234553502]). A presentation by the company’s senior management team will take place today in Oslo at 08:30 CET, see details below.

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Tone Kvåle, CFO and Interim CEO, commented: "We have been focusing our efforts, since the beginning of the year, on getting PARADIGME approved and started. While our progress with the start-up of this pivotal study has been encouraging, we saw reason in April to announce adjustments to the timelines for its duration and are now targeting the first data read-out from the study in the first half of 2020.

"We remain convinced of the significant potential of Betalutin based on the promising clinical data generated to-date. We also believe that PARADIGME provides a robust trial design to generate the data needed to support our regulatory and commercialisation strategy for Betalutin to become an important new treatment option for 3L FL patients."

Operational Highlights Q1’18

• Start-up activities ongoing for pivotal Phase 2b PARADIGME trial investigating Betalutin as a potential new treatment for patients with third-line relapsed/refractory follicular lymphoma (3L R/R FL)

o As at May 29th, 23 sites in 8 countries are open for enrolment

• Malene Brondberg appointed as Vice President, IR and Corporate Communications

Events after Q1’18

• Luigi Costa stepped down as CEO

o Tone Kvåle appointed as Interim CEO in addition to existing role as CFO

o Search for new CEO underway

• PARADIGME timelines revised with first results targeted for 1H 2020 (previously 2H 2019)

o Start-up activities and site initiations progressing

• Clinical development of Humalutin postponed for the foreseeable future as resources are re-focused on PARADIGME and the Betalutin development programme

Financial Highlights Q1 ‘18

(Figures in brackets = same period 2017 unless otherwise stated)

• Revenues in the first quarter 2018 amounted to NOK 0 (NOK 0.1 million).

• Total operating expenses for the quarter were NOK 82.3 million (NOK 65.8 million).

o Research and development (preclinical, clinical, medical affairs, regulatory and CMC activities) expenses accounted for 76.2 % of total operating expenses in the first quarter 2018 (72.2 %).

• Operating loss for the quarter was NOK 82.3 million (loss of NOK 65.7 million).

• Comprehensive loss for the quarter was NOK 90.7 million (loss of NOK 55.8 million).

• Cash and cash equivalents as at 31 March 2018 amounted to NOK 641.5 million, down from NOK 756.6 million at the end of 31 December 2017.

Outlook

Nordic Nanovector aspires to become a leader in the field of targeted therapies for haematological cancers by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.

Betalutin, the company’s most advanced product candidate, has a highly differentiated, competitive, clinical profile for R/R FL, based on the promising results from the LYMRIT 37-01 Phase 1/2a clinical study. The company’s pivotal Phase 2b PARADIGME trial with Betalutin in 3L R/R FL is underway with initial data read-outs from the study targeted for 1H 2020 and subsequent filing in 2020 for marketing approval.

Nordic Nanovector intends to maximize the value of Betalutin across other stages of FL, NHL and other haematological cancer indications.

The company is confident that Betalutin could become an attractive and convenient therapeutic option, which, based on detailed market research, has the potential to be commercially successful.

Current cash resources are expected to be sufficient to reach data read-out from PARADIGME in 1H 2020.

Presentation and webcast – First quarter 2018 results and webcast

A presentation by Nordic Nanovector’s senior management team will take place at 8:30 am CEST on 30 May at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: NYLAND

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2018 from 7:00 am CEST the same day.

Results presentation in Norwegian

As announced in April, a separate presentation of the results in Norwegian, to be hosted by Nordic Nanovector’s CFO and Interim CEO, and its VP IR & Corporate Communications, will take place on Thursday, 31 May 2018 at 8:30 am CEST at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: VIPPETANGEN

To attend the meeting please email – [email protected]

The presentation will NOT be recorded as a webcast

On May 30, 2018 Rocket Pharmaceuticals, Inc. (NASDAQ:RCKT) ("Rocket"), a leading U.S.-based multi-platform gene therapy company, reported that Gaurav Shah, M.D., Chief Executive Officer and President of Rocket, will present at the Jefferies 2018 Healthcare Conference on Thursday, June 7, 2018, at 2:00 p.m. Eastern Time (ET) (Press release, Rocket Pharmaceuticals, MAY 30, 2018, View Source;p=RssLanding&cat=news&id=2351191 [SID1234526942]).

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On May 30, 2018 GlycoMimetics, Inc. (NASDAQ: GLYC), a biopharmaceutical company focused on discovering and developing novel small-molecule drug candidates to treat rare diseases, reported it had signed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) (Press release, GlycoMimetics, MAY 30, 2018, View Source [SID1234526959]). Under the terms of the CRADA, GlycoMimetics will collaborate with both the NCI and the Alliance for Clinical Trials in Oncology to conduct a randomized, controlled clinical trial testing the addition of GMI-1271 to a standard cytarabine/daunorubicin regimen (7&3) in older adults with previously untreated acute myelogenous leukemia (AML) who are suitable for intensive chemotherapy. This Phase 3 trial will be led by Geoffrey Uy, M.D., Associate Professor of Medicine, Bone Marrow Transplantation and Leukemia, Washington University School of Medicine in St. Louis, and the primary endpoint will be overall survival, with a planned interim analysis based on event-free survival (EFS) after the first 250 patients have been enrolled in the study.

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"The NCI’s support of this clinical development program in AML reflects a high-level of interest from the U.S.’s leading clinical investigators and oncology thought leaders," noted Helen Thackray, M.D., FAAP, GlycoMimetics Senior Vice President, Clinical Development, and Chief Medical Officer. "Based on our Phase 2 data, we believe GMI-1271 has the ideal profile to become the possible foundation of treatment across the continuum of care in AML. This is an important collaboration for us as we seek to realize the full potential of this novel therapeutic."

Under the terms of the CRADA, the NCI may also fund additional research, including clinical trials involving pediatric patients with AML as well as preclinical experiments and clinical trials evaluating alternative chemotherapy regimens. GlycoMimetics will supply GMI-1271 as well as provide financial support to augment data analysis and monitoring for the Phase 3 program.

In addition, GlycoMimetics announced that the generic name for GMI-1271 will be uproleselan, and the drug candidate will be referred to by this name going forward.

About GMI-1271 (Uproleselan)

GMI-1271 is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell chemoresistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, GMI-1271 was evaluated in both newly diagnosed elderly and relapsed/refractory patients with acute myeloid leukemia (AML). In both populations, patients treated with GMI-1271 together with standard chemotherapy achieved better than expected remission rates and overall survival compared to historical controls, which have been derived from results from third party clinical trials evaluating standard chemotherapy, as well as lower than expected induction-related mortality rates. Treatment in these patient populations was generally well tolerated, with fewer than expected adverse effects. The FDA has granted GMI-1271 Breakthrough Therapy designation for the treatment of adult AML patients with relapsed/refractory disease.

On May 30, 2018 Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing next generation DNA Damage Response (DDR) therapeutics for the treatment of patients with cancer, reported that Dr. Nick Glover, President and Chief Executive Officer, will present an overview of the company at the Jefferies Global Healthcare Conference being held in New York on June 5-8 (Press release, Sierra Oncology, MAY 30, 2018, View Source [SID1234526943]). The presentation is scheduled for 8:30 a.m. ET on Thursday, June 7. A live audio webcast and archive of the presentation will be accessible through the Sierra Oncology website at www.sierraoncology.com.

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