On May 19, 2012 Nordic Nanovector ASA (OSE: NANO) reported its results for the first quarter 2016 (Press release, Nordic Nanovector, MAY 19, 2016, View Source [SID:1234512605]). A presentation of the results by the company’s senior management team will take place today at 8:30 a.m. CEST in Oslo – details below.

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Nordic Nanovector reports steady operational progress on Betalutin’s clinical development plan in Follicular Lymphoma (FL), with recruitment of both sites and patients proceeding according to schedule. The Lymrit 37-01 study is on track to define the optimized dose regimen to be used in PARADIGME, the pivotal Phase 2 study planned to start in 2H 2017. Updated data from this ongoing clinical study, presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) in April, confirm Betalutin’s efficacy potential, durability of response and favourable safety profile in patients with advanced FL.

The company continues to advance its product pipeline. Having received clearance of the Investigational New Drug (IND) Application from the FDA and acceptance of the protocol design from EU Authorities, Nordic Nanovector is ready to initiate its Phase 1 clinical study for Betalutin in diffuse large B cell lymphoma (DLBCL). Other progresses include the research and development collaboration with Paul Scherrer Institute, aiming at developing new Antibody-Radionuclide-Conjugates (ARCs) for treatment of single cell leukaemias. During the first quarter, the company received a grant of up to NOK 15 million from the Research Council of Norway’s User-driven Research-based Innovation programme to support the discovery and development of novel targeted therapeutics for leukaemia and NHL.

Luigi Costa, CEO of Nordic Nanovector, comments: "We are pleased to report that our operations are progressing according to plan and on track to meet milestones. The updated results from Betalutin in FL are promising and reinforce our belief in its promise to become a significant new treatment of NHL. We have also made good progress across all key areas, including the initiation of a clinical study for Betalutin in a second NHL indication, with a significant unmet medical need, and promising preclinical research highlighting further opportunities for our pipeline."

Operational Highlights

• Steady operational progress on Betalutin’s clinical development plan in number of sites activated and patients enrolled

• Received grant from Research Council of Norway

• Presented updated clinical results at AACR (Free AACR Whitepaper) in April, which confirm Betalutin’s promising efficacy and increasing Duration of Response

• Received clearance of the Investigational New Drug (IND) application, enabling initiation of the study in the US, for a new Phase 1 clinical study of Betalutin in DLBCL

• Research and development collaboration entered with Paul Scherrer Institute, aiming at developing new Antibody-Radionuclide-Conjugates for treatment of single cell leukaemias

• First good manufacturing process batch of the chimeric HH1 antibody successfully completed

Financial Highlights Q1 2016

(Figures in brackets = same period 2015 unless otherwise stated)

• Revenues amounted to MNOK 0.078 (MNOK 0.076)

• Total operating expenses were MNOK 52.7 (MNOK 35.9)

• Loss for the quarter amounted to MNOK 52.7 (loss of MNOK 35.8)

• Cash and cash equivalents amounted to MNOK 671.9 at 31 March 2016 (MNOK 743.4 at 31 December 2015)

Outlook

The promising updated results from the ongoing Phase 1/2 study with Betalutin, the good progress made in advancing this study and strong findings from the research and development pipeline bode well for Nordic Nanovector’s operations going forward. Management will continue to focus its efforts on the efficient execution of its plans and to meet the anticipated clinical milestones. Current cash resources are expected to be sufficient to reach the first regulatory submission for Betalutin in FL in 1H 2019.

Presentation and web cast details

A presentation by Nordic Nanovector’s senior management team will take place at 8:30 am CEST 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: Investor Relations/Webcast.

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investor Relations/Reports and Presentation/Quarterly Reports/2016 from 7:00 am CEST the same day.

On May 19, 2016 Clovis Oncology, Inc. (NASDAQ: CLVS) reported its presence at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, where it will share updated results from clinical studies of rucaparib (Press release, Clovis Oncology, MAY 19, 2016, View Source;p=irol-newsArticle_Print&ID=2170005 [SID:1234512606]). ASCO (Free ASCO Whitepaper) will take place June 3-7, 2016 in Chicago.

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"We look forward to providing updates on rucaparib data in ovarian cancer, including in patients with mutations beyond BRCA, as well as the first presentation of our pancreatic cancer data," said Patrick J. Mahaffy, CEO and President of Clovis Oncology. "These datasets demonstrate rucaparib’s encouraging clinical activity and tolerability profile in the treatment of ovarian and pancreatic cancers. Both represent diseases in which BRCA mutations play a significant role in certain patients, as well as areas where additional treatment options are very much needed."

Rucaparib is the Company’s oral, potent, small molecule inhibitor of PARP1-3 currently being developed for the treatment of ovarian cancer, specifically in patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA, including those with high genomic loss of heterozygosity (LOH) commonly referred to as "BRCA-like." Data from rucaparib studies are the subject of three poster presentations at the conference:

Abstract 4110 – RUCAPANC: An open-label, phase 2 trial of the PARP inhibitor rucaparib in patients (pts) with pancreatic cancer (PC) and a known deleterious germline or somatic BRCA mutation.

Susan M. Domchek, MD, University of Pennsylvania, Philadelphia, PA
Saturday, June 4 from 8:00am-11:30am CDT
Location: Hall A, Poster Board #102
Abstract 5540 – Refinement of prespecified cutoff for genomic loss of heterozygosity (LOH) in ARIEL2 part 1: A phase II study of rucaparib in patients (pts) with high grade ovarian carcinoma (HGOC).

Robert L. Coleman, MD, The University of Texas MD Anderson Cancer Center, Houston, TX
Monday, June 6 from 1:00pm-4:30pm CDT
Location: Hall A, Poster Board #363
Abstract 5549 – Feasibility of monitoring response to the PARP inhibitor rucaparib with targeted deep sequencing of circulating tumor DNA (ctDNA) in women with high grade serous carcinoma on the ARIEL2 trial.

Anna Piskorz, PhD, Cancer Research UK Cambridge Institute, University of Cambridge
Monday, June 6 from 1:00pm-4:30pm CDT
Location: Hall A, Poster Board #372
About Rucaparib

Rucaparib is an oral, potent small molecule inhibitor of PARP1-3 being developed for the treatment of ovarian cancer, specifically in patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA, including those with high genomic loss of heterozygosity (LOH) commonly referred to as "BRCA-like." Clovis is also exploring rucaparib in other solid tumor types with significant BRCA and BRCA-like populations, including prostate, breast and gastroesophageal cancers. Rucaparib was granted Breakthrough Therapy designation by the U.S. FDA in April 2015. Clovis holds worldwide rights for rucaparib.

On May 19, 2016 AstraZeneca and its global biologics research and development arm, MedImmune, reported that they will provide an update on their extensive oncology pipeline at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, USA, on 3-7 June 2016 (Press release, AstraZeneca, MAY 19, 2016, View Source [SID:1234512562]).

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Highlights will include new data demonstrating the strength and versatility of AstraZeneca’s industry-leading line of DNA damage response (DDR) medicines in multiple types of cancer. New data will highlight the continued momentum behind AstraZeneca’s numerous immuno-oncology (IO) programmes, and showcase small-molecule developments including Tagrisso (osimertinib) in leptomeningeal (brain) disease and the highly-selective Bruton’s tyrosine kinase (BTK) inhibitor, acalabrutinib, in chronic lymphocytic leukaemia (CLL).

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "Oncology is a strategic priority for AstraZeneca because of the potential of our broad pipeline to offer transformational therapies in cancer care. At ASCO (Free ASCO Whitepaper), we will update on our next-generation portfolio focusing on DNA damage response as a breakthrough paradigm in cancer treatment, including new long-term overall survival data for Lynparza. Our increased commitment to DDR therapies complements developments in our exciting immuno-oncology pipeline, from which we are expecting clinical results over the coming year."

DDR: A promising scientific platform, a leading position for AstraZeneca

DDR is a term describing the network of cellular pathways that minimise the daily impact of DNA damage. Currently, many cancers are known to have defects in DDR pathways, which makes them dependent on and therefore, highly sensitive to inhibition of the remaining DDR pathways. Targeting DDR deficiencies to preferentially kill cancer cells, while minimising the impact on normal cells, has potential for more selective, better tolerated therapies to improve survival in multiple cancers.

AstraZeneca is developing a comprehensive pipeline of compounds that target molecular pathways across the DDR system. These include the PARP inhibitor Lynparza (olaparib); Wee1 inhibitor AZD1775, ATM inhibitor AZD0156; ATR inhibitor AZD6738, and Aurora B Kinase inhibitor AZD2811. These compounds act on different cell-cycle points to prevent tumour cells from reproducing.

At the ASCO (Free ASCO Whitepaper) congress, DDR presentations will highlight:

The potential for maintenance of DDR therapies as shown by Lynparza overall survival data from Study 19 in ovarian cancer (Abstract # 5501). This abstract has been selected as a "Best of ASCO (Free ASCO Whitepaper)" abstract.
Opportunities for combination approaches with DDR and immuno-oncology therapies as shown in a Phase I study of the PD-L1 inhibitor, durvalumab, in combination with Lynparza or a VEGFR inhibitor, cediranib, in women’s cancers (Abstract # 3015)
The importance of selecting patients with a DDR pathway defect using the right diagnostic tool (abstract #4041)
The potential of DDR therapies against multiple biological DDR targets in different tumour types, with studies of the highly-selective WEE1 inhibitor, AZD1775, in advanced high-grade serous ovarian cancer (Abstract # TPS5610), squamous cell carcinoma of the head and neck (SCCHN) (Abstract # TPS6106), advanced solid tumours (Abstract # TPS2608) and glioblastoma (GBM) (Abstract # 2008)
Immuno-Oncology: Robust development momentum on track for read-outs in H1 2017

AstraZeneca is leading in a number of first-line studies with its IO strategy, where combined PD-L1 and CTLA-4 blockade – through the combination of durvalumab and tremelimumab – may address a significant unmet medical need for cancer patients who may not benefit from PD-1 pathway drugs in monotherapy.

Key updates include presentations covering pre-clinical data, late-stage trials and biomarker research:

Early study results of durvalumab monotherapy in urothelial bladder cancer from Phase Ib Study 1108 (Abstract # 4502)
Final results from a Phase III study of tremelimumab in mesothelioma (Abstract # 8502)
New study results on safety and clinical activity of durvalumab as first-line treatment in non-small cell lung cancer (NSCLC) (Abstract # 9029)
Ongoing investigation of the potential synergistic effects of durvalumab and the CTLA-4 inhibitor, tremelimumab, in bladder cancer (DANUBE trial – Abstract # TPS4574) and SCCHN (KESTREL trial – Abstract # TPS6101)
Enhanced understanding of PD-L1 biomarker expression in relation to primary versus metastatic tumours and sample age (Abstract # 3025)
Tagrisso in brain metastasis; acalabrutinib in CLL

AstraZeneca’s strong heritage in developing innovative targeted small molecules was underscored by the recent approval of Tagrisso as the first indicated treatment for EGFR T790M mutation-positive metastatic NSCLC in the US, EU and Japan. At ASCO (Free ASCO Whitepaper), new data will highlight the importance of Tagrisso activity in leptomeningeal disease through its ability to penetrate the blood-brain barrier. Further presentations will show the growing role of circulating tumour DNA (ctDNA) testing for diagnosis and treatment monitoring.

Key updates will also include presentation on the potential of our potent, highly-selective BTK inhibitor, acalabrutinib, in chronic lymphocytic leukaemia (CLL):

Data from the BLOOM study of Tagrisso in patients with leptomeningeal disease as a complication of EGFRm-metastatic NSCLC (Abstract # 9002)
Intensive plasma ctDNA profiling in experimental trials to identify markers of acquired drug resistance (Abstract # 11530)
Acalabrutinib – preliminary results from a first-line study as first-line therapy in CLL (Abstract # 7521) and in a Phase II study in combination with pembrolizumab in metastatic pancreatic cancer (Abstract # 4130)

May 19, 2016 Varian Medical Systems (NYSE: VAR) reported that it has been selected by the Apollo Hospitals Group to supply 12 advanced medical linear accelerators and five brachytherapy systems as India’s largest private hospital chain rolls out a program to replace ageing cancer treatment machines (Press release, InfiMed, MAY 19, 2016, View Source [SID:1234512584]). Based on an order placed in March, Varian will supply 11 TrueBeam systems, one Edge Radiosurgery system, and five GammaMed brachytherapy systems for the Apollo network over the next two years.

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The Edge Radiosurgery system, which will be installed in one of Apollo’s tertiary care centers, is a precise, non-invasive alternative to conventional surgery. With enhanced precision and speed, the Edge system offers state of the art radiosurgery and can treat a wide range of conditions across an ever increasing number of clinical indications. Varian’s flagship TrueBeam family of linear accelerators, to be installed at hospitals throughout the Apollo chain, incorporates numerous technical innovations that dynamically synchronize imaging, patient positioning, motion management, and treatment delivery during a radiotherapy or radiosurgery procedure.

As well as advanced treatment equipment, Apollo is ordering a full suite of Varian software tools including the Eclipse treatment planning system and ARIA oncology information management system, along with specific modules such as RapidPlan to enhance the speed and quality of treatment plans, and the InSightive Analytics real-time dashboard to maximize workflow in a clinic.

"We are pleased that Apollo has selected our technology-leading hardware and software to offer their cancer patients fast and precise treatments," says Ashok Kakkar, senior managing director of Varian India. "India is severely under-equipped when it comes to radiotherapy treatment machines and more than two million new cancer cases are detected each year in the country. Programs such as this help to make a big difference in the treatment of cancer patients in India."

Commenting on the collaboration, Dr. Preetha Reddy, executive vice chairperson of Apollo Hospitals Enterprise Limited said, "Healthcare has evolved by leaps and bounds in the past few years and technology has played a critical role in improving clinical outcomes for patients. Providing high quality healthcare on a par with global standards is our prime objective and we are glad to partner with Varian in this endeavor. Already enriched with highly skilled doctors, technicians and physicians, cutting edge technology will further enhance India’s positioning as a global healthcare destination."

Last year, Varian and Apollo announced a collaboration on the first radiotherapy educational co-operation of its kind between industry and a care provider in India. In this collaboration, Varian and Apollo will work together to bring greater access to training in modern radiotherapy by leveraging the existing Apollo Knowledge network that comprises several educational entities in the healthcare space in India. This collaboration with Apollo is a furtherance of Varian’s Access to Care program, which seeks to bridge the gap between the growing need for modern radiotherapy treatment machines in developing countries and the lack of trained personnel to operate them.

On May 19, 2016 GlycoMimetics, Inc. (NASDAQ: GLYC) reported that initial efficacy data from a Phase 1/2 clinical trial on the effects of drug candidate GMI-1271 combined with chemotherapy on patients with acute myeloid leukemia (AML) were accepted as a poster to be presented at the European Hematology Association (EHA) (Free EHA Whitepaper)’s 21st Congress, taking place June 9-12 in Copenhagen, Denmark (Press release, GlycoMimetics, MAY 19, 2016, View Source [SID:1234512607]).

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The poster (P191), entitled "Results of a Phase 1 study of GMI-1271, a novel E-selectin antagonist in combination with induction chemotherapy in relapse/refractory AML: a novel, well-tolerated regimen with a high remission rate," is scheduled for 5:15 p.m. CET on Friday, June 10.

The abstract is available here

About GMI-1271

GMI-1271 is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with acute myeloid leukemia (AML) cells in ways that help the cancer cells evade the effects of chemotherapy treatment. Preclinical research points to the drug’s potential role in moving cancerous cells out of the protective environment of the bone marrow where they hide and escape the effects of chemotherapy. By blocking E-selectin, GMI-1271 also may protect normal blood-producing cells, and reduce the toxic side effects of chemotherapy such as low white blood cell counts that make some patients more prone to infections. GMI-1271 may also reduce mucositis (inflammation or lesions in the intestinal tract and mouth), which can be a side effect of chemotherapy. GlycoMimetics has announced encouraging initial top line data from the first two cohorts in its ongoing Phase 1/2 clinical study.