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Roche to present new data from its extensive lung cancer programme at the 2018 World Conference on Lung Cancer (WCLC)

On September 6, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that new data from its broad clinical development programme across different types of lung cancer will be presented at the International Association for the Study of Lung Cancer (IASLC) 2018 World Conference on Lung Cancer (WCLC), taking place from 23–26 September in Toronto, Canada (Press release, Hoffmann-La Roche, SEP 6, 2018, View Source [SID1234529353]). 10 abstracts have been accepted, including three ‘late breakers’ and five oral presentations.

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"We look forward to presenting new data from our comprehensive lung cancer programme, including new immunotherapy and targeted treatment strategies across different types of lung cancer," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "We are particularly pleased to be sharing positive TECENTRIQ data in extensive-stage small cell lung cancer, which has seen limited progress in treatment over the last two decades, as well as new pivotal data for our investigational therapy entrectinib for the treatment of ROS1 fusion-positive lung cancer."

Key presentations
Progression-free survival (PFS) and overall survival (OS) data from the Phase III IMpower133 study of TECENTRIQ plus chemotherapy (carboplatin and etoposide) for the initial (first-line) treatment of people with extensive-stage small cell lung cancer (ES-SCLC) will be presented in the Presidential Symposium. These are the first positive survival data from a Phase III study with an immunotherapy-based combination in the initial treatment of ES-SCLC.

PFS and OS data will be presented from the Phase III IMpower132 study investigating TECENTRIQ plus pemetrexed and platinum-based chemotherapy (cisplatin or carboplatin) in the initial treatment of people with advanced non-squamous NSCLC. The IMpower132 and IMpower133 data will be featured as part of WCLC’s official press programme on Monday 24th and Tuesday 25th of September, respectively.

Additionally, results from a Phase Ib study investigating Tarceva plus TECENTRIQ in tyrosine kinase inhibitor (TKI)-naïve people with EGFR mutation-positive NSCLC will also be presented.

New pivotal results of entrectinib, an investigational oral, CNS-active treatment for people with locally advanced or metastatic ROS1 fusion-positive NSCLC, from a pooled analysis including the global Phase II STARTRK-2 basket study will be presented. These data have also been selected to be featured in the WCLC press programme on Monday 24th of September.

Follow Roche on Twitter via @Roche and keep up to date with WCLC 2018 congress news and updates by using the hashtag #WCLC2018.

For more information on Roche’s approach to cancer, visit Roche.com.

Overview of key presentations featuring Roche medicines at WCLC 2018

About NSCLC and SCLC
Lung cancer is the leading cause of cancer death globally.1 Each year 1.59 million people die as a result of the disease; this translates into more than 4,350 deaths worldwide every day.1 Lung cancer can be broadly divided into two major types: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). NSCLC is the most prevalent type, accounting for around 85% of all cases,2 with SCLC accounting for approximately 15% of all lung cancer cases.2 Survival rates for people with SCLC vary depending on the stage (extent) of the cancer at the time of diagnosis.3 The five-year relative survival rate for people with stage I SCLC is approximately 31%, however, at stage IV, the five-year relative survival rate declines to approximately 2%.4

About TECENTRIQ
TECENTRIQ is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, TECENTRIQ may enable the activation of T cells. TECENTRIQ has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Currently, Roche has eight Phase III lung cancer studies underway, evaluating TECENTRIQ alone or in combination with other medicines.

TECENTRIQ is already approved in the European Union, United States and more than 70 countries for people with previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC).

About ROS1 fusion-positive non-small cell lung cancer (NSCLC)
ROS1 is a tyrosine kinase, which play a role in controlling how cells grow and proliferate. When a ROS1 gene fusion occurs, ‘healthy’ cell signalling malfunctions, causing cells to grow and proliferate in an uncontrolled manner – this results in cancer.

ROS1 gene fusions account for 1-2% of NSCLC. Lung cancer is the leading cause of cancer-related death across the world. Each year, 1.59 million people die as a result of the disease; this translates into more than 4,350 deaths worldwide every day.1 NSCLC is the most prevalent type of lung cancer, accounting for around 85% of all cases.2 While the ROS1 gene fusion can be found in any patient with NSCLC, young never-smokers with NSCLC have the highest incidence of ROS1 fusions.

About entrectinib
Entrectinib (RXDX-101) is an investigational, oral medicine in development for the treatment of locally advanced or metastatic solid tumours that harbour NTRK1/2/3 or ROS1 fusions. It is a selective, CNS-active tyrosine kinase inhibitor designed to inhibit the kinase activity of the TRKA/B/C and ROS1 proteins, whose activating fusions drive proliferation in certain types of cancer. Entrectinib can block ROS1 and NTRK kinase activity and may result in the death of cancer cells with ROS1 or NTRK fusions. Entrectinib is being investigated across a range of solid tumour types, including NSCLC, pancreatic cancer, sarcomas, thyroid cancer, salivary cancer, gastrointestinal stromal tumours (GIST) and cancers of unknown primary (CUP).

Entrectinib has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA); Priority Medicines (PRIME) designation by the European Medicines Agency (EMA); and Sakigake designation by the Japanese health authorities for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumours in adult and paediatric patients who have either progressed following prior therapies or have no acceptable standard therapies.

Twentyeight-Seven Therapeutics Launches with a $65 Million Series A Funding

On September 6, 2018 Twentyeight-Seven Therapeutics (28-7), a biotechnology company focused on modulating non-coding RNA (ncRNA) biology to develop treatments for cancer and other diseases, reported the successful completion of its $65 million Series A financing (Press release, Twentyeight-Seven Therapeutics, SEPT 6, 2018, View Source [SID1234529351]). Founding investor MPM Capital and Novartis Venture Fund co-led the financing. They were joined by additional investors including Johnson & Johnson Innovation – JJDC, Inc., Vertex Ventures HC, Longwood Fund, and Astellas Venture Management. The funding will be used to advance 28-7’s lead program, aimed at the discovery and development of small molecules that increase the levels of the tumor suppressor microRNA (miRNA), Let-7, into serious cancer indications.

"This strong financing round was achieved thanks to the new biological understanding and impressive scientific data around non-coding RNA produced by our four scientific founders and the progress the 28-7 team has made since it was founded two years ago," said Kazumi Shiosaki, Ph.D., founding President and Chief Executive Officer, 28-7. "Our experienced investors realize the promise in this new field of therapeutics and in the robust leads produced by our founders, who have made many of the seminal discoveries in this field, and by the exceptional scientists within the company."

In addition, 28-7 announced that Shomir Ghosh, Ph.D., has joined as its Chief Scientific Officer. Most recently CSO and a founding scientist at IFM Therapeutics, Dr. Ghosh has 25 years of scientific research, drug discovery and development experience in biotech and large pharma, and has successfully delivered multiple compounds into preclinical and clinical development in the immunology, oncology and CNS therapeutic areas.

"I am incredibly excited to join 28-7 and support the advancement of its lead program," said Dr. Ghosh. "I look forward to working with Kazumi and our accomplished team and Board as we discover new ways to fight cancer and grow our operations."

28-7’s initial focus is on modulating miRNAs, which are short ncRNAs that inhibit target gene expression by suppressing mRNA translation and/or promoting mRNA decay. It is now well recognized that miRNAs are directly involved in cancer initiation, progression, and metastasis. 28-7’s technology does not focus on directly targeting the RNA itself or on developing oligonucleotides, but rather targets RNA modulating proteins (RMPs), enabling the use of small molecule drug candidates with broader access to cells and tissues. Let-7 is an miRNA that suppresses the translation of oncogenes in cells, and low levels of this miRNA are correlated with greater cancer aggressiveness. The company’s leading protein target is Lin28, an RMP that reduces the levels of Let-7, and has been shown to be an oncogene, promoting cellular transformation and tumorigenesis. 28-7 is developing first-in-class drugs that inhibit Lin28’s activity and thus raise levels of Let-7 for treatment of various cancers.

The company’s core technology comes from its four founding scientists, all leading researchers in RNA biology and cancer:

George Daley, M.D., Ph.D. ─ Dean of the Faculty of Medicine and Professor of Medicine, Biological Chemistry and Molecular Pharmacology, Harvard Medical School
Richard Gregory, Ph.D. ─ Professor of Biological Chemistry and Molecular Pharmacology, and Pediatrics, Harvard Medical School
Frank Slack, Ph.D. ─ Professor of Pathology, Harvard Medical School, Professor of Pathology and Director of Institute of RNA Medicine, Beth Israel Deaconess Medical Center
Piotr Sliz, Ph.D. ─ Associate Professor of Pediatrics and of Biological Chemistry and Molecular Pharmacology, Harvard Medical School
This founding group has been collaborating for years and has made substantial contributions to the science of ncRNA biology, including elucidating the role of ncRNAs in disease and identifying new RMP targets for drug discovery programs.

"Our founders have made important scientific contributions to the field of ncRNA biology, including the discovery of the Lin28/Let-7 pathway and its role in normal development, metabolism, and malignancy. Overall, our studies have established Lin28/Let-7 as a major regulatory pathway in stem cells and cancer," said George Daley, M.D., Ph.D., 28-7’s co-founder and Chairman of the company’s Scientific Advisory Board, and Dean and Professor of Medicine and Biological Chemistry and Molecular Pharmacology, Harvard Medical School. "We felt that the time was right to move these insights from the laboratory to pharmaceutical development, and we are very pleased by the progress the company achieved in the first two years of its existence. With this impressive round of funding and our continued support, 28-7 will unlock the therapeutic potential of our work."

In addition to Dr. Shiosaki, several investors will join 28-7’s Board of Directors, including:

· Luke Evnin, Ph.D. ─ Managing Director and co-founder, MPM Capital

· Briggs Morrison, M.D. ─ Executive Partner, MPM Capital and CEO of Syndax Pharmaceuticals, Inc.

· Carolyn Ng, Ph.D. ─ Principal, Vertex Ventures HC

· Michal Silverberg, M.B.A. ─ Managing Director, Novartis Venture Fund

Omeros to Present at the Morgan Stanley Global Healthcare Conference

On September 6, 2018 Omeros Corporation (NASDAQ: OMER), reported that Gregory A. Demopulos, M.D., chairman and chief executive officer, will present at the 16th Annual Morgan Stanley Global Healthcare Conference in New York next week (Press release, , SEPT 6, 2018, View Source;p=irol-newsArticle_Print&ID=2366529 [SID1234529346]). The presentation, which will be a fireside chat format, is scheduled for Thursday, September 13, 2018 at 5:15 p.m. EDT.

The presentation will be webcast. The live and archived webcasts can be accessed on the "Events" page of the company’s website at www.omeros.com.

Nicox First Half 2018 Financial Results and Business Update

On September 6, 2018 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmic company, reported the financial results for the Nicox Group for the six months ending June 30, 2018 and provided an update on its activities (Press release, NicOx, SEP 6, 2018, View Source [SID1234529343]).

Michele Garufi, Chairman and Chief Executive Officer of Nicox, said: "Nicox is entering a new and exciting phase with the initiation of the Phase 2 study for our lead product candidate NCX 470 for IOP reduction in patients with open-angle glaucoma or ocular hypertension, and by strengthening our U.S. presence in our new site in Research Triangle Park in North Carolina. We have assembled the right team to achieve our important near term clinical and corporate milestones and continue delivering on all objectives in line with our growth strategy."

Key Upcoming Milestones
Q1 2019: Planned Investigational New Drug (IND) submission to the United States (U.S). Food and Drug Administration (FDA) for NCX 4251 to enable a Phase 2 clinical study in patients with acute exacerbations of blepharitis.
Q1 2019: Expected delivery of ZERVIATETM (cetirizine ophthalmic solution), 0.24% commercial product to Eyevance Pharmaceuticals LLC, followed by a launch for the spring 2019 allergy season in the U.S.
H2 2019: Expected top-line data from the NCX 470 Phase 2 study for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Product and Product Candidates Updates
A Phase 2 study was initiated in Q3 2018 for Nicox’s product candidate NCX 470, a novel second generation nitric oxide (NO)-donating prostaglandin analog. This multicenter, double-masked, 28-day, parallel group, dose response study aims to evaluate the efficacy and safety of NCX 470 compared to latanoprost 0.005% in adult patients with elevated IOP due to open-angle glaucoma or ocular hypertension. The study is expected to randomize 420 patients in clinical sites across the U.S. The primary endpoint of the study is the mean reduction in diurnal IOP after 4 weeks of treatment, while the overall objective is to identify the appropriate dose of NCX 470 to be advanced into Phase 3 studies. This Phase 2 study was initiated following the submission of an IND application in June 2018, ahead of the previously disclosed target date of the third quarter of 2018. Nicox expects to report top-line data from this Phase 2 study in the second half of 2019.

Preclinical and formulation development of Nicox’s product candidate NCX 4251, a novel, patented ophthalmic suspension of fluticasone propionate nanocrystals, is continuing on track for the Q1 2019 IND submission to the U.S FDA to enable a Phase 2 study to evaluate the safety and efficacy of NCX 4251 compared to its vehicle in patients with acute exacerbations of blepharitis. An additional and positive pre-IND meeting was held with the U.S. FDA in June 2018, which addressed specific questions on development, including the potential primary endpoints. Based on FDA feedback, we are finalizing the design of the first-in-human Phase 2 study.

Two molecules from our future generation stand-alone NO-donors that target IOP reduction, NCX 667 and NCX 1660, are currently in formulation development and testing with the Re-Vana EyeLiefTM technology under the research collaboration agreement signed in October 2017. Depending on the release profile of these molecules with this technology in preclinical animal models of ocular pharmacokinetics, they may be advanced into further development and/or we may decide to test other molecules in the same technology.
Our research activities continue both in our research collaboration agreement with Ironwood, announced in June 2018, which is focused on combining Ironwood’s expertise in soluble guanylate cyclase with our proprietary NO-donating research platform, and in our internal programs combining NO with other undisclosed pharmacological mechanisms of action. We expect to be able to announce a preclinical candidate from one of these programs in the next 18 months.

VYZULTATM (latanoprostene bunod ophthalmic solution), 0.024% is now a revenue generating asset for Nicox, following the U.S. launch in December 2017 by partner Bausch + Lomb. In March 2018, the Company announced an amendment to the global licensing agreement under which royalties paid to Nicox on worldwide net sales of VYZULTA will increase by 1% over the original royalty on net sales above $300 million per year. In addition, the potential milestone payments payable to Nicox by Bausch + Lomb have been increased by $20 million.
We expect to ship commercial product and trade samples for ZERVIATETM (cetirizine ophthalmic solution), 0.24% to our partner Eyevance by Q1 2019, which will allow Eyevance to launch ZERVIATETM in the United States in time for the 2019 spring allergy season. The shipment of product triggers a $1 million milestone payment to Nicox by Eyevance, with up to $3 million of potential future milestones payments related to certain regulatory acceptance provisions and certain near term manufacturing objectives.
H1 2018 Financial Summary
Net revenue1 for the first half of 2018 was €0.3 million, comprised exclusively of royalties on H1 2018 sales of VYZULTATM by global partner Bausch + Lomb, after deduction of royalty payments due by Nicox. The Nicox Group recorded no revenues for the first half of 2017.

The operating expenses for the first half of 2018 were consistent with the same period last year (€10.0 million for the first six months of 2018 compared to €10.2 million for the first six months of 2017).

The Nicox Group recorded a net loss of €7.6 million for the six months ended June 30, 2018, compared to a net loss of €12.2 million for the same period in 2017.

As of June 30, 2018, the Nicox Group had cash and cash equivalents of €32.7 million as compared with €36.3 million at March 31, 2018 and €41.4 million at December 31, 2017.

Reference
1. Net revenue consists of revenue from collaborations less royalty payments which corresponds to Net profit from collaborations in the condensed consolidated statements of profit or loss for the six-month periods ended June 30, 2018.

The diligences related to the half-year review were performed by the auditors. The review report will be issued once procedures will be finalized over the half-year financial report.

OSE Immunotherapeutics Reports First-Half 2018 Results and Provides a Corporate Update

On September 6, 2018 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE), reported its consolidated half-year financial results as of June 30, 2018 and provided an update on the key milestones reached during the 2018 first semester (Press release, OSE Immunotherapeutics, SEP 6, 2018, View Source [SID1234529338]).

"With the completion of our license and collaboration agreement with Boehringer Ingelheim for OSE-172 in April, the first half 2018 marks an important second phase of growth for the Company, supported financially by our strategic partnerships and accompanied by a strengthened management team. Of significant note, the Company generated a financial profit of 8.9 million euros, which is a remarkable financial achievement for OSE," commented Alexis Peyroles, CEO of OSE Immunotherapeutics.

"We are focused on making significant clinical progress with four of our products, including three with our pharmaceutical partners: the initiation of a Phase 1/2 study of OSE-172 and a Phase 1 study of OSE-127 and the preparation of the entry into Phase 2 study with FR104. Furthermore, we were very pleased to receive the approval from the FDA and the EMA to actively advance the Tedopi Phase 3 trial in advanced non-small cell lung cancer in patients with immune escape after checkpoint inhibitors, a population for which no approved treatment is currently available. We also plan to start a Phase 2 trial of Tedopi combination therapy in pancreatic cancer by the end of 2018, a trial sponsored by the oncology group GERCOR. In the long term, our R&D teams are conducting innovative research to identify key targets of interest and develop new antibodies as candidates for clinical development in immuno-oncology," Mr. Peyroles continued.

Key First-Half 2018 Achievements

OSE-172, SIRPa antagonist and checkpoint inhibitor targeting suppressive myeloid/macrophage cells, in various solid tumors

Entered a global license and collaboration agreement with Boehringer Ingelheim to develop OSE-172. Under the terms of the agreement, OSE Immunotherapeutics has received a €15 million upfront payment from Boehringer Ingelheim, and will receive potential additional short-term milestones of up to €15 million upon initiation of a phase 1 clinical study. OSE Immunotherapeutics stands to receive more than €1.1 billion upon reaching pre-specified development, registration and sales milestones, plus royalties on worldwide net sales (cf. press release of April 4, 2018).
Expected to initiate clinical phase by the end of 2018, with potential application in various solid tumors, in partnership with Boehringer Ingelheim.
Tedopi, combination of optimized neoepitopes that induce specific T lymphocyte activation in immuno-oncology, in advanced lung cancer

Progressed an ongoing Phase 3 trial in patients with advanced and metastatic non-small cell lung cancer (NSCLC) who have failed a previous treatment with immune checkpoint inhibitors in Europe and in the U.S. Received approval from Israeli competent authorities to expand enrolment of the trial in this additional country.
Received a €435,000 grant from Bpifrance through the Eurostars European Programme to lead a research program within a consortium of five partners. The project aims to validate an immune algorithm specific to Tedopi and establish precision medicine targeting for the product. It will be conducted in conjunction with the Phase 2 clinical trial for Tedopi, combined with a PD-1 checkpoint inhibitor, in pancreatic cancer. This study, sponsored by the oncology cooperative group GERCOR, is expected to initiate in 2018.
OSE-127, humanized monoclonal antibody antagonist of the interleukin-7 receptor, in inflammatory bowel diseases

Presented new preclinical data further supporting the potential of OSE-127 for the treatment of inflammatory bowel diseases at the annual congress of the American Association of Immunologists.
Plans to initiate clinical phase in ulcerative colitis by the end of 2018, in partnership with Servier.
FR104, CD28-antagonist, in rheumatoid arthritis

Preparation for entry into a Phase 2 clinical trial in rheumatoid arthritis, in partnership with Janssen Biotech.
Moreover, the Company is continuing advancement of its innovative research program based on its several scientific and technological platforms (neoepitopes, agonist or antagonist monoclonal antibodies) positioned to fight cancer and autoimmune diseases.

Appointed Dominique Costantini as chairman of the board of directors and appointment of Alexis Peyroles to chief executive officer, a natural and seamless evolution following three structuring license agreements driving the next steps of the Company’s growth.
Strengthened the management team with the additions of Bérangère Vasseur, M.D., chief medical officer immuno-oncology (broad experience in oncology development while at Roche and at several biotechnology companies) and Emilienne Soma, PharmD, Ph.D., director of pharmaceutical program development (experience in R&D management and in alliances in several biotechnology companies).
2018 Half-Year Results

As of June 30, 2018, available cash* amounted to €18.6 million, giving a financial visibility until the second semester of 2019. Moreover, this cash could be reinforced by milestone payments provided by the partnerships with Boehringer Ingelheim, up to €15 million upon initiation of a Phase 1 of OSE-172, and with Servier, up to €12 million upon achievement of a new development step of OSE-127.

Of note, the development costs of the licensed projects are supported by the company’s partners: totally by Boehringer Ingelheim for OSE-172 and by Janssen Biotech for FR104, and partially by Servier for OSE-127. In parallel, the two public grants obtained, EFFIMab for OSE-127 and EFFI-CLIN for OSE-172, reinforce the funding.

The turnover amounted to €20.6 million, compared to €2.08 million as of June 30, 2017, due to the upfront payment from the collaboration agreement with Boehringer Ingelheim. During the first half of 2018, the Company recorded a net profit of €8.9 million.

Current operating expenses were €10.2 million, stable compared as of June 30, 2017. They include €8 million of R&D expenses during the first half of 2018. Over the same period of 2017, R&D expenses amounted to €7.9 million.

The consolidated balance sheet amounted to €84.6 million compared to €77.4 million as of December 31, 2017. This increase is mainly due to the cash received from the agreement with Boehringer Ingelheim.

*Available cash and cash equivalents and current financial assets

The Board of Directors of September 6, 2018 has approved the Company’s semester accounts as of June 30, 2018. The full "Semester financial report" (Regulated information) is available on : View Source The consolidated accounts have been subject to a limited review by the Statutory Auditors.