On April 19, 2018 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that financial results for the first quarter ended March 31, 2018 (Press release, Quest Diagnostics, APR 19, 2018, View Source [SID1234525534]).

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"We delivered strong revenue and earnings growth in the first quarter," said Steve Rusckowski, Chairman, President and CEO. "We grew revenue 3.7 percent despite severe winter weather and the impact of lower Medicare reimbursement under PAMA. Earnings growth was driven by our continued strong execution as well as the benefits of tax reform. Our two-point strategy of accelerating growth and driving operational excellence continues to produce results."

As used in this press release the term "reported" refers to measures under the accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP measures as follows: (i) for the purpose of income measures the term "adjusted" refers to operating performance measures that exclude special items such as restructuring and integration charges, excess tax benefit ("ETB") associated with stock based compensation and other items; and (ii) the term "adjusted diluted EPS excluding amortization" represents the company’s diluted EPS before the impact of special items (described above) and amortization expense.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables attached below include reconciliations of adjusted measures to GAAP measures.

Conference Call Information

Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed in listen-only mode by dialing 773-756-0467, passcode 3214469. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 800-846-1910 for domestic callers or 402-280-9953 for international callers. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on April 19, 2018 until midnight Eastern Time on May 3, 2018. Anyone listening to the call is encouraged to read the company’s periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On April 19, 2018 Medigene AG (FSE: MDG1, Prime Standard, TecDAX) reported that researchers from Medigene and Oslo University Hospital presented a poster on the generation of dendritic cell vaccines for Medigene’s ongoing Phase I/II clinical trial with Acute Myeloid Leukemia (AML) patients at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, USA (Press release, MediGene, APR 19, 2018, View Source [SID1234525552]).

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Dr. Kai Pinkernell, Chief Medical and Chief Development Officer (CMO/CDO) of Medigene, commented: "These results clearly demonstrate the feasibility and robustness of our production protocol for high numbers of clinical grade TLR7/8-polarized fast mature DCs from heavily pretreated AML patients, allowing for long-term vaccination of trial subjects."

A total of 20 patients with an average age of 59 years (range 24 – 73 years) were recruited to this ongoing trial. For vaccine production, autologous apheresis material was collected from each patient. Following isolation of DC precursor cells, fast DC generation was performed using Medigene’s proprietary TLR7/8-agonist containing maturation cocktail. The final DC vaccine product was cryopreserved in multiple aliquots prepared to deliver 5-10 million cells per vaccine dose.

Successful production runs of dendritic cells for vaccination were achieved for all 20 AML patients. An additional apheresis for a second production run in order to generate sufficient vaccine doses for the intended treatment period was performed during the trial for only 4 out of the 20 patients enrolled in the trial.

The production runs were performed at the Department of Cellular Therapy at the Oslo University Hospital, Norway.
To view the abstract of the poster entitled "Generation of clinical grade autologous TLR7/8-polarized fast dendritic cell vaccines for active immunotherapy of patients with AML" please visit: tiny.cc/12mtry

About Medigene’s DC vaccines: The platform for the development of antigen-tailored DC vaccines is the most advanced of Medigene’s highly innovative and complementary immunotherapy platforms. Currently Medigene evaluates its DC vaccines in a company-sponsored Phase I/II clinical trial in acute myeloid leukaemia (AML).

Dendritic cells (DCs) are the most potent antigen-presenting cells of our immune system. Their task is to take up, process and present antigens on their cell surface, which enables them to activate antigen-specific T cells for maturation and proliferation. This way T cells can recognize and eliminate antigen-bearing tumor cells. Dendritic cells can also induce natural killer cells (NK cells) to attack tumor cells. The team of Medigene Immunotherapies scientists has developed new, fast and effective methods for generating dendritic cells ex-vivo, which are able to activate both T cells and NK cells. The DC vaccines are developed from autologous (patient-derived) precursor cells, isolated from the patient’s blood, and can be loaded with tumor-specific antigens to treat different types of cancer. Medigene’s DC vaccines are in development for the treatment of minimal residual disease or for use in combination therapies.

About Medigene’s DC vaccine clinical trial: Medigene’s Phase I/II trial (NCT02405338) includes 20 AML patients who show complete remission after standard chemotherapy, but who are not eligible for stem cell transplantation that would reduce the risk of a relapse. All patients will be vaccinated with Medigene’s DC vaccines for two years. The primary objective is to assess safety and feasibility of the active immunotherapy with Medigene’s dendritic cells. Secondary objectives of the study are induction of immune responses, overall survival (OS), progression free survival (PFS), control of minimal residual disease (MRD) and time to progression (TTP).

About acute myeloid leukaemia (AML): Acute myeloid leukaemia is a malignant disease of the hematopoietic system, affecting mainly adults above 60 years of age. In Germany, about 3,600 incidences are registered annually.

AML is caused by uncontrolled growth of dysfunctional hematopoietic precursor cells in the bone marrow. These cells prevent the generation of normal blood cells, causing a drop in erythrocytes and platelets, for example. Typical symptoms of AML include anemia, fever, increased risk of infection, and blood coagulation disorder. AML progresses rapidly and may be fatal within a few weeks if untreated.

AML is treated initially with intensive chemotherapy. Another treatment option is allogeneic hematopoietic stem cell transplantation. Unfortunately, the majority of patients suffer a relapse. Only about 15 – 20% of the patients show long-term remission after conventional chemotherapy. Allogeneic hematopoietic stem cell transplantation is the only treatment option that offers a more positive prognosis.

Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard, TecDAX) is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene concentrates on the development of personalized T cell-based therapies, with associated projects currently in pre-clinical and clinical development.

On April 19, 2018 The biopharmaceutical company MOLOGEN AG reported that it presented data of its EnanDIM molecules, a new generation of potent non chemically-modified TLR9 agonists, at the AACR (Free AACR Whitepaper) Annual Meeting 2018 (American Association for Cancer Research) in Chicago, Illinois, U.S. (14 – 18 April 2018) (Press release, Mologen, APR 19, 2018, View Source [SID1234525553]). In murine tumor models, monotherapy with EnanDIM resulted in beneficial modulation of the tumor microenvironment (TME) translating into remarkable anti-tumor effects with highly increased survival rates. In two cancer models complete tumor regression in the majority of mice was observed. Importantly, in a subsequent re-challenge study all surviving mice rejected tumor cells, which indicates a sustained anti-tumor memory of the immune system. Hence, the data provide an excellent basis for further development of EnanDIM in cancer.

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"The presented data clearly reveal the enormous potential of the EnanDIM product family. Hence, besides our late-stage candidate lefitolimod, we have strong follow-up molecules and we aim to enter EnanDIM into the clinical phase as soon as possible, of course depending on available resources", said Dr Mariola Soehngen, Chief Executive Officer of MOLOGEN.

"We are excited about the beneficial TME-modulating effects of single-agent EnanDIM which translated into remarkable anti-tumor activity, a clear pre-clinical proof of concept", said Dr Matthias Baumann, Chief Medical Officer at MOLOGEN, "and keep in mind that we have already promising pre-clinical results with EnanDIM and checkpoint inhibitors which have been presented last year. In summary, this is a clear "Go" for further development of EnanDIM in the IO space."

EnanDIM (Enantiomeric, DNA-based, ImmunoModulator), as a new generation of immunomodulators and so called Immune Surveillance Reactivators (ISR), belongs to the class of TLR9 agonists and represents one of MOLOGEN’s follow-up compounds to lefitolimod exhibiting an variable immunomodulatory pattern dependent on the specific EnanDIM molecule, a one-step production process.

The EnanDIM molecules consist entirely of natural DNA, as is also the case with lefitolimod. The main difference between MOLOGEN’s two ISR families is their molecule structure. Whereas lefitolimod is dumbbell-shaped and covalently-closed, EnanDIM molecules have a linear structure. However, as with lefitolimod, due to its specific structure, no chemical modification is needed in order to protect the molecules against degradation by enzymes.

Latest data on the EnanDIM molecules have been presented not only at the AACR (Free AACR Whitepaper) in Chicago, but also at the ITOC-5 Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference in Berlin (19 – 21 March 2018).

On April 18, 2018 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, "Astellas" ) and Kite, a Gilead Company (Nasdaq: GILD, President and CEO: John Milligan, "Kite"), reported that an agreement has been completed for the transfer of certain Agensys research facilities in Santa Monica, California, USA, to Kite (Press release, Astellas Pharma US, APR 18, 2018, View Source [SID1234525501]). The asset transfer was completed on April 12, 2018. Additional financial information or further deal terms are not being disclosed.

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Astellas is a pharmaceutical company dedicated to improving the health of people around the world. (PRNewsFoto/Astellas Pharma Inc.)

The facilities transfer is part of the wind-down process of the Agensys research operations, as announced by Astellas on July 27, 2017. Additional wind-down activities were completed in the first quarter of calendar year 2018, following the Company’s decision to further refine its oncology strategy by expanding its investment in the research of new technologies and modalities and reducing its focus on Antibody-Drug Conjugate (ADC) research, which was the core focus of work conducted at Agensys. Astellas will continue certain clinical trials and collaborations on some ADC programs that have been in progress at Agensys, including its collaboration with Seattle Genetics, Inc.

On April 18, 2018 Sosei Group Corporation ("Sosei" or the "Company"; TSE Mothers Index: 4565), the world leader in GPCR medicine design and development, reported that new preclinical data for AZD4635 was presented by AstraZeneca in a poster (abstract 3751) yesterday at the American Association of Cancer Research Annual Meeting, 17 April 2018; Chicago, IL, USA (Press release, Sosei, APR 18, 2018, View Source;sid=1573490 [SID1234525518]).

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AZD4635 is a potent and selective, orally available, small molecule adenosine A2A receptor (A2AR) antagonist. It was discovered by Sosei’s wholly-owned subsidiary Heptares Therapeutics and AstraZeneca licensed exclusive global rights to the molecule in 2015.

The poster is entitled "Inhibition of A2AR by AZD4635 induces anti-tumor immunity alone and in combination with anti-PD-L1 in preclinical models," and highlighted the following results:

Adenosine signalling through the A2AR results in a range of immunosuppressive effects which can promote tumour growth
AZD4635 is an oral, specific A2AR antagonist that is demonstrated to reverse adenosine mediated T cell suppression.
Treatment with AZD4635 alone and in combination with an anti-PD-L1 antibody led to a significant reduction in tumour growth in syngeneic tumour models exhibiting both high and low levels of adenosine
These effects were absent in immune-deficient animals confirming the immune-mediated mechanism of action. Further exploration of target engagement by AZD4635 is ongoing.
These data suggest that AZD4635 has the potential to restore immune responsiveness resulting in anti-tumour benefits alone and in combination with other cancer immunotherapies irrespective of the background tumour adenosine levels
AZD4635 is currently in a Phase 1 clinical trial as a single agent and in combination with AstraZeneca’s anti-PD-L1 antibody IMFINZI (durvalumab) in patients with solid malignancies (NCT02740985).

Notes to Editors

About AZD4635

AZD4635 is a potent and selective, orally available, small molecule adenosine A2A receptor (A2AR) antagonist discovered by Sosei subsidiary Heptares Therapeutics and licensed to AstraZeneca in 2015. High levels of adenosine are found in tumour microenvironments and benefit the progression of cancer. By activating the adenosine A2A receptor increased adenosine levels impair T-cell function and result in suppression of the host immune response. AZD4635 specifically blocks adenosine signalling via the A2A receptor signalling resulting in increased immune responsiveness and potential to destroy cancer cells and decrease tumour burden, A2A receptor antagonism can therefore promote the anti-cancer response of T-cells within the tumour microenvironment, offering a novel mechanism of action as a mono- or combination therapy.