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.

On April 18, 2018 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF), currently developing REOLYSIN (pelareorep), an intravenously delivered immuno-oncolytic virus turning cold tumors hot, reported two posters highlighting data from pelareorep studies presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018. The conference takes place April 14-18, 2018, in Chicago (Press release, Oncolytics Biotech, 18 18, 2018, View Source [SID1234525555]).

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"These posters add additional confirmation of pelareorep’s promotion of an inflammatory signature in different cell lines," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "The study by doctor Wilkinson demonstrates that pelareorep can establish an inflamed tumor phenotype and the presentation by doctor Goel highlights the synergistic combination of pelareorep and an anti-PD1 agent. Taken together, these findings highlight that pelareorep is priming the immune system and enhancing the activity of checkpoint blockade. As MSS CRC typically does not respond to checkpoint blockade, viral priming could expand the use of this drug class by making non-susceptible tissue susceptible by turning cold tumors hot. This work will of course lead to additional studies in combination with other immunotherapies."

Presenter: Sanjay Goel, MD, Associate Professor of Medicine, Montefiore Medical Center
Presentation Title: Potentiating effect of reovirus in anti-PD1 therapy in colorectal cancer
Session Title: Receptor Targeting and the Tumor Microenvironment
Location: Poster Section 38
Poster Board #: 17
Poster Number: 3917

Data presented in the poster demonstrated:

pelareorep administration increased PD-L1 expression on MSS CRC cells;

possible evidence of a vaccine effect: immunologically competent mice were re-challenged with the original tumor and the tumor was unable to propagate;

combination therapy made statistically significant improvements in survival compared to controls in both BALB/c (median 42 vs. 16 days, p=0.003) and C57BL/6 (median 24 vs. 17 days, p=0.02) mice; and

pelareorep treated xenografted tumor tissue showed a higher infiltration of T lymphocytes as confirmed by CD8-positive and intensified granzyme staining.

Presenter: Grey Wilkinson, PhD, Translational Scientist, Oncolytics Biotech
Presentation Title:
Pelareorep promotes the expression of a chemokine signature that predicts response to immunotherapy
Session Title: Immunomodulatory Agents and Interventions 2
Location: Poster Section 33
Poster Board #: 10
Poster Number: 4707

Data presented in the poster demonstrated:

the expression of a chemokine signature that predicts response to immunotherapy;

global changes in gene expression are unique and different for each cell line following pelareorep infection and changes in gene expression occur before significant cell lysis;

pelareorep differentially promotes the expression of innate and adaptive immunity related genes in HCC, CRC, NSCLC cell lines; and

pelareorep promotes the expression of gene signatures that predict response to immuno-therapies in HCC cells.

These posters are now available on the Posters & Publications page of the company’s website: www.oncolyticsbiotech.com/technology/posters-publications.

About REOLYSIN/Pelareorep
REOLYSIN, also known as pelareorep, is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.

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On April 18, 2018 Abbott reported financial results for the first quarter ending March 31, 2018. Key takeaways from this morning’s earnings call include (Press release, BioSpace, APR 18, 2018, View Source [SID1234525502]):

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First-quarter reported sales growth of 16.7 percent
First-quarter organic sales growth of 6.9 percent
First-quarter adjusted earnings per share from continuing operations of 59 cents, at the upper end of the previous guidance range
Several recently launched products contributing to strong growth
"We’re off to a strong start to the year as we forecasted," said Miles D. White, chairman and chief executive officer. "We’re particularly pleased with the continued strong growth in medical devices and improving performance in our nutrition business."

The company’s adjusted income rose to 59 cents per share on $7.39 billion in sales for its first quarter, beating Zacks Investment Research estimates of 58 cents on $7.26 billion in sales. Last year at this time, Abbott shares were trading at 48 cents with $6.34 billion in sales.

An infographic from the company highlights an increase of 6.9 percent in worldwide organic sales led by successes in nutrition, diagnostics, established pharmaceuticals and medical devices.

"Back in January I commented that we were entering the year with strong momentum which has continued as we forecasted," White added during the earnings call. "The strong growth we are achieving is a direct result of the steps we have taken to position the company in the most attractive areas of health care as well as the outstanding productivity of our new product pipeline."

Despite the company’s upbeat attitude about its Q1 earnings, shares dipped 3.5 percent early Wednesday on pharmaceutical sales that lagged behind Wall Street’s expectations by nearly 4 percent.

Revenue from established pharmaceuticals fell short by $56 million, RBC Capital Markets wrote in a note to clients. Also, Evercore noted the $1.04 billion in sales for that unit missed the consensus by 3.6 percent.

Medical device sales had the best organic growth in Q1, rising 9.4 percent to $2.74 billion. That beat the consensus for $2.67 billion, Evercore noted. Diagnostics also performed well, rising 5.5 percent organically to $1.84 billion in sales to top the consensus by $69 million.

"For the full year 2018, we continue to forecast organic sales growth of 6 percent to 7 percent," said Chief Financial Officer Brian Yoor. "In addition, we continue to expect rapid diagnostics to contribute sales of a little more than $2 billion."

With a forecasted adjusted gross margin ratio of around 59 percent of sales, Yoor said that research and development investments will be adjusted to around 7.5 percent of sales, and selling, general and administrative expenses adjusted above 30.5 percent of sales."

Worldwide, nutrition sales were $1.76 billion, up 4.7 percent organically and topping guidance for low single-digit growth. Both adult and pediatric segments performed well, growing a respective 4.3 percent and 5.1 percent on an organic basis.

But, White cautioned, nutrition is a highly competitive business in a branded space. "I give our U.S. team a lot of credit for how well they’ve done in the pediatric and adult (nutrition) space. It’s extremely competitive and it’s competitive in both pediatric and adult. And we will see from time-to-time a competitor tries false advertising or other things to take momentary share. But I think overall, we’ve not only sustained our position, but steadily grown it, from a share standpoint."

For the year, Abbott reaffirmed its adjusted profit target of $2.80 to $2.90 a share. Analysts modeled adjusted earnings of $2.87 per share and $30.91 billion in sales. Abbott also sees second-quarter adjusted income coming in at 70 to 72 cents per share.