THE ROCHE INSTITUTE AND THE INSTITUT CURIE SIGN A FRAMEWORK AGREEMENT FOR 3 YEARS

On November 7, 2017 The Institut Curie and Roche reported that they have been collaborating since 2007, particularly in the treatment of breast cancers (Press release, Institut Curie, NOV 7, 2017, View Source [SID1234554040]).

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Since then, other translational research projects have been carried out and have created a strong scientific link between Institut Curie and the Roche Research Centers (gRED and pRED). This framework agreement, which has just been signed for a period of 3 years, is a continuation of more than 10 years of successful scientific collaboration.

Such an agreement facilitates and accelerates the operational implementation of scientific programs conducted in partnership, allowing close interaction between Roche R & D teams and the Institut Curie teams. Collaborations will include the implementation of research projects in partnership or training, stresses Amaury Martin, Director of Technology Transfer and Industrial Partnerships of the Institut Curie and Director of the Institut Carnot Curie Cancer .

The Institut Curie is a major actor in oncology research and Roche is the pioneer of personalized medicine. Our common ambition is to innovate to advance the fight against cancer. Today, the scope of the collaboration focuses on immuno-oncology. Thanks to a better understanding of cancer biology and the mechanisms of antitumor immunity, the research projects initiated in the framework agreement aim at optimizing the development of new treatments in order to allow a greater number of patients to benefit from immunotherapy, says Patrice Denèfle, Director of the Roche Institute.

10-Q – Quarterly report [Sections 13 or 15(d)]

Ionis Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Ionis Pharmaceuticals, 2017, NOV 7, 2017, View Source [SID1234521659]).

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10-Q – Quarterly report [Sections 13 or 15(d)]

TESARO has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, TESARO, 2017, NOV 7, 2017, View Source [SID1234521701]).

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Cambrex Reports Third Quarter 2017 Financial Results

On November 7, 2017 Cambrex Corporation (NYSE: CBM), a leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), reported results for the third quarter 2017 (Press release, Cambrex, NOV 7, 2017, View Source [SID1234521628]).

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Highlights

Net Revenue increased 13% to $112.6 million compared to $99.4 million in the same quarter last year. Excluding the impact of foreign exchange, net revenue increased 12%.
GAAP Diluted EPS from continuing operations increased 24% to $0.52 from $0.42 in the same quarter last year. Adjusted Diluted EPS increased 20% to $0.55 compared to $0.46 in the same quarter last year.
EBITDA increased 29% to $33.3 million compared to the same quarter last year (see table at the end of this press release).
Net cash was $118.4 million at the end of the quarter, an increase of $24.2 million during the quarter.
The Company continued to execute on its strategic growth plan, investing in new manufacturing capacity and analytical laboratory space at its facilities in Charles City, High Point, Karlskoga, and Milan.
The Company continues to expect full year 2017 Net Revenue, excluding the impact of foreign currency, to increase between 7% and 11% compared to 2016, Adjusted EBITDA to be between $171 and $177 million, an 11% to 15% increase compared to 2016 and Adjusted income from continuing operations to be between $3.00 – $3.12 per share.
The Company now expects 2017 free cash flow to be between $60 and $70 million, an increase of $5 million from the mid-point and capital expenditures to be between $65 and $70 million, a reduction of $5 million from the mid-point (see Financial Expectations – Continuing Operations section below for related explanations and additional financial guidance).
"We are pleased with our financial performance in the third quarter, and when combined with an expected strong fourth quarter, we are positioned to finish 2017 within our financial expectations. Continued strong performance at our manufacturing facilities resulted in higher profit margins in the quarter and year-to-date," commented Steven M. Klosk, President and Chief Executive Officer of Cambrex.

"We recently completed the installation of new, large scale manufacturing capacity at our Karlskoga and Charles City facilities. Construction of the new High Potency facility at our Charles City plant has begun, and the recently announced investment in R&D and manufacturing capabilities to support the development of generic APIs at our Milan facility should be completed by the end of this year. In addition, we are adding pilot plant capacity and new analytical laboratories at our High Point location. These investments will enable Cambrex to increase its capabilities and ensure our facilities continue to address favorable industry trends and the evolving demands of our customers."

Basis of Reporting

The Company has provided a reconciliation of GAAP amounts to adjusted (i.e. Non-GAAP) amounts at the end of this press release. Cambrex management believes that the adjusted amounts provide useful information to investors due to the magnitude and nature of certain expenses recorded in the GAAP amounts.

Third Quarter 2017 Operating Results – Continuing Operations

Net revenue was $112.6 million, an increase of $13.2 million, or 13%, compared to the third quarter of 2016. Excluding a 1% favorable impact of foreign exchange compared to the third quarter of 2016, net revenue increased 12%. The increase primarily reflects higher volumes partially offset by lower pricing. The increase in volumes was driven primarily by growth in all product categories, as well as the addition of Cambrex High Point.

Gross margin increased to 42% from 38% compared to the same quarter last year. The increase was primarily driven by high capacity utilization, manufacturing efficiency improvements and favorable product mix, partially offset by lower pricing.

Selling, general and administrative expenses were $17.6 million, compared to $15.0 million in the same quarter last year. The increase was mainly due to the addition of Cambrex High Point, higher personnel related expenses, and higher expenses related to the evaluation of acquisition opportunities.

Research and development expenses were $4.2 million, compared to $3.2 million in the same quarter last year. The increase was mainly driven by costs to develop new generic drug products.

Operating profit increased to $25.1 million from $19.5 million in the same quarter last year. The increase was primarily the result of higher gross profits in 2017 partially offset by higher operating expenses as described above. Adjusted EBITDA was $33.3 million compared to $25.9 million in the same quarter last year (see table at the end of this press release).

Income tax expense was $7.5 million resulting in an effective tax rate of 30% compared to $5.4 million and an effective tax rate of 28% in the same quarter last year. Excluding the favorable impact of immediately recognizing certain effects of share-based compensation as required by a recently adopted accounting standard, the effective tax rate in the current period would have been 33%.

Income from continuing operations was $17.3 million or $0.52 per share compared to $13.7 million or $0.42 per share in the same quarter last year. Adjusted income from continuing operations was $18.5 million or $0.55 per share, compared to $15.1 million or $0.46 per share in the same quarter last year (see table at the end of this press release).

Capital expenditures and depreciation were $14.9 million and $7.7 million, respectively, compared to $11.7 million and $6.2 million, respectively, in the same quarter last year.

Net cash was $118.4 million at the end of the third quarter, an increase of $24.2 million during the quarter.

Financial Expectations – Continuing Operations

The following table shows the Company’s current expectations for its full year 2017 financial performance versus its previous expectations:

Current Expectations Previous Expectations
Net revenue increase 7% – 11% 7% – 11%
Adjusted EBITDA $171 – $177 million $171 – $177 million
Adjusted income from continuing operations per share $3.00 – $3.12 $3.00 – $3.12
Free cash flow $60 – $70 million $55 – $65 million
Capital expenditures $65 – $70 million $70 – $75 million
Depreciation and amortization $32 – $34 million $32 – $34 million
Adjusted effective tax rate 31% – 33% 31% – 33%

Consistent with the Company’s usual guidance practices, these financial expectations are for continuing operations and exclude the impact of any potential acquisitions, divestitures, restructuring activities and outcomes of tax disputes. Net revenue expectations exclude the impact of foreign exchange. EBITDA, Adjusted EBITDA and Adjusted income from continuing operations per share for 2017 will be computed on a basis consistent with the reconciliation of the third quarter 2017 financial results in the tables at the end of this press release. Free cash flow is defined as the change in debt, net of cash during the year. Adjusted effective tax rate excludes certain effects of share-based payments that were possibly deferred under the previous guidance. The tax rate will be sensitive to the Company’s geographic mix of income, changes in the tax codes within the countries in which the Company operates and the effects of certain share-based payments.

The financial information contained in this press release is unaudited, subject to revision and should not be considered final until the Company’s Form 10-Q for third quarter 2017 is filed with the SEC.Conference Call and Webcast

A conference call to discuss the Company’s third quarter 2017 results will begin at 8:30 a.m. Eastern Time on November 7, 2017 and can be accessed by calling 1-866-548-4713 for domestic and +1-323-794-2093 for international. Please use the passcode 1511082 and call approximately 10 minutes prior to the start time. A webcast will be available in the Investors section on the Cambrex website located at www.cambrex.com. A telephone replay of the conference call will be available through November 14, 2017 by calling 1-888-203-1112 for domestic and +1-719-457-0820 for international. Please use the passcode 1511082 to access the replay.

Genocea Presents New Data Demonstrating the Power and Versatility of its ATLAS™ Antigen Identification Platform at SITC 2017

On November 7, 2017 Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing neoantigen cancer vaccines, reported details on its three poster presentations at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting taking place November 8 to 12, 2017 at the Gaylord National Hotel & Convention Center in National Harbor, Maryland (Press release, Genocea Biosciences, NOV 7, 2017, View Source [SID1234521649]). The posters, all of which will be presented on Saturday, November 11, highlight the power of Genocea’s proprietary antigen identification system ATLAS to identify and profile CD4+ and CD8+ T cell responses to neoantigens and tumor-associated antigens (TAAs) for potential use in cancer vaccines and as non-invasive biomarkers.

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"These data demonstrate the versatility of ATLAS and support our use of the technology in the development of next-generation neoantigen cancer vaccines," said Jessica Baker Flechtner, Ph.D., chief scientific officer at Genocea. "With our first personalized vaccine candidate expected to enter the clinic in 2018, we are excited that ATLAS continues to demonstrate superiority to in silico methods of neoantigen identification and believe that our ability to identify true neoantigens will be key to developing more effective immunotherapies. We are also eager to further explore, through partnerships, the potential of ATLAS in the identification of novel tumor-associated antigens for biomarkers and common antigen cancer vaccines."

Poster #430: "Neoantigen identification using ATLAS across multiple tumor types highlights limitations of prediction algorithms," will be presented during the session on Personalized Vaccines and Technologies/Personalized Medicine. Highlights include:

ATLAS identified true neoantigens of CD8+ and CD4+ T cells, independent of patient HLA type, across a broad cohort of patients with different tumor types, including those with high or low mutational burden
Cancer types studied include renal cell carcinoma, and prostate, colorectal, pancreatic, and non-small cell lung cancers
Only 4% of ATLAS-identified neoantigens were predicted by NetMHCpan (a widely used in silico tool for neoantigen prediction)
88% of neoantigens that were predicted by NetMHCpan and confirmed by ATLAS were inhibitory and thus questionable for inclusion in cancer vaccines
The identification of activating and inhibitory neoantigens for CD8+ and CD4+ T cells should better enable neoantigen vaccines to stimulate a protective immune response
Poster #8: "T cell response profiling in colorectal carcinoma patients reveals an enrichment in responses to specific tumor-associated antigens," will be presented during the session on Biomarkers and Immune Monitoring. Highlights include:

Tumor stage at time of diagnosis is considered to be the most important predictor of survival in colorectal cancer (CRC) patients; tumor-associated antigen (TAA)-specific responses in peripheral blood can be detected using ATLAS
ATLAS identified T cell responses to a subset of TAAs in individuals with pre-malignant adenomatous polyps that were similar to those in CRC patients and distinguishable from healthy individuals
Three TAAs that were most frequently identified in this cohort of patients were not aligned with those previously investigated as therapeutic vaccines
Data support investigation of this new set of TAAs as antigens for a novel vaccine to complement personalized cancer vaccine approaches
Data also support potential development of a non-invasive blood-based assay for early detection and diagnosis of CRC
Poster #28 entitled "Profiling of T cell responses to tumor-associated antigens in lung cancer patients treated with checkpoint inhibitors," will be presented during the session on Biomarkers and Immune Monitoring. Highlights include:

ATLAS identified both stimulatory and inhibitory CD8+ and CD4+ T cell responses to TAAs in lung cancer patients treated with checkpoint inhibitors
ATLAS confirmed two TAAs that elicited more frequent responses than NY-ESO-1, MUC1, and MAGEA3, three TAAs that have been studied previously in clinical trials as vaccine antigens for lung cancer patients
Data support investigation of these TAAs as antigens to include in a common-antigen immunotherapy for lung cancer
T cell response profiles associating with effective treatment with checkpoint blockade are under investigation