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TRILLIUM THERAPEUTICS TO PRESENT NEW DATA FROM TTI-621 PHASE 1 TRIAL

On February 15, 2017 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical-stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that it will present new data from the Phase 1 trial of its anti-CD47 checkpoint inhibitor TTI-621 at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium on February 24, in Orlando, Florida (Press release, Trillium Therapeutics, FEB 15, 2017, View Source [SID1234517738]).

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The presentation will highlight new pharmacokinetic and pharmacodynamic data from patients having received multiple weekly infusions of TTI-621. After 6 weeks of treatment, the terminal serum half-life of TTI-621 is significantly increased compared to the first infusion and is accompanied by an increase in circulating drug levels and target receptor occupancy. These data suggest that repeat dosing of TTI-621 overcomes the antigen sink and achieves circulating drug concentrations that are associated with biological activity in preclinical studies. The presentation will also feature an expanded pharmacodynamic biomarker analysis, with a focus on cytokines associated with macrophage-mediated phagocytic activity.

"These evolving data significantly advance our understanding of TTI-621 pharmacology," said Trillium’s Chief Scientific Officer, Dr. Bob Uger. "We believe continued weekly dosing overcomes the antigen sink while maintaining clinically acceptable platelet levels. In fact, emerging evidence suggests that the transient decrease in platelets observed immediately following TTI-621 exposure was attenuated in most patients receiving multiple infusions."

Leerink Partners Presentation

Trillium will provide a corporate update at Leerink Partners 6th Annual Global Healthcare Conference at the Lotte New York Palace Hotel at 3:30 pm ET today. A live audio webcast of this presentation will be available under the investor relations section of Trillium’s website at www.trilliumtherapeutics.com. A replay of the presentation will be available following the event.

TapImmune Advances TPIV 200 Phase 2 Triple-Negative Breast Cancer Trial After Favorable DSMB Safety Review

On February 15, 2017 TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics for the treatment of cancer and metastatic disease, reported its lead cancer vaccine candidate, TPIV 200, received a positive recommendation from an independent Data Safety Monitoring Board (DSMB) to continue dosing triple-negative breast cancer (TNBC) patients in an ongoing Phase 2 clinical trial (Press release, TapImmune, FEB 15, 2017, View Source [SID1234517725]).

The planned safety review was performed when enrollment had reached 25 percent benchmark (20/80 patients). The four-arm trial is designed to test the safety, dosing level and optimal treatment regimen of TPIV 200, the company’s novel five-peptide vaccine designed to elicit a long-lasting adaptive immune response against TNBC cells, involving both "helper" and "killer" T-cells. The study tests two vaccine dose levels with and without cyclophosphamide priming of the immune system and will monitor for sustained immune response and relapse-free survival for three years. TapImmune will be enrolling the remaining patients at 12 clinical centers in the U.S. with enrollment completion targeted for the end of 2017.

"Successful completion of this safety review represents yet another clinical milestone achieved for TPIV 200," said Dr. Glynn Wilson, chairman and CEO of TapImmune. "This is now our second TPIV 200 clinical study to complete a successful interim safety review allowing the continuation of recruitment according to the protocol. Our Phase 2 clinical trial in platinum-resistant ovarian cancer at Memorial Sloan Kettering Cancer Center, in combination with Astra-Zeneca’s durvalumab, had previously passed its initial safety review and this study has now recruited over 50 percent of total patients. We have two additional Phase 2 trials now enrolling or about to enroll ovarian and triple-negative breast cancer patients, and continue to believe TPIV 200 will have a significant impact in the cancer immunotherapy space. We look forward to bringing this product to these ovarian and breast cancer patients in need of advanced therapy in the most expeditious manner possible."

Compugen Reports Fourth Quarter and Calendar Year 2016 Results

On February 15, 2017 Compugen Ltd. (NASDAQ: CGEN), a leading predictive drug discovery company, reported financial results for the fourth quarter and year ended December 31, 2016 (Press release, Compugen, FEB 15, 2017, View Source [SID1234517721]).

Anat Cohen-Dayag, Ph.D., CEO and President of Compugen, stated, "During the past year the Company has made important achievements and tremendous progress. For the first time in the history of the Company, we now have an internal preclinical development stage immuno-oncology pipeline that is being aggressively advanced towards a clinical stage pipeline. In addition, we have programs in the target validation stage, which are queued for incorporation into our therapeutic development pipeline. With these assets in hand, we firmly believe that we are positioned to take a transformational step forward that will establish Compugen’s position in the industry as a leading product discovery and development company with a portfolio of potential first-in-class products for cancer immunotherapy, and a promising immune-tolerizing therapy for autoimmune diseases, all based on our unique predictive discovery infrastructure."

Martin Gerstel, Chairman of Compugen, stated, "The largest portion of my long-term chairmanship at Compugen has been devoted to establishing a world leading, broadly applicable predictive discovery capability, and then, based on the initial use of this unique capability, developing an extremely promising early stage immuno-oncology pipeline. I believe that based on our past achievements, and in particular, the progress made last year as mentioned by Anat, we have now clearly accomplished these very impressive objectives. Furthermore, in my opinion, following the entrance of a potential first-in-class product candidate from our Pipeline Program into human clinical testing, and the signing of an additional high-value collaboration agreement, these past achievements will be more broadly recognized, and I have no doubt that we will then be seen as, and in fact be, a very different company with both new opportunities and new challenges. Accordingly, I believe it would be appropriate for Compugen to have a new chairperson on board at that time to guide the next chapter of our corporate growth as the Company leverages its unique capabilities to expand and enhance our medical and commercial value."

Mr. Gerstel continued, "Therefore, I have requested the Board to initiate a process to identify and recruit an appropriate person with the required capabilities and experience to replace me as chairperson. A recruitment process for a chairperson of a publicly owned company typically takes six months or more from initiation until the new chairperson is in place. We are announcing this now so that we can begin a careful and open search without undo time pressure. Based on current estimates, a new chairperson may be selected before we have achieved both an IND filing on a Pipeline Product candidate and the signing of an additional industry collaboration. In any case, it is my intention to both continue with the Company, but of course in a different capacity in the event of a new chairperson, and to also maintain in total my equity ownership position until at least both of these key objectives are achieved."

Dr. Cohen-Dayag commented, "Martin’s leadership and vision have been a driving force for the Company for two decades, however, I fully understand his belief that we are rapidly nearing a time when a new chairperson would be appropriate to guide the next chapter of our corporate growth."

Financial Results
Revenues for the fourth quarter of 2016 were $0.1 million, compared with $8.3 million in the comparable period of 2015. The decrease in revenues is primarily attributable to achievement of the third preclinical Bayer collaboration milestone for CGEN-15001T in the amount of $7.8 million in the comparable quarter of 2015. Revenues for the year ended December 31, 2016 were $0.7 million, compared with $9.3 million for the year ended December 31, 2015. The decrease in revenues is attributed to the lower amount of Bayer milestones achieved in 2016 and the amortization of the $10 million upfront payment received in 2013 at the time the collaboration was signed.

R&D expenses for the fourth quarter and year ended December 31, 2016 were $6.3 million and $24.5 million, respectively, compared with $5.8 million and $21.2 million for the comparable periods in 2015. The increase reflects a substantial increase in our preclinical activities involving our Pipeline Program candidates, primarily COM701 and our anti-TIGIT antibody.

Net loss for the fourth quarter of 2016 was $8.5 million, or $0.17 per diluted share, compared with a net loss of $0.5 million, or $0.01 per diluted share, in the comparable period of 2015. Net loss for the year ended December 31, 2016 was $31.5 million, or $0.62 per diluted share, compared with a net loss of $20.2 million, or $0.40 per diluted share, for the year ended December 31, 2015.

As of December 31, 2016, cash, cash related accounts, short-term and long-term bank deposits totaled $61.5 million, compared with $81.4 million at December 31, 2015. The Company has no debt.

Genomic Health Announces 2016 Fourth Quarter and Year-End Financial Results, Provides 2017 Financial Outlook

On February 14, 2017 Genomic Health, Inc. (Nasdaq: GHDX) reported financial results and business progress for the quarter and year ended December 31, 2016 (Press release, Genomic Health, FEB 14, 2017, View Source [SID1234517742]).

Total revenue was $327.9 million in the full year 2016, compared with $287.5 million in 2015, an increase of 14 percent.

U.S. product revenue was $280.1 million in the full year 2016, compared with $246.0 million in 2015, an increase of 14 percent. Prostate test revenue in the U.S. was $10.8 million and contributed to approximately 3 percent of total product revenue growth in the year.

International revenue for the full year 2016 was $46.8 million compared with $41.5 million in 2015, an increase of 13 percent, and an increase of 15 percent on a constant currency basis.i

"In 2016, we delivered double-digit revenue and test growth for the year, and achieved profitability in the fourth quarter," said Kim Popovits, chairman of the board, chief executive officer and president of Genomic Health. "With substantial opportunity for growth in our global breast and U.S. prostate business and leverage of our unique commercial channel with the planned launch this year of Oncotype DX AR-V7 Nucleus Detect, we expect to continue to deliver long-term revenue growth with improved profitability."

Operating loss was $15.4 million for the year ended December 31, 2016, compared with an operating loss of $34.0 million for the year ended December 31, 2015. Net loss was $13.9 million for the year ended December 31, 2016, compared with a net loss of $33.3 million for the year ended December 31, 2015.

Basic and diluted net loss per share was $0.42 for the year ended December 31, 2016, compared with a basic and diluted net loss per share of $1.03 for the year ended December 31, 2015.

More than 118,570 Oncotype test results were delivered for the year ended December 31, 2016, an increase of 11 percent, compared with more than 107,030 test results delivered in 2015. Oncotype DX breast cancer tests delivered in the U.S. grew 7 percent in the full year, compared to the prior year. Oncotype DX Genomic Prostate Score tests delivered in the U.S. grew 16 percent in the full year, including 29 percent in the fourth quarter, and represented approximately 8 percent of total test volume in 2016. International tests delivered grew 23 percent in the full year compared to the prior year and represented approximately 24 percent of total test volume in 2016.

Additional Fourth Quarter 2016 Financial Results

Total revenue was $82.7 million in the fourth quarter of 2016, compared with $75.1 million in the fourth quarter of 2015, an increase of 10 percent.

U.S. product revenue was $70.0 million in the fourth quarter of 2016, an increase of 9 percent, compared with $64.5 million in the same period in the prior year. Prostate test revenue in the U.S. of $3.6 million contributed to approximately 4 percent of the year-over-year growth.

International product revenue was $12.0 million in the fourth quarter of 2016, compared with $10.6 million a year ago, an increase of 13 percent, and an increase of 16 percent on a constant currency basis.i

In the fourth quarter of 2016, more than 30,020 Oncotype test results were delivered, an increase of 8 percent, compared with more than 27,730 test results delivered in the same period in 2015.

Operating income for the fourth quarter of 2016 was $1.5 million, compared with an operating loss of $3.1 million for the fourth quarter of 2015. Net income was $1.4 million for the fourth quarter of 2016 compared with a net loss of $2.7 million for the fourth quarter of 2015.

Basic and diluted net income per share was $0.04 for the fourth quarter of 2016 compared with basic and diluted net loss per share of $0.08 for the same period in 2015.

Cash and cash equivalents and short-term marketable securities at December 31, 2016 were $87.7 million excluding the fair value of the company’s investment in a marketable security of $9.3 million, compared with $76.8 million at December 31, 2015 excluding the fair value of the company’s investment in a marketable security of $18.1 million.

2017 Financial Guidance

"In 2017 at the mid-point of revenue guidance, we expect to deliver 11 percent revenue growth and positive net income for the full year, which requires operating leverage of more than 40 percent," said Brad Cole, chief operating officer and chief financial officer of Genomic Health. "We anticipate that expected reimbursement progress in the second half of the year will contribute to accelerated revenue growth."

The company is providing the following financial guidance for the full year ending December 31, 2017:

· Total product revenue of between $355 to $370 million, representing growth of between 9 and 13 percent compared to 2016; and

· Positive net income at mid-point of revenue guidance.

Recent Business Highlights

Oncotype DX Commercial Progress

· The American Joint Committee on Cancer (AJCC) incorporated the Oncotype DX Breast Recurrence Score in its recently published Eighth Edition AJCC Cancer Staging Manual. Representing a rigorous, multi-disciplinary assessment, the updated criteria identify Oncotype DX as the only multi-gene test with Level I evidence to be used by pathologists and clinicians for formal staging of breast cancer patients.

· Established additional coverage for the Oncotype DX Genomic Prostate Score, bringing the total number of U.S. covered lives to more than 65 million.

· Knappschaft, one of Germany’s largest public health insurance funds, began offering Oncotype DX to early-stage breast cancer patients through an exclusive agreement, bringing the total number of German private covered lives to nearly 9 million.

Presentations and Publications

· Received acceptance to present results from a large Oncotype DX Genomic Prostate Score validation study, conducted in collaboration with Kaiser Permanente Northern California, at the Genitourinary (GU) Cancers Symposium, the European Association of Urology (EAU) Congress and the American Urological Association (AUA) Annual Meeting. With these new data, Oncotype DX is the first and only genomic prostate test validated in all major short- and long-term endpoints, including adverse pathology, biochemical recurrence, metastasis and prostate cancer specific death.

· Investigators from Memorial Sloan Kettering Cancer Center (MSK) and Epic Sciences Inc. published findings in European Urology demonstrating that only nuclear localization of the AR-V7 protein in circulating tumor cells (CTCs) from metastatic castration-resistant prostate cancer (mCRPC) patient blood samples is predictive of therapeutic benefit. Genomic Health expects to begin offering the Oncotype DX AR-V7 Nucleus Detect test this year.

· Presented results from multiple studies demonstrating the unparalleled value of the Oncotype DX test in individualizing breast cancer treatment decisions for patients with various stages of the disease at the 2016 CTRC-AACR San Antonio Breast Cancer Symposium. Presentations included two overviews of prospective outcomes data and clinical evidence supporting use of the test in both node-positive and node-negative disease.

· The Journal of the National Cancer Institute published results of an NSABP-led study demonstrating the Oncotype DX Breast Recurrence Score is an independent predictor of locoregional recurrence risk in node-positive breast cancer patients treated with chemo-endocrine therapy.

· The Journal of the National Cancer Institute published results of an additional analysis from the second clinical validation study of the Oncotype DX DCIS Score demonstrating its ability to identify women with low risk of recurrence following surgery who can avoid radiation therapy.

· The European Journal of Surgical Oncology published a UK decision impact study of node-negative and node-positive breast cancer patients demonstrating the Oncotype DX Breast Recurrence Score significantly reduced the use of chemotherapy and can lead to significant cost savings for the National Health Service (NHS).

· Received acceptance to present four Oncotype DX studies at the upcoming Miami Breast Cancer Conference and 15 Oncotype DX studies at the upcoming St. Gallen Breast Cancer Conference in March.

Incyte and Agenus Amend Collaboration Agreement

On February 14, 2017 Incyte Corporation (Nasdaq:INCY) and Agenus Inc. (Nasdaq:AGEN) reported that the companies have amended the License, Development and Commercialization Agreement that was originally entered into January 9, 2015 (Press release, Incyte, FEB 14, 2017, View Source [SID1234517737]). The amended agreement converts the ongoing GITR and OX40 antibody programs from co-funded development and profit-sharing arrangements to royalty-bearing programs, with Incyte now responsible for funding and conducting global development and commercialization. Should candidates from either of these two programs be approved, Agenus would now become eligible to receive 15 percent royalties on global net sales of each approved product.

The ongoing TIM-3 and LAG-3 antibody programs remain royalty-bearing programs, at tiered rates of 6 to 12 percent, with Incyte retaining exclusive world-wide clinical development and commercial responsibilities.

Pursuant to the amended agreement, Agenus will receive today accelerated milestone payments of $20 million from Incyte related to the clinical development of INCAGN1876 (anti-GITR agonist) and INCAGN1949 (anti-OX40 agonist). Across all programs in the collaboration, Agenus will now be eligible to receive up to a total of $510 million in future potential development, regulatory and commercial milestones.

The parties have also entered into a separate Stock Purchase agreement whereby Incyte will purchase 10 million shares of Agenus common stock today at $6 per share.

"The antibody discovery collaboration between Incyte and Agenus has progressed well and has already resulted in two programs in clinical trials. We look forward to further developing our GITR and OX40 antibody programs, and exploring immunotherapy combinations with these compounds and other agents in the near future," said Hervé Hoppenot, CEO of Incyte.

"We believe the amended agreement will help streamline the development of our collaboration portfolio, provide the opportunity to prioritize our other internal programs towards rapid commercialization and help foster the development of our portfolio of novel I-O programs," said Garo Armen, Ph.D., Chairman and CEO of Agenus. "The revised agreement will also strengthen Agenus’ balance sheet and reduce cash burn."