On February 2, 2017 QB3@953, the Bay Area’s premier life science incubator, reported the collaboration between one of its member companies, Telo Therapeutics, and one of its sponsor companies, GlaxoSmithKline (GSK) (Press release, Telo Therapeutics, FEB 2, 2017, View Source [SID1234574485]). Telo Therapeutics is a start-up biotechnology company co-founded by Joe Costello, PhD, UCSF Professor of Neurological Surgery, and Robert Bell, PhD, a former post doc in Dr. Costello’s lab. GSK’s Discovery Partnerships with Academia (DPAc) group recently extended its 2015 collaboration agreement with QB3@953, and has now formed a collaboration with Telo Therapeutics to develop a novel precision medicine with the aim to reverse cancer cell immortality.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We’re delighted to collaborate with GSK because of their extensive chemistry resources and drug development expertise," said Dr. Costello.

"This collaboration is a tremendous step forward for Telo, and it will accelerate our development timeline towards patient trials faster than would be possible alone," added Dr. Bell, now CEO of Telo Therapeutics.

"Telo is exactly the type of innovative target concept that we were hoping to see through our collaboration with QB3@953," said Carolyn Buser-Doepner, Head of the GSK DPAc team. "The principal scientists and their innovative, early target concept are an excellent fit for the DPAc model."

Telo first became a member of QB3@953 and then a collaborator with GSK’s DPAc team as well as the recipient of GSK’s "golden ticket" lab bench at QB3@953. The "golden ticket" is provided by QB3@953 to allow sponsor companies to select a promising Bay Area biotech company of their choice to allocate use of state-of-the-art research equipment and lab space granted to partners of QB3@953. As a "golden ticket" company, Telo Therapeutics will have access to GSK’s allocated space and equipment for one year while the two companies work together to perform a series of small molecule screens. If promising drug candidates are identified through this collaboration, a longer multi-year partnership between the parties could be established to advance the drug to the clinic.

"The formation of the collaboration between Telo Therapeutics and GSK is a great example of how QB3@953 serves as a launch pad to pair local researchers possessing great science and entrepreneurial aspirations with partner resources necessary to advance innovative programs within new companies," said Doug Crawford, QB3@953 Managing Director.

Third Quarter (April 1 – December 31, 2016) Flash Report (unaudited) Nine months ended December 31, 2016 February 2, 2017 Ono Pharmaceutical Co., Ltd. ("The Company") has announced its consolidated financial results for nine months ended December 31, 2016. The consolidated financial statements have been prepared in accordance with International Financial Reporting Standards ("IFRSs"). This Third Quarter Flash Report 2017 (unaudited) is summary information extracted from the financial statements announced, and the financial statements and the figures contained herein are prepared for reference only for the convenience of readers outside Japan with certain modifications and reclassifications made from the original financial statements presented in Japanese language. The translations of Japanese yen amounts into U.S. dollar amounts are included solely for the convenience of readers outside Japan using the rate of 116 to $1, the approximate rate of exchange at December 30, 2016. Amounts of less than one million yen and one thousand U.S. dollars have been rounded to the nearest million yen and one thousand U.S. dollars in the presentation of the accompanying consolidated financial statements. Financial Highlights Ono Pharmaceutical Co., Ltd. and Consolidated Subsidiaries Revenue ¥ 112,419 ¥ 160,284 ¥ 188,845 $ 1,627,977 Profit (Owners of the parent company) Total equity 483,313 476,255 509,342 4,390,881 Total assets 531,365 540,450 583,405 5,029,353 Basic earnings per share ¥ 36.19 ¥ 47.13 ¥ 80.13 $ 0.69 Diluted earnings per share ¥ 36.19 ¥ 47.13 ¥ 80.13 $ 0.69 (Note) The company conducted a stock split of common stocks at a ratio of 1:5 with an effective date of April 1, 2016. As for "Basic earnings per share" and "Diluted earnings per share", it is calculated assuming that the stock split was conducted at April 1, 2015. 366,140 24,979 19,181 US$ YenYen US$ 42,472 ONO PHARMACEUTICAL CO., LTD. Thousands of US$ Millions of yen 3rd Quarter 3rd Quarter ended Dec. 31, 2015 9 months Annual 12 months ended Mar. 31, 2016 9 months ended Dec. 31, 2016 3rd Quarter 9 months ended Dec. 31, 2016 1 Third Quarter (April 1 – December 31, 2016) Flash Report (unaudited) Nine months ended December 31, 2016 Revisions of Consolidated Financial Forecasts Ono Pharmaceutical Co., Ltd. and Consolidated Subsidiaries (1) Revisions to the full-year Consolidated Financial Forecasts Ending March 2017 (April 1, 2016 ~ March 31, 2017) (Unit: Millions of yen, except basic earnings per share) Revenue Operating Profit Profit before Tax Profit Profit (Owners of the Parent Company) Basic earnings per share (Owners of the Parent Company) Previous Forecast (A) * 240,000 54,000 56,000 42,000 41,800 78.86 Revised Forecast (B) 240,000 68,500 70,500 52,500 52,300 98.68 Change (B – A) ― 14,500 14,500 10,500 10,500 ― Change (%) ― 26.9% 25.9% 25.0% 25.1% ― (Reference) Results of the p revious p eriod 160,284 30,507 33,272 25,192 24,979 47.13 (Note) The company conducted a stock split of common stocks at a ratio of 1:5 with an effective date of April 1, 2016. As for "Basic earnings per share", it is calculated assuming that the stock split was conducted at the beginning of the previous period. * The previous forecast was announced on December 21, 2016 (2) Reasons for the revisions Although there was a dispute by filing a patent infringement litigation against sale of the anti-PD-1 antibody product by Merck (USA) and its subsidiaries, it was settled in January 2017. Ono will receive an initial payment and estimates the amount of the initial payment after deducting litigation costs and others as "Other income". Consequently, operating profit is forecasted to be ¥68.5 billion (an increase by ¥14.5 billion from the previous forecast), profit before tax to be ¥70.5 billion (an increase by ¥14.5 billion from the previous forecast), profit for the year attributable to owners of the parent company to be ¥52.3 billion (an increase by ¥10.5 billion from the previous forecast). (Note) The financial forecasts and statements contained in this announcement are made based on information that are available as of the date the announcement is made. Actual results may differ materially from those set forth in the announcements due to various uncertain factors. 2 Third Quarter (April 1 – December 31, 2016) Flash Report (unaudited) Nine months ended December 31, 2016 Consolidated Statement of Financial Position Ono Pharmaceutical Co., Ltd. and Consolidated Subsidiaries Current assets Cash and cash equivalents ¥ 110,485 ¥ 108,503 $ 935,368 Trade and other receivables 62,043 88,007 758,680 Marketable securities 21,583 19,584 168,829 Other financial assets 800 800 6,897 Inventories 23,232 24,562 211,738 Other current assets 5,430 4,409 38,005 Total current assets 223,573 245,864 2,119,517 Non-current assets Property, plant, and equipment 80,094 82,151 708,198 Intangible assets 38,324 43,211 372,512 Investment securities 182,396 179,335 1,545,990 Investments in associates 982 1,008 8,693 Other financial assets 6,753 26,747 230,579 Deferred tax assets 5,179 1,802 15,538 Other non-current assets 3,149 3,286 28,327 Total non-current assets 316,877 337,541 2,909,836 Total assets ¥ 540,450 ¥ 583,405 $ 5,029,353 As of December 31, 2016 Millions of yen Thousands of US$ ASSETS As o f March 31, 2016 As of December 31, 2016 3 Third Quarter (April 1 – December 31, 2016) Flash Report (unaudited) Nine months ended December 31, 2016 Consolidated Statement of Income Ono Pharmaceutical Co., Ltd. and Consolidated Subsidiaries Revenue ¥ 112,419 ¥ 188,845 $ 1,627,977 Cost of sales (29,981) (50,268) (433,345) Gross profit 82,438 138,577 1,194,632 Selling, general, and administrative expenses (30,391) (45,159) (389,306) Research and development costs (29,400) (38,980) (336,035) Other income 341 261 2,252 Other expenses (664) (1,396) (12,032) Operating profit 22,324 53,303 459,511 Finance income 3,081 2,937 25,320 Finance costs (257) (75) (645) Share of profit (loss) from investments in associates (37) 27 232 Profit before tax 25,112 56,193 484,419 Income tax expense (5,829) (13,611) (117,340) Profit for the p eriod 19,283 42,581 367,079 Profit for the period attributable to: Owners of the parent company 19,181 42,472 366,140 Non-controlling interests 101 109 940 Profit for the p eriod 19,283 42,581 367,079 Earnings per share: Basic earnings per share 36.19 80.13 0.69 Diluted earnings per share 36.19 80.13 0.69 Yen US$ Millions of yen Thousands of US$ 3rd Quarter 9 months ended Dec. 31, 2015 3rd Quarter 9 months ended Dec. 31, 2016 3rd Quarter 9 months ended Dec. 31, 2016 5 Third Quarter (April 1 – December 31, 2016) Flash Report (unaudited) Nine months ended December 31, 2016 Consolidated Statement of Comprehensive Income Ono Pharmaceutical Co., Ltd. and Consolidated Subsidiaries Profit for the period ¥ 19,283 ¥ 42,581 $ 367,079 Other comprehensive income: 9,662 10,246 88,326 (1,704) 373 3,218 (1) 111 7,957 10,620 91,555 (32) 23 199 (32) 23 199 Total other comprehensive income (loss) 7,925 10,643 91,754 Total comprehensive income for the period 27,208 53,225 458,834 Comprehensive income for the period attributable to: Owners of the parent company 27,080 53,112 457,861 Non-controlling interests 128 113 972 Total comprehensive income for the period 27,208 53,225 458,834 2016 Millions of yen 9 months 3rd Quarter 2015 ended Dec. 31, 2016 ended Dec. 31, Thousands of US$ 3rd Quarter ended Dec. 31, 9 months 3rd Quarter 9 months Items that will not be reclassified to profit or loss: Net gain (loss) on financial assets measured at fair value through other comprehensive income Remeasurement of defined benefit plans Share of net gain (loss) on financial assets measured at fair value through other comprehensive income of investments in associates Exchange differences on translation of foreign operations Items that may be reclassified subsequently to profit or loss: 6 Third Quarter (April 1 – December 31, 2016) Flash Report (unaudited) Nine months ended December 31, 2016 Consolidated Statement of Changes in Equity Ono Pharmaceutical Co., Ltd. and Consolidated Subsidiaries Share capital Capital reserves Treasury shares Other components of equity Retained earnings Equity attributable to owners of the parent company Non-controlling interests Total equity Balance at April 1, 2015 ¥17,358 ¥17,080 (¥59,308) ¥45,756 ¥449,690 ¥470,575 ¥4,638 ¥475,213 Profit for the period 19,181 19,181 101 19,283 Other comprehensive income 7,899 7,899 26 7,925 Total comprehensive income for the period – – – 7,899 19,181 27,080 128 27,208 Purchase of treasury shares (40) (40) (40) Cash dividends (19,081) (19,081) (3) (19,084) Share-based payments 16 16 16 Transfer from other components of equity to retained earnings 999 (999) – – Total transactions with the owners – 16 (40) 999 (20,080) (19,105) (3) (19,108) Balance at December 31, 2015 ¥17,358 ¥17,095 (¥59,348) ¥54,654 ¥448,791 ¥478,550 ¥4,763 ¥483,313 Share capital Capital reserves Treasury shares Other components of equity Retained earnings Equity attributable to owners of the parent company Non-controlling interests Total equity Balance at April 1, 2016 ¥17,358 ¥17,103 (¥59,358) ¥43,307 ¥452,983 ¥471,393 ¥4,862 ¥476,255 Profit for the period 42,472 42,472 109 42,581 Other comprehensive income 10,640 10,640 4 10,643 Total comprehensive income for the period – – – 10,640 42,472 53,112 113 53,225 Purchase of treasury shares (23) (23) (23) Cash dividends (20,142) (20,142) (3) (20,145) Share-based payments 30 30 30 Transfer from other components of equity to retained earnings (2,809) 2,809 – – Total transactions with the owners – 30 (23) (2,809) (17,333) (20,135) (3) (20,138) Balance at December 31, 2016 ¥17,358 ¥17,133 (¥59,381) ¥51,138 ¥478,122 ¥504,370 ¥4,972 ¥509,342 Share capital Capital reserves Treasury shares Other components of equity Retained earnings Equity attributable to owners of the parent company Non-controlling interests Total equity Balance at April 1, 2016 $149,640 $147,442 ($511,711) $373,336 $3,905,024 $4,063,732 $41,917 $4,105,649 Profit for the period 366,140 366,140 940 367,079 Other comprehensive income 91,722 91,722 33 91,754 Total comprehensive income for the period ––– 91,722 366,140 457,861 972 458,834 Purchase of treasury shares (194) (194) (194) Cash dividends (173,638) (173,638) (27) (173,665) Share-based payments 258 258 258 Transfer from other components of equity to retained earnings (24,214) 24,214 –– Total transactions with the owners – 258 (194) (24,214) (149,425) (173,574) (27) (173,601) Balance at December 31, 2016 $149,640 $147,700 ($511,905) $440,844 $4,121,739 $4,348,019 $42,862 $4,390,881 Millions of yen Equity attributable to owners of the parent company Millions of yen Equity attributable to owners of the parent company Thousands of US $ Equity attributable to owners of the parent company 7 Third Quarter (April 1 – December 31, 2016) Flash Report (unaudited) Nine months ended December 31, 2016 Consolidated Statement of Cash Flows Ono Pharmaceutical Co., Ltd. and Consolidated Subsidiaries Cash flows from operating activities Profit before tax ¥ 25,112 ¥ 56,193 $ 484,419 Depreciation and amortization 4,857 5,651 48,716 Impairment losses 1,182 736 6,349 Interest and dividend income (2,668) (2,836) (24,446) Interest expense 9 10 89 (Increase) Decrease in inventories 2,959 (1,278) (11,017) (Increase) Decrease in trade and other receivables (11,553) (25,959) (223,784) Increase (Decrease) in trade and other payables 1,940 6,432 55,451 Increase (Decrease) in retirement benefit liabilities (6,013) 304 2,624 (Increase) Decrease in retirement benefit assets (87) – – Increase (Decrease) in long-term advances received (526) (319) (2,754) Other (2,722) 6,788 58,521 Subtotal 12,491 45,723 394,167 Interest received 242 114 985 Dividends received 2,456 2,732 23,553 Interest paid (9) (10) (89) Income taxes paid (9,922) (11,401) (98,283) Net cash provided by (used in) operating activities 5,258 37,159 320,333 Cash flows from investin g activitie s Purchases of property, plant, and equipment (5,700) (12,608) (108,686) Purchases of intangible assets (5,811) (6,719) (57,923) Purchases of investments (250) (2,437) (21,009) Proceeds from sales and redemption of investments 22,079 22,341 192,595 Payments into time deposits (600) (20,600) (177,586) Other 392 596 5,134 Net cash provided by (used in) investing activities 10,110 (19,427) (167,476) Cash flows from financin g activitie s Dividends paid to owners of the parent company (18,223) (19,347) (166,789) Dividends paid to non-controlling interests (3) (3) (30) Repayments of long-term borrowings (274) (290) (2,499) Net increase (decrease) in short-term borrowings 92 (37) (319) Purchases of treasury shares (39) (22) (187) Net cash provided by (used in) financing activities (18,446) (19,699) (169,823) Net increase (decrease) in cash and cash equivalents (3,078) (1,968) (16,966) Cash and cash equivalents at the beginning of the period 104,222 110,485 952,455 Effects of exchange rate changes on cash and cash equivalents (40) (14) (121) Cash and cash equivalents at the end of the period ¥ 101,105 ¥ 108,503 $ 935,368 Millions of yen Thousands of US$ 3rd Q uarter 9 months ended Dec. 31, 3rd Q uarter 9 months ended Dec. 31, 2016 3rd Q uarter 9 months ended Dec. 31, 2016 2015 8 Ongoing clinical studies Product Name / Development Code Development Indications Clinical Stage Area In-house / In-license Opdivo  Intravenous Infusion (ONO-4538) / BMS-936558 Gastric cancer Phase III USA Europe In-house (Co-development with Bristol-Myers Squibb Company) Malignant pleural mesothelioma Phase III USA Europe In-house (Co-development with Bristol-Myers Squibb Company) Diffuse large B cell lymphoma Phase II USA Europe In-house (Co-development with Bristol-Myers Squibb Company) Follicular lymphoma Phase II USA Europe In-house (Co-development with Bristol-Myers Squibb Company) Primary central nervous system lymphoma / Testicular malignant lymphoma Phase II USA Europe In-house (Co-development with Bristol-Myers Squibb Company) Colon cancer Phase I/II USA Europe In-house (Co-development with Bristol-Myers Squibb Company) Solid tumors (triple negative breast cancer, gastric cancer, pancreatic cancer, small cell lung cancer, urothelial cancer, ovarian cancer) Phase I/II USA Europe In-house (Co-development with Bristol-Myers Squibb Company) Virus-positive/negative solid tumor Phase I/II USA Europe In-house (Co-development with Bristol-Myers Squibb Company) Hematologic cancer (T-cell lymphoma, multiple myeloma, chronic leukemia, etc.) Phase I USA Europe In-house (Co-development with Bristol-Myers Squibb Company) Chronic myeloid leukemia Phase I USA Europe In-house (Co-development with Bristol-Myers Squibb Company) Hepatitis C Phase I USA Europe In-house (Co-development with Bristol-Myers Squibb Company) Sepsis *7 Phase I USA In-house (Co-development with Bristol-Myers Squibb Company) Changes from Second Quarter Flash Repor t for the Fiscal Year ending March 2017 announced on November 7, 2016 *7: Phase I of Opdivo  Intravenous Infusion was initiated for the treatment of Sepsis. Note : "In-house" compounds include a compound ge nerated from collaborative research. In the case of clinical development of the anticancer co mpound in the same indication, the most advanced clinical phase is described. 17 Third Quarter (April 1– December 31, 2016) Flash Report (unaudited) Nine months ended December 31, 2016 Supplemental Information Status of Development Pipeline as of January 31, 2017 I. Main Pipelines Other than ONO-4538 i. Developments Status in Japan Approved  PARSABIV  Intravenous Injection for Dialysis (ONO-5163) / AMG-416 / Etelcalcetide Hydrochloride *1 ・ New chemical entities ・ Secondary hyperparathyroidism [Calcium sensing receptor agonist] ・ Injection ・ In-license (Amgen Inc.) Ongoing clinical studies ● Onoact  Intravenous Infusion 50 mg / 150 mg (ONO-1101) ・ Additional indication for pediatric use ・ Tachyarrhythmia in low cardiac function [Short acting beta 1 blocker] / Phase II/III ・ Injection ・ In-house Filed  KYPROLIS  Intravenous Injection (ONO-7057) / Carfilzomib ・ Additional Dosage and Administration ・ Multiple Myeloma [Proteasome inhibitor] ・ Injection ・ In-license (Onyx Pharmaceuticals, Inc.) ● Onoact  Intravenous Infusion 50 mg / 150 mg (ONO-1101) ・ Additional indication ・ Ventricular arrhythmia [S hort acting beta 1 blocker] / Phase II/III ・ Injection ・ In-house Ongoing clinical studies  Orencia  IV (ONO-4164) / BMS-188667 ・ Additional indication ・ Juvenile Rheumatoid Arthritis [T-cell activation inhibitor] / Phase III ・ Injection ・ In-licens e (Bristo l-M y ers S q uibb Com p an y)  ONO-2370 / Opicapone ・ New chemical entities ・ Parkinson’s disease [Long acting COMT inhibitor] / Phase II ・ Tablet ・ In-license (Bial)  Orencia  IV (ONO-4164) / BMS-188667 ・ Additional indication ・ Lupus nephritis[T-cell act ivation inhibitor] / Phase III ・ Injection ・ In-license (Bristol-Myers Squibb Company)  ONO-5371 / Metyrosine ・ New chemical entities ・ Pheochromocytoma [Tyrosine hydroxylase inhibitor] / Phase I/II ・ Capsule ・ In-license (Valeant Pharmaceuticals North America LLC.)  Orencia  SC (ONO-4164) / BMS-188667 ・ Additional indication ・ Rheumatoid Arthritis [T-cell activation inhibitor] / Phase III ・ Injection ・ In-licens e (Bristol-Myers Squibb Company)  ONO-7268 MX1 ・ New chemical entities ・ Hepatocellular carcinoma [Therapeutic cancer peptide vaccines] / Phase I ・ Injection ・ In-license (OncoTherapy Science, Inc.)  Orencia  SC (ONO-4164) / BMS-188667 *2 ・ Additional indication ・ Primary sjögren syndrom e [T-cell activation inhibitor] / Phase III ・ Injection ・ In-licens e (Bristol-Myers Squibb Company)  ONO-7268 MX2 ・ New chemical entities ・ Hepatocellular carcinoma [Therapeutic cancer peptide vaccines] / Phase I ・ Injection ・ In-license (OncoTherapy Science, Inc.)  KYPROLIS  Intravenous In j ection (ONO-7057) / Carfilzomib ・ Additional Dosage and Administration ・ Multiple Myeloma [Proteasome inhibitor] / Phase III ・ Injection ・ In-license (Onyx Pharmaceuticals, Inc.)  ONO-2160 / CD ・ New chemical entities ・ Parkinson’s disease [le vodopa pro-drug] / Phase I ・ Tablet ・ In-house  ONO-1162 / Ivabradine ・ New chemical entities ・ Chronic heart failure [If channel inhibitor] / Phase III ・ Tablet ・ In-license (Les Laboratoi res Servier)  ONO-4059 ・ New chemical entities ・ B cell lymphoma [Bruton’s tyrosine kinase (Btk) inhibitor] / Phase I ・ Capsule ・ In-house  ONO-7643 / Anamorelin ・ New chemical entities ・ Cancer anorexia/cachexia [Ghrelin mimetic] / Phase III ・ Tablet ・ In-license (Helsinn Healthcare, S.A.)  ONO-8577 ・ New chemical entities ・ Overactive bladder [bladder smooth muscle relaxant] / Phase I ・ Tablet ・ In-house 12 Ongoing clinical studies  ONO-4578 *3 ・ New chemical entities ・ Solid tumor [PG receptor (EP4) antagonist] / Phase I ・ Tablet ・ In-house Changes from Second Quarter Flash Repor t for the Fiscal Year ending March 2017 announced on November 7, 2016 *1: A manufacturing and mark eting approval for PARSABIV  intravenous injection for dialysis (calcium sensing receptor agonist) was obtained in Japan for the treatment of sec ondary hyperparathyroidism in patients on hemodialysis *2: Phase III of Orencia  SC (ONO-4164) / BMS-188667 (T-cell activation in hibitor) was initiated for primary sjögren syndrome. *3: Phase I of ONO-4578 (PG receptor (EP4) antagonist) was initiated for solid tumor. Note : "In-house" compounds include a compound ge nerated from collaborative research. In the case of clinical development of the anticancer co mpound in the same indication, the most advanced clinical phase is described. ii. Developments Status outside Japan Ongoing clinical studies  ONO-4474 ・ New chemical entities ・ Osteoarthritis [Tropomyosi n receptor kinase (Trk) inhibitor] / Phase II ・ Capsule ・ Europe ・ In-house  ONO-7475 *5 ・ New chemical entities ・ Acute leukemia [Axl / Mer inhibitor] / Phase I ・ Tablet ・ USA ・ In-house  ONO-4059 *4 ・ New chemical entities ・ B cell lymphoma [Bruton’s tyrosine kinase (Btk) inhibitor] / Phase II ・ Capsule ・ USA & Europe ・ Ou t-license (Gilead Sciences, Inc.)  ONO-7579 *6 ・ New chemical entities ・ Solid tumor [Tropomyosin receptor kinase (Trk) inhibitor] / Phase I ・ Tablet ・ USA & Europe II. Main Pipelines ONO-4538 etc i. Developments Status in Jap an, South Korea, and Taiwan Approved Product Name / Development Code Development Indications Area In-house / In-license Opdivo  Intravenous Infusion (ONO-4538) / BMS-936558 Hodgkin’s lymphoma *1 Japan In-house (Co-development with Bristol-Myers Squibb Company) Changes from Second Quarter Flash Repor t for the Fiscal Year ending March 2017 announced on November 7, 2016 *1: Approval for the partial change in approved items of the manufacturing and marketing approval for Opdivo  Intravenous Infusion was obtained in Japan for the treatment of relapsed or refractory classical Hodgkin lymphoma. Note : "In-house" compounds include a compound ge nerated from collaborative research. In the case of clinical development of the anticancer co mpound in the same indication, the most advanced clinical phase is described. Filed Product Name / Development Code Development Indications Area In-house / In-license Opdivo  Intravenous Infusion (ONO-4538) /BMS-936558 Non-small cell lung cancer (Non-Squamous) Taiwan In-house (Co-development with Bristol-Myers Squibb Company) Renal cell carcinoma Taiwan In-house (Co-development with Bristol-Myers Squibb Company) Head and neck cancer Japan Taiwan In-house (Co-development with Bristol-Myers Squibb Company) Gastric cancer *2 Japan In-house (Co-development with Bristol-Myers Squibb Company) Changes from Second Quarter Flash Repor t for the Fiscal Year ending March 2017 announced on November 7, 2016 *2: A supplemental application for Opdivo  Intravenous Infusion was filed in Japan fo r the treatment of unr esectable advanced or recurrent gastric cancer for a partial change in the a pproved items of the manufacturing and marketing approval. Note : "In-house" compounds include a compound ge nerated from collaborative research. In the case of clinical development of the anticancer co mpound in the same indication, the most advanced clinical phase is described. Ongoing clinical studies Product Name / Development Code Development Indications Clinical Stage Area In-house / In-license Opdivo  Intravenous Infusion (ONO-4538) /BMS-936558 Head and neck cancer Phase III South Korea In-house (Co-development with Bristol-Myers Squibb Company) Gastric cancer Phase III South Korea Taiwan In-house (Co-development with Bristol-Myers Squibb Company) Esophageal cancer Phase III Japan South Korea Taiwan In-house (Co-development with Bristol-Myers Squibb Company) Esophagogastric junction cancer and Esophageal cancer Phase III Japan South Korea Taiwan In-house (Co-development with Bristol-Myers Squibb Company) Small cell lung cancer Phase III Japan South Korea Taiwan In-house (Co-development with Bristol-Myers Squibb Company) 14 Ongoing clinical studies Product Name / Development Code Development Indications Clinical Stage Area In-house / In-license Opdivo  Intravenous Infusion (ONO-4538) /BMS-936558 Hepatocellular carcinoma Phase III Japan South Korea Taiwan In-house (Co-development with Bristol-Myers Squibb Company) Glioblastoma Phase III Japan In-house (Co-development with Bristol-Myers Squibb Company) Urothelial carcinoma Phase III Japan South Korea Taiwan In-house (Co-development with Bristol-Myers Squibb Company) Malignant pleural mesothelioma Phase III Japan In-house (Co-development with Bristol-Myers Squibb Company) Ovarian cancer *3 Phase III Japan In-house (Co-development with Bristol-Myers Squibb Company) Solid tumor (Cervical cancer, Endometrial cancer, Soft tissue sarcoma) Phase II Japan In-house (Co-development with Bristol-Myers Squibb Company) Primary central nervous system lymphoma / Testicular malignant lymphoma Phase II Japan In-house (Co-development with Bristol-Myers Squibb Company) Virus-positive/negative solid tumor Phase I/II Japan South Korea Taiwan In-house (Co-development with Bristol-Myers Squibb Company) Biliary tract cancer Phase I Japan In-house (Co-development with Bristol-Myers Squibb Company) Anti-TIGIT Antibody (ONO-4686 / BMS-986207) Solid tumor *4 Phase I/II Japan In-license (Co-development with Bristol-Myers Squibb Company) Urelumab (ONO-4481 / BMS-663513) Solid tumor Phase I Japan In-license (Co-development with Bristol-Myers Squibb Company) Anti-LAG3 Antibody (ONO-4482 / BMS-986016) Solid tumor Phase I Japan In-license (Co-development with Bristol-Myers Squibb Company) Changes from Second Quarter Flash Repor t for the Fiscal Year ending March 2017 announced on November 7, 2016 *3: Phase III of Opdivo  Intravenous Infusion was initiated for the treatment of ovarian cancer. *4: Phase I/II of Anti-TIGIT Antibody (ONO-4686 / BMS-986207) was initiated for the treatment of solid tumor. Note : "In-house" compounds include a compound ge nerated from collaborative research. In the case of clinical development of the anticancer co mpound in the same indication, the most advanced clinical phase is described. ・ In-house  ONO-8055 ・ New chemical entities ・ Underactive bladder [PG receptor (EP2 / EP3) agonist] / Phase I ・ Tablet ・ Europe ・ In-house Changes from Second Quarter Flash Repor t for the Fiscal Year ending March 2017 announced on November 7, 2016 *4: Phase II of ONO-4059 (Bruton’s tyrosine kinase (Btk) inhibitor) was initiated for B cell lymphoma. *5: Phase I of ONO-7475 (Axl / Mer inhib itor) was initiated for acute leukemia. *6: Phase I of ONO-7579 (Tropomyosin receptor kinase (Trk) inhibitor) was initiated for solid tumor. * Development of ONO-2952 (TSPO antagonist) for the treatment of irritable bowel syndrome was discontinued due to the strategic reason considering differentia tion among existing product and competing product under development and others comprehensively. * Development of ONO-4232 (PG receptor (EP4) agonist) for the trea tment of acute heart failure was discontinued due to the strategic reason considering future development peri od, development cost, and others comprehensively. Note : "In-house" compounds include a compound ge nerated from collaborative research. In the case of clinical development of the anticancer co mpound in the same indication, the most advanced clinical phase is described. 13

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On February 2, 2017 Eisai Co., Ltd. reported financial results for the Nine-Month Period Ended December 31, 2016 (Report, Eisai, FEB 2, 2017, View Source [SID1234517643]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Know more, wherever you are:
Latest on How to Stay Tuned to 10 Major Cancer Meetings, book your free 1stOncology demo here.

Gross profit for the the nine-month periods ended December 2016 was 261.4 billion Yen in comparison to that of 277.2 billion Yen for the the nine-month period ended December 2015.

For Eisai’s detailed sales figures, View Source

On February 2, 2017 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported the treatment of the first patient in the PROCLAIM (Probody Clinical Assessment In Man) CX-072 study, a Phase 1/2 clinical trial evaluating CX-072, a PD-L1-targeting Probody therapeutic, as monotherapy and in combination with Yervoy (ipilimumab) or Zelboraf(vemurafenib) in patients with all types of cancers (Press release, CytomX Therapeutics, FEB 2, 2017, View Source;p=irol-newsArticle&ID=2241629 [SID1234517635]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Treating the first patient with CX-072 marks a key milestone as we advance our broad pipeline of innovative Probody therapeutics into clinical development within the PROCLAIM program," said Rachel W. Humphrey, M.D., chief medical officer of CytomX Therapeutics. "Advancement of this potentially transformational treatment, derived from our Probody technology platform, would not be possible without the patients who are willing to engage with the scientific community by enrolling in clinical trials. We thank them for their participation."

About the PROCLAIM-072 Trial
The first clinical trial under the international umbrella program PROCLAIM is the open-label, dose-finding Phase 1/2 study evaluating CX-072 as monotherapy and in combination with Yervoy (ipilimumab) or Zelboraf(vemurafenib) in patients with all types of cancers. As part of the study, CytomX aims to achieve three goals as part of the PROCLAIM-072 clinical trial:

Tolerability: Demonstrate that CX-072 is well tolerated in patients and potentially improves safety, particularly in the combination setting.
Anti-cancer activity: Demonstrate initial evidence of CX-072’s anti-cancer activity as monotherapy and in combination.
Translational program and Probody platform proof-of-concept: Explore mechanistic aspects of Probody activity in patients as observed in preclinical studies.

More information about the trial is available at clinicaltrials.gov.

On February 2, 2017 TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer and metastatic disease, reported it has successfully completed a multi-gram scale-up and GMP manufacturing of a second clinical lot of TPIV 200, the company’s multi-epitope T-cell vaccine targeting folate receptor alpha (Press release, TapImmune, FEB 2, 2017, View Source;utm_medium=email&utm_campaign=investor_alerts&utm_content=%5B%5Brssitem_title%5D%5D [SID1234517634]). The manufactured vaccine product will be used to supply an ongoing Phase 2 study of TPIV 200 for the treatment of platinum-sensitive ovarian cancer, as well as a planned Phase 2 study sponsored by the Mayo Clinic for treating triple-negative breast cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The successful release of our second lot of TPIV 200 represents another important milestone in the progression of our product pipeline and technologies," said Dr. Glynn Wilson, Chairman and CEO of TapImmune. "Improvements to the manufacturing process include a process change to improve scalability and a formulation change to improve the physical appearance and consistency of the final vialed product. The end result is a superior formulation that is more amenable to large scale manufacturing and commercialization."

"Our first TPIV 200 lot was manufactured in early 2016 to fully supply a TapImmune-sponsored Phase 2 trial evaluating the vaccine for the treatment of triple-negative breast cancer as well as a Phase 2 trial evaluating the vaccine in combination with a checkpoint inhibitor for platinum-resistant ovarian cancer, both of which are currently enrolling patients," said Dr. John Bonfiglio, President and COO of TapImmune. "The current, larger clinical batch of TPIV 200 will fully supply the first TapImmune-sponsored Phase 2 trial in platinum-sensitive ovarian cancer, for which a number of clinical sites are currently being screened and initiated. The batch will also supply a planned Mayo Clinic-sponsored Phase 2 trial for triple-negative breast cancer, which is fully funded by a grant from the Department of Defense."