1stOncology™: Cancer Intelligence Service – Page 13844 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

China Biologic Reports Financial Results for the First Quarter of 2019

On May 10, 2019 China Biologic Products Holdings, Inc. (NASDAQ: CBPO, "China Biologic" or the "Company"), a leading fully integrated plasma-based biopharmaceutical company in China, reported its unaudited financial results for the first quarter of 2019 (Press release, China Biologic Products, MAY 10, 2019, View Source [SID1234536177]).

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!

First Quarter 2019 Financial Highlights

Total sales in the first quarter of 2019 increased by 22.3% in RMB terms and 15.4% in USD terms to $129.8 million from $112.5 million in the same quarter of 2018.
Gross profit increased by 8.6% to $85.6 million from $78.8 million in the same quarter of 2018. Gross margin decreased to 65.9% from 70.0% in the same quarter of 2018.
Income from operations increased by 12.8% to $44.0 million from $39.0 million in the same quarter of 2018. Operating margin decreased to 33.9% from 34.7% in the same quarter of 2018.
Non-GAAP adjusted income from operations increased by 10.5% in RMB terms and 4.2% in USD terms to $52.2 million from $50.1 million in the same quarter of 2018.
Net income attributable to the Company increased by 26.5% in RMB terms and 19.3% in USD terms, to $37.7 million from $31.6 million in the same quarter of 2018. Fully diluted earnings per share increased to $0.94 compared to $0.92 in the same quarter of 2018.
Non-GAAP adjusted net income attributable to the Company increased by 14.3% in RMB terms and 7.7% in USD terms to $44.5 million from $41.3 million in the same quarter of 2018. Non-GAAP adjusted earnings per share decreased to $1.11 from $1.21 in the same quarter of 2018.
"China Biologic achieved better-than-expected financial results for the first quarter, with growth in operating profit that exceeded expectations. Despite this welcome news, the challenging policy headwinds and heightened competition within the Chinese plasma industry persist and we maintain our overall outlook for the year," said Joseph Chow, Chairman of the China Biologic Board of Directors.

"This quarter’s outperformance in terms of operating profit growth can be largely attributed to higher-than-expected sales of albumin. This was due to a temporary shortage of albumin supply in the market related to lower import volumes combined with increased plasma fractionation capability at our new Shandong facility launched last February. However, sales of IVIG products did not meet our expectations, due to reduced purchase volumes at many regional hospitals as mandated by government controls on healthcare spending. The performance of our placenta polypeptide product was largely in line with expectations, with sales down 50% year over year. As market prices decline for our major products, our gross margin continues to be negatively impacted. Although our prior efforts and investments towards improving our sales and marketing capabilities have been successful in broadening our sales channel coverage and reducing Guizhou Taibang’s IVIG inventory, the prescription volumes of IVIG and certain high-unit-price coagulation products remain sluggish."

"We recently received Dr. Bing Li’s resignation as CEO and also from the Board of Directors due to personal reasons. We thank Dr. Li for his contribution in helping China Biologic optimize our sales and marketing team and improve corporate governance. The Board has formed a search committee comprised of independent directors to seek a new CEO and in the interim has appointed me as the acting CEO."

"Looking ahead to the rest of the year, given the relatively fixed annual volume of our available plasma inventory and the oversold albumin volume in the first quarter, the overall albumin sales growth rate in the remaining quarters of this year will likely decelerate. Our new sales and marketing talent will leverage our expanded sales coverage in various channels to offer a variety of products, with renewed efforts towards improving the prescription volumes at regional hospitals and educating doctors about the benefits of IVIG, PCC and other coagulation factor products in treating patients across a wide range of clinical indications. We expect these efforts to help decrease our IVIG inventory position, which is currently above the normal level, both internally and with our distributors."

Share Repurchase Program

In late April 2019, the Company completed the share repurchase program previously authorized by its Board of Directors in 2018, repurchasing 1,074,376 shares at a total of $100 million.

In May 2019, the Company’s Board of Directors authorized a new share repurchase program under which China Biologic may repurchase up to US$150 million worth of shares over the next 12 months.

The Company’s repurchases may be made from time to time on the open market at prevailing market prices, in negotiated transactions off the market, in block trades or through other legally permissible means. The timing and extent of any purchases will depend upon market conditions, the trading price of its shares and other factors, and are subject to the restrictions relating to volume, price and timing under applicable law.

First Quarter 2019 Financial Performance

Total sales in the first quarter of 2019 increased by 22.3% in RMB terms, or 15.4% in USD terms, to $129.8 million from $112.5 million in the same quarter of 2018.

Total sales for biopharmaceutical products (including plasma products and placenta polypeptide products) increased by 22.2% in RMB terms, or 15.2% in USD terms, to $116.5 million from $101.1 million in the same quarter of 2018, as a result of increases in the sales of human albumin products and coagulation factor products, which was partly offset by decreases in the sales of IVIG and placenta polypeptide products. For plasma products, total sales in the first quarter of 2019 increased by 35.8% in RMB terms, or 28.0% in USD terms, to $108.8 million from $85.0 million in the same quarter of 2018.

Total sales for biomaterial products in the first quarter of 2019 increased by 23.8% in RMB terms, or 16.7% in USD terms, to $13.3 million from $11.4 million in the same quarter of 2018, as a result of higher sales concentration in higher-unit-price artificial dura mater products.

During the first quarter of 2019, human albumin and IVIG products remained the Company’s two largest sales contributors. Revenue from human albumin increased by 78.2% in RMB terms, or 68.0% in USD terms, from $33.8 million in the first quarter of 2018 to $56.8 million in the first quarter of 2019. Revenue from IVIG products decreased by 3.1% in RMB terms, or 8.8% in USD terms, from $31.8 million in the first quarter of 2018 to $29.0 million in the first quarter of 2019. As a percentage of total sales, sales from human albumin and IVIG products were 43.8% and 22.4%, respectively, in the first quarter of 2019.

The sales volume of human albumin products increased by 85.8% for the first quarter of 2019, primarily due to increased sales volumes in the distributor and pharmacy channels, supplemented by increased direct sales to hospitals and inoculation centers. The sales volume of IVIG products increased by 1.1% for the first quarter of 2019 as a result of increased sales through the distributor channel.

The average prices for human albumin and IVIG products decreased by 4.1% and 4.2%, respectively, in RMB terms in the first quarter of 2019 compared to the same quarter of 2018 because of higher sales volume in the distributor channel and lower prices to certain distributors reflecting intensified market competition for major plasma products. In USD terms, the average price for human albumin and IVIG products decreased by 9.5% and 9.7%, respectively, in the first quarter of 2019 compared to the same quarter of 2018.

Revenue from other immunoglobulin products increased by 6.6% in RMB terms, or 0.5% in USD terms in the first quarter of 2019 compared to the same quarter of 2018, reaching 10.1% of total sales as compared to 11.6% of total sales in the same quarter of 2018. The revenue increase was mainly attributable to increased sales volume of human tetanus immunoglobulin products.

Revenue from other plasma products, including human coagulation factor VIII, human prothrombin complex concentrate, and human fibrinogen products, increased by 64.2% in RMB terms, or 54.9% in USD terms, in the first quarter of 2019 compared to the same quarter of 2018, representing 7.6% of total sales in the first quarter of 2019. The growth mainly came from increased sales through the distributor channel.

Revenue from placenta polypeptide products decreased by 52.4% in USD terms for the first quarter of 2019 as compared to the same quarter of 2018, accounting for 5.9% of total sales compared to 14.3% of total sales in the first quarter of 2018, mainly in line with a decrease in sales volume as a result of the inclusion of placenta polypeptide products in regional adjuvant drug lists, which put a downward pressure on their prescription volume.

Cost of sales increased by 31.2% to $44.2 million in the first quarter of 2019 from $33.7 million in the same quarter of 2018. As a percentage of total sales, cost of sales increased to 34.1% from 30.0% in the same quarter of 2018, mainly because of decreased sales prices for most of the Company’s plasma products, increased plasma collection costs, and increased depreciation expenses due to the launch of the Company’s new facility in Shandong in February 2018.

Gross profit increased by 8.6% to $85.6 million in the first quarter of 2019 from $78.8 million in the same quarter of 2018. Gross margin was 65.9% and 70.0% in the first quarter of 2019 and 2018, respectively.

Total operating expenses in the first quarter of 2019 increased by $1.8 million, or 4.5%, to $41.6 million from $39.8 million in the same quarter of 2018. This increase mainly consisted of an increase of $3.2 million in general and administrative expenses, partially offset by a decrease of $2.0 million in selling expenses. As a percentage of total sales, total operating expenses decreased to 32.0% in the first quarter of 2019 from 35.4% in the same quarter of 2018.

Selling expenses in the first quarter of 2019 decreased by $2.0 million, or 9.7%, to $18.7 million from $20.7 million for the first quarter of 2018. As a percentage of total sales, selling expenses decreased to 14.4% for the first quarter of 2019 from 18.4% in the same quarter of 2018. The decrease in selling expenses is primarily due to a decrease in marketing and promotion expenses related to placenta polypeptide products, which is partly offset by increased selling expenses for plasma products.

General and administrative expenses in the first quarter of 2019 increased by $3.2 million, or 18.4%, to $20.6 million from $17.4 million in the same quarter of 2018. As a percentage of total sales, general and administrative expenses increased to 15.9% for the first quarter of 2019 from 15.5% for the same quarter of 2018. The increase in general and administrative expenses was mainly a combined result of the increased allowance for doubtful accounts receivable and increased depreciation expenses for the Company’s new facility in Shandong, which was partially offset by the decrease in share-based compensation expenses.

Research and development expenses in the first quarter of 2019 increased by $0.6 million, or 35.3%, to $2.3 million from $1.7 million in the same quarter of 2018. In the first quarter of 2019 and 2018, the Company received government grants totaling $0.4 million and $0.1 million, respectively, and the Company recognized them as a reduction of the research and development expenses. Excluding this impact, research and development expenses increased by $0.9 million for the first quarter of 2019 from the same quarter of 2018. As a percentage of total sales, research and development expenses, excluding the impact of these recognized government grants, increased to 2.1% for 2019 from 1.6% compared to the same quarter of 2018.

Income from operations in the first quarter of 2019 increased by 19.4% in RMB terms, or 12.8% in USD terms, to $44.0 million from $39.0 million in the same quarter of 2018. Operating margin decreased to 33.9% in the first quarter of 2019 from 34.7% in the first quarter of 2018.

Income tax expense in the first quarter of 2019 increased by $1.2 million, or 17.9%, to $7.9 million from $6.7 million in the same period of 2018. The effective income tax rate was 15.0% and 15.1% for the first quarter of 2019 and 2018, respectively.

Net income attributable to the Company increased by 26.5% in RMB terms, or 19.3% in USD terms, to $37.7 million in the first quarter of 2019 from $31.6 million in the same period of 2018. Net margin increased to 29.1% in the first quarter of 2019 from 28.1% in the same period of 2018. Diluted net earnings per share increased to $0.94 in the first quarter of 2019 compared to $0.92 in the same period of 2018.

Non-GAAP adjusted income from operations increased by 10.5% in RMB terms, or 4.2% in USD terms, to $52.2 million in the first quarter of 2019 from $50.1 million in the same period of 2018.

Non-GAAP adjusted net income attributable to the Company increased by 14.3% in RMB terms and 7.7% in USD terms, to $44.5 million in the first quarter of 2019 from $41.3 million in the same period of 2018. Non-GAAP net margin decreased to 34.3% in the first quarter of 2019 from 36.7% in the same period of 2018. Non-GAAP adjusted net income per diluted share decreased to $1.11 in the first quarter of 2019 from $1.21 in the same period of 2018.

Non-GAAP adjusted income from operations for the first quarter of 2019 excludes $6.3 million in non-cash employee share-based compensation expenses, and $2.1 million in amortization expense of intangible assets and land use rights related to the acquisition of TianXinFu.

Non-GAAP adjusted net income and diluted earnings per share for the first quarter of 2019 exclude $5.5 million in non-cash employee share-based compensation expenses, and $1.4 million in amortization expense of intangible assets and land use rights related to the acquisition of TianXinFu.

As of March 31, 2019, the Company had $99.0 million in cash on hand and demand deposits, $653.8 million in time deposits, and $171.2 million in short term investments.

Net cash provided by operating activities for the first quarter of 2019 was $32.2 million as compared to $23.3 million for the same period of 2018. The $8.9 million increase in net cash provided by operating activities was a combined result of the increase in both net income and non-cash expenses, which mainly include depreciation expenses and allowance for doubtful accounts receivable.

Accounts receivable increased by $11.6 million during the first quarter of 2019 as compared to $15.5 million during the same period of 2018. The accounts receivable turnover days for plasma products increased to 100 days during the first quarter of 2019 from 84 days during the same period of 2018, reflecting longer credit terms to hospitals as a result of the nationwide implementation of healthcare reform measures and intensified competition in the distributor channel.

Inventories increased by $4.0 million in the first quarter of 2019, which was milder than the increase of $10.8 million in the same period of 2018, mainly comprised of increased raw material plasma both out-sourced and from the Company’s own collection stations.

Net cash used in investing activities for the first quarter of 2019 was $214.7 million as compared to $135.5 million for the same period of 2018. During the first quarter of 2019, the Company paid $7.9 million for the acquisition of property, plant and equipment, intangible assets and land use rights, and the Company also purchased time deposits and short-term investments in the amount of $937.4 million. This was partly offset by $730.6 million from the maturity of time deposits and short term investments. Net cash used in investing activities in the first quarter of 2018 mainly consisted of $264.7 million payment for purchase of time deposits and short term investments, $11.3 million for the acquisition of property, plant and equipment, intangible assets, and land use rights, which was partly offset by $97.7 million cash received upon acquisition of TianXinFu and the maturity of $42.8 million time deposits and short term investments.

Net cash used in financing activities for the first quarter of 2019 was $60.0 million as compared to net cash provided by financing activities of $0.3 million for the same period of 2018. In the first quarter of 2019, $60.0 million was remitted to an investment bank by the Company to execute the previously approved share repurchase program on behalf of the Company. As of March 31, 2019, 415,356 shares had been repurchased at a total amount of $36.8 million with the remaining $23.2 million as down payment to the investment bank for further repurchases. Net cash provided by financing activities in the first quarter of 2018 represented proceeds of $0.3 million from stock options exercised.

Financial Outlook

The Company reiterates its forecast for the full year 2019. The company expects both non-GAAP adjusted income from operations and non-GAAP adjusted net income to increase by 4% to 6% in RMB terms over full year 2018 financial results.

This guidance does not factor in any potential foreign currency translation impact. Having previously adopted an exchange rate of approximately RMB6.59 = $1.00 based on weighted average quarterly exchange rates in 2018 in translating 2018 financial results, the Company expects that the total sales and non-GAAP adjusted net income in USD terms in 2019 could be affected by the foreign currency translation impact.

This guidance excludes potential acquisitions, and necessarily assumes no significant adverse product price changes during 2019. This forecast reflects the Company’s current and preliminary views, which are subject to change.

Conference Call

The Company will host a conference call at 7:30 am Eastern Time on May 13, 2019, which is 7:30 pm Beijing Time on May 13, 2019, to discuss its first quarter 2019 results and answer questions from investors. Listeners may access the call by dialing:

US:

1 888 346 8982

International:

1 412 902 4272

Hong Kong:

800 905 945

China:

400 120 1203

A telephone replay will be available one hour after the conclusion of the conference all through May 20, 2019. The dial-in details are:

US:

1 877 344 7529

International:

1 412 317 0088

Passcode:

10131286

A live and archived webcast of the conference call will be available through the Company’s investor relations website at View Source

Enzo Biochem Inc. Announces Issuance of United States Patent for Treatment of Liver Cancer Using Ozanimod

On May 10, 2019 Enzo Biochem, Inc. (NYSE:ENZ) reported that on May 7, 2019 it was issued U.S. Patent No. 10,278,960 entitled "Sphingosine Pathway Modulating Compounds for the Treatment of Cancers" that is directed to methods for treating hepatocellular carcinoma (HCC), the most common human liver cancer, using the compound Ozanimod (Press release, Enzo Biochem, MAY 10, 2019, View Source [SID1234536176]).

Ozanimod is a product of Celgene Corporation (NASDAQ:CELG) that is in late-stage clinical development for the treatment of relapsing multiple sclerosis and inflammatory bowel disease. It targets a different part of the same cell signaling pathway, the "sphingosine pathway," also targeted by Enzo’s proprietary sphingosine kinase inhibitor, SK1-I, which Enzo is currently developing for the treatment of HCC. The sphingosine pathway is a key cellular signaling pathway implicated in various cancers and functions of the immune system. Enzo has already obtained a number of U.S. and foreign patents covering SK1-I and its use in the treatment of cancers.

Elazar Rabbani, CEO of Enzo stated, "Our findings with Ozanimod provide further validation for targeting the sphingosine pathway in hepatocellular carcinoma and complement our current program to develop Enzo’s proprietary sphingosine kinase inhibitor, SK1-I, for the treatment of HCC. Animal xenotransplantation studies examining the efficacy of each of SK1-I and Ozanimod against tumors derived from human liver cancer cells are currently in progress."

HCC represents more than 90% of primary human liver cancers and a significant unmet medical need in the United States and globally.

Sangamo Therapeutics Announces Participation In The Bank Of America Merrill Lynch 2019 Health Care Conference

On May 10, 2019 Sangamo Therapeutics, Inc. (NASDAQ: SGMO) reported that Sangamo will participate in the Bank of America Merrill Lynch 2019 Health Care Conference being held next week in Las Vegas (Press release, Sangamo Therapeutics, MAY 10, 2019, View Source [SID1234536175]). A "fireside chat" discussion with Sangamo CEO Sandy Macrae is scheduled for Tuesday, May 14th at 5 p.m. PT.

The discussion will be webcast live and may be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. The event will be archived on the Sangamo website for two weeks after the event.

Fortress Biotech Reports First Quarter 2019 Financial Results and Recent Corporate Highlights

On May 10, 2019 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on identifying, in-licensing and developing high-potential marketed and development-stage drugs and drug candidates, reported financial results and recent corporate highlights for the first quarter ended March 31, 2019 (Press release, Fortress Biotech, MAY 10, 2019, View Source [SID1234536161]).

Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, "We enjoyed a strong start to 2019, with compelling data recently published in the New England Journal of Medicine pertaining to our partner company Mustang’s lentiviral gene therapy for infants under the age of two diagnosed with X-linked severe combined immunodeficiency ("XSCID"), and the closing of two promising partnership deals with Alexion Pharmaceuticals and InvaGen Pharmaceuticals (a subsidiary of Cipla Limited) in the first quarter. These significant achievements demonstrate how our business model is designed to drive value for our shareholders. We have several opportunities to increase economics and decrease risk for our shareholders with multiple possible near-term revenue streams due to our specialty pharmaceutical business; large equity stakes in our partner companies; strategic, flexible potential exits; and potential royalties on product sales."

Dr. Rosenwald continued, "We look forward to advancing our and our partner companies’ development programs and achieving numerous milestones during the remainder of 2019, including important data readouts and the potential for the first New Drug Application ("NDA") filing by a Fortress partner company later this year. Our sizable business development team continues to source and in-license high-potential marketed and development-stage programs to enhance the growing, diversified portfolio of seven commercial products and over 25 product candidates in development across our partner companies."

Financial Results:1

·As of March 31, 2019, Fortress’ consolidated cash, cash equivalents, short-term investments (certificates of deposit), and restricted cash totaled $137.5 million, compared to $99.2 million as of December 31, 2018, an increase of $38.3 million for the quarter.
·Fortress’ net revenue totaled $6.5 million for the first quarter of 2019, compared to $5.9 million for the first quarter of 2018.
·Research and development expenses were $23.3 million for the first quarter of 2019, of which $22.6 million was related to Fortress partner companies. This compares to $25.0 million for the first quarter of 2018, of which $22.8 million was related to Fortress partner companies. Non-cash, stock-based compensation expenses included in research and development were $0.6 million for the first quarter of 2019, compared to $2.3 million for the first quarter of 2018.
·Research and development expenses from license acquisitions totaled $0.5 million for the first quarter of 2019, compared to $0.1 million for the first quarter of 2018.
·General and administrative expenses were $13.5 million for the first quarter of 2019, of which $8.9 million was related to Fortress partner companies. This compares to $13.5 million for the first quarter of 2018, of which $8.4 million was related to Fortress partner companies. Non-cash, stock-based compensation expenses included in general and administrative expenses were $2.7 million for the first quarter of 2019, compared to $2.4 million for the first quarter of 2018.
·Net income attributable to common stockholders was $1.4 million, or $0.03 per share, for the first quarter of 2019, compared to a net loss attributable to common stockholders of $21.0 million, or $0.49 per share, for the first quarter of 2018.

Marketed Dermatology Products

·In the first quarter of 2019, our seven marketed products generated net revenue of $6.1 million, compared to $6.0 million in the fourth quarter of 2018 and $5.5 million in the first quarter of 2018.

IV Tramadol

·The stock purchase stage of the strategic transaction between InvaGen and our partner company Avenue closed in February 2019. InvaGen acquired approximately 5.8 million shares of Avenue Therapeutics’ common stock at $6.00 per share for total gross consideration of $35.0 million, representing a 33.3% stake in Avenue’s capital stock on a fully-diluted basis.
·Avenue is currently running a second pivotal Phase 3 efficacy and safety study of IV tramadol in patients with post-operative pain following abdominoplasty procedure, as well as an open-label, single-arm safety study. Both are expected to complete around mid-2019.

CAEL-101

·In January 2019, Caelum Biosciences, Inc. ("Caelum") signed an agreement with Alexion Pharmaceuticals, Inc. ("Alexion") to advance the development of CAEL-101. Under the terms of the agreement, Alexion purchased a 19.9% minority equity interest in Caelum for $30 million. Additionally, Alexion has agreed to make potential payments to Caelum upon the achievement of certain developmental milestones, in exchange for which Alexion obtained a contingent exclusive option to acquire the remaining equity in the company for pre-negotiated economics.

Triplex

·The multicenter Phase 2 study of Triplex for cytomegalovirus ("CMV") control in allogeneic stem cell transplant recipients has concluded, and its primary endpoint was met. The full dataset was presented at the 45th Annual Meeting of the European Society for Blood and Marrow Transplantation ("EBMT") in March 2019. We plan to complete an End of Phase 2 Meeting with the FDA for Triplex in the second half of 2019 and plan to initiate a Phase 3 study of Triplex in the first half of 2020.

MB-107 (XSCID gene therapy)

·In April 2019, the New England Journal of Medicine published data from St. Jude Children’s Research Hospital ("St. Jude"). The data are from a Phase 1/2 clinical trial of a lentiviral gene therapy for the treatment of newly diagnosed infants under two years old with XSCID. Data demonstrate the lentiviral gene therapy achieved normalization of T-cell numbers in all eight newly diagnosed infants with XSCID to date, and disseminated infections resolved completely in all affected infants. Seven of the eight infants treated have developed normal IgM levels to date. Four of those seven infants have discontinued monthly infusions of intravenous immunoglobulin (IVIG) therapy to date. Three of those four infants who discontinued monthly IVIG infusions have responded to vaccines to date.
·MB-107 (XSCID gene therapy) is currently in development at our partner company, Mustang Bio, Inc.

Cosibelimab (formerly referred to as CK-301, an anti-PD-L1 antibody)

·In January 2019, we announced that the ongoing multi-center clinical trial of anti-PD-L1 antibody, cosibelimab, was expanded to enroll patients in three endometrial and colorectal cohorts intended to support potential requests for accelerated approval and Biologics License Application ("BLA") submissions to the U.S. Food and Drug Administration ("FDA"). The ongoing trial is also enrolling cohorts of patients with non-small cell lung cancer ("NSCLC") and cutaneous squamous cell carcinoma.
·In May 2019, we announced positive interim results from our ongoing multicenter Phase 1 clinical trial of cosibelimab. There were >40% objective response rates observed in first-line non-small cell lung cancer and cutaneous squamous cell carcinoma and the antibody was well-tolerated.
·Cosibelimab (anti-PD-L1 antibody) is currently in development at our partner company, Checkpoint Therapeutics, Inc.

CK-101 (third-generation EGFR inhibitor)

·In March 2019, we announced two new patent issuances by the U.S. Patent and Trademark Office and the European Patent Office for CK-101. The patents cover CK-101 in the U.S. and Europe through at least August 2034, not including any potential patent term extensions.
·CK-101 (third-generation EGFR inhibitor) is currently in development at our partner company, Checkpoint Therapeutics, Inc.

MB-108 (Oncolytic Virus C134)

·In February 2019, we partnered and entered into an exclusive worldwide license agreement with Nationwide Children’s Hospital to develop an oncolytic virus (C134) for the treatment of glioblastoma multiforme. We intend to combine MB-108 with MB-101 (IL13Rα2-specific CAR) to potentially enhance efficacy in treating glioblastoma multiforme.
·MB-108 (oncolytic virus C134) is currently in development at our partner company, Mustang Bio, Inc.

MB-104 (CS1-specific CAR T)

·In May 2019, we announced that City of Hope began enrolling patients with relapsed or treatment-resistant multiple myeloma in an innovative CS1 chimeric antigen receptor ("CAR") T cell therapy (MB-104) trial. The Phase 1 clinical trial is the first autologous CAR T trial to target the CS1 protein, which is expressed by cancer cells in nearly all multiple myeloma patients.
·MB-104 (CS1-specific CAR T) is currently in development at our partner company, Mustang Bio, Inc.

Roche to present new data highlighting comprehensive approach to cancer care at 2019 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 10, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that new data from clinical trials of 17 approved and investigational medicines across 27 cancer types, including hard-to-treat and rare tumours, will be presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL, United States, from 31 May– 4 June, 2019 (Press release, Hoffmann-La Roche, MAY 10, 2019, View Source [SID1234536160]). A total of 155 abstracts that include a Roche medicine will be presented at this year’s meeting.

"At this year’s ASCO (Free ASCO Whitepaper) meeting, we are excited to present new data with targeted therapies, immunotherapy and pipeline combinations across a broad range of diseases including blood, breast and lung cancers, as well as paediatric tumours treated with our personalised cancer medicine, entrectinib," said Sandra Horning, MD, chief medical officer and head of Global Product Development. "Through pioneering science, strategic partnerships and data and analytics, we’re striving to develop transformative medicines that can help improve outcomes for each individual patient."

Further information on Roche’s contribution to the ASCO (Free ASCO Whitepaper) 2019 scientific programme, as well as the latest innovations and developments in Roche’s approach to accelerating progress in cancer care, will be featured during the Roche Media Briefing from 09:00 – 10:30 CDT on Friday 31 May at the Chicago Marriott Downtown Magnificent Mile, Chicago, IL, US. This event, independently organised by Roche, is open to journalists from outside the United States who have registered as media with the ASCO (Free ASCO Whitepaper) 2019 Annual Meeting.

To register for the Roche Media Briefing, please follow this link: http://roche.cvent.com/d/v6qcp1?ct=94fca666-18b0-4c40-b5f7-6b4b845171c7.

Keep up to date on ASCO (Free ASCO Whitepaper) meeting news and updates by following Roche on Twitter via @Roche and using the hashtag #ASCO19.

Key presentations in blood cancers
The first data from the pivotal Phase III CLL14 study will be presented at ASCO (Free ASCO Whitepaper), evaluating the 12-month, fixed-duration, chemotherapy-free combination of Venclexta/Venclyxto (venetoclax) plus Gazyva/Gazyvaro (obinutuzumab) compared to Gazyva/Gazyvaro plus chlorambucil in people with previously untreated chronic lymphocytic leukaemia (CLL) and co-existing medical conditions. The CLL14 study is being conducted in cooperation with the German CLL Study Group (GCLLSG), headed by Michael Hallek, MD, University of Cologne.

The US Food and Drug Administration (FDA) is reviewing a supplemental New Drug Application (sNDA) based on results of the CLL14 study under the FDA’s Real-Time Oncology Review and Assessment Aid pilot programmes. Venclexta is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche group, in the US and commercialised by AbbVie outside of the US.

Key presentations in paediatric cancers
The first data from the Phase I/II STARTRK-NG study of the investigational medicine entrectinib in children and adolescents with recurrent or refractory solid tumours harbouring neurotrophic tyrosine receptor kinase (NTRK), ROS1 or anaplastic lymphoma kinase (ALK)-positive tumours, including central nervous system tumours, will be presented. The study enrolled children and adolescents aged 4.9 months through 20 years (median of seven years) across several different cancer types, including some rare tumours. The STARTRK-NG data will be featured as part of ASCO (Free ASCO Whitepaper)’s official press programme on Wednesday, 15 May.

The FDA recently granted Priority Review for entrectinib for the treatment of paediatric and adult patients with NTRK fusion-positive, locally advanced or metastatic solid tumours who have either progressed following prior therapies or as initial therapy when there are no acceptable standard therapies, and for the treatment of people with metastatic, ROS1-positive non-small cell lung cancer (NSCLC). These NDAs are based on results from the integrated analysis of the pivotal Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 trials, and data from the STARTRK-NG study. The FDA is expected to make a decision on the approval by 18 August 2019.

Key presentations in breast cancers
Key data to be presented at ASCO (Free ASCO Whitepaper) include updates from Roche’s breast cancer programme across multiple subtypes of the disease, including the second interim analysis of overall survival (OS) results, updated safety data and patient-reported outcomes (PROs) from the Phase III IMpassion130 study of Tecentriq (atezolizumab) plus chemotherapy (Abraxane [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the treatment of PD-L1-positive, metastatic triple-negative breast cancer (TNBC). This combination was recently granted accelerated approval from the FDA based on progression-free survival (PFS) for the treatment of adults with unresectable locally advanced or metastatic TNBC in people whose tumours express PD-L1, as determined by an FDA-approved test.

Additional data include an eight-year, end-of-study analysis from the Phase III CLEOPATRA study of Perjeta (pertuzumab) plus Herceptin (trastuzumab) and chemotherapy for first-line treatment of HER2-positive metastatic breast cancer.

Key presentations in lung cancers
Key data from Roche’s broad lung cancer programme will be presented across different types of the disease, including results from the Phase III IMpower150 trial of Tecentriq plus Avastin (bevacizumab) and chemotherapy (carboplatin and paclitaxel) in chemotherapy-naïve people previously untreated for metastatic NSCLC whose cancer has spread to the liver, which affects approximately 20% of people with the disease. Additionally, results from studies in partnership with Flatiron Health will be presented, including validation of the use of next-generation sequencing data on a broad scale to improve the understanding of clinical outcomes in people with metastatic lung cancer, and results that illustrate how real-world data can be used to supplement evidence from clinical trials in rare tumour types such as ROS1-positive lung cancer.

Key presentations featuring Roche medicines at ASCO (Free ASCO Whitepaper) 2019

About Roche in Oncology
Roche has been working to transform cancer care for more than 50 years, bringing the first specifically designed anti-cancer chemotherapy drug, fluorouracil, to patients in 1962. Roche’s commitment to developing innovative medicines and diagnostics for cancers remains steadfast.

The Roche Group’s portfolio of innovative cancer medicines includes: Alecensa (alectinib); Avastin (bevacizumab); Cotellic (cobimetinib); Erivedge (vismodegib); Gazyva/Gazyvaro (obinutuzumab); Herceptin (trastuzumab); Kadcyla (trastuzumab emtansine); MabThera/Rituxan (rituximab); Perjeta (pertuzumab); Tarceva (erlotinib); Tecentriq (atezolizumab); Venclexta/VenclyxtoTM (venetoclax); Xeloda (capecitabine); Zelboraf (vemurafenib). Furthermore, the Roche Group has a robust investigational oncology pipeline focusing on new therapeutic targets and novel combination strategies.

For more information on Roche’s approach to cancer, visit www.roche.com.