On March 14, 2018 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported that data for ZEJULA, TSR-042 (anti-PD-1 antibody) and the company’s immuno-oncology portfolio will be presented at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held April 14-18, 2018 in Chicago (Press release, TESARO, MAR 14, 2018, View Source [SID1234524775]).

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"This year’s AACR (Free AACR Whitepaper) annual meeting will mark the first presentation of initial data from the GARNET trial of TSR-042, our anti-PD-1 antibody, in patients with MSI-high endometrial cancer or non-small cell lung cancer," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "TSR-042 provides a strategic advantage for TESARO in further developing niraparib and our immuno-oncology product candidates, and we expect to complete enrollment in the MSI-high registration trial at the end of this year. The breadth of our IO portfolio, which also includes antibodies targeting TIM-3 and LAG-3, enables TESARO to evaluate novel combination approaches with a goal of providing transformative therapies for people living with cancer."

Please plan to visit TESARO at Booth #1645 for information on the expanded development program for ZEJULA, TSR-042 and our broader immuno-oncology portfolio.

Poster Information (all times local):

Immuno-oncology

Monday, April 16, 2018, 8:00 AM to 12:00 PM
Preliminary safety, efficacy and PK/PD characterization from GARNET, a phase I clinical trial of the anti-PD-1 monoclonal antibody, TSR-042, in patients with recurrent or advanced NSCLC or MSI-H endometrial cancer
Poster Session, Abstract: CT053, Location: Exhibit Hall A, Poster Section 42, Poster Board 6

Monday, April 16, 2018, 8:00 AM to 12:00 PM
Checkpoint inhibitor signatures across endometrial cancer histologies
Poster Session, Abstract: 1687, Location: Exhibit Hall A, Poster Section 31, Poster Board 12

Monday, April 16, 2018, 8:00 AM to 12:00 PM
Simultaneous measurement and significance of PD-1, LAG-3 and TIM-3 expression in human solid tumors
Poster Session, Abstract: 1681, Location: Exhibit Hall A, Poster Section 31, Poster Board 6

Monday, April 16, 2018, 1:00 PM to 5:00 PM
Investigation of the expression profile and functional role of PD-1, TIM-3 and LAG-3 in human tumors
Poster Session, Abstract: 2722, Location: Exhibit Hall A, Poster Section 32, Poster Board 14

Wednesday, April 18, 2018, 8:00 AM to 12:00 PM
Characterization of tumor growth and immune microenvironment in humanized NOG-EXL mice implanted with A549, MDA-MB-436 and A375 cells
Poster Session, Abstract: 5690, Location: Exhibit Hall A, Poster Section 31, Poster Board 26

ZEJULA (niraparib)

Monday, April 16, 2018, 1:00 PM to 5:00 PM
Efficacy and pharmacokinetics of niraparib in BRCA-mutant and wild-type intracranial triple negative breast cancer murine models
Poster Session, Abstract: 2813, Location: Exhibit Hall A, Poster Section 37, Poster Board 3

Monday, April 16, 2018, 8:00 AM to 12:00 PM
Evaluation of niraparib in combination with anti-PD1/anti-PD-L1 in preclinical models
Poster Session, Abstract: 1724, Location: Exhibit Hall A, Poster Section 32, Poster Board 19

Wednesday, April 18, 2018, 8:00 AM to 12:00 PM
Enhanced anti-tumor effects of selinexor and niraparib in preclinical models of ovarian cancer
Poster Session, Abstract: 5826, Location: Exhibit Hall A, Poster Section 37, Poster Board 22

Niraparib is marketed in the United States and Europe under trade name ZEJULA.

About ZEJULA (niraparib)
Niraparib is marketed in the United States and Europe under trade name ZEJULA. ZEJULA (niraparib) is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect. Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including some fatal cases, was reported in patients treated with ZEJULA. Discontinue ZEJULA if MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia), as well as cardiovascular effects (hypertension and hypertensive crisis) have been reported in patients treated with ZEJULA. Monitor complete blood counts to detect hematologic adverse reactions, as well as to detect cardiovascular disorders, during treatment. ZEJULA can cause fetal harm and females of reproductive potential should use effective contraception. Please see full prescribing information, including additional important safety information, available at www.zejula.com.

About TSR-042
TSR-042 is a monoclonal antibody targeting PD-1 and was developed as part of the collaboration between TESARO and AnaptysBio, Inc. This collaboration was initiated in March of 2014, and is focused on the development of monospecific antibody drugs targeting PD-1, TIM-3 (TSR-022), and LAG-3 (TSR-033), in addition to a bi-specific antibody drug candidate targeting PD-1/LAG-3 (TSR-075).

On March 14, 2018 CBT Pharmaceuticals (CBT), a U.S. and China-based innovative biopharmaceutical company committed to becoming a leader in the discovery and development of oncology combination therapies, reported that the company reported that it will present at two upcoming investor conferences (Press release, CBT Pharmaceuticals, MAR 14, 2018, View Source [SID1234524758]):

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March 23, 2018 – Future Leaders in the Biotech Industry at 2:45 – 3:00 p.m. EST in New York, N.Y.
March 28, 2018 – China Healthcare Investment Conference (CHIC) at 3:15 – 5:15 p.m. CST in Shanghai, P.R. China

On March 14, 2018 Verastem, Inc. (NASDAQ:VSTM), focused on developing and commercializing drugs to improve the survival and quality of life of cancer patients, reported that the Company will present at the 28th Annual Oppenheimer & Co. Healthcare Conference on Tuesday, March 20, 2018 at 8:00am in New York City, NY, USA (Press release, Verastem, MAR 14, 2018, View Source;p=RssLanding&cat=news&id=2338094 [SID1234524776]). Verastem’s presentation was originally scheduled for 11:30am but was subsequently moved to 8:00am.

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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

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A live webcast of the presentation will be available on the investors section of the Company’s website at www.verastem.com. An archived presentation will be available for 90 days.

On March 14, 2018 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small-molecule drugs that address cancer, liver disease and inflammatory diseases, reported that Dr. Pnina Fishman, Can-Fite’s Chief Executive Officer, will present at the 2nd Annual H.C. Wainwright NASH Investor Conference on March 19 at 5:20 p.m. ET in New York City (Press release, Can-Fite BioPharma, MAR 14, 2018, View Source [SID1234524757]). The presentation will focus on its drug candidate Namodenoson (CF102), A3 adenosine receptor (A3AR), currently in a Phase II trial for the treatment of NAFLD, and non-alcoholic steatohepatitis (NASH).

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

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Recent Positive Safety Data on Namodenoson

Can-Fite’s current Phase II study is being conducted in three Israeli sites, including Hadassah Medical Center, Jerusalem, and the Rabin Medical Center, Petach Tikva. Patients who suffer from NAFLD/NASH with evidence of active inflammation are treated twice daily with 12.5 or 25 mg of oral Namodenoson vs. placebo. The primary end point of the Phase II study is the anti-inflammatory effect of the drug, as determined by ALT blood levels, and the secondary end points include percentage of liver fat, as measured by MRI-PDFF (proton density fat fraction). The Company anticipates the completion of patient enrollment toward the end of 2018 and data release in the first half of 2019.

Recent safety data showed that Namodenoson has a favorable safety profile and lack of hepatotoxicity in patients. Preclinical data demonstrate robust anti-inflammatory, anti-fibrogenic and anti-steatotic effects, supporting its development for the NAFLD/NASH indication.

On March 14, 2018 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported financial results for the year ended December 31, 2017 (Press release, Zymeworks, MAR 14, 2018, View Source [SID1234524777]).

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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

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"2017 was marked by a number of key corporate successes," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "We continued to generate promising clinical results for ZW25, added a sixth global pharmaceutical partner, and saw important progress in our partners’ programs as they advanced compounds utilizing our technology towards the clinic."

2017 Business Highlights and Recent Developments

Expanded Clinical Dataset for ZW25
The Company reported results from the dose-escalation portion of its ongoing Phase 1 clinical trial, showing encouraging tolerability and anti-tumor activity in heavily pretreated patients with HER2-expressing cancers, including breast and gastric cancers. Zymeworks has increased the number of clinical trial sites in the United States and is in the process of activating multiple sites across Canada.
Established New Corporate Partnership
Zymeworks provided a license to Janssen to develop up to six bispecific antibodies in a transaction potentially worth US$1.45 billion including a US$50 million upfront payment, milestones, and tiered royalties on product sales.
Partners’ Programs Progress Towards the Clinic
Two long-term partners (Lilly and Merck) have selected lead Azymetric bispecific candidates for advancement towards the clinic, and Daiichi Sankyo’s program achieved a significant research milestone resulting in a payment to Zymeworks.
Dr. Tehrani noted, "Looking ahead, we plan to build on the momentum established last year as we create additional value throughout our business. We anticipate achieving the following milestones: complete enrollment in our Phase 1 study and report additional data for ZW25; file an Investigational New Drug (IND) Application for our second clinical compound, ZW49; present preclinical data on our other product candidates; and expand our partnering activities."

Financial Results for the Year Ended December 31, 2017

Revenue in 2017 was $51.8 million as compared to $11.0 million in 2016. The increase of $40.8 million was primarily due to the recognition of a $50.0 million upfront fee received from Janssen and a $1.0 million milestone payment from Daiichi Sankyo.

For the year ended December 31, 2017, research and development expenditures were $41.7 million as compared to $36.8 million in the prior year. The increase was primarily due to clinical costs for ZW25 and development costs for ZW49. General and administrative expenses were $18.6 million in 2017 and $12.6 million in 2016. The change between the periods was primarily due to an increase in compensation costs, professional fees, and other administrative expenses.

The net loss for the year ended December 31, 2017, decreased to $10.4 million as compared to $33.8 million in 2016, primarily due to increased revenue offsetting research and development expenses as previously noted. Zymeworks expects research and development expenditures to increase over time due to the ongoing development of product candidates and other clinical, preclinical, and regulatory activities.

As of December 31, 2017, Zymeworks had $87.8 million in cash and cash equivalents and short-term investments. Zymeworks expects to continue receiving revenue from its existing and future corporate collaborations, including technology access fees, research and development fees for services rendered and milestone-based payments. However, its ability to receive these payments is dependent upon either Zymeworks or its collaborators successfully completing specified research and development activities.