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Five Prime Announces Fourth Quarter and Full Year 2016 Financial Results

On February 23, 2017 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported a corporate update and reported financial results for the fourth quarter and full year ending December 31, 2016 (Press release, Five Prime Therapeutics, FEB 23, 2017, View Source [SID1234517836]).

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"2016 was a year of tremendous progress in Five Prime’s clinical and preclinical pipeline," said Lewis T. "Rusty" Williams, M.D., Ph.D., president and chief executive officer of Five Prime. "We advanced our three clinical-stage programs and look forward to announcing data from each of these programs this year. With a concerted focus on building out our pipeline, we also unveiled three preclinical programs that we advanced into IND-enabling activities. We are on track to meet our goal of filing at least one IND application for a new molecule each year for the foreseeable future, beginning this year."

2016 Business Highlights and Recent Developments

Clinical Pipeline:

Cabiralizumab (FPA008): an investigational antibody that inhibits CSF1R and has been shown to block the activation and survival of monocytes and macrophages. In the setting of advanced cancer, tumor-associated macrophages can inhibit the immune system’s ability to eradicate the disease. In pigmented villonodular synovitis (PVNS), a CSF-1-driven tumor, the bulk of the tumor mass in joints is formed by the macrophages themselves. Five Prime and Bristol-Myers Squibb (BMS) have an exclusive worldwide collaboration agreement for the development and commercialization of cabiralizumab for these and potentially additional indications.
– Initiated Phase 1b portion of cabiralizumab/OPDIVO trial.
In October 2016, Five Prime initiated the Phase 1b portion of the clinical trial evaluating the immunotherapy combination of cabiralizumab with the PD- 1 immune checkpoint inhibitor OPDIVO (nivolumab) in multiple tumor types. Five Prime and BMS are evaluating the safety, tolerability and preliminary efficacy of the combination in advanced solid tumors, including non-small cell lung cancer, squamous cell carcinoma of the head and neck, pancreatic cancer, glioblastoma, renal cell carcinoma and ovarian cancer. Five Prime expects to complete enrollment in the current Phase 1b trial cohorts in the second half of 2017.

– Advanced the Phase 2 trial of cabiralizumab in patients with tenosynovial giant cell tumor (TGCT), also known as pigmented villonodular synovitis (PVNS).
Five Prime expects to complete enrollment of the Phase 2 trial of cabiralizumab in PVNS in the first half of 2017. Five Prime is evaluating clinical measures, including response rate, pain and range of motion in approximately 30 PVNS patients.

– Five Prime plans to seek regulatory guidance on a pivotal trial in diffuse PVNS.

– Five Prime plans to disclose clinical data from the cabiralizumab PVNS trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2017 Annual Meeting and from the cabiralizumab immuno-oncology trial in the second half of 2017.

FPA144: an isoform-selective antibody in development as a targeted immuno-therapy for tumors that overexpress FGFR2b, a splice variant of a receptor for some members of the fibroblast growth factor (FGF) family. FPA144 has been engineered for enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) to increase direct tumor cell killing by recruiting natural killer (NK) cells. Five Prime retains global development and commercialization rights to FPA144.
– Opened new gastric cancer cohorts and added a bladder cancer cohort in Phase 1 monotherapy trial of FPA144. Enrollment continues in the expansion portion of the trial, evaluating the safety, PK and efficacy of biweekly 15 mg/kg infusions of FPA144 in patients with gastric cancer whose tumors highly overexpress FGFR2b. During the third quarter of 2016, Five Prime added cohorts to evaluate FPA144 in patients with bladder cancer whose tumors overexpress FGFR2b and in patients with gastric cancer whose tumors express moderate or low levels of FGFR2b. Five Prime reported initial single-agent efficacy and safety data at the ASCO (Free ASCO Whitepaper) 2016 Annual Meeting and at the ASCO (Free ASCO Whitepaper) 2016 Gastrointestinal Cancers Symposium.

– Five Prime plans to seek regulatory guidance on a registrational path for FPA144 in combination with chemotherapy as an early-line gastric cancer therapy.

– Five Prime plans to disclose updated clinical data from the FPA144 program at the ASCO (Free ASCO Whitepaper) 2017 Annual Meeting.

FP-1039: a protein drug designed to block FGF signaling. As a ligand trap, FP-1039 binds to and neutralizes a subset of FGF ligands (such as FGF2), preventing these growth-promoting and angiogenic proteins from reaching FGFR1 on the surface of tumor cells.
– Five Prime plans to make decisions on potential future development of FP-1039 in mesothelioma after data on objective response rate, disease control rate and progression-free survival are mature. Five Prime regained full rights to FP-1039 from GlaxoSmithKline (GSK) in September 2016. GSK is completing the ongoing Phase 1b trial combining FP-1039 with 1st-line pemetrexed and cisplatin in untreated, unresectable mesothelioma. GSK concluded trial recruitment with 25 patients enrolled at the 15 mg/kg dose in June 2016, and continues to dose and follow patients.

– Five Prime plans to disclose clinical data from this program at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress.

Preclinical Research and Development:

Five Prime unveiled three preclinical development candidates in IND-enabling studies at its R&D Day in New York City in December 2016.
– FPA150 (anti-B7-H4)

— An antibody designed for two mechanisms of action: to block an inhibitory T cell checkpoint pathway and to enhance killing of B7-H4-expressing tumors by ADCC.
— Investigational New Drug (IND) application planned for the fourth quarter of 2017.

– FPA154 (GITR agonist antibody)

— A tetravalent agonist antibody designed for greater GITR activation versus conventional antibodies. Conventional GITR agonist antibodies have two GITR binding sites while FPA154 has four.
— IND application planned for the fourth quarter of 2017.

– FPT155 (CD80)

— A natural, multi-targeting immune modulator that stimulates T cell responses through three critical pathways: CTLA4 blockade, CD28 agonism (without superagonism) and PD-L1 blockade that removes a potent inhibitory checkpoint.
— IND planned in 2018.

Progress in pre-clinical and research programs is on track for the company to achieve the goal of filing at least one IND application for a new molecule each year for the foreseeable future, beginning this year.

Completed multiple immuno-oncology research screens to identify new targets and drug candidates. Five Prime’s research team completed functional screens on CD8 T cells and regulatory T cells, as well as a comprehensive screen of all extracellular binding interactions in the "immunome," a defined subset of 700 extracellular proteins enriched for potential immune cell modulators. Five Prime conducted the screens to identify new immuno-oncology targets, which the company is prioritizing for further development as targets for new drug candidates or drug candidates themselves, either as monotherapies or as part of rational combination regimens.

Five Prime will feature three preclinical research poster presentations during the 2017 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 1 – 5, 2017, in Washington, D.C.
Summary of Financial Results and Guidance:

Cash Position. Cash, cash equivalents and marketable securities totaled $421.7 million on December 31, 2016 compared to $517.5 million on December 31, 2015. The decrease in year-end cash in 2016 was primarily attributable to net cash used in operations to advance the company’s clinical and preclinical pipeline.
Revenue. Collaboration and license revenue for the fourth quarter of 2016 was $8.3 million compared to $363.3 million for the fourth quarter of 2015. During the fourth quarter of 2015, the company recognized the entire upfront payment of $350 million as revenue under the cabiralizumab license and collaboration agreement with BMS. Collaboration and license revenue for the full year 2016 was $30.7 million compared to $379.8 million for the full year 2015.
R&D Expenses. Research and development expenses for the fourth quarter of 2016 increased by $8.2 million, or 39%, to $29.1 million from $21.0 million in the fourth quarter of 2015. Full year 2016 research and development expenses increased by $23.9 million, or 34%, to $94.1 million in 2016 from $70.2 million in 2015. These increases were primarily related to advancing the FPA144 program in a phase 1 clinical trial, advancing the cabiralizumab program in immuno-oncology and PVNS, and advancing our internal immuno-oncology preclinical and research activities.
G&A Expenses. General and administrative expenses for the fourth quarter of 2016 increased by $1.9 million, or 22%, to $10.5 million from $8.6 million in the fourth quarter of 2015. Full year 2016 general and administrative expenses were $35.8 million, an increase of $13.2 million, or 58%, from $22.6 million in 2015. This increase was primarily due to increases in personnel related expenses, including stock-based compensation.
Net Income (Loss). Net loss for the fourth quarter of 2016 was $20.1 million, or $0.73 per basic share and diluted share, compared to net income of $296.1 million, or $11.37 per basic share and $10.63 per diluted share, for the fourth quarter of 2015. Full year 2016 net loss was $65.7 million, or $2.44 per basic share and diluted share, compared to net income of $249.6 million, or $9.73 per basic share and $9.23 per diluted share. These decreases in net income were primarily related to recognizing the 2015 upfront payment of $350 million as revenue under the cabiralizumab license and collaboration agreement with BMS.
Cash Guidance. Five Prime expects full-year 2017 net cash used in operating activities to be less than $120 million. The company estimates ending 2017 with approximately $300 million in cash, cash equivalents and marketable securities.

Ipsen delivers strong 2016 results and expects further sales growth and margin enhancement for 2017

oN February 23, 2017 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven pharmaceutical group, reported financial results for the full year 2016.

Commenting on the 2016 full year performance, David Meek, Chief Executive Officer of Ipsen, said: "The strong operating performance in 2016 serves as a solid foundation for the company in this new era of accelerated momentum and transformation. Sales grew by nearly 12% year-on-year, a record high for Ipsen, and core operating margin improved despite additional investments for the Cabometyx launch in Europe."

David Meek added: "2016 was a very productive year for Ipsen with the Cabometyx approval and launch for second line renal cell carcinoma in Europe, the launch of new indications for Dysport in the U.S., a new corporate governance structure implemented, and most recently, the acquisition of Onivyde, which reinforces our specialty oncology strategy. The focus for 2017 will be on building upon the strong momentum of the current business and the successful launch of Cabometyx, which combined with the expected addition of Onivyde and the new Primary Care products, will significantly contribute to the growth and profitability of the company in the coming years."

New definition of Core Financial Measures

Ipsen has updated its definition of Core financial measures (Core Operating income, Core consolidated net profit, Core EPS) to exclude the amortization of intangible assets (excluding software) and the gain or loss on disposal of fixed assets.

Core financial measures are the key performance indicators for understanding and measuring the performance of the Group. Ipsen believes that the updated financial indicators reflect with better clarity the Group’s underlying business trends and enable more meaningful comparisons year on year, as they exclude non-core items which may vary significantly.

These performance indicators do not replace IFRS indicators, and should not be relied upon as such.

Reconciliations between IFRS 2015/2016 results and the newly defined Core financial measures are presented in Appendix 4 and in the "Reconciliation from Core consolidated net profit to IFRS consolidated net profit" table on page 12.

Review of the full year 2016 results

Note: Unless stated otherwise, all variations in sales are stated excluding foreign exchange impacts.

In 2016, Group sales reached €1,584.6 million, up 11.8% year-on-year.

Specialty Care sales reached €1,273.0 million, up 16.1%, driven by the strong growth of Somatuline in North America, as well as a solid performance throughout Europe.

Dysport good sales performance in aesthetics in the U.S. through Galderma, and in Russia and the Middle East was offset by importation issues in Brazil that occurred in the second half of the year due to a temporary cancellation of the certificate of Good Manufacturing Practices (cGMP). Decapeptyl sales reflect good volume growth in Europe and China offset by price pressure in the region. The Group booked during the fourth quarter the first sales of Cabometyx in Europe, mainly in Germany, Austria and France following the product approval by EMA in September.

Primary Care sales reached €311.6 million, down 2.7%, impacted by lower sales in Russia for Tanakan and other Primary Care products, while Smecta sales were slightly up driven by the implementation of the new OTx6 commercial model.

Core Operating Income totaled €363.9 million, up 11.1%. Core operating margin reached 23.0%, up 0.3 points compared to 2015, mainly driven by strong business performance, partially offset by investments for the Cabometyx launch and the adverse impact of foreign currencies.

Core consolidated net profit was €263.6 million, up 12.8% over the period, compared to €233.8 million in 2015.

Core earnings per share – fully diluted (see Appendix 4) grew by 13.0% year-on-year to reach €3.18 for 2016, compared to €2.82 in 2015.

Free cash flow generated in 2016 reached €228.8 million, up by €52.5 million, driven by the strong operating performance and a good management of working capital and capital expenditures.

Closing net cash reached €68.6 million at the end of the period, compared to €186.9 million in 2015, notably after payments to Exelixis for the original cabozantinib license and subsequent extension to Canada, as well as regulatory and commercial milestones, for a total of €257.3 million in 2016.

IFRS Operating Income totaled €304.7 million, up 24.8% from €244.0 million in 2015, impacted by lower impairment charge, with an Operating margin at 19.2%, up 2.3 points compared to 2015.

IFRS Consolidated net profit was €226.6 million, up 18.8% over the period, compared to €190.7 million in 2015 and fully diluted EPS at €2.73 in 2016, was up 18.7% from €2.30 in 2015.

Comparison of 2016 performance with financial objectives

The Group exceeded the raised guidance provided on 26 October 2016 for Specialty Care sales and Core operating margin and came in at the favorable end of revised guidance for Primary Care sales.

The table below shows the comparison between the financial objectives provided on 26 October 2016 and 2016 actuals, both including the amortization of intangible assets.

Picture 2

Below is a reconciliation of the Core Operating Income from the previous definition to the new reported definition:

Picture 3

Dividend for the 2016 financial year proposed for the approval of Ipsen’s shareholders

The Ipsen S.A. Board of Directors, which met on 22 February 2017, has decided to propose at the annual shareholders’ meeting on 7 June 2017 the payment of a dividend of €0.85 per share, stable year-on-year.

2017 Financial objectives

The Group has set the following financial targets for 2017 assuming a successful closing of the Onivyde transaction with Merrimack by the end of the first quarter 2017, and of the Consumer Healthcare transaction with Sanofi in the second quarter of 2017:

Specialty Care sales growth year-on-year greater than +18.0%;
Primary Care sales growth year-on-year greater than +4.0%;
Core operating margin (excluding amortization of intangible assets) greater than 24% of net sales.
Sales objectives are set at constant currency.

CBT PHARMACEUTICALS PRESENTS DATA DEMONSTRATING ANTI-TUMOR ACTIVITY OF ITS PROGRAMMED DEATH-1 ANTIBODY, CBT-501, AT ASCO-SITC CLINICAL ONCOLOGY SYMPOSIUM

On February 23, 2017 CBT Pharmaceuticals, Inc. (CBT), a life sciences company focused on developing innovative oncology therapeutics, reported preclinical data demonstrating the efficacy of its Programmed Death-1 (PD-1) antibody, CBT-501 (genolimzumab, GB-226), in stimulating various immune cells, generating anti-tumor immunity, and suppressing tumor growth and delaying tumor progression in a preclinical model of colon cancer (Press release, CBT Pharmaceuticals, FEB 23, 2017, View Source [SID1234517818]). The data were presented in a poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) – Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Clinical Immuno-Oncology Symposium being held from February 23 – 25, 2017 in Orlando, Florida. The symposium is focused on the latest clinical and translational research in immuno-oncology and the implications for clinical care.

"The strong in-vivo preclinical data suggest that CBT-501 may have clinical benefit in a variety of tumor types," said Sanjeev Redkar, Ph.D., Chief Executive Officer and President at CBT Pharmaceuticals. "CBT-501’s novel epitope, with overlapping yet distinct regions compared to incumbent PD-1 inhibitors, may offer a point of differentiation in the clinical setting."

Presentation Highlights:

CBT-501 efficiently inhibited binding of PD-L1/L2 to PD-1 through competitive action.
CBT-501 enhanced human T-cell activation, as shown by increased release of IL-2 and INF-gamma.
In a humanized preclinical model expressing human PD-1 and implanted with a colon adenocarcinoma (MC38) cell line, CBT-501 significantly inhibited tumor growth in a dose-dependent manner that was comparable or improved over nivolumab.
"These studies support our commitment to advancing the clinical development of genolimzumab (CBT-501) as an immuno-oncology therapy for many types of cancer. Based on these findings, a Phase 1 dose escalation and dose and disease expansion study will be initiated in the first half of 2017," said Gavin Choy, Pharm.D., Chief Operating Officer at CBT Pharmaceuticals.

Genolimzumab Injection (CBT-501)

CBT-501 is a novel humanized IgG4 monoclonal antibody targeting the Programmed Death-1 (PD-1) membrane receptor on T lymphocytes and other cells of the immune system. CBT-501 has a comparable efficacy profile in in vitro and in vivo studies to marketed anti-PD-1 antibodies and has a superior safety profile with very low undesirable antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) activity. The antibody (GB226) has been developed by Genor BioPharma Co. Ltd., a Walvax Company, who owns development and commercialization rights in China. CBT Pharmaceuticals, Inc. retains rest of the world (ROW) rights. An investigational new drug application has been approved by the China Food and Drug Administration (CFDA), and a phase 1 trial will be initiated in China by Genor.

Zymeworks Submits ZW25 Phase 1 Clinical Study Findings Abstract for ASCO 2017

On February 23, 2017 Zymeworks Inc. ("Zymeworks"), a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics, initially focused on the treatment of cancer, reported that it has submitted an abstract for the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") annual meeting that contains preliminary Phase 1 data from the ZW25 Phase 1 clinical trial for treatment of HER2-expressing tumors (Press release, Zymeworks, FEB 23, 2017, View Source [SID1234517817]).

"Two of the three cohorts from the dose escalation portion of the ZW25 Phase 1 clinical trial have been fully enrolled and preliminary data has been received for those patients," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "ZW25 is being evaluated for safety, as well as preliminary anti-tumor activity, and we are pleased to have been able to compile these results and submit them for presentation at this year’s ASCO (Free ASCO Whitepaper) annual meeting."

The 2017 ASCO (Free ASCO Whitepaper) annual meeting will be held June 2nd through June 6th in Chicago, Illinois. The ASCO (Free ASCO Whitepaper) annual meeting brings together more than 30,000 oncology professionals from around the world to discuss state-of-the-art treatment modalities, new therapies and ongoing developments in the field of oncology. Abstracts will be released to the public on May 17th at 5:00 P.M. EDT and made available on ASCO (Free ASCO Whitepaper)’s website.

About ZW25

ZW25 is Zymeworks’ lead product candidate currently being evaluated in an adaptive Phase 1 clinical trial in the United States, based on our Azymetric platform. It is a bispecific antibody that can simultaneously bind two non-overlapping epitopes, known as biparatopic binding, of HER2 resulting in dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and enhanced effector function. These combined mechanisms of action have led to significant anti-tumor activity in preclinical models. We are developing ZW25 as a best-in-class HER2-targeting antibody intended as a treatment option for patients with any solid tumor that expresses HER2.

MabVax Therapeutics Announces FDA Authorization to Proceed with MVT-1075 in a Phase I Clinical Trial for the Treatment of Pancreatic Cancer

On February 23, 2017 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage oncology drug development company, announces that it has received notice from the U.S. Food and Drug Administration (FDA) authorizing the initiation a Phase I clinical trial with MVT-1075 as a therapeutic treatment for pancreatic cancer (Press release, MabVax, FEB 23, 2017, View Source [SID1234517816]). MVT-1075 (177Lu-CHX-A″-DTPA-HuMab5B1) is the Company’s novel fully human antibody radioimmunotherapy (RIT). MabVax plans to initiate the phase I clinical trial in patients with recurrent pancreatic cancer and other CA19-9 positive malignancies the first half in 2017. This is the third IND authorized by FDA in the last fourteen months by MabVax that builds on the tumor targeting characteristics of the HuMab-5B1 antibody discovered from immune responses of cancer patients vaccinated with the Company’s proprietary cancer vaccines.

The MVT-1075 RIT agent combines the targeting specificity of the HuMab-5B1 antibody for an antigen overexpressed on pancreatic cancer and other CA19-9 positive cancers with 177Lutetium to target delivery of therapeutic radiation to cancer cells. Preclinical studies have demonstrated marked suppression and in some instances regression in xenograft animal models of pancreatic cancer, potentially making it an important new therapeutic agent in the treatment of pancreatic cancer and other cancers expressing the same antigen, CA19-9.

In this initial phase I trial the Company plans to evaluate the safety, dosimetry, and pharmacokinetics of MVT-1075. Patients enrolled in the study will have been diagnosed with recurrent locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other CA19-9 positive malignancies. Patient disease status will be evaluated based on tumor measurements using RECIST 1.1 criteria. The investigative sites will include Memorial Sloan Kettering Cancer Center in New York City.

In November 2016, MabVax reported positive interim results from two phase I trials. The first trial is evaluating the Company’s therapeutic antibody MVT-5873, in which safety was reported to have been established at three incremental dose levels by treating patients at three clinical sites. Patients continue to be recruited to establish the recommended phase II dose (RP2D). The second trial is evaluating the Company’s Immuno-PET diagnostic agent MVT-2163. The Company reported that phase I trial results demonstrated acceptable interim safety, pharmacokinetics, and biodistribution. Target specificity was demonstrated by correlation with lesions identified by conventional computerized tomography (CT) scans and patients are actively being recruited to this trial.

David Hansen, MabVax’s President and Chief Executive Officer, said, “We are executing on the development strategy we have outlined and we are excited to take this next step forward. We are expanding the HuMab-5B1 program to include delivery of a potent new radiotherapy agent. We are hopeful that this approach will provide a new treatment option for these difficult-to-treat cancers.”