8-K – Current report

On October 27, 2015 Bristol-Myers Squibb Company (NYSE:BMY) reported results for the third quarter of 2015, which were highlighted by strong global sales, key regulatory and clinical milestones in Immuno-Oncology and the completion of several business development transactions strengthening the company’s diversified pipeline (Filing, 8-K, Bristol-Myers Squibb, OCT 27, 2015, View Source [SID:1234507796]).

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"In the third quarter we advanced our leadership position in Immuno-Oncology with two accelerated approvals in the U.S. and the presentation of important new clinical data that demonstrates the breadth and depth of our development program," said Giovanni Caforio, M.D., chief executive officer, Bristol-Myers Squibb. "We delivered strong operational performance driven by top-line growth, the successful launch of Opdivo and continuing positive trends for Eliquis. I remain confident in our strategy and that we are entering our exciting next chapter in a position of strength."

THIRD QUARTER FINANCIAL RESULTS

• Bristol-Myers Squibb posted third quarter 2015 revenues of $4.1 billion, an increase of 4% compared to the same period a year ago. Global revenues increased 11% adjusted for foreign exchange impact.

• U.S. revenues increased 4% to $2.0 billion in the quarter compared to the same period a year ago. International revenues increased 4%, or 19% adjusted for foreign exchange impact.

• Gross margin as a percentage of revenues was 73.0% in the quarter compared to 74.3% in the same period a year ago.

• Marketing, selling and administrative expenses decreased 4% to $983 million in the quarter.

• Advertising and product promotion spending increased 13% to $193 million in the quarter.

• Research and development expenses increased 15% to $1.1 billion in the quarter.

• The effective tax rate was 26.0% in the quarter, compared to 27.4% in the third quarter last year.

• The company reported net earnings attributable to Bristol-Myers Squibb of $706 million, or $0.42 per share, in the quarter compared to net earnings of $721 million, or $0.43 per share, a year ago.

• The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $648 million, or $0.39 per share, in the third quarter, compared to $750 million, or $0.45 per share, for the same period in 2014. An overview of specified items is discussed under the "Use of Non-GAAP Financial Information" section.

• Cash, cash equivalents and marketable securities were $10.0 billion, with a net cash position of $2.8 billion, as of September 30, 2015.

THIRD QUARTER PRODUCT AND PIPELINE UPDATE

Bristol-Myers Squibb’s global sales in the third quarter included Daklinza and Sunvepra, which grew by $353 million, Opdivo, which grew by $304 million, Eliquis, which grew by $250 million, Orencia, which grew 9%, and Sprycel, which grew 7%.

Opdivo
• In October, the U.S. Food and Drug Administration (FDA) approved Opdivo for the treatment of previously treated patients with non-squamous (NSQ) non-small cell lung cancer (NSCLC) regardless of PD-L1 expression, which expands upon the current indication for Opdivo in patients with previously treated squamous (SQ) NSCLC. Opdivo is the only PD-1 inhibitor approved for previously treated metastatic SQ and now NSQ NSCLC patients regardless of PD-L1 expression and the only PD-1 inhibitor approved by the FDA to deliver superior overall survival compared to docetaxel in previously treated metastatic NSCLC. The accelerated approval was based on data from CheckMate -057, a Phase 3 study that evaluated the survival of patients with NSQ NSCLC who had progressed during or after one prior platinum doublet-based chemotherapy regimen.

• In October, the FDA approved Opdivo in combination with Yervoy for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. The approval marks the first and only FDA approval of a regimen of two Immuno-Oncology agents in cancer. The indication was approved under accelerated approval based on tumor response rate and durability of response data from CheckMate -069. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

• In September, the FDA granted Breakthrough Therapy Designation to Opdivo for the potential indication of advanced or metastatic renal cell carcinoma (RCC). This designation is based on results of CheckMate -025, a Phase 3 study that evaluated the survival of patients with previously treated advanced or metastatic clear-cell RCC versus everolimus. The trial was stopped early in July 2015 because an assessment conducted by the independent Data Monitoring Committee concluded that the study met its primary endpoint of overall survival.

• In September, the FDA accepted for filing and review a Supplemental Biologics License Application (sBLA) for the Opdivo +Yervoy regimen to include clinical data from CheckMate -067, a landmark Phase 3 trial in patients with previously untreated advanced melanoma. If approved, this application would expand upon the initial Opdivo+Yervoy regimen, which was approved based on tumor response rate and safety data from the Phase 2 randomized trial, CheckMate -069. The FDA granted Priority Review for this application with a target action date of January 23, 2016.

• In September, the company announced results from two Phase 3 clinical trials at the 2015 European Cancer Congress:

◦ CheckMate -025 – In this study comparing Opdivo to everolimus in patients with advanced RCC after prior anti-angiogenic treatment, Opdivo demonstrated significant overall survival (OS) benefit compared to the standard of care with a median OS benefit of 25 months compared to 19.6 months for everolimus and clinical benefit regardless of level of PD-L1 expression. The safety profile shown was consistent with previously reported Opdivo trials. The results were published in The New England Journal of Medicine (NEJM).

◦ CheckMate -057 – In this study evaluating Opdivo vs. docetaxel in previously treated patients with advanced NSQ NSCLC, Opdivo continued to demonstrate superior OS with an estimated 39% of patients alive at 18 months versus 23% for docetaxel, based on a minimum follow-up of 17.1 months. Opdivo also continued to demonstrate a reduction in the risk of death by 28%. Grade 3-4 treatment-related adverse events were reported in 10% of patients treated with Opdivo versus 54% in the docetaxel arm. The results were published in NEJM.

• In September, the company announced results from multiple clinical trials at the World Conference on Lung Cancer in Denver:

◦ CheckMate -017 and CheckMate -063 – In these two studies evaluating patients with previously treated SQ NSCLC, Opdivo demonstrated sustained survival benefit with an estimated 18 month OS rate of 27% (CheckMate -063) to 28% (CheckMate -017); survival benefit was independent of PD-L1 expression. The safety profile of Opdivo was consistent with previously-reported trials, and in CheckMate -017, was also favorable compared to docetaxel.

◦ CheckMate -012 – In this multi-arm Phase 1b study evaluating Opdivo in patients with chemotherapy-naïve advanced NSCLC, new dosing schedules of the Opdivo+Yervoy arms confirmed objective response rates (ORR) ranging from 13% to 39% depending on the administered regimen, and encouraging efficacy with highest ORR for the Opdivo 3 mg and Yervoy 1 mg (31% to 39%) regimen. Median duration of response was not reached in any of these arms with a median follow-up of 6.2 months to 16.6 months, and median progression-free survival ranged from 4.9 months to 10.6 months. Treatment-related serious adverse events reported in these cohorts for CheckMate -012 were consistent with other previously reported Opdivo+Yervoy cohorts of this trial, and the new dosing schedules resulted in less toxicity than previously-reported dosing schedules, and an acceptable tolerability profile with 10% or fewer subjects discontinuing for grade 3-4 adverse events.

• In August, the company announced that the FDA extended the action date for the sBLA for Opdivo for the treatment of patients with previously untreated advanced melanoma. The company submitted additional data from the Opdivo clinical trial program to ensure the broadest data set, irrespective of BRAF status, was available for review. This submission constitutes a major amendment that will require additional time for review and the new projected FDA action date is November 27, 2015.

Yervoy
• The company announced today that a Yervoy Phase 3 trial, Study -104 in subjects with stage IV/recurrent NSCLC, which compared the efficacy of Yervoy in combination with paclitaxel and carboplatin versus placebo, and versus paclitaxel and carboplatin alone did not meet the primary endpoint of overall survival for the Yervoy treatment arms and has been discontinued. No new safety concerns with Yervoy were identified in either study. The company will complete a full evaluation of the data and work with investigators on the future publication of the results.

Elotuzumab
• In August, the FDA accepted for priority review the Biologics License Application for elotuzumab, an investigational Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory antibody, for the treatment of multiple myeloma as combination therapy in patients who have received one or more prior therapies. Elotuzumab was previously granted Breakthrough Therapy Designation. The filing acceptance was primarily supported by data from ELOQUENT-2, a Phase 3, randomized, open-label study, which evaluated elotuzumab in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone. Additionally, the filing was supported by data from study CA004-009, a Phase 2, randomized, open-label study that evaluated elotuzumab with bortezomib and dexamethasone versus bortezomib and dexamethasone alone.

• In July, the European Medicines Agency (EMA) validated for review the Marketing Authorization Application for elotuzumab for the treatment of multiple myeloma as combination therapy in adult patients who have received one or more prior therapies. The application was granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use. Elotuzumab previously obtained orphan drug designation in the European Union (EU). The filing acceptance includes data from ELOQUENT-2 and Study CA004-009.

Sprycel
• In August, the company and its partner Otsuka America Pharmaceutical, announced that the FDA approved an update to the Sprycel product labeling to include five-year efficacy and safety data in adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) and seven-year data in the same patient population who are resistant or intolerant to prior therapy, including imatinib.

Daklinza
• In October, the FDA accepted for priority review three supplemental New Drug Applications (sNDAs) for Daklinza for use with sofosbuvir with or without ribavirin. The applications are for the treatment of patients with chronic hepatitis C (HCV) coinfected with human immunodeficiency virus (HIV-1), patients with advanced cirrhosis (including decompensated cirrhosis), and for patients with post-liver transplant recurrence of HCV. The new sNDAs accepted by the FDA for review include data from the ALLY-1 and ALLY-2 clinical trials.

• In October, the company announced that the National Institute for Health and Care Excellence (NICE) has recommended Daklinza in England and Wales for the treatment of adult patients with chronic HCV infection genotypes 1, 3 and 4.

• In September, the company announced the European Commission approved an updated label for Daklinza for the treatment of chronic HCV genotype 3, one of the most difficult-to-treat genotypes. The update allows the use of Daklinza in combination with sofosbuvir for 12 weeks in patients without cirrhosis in all 28 Member States of the EU, and marks the first time these patients with genotype 3 HCV have a once-daily, all-oral treatment regimen of this shorter duration. The approval is based on data from the Phase 3 open-label ALLY-3 clinical trial.

• In July, the FDA approved Daklinza for the treatment of patients with chronic HCV genotype 3. The approval marks the first time patients in the U.S. have a 12-week, once-daily, all-oral treatment option, and is the first approval for Daklinza in the U.S. The approval is based on data from the Phase 3 open-label ALLY-3 clinical trial.

HIV
• In October, the company announced overall antiviral activity and safety results from a three-part Phase 2a proof-of-concept study of BMS-955176, a novel investigational therapy designed to prevent the maturation of HIV-1. The overall results of the study demonstrate BMS-955176’s antiretroviral activity against the HIV-1 virus as both monotherapy and in combination with other antiretroviral medicines, and across patient subtypes (B, C), including those infected with the HIV-1 virus with changes in a critical protein ("Gag polymorphisms") that were not responsive to a previously investigated maturation inhibitor. Results were presented at the European AIDS Clinical Society’s 15th European AIDS Conference (EACS) in Barcelona.

BUSINESS DEVELOPMENT UPDATE

• In October, the company announced an exclusive worldwide license and collaboration agreement with Five Prime Therapeutics, Inc. for the development and commercialization of Five Prime’s colony stimulating factor 1 receptor (CSF1R) antibody program, including FPA008 which is in Phase 1 development for immunology and oncology indications. The agreement replaces the existing clinical collaboration agreement between both companies to evaluate the safety, tolerability and preliminary efficacy of combining Opdivo with FPA008 in six tumor types.

• In August, the company announced the establishment of the Immuno-Oncology Rare Population Malignancy (I-O RPM) program in the U.S. The I-O RPM program is a multi-institutional initiative with academic-based cancer centers focused on the clinical investigation of Immuno-Oncology therapeutics as potential treatment options for patients with high risk, poor prognostic cancers, defined as a rare population malignancy. As part of the I-O RPM program, Bristol-Myers Squibb subsequently announced two collaborations:

◦ In August, the company announced an agreement with the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (Lurie Cancer Center) and the Northwestern Medicine Developmental Therapeutics Institute (NMDTI) whereby the Lurie Cancer Center and NMDTI will conduct a range of early phase clinical studies and Bristol-Myers Squibb will fund positions within the NMDTI Developmental Therapeutics Fellowship program.

◦ In September, the company announced an agreement with Moffitt Cancer Center in which Bristol-Myers Squibb and Moffitt will conduct a range of early phase clinical studies, including clinical investigations by young investigators to strengthen their development as clinical research scientists.

• In August, the company announced an agreement that grants Bristol-Myers Squibb an exclusive right to acquire Promedior, a company pioneering the development of targeted therapeutics to treat fibrotic diseases, and gain worldwide rights to its lead asset PRM-151, a recombinant form of human pentraxin-2 protein in Phase 2 development for the treatment of idiopathic pulmonary fibrosis (IPF) and myelofibrosis (MF). PRM-151 has been granted Fast Track designation in the U.S. and Orphan Designation in the U.S. and Europe for the treatment of MF, and Orphan Designation in the U.S. and Europe for the treatment of IPF.

• In August, the company announced a research collaboration and license agreement with QIMR Berghofer Medical Research Institute to discover novel therapeutic antibodies against an undisclosed Immuno-Oncology target.

• In July, the company announced a clinical trial collaboration agreement with Kyowa Hakko Kirin Co., Ltd., to conduct a Phase 1/Phase 2 combination study of Opdivo and mogamulizumab, an anti-CCR4 antibody. The study, which will be conducted in the U.S., will focus on evaluating the safety, tolerability and anti-tumor activity of combining mogamulizumab and Opdivo as a potential treatment option for patients with advanced or metastatic solid tumors.

2015 FINANCIAL GUIDANCE

Bristol-Myers Squibb is refining its 2015 GAAP EPS guidance range from $1.02 – $1.12 to $1.02 – $1.07. The company is increasing its non-GAAP EPS guidance range from $1.70 – $1.80 to $1.85 – $1.90. Both GAAP and non-GAAP guidance assume current exchange rates and that the R&D tax credit will be extended by Congress in 2015. Key revised 2015 non-GAAP line-item guidance assumptions include:

• Worldwide revenues between $16.0 and $16.4 billion.
• An effective tax rate of approximately 20%.

The financial guidance for 2015 excludes the impact of any potential future strategic acquisitions and divestitures, and any specified items that have not yet been identified and quantified. The non-GAAP 2015 guidance also excludes other specified items as discussed under "Use of Non-GAAP Financial Information." Details reconciling adjusted non-GAAP amounts with the amounts reflecting specified items are provided in supplemental materials available on the company’s website.

PharmaMar to Present New Studies for YONDELIS® and PM1183 in Ovarian Cancer during ESGO 2015

On October 26th, 2015 PharmaMar reported that for the next few days, thousands of oncology experts in gynecologic cancers are gathering during the 19th Biennial Meeting of the European Society of Gynecological Oncology (ESGO 2015), which is taken place from October 24-27, 2015 in Nice, France. ESGO is the European leading organization that aims to advance gynecologic cancer care and is strongly committed to help women in Europe with this disease. This forum is an excellent opportunity for clinicians, researchers, patient associations and drug developers to learn about the most exciting developments in the field of gynecologic cancers, which include ovarian, cervical, uterine, vaginal and vulvar cancers.

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The initial standard treatment for ovarian cancer implies a platinum-based combination therapy. However, after recurrence, leading oncologists in the field recommend evaluating patients on a case-by-case basis to identify the best therapeutic option for each patient. In this scenario, platinum-free therapies keep gaining traction among clinicians.

"Making the most of every option in the treatment of ovarian cancer. Choosing the optimal sequency" is the title of the satellite symposium organized by PharmaMar, which gathered more than 600 oncologists, during ESGO 2015 to bring together
national and international oncologists and discuss the different aspects that need to be considered from a clinical standpoint to treat women with recurrent ovarian cancer. Among the most crucial topics to be discussed are the best approaches to
manage and overcome platinum hypersensitivity and the clinical benefit of platinum-free therapies after recurrence.

One of the participants, Nicoletta Colombo, MD, European Oncology Institute, University of Milan-Bicocca, Milan, has pointed how certain platinum sensitive tumors can also respond to other therapies and said "among the benefits of switching from a platinum-based therapy to a non-platinum treatment you can find two important aspects of the management of these patients; the probable recovery from neurotoxicity that is associated to platinum, and the potential to reduce and even prevent the hipersensitivity often found during treatment of these women with platinum".

When a patient is partially sensitive to platinum, that is the patient relapses within 6 to 12 months after treatment with platinum, among the recommended therapeutic options, oncologists and the most recent ESMO (Free ESMO Whitepaper) Clinical Practice Guidelines suggest a treatment combining YONDELIS (trabectedin) with pegylated liposomal doxorubicin followed by a platinum-based therapy. Dr. Colombo explained that with this sequential treatment, an overall survival of 6 months and a 41 percent reduction in the risk of death can be obtained. Also, the treated patient can recover from the toxicity caused by platinum-based therapiesi". The hypothesis to explain the benefit of this sequential treatment is that such approach could enhance the sensitivity of the tumor to a next platinum therapy, thus increasing the survival of the patient.

Studies highlighted at ESGO 2015
PharmaMar introduces several posters to show clinical data about the treatment combining YONDELIS with PLD in different patient profiles.

YONDELIS (trabectedin)

 Complete response to trabectedin in combination with pegylated liposomal doxorubicin (PLD) in heavily pre-treated BRCA-2 mutated platinum-sensitive intermediate epithelial ovarian cancer (EOC)
Poster: Saturday 24th, October, e-poster station
Lead author: P. Biondani, Hôpital Tenon 4 Rue de la chine 75020 Paris

 BRCA mutated ovarian cancer complete remission following second line treatment with trabectedin and lposomal Adriamycin
Poster: Saturday 24th, October, e-poster station
Lead author: Dr. Raffaella Bracci, Clinica di Oncologia Medica
Centro Regionale Genetica Oncologica, Azienda Ospedaliero-Universitaria
Ospedali Riuniti, Italy

 Extending the platinum-free interval (PFI) with trabectedin plus pegylated liposomal doxorubicin (PLD) in a patient with partially
platinum-sensitive (PPS) recurrent ovarian cancer (ROC)
Poster: Saturday 24th, October, e-poster station
Lead autor: Dr.ssa Sara Giovannoni, U.O.C.Oncologia B, Policlinico Umberto
I Roma

 Long-lasting complete response with trabectedin plus pegylated liposomal doxorubicin (PLD) in a young BRCA-mutated woman with platinum-sensitive relapsed ovarian cancer (ROC): a case report
Poster: Saturday 24th, October, e-poster station
Lead autor: Dr.ssa Sara Giovannoni, U.O.C.Oncologia B, Policlinico Umberto
I Roma

 Prolonged treatment with trabectin plus pegylated liposomal doxorubicin (PLD) combination in a heavily pretreated patient with
metastatic relapsed ovarian cancer (ROC)
Poster: Saturday 24th, October, e-poster station
Lead author: Dr Pierre Guillet, Centre Hospitalier Sainte Musse, Toulon

 Trabectedin in combination with pegylated liposomal doxorubicin to treat heavily-treated patient with relapsed ovarian cancer
Poster: Saturday 24th, October, e-poster station
Lead author: Professor Dr Saad Tahir. Broomfield Hospital. Chelmsford

 Trabectedin in monoteraphy, a therapeutic option
Poster: Saturday 24th, October, e-poster station
Lead autor: Dr S. Rego, Hospital da Arrábida, Portugal

 METASTATIC OVARIAN CANCER – CHRONIC DISEASE?
Poster: Saturday 24th, October, e-poster station
Lead autor: Dr S. Rego, Hospital da Arrábida, Portugal

 Multicenter retrospective study to analyze the effectiveness and safety of trabectedin (T) + PLD in recurrent ovarian cancer (ROC)
patients according to SMPC. GEICO-1402r study
Poster: Saturday 24th, October, e-poster station
Lead author: Dr L. Vidal, Hospital Universitari Clinic de Barcelona

 Trabectedin in advanced gynaecological carcinosarcomas – a single institution series (abstract #57)
Poster: Sunday 25th, October, poster area (endometrial cancer)
Laed author: Dr. J. Gounaris, Department of Oncology, Addenbrooke´s
Hospital, Cambridge, UK

PM1183 (lurbinectedina)
The Company also shows another poster about PM1183, a novel transcription inhibitor and DNA repair, to treat relapsed platinum-sensitive ovarian cancer

 LURBINECTEDIN (PM01183) EFFICACY IN PLATINUMRESISTANT/REFRACTORY OVARIAN CANCER (PRROC) PATIENTS CORRELATES WITH DRUG EXPOSURE USING
PHARMACOKINETIC/PHARMACODYNAMIC (PK/PD) MODELLING
(abstract #157)
Poster: Monday 26th, October, poster area
Lead author: C. Fernandez-Teruel

Loxo Oncology Announces Broad Pipeline Update at AACR-NCI-EORTC, Including New LOXO-101 Phase 1 Data

On October 26, 2015 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that it will present clinical and preclinical data from its pipeline of targeted, investigational oncology medicines at the 27th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics taking place in Boston on November 5-9, 2015 (Press release, Loxo Oncology, OCT 26, 2015, View Source [SID:1234507794]). New results from the Phase 1 study of Loxo Oncology’s tropomyosin receptor kinase (TRK) inhibitor, LOXO-101, will be reported in a late-breaking oral presentation. This presentation was selected for inclusion in the press program, and as a result, only the abstract title will appear in the October 26, 2015 online data release. The study data will remain embargoed until November 8, 2015 at 10:30 a.m. Eastern Time.

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Loxo Oncology will also present two preclinical posters containing the first publicly disclosed data for its Rearranged during Transfection (RET) and Fibroblast Growth Factor Receptor (FGFR) programs. The posters will include in vitro and in vivo data on chemistry series showing potential best-in-class selectivity and target coverage profiles for these exciting emerging targets. Like TRK, RET and FGFR are known to participate in gene fusion events, and thus, activate cancers as single-gene alterations. In addition, RET and FGFR are also known to harbor activating gene mutations which are also likely to confer drug sensitivity. Loxo Oncology plans to use genetically driven patient enrollment strategies to demonstrate proof of efficacy early in clinical development for the RET and FGFR programs.

Loxo Oncology recently announced enrollment of the first patient in its Phase 2 basket trial of LOXO-101. A basket trial is a new clinical trial design that enrolls patients based on a common, defining genetic feature of their cancer rather than based on an anatomic definition. General information about basket trial designs will be discussed in a plenary presentation on November 8, 2015 at 8:50 a.m. Eastern Time in the Veterans Memorial Auditorium by David Hyman, M.D. of Memorial Sloan Kettering Cancer Center, LOXO-101 global principal investigator.

The details of the LOXO-101 oral presentation is as follows:

Press Program Date & Time: November 8, 2015, 10:30 a.m. Eastern Time
Oral Presentation Date & Time: November 8, 2015, 3:45 p.m. to 4:25 p.m. Eastern Time
Title: Clinical Safety and Activity from a Phase 1 Study of LOXO-101, a Selective TRKA/B/C Inhibitor, in Solid Tumor Patients with NTRK Gene Fusions
Session: Spotlight on Proffered Papers Session 3
Presenter: David Hong, M.D., deputy chair, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center
Location: Veteran’s Memorial Auditorium

The details of the Loxo Oncology poster presentations are as follows:

Poster Session Data & Time: November 7, 2015, 12:30 p.m. to 3:30 p.m. Eastern Time
Title: Identification and Characterization of Highly Potent and Selective Kinase Inhibitors for the Treatment of RET-Driven Cancers
Session: Poster Session B, Therapeutic Agents: Small Molecule Kinase Inhibitors
Abstract Number: B192
Location: Exhibit Hall C-D

Poster Session Date & Time: November 8, 2015, 12:30 p.m. to 3:30 p.m. Eastern Time
Title: Identification of First-in-Class, Highly Potent FGFR Kinase Inhibitors that Spare FGFR1
Session: Poster Session C, Therapeutic Agents: Small Molecule Kinase Inhibitors
Abstract Number: C196
Location: Exhibit Hall C-D

Conference Call and Webcast Information

Loxo Oncology will host a conference call, live webcast with slides and Q&A on Monday, November 9, 2015 at 8:00 a.m. Eastern Time to discuss the LOXO-101 data and pipeline program updates. To participate in the conference call, please dial (877) 930-8065 (domestic) or (253) 336-8041 (international) and refer to conference ID 66690460. A live webcast of the presentation will be available at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the company’s website for 30 days following the call.

About LOXO-101

LOXO-101 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an ongoing Phase 1 clinical trial, LOXO-101 has demonstrated encouraging preliminary efficacy. LOXO-101 is also being evaluated in a global Phase 2 multi-center basket trial in patients with solid tumors that harbor TRK gene fusions. For additional information about both the LOXO-101 clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123.

Data to be Presented on CYC065, Cyclacel’s CDK2/9 Inhibitor, at AACR-NCI-EORTC International Conference

On October 26, 2015 Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) ("Cyclacel" or the "Company"), reported an upcoming presentation of preclinical data from a study with the Company’s second generation cyclin dependent kinase (CDK) 2/9 inhibitor, CYC065, at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), November 5-9, 2015, in Boston (Press release, Cyclacel, OCT 26, 2015, View Source [SID:1234507793]).

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The study evaluated the molecular rationale and dosing schedule of CYC065 for targeting tumors that are either dependent on sustained expression of CDK9 transcription targets, including Mcl-1 and MYC, or on activation of CDK2 by overexpression of cyclin E.

Details of the presentation are as follows:

Abstract Number: B182
Presentation Title: Molecular Basis for Clinical Development of the Novel CDK2/9 Inhibitor CYC065 in Oncology
Presentation Time: Saturday, November 7, 2015, 12:30 PM – 3:30 PM
Location: Exhibit Hall C-D
Poster Board Number: Poster Session B
Authors: Craig MacKay, Sheelagh Frame, Chiara Saladino, Elizabeth Pohler, Daniella Zheleva, David Blake. Cyclacel Ltd, Dundee, United Kingdom

The abstract can be accessed through the conference website, View Source

BIND Therapeutics’ Presentations at Upcoming AACR-NCI-EORTC Conference Reinforce Potential of Accurin Platform to Develop Best-in-Class Therapeutics

On October 26, 2015 BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine company developing targeted and programmable therapeutics called Accurins, reported that four abstracts have been accepted for presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) being held in Boston, November 5-9, 2015 (Press release, BIND Therapeutics, OCT 26, 2015, View Source [SID:1234507792]). The abstracts were published today on the AACR (Free AACR Whitepaper) website at www.AACR.org.

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"These posters highlight compelling data across multiple payloads and therapeutic pathways that reinforce what we believe is a powerful platform with the potential to create best-in-class therapeutics," said Andrew Hirsch, president and chief executive officer at BIND. "These data add to a growing body of evidence that further validate the ability of our Accurins to control the biodistribution of therapeutic payloads to target diseased cells while limiting exposure to healthy tissues and minimizing on-target but off-tissue toxicities. We are committed to creating innovative medicines, both through internal discovery and collaborations with leading biopharmaceutical companies, that fully leverage the benefits of our proprietary nanomedicine platform."

The posters will include preclinical and clinical pharmacokinetic data from BIND’s clinical stage Accurin compound, BIND-014, data from BIND’s preclinical stage Accurin, BIND-510, and new data from a previously unannounced feasibility study with Merck, demonstrating the potential value of an Accurin formulation of Merck’s proprietary AKT inhibitor, MK-2206.

Poster presentations at AACR (Free AACR Whitepaper) include the following:

BIND-014

1. Poster title: Cardiovascular safety profile of BIND-014 (docetaxel nanoparticles for injectable suspension) evaluated in phase 1 and 2 studies (Abstract/poster board #A161)

Date/time: November 6, 2015; 12:15 – 3:15 pm ET
Poster session category: Therapeutic Agents: Other
Location: Poster Session A; Exhibit hall C-D
2. Poster title: Evaluation of total and encapsulated drug pharmacokinetics for BIND-014 (docetaxel nanoparticles for injectable suspension) in a phase 1 study (Abstract/poster board #B144)

Date/time: November 7, 2015; 12:30 – 3:30 pm ET
Poster session category: Pharmacokinetics and Pharmacodynamics
Location: Poster Session B; Exhibit hall C-D
BIND-510

1. Poster Title: BIND-510 improves the pharmacokinetics, tolerability, tumor accumulation and tumor growth inhibition in preclinical models of cancer compared to vincristine sulfate (Abstract/poster board #C184)

Date/time: November 8, 2015; 12:30 – 3:15 pm ET
Poster session category: Therapeutic Agents: Other
Location: Poster Session C; Exhibit Hall C-D
MK-2206 Accurin

1. Poster Title: Accurins improve the pharmacokinetics, pharmacodynamics, tolerability and anti-tumor activity of the AKT inhibitor MK-2206 (Abstract/poster board #C197)

Collaborator: Merck
Date/time: November 8, 2015; 12:30 – 3:30 pm ET
Poster session category: Therapeutic Agents: Small Molecule Kinase Inhibitors
Location: Poster Session C