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Kura Oncology Announces Proof of Concept in Angioimmunoblastic T-Cell Lymphoma, Validation of CXCL12 as a Therapeutic Target of Tipifarnib in Peripheral T-Cell Lymphoma

Sunday December 2 nd 2018

– Two CRs, four PRs (46% ORR) observed in advanced AITL patients in Phase 2 trial of tipifarnib in PTCL –

– AITL and other PTCL patients with high CXCL12 expression experienced 50% ORR and 90% clinical benefit with tipifarnib after median of three prior therapies –

– High expression of CXCL12 observed in approximately 40% of PTCL and was associated with poor prognosis for standard-of-care therapy –

– Management to host webcast today at 11:30 p.m. ET / 8:30 p.m. PT –

SAN DIEGO, Dec. 02, 2018 (GLOBE NEWSWIRE) —  Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported preliminary data in angioimmunoblastic T-cell lymphoma (AITL) and CXCL12+ peripheral T-cell lymphoma (PTCL), the two expansion cohorts in its Phase 2 clinical trial of its lead drug candidate tipifarnib in patients with relapsed or refractory PTCL.

The data, presented today at the American Society of Hematology (ASH) Annual Meeting in San Diego, showed encouraging activity with tipifarnib in late-stage PTCL patients, including a significant association between CXCL12 expression and clinical benefit, and proof of concept in AITL, an aggressive form of T-cell lymphoma often characterized by high levels of CXCL12 expression. A copy of the poster is available on the Company’s website at www.kuraoncology.com.

“The mechanism of action of farnesyl transferase inhibitors has remained elusive for several decades,� said Antonio Gualberto, M.D., Ph.D., Head of Development and Chief Medical Officer of Kura Oncology. “Our initial data in HRAS mutant head and neck cancer provided strong evidence of activity in tumors driven by this oncogene. However, many other tumors such as T- and B-cell lymphomas, myeloid leukemias, pancreatic or breast cancers, in which anecdotal evidence of tipifarnib activity has been reported, do not usually carry HRAS mutations. We believe the preliminary results reported at ASH validate our observation that the CXCL12 pathway is a therapeutic target of tipifarnib and provide a potential path to expand the development of tipifarnib well beyond HRAS mutant solid tumors by using CXCL12-related biomarkers to enrich for patients most likely to benefit from treatment. We will continue our efforts to identify these patient subsets and to bring this important drug candidate to patients in need.�

As of November 21, 2018, a total of 39 patients were enrolled in the ongoing Phase 2 trial, including 19 patients with AITL (16 patients in the AITL extension cohort and 3 patients in the previous portion of the study). Six of the 16 AITL patients were not evaluable as of the data cutoff date, including two who were pending initial efficacy assessments. Of the 13 evaluable AITL patients, two achieved a complete response (CR) and four achieved a partial response (PR), for an objective response rate (ORR) of 46% (six of 13). According to the study protocol, the AITL cohort is considered positive when four or more responses are observed.

The study also identified a particularly responsive subset within AITL and non-AITL patients. Specifically, patients with a high ratio of expression of CXCL12 to its receptor CXCR4 experienced a 50% ORR (five of 10) and a 90% clinical benefit rate (nine of 10 with either complete response, partial response or stable disease) with tipifarnib. Patients in this Phase 2 trial had a median of three prior lines of therapy (range 1-7). The high CXCL12/CXCR4 expression ratio had 90% sensitivity and 93% specificity to identify PTCL patients likely to benefit from tipifarnib.

In addition to the Phase 2 clinical data, the results from two ancillary, non-clinical studies were also reported at ASH. In the first, the expression of CXCL12 and CXCR4 was investigated using tumor bank samples of PTCL patients treated with standard-of-care agents. Worse prognosis was observed in PTCL patients with high CXCL12/CXCR4 expression ratio, indicating that CXCL12 is a negative prognostic factor for standard PTCL therapy. In the second study, the effect of the incubation of stroma cells with tipifarnib on CXCL12 secretion was investigated in a mouse model of bone marrow culture. Tipifarnib reduced secretion of the CXCL12 chemokine from the stromal cells, providing a potential mechanism of action for the observed clinical activity.

“To our knowledge, these results position tipifarnib as the first CXCL12 inhibitor with reported proof-of-concept data, marking a significant advancement in our development strategy,� said Troy Wilson, Ph.D., President and CEO of Kura Oncology. “Our data suggest that as many as 40% of PTCL patients express high CXCL12. In addition, the discovery of CXCL12-related biomarkers offers the potential to increase the opportunity for tipifarnib into other hematological and solid tumor indications. We intend to explore those indications while continuing to gather additional data from our ongoing Phase 2 study and expect to provide an update at a medical meeting next year.�

The Phase 2 study was designed to investigate the anti-tumor activity of tipifarnib in patients with relapsed or refractory PTCL. After preliminary data suggested that CXCL12 expression was associated with tipifarnib’s clinical activity, two expansion cohorts were added to enroll patients with tumors expected to overexpress CXCL12: AITL tumors, and those non-AITL tumors that lack a single nucleotide variation in the 3’-untranslated region (3′-UTR) of the CXCL12 gene (CXCL12+ PTCL). CXCL12 is a stroma-derived chemokine that promotes the progression of lymphoma and other hematological and solid tumors carrying the CXCR4 receptor, and our previous results had suggested an association between CXCL12 expression and the most common form of the 3’-UTR CXCL12 variant. In the expansion cohorts, both the presence or absence of this variant and the expression levels of CXCL12 and CXCR4 were assessed.

In the expansion cohorts in the Phase 2 trial tipifarnib was dosed at 300 mg twice daily on days 1-21 of a 28-day cycle. The reported data indicated that tipifarnib was generally well-tolerated, with adverse events consistent with its known safety profile. The most common treatment-related adverse events (grade ≥ 3) were hematology-related, including neutropenia, thrombocytopenia, leukopenia, febrile neutropenia and anemia.

Last week, the U.S. Patent and Trademark Office (USPTO) issued a new patent for tipifarnib as a method of treating patients with AITL. In May 2018, the USPTO issued a patent for tipifarnib as a method of treating patients with certain CXCL12-expressing cancers, including PTCL. Both patents expand protection for tipifarnib, providing exclusivity in the U.S. to 2037.

Webcast Information

Kura’s management will host a webcast at 11:30 p.m. ET / 8:30 p.m. PT today, December 2, 2018, following the conclusion of the poster presentation at the ASH 2018 Annual Meeting. The live audio webcast and slides of the presentation will be available from the Investors and Media section of the company website at www.kuraoncology.com, and will be archived there for 30 days.

About Tipifarnib

Kura Oncology’s lead drug candidate, tipifarnib, is a potent and highly selective inhibitor of farnesylation, a key cell signaling process implicated in cancer initiation and development. Tipifarnib was previously studied in more than 5,000 cancer patients and showed compelling and durable anti-cancer activity in certain patient subsets, however no molecular mechanism of action had previously been determined that could explain its activity across a range of diverse clinical indications, including squamous tumors that carry mutant HRAS, as well as in lymphoid, myeloid and solid tumors that do not carry HRAS mutations. Leveraging advances in next-generation sequencing as well as emerging information about cancer genetics and tumor biology, Kura is seeking to identify those patients most likely to benefit from tipifarnib. In November 2018, Kura initiated its first global, registration-directed trial of tipifarnib in patients with recurrent or metastatic HRAS mutant HNSCC.

About Kura Oncology

Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of small molecule drug candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura’s lead drug candidate is tipifarnib, a farnesyl transferase inhibitor, for which the Company has initiated a registration-directed trial of tipifarnib in recurrent or metastatic patients with HRAS mutant HNSCC. In addition, tipifarnib is being evaluated in multiple other Phase 2 clinical trials in solid tumor and hematologic indications. Kura’s pipeline also includes KO-947, an ERK inhibitor, currently in a Phase 1 dose-escalation trial, and KO-539, a menin-MLL inhibitor, currently in IND-enabling studies. For additional information about Kura Oncology, please visit the Company’s website at www.kuraoncology.com.

Forward-Looking Statements

This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of tipifarnib and the Company’s other product candidates, the conduct, results and timing of Kura Oncology’s clinical trials, including the Phase 2 clinical trial of tipifarnib in patients with PTCL, plans regarding future clinical trials and development and commercial activities, the regulatory approval path for tipifarnib and expectations regarding intellectual property and biomarkers related to Kura Oncology’s product candidates. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura Oncology may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings and applications, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,� “will,� “would,� “could,� “should,� “believes,� “estimates,� “projects,� “promise,� “potential,� “expects,� “plans,� “anticipated,� “intends,� “continues,� “designed,� “goal,� or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to the Company’s periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura Oncology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

Company:
Pete De Spain
Vice President, Investor Relations
Corporate Communications
(858) 500-8803
pete@kuraoncology.com

Investors:
Robert H. Uhl
Managing Director
Westwicke Partners, LLC
(858) 356-5932
robert.uhl@westwicke.com

Media:
Jason Spark
Managing Director
Canale Communications
(619) 849-6005
jason@canalecomm.com

Blueprint Medicines Announces Updated Results from Ongoing EXPLORER Clinical Trial of Avapritinib Demonstrating Broad Clinical Activity and Significant Symptom Reductions in Patients with Systemic…

CAMBRIDGE, Mass., Dec. 2, 2018 /PRNewswire/ — Blueprint Medicines Corporation (NASDAQ: BPMC), a leader in discovering and developing targeted kinase medicines for patients with genomically defined diseases, today announced updated results for the Phase 1 EXPLORER clinical trial of avapritinib, a potent and highly selective inhibitor of D816V mutant KIT, the common disease driver in nearly all patients with systemic mastocytosis (SM). The updated EXPLORER trial data in patients with advanced SM showed durable clinical responses that deepened over time, regardless of disease subtype, prior therapy or starting dose. Avapritinib was generally well-tolerated, and most adverse events (AEs) reported by investigators were Grade 1 or 2. These results will be presented today in an oral presentation at the 60th American Society of Hematology Annual Meeting and Exposition in San Diego, California.

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As of the data cutoff date of September 30, 2018, the updated results from the ongoing EXPLORER trial showed an overall response rate (ORR) of 83 percent. Twenty-four percent of patients had a complete response with a full or partial recovery of peripheral blood counts (CR/CRh). Responses deepened over time, with a median time to initial response of two months and a median time to CR/CRh of nine months. The median duration of response (DoR) was not reached, and the 12-month DoR rate was 76 percent.

In addition, statistically significant improvements in patient-reported disease symptoms were observed. A 41 percent mean reduction (p=0.043) in patient-reported disease symptoms was demonstrated on the Advanced SM Symptom Assessment Form (AdvSM-SAF), the first patient-reported outcomes tool designed specifically to assess advanced SM.

“Systemic mastocytosis is a complex rare disorder that causes debilitating symptoms across all forms of the disease and reduced survival in advanced patients,” said Jason Gotlib, M.D., professor of Medicine, Hematology, at the Stanford University Medical Center and an investigator on the EXPLORER trial. “The updated EXPLORER study results show that selectively targeting D816V mutant KIT with avapritinib led to profound and durable clinical activity in patients with advanced systemic mastocytosis, including significant improvements in patient-reported disease symptoms and quality of life. Combined with encouraging preliminary data from an initial cohort of indolent systemic mastocytosis patients from the EXPLORER study, these results highlight the potential of avapritinib to improve objective and subjective measures of disease burden across the spectrum of mastocytosis subtypes.”

“The data further validate Blueprint Medicines’ precision therapy approach, where we target genetic drivers of disease with potent and highly selective inhibitors,” said Andy Boral, M.D., Ph.D., Chief Medical Officer of Blueprint Medicines. “With robust clinical data from the EXPLORER trial, favorable FDA feedback on potential registration pathways and Breakthrough Therapy Designation for advanced systemic mastocytosis, we believe avapritinib has a strong foundation for expedited development across all forms of the disease. In particular, the new data showing a significant decrease in symptom burden in patients enrolled in the EXPLORER trial increase our confidence in avapritinib’s potential in indolent systemic mastocytosis.”

Data Highlights from the Ongoing Phase 1 EXPLORER Clinical Trial

As of the data cutoff date of September 30, 2018, 67 patients were treated with avapritinib in the dose escalation and expansion portions of the Phase 1 EXPLORER clinical trial, including 23 patients with aggressive SM (ASM), 30 patients with advanced SM with an associated hematological neoplasm (SM-AHN), seven patients with mast cell leukemia (MCL) and seven patients with indolent or smoldering SM. Forty patients (60 percent) had a prior treatment, including 14 patients (23 percent) who had previously received Rydapt® (midostaurin).

Safety Data

As of the data cutoff date, avapritinib was generally well-tolerated. Most AEs were reported by investigators as Grade 1 or 2. Across all enrolled patients, 52 patients (78 percent) remained on treatment as of the data cutoff date. Three patients (4 percent) discontinued treatment with avapritinib due to treatment-related AEs.

Across all grades, the most common non-hematological treatment-emergent AEs (regardless of relationship to avapritinib) reported by investigators (15 percent) were periorbital edema, fatigue, nausea, diarrhea, peripheral edema, vomiting, cognitive effects, hair color changes, arthralgia, dizziness and abdominal pain. The most common hematological treatment-emergent AEs reported by investigators (10 percent) were anemia, thrombocytopenia and neutropenia. Grade 3 and 4 treatment-related AEs occurred in 44 patients (66 percent), and these events were most commonly hematological AEs, typically in patients with low blood counts (cytopenias) at study entry.

Clinical Activity Data

IWG-MRT-ECNM Assessments and Objective Measures of Mast Cell Burden                               

As of the data cutoff date, 29 patients were evaluable for response by the modified IWG-MRT-ECNM criteria, a rigorous method for assessing clinical response in advanced SM patients with regulatory precedent in the U.S. and Europe. Responses were centrally reviewed by a committee of SM experts.

Avapritinib demonstrated durable clinical responses across all doses studied and in each subtype of advanced SM – ASM, SM-AHN and MCL. The duration of treatment was up to 31 months as of the data cutoff date, with a median follow-up time of 14 months in evaluable patients.

Across all evaluable patients at all doses, the ORR was 83 percent. Seven patients had a CR/CRh (24 percent, two pending confirmation), 14 patients had a partial response (48 percent, three pending confirmation) and three patients had clinical improvement (10 percent, one pending confirmation). Three of the pending responses were previously confirmed responses (two partial responses, one clinical improvement) that are transitioning to a deeper response. No patients had documented disease progression per modified IWG-MRT-ECNM criteria.

In addition, strong clinical activity was demonstrated in evaluable patients treated with a starting dose of less than or equal to 200 mg once daily (QD), the dose under evaluation in the ongoing registration-enabling Phase 2 PATHFINDER clinical trial in patients with advanced SM. These 10 patients had an ORR of 90 percent and a CR/CRh rate of 50 percent (one complete response pending confirmation).

All patients evaluable on objective measures of mast cell burden showed reductions from baseline. These results were shown regardless of disease subtype, prior therapy (including midostaurin or the investigational agent DCC-2618), or co-mutation status. These measures consisted of declines in bone marrow mast cells, serum tryptase, spleen volume and KIT D816V mutant allele burden.

At baseline, 22 SM patients received steroids for mastocytosis symptoms. As of the data cutoff date, 18 patients (80 percent) decreased their steroid dose, including nine patients (41 percent) who were able to entirely discontinue their steroids.

Patient-Reported Outcomes

As of the data cutoff date, 32 patients in the dose expansion portion of the Phase 1 EXPLORER trial were evaluated using the AdvSM-SAF, the first patient-reported outcomes tool developed specifically for advanced SM patients. It was designed to evaluate symptoms across the gastrointestinal domain (abdominal pain, diarrhea, nausea and vomiting) and skin domain (spots, itching and flushing), as well as fatigue. Patients reported their symptoms daily using an electronic diary.

In advanced SM patients, benefits were shown across each individual symptom studied. There was a 41 percent improvement from baseline in the AdvSM-SAF Total Symptom Score (p=0.043). The most symptomatic patients (n=16, top 50th percentile) had the largest mean improvement in the AdvSM-SAF Total Symptom Score (46 percent, p=0.038).

In addition, an improvement in patient-reported quality of life was observed. As of the data cutoff date, 30 patients were evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30), a validated and commonly used patient-reported outcomes tool in oncology clinical trials. Results showed a statistically significant improvement in quality of life score, approaching levels observed in healthy aged-matched controls, with a pronounced improvement observed in the most symptomatic patients.

Proof-of-Concept in Indolent and Smoldering SM

All evaluable patients with indolent and smoldering SM showed profound reductions in bone marrow mast cells, serum tryptase, spleen volume and KIT D816V mutant allele burden. The data also showed avapritinib led to improvements in patient-reported symptoms. These encouraging data support Blueprint Medicines’ planned Phase 2 PIONEER clinical trial in patients with indolent and smoldering SM.

About the Clinical Development Program for Avapritinib in SM

Blueprint Medicines is pursuing a broad clinical development program for avapritinib across advanced, indolent and smoldering forms of SM. Avapritinib is currently being evaluated in two ongoing clinical trials for advanced SM: the Phase 1 EXPLORER clinical trial and the registration-enabling Phase 2 PATHFINDER clinical trial.

The Phase 1 EXPLORER clinical trial of avapritinib was designed to identify the recommended Phase 2 dose for further study and demonstrate proof-of-concept in advanced SM. The dose escalation portion is complete, and the expansion portion of the trial is enrolling patients with ASM, SM-AHN and MCL at multiple sites in the United States and United Kingdom. Trial objectives include assessing safety and tolerability, response per modified IWG-MRT-ECNM criteria and patient-reported outcomes.

The Phase 2 PATHFINDER clinical trial is an open-label, single-arm, registration-enabling clinical trial in patients with advanced SM. Patient dosing is now ongoing in the clinical trial, which is designed to enroll up to 60 advanced SM patients at sites in the United States, Canada and Europe. The primary efficacy endpoints are ORR and DoR based on modified IWG-MRT-ECNM criteria.

Blueprint Medicines expects to initiate the Phase 2 PIONEER clinical trial, a randomized, placebo-controlled, registration-enabling trial in patients with indolent and smoldering SM, by the end of 2018. The trial’s primary endpoint will be symptom reductions for avapritinib versus placebo based on the Indolent and Smoldering SM Assessment Form Total Symptom Score. All patients who complete the dose-finding (part 1) and placebo-controlled efficacy (part 2) portions of this trial will have an opportunity to receive avapritinib in an open-label extension (part 3).

SM patients and clinicians interested in ongoing or planned clinical trials can contact the Blueprint Medicines study director at SM@blueprintmedicines.com or 1-617-714-6707. Additional details are available at www.pathfindertrial.com, www.pioneertrial.com or www.clinicaltrials.gov.

About SM

SM results from the abnormal proliferation and survival of mast cells, which mediate allergic responses. There are several forms of the disease, including indolent SM, smoldering SM and three advanced subtypes – ASM, SM-AHN and MCL. The KIT D816V mutation drives approximately 90 to 95 percent of all SM cases, causing debilitating and difficult-to-manage symptoms such as pruritus, flushing, headaches, bone pain, nausea, vomiting, diarrhea, anaphylaxis, abdominal pain and fatigue. While these effects occur across SM patients, symptom burden and poor quality of life are the predominant disease manifestations of indolent and smoldering SM. Advanced SM patients experience organ damage and a median overall survival of about 3.5 years in ASM, two years in SM-AHN and less than six months in MCL.

Currently, there are no approved therapies that selectively inhibit KIT D816V in advanced SM, and no approved therapies for indolent and smoldering SM. New treatments are needed that are more effective and better tolerated than existing advanced SM therapy, as well as for indolent and smoldering SM patients whose symptoms are often not well controlled with symptom-directed therapies.

About Avapritinib

Avapritinib is a potent and selective oral inhibitor of KIT and PDGFRA mutant kinases. It is a type 1 inhibitor designed to target the active kinase conformation; all oncogenic kinases signal via this conformation. Avapritinib has demonstrated broad inhibition of KIT and PDGFRA mutations associated with gastrointestinal stromal tumors (GIST), and the most potent activity against activation loop mutations, which currently approved therapies for GIST do not inhibit. In contrast with existing multi-kinase inhibitors, avapritinib has shown marked selectivity for KIT and PDGFRA over other kinases. In addition, avapritinib is uniquely designed to selectively bind and inhibit D816V mutant KIT, the primary driver of disease in approximately 90 to 95 percent of all SM patients. Preclinical studies have shown avapritinib potently inhibited KIT D816V at sub-nanomolar potencies with minimal off-target activity.

Blueprint Medicines is initially developing avapritinib, an investigational medicine, for the treatment of advanced GIST, advanced SM, and indolent and smoldering SM. The U.S. Food and Drug Administration has granted avapritinib two Breakthrough Therapy Designations, one for the treatment of PDGFRα D842V-driven GIST and one for advanced SM.

Blueprint Medicines has an exclusive collaboration and license agreement with CStone Pharmaceuticals for the development and commercialization of avapritinib and certain other drug candidates in Mainland China, Hong Kong, Macau and Taiwan. Blueprint Medicines retains development and commercial rights for avapritinib in the rest of the world.

About Blueprint Medicines

Blueprint Medicines is developing a new generation of targeted and potent kinase medicines to improve the lives of patients with genomically defined diseases. Its approach is rooted in a deep understanding of the genetic blueprint of cancer and other diseases driven by the abnormal activation of kinases. Blueprint Medicines is advancing multiple programs in clinical development for subsets of patients with gastrointestinal stromal tumors, hepatocellular carcinoma, systemic mastocytosis, non-small cell lung cancer, medullary thyroid cancer and other advanced solid tumors, as well as multiple programs in research and preclinical development. For more information, please visit www.blueprintmedicines.com.

Cautionary Notes Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding plans and timelines for the clinical development of avapritinib, including plans and timelines for the ongoing Phase 1 EXPLORER clinical trial, ongoing Phase 2 PATHFINDER clinical trial and planned Phase 2 PIONEER clinical trial; expectations regarding the potential for the Phase 1 EXPLORER clinical trial, Phase 2 PATHFINDER clinical trial or Phase 2 PIONEER clinical trial to be registration-enabling for avapritinib in SM; Blueprint Medicines’ ability to implement its clinical development plans for avapritinib in SM; expectations regarding the potential benefits of avapritinib in treating patients with SM, including advanced, indolent and smoldering SM; expectations regarding the development of avapritinib as a treatment for patients with SM, including advanced, indolent and smoldering SM; expectations regarding the potential for expedited development of avapritinib; and Blueprint Medicines’ strategy, business plans and focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to the delay of any current or planned clinical trials or the development of Blueprint Medicines’ drug candidates, including avapritinib, BLU-554, BLU-667 and BLU-782; Blueprint Medicines’ advancement of multiple early-stage efforts; Blueprint Medicines’ ability to successfully demonstrate the safety and efficacy of its drug candidates; the preclinical and clinical results for Blueprint Medicines’ drug candidates, which may not support further development of such drug candidates; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials; Blueprint Medicines’ ability to develop and commercialize companion diagnostic tests for its current and future drug candidates, including companion diagnostic tests for avapritinib for PDGFRα D842V-driven GIST, BLU-554 for FGFR4-driven hepatocellular carcinoma and BLU-667 for RET-driven non-small cell lung cancer; the success of Blueprint Medicines’ current and future collaborations, including its cancer immunotherapy collaboration with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. and its collaboration with CStone Pharmaceuticals. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Blueprint Medicines’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, as filed with the Securities and Exchange Commission (SEC) on October 30, 2018, and any other filings that Blueprint Medicines has made or may make with the SEC in the future. Any forward-looking statements contained in this press release represent Blueprint Medicines’ views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Blueprint Medicines explicitly disclaims any obligation to update any forward-looking statements.

Trademarks

Rydapt® is a registered trademark of Novartis AG. All other trademarks and trade names in this press release are the property of Blueprint Medicines Corporation or used with permission.

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SOURCE Blueprint Medicines

Dealer eProcess Now Enrolled in the General Motors Digital Advertising Program

LISLE, Ill., Dec. 2, 2018 /PRNewswire-PRWeb/ – We are proud to announce that Dealer eProcess has completed all requirements to participate in the Digital Advertising Program under the GM Dealer Digital Solution.

This allows Dealers the opportunity to leverage in-Market Retail (iMR) funds to reimburse themselves for the cost of their Digital Advertising services. Please refer to the iMR Dealer Program guidelines located at https://www.gmlam.com for further information.

Providers who are participating in the Digital Advertising Program provide advertising solutions that include:

  • Improved efficiency, coordinated spend and strategy across all tiers of advertising
  • Participation commitment for:
  • Streamlined packages each offering full service solutions for sales and fixed ops
  • A single, managed monthly fee with cap
  • Performance accountability
  • Day 1 Go-to-Market readiness
  • Strategic and tactical advertising coordination with brands and LMAs
  • Dashboard for visibility into performance

If you have any questions about the benefits of Digital Advertising Program, please do not hesitate to reach out to our Support Team at 866-249-6248 or via email at gmdigad@dealereprocess.com for further details.

 

SOURCE Dealer eProcess

Facebook is betting that shows with cult followings like ‘Buffy the Vampire Slayer’ can juice up Facebook Watch and bring in millennial viewers

buffyWB

  • Facebook has inked a deal with 20th Century Fox to distribute all seasons of “Buffy the Vampire Slayer,” “Angel,” and “Firefly” on Facebook Watch.
  • It’s one of the platform’s bigger licensing deals and is a departure from Watch’s goal of commissioning platform-exclusive programs.
  • Facebook’s strategy with Watch continues to change and is looking more like YouTube’s model than other streaming services.

Facebook is hoping that a crop of popular ’90s shows can beef up Facebook Watch and the company’s big bet on TV-like video programming.

On Friday, Facebook dropped all 268 episodes of “Buffy the Vampire Slayer,” “Angel,” and “Firefly” on Watch as part of a licensing deal with 20th Century Fox.

Each show has its own Page, and the programming is not exclusive to Watch. The three shows aired on TV between 1996 and 2004, and are also available on Hulu. The drop of the shows comes at the same time that Facebook is widely rolling out its Watch Party feature, which allows people to watch videos together and comment on them in real time.

Read more:It is critically important for Facebook to get this right’: Publishers say Facebook’s rollout of Watch ads is methodical but picking up speed

The three shows, created by Joss Whedon, “have incredibly dedicated fanbases that have persisted and even grown online,” Matthew Henick, Facebook’s head of content planning and strategy for media partnerships,told Variety. “What we’ve been focused on Watch [Sic] is building a people-centric video platform, creating a social viewing experience where you can connect with other people who love the shows, and even the creatives who worked on them.”

Facebook’s strategy continues to morph with Watch

Watch is a little over a year old but execs continue to switch gears with its big ambitions for video.

Distributing the old 20th Century Fox shows on Watch is another example of how Watch is looking like YouTube and taking pages out of the Google-owned platform’s playbook.

After initially pitching Watch as a platform for exclusive shows, Facebook has opened up Watch to include both shows and regular video clips and has also rolled out a self-serve tool that lets creators set up their own Watch shows and get money from ad breaks that run during their clips.

The 20th Century Fox deal also seems to support a recent report from CNBC that Facebook is increasingly focusing on programs geared for older audiences as opposed to the lucrative market of teens and millennials.

This isn’t the first time that Facebook has experimented with nostalgia programming. Viacom’s MTV Studios and Bunim/Murray Productions are working with Watch to co-produce three seasons of The Real World, another franchise that millennials grew up with. Unlike Facebook’s deal with 20th Century Fox, though, Viacom is creating new episodes of The Real World with voting features designed specifically for Watch that will allow users to choose who appears on the show before it airs. 

Twitter’s mysterious drop is ‘completely technical,’ trader says (TWTR)

Thursday November 29 th 2018

Jack DorseyAP Images

  • Twitter fell more than 8% early Thursday amid a lack of any news or Wall Street downgrades.
  • The selling was “completely technical” according to a veteran floor trader at the New York Stock Exchange.
  • Watch Twitter trade live.

Twitter shares fell as much as 8.53% early Thursday amid a lack of news and headlines, to their lowest level in more than a month, and one veteran New York Stock Exchange floor trader trader says to find the reason all you need to do is look at the charts.

“It’s completely technical,” said Kenny Polcari, managing director at O’Neil Securities.

“Over the last couple days Twitter failed at $32.16/32.20 where it hit a downward trend resistance line. It had to fill the gap which is exactly what it has done.” Polcari says shares could trade as low as $29.77 — they fell to $29.87 earlier on Thursday. 

Twitter shares have been under pressure since July amid the fallout from Russian interference in the 2016 presidential election. The stock has shed more than 28% since its second-quarter earnings report out in July warned of a decline in the number of new users.

At the time, the company pinned the decline on new European privacy rules, its decision not to move to paid SMS carrier relationships, and on its efforts to clean up the platform. 

But before Twitter’s warning, its stock had been one of the top performers on the Nasdaq, trading up 80%, after posting a profit in two consecutive quarters.

Twitter has pared its losses over the course of Thursday’s session, and now trades down 4.61% at $31.21 a share. It was up more than 29% this year. 

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