On September 28, 2016 GSK and Oncodesign (Paris:ALONC) reported that they have signed an agreement for Oncodesign to acquire the François Hyafil Research Centre located in Villebon-sur-Yvette (Essonne) from GSK, part of the Paris Saclay innovation cluster, including transfer of the team of highly qualified drug discovery staff located at the site (anticipated to be 57 employees) (Press release, Oncodesign, SEP 28, 2016, View Source [SID:SID1234515483]). Under the terms of the agreement, GSK will provide €35 million support over a four year period, and Oncodesign will use this funding to integrate the site and its capabilities into its business and ensure the continued employment of the transferring staff over this period. The agreement is expected to become unconditional and effective by or on 1st December 2016. Schedule your 30 min Free 1stOncology Demo! Established in 1987 and located in a new state-of-the-art research facility opened in 2010, the François Hyafil Research Centre was most recently a Flexible Discovery Unit that provided scientific expertise and resources to support drug discovery and incubate new science within GSK. The capabilities within the facility include delivery of medicinal chemistry, biology, in vivo pharmacology and drug metabolism/pharmacokinetics capabilities with experience in many therapeutic areas.
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"We welcome the François Hyafil Research Centre staff, who are recognized industry-wide. This strategic acquisition of GSK’s research center is a key next step for Oncodesign and without any dilutive impact for our shareholders. It will allow Oncodesign to boost its Drug Discovery programs and Experimentation businesses and to position itself as a leading player in the business of Full Drug Discovery Services, a new market for Oncodesign" said Philippe Genne, CEO and founder of Oncodesign. "This acquisition further accelerates the development of our strategic partnerships, with IPSEN, BMS and UCB. In addition, it will speed up our Nanocyclix based drug discovery internal programs through increased capabilities and productivity in both oncology and non-oncology areas. Oncodesign will thus strengthen its scientific expertise in one of the most modern research centres in France in addition to acquiring new and complementary capabilities and expansion in non-oncology space. Together with our presence at the Open Campus IPSEN site, the FHRC integration will further establish our presence in the Paris Saclay science cluster and allow us to benefit from the innovation in this region in complement to that of our Dijon site."
In 2015, GSK streamlined its R&D organizational operations to consolidate around two major R&D centres: Upper Providence (USA) and Stevenage (UK), with a reduction in the number of satellite R&D sites that support activities at these two central hubs. As a result of these changes, in September 2015 GSK announced that it would be searching for a robust organization to acquire the François Hyafil Research Centre and continue activities in this location.
"GSK has been fully committed to searching for a high quality research organisation that could acquire the François Hyafil Research Centre, and I am delighted that, through this agreement, the skilled scientists based at the site will have a secure future and can remain part of the science research community in France" commented Jean-Francois Brochard, General Manager GSK France.
Dave Allen, SVP, GSK Pharmaceuticals R&D said. "Oncodesign is a fast-growing French company with innovative technologies and novel programs, which has a robust plan for the long term success of the François Hyafil Research Center. Acquisition of the site will allow the scientist’s drug discovery capabilities to continue to be used to advance human medicines. I am pleased that we have secured this agreement with Oncodesign and am confident the team can become an important and integrated part of their company."
Evotec enters into strategic multi-target alliance with C4X Discovery
On September 28, 2016: Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) reported a multi-target collaboration with C4X Discovery Holdings plc ("C4XD") (Press release, Evotec, SEP 28, 2016, View Source [SID:SID1234515478]). The new agreement builds on the successful research collaboration with C4XD announced in January 2015 and will see C4XD and Evotec work together to develop new small molecule drugs across a range of targets, therapeutic areas and stages of development, with the initial programmes targeted towards the treatment of cancer and autoimmune diseases. Schedule your 30 min Free 1stOncology Demo! The new long-term strategic alliance will be a rolling multi-target programme with a minimum of three parallel drug discovery projects active at any point in time. As part of the agreement, Evotec will apply its extensive assay and screening technologies, laboratory scientists and medicinal chemistry know-how to selected C4XD programmes, in return for funding to partially cover operational costs, milestones dependent on developmental success and a share of potential future royalties.
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Each programme will run until the point of Potential Development Candidate ("PDC") nomination, after which C4XD, which retains all IP, will have the right to out-license successful projects to the pharma industry or proceed itself to clinical studies on a case-by-case basis, as per its existing model.
Financial terms have not been disclosed.
Dr Mario Polywka, Chief Operating Officer of Evotec, commented: "We are very pleased to continue and expand the broad-based drug discovery collaboration with C4XD. This integrated drug discovery deal showcases our broad target class expertise coupled with our industry leading platform, which perfectly complements C4XD’s technology and expertise. We look forward to a fruitful collaboration with our scientific colleagues and friends at C4XD."
Clive Dix, CEO of C4X Discovery, added: "We are delighted to expand on our successful relationship with Evotec through this alliance that is designed to support us in achieving our vision of becoming the world’s most productive drug discovery engine. This new long-term agreement is a step change from our previous collaboration as now the risk of small molecule development will be shared as we progress candidates towards the clinic. We have already identified the first three small molecule targets and the combination of our unique technologies and the infrastructure and expertise that Evotec has in place will enable us to accelerate the development of novel small molecule drug candidates."
Pfizer Completes Acquisition of Medivation
On September 28, 2016 Pfizer Inc. (NYSE: PFE) reported the successful completion of its acquisition of Medivation, Inc.(NASDAQ: MDVN) (Press release, Pfizer, SEP 28, 2016, View Source [SID:SID1234515476]). As of the tender offer expiration, 115,574,041 shares of Medivation common stock were validly tendered, representing approximately 69.1% of the shares outstanding and have been accepted for payment under the terms of the tender offer for $81.50 per share in cash, without interest, subject to any required withholding of taxes. In addition, notices of guaranteed delivery have been delivered for 17,659,861 shares of Medivation common stock, representing approximately 10.6% of the shares outstanding. Following its acceptance of the tendered shares, Pfizer completed its acquisition of Medivation through a second-step merger. Pfizer and its wholly-owned subsidiary accepted for payment and will promptly pay for all shares validly tendered and not validly withdrawn. Schedule your 30 min Free 1stOncology Demo! "Pfizer and Medivation are now one unified team combining research and resources to combat cancer. This acquisition represents a rare opportunity to expand our business offering with an attractive pipeline and with XTANDI, an important medicine for men with prostate cancer. We welcome our new Medivation colleagues to the team and look forward to continuing the successful partnership with Astellas for XTANDI," said Albert Bourla, group president, Pfizer Innovative Health. "Given the breadth of Pfizer’s existing oncology portfolio and emerging immuno-oncology pipeline, Medivation’s assets will potentially benefit from many novel and productive combinations. Together, we are well positioned to becoming a leading oncology company, speeding cures and making accessible breakthrough medicines to patients – our number one priority."
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Pfizer continues to expect the transaction to be immediately accretive to Pfizer’s Adjusted Diluted EPS upon closing, approximately $0.05 accretive in the first full year after close with additional accretion and growth anticipated thereafter.
The Offer
The tender offer for all of the outstanding shares of Medivation common stock expired as scheduled at the end of the day, one minute after 11:59 p.m., Eastern Time, on September 27, 2016. Computershare Trust Company, N.A., the depositary and paying agent for the tender offer, has advised Pfizer that 115,574,041 shares of Medivation common stock were validly tendered into and not validly withdrawn from the tender offer, representing approximately 69.1% of the shares outstanding, and notices of guaranteed delivery have been delivered for 17,659,861 shares of Medivation common stock, representing approximately 10.6% of the shares outstanding. All of the conditions to the offer have been satisfied and on September 28, 2016, Pfizer and its wholly-owned subsidiary Montreal, Inc. accepted for payment and will promptly pay for all shares validly tendered and not validly withdrawn.
Following its acceptance of the tendered shares, Pfizer completed its acquisition of Medivation through the merger of Montreal, Inc. with and into Medivation without a vote of Medivation’s stockholders pursuant to Section 251(h) of the Delaware General Corporation Law. As a result of the merger, Medivation became a wholly-owned subsidiary of Pfizer. In connection with the merger, all Medivation shares not validly tendered into the tender offer (other than treasury shares held by Medivation, any shares owned by Pfizer, Montreal, Inc. or any other direct or indirect wholly-owned subsidiary of Pfizer and shares held by any person who was entitled to and has properly demanded statutory appraisal of his or her shares) have been cancelled and converted into the right to receive the same $81.50 per share in cash (without interest but subject to required withholding of taxes) as will be paid for all shares that were validly tendered and not validly withdrawn in the tender offer. Medivation common stock will cease to be traded on the NASDAQ Global Market.
Peregrine Pharmaceuticals Presents Preclinical Data Demonstrating PS-Targeting Antibodies Significantly Enhance the Anti-Tumor Activity of Multiple Checkpoint Targeting Agents in Model of Triple Negative Breast Cancer (TNBC)
On September 27, 2016 (GLOBE NEWSWIRE) Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company committed to improving patient lives by manufacturing high quality products for biotechnology and pharmaceutical companies and advancing its proprietary R&D pipeline, reported the presentation of preclinical study data demonstrating that phosphatidylserine (PS)-targeting antibodies similar to bavituximab are able to enhance the anti-tumor activity of multiple checkpoint targeting agents including anti-PD-1 and anti-LAG3 therapies in a model of triple negative breast cancer (TNBC) (Press release, Peregrine Pharmaceuticals, SEP 27, 2016, View Source [SID:SID1234515466]). Data showed that eight of the ten (80%) animals receiving the preclinical bavituximab equivalent (ch1N11) combined with anti-PD-1 and anti-LAG3 therapies ("Triple Combination") experienced complete tumor regressions, whereas there were no animals (0/10) in the anti-PD-1 and anti-LAG3 combination treatment arm that had a complete regression.
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Additional data demonstrated that the Triple Combination featuring ch1N11 led to a 99% reduction in total tumor volume at the interim analysis point (Day 25) across all animals as compared to the control arm. In addition, the Triple Combination showed a statistically significant increase in tumor growth inhibition (TGI) as compared to the anti-PD-1 and anti-LAG3 combination treatment (99% vs. 62%; p < 0.05). Peregrine’s Michael J. Gray, Ph.D., the study’s lead scientist, presented the study findings at the Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) September 25-28, 2016, in New York City.
The presented study evaluated various combinations of ch1N11, anti-PD-1 and anti-LAG3 therapy in the well-characterized E0771 murine model of TNBC. Other key study findings included:
Treatment with Triple Combination therapy (ch1N11/anti-PD-1/anti-LAG3) led to a significant increase in tumor infiltrating lymphocytes (TILs), particularly CD8+ T cells, as compared with anti-PD-1 and anti-LAG3 combination treatments.
Treatment with Triple Combination therapy (ch1N11/anti-PD-1/anti-LAG3) resulted in a reduction in immunosuppressive cell types, including CD4+ cells, regulatory T cells (Tregs) and myeloid derived suppressor cells (MDSCs). These results show that the Triple Combination therapy is capable of significantly altering the tumor microenvironment from highly immunosuppressive to highly immuno-stimulatory. Other treatment combinations evaluated in the study lacked a statistically significant reduction in immunosuppressive cells.
"These data offer compelling evidence for the therapeutic potential of including PS-targeted therapies in combination with multiple checkpoint inhibitors in the treatment of TNBC. This is highlighted by the dramatic distinction in complete tumor regression rates seen between the Triple Combination and anti-PD-1/anti-LAG3 treatment arms, combined with the significant difference in tumor growth inhibition percentages witnessed for these groups," stated Jeff T. Hutchins, Ph.D., Peregrine’s vice president, preclinical research. "In addition to its impact on tumor growth, we saw very important changes in the tumor microenvironment with the Triple Combination treatment with a significant reduction in cell types that contribute to immune suppression such as CD4+ cells, Tregs and MDSCs coupled with the expansion of tumor fighting cells such as CD8+ T cells. These data offer mechanistic evidence that highlight the manner by which the combination of ch1N11/anti-PD-1/anti-LAG3 may be eliciting such anti-tumor responses."
Bavituximab is an investigational monoclonal antibody that targets PS. Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab is believed to override PS mediated immunosuppressive signaling by blocking the engagement of PS with its receptors as well as by sending an alternate immune activating signal. Previous studies demonstrated PS-targeting antibodies shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor responses. Peregrine evaluates the preclinical equivalent of bavituximab, ch1N11, in animal model studies to guide clinical development.
Peregrine’s clinical development strategy for bavituximab currently focuses on small, early-stage, proof-of-concept trials evaluating the drug in combination with other cancer treatments. This approach includes the recently announced grants by the National Comprehensive Cancer Network (NCCN) to support three different clinical trials of bavituximab treatment combinations. Those trials will evaluate novel bavituximab combinations in glioblastoma, head and neck cancer, and hepatocellular carcinoma including an immunotherapy combination. Additionally, Peregrine continues to advance its pre-clinical collaboration with Memorial Sloan Kettering Cancer Center with the goal of evaluating combinations of bavituximab with other checkpoint inhibitors and immune stimulatory agents. The intent behind this strategy is to focus our research and development spending to further validate bavituximab’s combination potential as we seek to advance the program though a pharmaceutical or biotechnology partner.
Ipsen Announces Data Presentations of Cabozantinib (Cabometyx™), Lanreotide (Somatuline® Autogel®) and Telotristat Ethyl* at the European Society for Medical Oncology (ESMO) 2016 Congress
On September 27, 2016 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven pharmaceutical group, reported that Cabometyx (cabozantinib), Somatuline Autogel (lanreotide) and telotristat ethyl (*previously known as telotristat etiprate) will be the subject of 16 presentations at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 congress:
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Cabozantinib to be featured in eight presentations
CABOSUN results accepted as late-breaker presentation in oral session at the Presidential Symposium
[LBA30] "CABOzantinib versus SUNitinib (CABOSUN) as initial targeted therapy for patients with metastatic renal cell carcinoma (mRCC) of poor and intermediate risk groups: Results from ALLIANCE A031203 Trial (Press release, Ipsen, SEP 27, 2016, View Source [SID:SID1234515444])."
Dr. Toni Choueiri, Director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Session: Presidential session 3
Oral presentation Monday, October 10, 4:30 – 6:10 p.m. CEST, Copenhagen
Note: This is a National Cancer Institute Cancer Therapy Evaluation Program (NCI-CTEP) study.
Poster Discussion
[774PD] "A phase I study of cabozantinib plus nivolumab (CaboNivo) in patients (pts) with refractory metastatic urothelial carcinoma (mUC) and other genitourinary (GU) tumors."
Dr. Andrea Borghese Apolo, Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA
Session: Genitourinary Tumours, Non-Prostate
Poster presented Sunday, October 9, 4:30 – 5:30 p.m. CEST, Athens
Note: This is an NCI-CTEP study.
Poster Presentations
[787P] "A phase II study of cabozantinib in patients (pts) with relapsed/refractory metastatic urothelial carcinoma (mUC)."
Dr. Rosa Nadal, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland, USA
Session: Genitourinary Tumours, Non-Prostate
Poster presented Sunday, October 9, 1 – 2 p.m. CEST, Hall E
Note: This is an NCI-CTEP study.
[814P] "Efficacy of cabozantinib (cabo) vs everolimus (eve) by metastatic site and tumor burden in patients (pts) with advanced renal cell carcinoma (RCC) in the phase 3 METEOR trial."
Dr. Thomas Powles, Barts Cancer Institute, Cancer Research UK Experimental Cancer Medicine Centre, Queen Mary University of London, Royal Free NHS Trust, London, GB
Session: Genitourinary Tumours, Non-Prostate
Poster presented Sunday, October 9, 1 – 2 p.m. CEST, Hall E
[815P] "Evaluation of the novel "trial within a trial" design of METEOR, a randomized phase 3 trial of cabozantinib versus everolimus in patients (pts) with advanced renal cell carcinoma (RCC)."
Colin Hessel, Exelixis, Inc., South San Francisco, California, USA
Session: Genitourinary Tumours, Non-Prostate
Poster presented Sunday, October 9, 1 – 2 p.m. CEST, Hall E
[816P] "Quality of life (QoL) in the phase 3 METEOR trial of cabozantinib vs everolimus for advanced renal cell carcinoma (RCC)."
Dr. David Cella, Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
Session: Genitourinary Tumours, Non-Prostate
Poster presented Sunday, October 9, 1 – 2 p.m. CEST, Hall E
[818P] "Analysis of regional differences in the phase 3 METEOR study of cabozantinib (cabo) versus everolimus (eve) in advanced renal cell carcinoma (RCC)."
Dr. Nizar Tannir, University of Texas, MD Anderson Cancer Center, Houston, Texas, USA
Session: Genitourinary Tumours, Non-Prostate
Poster presented Sunday, October 9, 1 – 2 p.m. CEST, Hall E
[1421TiP] "A randomized double-blind phase II study evaluating the role of maintenance therapy with cabozantinib in high grade undifferentiated uterine sarcoma (HGUS) after stabilization or response to doxorubicin +/- ifosfamide following surgery or in metastatic first line treatment."
Dr. Isabelle Ray-Coquard, Cancer Research Center of Lyon, Lyon, France
Session: Basic science
Poster presented Monday, October 10, 1 – 2 p.m. CEST, Hall E
Note: This is an investigator-sponsored trial.
Lanreotide (Somatuline Autogel) will be featured in 6 presentations:
[438P] "Efficacy of lanreotide autogel/depot (LAN) vs placebo (PBO) for symptomatic control of carcinoid syndrome (CS) in neuroendocrine tumor (NET) patients from the ELECT study"
Dr Edward Wolin, Montefiore Einstein Center for Cancer Care, Bronx, NY, USA
Session: Endocrine and neuroendocrine tumours
Poster presented Saturday, October 8, 1 – 2 p.m. CEST, Hall E
[440P] "Longer term efficacy of lanreotide autogel/depot (LAN) for symptomatic treatment of carcinoid syndrome (CS) in neuroendocrine tumor (NET) patients from the ELECT open label study"
Dr George Fisher. Stanford University School of Medicine, Stanford, CA, USA
Session: Endocrine and neuroendocrine tumours
Poster presented Saturday, October 8, 1-2 p.m. CEST, Hall E
[439P] "Long-term safety/tolerability of lanreotide autogel/depot (LAN) treatment for metastatic intestinal and pancreatic neuroendocrine tumours (NETs): final results of the CLARINET open-label extension (OLE)"
Dr Martyn Caplin, Royal Free Hospital, London, UK
Session: Endocrine and neuroendocrine tumours
Poster presented Saturday, October 8, 1 – 2 p.m. CEST, Hall E
[449TiP] "Safety and Efficacy of Lanreotide Autogel/Depot Every 14 Days for Patients with Pancreatic or Midgut Neuroendocrine Tumours Progressing on Lanreotide Every 28 Days: The Prospective, International CLARINET FORTE Study"
Dr Marianne Pavel. Charité University Medicine, Berlin, Germany
Session: Endocrine and neuroendocrine tumours
Poster presented Saturday, October 8, 1 – 2 p.m. CEST, Hall E
[450TiP] "Safety of lanreotide 120 mg ATG in combination with metformin in patients with advanced well-differentiated gastro-intestinal (GI) or lung carcinoids. A pilot, one-arm, open-label, prospective study: The MetNET-2 trial"
F. De Braud et al.
Session: Endocrine and neuroendocrine tumours
Poster presented Saturday, October 8, 1-2 p.m. CEST, Hall E
Note: This is a National Cancer Institute Milan sponsored study
[451TiP] "Combined Lanreotide Autogel and Temozolomide Therapy in Progressive Neuroendocrine Tumours: The SONNET Study"
Dr Dieter Hörsch, Zentralklinik Bad Berka, Bad Berka, Germany
Session: Endocrine and neuroendocrine tumours
Poster presented Saturday, October 8, 1 – 2 p.m. CEST, Hall E
Telotristat ethyl will be featured in one presentation:
[422PD] "Integrated placebo-controlled safety analysis from clinical studies of telotristat ethyl for the treatment of carcinoid syndrome"
Dr Matthew Kulke, Dana-Farber Cancer Institute, Boston, MA, USA
Session: Endocrine and neuroendocrine tumours
Poster discussion, Monday, October 10, 11-12 a.m. CEST, Room Berlin
In addition, Ipsen supported a collaborative study to understand the epidemiology of NET in European countries:
[424PD] "Prevalence of gastroenteropancreatic and lung neuroendocrine tumours in the European Union"
A. Bergamasco et al.
Session: Endocrine and neuroendocrine tumours
Poster discussion, Monday, October 10, 11-12 a.m. CEST, Room Berlin
Ipsen and Exelixis will host a joint investor / media event on October 10, 2016 at 6:30 p.m. (room 21, 1st floor, press area, Bella Center). Further information will follow with webcast and conference call details.