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its wholly-owned subsidiary accepted for payment and will promptly pay for all shares validly tendered and not validly withdrawn.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.
Author: [email protected]
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.
Galera Therapeutics Announces Presentation of One-Year Follow-up Data from a Phase 1b/2a Study of GC4419 In the Reduction of Severe Oral Mucositis
On September 27, 2016 Galera Therapeutics, Inc., a clinical-stage biotechnology company developing new treatments for cancer patients, reported the presentation of final data, including one-year tumor control, from a Phase 1b/2a clinical trial of GC4419, an investigational drug candidate for the reduction of severe chemoradiation-induced oral mucositis (OM), in an oral presentation at the American Society of Radiation Oncology (ASTRO) Annual Meeting (Press release, Galera Therapeutics, SEP 27, 2016, View Source [SID:SID1234515442]). The OM efficacy data from this study in head and neck cancer patients were previously presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June and demonstrated marked reductions in the incidence, severity and duration of severe OM when compared to historical experience.
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The new one-year tumor control follow-up data presented today in Boston, Massachusetts further shows that local and distant tumor control, progression-free survival and overall survival compared well with historical experience for patients receiving chemoradiation for head and neck cancers.
This Phase 1b/2a trial assessed the safety and pharmacokinetics of GC4419, administered intravenously prior to each dose of standard intensity modulated radiotherapy (IMRT) and cisplatin therapy, in 46 head and neck cancer patients. The study demonstrated that, compared to historic controls, GC4419 delayed the onset, reduced the incidence, shortened the duration and reduced the intensity of severe OM (defined as WHO Grades 3 and 4 OM). Furthermore, only 4.3% of patients required breaks in IMRT of 5 consecutive fractions or more, as opposed to published rates of 15% in historical studies. In combination, GC4419 had a safety profile consistent with the underlying IMRT and cisplatin regimen.
Now with a full one year of follow-up in all consenting patients (44/46), investigators further report that the overall 1-year local-regional control, the 1-year distant metastasis-free rate and the 1-year overall survival were each 93%. The 1-year progression-free survival was 84%. These rates compare favorably with historic controls.
"We are encouraged to see that after one year of follow-up, tumor control in these patients appears to be maintained," said J. Mel Sorensen, MD, President and CEO of Galera. "These findings support the continuing development of GC4419, now in a randomized double-blinded Phase 2 trial for this patient population. As radiation oncologists know well, severe OM is a debilitating side effect that can result in treatment interruptions of potentially life-saving chemoradiation therapy. We look forward to advancing our clinical development program for GC4419, as well as our pipeline of orally active dismutase mimetics."
About Oral Mucositis (OM)
Oral mucositis is a common debilitating side effect of radiation treatment in head and neck cancer (HNC) patients. Severe OM, defined as Grade 3 or 4 OM on the World Health Organization Oral Mucositis Scale, occurs in 60 to 80 percent of HNC patients who receive radiation therapy. Importantly, severe OM may result in interruptions in radiation treatment, which can compromise the otherwise good prognosis for tumor control in many of these patients. In addition, patients suffer significant pain, may develop serious infections, and may be unable to eat solid food or even drink liquids. Further, the costs of managing these side effects are substantial, particularly when hospitalization and/or surgical placement of PEG tubes to maintain nutrition and hydration is required. There is currently no drug approved to prevent or treat severe OM in head and neck cancer patients.
About GC4419
GC4419 is a superoxide dismutase mimetic, a small molecule drug that is designed to convert superoxide to hydrogen peroxide and oxygen. This mechanism is thought to block the large burst of superoxide induced by radiotherapy, the initiating step in the development of OM, and has been shown to be protective of normal tissue but not tumor in preclinical models. In preliminary clinical studies, GC4419 markedly delayed the onset, shortened the duration and decreased the incidence of severe OM when administered intravenously prior to each dose of intensity modulated radiotherapy (IMRT) and cisplatin. GC4419 has now entered randomized Phase 2 development to reduce the incidence, severity and duration of severe OM in patients receiving radiation and chemotherapy for the treatment of head and neck cancer.
Clinical Data Support Mechanism of Action and Patient Selection Biomarker for Imprime PGG, Biothera Pharmaceutical’s Phase 2 Cancer Immunotherapy
On September 27, 2016 Biothera Pharmaceuticals, Inc. reported the presentation of clinical data demonstrating the mechanism of action of Imprime PGG, the Company’s Phase 2 cancer immunotherapy drug, in healthy human volunteers (Press release, Biothera, SEP 27, 2016, View Source [SID:SID1234515441]). These are the first data to show that when administered intravenously to healthy human subjects, Imprime PGG drives the immunopharmacodynamic (IPD) responses observed in ex vivo human and in vivo mouse studies. Specifically, the study demonstrated that formation of an immune complex between Imprime PGG and endogenous anti-beta glucan antibodies (ABA) was critical to elicit Imprime-induced immune activating events in humans. These findings provide additional evidence that ABA levels may be a particularly useful biomarker for selecting patients most likely to respond to Imprime-based therapy. These data, as well as additional preclinical research demonstrating Imprime’s ability to reshape the suppressive immune microenvironment of the tumor and elicit robust anti-tumor immunity, were presented in poster presentations during the CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper), taking place in New York City, September 25-28, 2016.
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"For the first time we are showing that Imprime PGG elicits multiple innate immune-activating events after systemic dosing in humans. These immune-activating events are the same events necessary for efficacy in preclinical models," said Jeremy Graff, Ph.D., Biothera’s Chief Scientific Officer and Senior Vice President, Research. "These data also further bolster our extensive research to show that pre-treatment ABA levels represent a viable, non-invasive, mechanism-based patient selection biomarker that will be deployed in our upcoming clinical trials."
Imprime PGG is a Pathogen Associated Molecular Patterning (PAMP) molecule that acts therapeutically as an immunological "ignition switch" to enlist the functionality of the innate immune system and to enhance the efficacy of tumor targeting, anti-angiogenic, and immune checkpoint inhibitor antibodies. Biothera and Merck are advancing a phase 2 clinical research collaboration to evaluate Imprime PGG and Merck’s anti-PD-1 inhibitor KEYTRUDA (pembrolizumab) in patients with either advanced melanoma or metastatic triple negative breast cancer. Biothera and Merck are also collaborating with the Big Ten Cancer Research Consortium to commence an Imprime PGG plus KEYTRUDA Phase 1b/2 study in patients with non-small cell lung cancer.
In a second poster presentation at the conference, Biothera presented preclinical data further demonstrating the ability of Imprime PGG to re-orient the immunosuppressive tumor microenvironment, disabling the immunosuppression that shields cancer cells from immune attack. Imprime PGG promotes the differentiation of human myeloid-derived suppressor cells (MDSCs), significantly upregulating the expression of co-stimulatory molecules (iNOS, CD80, CD86) that drive anti-tumor activity and relieving MDSC-mediated inhibition of T Cell proliferation. Previous preclinical studies have reported that Imprime PGG also promotes repolarization of M2 macrophages to an anti-tumor, M1-like orientation while triggering maturation of critical antigen presenting cells (i.e. dendritic cells) to enable antigen-specific T cell expansion and the production of the potent anti-tumor cytokine interferon gamma. Collectively, these data show that Imprime PGG treatment can reshape the tumor microenvironment favoring robust anti-tumor immune responses.