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OSE Pharma appoints Simbec-Orion to conduct its Tedopi® Phase III international clinical trial in advanced lung cancer patients

On January 29, 2015 OSE Pharma reported that they have entered into a collaboration agreement to conduct the upcoming Tedopi Phase III pivotal trial in HLA-A2 positive advanced non-small cell lung cancer (NSCLC) patients who have failed on previous therapy (Press release, OSE Pharma, JAN 29, 2015, View Source [SID:1234502959]).

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The protocol of this pivotal Phase III trial, which will treat advanced invasive (stage IIIb) or metastatic (stage IV) NSCLC patients who express the HLA-A2 receptor (approximately 45% of the NSCLC population), has been recently approved both by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency’s (EMA). Simbec-Orion will manage this multi-centre, multi-country study involving up to 70 sites and 500 patients in the United States and Europe.

Simbec-Orion has started the feasibility study for the planned study with international clinical experts and patient enrolment is planned for the second half of 2015. Simbec-Orion will be responsible for site selection, patient enrolment, clinical monitoring, data management, statistical analysis and regulatory affairs.

Simbec-Orion has been selected because of its expertise in oncology and rare diseases offering medical and operational strengths, flexibility, commercial insight and a shared commitment to patients. As part of the collaboration agreement, Simbec-Orion has accepted warrants giving right to equity as part of payment for a portion of its fees. OSE Pharma and Simbec-Orion believe that this will closely align both parties’ interests.

"We are delighted to be collaborating with OSE Pharma in this pivotal step prior to registration of OSE Pharma’s Tedopi," said Ronald Openshaw, Chief Executive Officer of Simbec-Orion. "We have combined the development expertise of OSE Pharma with our broad clinical know-how to create a true strategic partnership."

"After an extensive global review of potential clinical research organisations, we selected Simbec-Orion as a strategic partner for our Phase III programme. This partnership provides clinical development support for Tedopi and will help us accelerate in the race for registration of immunotherapies", said Dominique Costantini CEO of OSE Pharma.

"Although pricing was an important consideration in our evaluation process, Simbec-Orion’s understanding of our mission was crucial and weighed heavily in our final decision. We are very pleased to have this team involved in such an important aspect of OSE Pharma’s future. We believe this Phase III study conducted with Simbec-Orion is an important step to validate the results of earlier studies and demonstrate the risk/benefit ratio of Tedopi alone.

"We believe that the combinatorial approach of Tedopi with other immune-oncology therapies on which we are also currently working will enable to deliver synergies and increase the duration of patients’ response."

About OSE Pharma

OSE Pharma is a European cancer immunotherapy company with a multi-epitope technology named Memopi that directs the body’s immune system to generate a specific cytotoxic T response to prevent cancer cell growth.

OSE Pharma’s lead product, OSE-2101, Tedopi combines 10 "neo-epitopes" directed against five tumour associated antigens. In its most advanced application, it is about to enter a pivotal Phase III study in patients with advanced non-small cell lung cancer (NSCLC) who express HLA-A2 and failed first line therapy. Tedopi has orphan drug status in the USA and is considered as personalized medicine in Europe in HLA-A2 positive patients.

OSE Pharma is also planning a new Phase II clinical trial in combination with another immunotherapy treatment in NSCLC.

Tedopi targets five tumour associated antigens (TAA), selected because their presence is linked to a poor prognosis and the severity of various cancers. Tedopi contains ten optimized epitopes, or "neo- epitopes", designed on the binding of HLA-A2 and TCR,. These neo-epitopes generate strong specific T cytotoxic responses that fight cancer and prevent tumour escape..

Dendreon Reaches Agreement For Valeant To Serve As "Stalking Horse Bidder" In Court-Supervised Sales Process

On January 29, 2015 Dendreon reported that it has reached an agreement with Valeant Pharmaceuticals International pursuant to which, subject to bankruptcy court approval, Valeant will serve as the "stalking horse" bidder in conjunction with a court-supervised sales process (Press release Dendreon, JAN 29, 2015, View Source [SID:1234501440]).

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Under the terms of the agreement, Valeant would acquire the world-wide rights of PROVENGE (sipuleucel-T) and certain other Dendreon assets for $296 million, subject to higher and better bids.

Valeant is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, eye health, neurology and branded generics.

"We are pleased to reach this agreement with Valeant and to move forward with the court-supervised sales process," said W. Thomas Amick, president and chief executive officer of Dendreon. "We are confident that this process will result in a strong new owner for PROVENGE, and that patients will continue to receive treatments with no disruption moving forward. We thank our employees for their continued hard work, dedication and commitment to serving our physicians and their patients."

The Company also announced that it would be extending the bid deadline for interested parties to submit qualified bids to participate in an auction for the Company’s assets from January 29, 2015 at 5:00 p.m. Eastern Time to February 10, 2015 at 5:00 p.m. Eastern Time. Assuming additional qualified bids are submitted, an auction would be held on February 12, 2015.

The full terms of the agreement will be filed with the Securities and Exchange Commission. Court documents and additional information are available through Dendreon’s claims agent, Prime Clerk, at View Source or 844-794-3479.

Skadden, Arps, Slate, Meagher & Flom LLP is serving as the Company’s legal advisor, AlixPartners is serving as its financial advisor and Lazard is serving as its investment bank.

Weil, Gotshal & Manges LLP acted as legal advisor to Valeant.

Valeant Selected As Lead Bidder To Acquire Dendreon And Its Leading Immunotherapy Treatment, PROVENGE® (sipuleucel-T)

On January 29, 2015 Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) reported that it has entered into a "stalking horse" asset purchase agreement to acquire certain assets of Dendreon Corporation ("Dendreon") for $296 million in cash (Press release Valeant, JAN 29, 2015, http://ir.valeant.com/investor-relations/news-releases/news-release-details/2015/Valeant-Selected-As-Lead-Bidder-To-Acquire-Dendreon-And-Its-Leading-Immunotherapy-Treatment-PROVENGE-sipuleucel-T/default.aspx [SID:1234501430]).

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Pursuant to the terms of the agreement, Valeant will acquire the world-wide rights to Dendreon’s PROVENGE (sipuleucel-T) product and certain other Dendreon assets. PROVENGE (sipuleucel-T) is an immunotherapy treatment designed to treat men with advanced prostate cancer by taking the body’s own immune cells and reprograming them to attack advanced prostate cancer. The product was approved by the U.S. Food and Drug Administration (FDA) in April 2010 and realized revenues of approximately $300 million in 2014. PROVENGE was approved by the European Medicines Agency in 2013.

Dendreon has been a debtor pursuant to chapter 11 of the U.S. Bankruptcy Code since November of 2014. The asset purchase agreement constitutes a "stalking horse bid" in a sale process being conducted under Section 363 of the U.S. Bankruptcy Code. As the "stalking horse bidder," Valeant will be entitled to a break-up fee and expense reimbursement if it ultimately does not prevail as the successful bidder at a subsequent auction for Dendreon’s assets. Valeant’s role as a stalking horse bidder, and the sale itself, are subject to approval by the Bankruptcy Court. In addition, completion of the transaction remains subject to higher or better offers at such auction and customary closing conditions.

"We believe that oncology has similar characteristics to our current therapeutic portfolios, such as strong growth, high durability, strong patient and physician loyalty, and a terrific reimbursement regime," stated J. Michael Pearson, chairman and chief executive officer. "We have not previously found an economic way to enter this market, but with the unique dynamics of this situation, we believe that this transaction will create significant shareholder value."

Court documents and additional information are available through Dendreon’s claims agent, Prime Clerk, at View Source or 844-794-3479.

Weil, Gotshal & Manges LLP is serving as Valeant’s legal advisor. Skadden, Arps, Slate, Meagher & Flom LLP is serving as Dendreon’s legal advisor, AlixPartners is serving as its financial advisor and Lazard is serving as its investment bank.

PHASE II TRIAL OF ANTICANCER AGENT LENVATINIB IN RENAL CELL CARCINOMA MEETS PRIMARY ENDPOINT

On January 30, 2015 Eisai reported that the Phase II part of a Phase I/II clinical trial (Study 205) of its in-house developed anticancer agent lenvatinib mesylate (lenvatinib) in unresectable advanced or metastatic renal cell carcinoma has met its primary endpoint (Press release Eisai, JAN 30, 2015, View Source [SID:1234501422]).

The second part of Study 205 was an open-label, multicenter study of lenvatinib alone, and in combination with the anticancer agent everolimus, in patients with unresectable advanced or metastatic renal cell carcinoma following one prior VEGF-targeted treatment. 153 patients were randomized in a 1:1:1 ratio to one of three treatment arms to receive either lenvatinib
(18 mg) plus everolimus (5 mg), lenvatinib alone (24 mg), or everolimus alone (10 mg) to compare the safety and efficacy of these three regimens.

From the preliminary results of the study, both lenvatinib plus everolimus and the lenvatinib alone groups prolonged progression free survival (PFS), the study’s primary endpoint, compared to everolimus alone, and the lenvatinib plus everolimus group in particular showed a highly statistically significant improvement. The most common treatment-related adverse events reported in the lenvatinib plus everolimus group were diarrhea, decreased appetite, fatigue, nausea, and hypertension, and in the lenvatinib alone group were diarrhea, nausea, decreased appetite, hypertension, fatigue, and vomiting. Detailed results of the study will be presented at an academic conference in the near future.

Renal cell carcinoma is the most common form of cancer to affect the kidneys. For metastatic or advanced renal cell carcinoma that is difficult to treat with surgery, the standard treatment method is molecular targeted drug therapy, however with low 5-year survival rates, this remains a disease with significant unmet medical needs. According to the result
s of this study, lenvatinib plus everolimus showed superior PFS over everolimus alone which is recommended by the National Comprehensive Cancer Network guidelines as a 2nd-line therapy for unresectable advanced or metastatic renal cell carcinoma. Currently, no combination therapy for this indication has been approved in any major country worldwide. Eisai will share these study results with regulatory authorities to discuss further steps.

Lenvatinib is an oral molecular targeted agent that selectively inhibits the activities of several different molecules including VEGFR, FGFR, RET, KIT and PDGFR, involved in angiogenesis and tumor proliferation. It is the first compound that has been confirmed through X-ray crystal structural analysis to possess a novel binding mode (Type V) to VEGFR2. Furthermore, lenvatinib exhibits rapid and potent inhibition of kinase activity, according to kinetic analysis. Currently, Eisai has already submitted regulatory applications for lenvatinib seeking indication approval for thyroid cancer to health authorities firstly in Japan, the United States and the EU, and is filing subsequent applications in other countries worldwide. Eisai has also initiated a global Phase III trial of lenvatinib in hepatocellular carcinoma and Phase II studies of lenvatinib in several other tumor types are also underway.

U.S. FDA Approves IMBRUVICA® (ibrutinib) for Treatment of Waldenstrom’s macroglobulinemia (WM)

On January 29, 2015 Pharmacyclics reported that the U.S. Food and Drug Administration (FDA) has granted single-agent IMBRUVICA (ibrutinib) regular (full) approval in all lines of therapy as the first and only treatment for patients with Waldenstrom’s macroglobulinemia (WM), a rare, indolent type of B-cell lymphoma (Press release Pharmacyclics, JAN 29, 2015, View Source [SID:1234501415]). This is the fourth indication for IMBRUVICA, an oral therapy, which received FDA Breakthrough Therapy Designation for this indication in February 2013. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc.

“Because there has never been an FDA-approved treatment for Waldenstrom’s macroglobulinemia since it was first identified over 70 years ago, doctors had to rely on therapies borrowed from similar cancers to treat these patients,” Steven P. Treon, M.D., Ph.D., Director of the Bing Center for Waldenstrom’s Macroglobulinemia at the Dana-Farber Cancer Institute and Associate Professor at Harvard Medical School, Boston, Mass., and lead investigator of the WM trial data submitted to the FDA for this approval. “I am truly grateful to the FDA for recognizing this need and for approving IMBRUVICA, and I thank those scientists whose hard work and dedication helped discover the genetic cause of this disease and identified ibrutinib as a targeted therapy, and those clinicians at several leading medical centers who diligently enrolled the clinical trial showing that IMBRUVICA is a safe and highly effective therapy for patients with Waldenstrom’s macroglobulinemia.”

“The FDA’s approval of IMBRUVICA for Waldenstrom’s macroglobulinemia marks a significant milestone for patients living with this rare disease and has the potential to positively impact the lives of a number of patients,” said Carl Harrington, President of the International Waldenstrom’s Macroglobulinemia Foundation, who also is a patient living with WM.
The approval is based on results from a multi-center, Phase II study that evaluated the efficacy and tolerability of IMBRUVICA in 63 patients with previously treated WM. In this study, IMBRUVICA demonstrated a response rate of 62% according to an Independent Review Committee. Very good partial responses (VGPR) of 11% and partial responses (PR) of 51% were observed. These responses were maintained and the median duration of response (DOR) has not been reached, with a range of 2.8+ to 18.8+ months.
“IMBRUVICA has demonstrated its effectiveness in patients living with Waldenstrom’s macroglobulinemia who, until now, did not have an FDA-approved standard-of-care therapy,” said Thorsten Graef, M.D., Ph.D., Head of Hematology at Pharmacyclics. “This approval is a proud moment for our Pharmacyclics and Janssen teams and would not have been possible without the dedication and support of our patients, clinical investigators and the FDA’s recognition of IMBRUVICA as a breakthrough therapy for these patients.”

WM (a clinically recognized subset of lymphoplasmacytic lymphoma, or LPL) is a slow-growing and rare blood cancer that most commonly originates from B cells, a type of white blood cell (lymphocyte) that develops in the bone marrow.2 In the United States, approximately 1,000 to 1,500 people are diagnosed each year,3 with the median age at diagnosis being 60 to 70 years of age.4 WM occurs as the result of a malfunction in the healthy lifecycle of a B cell, causing the cell to become malignant and reproduce at an abnormal rate. The malignant B cells produce large amounts of an abnormal type of antibody protein called immunoglobulin M (IgM). Excess IgM causes the blood to thicken and causes many of the symptoms of WM.2
Consistent with the previous label, the most commonly occurring adverse reactions in WM patients treated with IMBRUVICA ( > 20%) were neutropenia, thrombocytopenia, diarrhea, rash, nausea, muscle spasms, and fatigue. Six percent of patients receiving IMBRUVICA in the WM trial discontinued treatment due to adverse events. Adverse events leading to dose reduction occurred in 11% of patients.
In addition, the warnings and precautions for IMBRUVICA were updated and reflect the most current safety knowledge based on ongoing clinical investigation and commercial use.