On February 3, 2015 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported the signing of a license agreement with Sermonix Pharmaceuticals LLC for the development and commercialization of oral lasofoxifene in the United States and additional territories (Press release, Ligand, FEB 3, 2015, View Source [SID1234532265]). Under the terms of the agreement, Ligand has received an undisclosed initial payment, and is entitled to receive up to $45 million in potential regulatory and commercial milestone payments and tiered royalties of 6% to 10% on future net sales. Lasofoxifene is an estrogen partial agonist for the treatment of osteoporosis and other diseases.

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"Lasofoxifene has a promising profile and a large clinical dataset, and we are excited to see development of the oral form move forward in additional territories," commented John Higgins, Chief Executive Officer of Ligand. "Sermonix is highly familiar with lasofoxifene and is well-positioned to advance its development, and we look forward to their progress with this important program. This transaction represents yet another partnership for lasofoxifene as we continue to build on our portfolio of more than 100 shots-on-goal."

Based on the lasofoxifene safety and efficacy data from clinical trials in more than 15,000 women, Sermonix plans to seek regulatory approvals in several women’s health indications.

"Sermonix is excited to partner with Ligand on lasofoxifene, a best-in-class selective estrogen receptor modulator, or SERM, and to seek regulatory approval of this remarkable drug," stated David Portman, M.D., Chief Executive Officer of Sermonix. "The robust clinical development program to date has demonstrated efficacy for many common conditions greatly impacting women’s health in mid-life, with targeted beneficial effects on the vagina, bone and breast. With several SERMs approved in the last two years, lasofoxifene is well-positioned to offer women a tremendous and much-needed alternative to hormone therapy to improve their overall menopausal health."

About Lasofoxifene and Ligand’s Lasofoxifene Partnerships

Lasofoxifene was discovered through a research collaboration between Ligand and Pfizer that began in 1991. The oral, 0.5 mg form of lasofoxifene tartrate was developed by Pfizer under the trade name Fablyn, and progressed through regulatory approval in the EU. After Pfizer acquired Wyeth and its Conbriza (bazedoxifene), a similar SERM program, rights to all forms of lasofoxifene reverted to Ligand in 2011. In July 2013 Ligand licensed lasofoxifene to Azure Biotech for the development of a novel formulation targeting an underserved market in women’s health. Also in July 2013 Ligand licensed to Ethicor Pharmaceuticals Ltd rights to manufacture and distribute oral lasofoxifene as an unlicensed medicinal product in the European Economic Area, Switzerland and the Indian Subcontinent.

On February 3, 2015 Genmab reported preliminary results from the Phase II study of daratumumab in double refractory multiple myeloma conducted by its collaboration partner Janssen Biotech (Press release Genmab, FEB 3, 2015, View Source [SID:1234501450]). The overall response rate (ORR) in the study was 29.2% in the 16 mg/kg dosing group and the median duration of response was 7.4 months as determined by an Independent Review Committee (IRC). The study evaluated multiple myeloma patients who have received at least three different lines of therapy including both a proteasome inhibitor and an immunomodulatory agent (IMiD) or who are double refractory to a proteasome inhibitor and an IMiD. This is the indication for which daratumumab was granted Breakthrough Therapy Designation from the FDA in May 2013.

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Daratumumab showed a manageable safety profile. The data will be discussed with health authorities at upcoming meetings, pending their agreement.

"We are very pleased with these positive results in this study of daratumumab as a monotherapy for the treatment of double refractory multiple myeloma," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We look forward to presenting additional data of this trial at a key upcoming medical conference this year."

On February 3, 2015 CTI BioPharma reported that the Gynecologic Oncology Group, now part of NRG Oncology, informed CTI BioPharma that an independent Data Monitoring Committee (DMC) recommended continuation of the GOG-0212 Phase 3 clinical study of OPAXIO (paclitaxel poliglumex) as maintenance therapy in ovarian cancer with no changes following a second of four planned interim analyses for survival and futility (Press release CTI BioPharma, FEB 2, 2015, View Source;p=RssLanding&cat=news&id=2012846 [SID:1234501445]). CTI BioPharma remains blinded to the interim analysis results. GOG-0212 is the largest maintenance study in this setting, having enrolled 1,150 patients.

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The trial is being conducted and managed by the Gynecologic Oncology Group, now part of NRG Oncology, which is one of the National Cancer Institute’s funded cooperative cancer research groups with a focus on the study of gynecologic malignancies.

"We believe that there remains a significant unmet need in keeping a patient’s cancer from returning following initial treatment for ovarian cancer," said James A. Bianco, M.D., CTI BioPharma’s President and Chief Executive Officer. "The GOG-0212 study is designed to investigate whether Opaxio, when used in a maintenance setting in ovarian cancer, could keep these women in remission and potentially extend their lives."

On January 30, 2015 Stemline Therapeutics reported that SL-701 has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of glioma (Press release Stemline Therapeutics, JAN 30, 2015, View Source [SID:1234501432]).

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SL-701 is an enhanced immunotherapy designed to activate the immune system to kill malignant gliomas, which are aggressive malignancies of the brain that arise in both adults and children. A multicenter Phase 2 clinical trial is currently evaluating the antitumor activity of SL-701 in adult patients with second-line glioblastoma multiforme (GBM), a particularly aggressive type of glioma. An earlier version of the therapy demonstrated clinical activity, including durable complete responses (CRs) and partial responses (PRs) as well as prolonged disease stabilizations and an overall survival signal, in both adults and children with malignant glioma.

"We are pleased with the FDA’s decision to grant Orphan Drug designation to SL-701 as it provides Stemline with a number of benefits through development and commercialization of this novel therapy," noted Eric K. Rowinsky, M.D., Stemline’s Chief Medical Officer and Head of Research and Development. He continued, "GBM is a highly aggressive disease with few effective treatment options and remains a major unmet need. Instead of targeting a single component of the cancer, SL-701 is designed to activate and direct the immune system against multiple targets overexpressed on glioma cells. We are very pleased about the high level of interest in the study from patients and clinicians alike."

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..