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Medivation Inc. Licenses Clinical Stage Anti-PD-1 Immune Modulatory Monoclonal Antibody From CureTech Ltd. for Potential Applications in Oncology

On October 23, 2014 Medivation and CureTech reported that Medivation has licensed exclusive worldwide rights to CureTech’s late-stage clinical molecule pidilizumab (CT-011), an immune modulatory anti-PD-1 monoclonal antibody (Press release Medivation, OCT 23, 2014, View Source [SID:1234500873]). Under the license agreement, Medivation will be responsible for all development, regulatory and commercialization activities for pidilizumab for all indications, including oncology.

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"Immuno-oncology is a significant area of interest for researchers in the development of anti-cancer therapies, marked by its potential to stimulate the body’s immune system to fight disease," said David Hung, M.D., President and Chief Executive Officer of Medivation. "Licensing rights to pidilizumab under this agreement marks an important step in our strategy to further diversify our portfolio."

"We believe that Medivation’s expertise and accomplishments in drug development will be a tremendous advantage in the highly competitive field of oncology immunotherapy," said Michael Schickler, Chief Executive Officer of CureTech. "We are pleased that Medivation will advance this molecule to the next stage of development and potential commercialization."

The arrangement with CureTech also includes a manufacturing and supply agreement, under which CureTech will manufacture and supply the antibody to Medivation over the next 3 years for clinical development purposes. In addition, the arrangement contemplates a guaranty agreement between Medivation and CureTech’s largest (53%) shareholder — Clal Biotechnology Industries Ltd. (CBI) — with respect to certain obligations of CureTech. The guaranty is subject to approval by CBI shareholders. If approval of the guaranty agreement is not obtained, Medivation has the option to terminate both the license agreement and the manufacturing and supply agreement or proceed with such agreements on reduced economic terms (i.e. a reduction of $2 million in the upfront payment and 1% from each tier of royalties). The shareholder vote on the guaranty and Medivation’s exercise of its option to continue to maintain the license are expected to occur in December 2014.

Under the terms of the license agreement, and depending on whether the guaranty from CBI is obtained, CureTech would receive an upfront payment of up to $5.0 million from Medivation and would also be entitled to payments upon the attainment of certain development and regulatory milestones totaling $85 million. In addition, CureTech would be eligible to receive sales based milestone payments totaling up to $245 million, upon the achievement of certain annual worldwide net sales thresholds, and tiered royalties ranging from 4%-11% based on annual worldwide net sales.

Clovis Oncology Announces First Patient Enrolled in Lucitanib Phase 2 Study in Squamous Non-small Cell Lung Cancer

On October 23, 2014 Clovis Oncology reported that its global Phase 2 study of lucitanib in patients with FGFR1-amplified squamous non-small cell lung cancer (NSCLC) has commenced and the first patient has been dosed at a U.S. study site (Press release Clovis Oncology, OCT 23, 2014, View Source;p=RssLanding&cat=news&id=1981074 [SID:1234500872]). Lucitanib is the Company’s oral, potent inhibitor of the tyrosine kinase activity of fibroblast growth factor receptors 1 through 3 (FGFR1-3), vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3) and platelet-derived growth factor receptors alpha and beta (PDGFR α-ß).

"The lucitanib data presented to date in patients with FGF-aberrant breast cancer are very encouraging, and we know that FGFR1 amplification occurs in approximately 15 percent of patients with squamous non-small cell lung cancer," said Dr. Benjamin Besse, Head of Thoracic Oncology, Institut Gustave Roussy, and the lead investigator of the study in squamous NSCLC. "Accordingly, we are very enthusiastic to explore lucitanib in this selected population of patients with lung cancer, for whom there is significant need for novel therapies."

"Less than a year after acquiring lucitanib, we are commencing a broad clinical development program, which includes this study in FGFR1-amplified squamous NSCLC, as well as our ongoing study currently underway in FGF-aberrant breast cancer," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We are enthusiastic about the opportunity to explore lucitanib in these indications, and potentially in other solid tumors exhibiting FGFR pathway activation."

The Phase 2 study will enroll FGFR1-amplified squamous NSCLC patients with advanced disease who have progressed on at least one prior line of therapy. The global study will assess objective response rate, progression-free survival, and duration of response, as well as the safety, tolerability, and pharmacokinetics of lucitanib.

Lucitanib is unique among tyrosine kinase inhibitors being developed for cancer therapy, as it effectively targets fibroblast growth factor receptors (FGFR)1-3, vascular endothelial growth factor receptors (VEGFR)1-3, and platelet-derived growth factor receptors (PDGFR) alpha and beta with minimal off-target activity. This selectivity profile allows lucitanib to provide a potential benefit to cancer patients by targeting multiple pathways of tumor development. Specifically, by targeting the FGFR pathway, lucitanib can have a direct antitumor effect in FGF/FGFR driven tumors such as breast or lung cancers harboring amplification of the FGFR1 gene. In addition, by targeting the FGFR, VEGFR and PDGFR receptors lucitanib also can inhibit the development of blood vessels that are required by the tumor to grow and spread.

In addition to this Clovis-sponsored Phase 2 study in squamous NSCLC, a global development program for lucitanib in breast cancer is underway, which includes the Clovis-sponsored Phase 2 study in FGF-aberrant advanced breast cancer being conducted in the U.S., the Servier-sponsored FINESSE study of lucitanib monotherapy being conducted in Europe, Canada and Australia as well as the Servier-sponsored INES study evaluating lucitanib in combination with fulvestrant after failure of endocrine therapy.

Aduro Presents Updated Interim Results from Phase 1b Clinical Trial in Mesothelioma at International Mesothelioma Interest Group Conference

On October 23, 2014 Aduro BioTech reported the presentation of updated safety and efficacy data from an ongoing Phase 1b clinical trial of its novel immunotherapy CRS-207 in combination with standard chemotherapy in patients with unresectable malignant pleural mesothelioma (MPM) (Press release Aduro BioTech, OCT 23, 2014, View Source [SID:1234500871]). Of 16 evaluable patients with response data, 75% (12/16) had confirmed durable partial responses (PR) and 19% (3/16) experienced stable disease (SD) after CRS-207 and chemotherapy, for a 94% rate of disease control (PR and SD). At the time of the presentation, estimated progression-free survival was 7.5 months with one patient on study for more than 19 months, currently receiving maintenance therapy with CRS-207 following the combination treatment.

The results were presented by Raffit Hassan, M.D., winner of the 2014 Wagner Medal for his career work in mesothelioma and co-chief of the Thoracic and GI Oncology Branch at the National Cancer Institute, in an oral presentation at the International Mesothelioma Interest Group (iMig) Conference held in Cape Town, South Africa. CRS-207, based on Aduro’s live-attenuated, double-deleted (LADD) Listeria monocytogenes immunotherapy platform, has been engineered to induce a potent innate immune response as well as an adaptive immune response targeting mesothelin, an antigen over-expressed in MPM tumors.

"We continue to be excited by the results from this trial of our novel immunotherapy in combination with chemotherapy in this difficult-to-treat patient population," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "While the findings warrant further investigation, we believe CRS-207 may prove to be a very attractive therapeutic option in the armamentarium to improve overall response rates and boost the duration of those responses."

Dirk G. Brockstedt, Ph.D., senior vice president of research and development at Aduro, added, "These results continue to support the promise of our technology as a method to boost and rally a patient’s immune system to target tumors. We plan to further evaluate CRS-207 in combination with chemotherapy in a randomized, controlled Phase 2 clinical trial in mesothelioma, which we anticipate to begin in the first half of 2015."

The multi-center Phase 1b study is open to patients with unresectable MPM who are chemotherapy-naïve, have good performance status (ECOG 0 or 1) and adequate organ function. Under the trial design, eligible patients receive two prime vaccinations with CRS-207 two weeks apart, followed by up to six cycles of standard of care pemetrexed and cisplatin chemotherapy three weeks apart and then two CRS-207 boost vaccinations three weeks apart. Clinically stable patients are eligible to receive CRS-207 maintenance vaccinations every eight weeks. Subjects are followed every eight weeks until disease progression. Objectives of the study are to assess safety, immunogenicity, objective tumor responses and tumor marker kinetics. Twenty-three patients have been enrolled thus far and additional response, follow-up and immune response data are pending.

At the time of the presentation, the median time on study was 229 days (range: 155-570 days). No treatment-related serious adverse events or unexpected toxicities were observed. The most common adverse events associated with CRS-207 were infusion-related chills and fever, which were transient, mild and self-limiting.

Pfizer Wins SUTENT® Patent Case In Delaware District Court

On October 23, 2014 Pfizer reported that the U.S. District Court for the District of Delaware upheld its basic patent and the L-malate salt patent covering SUTENT (sunitinib malate) capsules (Press release Pfizer, OCT 23, 2014, http://www.pfizer.com/news/press-release/press-release-detail/pfizer_wins_sutent_patent_case_in_delaware_district_court [SID:1234500866]). This decision, which is subject to appeal, affirms Pfizer’s right to exclusively provide sunitinib malate as SUTENT to patients through the term of the patent, which expires in 2021.

"The Court’s decision acknowledges the validity and infringement of our patents and affirms the value of SUTENT, a standard of care in the treatment of advanced renal cell carcinoma," said Douglas M. Lankler, executive vice president and general counsel for Pfizer. "Defending our intellectual property is crucial to our ability to discover and develop innovative new medicines, which is at the very core of what we do."

Pfizer filed suit in June 2010 after Mylan Pharmaceuticals Inc. applied to the U.S. Food and Drug Administration (FDA) to market a generic version of SUTENT prior to the expiration of the patents covering sunitinib malate and its uses. After a four-day trial, the Court agreed that Mylan infringed the valid patents covering SUTENT.

The patents at issue are U.S. Patent Nos.6,573,293 and 7,125,905.

Genmab Reaches USD 10 Million Milestone in Daratumumab Collaboration with Janssen

On October 23, 2014 Genmab reported that it has reached the fourth milestone in its daratumumab collaboration with Janssen Biotech (Press release Genmab, OCT 23, 2014, View Source [SID:1234500865]). The USD 10 million milestone payment was triggered by progress in the ongoing Phase III study ("CASTOR" MMY3004) of daratumumab in combination with bortezomib and dexamethasone compared to bortezomib and dexamethasone alone for the treatment of relapsed or refractory multiple myeloma.

"We are very pleased with the firm progress being made in the daratumumab development program under the direction of our strategic partner Janssen. At Genmab we are committed to developing differentiated therapeutics to fight cancer, and it is therefore rewarding to see one of our antibodies moving rapidly through clinical development," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

This milestone payment is included in Genmab’s 2014 financial guidance as published on August 13, 2014.