Clovis Oncology aims for its first New Drug Application (NDA) submission by 2015. Lined up is a global Phase 3 registration study for rucaparib and plans to initiate registration studies for CO-1686 in the second quarter of 2014 (Press release Clovis Oncology, FEB 27, 2014, View Source [SID:1234500190]).
Immune Design Announces Treatment of First Patient in Phase 1 Clinical Trial of ID-G305 Cancer Immunotherapy Agent
On February 27, 2014 Immune Design announced treatment of the first patient in a Phase 1 clinical trial of ID-G305 (Press release Immune Design, FEB 27, 2014, View Source [SID:1234500179]).
The Phase 1 open label, dose-escalation trial is designed to evaluate the safety, tolerability and immunogenicity of ID-G305 in patients with unresectable, relapsed, or metastatic cancer expressing the NY-ESO-1 antigen, including melanoma, sarcoma, lung, ovarian or breast cancer. The trial is being conducted in up to 18 patients at several clinical centers in the United States.
Epizyme Achieves Lead Candidate Selection Milestone in GSK Collaboration, Earning $2 Million Milestone
On February 27, 2014 Epizyme reported the achievement of the lead candidate selection milestone for one of the histone methyltransferase (HMT) targets in the company’s collaboration with GSK (Press release Epizyme, FEB 27, 2014, View Source [SID:1234500178]). This achievement triggers a milestone payment of $2 million and follows the announcement in January 2014 of the achievement of a development candidate milestone for another of the HMT targets in the collaboration, which earned Epizyme a $4 million milestone payment.
Infinity Provides Company Update and Reports Full-Year 2013 Financial Results
Infinity reported at the 55th Annual Meeting of the American Society for Hematology (ASH) (Free ASH Whitepaper) Phase 1 data of IPI-145 monotherapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma (iNHL), demonstrating that IPI-145 was generally well tolerated and clinically active, with an overall response rate (ORR) of 73 percent, including three complete responses, among 15 patients receiving IPI-145 dosed at ≤ 25 mg twice daily (BID) (Press release Infinity Pharmaceuticals, FEB 25, 2014, View Source;p=RssLanding&cat=news&id=1903166 [SID:1234500160]). Data also showed that 53 percent of patients remained progression free for over one year. These data support the clinical rationale for DYNAMOTM, the ongoing Phase 2 study of IPI-145 in patients with refractory iNHL.
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6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]
On February 25, 2014 Can-Fite reported that the Japan Patent Office (JPO) has granted a Japanese patent which bears the Patent No. 5467872 and is titled "Process for the Synthesis of IB-MECA" (Press release Can-Fite BioPharma, FEB 25, 2014, View Source [SID:1234500158]). This patent describes a method for the chemical synthesis of the A3 adenosine receptor agonist, IB-MECA, which is the active pharmaceuticals ingredient (API) of the CF101 drug candidate. Under its patent rights, Can-Fite will have exclusive rights for the manufacturing of CF101 in Japan till 2028.
This patent has added significance for the company in light of the exclusive Japanese license agreement that Can-Fite has already entered into with Seikagaku Corporation (SKK). Under the agreement, Can-Fite granted a license to SKK to develop and commercialize CF101 for autoimmune inflammatory indications in Japan. The terms included up to $20 M in upfront and milestone payments plus up to 12% royalties. Such payments are subject to development and marketing milestones. To date $7.5M has been already received.
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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
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