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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10-K – Annual report [Section 13 and 15(d), not S-K Item 405]
In September 2013 Infinity announced topline data from its Phase 2 study evaluating retaspimycin hydrochloride, or HCl, a novel, potent and selective inhibitor of heat shock protein 90, or Hsp90, in combination with docetaxel, a chemotherapy, in 226 patients with second or third-line non-small cell lung cancer, or NSCLC, who are naïve to docetaxel treatment and have a history of heavy smoking (Press release Infinity Pharmaceuticals, FEB 25, 2014, View Source [SID:1234500157]). In this randomized, double-blind, placebo-controlled study, retaspimycin HCl did not meet its pre-specified efficacy endpoints for demonstrating an improvement in overall survival in the total patient population or in patients with squamous cell carcinoma, despite observing partial responses in patients with squamous cell carcinoma during the Phase 1b testing. Additionally, the combination of retaspimycin HCl plus docetaxel did not show a treatment benefit in patient populations defined by pre-specified biomarkers, including KRAS, p53 and plasma levels of Hsp90-alpha. Infinity expects to present final data in a peer-reviewed setting after all analyses are complete.
Infinity has completed enrollment of the final cohort of patients in our separate, exploratory study of retaspimycin HCl in combination with everolimus (an mTOR inhibitor) in NSCLC patients with a KRAS mutation. Completing enrollment has concluded our development of retaspimycin HCl, and we will not initiate any new trials with retaspimycin HCl.
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8-K – Current report
Orphan Drug Status
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Radio/chemotherapy-induced peripheral neuropathy
USA (2014); KRN5500 for the parenteral treatment of painful, chronic, chemotherapy-induced peripheral neuropathy that is refractory to conventional analgesics (US FDA, FEB 21, 2014, View Source & Filing 8K , Dara Biosciences, FEB 25, 2014, View Source [SID:1234500151]).