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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.

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.

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]).

Verastem Acquires Rights to Cancer Stem Cell Inhibitor VS-4718

On February 25, 2014 Verastem announced that it has acquired the license to VS-4718 held originally by Poniard Pharmaceuticals (Press release Verastem, FEB 25, 2014, View Source [SID:1234500140]). The previous and future developmental, regulatory and commercial royalty milestones and payments associated with the development and potential future sales of VS-4718 due to Poniard Pharmaceuticals are now owned by Verastem. Verastem retains a license to VS-4718 from The Scripps Research Institute.
Under the terms of the Asset Purchase Agreement, Verastem acquired the existing and future developmental, regulatory and commercial royalty milestones and payments associated with the development and potential future sales of VS-4718 due to Poniard Pharmaceuticals. Verastem has issued 97,500 shares of common stock in the acquisition of the asset. In addition, Verastem is now the direct licensee of VS-4718 from The Scripps Research Institute with a potential obligation of up to $3m in developmental and regulatory milestones and a low single digit royalty on potential future sales.