On November 11, 2013 ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted anticancer therapeutics, reported that Novartis has licensed the exclusive right to use the Company’s antibody-drug conjugate (ADC) technology to develop anticancer therapeutics to an undisclosed target (Press release, Novartis, NOV 11, 2013, View Source [SID:1234503696]). This is the third license to be taken by Novartis — and the fifth to be taken by a major healthcare company — this year.

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"In the past year, Novartis, Eli Lilly and Amgen have each licensed exclusive rights to use our industry-leading ADC technology for one or more targets," commented Daniel Junius, President and CEO. "There are now numerous highly promising product candidates in the clinic through our own programs and through our partnerships, with many earlier-stage compounds advancing behind these."

The terms of this third Novartis license are consistent with the license announced last month.

(Filing, 10-Q, Momenta Pharmaceuticals, NOV 8, 2013, View Source [SID:1234504029])

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On November 8, 2013 Patrys reported that it has been granted a second US patent for lead anti-cancer product PAT-LM1 (Press release Patrys, NOV 8, 2013, View Source [SID:1234500547]).
The United States Patent Office has issued the official "Letters Patent" on a key patent in the PAT-LM1 family; US patent 8,562,995 entitled "Neoplasm specific antibodies and uses thereof". It offers patent protection through to March 2024.
This is the second patent to be granted in the US jurisdiction, and the third for the PAT-LM1 family. In June this year a patent covering the use of the PAT-LM1 antibody or binding fragments for the treatment or prevention of metastasis was granted in New Zealand.
The patent claims the PAT-LM1 antibody and other variants comprising the Complementary Determining Region (CDRs) of the PAT-LM1 antibody.

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On November 8, 2013 HitGen Ltd reported that it has entered into a research collaboration with The University of Manchester’s Cancer Research UK Manchester Institute Drug Discovery Group and Cancer Research Technology using HitGen’s proprietary lead discovery technology (Press release, Cancer Research Technology, AUG 8, 2013, View Source [SID1234523247]). Within the framework of the collaboration, hundreds of millions of small molecules will be screened to discover and advance drug candidates against multiple new oncology targets of interest to the Cancer Research UK Manchester Institute.

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HitGen’s encoded libraries have been designed to contain many hundreds of millions of small molecules with drug-like properties and have been synthesized on many chemically diverse scaffolds in order to provide maximum opportunity for finding drug leads against protein targets from known and novel protein classes.

Under the terms of the agreement the Cancer Research UK Manchester Institute will provide HitGen with funding for collaborative research and success-based milestone payments as candidate molecules progress through preclinical testing and into clinical development. Further financial details were not disclosed.

"We are very pleased to initiate our research partnerships by entering into this drug discovery collaboration with the Cancer Research UK Manchester Institute, a world leading cancer research group." said Dr Jin Li, CEO of HitGen Ltd. "We are looking forward to successfully tackling challenging targets using this cutting edge technology in collaboration with the innovative scientists at the Cancer Research UK Manchester Institute."

"We are very excited by this collaboration; HitGen’s technology offers us a novel way of prosecuting cancer targets derived from Cancer Research UK funded research" said Dr Donald Ogilvie, Head of the Drug Discovery Unit at the Cancer Research UK Manchester Institute. "We anticipate that this will allow us to tackle targets which have not been amenable to more traditional hit finding methods". He went on to say that "in the longer term we hope that this collaboration will allow us to deliver real patient benefit to the global cancer community."

"This important collaboration will allow us to access a library of millions of compounds enabling us to develop new ways to block challenging targets. This agreement will pave the way for new treatments and new options for patients which we hope ultimately will one day save more lives from cancer" said Dr Phil L’Huillier, Director of Business Development at CRT.

On November 5, 2013, the Company received written notification from the United States Food and Drug Administration (FDA) that its Phase 1 study of CUDC-427 has been placed on partial clinical hold following the report of death of a patient who progressed to liver failure approximately one month following the discontinuation of CUDC-427 dosing (Press release Curis, NOV 6, 2013, View Source [SID:1234500346]). Under this partial clinical hold, new patients may not be enrolled in the study until Curis provides the FDA with requested additional data and analysis on patients treated with CUDC-427 and a proposed protocol amendment is submitted to and accepted by the FDA. The Company expects to respond to the FDA’s requests for additional information and also plans to submit an amendment to the current protocol in a timely manner.
The current open-label, single-agent, dose escalation Phase 1 study of CUDC-427 was initiated in the third quarter of 2013 in patients with advanced and refractory solid tumors or lymphomas. The study was designed to determine the maximum tolerated dose (MTD) and recommended single-agent Phase 2 dose of CUDC-427 using a continuous, twice-daily treatment schedule. One patient with breast cancer metastatic to the liver, lungs, bone and ovaries developed serious adverse events related to liver function, including increases in serum levels of AST and ALT enzymes and bilirubin. Unlike prior clinical experience with CUDC-427, this patient’s liver enzyme levels did not recover in response to CUDC-427 discontinuation, and the patient died of liver failure approximately one month following the discontinuation of CUDC-427 dosing. While elevations in liver enzyme levels have previously occurred in patients receiving CUDC-427, no other patients in this or a prior Phase 1 CUDC-427 trial have experienced a serious adverse event of this nature. There are no patients currently being treated with CUDC-427 in this study as all other patients enrolled in this study have discontinued dosing due to disease progression or patient or physician discretion during the ordinary course of the study.

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