On September 25, 2013 Infinity reported topline data from its Phase 2 study of retaspimycin hydrochloride (HCl) in patients with non-small cell lung cancer (NSCLC) who had a history of smoking. In this double-blind, randomized, 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. In the study, the safety profile of retaspimycin HCl plus docetaxel was comparable to docetaxel and placebo. Infinity expects to present the final data in a peer-reviewed setting after all analyses are complete. The company will not initiate any new trials with retaspimycin HCl (Press release Infinity Pharmaceuticals, SEP 25, 2013, View Source;p=irol-newsArticle&ID=1857866&highlight= [SID:1234500162]).
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. In addition, the combination did not show a treatment benefit in patient populations defined by pre-specified biomarkers, including KRAS, p53 and plasma levels of Hsp90-alpha. The safety profile of retaspimycin HCl plus docetaxel was comparable to docetaxel and placebo.
The Phase 2, randomized, placebo-controlled study evaluated the efficacy and safety of retaspimycin HCl plus docetaxel compared to placebo plus docetaxel in 226 patients with second- or third-line NSCLC who were naïve to docetaxel treatment and had a smoking history. Patients received 450 mg/m2 retaspimycin HCl or placebo dosed weekly in combination with the standard dose of docetaxel dosed once every three weeks during a 21-day cycle. The co-primary efficacy endpoints were overall survival in the entire patient population and overall survival in patients with squamous cell carcinoma.
Infinity today also announced that it will complete enrollment of the final cohort of patients in its separate, exploratory study of retaspimycin HCl in combination with everolimus (an mTOR inhibitor) in NSCLC patients with a KRAS mutation by the end of 2013 to conclude its development of retaspimycin HCl.

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(Poster Discovery on Target 2013, Sorrento Therapeutics, SEP 24, 2013, View Source [SID:1234500784])

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On September 24, 2013 The Cancer Research Technology Pioneer Fund (CPF), London Stock Exchange-listed investment company, BACIT Limited (BACIT), and drug discovery company, Sareum Limited (Sareum), reported an agreement to co-fund the further development of a class of cancer drugs called CHK1 inhibitors (Press release, Cancer Research Technology, 24 24, 2013, View Source [SID1234523250]).

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The candidate inhibitor originates from research in the Cancer Research UK Cancer Therapeutics Unit at The Institute of Cancer Research, London, by scientists funded by Cancer Research UK working alongside Sareum’s researchers, and in collaboration with Cancer Research Technology (CRT).

A significant proportion of the further work funded by this new investment will be carried out at The Institute of Cancer Research (ICR), and it is expected that the drug candidate will be taken into clinical development at The Royal Marsden NHS Foundation Trust.

The rights to the preclinical programme have been licensed into CPF from CRT and the ICR. Under the terms of the deal, CPF obtains worldwide rights to the preclinical CHK1 inhibitor programme and is responsible, for future development and commercialisation, funded by CPF, BACIT and Sareum. CRT and the originating research partners, Sareum and the ICR, are entitled to an up-front fee plus success milestone and royalty payments. Financial terms of the licence are not disclosed.

The investment is the first by BACIT in a drug development or medical innovation project at the ICR.

CHK1 inhibitors control a cancer cell’s response to DNA damage. Blocking CHK1 could boost the efficacy of chemotherapy drugs by blocking repair of the DNA damage caused by these drugs, but without harming healthy cells.

The developers of the programme believe the candidate CHK1 inhibitor to be developed could potentially treat a range of cancers including pancreatic, bowel and non-small cell lung cancer (NSCLC) in combination with DNA-damaging chemotherapy drugs and radiotherapy. The inhibitor could also potentially treat certain neuroblastoma and acute myeloid leukaemia (AML) types when dosed alone.

Ian Miscampbell, managing partner of Sixth Element Capital, the Manager of CPF, said: "This is the third investment made by the £50M CPF which CRT and the European Investment Fund launched in 2012 to bridge the UK funding gap between cancer drug discovery and early treatment development.

"We’re delighted to be working in partnership with BACIT and Sareum to fund this exciting development programme. This kind of funding collaboration will ensure that we can maximise the amount of money which can be committed through the CPF to develop new cancer therapies."

Tom Henderson of BACIT, said: "This collaboration marks BACIT’s first investment in a drug development project, and we’re delighted to be involved in such an exciting programme with the potential to deliver benefits for patients with many different types of cancer."

Dr Tim Mitchell, CEO of Sareum, said: "The funding which we are announcing today will enable the project to move swiftly towards, and potentially into Phase I clinical trials, the successful outcome of which should pave the way for the further development and commercialisation of a novel and broadly applicable cancer treatment."

Professor Paul Workman, deputy chief executive of The Institute of Cancer Research, said: "We’re delighted to be working with this innovative and powerful consortium to accelerate progress on the CHK1 inhibitor programme. The support of BACIT has been particularly welcome and this type of funding is absolutely essential if we are to deliver benefits from new molecularly targeted cancer drugs to patients.

"Our CHK1 inhibitor has exciting potential both as a cancer treatment in its own right and also as a drug to boost the effectiveness of chemotherapy and radiotherapy. All the partners are eager to expedite the drug candidate into clinical trials as quickly as possible because of the potential to treat large numbers of cancer patients with this approach."

Dr Keith Blundy, chief executive of Cancer Research Technology, said: "We’re delighted that this investment will bridge the gap to develop a promising molecule so that it can be taken into clinical trials to give to patients – a huge step on the way to providing new options for patients and one that may have been delayed for years without the vital injection of cash and resources provided through the CRT Pioneer Fund."

(Press release, Shield Biotech, SEP 17, 2013, View Source [SID:1234503738])

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On September 16, 2013 : Affimed Therapeutics AG and The Leukemia & Lymphoma Society (LLS) reported a partnership to co-fund a phase 2 trial with the Recruit – TandAb AFM13, a novel tetravalent bispecific antibody directed against human CD30 and CD16A in Hodgkin Lymphoma (HL) patients for whom currently available treatment s have failed (Press release, Affimed Therapeutics, SEP 16, 2013, View Source [SID:SID1234515605]). AFM13 is a first – in – class immunotherapy drug designed to treat HL patients and patients with CD30 – positive malignancies . LLS has committed to investing up to $4.4 million over 2 years to support the project.
Dr . Richard Winneker, SVP Research for LLS , stated, " Though the cure rate for Hodgkin Lymphoma is high compared to other types of blood cancers , refractory and relapse d patients have few therapeutic options . More importantly current treatments for HL patients involve cytotoxic drug therapies and radiotherapy , which are likely responsible for secondary tumors and other considerable long term side effects developing later in a patient ’ s life , leaving open a critical need for safer and more durable therapies. LLS is committed to advancing breakthrough therapies, particularly for patients with unmet medical need s, and Affimed’s immunotherapy is emerging as a promising thera peutic option for HL patients . "
"The partnership between Affimed and LLS is a significant validation of the high potential of our TandAb platform and reinforces our strategy to develop this novel bispecific construct for hematological tumors", said Dr. Adi Hoess, CEO of Affimed AG. "We very much welcome LLS ’s commitment to AFM13 , and we look forward to an accelerated de velopment of this therapy for patients with limited treatment options to date."
In a phase 1 trial , AFM13 has shown a good safety profile , as it was well tolerated at all dose levels tested. Furthermore, AFM13 showed clear and meaningful signs of efficacy in some patients deemed to have a poor prognosis, including patients who had not benefited from the recently approved CD30 targeting drug , brentuximab vedotin ( Adcetris , Seattle Genetics). These encouraging data warrant the further investigation of AFM13 in a phase 2 trial to further assess its efficacy. Moreover, these trials could provide proof of concept for using bispecific antibodies to elicit natural killer (NK) cells, vital lymphocytes of the innate immune system, to effectively kill cancer cells.

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