(Filing, 10-K, iBio, SEP 30, 2013, View Source [SID:1234502731])

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On September 25, 2013 Boehringer Ingelheim reported that the European Commission has granted marketing authorisation for afatinib monotherapy, for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s) (Press release, Boehringer Ingelheim, SEP 25, 2015, View Source [SID:1234510771]). Afatinib will be marketed in Europe under the brand name GIOTRIF.

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"We are delighted with the decision by the European Commission. We hope this will be the first of many registrations for drugs from our in-house oncology research program," commented Prof Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "The approval of afatinib in Europe reinforces our commitment to bringing the right treatments to the right patients. This is a significant step towards meeting the substantial unmet need in lung cancer treatment."

Lung cancer is one of the most common forms of cancer, accounting for 1.6 million new cases each year.2 It is the most deadly; more people die of lung cancer than of colon, breast and prostate cancers combined.3 In Europe alone, lung cancer is responsible for almost 270,000 deaths each year.4 Although incidence rates are higher in men than women it has been suggested that, by 2015, lung cancer will overtake breast cancer as the biggest cause of female cancer death in Europe.4

Because lung cancer is more than one disease, distinct subtypes can be characterised by receptors that are frequently altered or overexpressed in cancer cells. One such molecular marker is EGFR (a member of the ErbB Family of receptors). The prevalence of tumours harbouring EGFR mutations is between 10-15% in Caucasian and 40% in Asian NSCLC patients.5

In clinical trials, afatinib has been shown to offer patients with this type of lung cancer a significant delay in tumour progression, coupled with improvements in their lung cancer related symptoms (e.g. shortness of breath, cough and chest pain) and quality of life.1,6 Therefore, early mutation testing for EGFR status is a crucial step in the treatment-decision pathway, to give patients the opportunity to receive the appropriate personalised therapy from the start.

"Its unique mode of action allows afatinib to block EGFR and other members of the ErbB Family of receptors that play a key role in the growth and spread of cancers associated with a high mortality such as lung cancer," said Dr. Sanjay Popat, Consultant Medical Oncologist, The Royal Marsden NHS Foundation Trust, London and clinical investigator in the LUX-Lung 3 trial. "Clinical data demonstrates afatinib’s efficacy in delaying tumour growth and improving lung cancer related symptoms, making it an important addition to our treatment options in Europe."

Following recent approvals in the U.S., Taiwan and Mexico, European Union approval of afatinib is based on data from the pivotal LUX-Lung 3 trial and other Phase III and Phase II lung cancer studies. Data from Phase III LUX-Lung 3 trial have shown that patients taking afatinib as a first-line treatment lived for almost one year without their tumour growing again (median progression-free survival (PFS) of 11.1 months) versus just over half a year (PFS of 6.9 months) for those treated with pemetrexed/cisplatin. In addition, a subgroup analysis has shown that NSCLC patients with tumours harbouring the two most common EGFR mutations (Del19 or L858R) taking afatinib lived for well over a year without tumour progression (PFS of 13.6 months) versus just over half a year (PFS of 6.9 months) for those in the comparator arm.1

The most common grade 3 drug-related adverse events observed in the afatinib treatment arm were diarrhoea (14%), rash (16%), and inflammation of the nail bed (paronychia) (11%). The most common drug-related grade 3 adverse events observed in the chemotherapy arm (pemetrexed/cisplatin) were neutropenia (15%), fatigue (13%), and leucopenia (8%). There was a low discontinuation rate associated with treatment-related adverse events in

About Afatinib
In the European Union, Taiwan and Mexico, afatinib is approved under the brand name GIOTRIF for the treatment of patients with metastatic NSCLC whose tumours have epidermal growth factor receptor (EGFR) mutations.

In the U.S., afatinib is approved under the brand name GILOTRIFTM for the first-line treatment of patients with metastatic NSCLC whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.7
Afatinib is an irreversible ErbB Family Blocker, which blocks EGFR (ErbB1) as well as the other relevant members of the ErbB Family that are known to play a critical role in the growth and spread of the most pervasive cancers and cancers associated with high mortality. The covalent and, therefore, irreversible binding of afatinib is unlike other compounds which are reversible in that it provides a sustained, selective, and complete ErbB Family Blockade, and therefore may lead to a distinct therapeutic benefit.8,9

Afatinib is currently in Phase III clinical development in NSCLC and head & neck cancer.

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."