On August 30, 2011 Gedeon Richter and STADA Arzneimittel reported that the two companies have signed two separate license and collaboration agreements in respect of the development and marketing of two biosimilar products, two monoclonal antibodies Rituximab and Trastuzumab (Press release Gedeon Richter, AUG 30, 2011, View Source [SID:1234501390]).

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​According to the agreement STADA receives non exclusive distribution rights for the area of geographical Europe and the CIS area, but due to regulatory reasons, excluding Russia, for the biopharmaceutical active ingredient Rituximab, which Richter is currently developing and whose approval from today’s perspective can be expected at the end of 2017. In addition to STADA and eventual own marketing, Richter may grant a maximum of one additional partner a relevant distribution license in the contract area. If such a partially exclusive license marketing in Russia become regulatory possible, STADA would also receive such a distribution license there from Richter.

Under the terms of the agreement in addition to a payment on the event of signing the contract, STADA is obliged to make further payments each depending on the progress of the project which amount in total to a low double-digit million Euro figure. STADA will exclusively purchase the Rituximab biosimilar from Richter for marketing and distribution of the product for which the major commercial terms are already agreed on.

STADA, as is known, has done preparatory work for the biopharmaceutical active ingredient Trastuzumab, which, however, was stopped at the end of 2010 because STADA made the strategic decision to pursue the lower-cost approach of an in-licensing. The stage of development that STADA had reached up until that point will now be acquired by Richter as part of a contract concluded today for a low single-digit million Euro figure, in order to thus accelerate the ongoing own development for a Trastuzumab biosimilar. In addition, STADA receives, at the time of the beginning of the clinical studies in approximately two years, a unilaterally for STADA exercisable option from Richter to acquire also for such a Trastuzumab biosimilar a distribution license at commercial conditions analogous to those of the Rituximab.

The CEOs both of STADA and Richter expressed their commitment to the established cooperation.

For Hartmut Retzlaff, Chairman of the Executive Board of STADA Arzneimittel AG, the cooperation agreed on today shows that the STADA strategy of refraining from its own cost-intensive biosimilar development and to instead rely on cooperations and licenses for these biosimilar projects was correct. "With today’s cooperation we have secured marketing access to two biosimilars with particularly high sales potential for our core markets in Europe at substantially more favorable conditions than with a development of our own – and that with such an outstanding partner like Richter which is known in the industry for its high degree of expertise and reliability", said Retzlaff.

Erik Bogsch, CEO of Gedeon Richter Plc., added following comments on today’s contracts:
„We always considered the development of biosimilar products as an important strategic initiative for Richter and we made significant efforts to establish our future presence in the field of biotechnology, thereby enhancing the proportion of high added value products. This agreement is considered to be a significant move in line with Richter’s aim to find strategic partners for the development, marketing and distribution of our biosimilar product portfolio. With STADA we gained an excellent, high class cooperation partner whose traditionally strong presence and expertise in the field of developing and marketing both generic and biosimilar product groups, will contribute to fulfil our long term strategy."

The development of both biosimilars will now be continued under the leadership of Richter. A supporting function from STADA for specific patent rights questions in both projects has also already been agreed upon today. STADA will also support if necessary the relevant approval processes with its own expertise in the area of EU approvals of biosimilars.

On August 25, 2011 A team led by Professor Stephen Jackson together with Cancer Research Technology (Cancer Research UK’s commercial arm) and the University of Cambridge has reported the launch of MISSION Therapeutics Ltd, with Series A funding from a top venture capital syndicate (Press release, Cancer Research Technology, AUG 25, 2011, View Source [SID1234523321]).

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The new spin-out company will translate cutting-edge cell biology research on DNA repair from Professor Jackson’s laboratory at the Gurdon Institute, University of Cambridge, into drugs that will markedly improve the management of life-threatening diseases, particularly cancer. The company will be based at the Babraham Research Campus, Cambridge, UK.

MISSION Therapeutics is developing a broad platform of technologies for the discovery and development of first-in-class drugs targeting enzymes involved in cancer and other diseases. The company will predominantly exploit new and exciting research on ubiquitin pathways that control cellular responses to DNA damage.

The company has raised £6 million in Series A funding from a strong venture capital syndicate led by Sofinnova Partners, and comprising Imperial Innovations, SR One and Roche Venture Fund.

The founding scientists of MISSION Therapeutics, which include Professor Jackson, Dr Niall Martin, Dr Xavier Jacq and Dr Keith Menear, comprise a highly successful team with extensive experience and a proven track-record in translating new scientific concepts all the way to clinical trials. Each of the founders was until recently a key scientist at KuDOS Pharmaceuticals, a Cambridge-based biotech company also founded by Professor Jackson.

Professor Jackson, said: "It’s very exciting to be part of this venture to develop new drugs to improve the lives of people with cancer. Importantly, while having the potential to be effective by themselves, these drugs could also improve the effectiveness of existing cancer treatments, such as radiotherapy and certain chemotherapies."

Graziano Seghezzi, partner at Sofinnova, said on behalf of the investors: "Novel effective treatments for cancer remain in high demand. Mission Therapeutics, under Professor Jackson’s scientific leadership, has the potential to discover new molecularly-targeted drugs that could revolutionise the way cancer patients are treated".

Dr Keith Blundy, CEO of Cancer Research Technology, added: "It’s fantastic that the cutting-edge science funded by Cancer Research UK can attract additional cancer drug discovery funding from commercial sources to develop exciting new treatments for cancer patients in the future."

On August 19, 2011 Sareum, the specialist cancer drug discovery business, The Institute of Cancer Research ("the ICR") and Cancer Research UK’s commercial arm, Cancer Research Technology Limited ("CRT") reported the selection of a preclinical development candidate from their joint research collaboration (Press release, Cancer Research Technology, AUG 19, 2011, View Source [SID1234523523]).

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The joint research collaboration targets Chk1 (Checkpoint Kinase 1). Chk1 is important in controlling a cancer cell’s response to DNA damage, which may be a consequence of the cancer itself, or intentionally caused by chemotherapy or radiotherapy.

Preclinical model studies carried out at the Cancer Research UK Cancer Therapeutics Unit at the ICR demonstrate that the Chk1 candidate, dosed via the oral route, in combination with the chemotherapeutics gemcitabine or irinotecan significantly reduces cancer growth rates compared to treatment with the same dose of chemotherapeutic without the Chk1 inhibitor.

Further preclinical studies demonstrate the potential for the collaboration Chk1 development candidate to reduce tumour growth when given as a sole treatment in models of certain cancer types that are believed to be dependent on Chk1 for survival.

Sareum’s CEO, Dr Tim Mitchell, commented: "The selection of a preclinical development candidate is a major milestone for the collaboration that will significantly enhance the licensing package. Our research indicates that the selectivity and oral dosing properties of this candidate give it a competitive advantage."

Professor Paul Workman, Director of the Cancer Research UK Cancer Therapeutics Unit at the ICR, said: "The significant progress made so far is very pleasing and highlights the value of partnerships between industry and academic drug discovery groups like ours. There is further important development work to be done so that patients can one day benefit from these drugs, and we look forward to the progress of the compound towards the clinic."

Dr Philip Masterson, Associate Director at Cancer Research Technology, said: "We are working to select the right commercial partner to take the Chk1 programme into clinical development. Our ultimate aim is that one day, this drug will become available to treat a range of cancers and save more lives from the disease.

Our scientists have shown that this drug is promising in preclinical studies, and we hope further research will prove that it can be used on its own or alongside chemotherapy and radiotherapy to destroy cancer cells in patients."

(Press release, Heartlink, AUG 16, 2011, View Source [SID:1234502004])

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On August 11, 2011 TapImmune reported that following FDA IND approval, it will sponsor a Phase I HER-2/neu targeted therapeutic vaccine trial in HER-2/neu positive breast cancer patients at the Mayo Clinic (Press release TapImmune, AUG 11, 2011, View Source [SID:1234501503]).

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The trial stems from a technology license option and sponsored research agreements between Mayo Clinic and TapImmune and is based on research on novel immunogenic peptide epitopes of the HER-2/neu antigen discovered in breast cancer patients with pre-existing immunity to HER-2/neu. The trial is jointly led by Keith Knutson, Ph.D and Amy Degnim, M.D. Mayo Clinic. According to Dr Knutson, "HER-2/neu is associated with aggressiveness in breast cancer and in our preclinical mouse studies we found that boosting HER-2/neu-specific immunity blocks tumor growth. In the planned human clinical trial, the goal will be to determine whether we can also boost immunity to HER-2/neu in patients, hopefully paving the way to asking whether vaccination blocks tumors in humans".

In the upcoming trial, HER-2/neu positive breast cancer patients will be given the vaccine mixed with GM-CSF as an adjuvant to enhance immunity. The trial aims to evaluate the safety of this vaccine as well as immune responses.

According to TapImmune’s Chairman and CEO, Dr Glynn Wilson, this major milestone event for the company represents the first step in the development of a novel HER-2/neu vaccine that augments both CD4 T-helper cells and CD8 cytotoxic T-cells. This technology may ultimately work synergistically with TapImmune’s core TAP technology with the aim of producing a robust and long-acting immune response in a broad population of HER-2/neu positive breast cancer patients. "Immunotherapies are increasingly playing a major role in oncology to prolong patient survival and quality of life. TapImmune is delighted to be collaborating with leaders at the Mayo Clinic to translate pioneering research into new treatments."

The trial is due to commence recruitment in the 4th quarter of 2011. Under the terms of the technology license option agreement with the Mayo Clinic, TapImmune has an exclusive worldwide option to become the exclusive licensee for sale of any resulting commercial vaccines.