On September 18, 2013 Université de Montréal (UdeM) and the Institute for Research in Immunology and Cancer – Commercialization of Research (IRICoR) reported that researchers from UdeM’s Institute for Research in Immunology and Cancer (IRIC) and Bristol-Myers Squibb Company have jointly identified a small molecule drug candidate against a novel target (Press release, Université de Montréal, SEP 8, 2013, View Source [SID1234626494]). This achievement represents a major pre-clinical milestone in the research collaboration between UdeM, IRICoR and Bristol-Myers Squibb and triggers a milestone payment to UdeM.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The UdeM and IRICoR medicinal chemistry component of this collaboration was carried out in IRIC’s medicinal chemistry core facility. This facility employs 20 industry-trained chemists who are supported by 5 biologists and other professionals who are actively working on a number of innovative drug discovery projects being funded by IRICoR.

"We are very pleased that our medicinal chemistry team achieved this very important milestone. The clinical candidate molecule that was identified in close collaboration with Bristol-Myers Squibb meets very stringent criteria," commented Dr. Anne Marinier, Director of IRIC’s Medicinal Chemistry Core Facility at UdeM. "This speaks to the talent of our team and our ability to deliver high-quality, optimized small molecules based on a seamless integration of biology and medicinal chemistry groups under a same roof’."

"This milestone in our long-standing collaboration with Bristol-Myers Squibb, and its associated payment, further validates IRICoR’s business model of working closely with leading pharmaceutical companies to identify clinical candidate molecules," explains Dr. Michel Bouvier, President and CEO of IRICoR.

On September 2, 2013 Kymab, a monoclonal antibody biopharmaceutical company, reported the appointment of Dr Christian Groendahl as Chief Executive Officer and Dr David Chiswell, currently non-executive Director of Kymab, as Chairman, to take effect from 16 September 2013 (Press release, Kymab, SEP 2, 2013, View Source [SID1234537015]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Kymab is using the Kymouse transgenic human antibody platform to discover and develop fully human monoclonal antibody drugs. Under the leadership of Dr Groendahl, Dr Chiswell and Dr Allan Bradley, Chief Scientific Officer, Kymab plans to further develop its platform and advance several drug candidates to clinical development stage over the next five years.

"Christian’s track record at Novo Nordisk and Zealand Pharma in building drug portfolios and progressing new medicines through clinical development, from both within and in partnership with global pharma companies, will enable us to maximise the potential of the Kymouse platform," said Dr Chiswell, newly appointed Chairman of Kymab.

"I would like to thank Andrew Sandham, who is stepping down as Chairman and CEO. Andy has done a tremendous job establishing Kymab and leading us from inception to this important transition stage. We all wish him every success in his next venture."

Dr Groendahl has worked in the pharmaceutical industry for nearly 20 years. Previously, he served as Chief Scientific Officer of Zealand Pharma, where he was responsible for building its clinical stage R&D portfolio and forging corporate partnerships with major pharma companies and took part in its initial public offering on the NASDAQ OMX in 2010.

Before this, Christian held research, development, clinical and corporate roles over a long career with Novo Nordisk, including VP Cancer and Inflammation, Corporate VP for Global Clinical Development and Corporate Development and Alliance Management.

"Kymab has developed a world class human antibody discovery platform since its formation in 2009. Christian’s unique mix of skills and experience will be invaluable in taking the company to the next level," added Dr Allan Bradley, Founder and Chief Scientific Officer of Kymab.

"The Kymouse technology provides a world class platform for the discovery of highly selective, potent therapeutic human monoclonal antibodies for a broad range of unmet medical needs," commented Dr Groendahl. "I am delighted to be joining Kymab and look forward to working with the founder Professor Allan Bradley, the board and the excellent Kymab team in building a substantial biopharmaceutical business in Europe over the next decade."

Dr Chiswell has over 30 years’ experience in the biotechnology industry, having co-founded Cambridge Antibody Technology in 1990 and, as CEO, built and developed the business and led public offerings on the LSE and NASDAQ exchanges. Since 2002 he served as chairman of a number of biotechnology companies including Nabriva Therapeutics, Sosei, and Daniolabs. He is currently also non-executive chairman of Albireo Pharma and a director of Nabriva Therapeutics. He joined the Kymab board in 2012.

Andrew Sandham will continue to support Kymab as a consultant until the end of the year.

On September 2, 2013 WILEX reported that its subsidiary Heidelberg Pharma signed a license agreement with Roche covering the development of a novel class of antibody drug conjugates (ADCs) based on Heidelberg Pharma’s patented technology to couple α-Amanitin to antibodies (Press release Heidelberg Pharma, SEP 2, 2013, View Source [SID:1234501083]). The license agreement covers initial joint research to apply this technology to multiple Roche antibodies towards the identification of development candidates with favourable efficacy/safety profiles.
Heidelberg Pharma will receive regular payments for granting access to its technology and providing research services. Roche will subsequently have the opportunity to exercise options for licenses to develop and market selected Antibody Targeted Amanitin Conjugates (ATACs). Heidelberg Pharma will manufacture these substances and receive customary upfront payments, milestone payments and royalties for each development candidate selected by Roche.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

α-Amanitin is a bicyclic peptide naturally occurring in the green Death Cap mushroom. It potently inhibits the biosynthesis of RNA, a mechanism which is critical for the survival of cells. Accordingly, ATACs exhibit comparable activity against proliferating and resting tumour cells. This proliferation independent activity differentiates ATACs from other ADCs, which preferentially target proliferating tumour cells. As an additional advantage ATACs could offer a substantial capability to overcome the resistance mechanisms which might limit the efficacy of other antibody drug conjugates. The ATACs tested so far have shown strong anti-tumour activity in several preclinical tumour models.

Dr Jan Schmidt-Brand, Managing Director of Heidelberg Pharma GmbH and Chief Financial Officer of WILEX AG, commented: "We are delighted about the opportunity to collaborate with a company as renowned as Roche. This cooperation is an important external validation of our technology. We will use this cooperation to jointly explore and technically expand the applicability of our technology to selected antibodies."

Dr Klaus Bosslet, heading Roche Discovery Oncology in Penzberg, Germany, added: "We look forward to collaborating with Heidelberg Pharma to elect and develop the most promising ATACs. Ultimately, these ATACs may provide novel treatment options for cancer patients, whose tumours do not respond to available cancer therapeutics."

On August 29, 2013 Astex Pharmaceuticals, Inc. (Nasdaq:ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, reported that Janssen Pharmaceutica NV has received clearance to commence a Phase I clinical trial of a Fibroblast Growth Factor Receptor (FGFR) kinase inhibitor from its collaborative, cancer drug discovery program with Astex (Press release, Cancer Research Technology, AUG 29, 2013, View Source [SID1234523520]). The regulatory approval required to take the compound into Phase I triggers a milestone payment to Astex of £3.5 million (US$5.4 million). Astex is also eligible to receive further milestones during clinical development and royalties on commercialization of products derived from the collaboration.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The FGFR inhibitor program between Janssen and Astex originated from an earlier collaboration between Astex, Cancer Research Technology, the Cancer Research UK Drug Discovery Group at the Newcastle Cancer Centre (NCC), and the Northern Institute for Cancer Research, Newcastle University, UK. As part of the collaboration, Astex applied its fragment-based drug discovery approach, Pyramid, to identify lead compounds inhibiting FGFR kinase. The partnership with Janssen was entered into in June 2008. Janssen is responsible for the clinical and regulatory development of all products arising from the collaboration and for their global commercialization.

Harren Jhoti, PhD, president of Astex, commented: "We are delighted that Janssen has received approval to commence a Phase I study on this FGFR kinase inhibitor, a drug that has the potential to address a significant area of unmet medical need. This milestone underscores how effective collaborations between leading research institutions, biotech companies and pharmaceutical partners can be in delivering new drug candidates for patients."

On August 19, 2013 Cell Therapeutics reported that the Transparency Commission (Commission de la Transparence or CT) of the French National Health Authority (Haute Autorite de Sante or HAS) has granted market access for the medicinal product PIXUVRI (pixantrone) as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (patients with aggressive B-cell NHL who failed 2 or 3 prior lines of therapy) (Press release , AUG 18, 2013, View Source;p=RssLanding&cat=news&id=1848275 [SID:1234500566]). The next and final step in France’s pharmaceutical reimbursement process is inclusion on the list of medicines approved for hospital use and subsequent publication in the Journal Officiel in France, which CTI now intends to pursue.
The CT noted that aggressive NHL is a serious disease and that there are no standard treatments for patients with this stage of disease. All registered pharmaceuticals in France are subjected to an evaluation process known as Evaluation of Therapeutic Benefit (Amelioration du Service Medical Rendu, or ASMR) by the CT, with the resulting evaluation expressed as a classification between 1 and 6. The CT rated PIXUVRI at level 5, which allows PIXUVRI to be included in the reimbursed drugs list for hospital use. The CT will reassess the ASMR rating for PIXUVRI within two years.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!