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INSTINCTIF PARTNERS HOSTS CANCER RESEARCH TECHNOLOGY EVENT ON INNOVATIVE CANCER DIAGNOSTICS AND TREATMENTS

On September 24, 2014 Instinctif Partners (formerly College Hill) reported they sponsored and hosted a breakfast briefing with Cancer Research Technology (CRT), entitled "Innovative approaches to better diagnose and treat cancer patients: analysis of blood borne tumour cells and DNA" on 23 September 2014 (Press release, Cancer Research Technology, SEP 24, 2014, View Source [SID1234523516]).

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There is a pressing need to improve methods used to assess cancer diagnosis and treatment especially in light of the recent demonstration that tumours are heterogeneous genetically. Multiple direct biopsies, either from different sites or over time (or both), are difficult to achieve for many reasons. The discoveries that in the blood of cancer patients both circulating tumour cells (CTCs) and cell-free tumour DNA (cfDNA) can be detected offers new ‘non-invasive’ methods to determine the true genetic make-up of a cancer, its likelihood of spreading and its response to therapy during a course of treatment. Overall, both CTCs and cfDNA show the potential for improving drug development including in immunotherapy, an area which is demonstrating how cancer research is improving patient outcomes.

The breakfast briefing was chaired by CRT Chief Scientific Officer Dr Clive Stanway, and included discussions on these innovative developments by leading Cancer Research UK-funded scientists Professor Carlos Caldas, Dr Nitzan Rosenfeld, and Professor Caroline Dive. The event attended by key journalists from the industry provided an excellent opportunity for media exposure to this rapidly evolving field.

Dr Clive Stanway, CRT Chief Scientific Officer explained: "This event really helped us demonstrate the potential of analysing circulating tumour cells (CTCs) and cell-free tumour DNA (cfDNA), two new technologies for cancer patient treatment and drug discovery. The Instinctif Partners team was instrumental in helping us getting this message across, the planning and execution of the event went very smoothly and it has been great to work with the team."

Commenting on Instinctif Partner’s sponsorship of the event, Dr Christelle Kerouedan, Associate Partner, added: "Using our extensive experience and resources in media event planning and execution, Instinctif has helped Cancer Research Technology to highlight this rapidly evolving field of cancer research to key journalists. We are delighted to have worked with the CRT team on the organisation of this successful event".

Baxter and Merrimack Pharmaceuticals Enter into Exclusive Ex-U.S. Licensing Agreement to Develop and Commercialize Novel Cancer Compound MM-398

On September 24, 2014 Baxter International and Merrimack Pharmaceuticals jointly reported an exclusive license and collaboration agreement for the development and commercialization of MM-398 (nanoliposomal irinotecan injection), also known as “nal-IRI” (Press release Merrimack, SEP 24, 2014, View Source [SID:1234500761]). Through the agreement, Baxter gains exclusive commercialization rights for all potential indications of MM-398 outside the United States and Taiwan, and Merrimack retains commercialization rights in the United States; the rights in Taiwan are held separately.

MM-398 is an investigational drug candidate for which Merrimack is preparing a New Drug Application in the United States for the treatment of patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy. Pancreatic cancer is a rare and deadly disease that is difficult to diagnose and has limited treatment options available today.

”Oncology represents an exciting new area and growth driver for our biopharmaceutical business,” said Ludwig Hantson, Ph.D., president of Baxter BioScience. ”With this new collaboration with Merrimack on MM-398, a promising new anti-cancer agent, we continue to augment our growing pipeline focused on challenging diseases with significant unmet needs, while capitalizing on our broad global reach.”

Under the terms of the agreement, Merrimack receives a $100 million upfront payment from Baxter, which will be recorded by Baxter as a special pre-tax in-process research and development charge in the third quarter of 2014. Merrimack is also eligible to receive $120 million in regulatory milestone payments related to the first pancreatic cancer indication as these milestones are achieved, and $280 million in development and regulatory milestone payments for a second pancreatic cancer indication.

Merrimack is also eligible to receive $220 million in future development and regulatory milestone payments related to two additional indications. Merrimack has the potential to receive $250 million in sales milestone payments, as well as tiered royalties on net sales of MM-398 in the licensed geographies.

”Baxter possesses the commercial and technical expertise, experience and vision to obtain market approval and accelerate the global commercialization of MM-398 in markets all over the world for patients with metastatic pancreatic cancer who have few treatment options following gemcitabine-based therapy,” said Robert Mulroy, President and CEO at Merrimack. ”This partnership also complements our strategy by allowing us to develop our own commercial efforts in the United States while aggressively pursuing the development of MM-398 across multiple cancer indications.”

MM-398 is a novel encapsulation of irinotecan in a long-circulating nanoliposomal formulation designed to increase drug deposition and prolong cytotoxic effects, with the goal of improving its anti-cancer properties. In May 2014, Merrimack announced that the Phase 3 trial, known as NAPOLI-1, studying MM-398 in combination with 5-fluorouracil (5-FU) and leucovorin achieved its primary and secondary endpoints for patients with metastatic pancreatic cancer who were previously treated with a gemcitabine-based therapy. In the study, the combination of MM-398 with 5-FU and leucovorin demonstrated a statistically significant improvement in overall survival, progression free survival and overall response rate compared to the control arm of 5-FU and leucovorin alone. This was the first positive global Phase 3 study in a post-gemcitabine setting to show a survival benefit in this aggressive disease.

The U.S. Food and Drug Administration (FDA) and European Medicines Agency have granted MM-398 orphan drug designation in metastatic pancreatic cancer. Merrimack is planning to submit a New Drug Application for MM-398 with the FDA in 2014. Baxter expects to submit for regulatory approvals outside of the United States beginning in 2015.

Inivata raises £4m to realise the potential of ctDNA analysis to improve cancer treatment through simple blood tests

On September 23, 2014 Inivata, a clinical cancer genomics company focused on harnessing the potential of circulating tumour DNA (ctDNA) analysis to improve cancer testing and treatment, reported it has raised £4m in a funding round led by Imperial Innovations and including Cambridge Innovation Capital and Johnson & Johnson Development Corporation (Press release, Cancer Research Technology, SEP 23, 2014, View Source [SID1234523223]).

Inivata is focused on developing clinical applications of ctDNA through collaborations with clinical oncologists at prominent academic institutions, leading community treatment centres and innovative biopharmaceutical companies.

Novel applications of ctDNA are enabled by Inivata’s technology platform which includes its proprietary, enhanced TAm-Seq technology. TAm-Seq, which is licensed to Inivata from Cancer Research Technology and the University of Cambridge, allows the detection and analysis of genomic material from a cancer patient’s cell-free ctDNA collected through routinely accessible blood samples. This non-invasive approach – a liquid biopsy – offers a revolution in how cancer is detected, monitored and treated. Inivata’s founders are recognised leaders in the clinical genomics and ctDNA fields having developed pioneering ctDNA and novel treatment approaches in Cancer Research UK-funded laboratories at the University of Cambridge.

Inivata works with industry and academics to develop new clinical applications for ctDNA analysis which will bring real benefits to physicians, patients, pharmaceutical companies and payers. Inivata’s goal is to provide physicians with the information they need to provide the best outcomes for patients and effective design for clinical trials.

Michael Stocum, CEO of Inivata, said: "There is major focus on ctDNA analysis which promises the ability to improve monitoring and treatment of cancer based on information from routine blood samples. We are taking a collaborative approach to the development of clinical applications for ctDNA analysis which have the potential to transform how the disease is understood and treated.

"Nitzan Rosenfeld and his team are leaders in the field. I am excited to be working with our scientific founders, and with this significant fund raising secured we are now focused on working with pharmaceutical, clinical and academic partners to identify applications and rapidly realise the potential of the enhanced TAm-Seq approach."

Rob Woodman of Imperial Innovations said: "The oncology molecular testing and treatment market is large and growing. Inivata is well-placed to capitalise on this market growth by bringing real benefits to physicians, patients, pharmaceutical companies and payers."

Robert Tansley of Cambridge Innovation Capital said: "The research by Dr Rosenfeld’s team is ground breaking and offers new options in cancer monitoring to better manage treatment response prediction. This investment will secure the development of this technology in Cambridge and facilitate its translation into the clinic for the benefit of patients."

Keith Blundy, Chief Executive Officer of Cancer Research Technology and Inivata board member, said: "We’re delighted to be involved in taking this promising technology developed by Cancer Research UK scientists to the next level. Developing technologies that allow clinicians to monitor how tumours respond to treatment non-invasively and in real-time forms a crucial part of Cancer Research UK’s commitment to deliver the promise of precision cancer medicine to patients."

Circle Pharma Announces Receipt of Seed Funding and Initiation of Two Collaborations

On September 22, 2014 Circle Pharma, Inc., a newly created, early-stage biotechnology company, reported that it has received seed funding from Pfizer Inc. and QB3’s seed-stage venture fund, Mission Bay Capital, LLC, and has initiated two collaborations with Pfizer to develop cell permeable macrocyclic peptide therapeutics (Press release, Circle Pharma, SEP 22, 2014, View Source [SID1234638553]).

"We are very pleased to have launched Circle with the backing of Pfizer and Mission Bay Capital, and to have initiated two exciting collaborative projects with Pfizer," said David J. Earp, J.D., Ph.D., Circle’s President and CEO. "In addition to these collaborations, Circle will be undertaking development work against our own therapeutic targets. We are open to additional collaborations with partners who share our excitement in the potential of permeable macrocyclic peptides, which, we believe, could be applicable to a large number of important therapeutic targets."

Circle’s technology is based in part on research sponsored by Pfizer through an agreement with QB3.

About Macrocyclic Peptides
Macrocyclic peptides have the potential to provide access to therapeutic targets that are considered undruggable with conventional small molecule or biologic modalities. In particular, there is great interest in developing macrocycles to modulate protein-protein interactions, which play a role in almost all disease conditions, including cancer, fibrosis, inflammation and infection. However, the development of macrocyclic therapeutics has been limited to this point by the need for a greater understanding of how to design macrocycles with appropriate pharmacokinetics, cell permeability and oral bioavailability. Indeed, today, most clinical programs testing macrocyclic peptides are aimed at extracellular protein targets because of the challenge of identifying cell permeable macrocycles. The ability to design potent macrocycles with inherent permeability is expected to give access to a large number of important therapeutic targets that have been out of reach to this point.

Xenetic Biosciences to Hold Business Update Conference Call September 23 at 6:00 a.m. Eastern Time

On September 22, 2014 Xenetic Biosciences, Inc. (OTCBB: XBIO), a biopharmaceutical company focused on developing next-generation biologic drugs and novel oncology therapeutics, reported that it will hold a business update conference call on Tuesday, September 23, 2014 at 11:00 a.m. GMT (6:00 a.m. EDT) (Press release, Xenetic Biosciences, SEP 22, 2014, View Source [SID1234537818]). M. Scott Maguire, chief executive officer, and Colin Hill, U.K. chief financial officer and board member, will provide a business update and answer questions.

To access the conference call, U.K.-based participants should call 0800 368 0649; London-based participants should call 020 3059 8129; and, participants in all other locations should call +44 20 3059 8125. A telephone replay will be available for seven days following the call’s conclusion. Replay dial-in numbers are as follows: United Kingdom 0121 260 4861; United States 866-268-1947; and all other locations + 44 121 260 4861. Please provide conference ID 7591229 when accessing the replay. In addition, a replay of the call will be posted to the Investor Relations section of www.xeneticbio.com in the "Events and Presentations" tab.