On January 14, 2020 Ipsen (Euronext: IPN; ADR: IPSEY) reported the appointment of Dr. Steven Hildemann as Executive Vice President, Chief Medical Officer, Head of Global Medical Affairs and Pharmacovigilance effective March 1, 2020 (Press release, Ipsen, JAN 14, 2020, View Source [SID1234553156]). Based in Paris, France, Dr. Hildemann will report directly to Aymeric Le Chatelier, CEO, Ipsen and serve on the Executive Leadership Team .

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!

Aymeric Le Chatelier, CEO, Ipsen, commented, "As we advance as a leading global biopharmaceutical company focused on innovation and Specialty Care, it is my great pleasure to appoint Dr. Hildemann to lead Ipsen’s Global Medical Affairs, Patient Affairs and Pharmacovigilance organizations through patient-centric leadership, sound medical governance and business conduct. With over 20 years of service in the pharmaceutical industry and 10 years as a physician-scientist in academic medicine, he brings a wealth of experience in medical affairs, clinical operations and patient safety from major global biopharmaceutical companies. Dr. Hildemann will play a crucial role in delivering on our global medical and patient safety strategy, engaging in structured, ethical and high-quality dialogue with patients, external and internal stakeholders throughout the entire life-cycle of Ipsen’s portfolio."

Dr. Hildemann will act as a strategic partner to Ipsen’s scientific, clinical and business teams. He will provide a global medical strategy based on real value to patients and caregivers. In close partnership with R&D, Dr. Hildemann will lead the generation of post-launch clinical trial data by defining, prioritizing, optimizing or guiding studies in line with this strategy. As a member of the Executive Leadership team, he will actively contribute to the overall management and strategic leadership of the company.

Prior to joining Ipsen, Dr.Hildemann held leadership roles in science-based bioethics and built an innovative digital health startup in cancer care after serving for five years as Chief Medical Officer, Senior Vice President, Head of Global Medical Affairs and Global Patient Safety at Merck. He also held several strategic leadership positions with biopharmaceutical companies such as Pharmacia-Pfizer and Schering-Plough-MSD. Dr Hildemann is board certified in internal medicine and cardiology with broad clinical training across internal medicine including medical oncology, gastroenterology, rheumatology and pulmonary oncology at university hospitals in Munich, Germany. Throughout his career, he has engaged in part-time clinical practice, late-stage pharmaceutical research and medical teaching. Dr. Hildemann received his MD-PhD at the Albert Ludwig University of Freiburg, Germany, where he continues to serve as an adjunct Professor of Medicine.

On January 14, 2020 Masimo (NASDAQ: MASI), a global leader in noninvasive monitoring technologies, and NantHealth, Inc. (NASDAQ: NH), a next-generation, evidence-based, personalized healthcare company, reported the signing of a definitive agreement under which Masimo will acquire the Connected Care assets from NantHealth, Inc. for a $47.25 million upfront cash payment (Press release, NantHealth, JAN 14, 2020, View Source [SID1234553155]). NantHealth’s Connected Care solutions provide medical device interoperability to hospitals and health systems. The portfolio includes DCX device connectivity (formerly known as DeviceConX), VCX patient vitals software (formerly known as VitalsConX), HBox connectivity hub, and Shuttle interface cable.

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 acquisition supports Masimo’s goal to help hospitals improve the continuum of great care through hospital automation, connectivity, and innovative noninvasive monitoring technologies. The Connected Care franchise is an established leader in providing connectivity solutions to hospitals, enabling streamlined collection and storage of medical device data through a vendor-agnostic platform into the EHR or other clinical information systems.
"One of the strategic priorities for Masimo is, through our Hospital Automation solutions, to reduce clinician cognitive overload and reduce errors of omission. Through connectivity, predictive algorithms, and decision support, we hope to improve the continuum of great care. The connectivity assets we are acquiring are completely in line with our mission as they will help accelerate our internal growth initiatives in this area," said Joe Kiani, Founder, Chairman, and CEO of Masimo. "Not only does Connected Care immediately increase our customer footprint but also provides us with products which complement our current portfolio. As a result, we are very excited to welcome the Connected Care’s talented team to Masimo and look forward to realizing our vision together."

Patrick Soon-Shiong, MBBCh, MSc, FRCS (C), NantHealth Chief Executive Officer and Chairman of the Board said, "Our decision to sell the Connected Care business enables us to focus on accelerating growth for our NaviNet and Eviti SaaS solutions, our data and molecular analytics capabilities, and pursue other strategically aligned goals. We believe Masimo has the best connectivity solutions, and we are delighted to have found the right home for our Connected Care business and our committed team of employees. We are working with Masimo to ensure a smooth transition for our Connected Care customers."

The transaction is expected to close in the first quarter of 2020, subject to customary closing conditions. Masimo expects to fund the acquisition with existing cash on hand. The estimated financial impact of the transaction is included in Masimo’s full-year 2020 financial guidance.

On January 13, 2020 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported that program updates for its four drug candidates and ongoing clinical studies (Press release, Turning Point Therapeutics, JAN 13, 2020, View Source [SID1234564381]).

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!

"Following a transformational year in 2019, we are pleased with the progress in our ongoing clinical studies, our recent Fast Track designation for repotrectinib and nomination of our ALK inhibitor candidate for IND-enabling studies," said Athena Countouriotis, M.D., president and CEO.

"In addition, we have now dosed multiple patients with our RET/SRC-inhibitor, TPX-0046, who presented with solvent-front mutations and were previously treated with other investigational RET inhibitors. The emergence of RET solvent-front mutations is an indication of the need for a next-generation RET inhibitor given the limited treatment options for these patients."

PROGRAM UPDATES AND 2020 MILESTONES

Repotrectinib
Clinical study of repotrectinib continues to progress in the Phase 2 registrational portion of the TRIDENT-1 global study and Phase 1/2 study in pediatric patients. With sites activating globally in the TRIDENT-1 study, the company continues to anticipate reporting early interim data from initial patients in some of the registrational cohorts in the second half of the year.

The company announced today that repotrectinib has been granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of ROS1-positive advanced non-small cell lung cancer (NSCLC) patients who have been previously treated with one prior line of platinum-based chemotherapy and one prior line of a ROS1 tyrosine kinase inhibitor (TKI). There are currently no approved targeted therapies for TKI-pretreated ROS1-positive NSCLC patients.

Following ongoing dialogue with health authorities, the company recently amended the TRIDENT-1 protocol for expansion cohorts 2 and 3 to clarify that ROS1-positive advanced NSCLC patients must have had one prior platinum-based chemotherapy regimen in addition to one prior TKI (cohort 2) or two prior TKIs (cohort 3). This amendment to cohort 2 is in line with the patient population granted fast track designation. Additionally, based on the potential future treatment paradigm, expansion cohort 4 has been amended to enroll only ROS1-positive advanced NSCLC patients with one prior TKI and no prior chemotherapy. This amendment is aimed at expanding enrollment in multiple ROS1-positive advanced NSCLC TKI-pretreated patient populations.

TPX-0022 – MET/CSF1R/SRC Inhibitor
Study of TPX-0022 continues to progress in a Phase 1 clinical trial in advanced solid tumor patients with MET genetic alterations. The company continues to anticipate reporting early interim data from initial patients during the second half of the year.

TPX-0046 – RET/SRC Inhibitor
Study of TPX-0046 continues to progress in a Phase 1/2 clinical trial, with early enrollment including multiple RET-positive patients with solvent-front mutations previously treated with other investigational RET inhibitors. In preclinical studies against proxy molecules for other investigational RET inhibitors, TPX-0046 showed comparable or stronger potency against wildtype and certain RET solvent-front mutations.

TPX-0131, A Next-Generation ALK Inhibitor
The company reported the advancement of TPX-0131, its next-generation ALK inhibitor candidate, into IND-enabling studies. TPX-0131 has been designed with a compact macrocyclic structure and in preclinical studies has been shown to potently inhibit wildtype ALK and numerous ALK mutations, in particular the clinically observed G1202R solvent-front mutation and G1202R/L1196M compound mutation. ALK-driven tumors are estimated to represent up to 7 percent of driver oncogenes in NSCLC and of patients who develop a resistance mutation, G1202R has been reported in approximately 42 percent.

2020 Milestones
Key milestones anticipated in 2020 include:

Additional TPX-0131 preclinical data during the first half of the year;
Present preclinical repotrectinib combination data;
Early interim data from initial patients in some of the registrational cohorts of the repotrectinib TRIDENT-1 Phase 2 study during the second half of the year;
Early interim data from initial patients treated with TPX-0022 during the second half of the year; and
Submitting the IND for TPX-0131 by early 2021.

On January 13, 2020 Oncternal Therapeutics Presented the Corporate Presentation (Presentation, Oncternal Therapeutics, JAN 13, 2020, View Source [SID1234554377]).

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!

On January 13, 2020 Personalised cancer treatment is one step closer to becoming a reality for more patients, thanks to a Cancer Council Beat Cancer Project grant awarded to University of South Australia researcher Dr Stephanie Reuter Lange to explore how computer-based modelling can optimise cancer treatment and remove the need for expensive clinical trials (Press release, University of South Australia, JAN 13, 2020, View Source [SID1234554068]).

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!

Dr Reuter Lange’s $300,000 project is one of two UniSA projects successful in today’s Cancer Council Beat Cancer Project funding announcement with Professor Peter Hoffmann also securing $100,000 to further critical work in identifying the extent of endometrial cancer and where it has spread.

While cancer treatments are most successful when personalised to an individual, Dr Reuter Lange says most cancer medicines are still administered with a "one size fits all" approach.

"Despite substantial improvements in the treatment of cancer, three out of 10 patients will still not survive longer than five years, due to either cancer progression or death from severe treatment-related side effects," Dr Reuter Lange says.

"There is no field of medicine in which individualisation of medicines is more important than in the area of oncology. There is large variability in how patients respond to many cancer medicines, which can result in either undertreatment that leads to cancer progression, or overtreatment that can have significant toxic side effects.

"The concept of dose individualisation means we can tailor the amount of a drug administered to an individual patient to maximise tumour response and minimise side effects. My focus will be to use computer-based modelling methods to identify dose individualisation strategies for best treatment practice."

While the merits of individualised drug dosages are clear, conducting the large-scale clinicial trials required to implement the treatment in practice is a complex and costly process which means cancer treatments currently on offer remain standardised rather than personalised.

Dr Reuter Lange’s work uses the science of mathematical and stasitical models to characterise drug behaviour, helping clinicians make an educated decision on the most appropriate treatment regimes.

"This work will provide an evidence-basis for dose individualisation of cancer therapies, offsetting the need for the conduct of costly, large-scale clinical trials," she says.

"Ultimately this work will lead to improved patient outcomes and provide a framework on which treatment guidelines can be based for the optimal use of new and existing cancer therapies."

UniSA Professor Hoffmann’s research project will focus on developing less intrusive diagnosis and treatment techniques for endometrial cancer, the most diagnosed gynaecological cancer in Australia.

According to Professor Hoffmann, radiological imaging is unreliable in determining the stage of endometrial cancer, meaning the majority of patients have to undergo surgical staging (and removal of lymph nodes) even though the minority will actually have cancer that has spread to the lymph nodes (metastatic disease).

He says the Cancer Council SA funding will go towards identifying molecular tissue markers that indicate the presence of metastatic disease so that future patients may not need to undergo unnecessary radical surgery (Lymphadenectomy) to get an accurate diagnosis.

Established in 2011 Cancer Council’s Beat Cancer Project is a collaboration between Cancer Council SA, the State Government, SAHMRI and the universities and providing research funding to improve the lives of all South Australians impacted by cancer. For more information on the project, go to cancersa.org.au/research/beat-cancer-project.