Michael Sen to succeed Stephan Sturm as CEO of Fresenius

On August 19, 2022 Fresenius reported Michael Sen (53) will become Chief Executive Officer on October 1, 2022 (Press release, Fresenius, AUG 19, 2022, View Source [SID1234618504]). He was appointed unanimously by the Supervisory Board of Fresenius Management SE today to succeed Stephan Sturm (59), who will leave the company on good terms on September 30. Michael Sen will, in addition, continue to serve as CEO of Fresenius Kabi until a successor is decided for this position.

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Michael Sen has been responsible for the Fresenius Kabi business segment on the Fresenius Management Board since April 2021. Previously, he was a member of the Management Board of Siemens AG, where he was responsible for the healthcare business Siemens Healthineers and for Siemens’ energy business. From 2015 to 2017 he was Chief Financial Officer of E.ON SE.

Stephan Sturm has been a member of the Fresenius Management Board since 2005, beginning as CFO. He became CEO of Fresenius on July 1, 2016.

Stephan Sturm said: "Fresenius has always been more than just a job to me. This company was and is still close to my heart. I look back with gratitude and pride on my more than 17 years here, during which we accomplished a lot together and developed Fresenius into a leading global healthcare company – one that provides ever more people with ever better medicine. I’m especially thankful for the many colleagues with whom I was privileged to work, and with whom I will remain connected even after my time at Fresenius. This is a great company, with outstanding growth prospects."

Wolfgang Kirsch, Chairman of the Supervisory Board of Fresenius, said: "On behalf of the entire Supervisory Board, I want to thank Stephan Sturm for his many years of outstanding commitment and service to Fresenius. Starting from his time as CFO he has played a major role in our successful development and in our continued, profitable growth. As CEO he has steered our company through increasingly rough waters over the past few years, and kept it on course. The pandemic, in particular, did not make this easy. Stephan Sturm has identified totally with our company and devoted all his energy and capabilities to its success. For this we owe him respect and great thanks. Following the orderly transition to his successor, I sincerely wish him all the very best for the future.

"At the same time, I’m very pleased that in our own ranks we have, in the person of Michael Sen, an outstanding manager who is supremely well qualified to take on this important position," Kirsch added. "He has extensive and relevant experience in industry. He is accomplished in designing and implementing transformation and change processes. And he has strategic skills, as he has shown during his first year-and-a-half as CEO of Fresenius Kabi with the development of ‘Vision 2026’ and the successful start to its implementation. My colleagues on the Supervisory Board and I are firmly convinced that the Management Board, under Michael Sen’s leadership, will give new impetus to our growth strategy. In this he has our full support. I wish him good luck and great success."

Michael Sen, CEO of Fresenius Kabi and designated CEO of Fresenius, said: "I’m very pleased about the trust being placed in me and in my capabilities. I am taking on leading this company, which brings both great responsibility and excitement, with respect but above all with great joy and confidence. This is because, despite the temporary challenges and headwinds we encounter, our prospects for achieving future success are very promising: The markets we are active in are fundamentally attractive, and our businesses in many areas are strongly positioned. Being agile and taking prudent strategic decisions will enable us to tap into our full potential and accelerate our growth dynamics again. Together with my Management Board colleagues and all our employees, I will devote my full energy to this. Fresenius is a fantastic company that creates value in so many ways, and I have a strong personal commitment to advancing innovation in medicine for the health and well-being of all people. I want to contribute so that, going forward, all our stakeholders will benefit even more from an even stronger Fresenius."

Menarini Group’s Elacestrant Marketing Authorization Application Accepted for Review by the European Medicines Agency (EMA) for the Treatment of ER+/HER2- Advanced or Metastatic Breast Cancer

On August 19, 2022 The Menarini Group ("Menarini"), a privately held Italian pharmaceutical and diagnostics company, and Stemline Therapeutics ("Stemline"), a wholly-owned subsidiary of the Menarini Group, reported that EMA has validated the Marketing Authorization Application (MAA) for elacestrant, a selective estrogen receptor degrader (SERD), for patients with ER+/HER2- advanced or metastatic breast cancer (Press release, Menarini, AUG 19, 2022, View Source;Advanced-or-Metastatic-Breast-Cancer/?feedref=JjAwJuNHiystnCoBq_hl-RLXHJgazfQJNuOVHefdHP-D8R-QU5o2AvY8bhI9uvWSD8DYIYv4TIC1g1u0AKcacnnViVjtb72bOP4-4nHK5ieT3WxPE8m_kWI77F87CseT [SID1234618503]). Validation of the application confirms the submission is complete and begins EMA’s centralized review procedure.

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"There is a major unmet need in the treatment of advanced or metastatic ER+/HER2- breast cancer after resistance builds in the earlier lines of treatment," commented Elcin Barker Ergun, Chief Executive Officer of the Menarini Group. "The acceptance of our application for review by the EMA represents a significant step for our company and we look forward to working with the agency to potentially bring elacestrant to patients suffering from second- and third-line ER+/HER2- advanced or metastatic breast cancer in Europe."

The Phase 3 EMERALD study (NCT03778931) evaluated elacestrant compared to SOC endocrine monotherapy (investigators’ choice of either fulvestrant or an aromatase inhibitor) in ER+/HER2- advanced or metastatic breast cancer patients. The study results were recently published online in the Journal of Clinical Oncology (JCO) on May 18, 2022. Further post-hoc analysis from the study will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 taking place September 9-13, 2022, in Paris, France.

The Menarini Group obtained global licensing rights for elacestrant in July 2020 from Radius Health, Inc, who conducted and successfully completed the EMERALD study. Based on the positive phase 3 data, Stemline submitted a MAA to EMA on July 27, 2022. The regulatory review for elacestrant is also underway in the U.S. as the Food and Drug Administration (FDA) has recently accepted a New Drug Application for elacestrant designating a Priority Review. The Menarini Group is now fully responsible for global registration, commercialization and further development activities for elacestrant.

About Elacestrant (RAD1901) and the EMERALD Phase 3 Study
Elacestrant is an investigational selective estrogen receptor degrader (SERD). In 2018, elacestrant received Fast Track designation from the FDA. Preclinical studies completed prior to EMERALD indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer. The EMERALD Phase 3 trial is a randomized, open label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in ER+/HER2- advanced/metastatic breast cancer patients. The study enrolled 477 patients who had received prior treatment with one or two lines of endocrine therapy, including a CDK 4/6 inhibitor. Patients in the study were randomized to receive either elacestrant or the investigator’s choice of an approved hormonal agent. The primary endpoint of the study was progression-free survival (PFS) in the overall patient population and in patients with estrogen receptor 1 gene (ESR1) mutations. Secondary endpoints included evaluation of overall survival (OS), objective response rate (ORR), and duration of response (DOR) and safety.

Accutar Biotechnology Receives NMPA Clearance of IND Application for AC0176 in Prostate Cancer

On August 19, 2022 Accutar Biotechnology, Inc., a clinical stage biotechnology company focusing on artificial intelligence (AI)-empowered drug discovery, reported that the China National Medical Products Administration (NMPA) has cleared the company’s investigational new drug application (IND) for AC0176 for the treatment of patients with metastatic Castration Resistant Prostate Cancer (mCRPC) (Press release, Accutar Biotechnology, AUG 19, 2022, View Source [SID1234618502]). AC0176 is an orally bioavailable chimeric degrader molecule designed to target Androgen Receptor (AR) protein with high potency and selectivity.

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"Prostate cancer is one of the most common cancers among men in China, and the speed of increase in its incidence and death rates ranks highest in China. We are excited about the IND clearance of AC0176 in China, after its IND clearance and initiation of the first-in-human Phase 1 study in the US early this year," said Jie Fan, Ph.D., Chief Executive Officer, Accutar Biotechnology, Inc. "We look forward to accelerating the development of AC0176 and furthering our commitment to bringing innovative medicines to patients worldwide."

The Phase 1 study in China will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0176 treatment in Chinese patients with mCRPC. Accutar expects to begin enrollment of this study in the second half of this year.

About AC0176

AC0176 is an investigational orally bioavailable, chimeric degrader of androgen receptor (AR) for the potential treatment of prostate cancers. AR is a hormonal transcription factor, and plays important roles during prostate cancer onset and progression. In preclinical studies, AC0176 has demonstrated potent and selective AR protein degradation with broad coverage of AR mutants, favorable pharmacological properties, as well as promising anti-tumor activities in animal models.

AskGene Announces Appointment of Chief Medical Officer and VP of Preclinical & Clinical Pharmacology

On August 19, 2022 AskGene Pharma Inc. (AskGene) reported the appointment of Barbara Hickingbottom, J.D., M.D. as Chief Medical Officer and Matt Hsu, Ph.D. as VP of Preclinical and Clinical Pharmacology (Press release, AskGene Pharmaceuticals, AUG 19, 2022, View Source [SID1234618501]). Dr. Hickingbottom will be responsible for leading the global clinical development of AskGene, including pipeline strategy, clinical development plans and operations, product registration, and guiding the global clinical collaborations with existing and potential partners. Dr. Hsu will be responsible for leading global preclinical and clinical pharmacology activities.

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Jian-Feng (Jeff) Lu, Ph.D., CEO of AskGene commented: "We are pleased to welcome Dr. Hickingbottom and Dr. Hsu to our management team earlier this year. They will each bring us over two decades of global industry experience, which will help AskGene to continue to optimize our clinical development and global registration strategies for our lead biological products and to progress our promising pipeline of novel drugs positioned to address major areas of unmet clinical needs. We believe the appointment will bring strong energy and leadership to AskGene for our global clinical development and facilitate regulatory approval of lead innovative cytokine projects and other innovative molecules."

Barbara Hickingbottom J.D., M.D., CMO of AskGene commented: "I am profoundly excited to bring my experience to AskGene pipeline and join AskGene at this important time as ASKG315 is entering into the clinical stage in Australia. The early preclinical data for ASKG315 and ASKG915 are very promising, and I look forward to working alongside AskGene’s highly skilled scientific teams to bring the whole AskGene portfolio to patients globally."

Dr. Matt Hsu, VP of Preclinical and Clinical Pharmacology commented: "AskGene’s innovative SmartKine platform with a prodrug approach for cytokine therapies has demonstrated promising anti-tumor activities in preclinical species. With strong efficacy and reduced toxicity, this technology has a potential to overcome the limitation of cytokine use clinically and revolutionize immunotherapies. Therefore, I am looking forward to working with the company’s leadership team to advance novel and highly innovative clinical projects and candidates in the areas of oncology and immunological diseases, and to build a robust pipeline that has the opportunity to transform care for many more patients in need around the world."

Before joining AskGene, Dr. Hickingbottom served as the Head of Clinical Development at Xencor, Inc. (Xencor). During her time at Xencor, she was deeply involved in the clinical development of 12 anti-tumor biological innovative drugs in Xencor’s pipeline and responsible for all of the company’s clinical-stage products. Prior to Xencor, Dr. Hickingbottom worked as both a consultant and a scientist in many biopharmaceutical companies, including BioMarin, Mannkind, Novartis, Xoma, Novacea, and CTL Immunotherapies. Dr. Hickingbottom is an accomplished clinical pathologist with over 25 years of life sciences experience in clinical development, medical affairs, and registration strategy. She received her Medicine Doctor degree from the Tufts University School of Medicine and completed her internship and residency in pathology at Stanford. She also received a Juris Doctor degree from the Harvard Law School.

Dr. Hsu has more than two decades of experiences in drug development, ranging from proof of concept to approval. Previously, Dr. Hsu was Senior Principal Scientist in the Clinical Pharmacology Modeling & Simulation group at Amgen, where he led the Technical and Professional Unit for clinical study data and report preparation, conducted clinical pharmacology studies in translational sciences, applied PK/PD knowledge for dose selection at IND and End-of-Phase 2 stages, and prepared NDA/BLA submission for drug approvals. Prior to Amgen, Dr. Hsu worked in Preclinical Development at Johnson & Johnson in New Jersey and received his Ph.D. in Pharmaceutical Sciences from the University of Michigan. He has published more than 35 peer-reviewed papers.

Scandion Oncology receives approvals for next parts of the CORIST trial

On August 19, 2022, Scandion Oncology (Scandion), a biotech company developing first-in-class medicines aimed at treating cancer which is resistant to current treatment options, reported that it has now received approvals from authorities and ethical committees in Denmark and Germany for the next parts of the ongoing CORIST phase II-trial (Press release, Scandion Oncology, AUG 19, 2022, View Source,c3615707 [SID1234618499]). The trial studies Scandion’s lead compound SCO-101 as a combination treatment in patients with metastatic colorectal cancer (mCRC). Thus, the development of SCO-101 can continue as planned and communicated in connection with Scandion’s recently completed rights issue.

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Part 1 of the CORIST trial has been completed and part 2 is currently ongoing with topline data expected to be communicated during the third quarter of 2022. To ensure a seamless continuation of the trial, parts 3 and 4 have been planned, and part 3 is ready to start independently of part 2. Patient recruitment in part 3 is expected to commence during the third quarter of 2022, and topline results from CORIST part 3 are expected most likely within the third quarter of 2023.

CORIST part 3 represents an expansion of the development program, in order to best exploit SCO-101’s potential in mCRC. As described in connection with the rights issue the expansion is expected to approximately double the commercial potential of SCO-101 in this indication.

The trial is expanded by adding a new schedule for combining SCO-101 and chemotherapy (FOLFIRI), which will be evaluated in patients with both RAS wild-type and RAS mutated tumors. The expansion was done through an amendment of the ongoing trial, making it possible to initiate the expansion while finalizing part 2, thereby keeping the momentum in the trial and utilizing already activated trial sites.

"We are pleased to have received formal approvals so swiftly and thereby be able to advance the CORIST trial as soon as practically possible. The expansion of the trial will greatly enhance both the medical and commercial potential of SCO-101 and we are delighted to be able to invest in maximizing the value of this compound to the benefit of patients, physicians and Scandion", says Bo Rode Hansen, President & CEO of Scandion.

The CORIST trial is also carried out in Spain. Parts 3 and 4 of the trial are expected to recruit patients here as well as in Denmark and Germany pending one outstanding approval in Spain.