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.

On August 19, 2022 Medivir reported that (Press release, Medivir, AUG 19, 2022, View Source;interim-report-january–june-2022-301609058.html [SID1234618518])

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The clinical development of fostrox remains the focus

April – June

Financial summary for the quarter

Net turnover amounted to SEK 0.5 (0.9) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -21.5 (-17.1) million. Basic and diluted earnings per share amounted to SEK -0.42 (-0.31) and SEK -0.42 (-0.31) respectively.
Cash flow from operating activities amounted to SEK -17.6 (-21.9) million.
Cash and cash equivalents at the end of the period amounted to SEK 162.8 (247.8) million.
Significant events during the quarter

At Medivir’s AGM on May 5, Uli Hacksell, Lennart Hansson, Bengt Westermark and Yilmaz Mahshid were re-elected and Anette Lindqvist was newly elected as board members in the company. Uli Hacksell was re-elected as chairman of the board. An van Es Johansson had declined re-election.
January – June

Financial summary for the period

Net turnover amounted to SEK 1.0 (10.8) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -52.9
(-24.3) million. Basic and diluted earnings per share amounted to SEK -1.00 (-0.51) and SEK -1.00 (-0.51) respectively.
Cash flow from operating activities amounted to SEK -57.5 (-23.3) million.
Cash and cash equivalents at the end of the period amounted to SEK 162.8 (247.8) million.
Significant events after the period

Fostroxacitabinebralpamide – the name given to MIV-818 by the World Health Organization (WHO) – received formal approval as a pharmaceutical name in the USA by the United States Adopted Names (USAN) Council.
Conference call for investors, analysts and the media

The Interim Report January – June 2022 will be presented by Medivir’s CEO, Jens Lindberg.

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.

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.

On August 19, 2022 Huahui Health, a Beijing-based, clinical stage biotechnology company focused on discovering and developing virology, hepatology and oncology therapies, reported that its "First-in-Class" anti-tumor drug candidate HH-009 has completed the first patient dose in a Phase Ia clinical trial conducted in China (Press release, Huahui Health, AUG 19, 2022, View Source [SID1234642185]). It marked the first molecule amongst those investigational therapies of the same target in the world that entered clinical development stage. Currently, Huahui has brought 5 products with "First-in-Class" or "Best-in-Class" potential into clinical stage, including 3 anti-viral and 2 anti-tumor clinical assets.

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As a potential "First-in-Class" anti-tumor therapy, HH-009 initiated a Phase Ia clinical study to evaluate its safety, tolerability and pharmacokinetic in solid tumors. Compared to other small-molecule inhibitors of the same target, HH-009 is a fully human monoclonal antibody with a novel mechanism of action, offering potential safety advantages over small-molecule drug candidates.

HH-009 has also planned to open an IND in the US by end of 2022.