On May 18, 2020 Liquidia Technologies, Inc. (Nasdaq: LQDA), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel products utilizing its proprietary PRINT technology, reported the appointment of Tushar Shah, M.D., to the newly created position of Chief Medical Officer (Press release, Liquidia Technologies, MAY 18, 2020, View Source [SID1234558272]). In this role, Dr. Shah will oversee all aspects of research, clinical development, medical affairs, and regulatory affairs for Liquidia. Dr. Shah has 27 years of pharmaceutical research and development experience, successfully moving more than 20 products from discovery to commercialization.

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. Shah has had a long and distinguished career with nearly three decades of successful clinical development experience in high-profile therapeutic areas such as respiratory, immunology and neurology," said Neal Fowler, Chief Executive Officer of Liquidia. "His extensive leadership in this area comes at a pivotal moment in our company’s history with the LIQ861 NDA under review, LIQ865 in clinical development and a growing list of PRINT-derived preclinical candidates. Dr. Shah shares our passion for improving patients’ lives and I am confident that this addition to our outstanding management team moves us closer to achieving our mission."

Dr. Shah joins Liquidia from Teva Pharmaceuticals, where he served as Head of Global Specialty Clinical Development with oversight of all phases of clinical development across all therapeutic areas including CNS, immunology, respiratory, oncology and biosimilars. While at Teva, he led the transformation of the company into a discovery-based, specialty clinical organization that embraced innovative approaches to improve outcomes in early and late-stage clinical development through faster and more informed data reviews.

Prior to Teva, Dr. Shah served as Senior Vice President, Scientific and Clinical Development at Altana Pharma US where he built and led their clinical development function, including clinical research and operations, medical affairs, regulatory affairs and quality assurance, pharmacovigilance and drug safety, biostatistics and data management. He began his career at GlaxoSmithKline (GSK), where he held roles of increasing responsibility, rising to the position of U.S. Head, Respiratory and Inflammation, Discovery Medicine and Clinical Pharmacology with responsibility for early-stage clinical development of new therapies for the treatment of chronic obstructive pulmonary disease (COPD), asthma, and rhinitis.

"I have dedicated my career to advancing strong science through the rigors of clinical development and regulatory approval with the goal of delivering meaningful benefit to patients in need. Liquidia is pioneering new ways to make good science better to achieve this objective," noted Dr. Shah. "Using PRINT technology, we can specifically engineer therapies with the expressed goal of avoiding technical obstacles that stand in the way of addressing patient needs. This endeavor excites me, both professionally and intellectually, and I look forward to joining this incredibly talented team during a truly exciting and defining period for the company."

Dr. Shah received a M.D. degree from the Hershey Medical College at Pennsylvania State University. He completed his residency in Internal Medicine at the University of North Carolina and fellowship in Allergy, Asthma and Clinical Immunology at Johns Hopkins University.

On May 18, 2020 Tolmar Pharmaceuticals Inc., a specialty pharmaceutical company, reported publication in the April issue of the Journal of Urology of a real-world analysis of medical records of patients with prostate cancer treated with LHRH agonist therapies (Press release, Tolmar Pharmaceuticals, MAY 18, 2020, View Source [SID1234558265]). The retrospective review evaluated the records of 22,860 patients with prostate cancer who were treated with LHRH agonists from January 2007 through June 2016 to further understand the impact of non-adherence to dosing schedules on testosterone (T) suppression levels. It also captured real-world data on these patients to assess the frequency of measurement of levels of T and prostate-specific antigen (PSA).

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!

Androgen deprivation therapy (ADT) is the standard of care for patients with advanced prostate cancer. The goal of ADT is to reduce T to castration levels and thereby inhibit the growth of malignant prostate cancer cells. The target level for castration has historically been set at 50ng/dL; however, increasing evidence suggests that levels of less than 20ng/dL are seen following surgical castration.i ADT is widely used to suppress levels of T in the blood in men with advanced prostate cancer.

Analysis Demonstrated Late Dosing Patterns, Limited Testosterone Testing

84% of injections were administered late with a 28-day month schedule, with 60% more than one week late and 29% more than two weeks late.
Delays in injection timing were also frequent with extended month (a little longer than calendar months) schedules, which may be more representative of dosing in real-world clinical practice. 27% of injections were late, with 13% more than one week late and 9% more than two weeks late.
T assessments were performed with only 13% of ADT injections, compared to 83% for PSA tests.
Impact on Testosterone Suppression

Notably, with early/on time administration, only 4% of injections were associated with T levels >50ng/dL for both 28-day and extended month analyses. In contrast, when injections were administered late, 15% of tests for the 28-day month and 27% for the extended month showed T levels >50ng/dL.
The impact of late dosing was especially pronounced when considering levels of T >20ng/dL. For the 28-day month, 31% of T levels >20ng/dL and 43% for the extended month.
The greatest impact on T suppression was when dosing was more than two weeks late. For example, in the extended month analysis, half of T levels were >20ng/dL.
"These new real-world findings confirm that late injection of LHRH agonists is common in clinical practice along with infrequent measurement of levels of testosterone. This is concerning as men with advanced prostate cancer not receiving their ADT on time may experience inadequate testosterone suppression, which could adversely impact disease progression and survival," said E. David Crawford, M.D., lead study author and Professor of Urology at the University of California, San Diego. "Our analysis underscores the importance of administering LHRH injections in a timely fashion and conducting more frequent testosterone testing to ensure target levels below 20ng/dL are achieved to reach the levels achieved with surgical castration."

Dr. Jason M. Hafron, M.D., study author and Partner at the Michigan Institute of Urology commented, "These data underscore how important it is for Advanced Prostate Cancer Care (APCC) pathways to include mechanisms that ensure patients receive their LHRH injections on time and that treatment effects are monitored with both testosterone and PSA tests. In the current environment of restrictions in the number of patient visits due to the COVID-19 pandemic, these data are particularly relevant. It should also be recognized that use of the longest acting doses of LHRH agonists, such as 6-month, would reduce the potential for delays in dosing."

"As the manufacturer of the LHRH agonist Eligard, we are committed to collaborating with clinical experts to advance the science around the treatment of advanced prostate cancer," said Dr. Stuart Atkinson, Vice President of Medical Affairs at Tolmar Pharmaceuticals. "This real-world, retrospective analysis of the medical records of nearly 23,000 patients who were treated with LHRH agonists for prostate cancer exemplifies how we hope to equip healthcare providers with relevant and timely information that may help inform their approach to delivering high-quality care."

About ELIGARD

ELIGARD (leuprolide acetate) for injectable suspension is a prescription drug, given by injection, for the palliative treatment of advanced prostate cancer. ELIGARD is an LHRH agonist. ELIGARD uses a novel, polymeric gel, extended-release delivery technology that is designed to release leuprolide acetate at a controlled rate over an extended dosing period and enables subcutaneous administration. ELIGARD is available in 1-, 3-, 4- and 6-month dosing forms.

Important Safety Information

ELIGARD is indicated for the palliative treatment of advanced prostate cancer. ELIGARD is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs, or any of the components of ELIGARD. Anaphylactic reactions to synthetic GnRH or GnRH agonist analogs have been reported in the literature. Transient increase in serum levels of testosterone during treatment may result in worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment, including bone pain, neuropathy, hematuria, bladder outlet obstruction, ureteral obstruction, or spinal cord compression.

Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH analogs. Monitor blood glucose level and manage according to current clinical practice. Increased risk of myocardial infarction, sudden cardiac death and stroke has also been reported with use of GnRH analogs in men. Monitor for cardiovascular disease and manage according to current clinical practice. Androgen deprivation therapy may prolong the QT/QTc interval. Consider risks and benefits. May cause fetal harm. Convulsions have been observed in patients taking leuprolide acetate with or without a history of predisposing factors. Manage convulsions according to the current clinical practice.

ELIGARD may impair fertility in males of reproductive potential.

The most common injection site adverse events are transient burning and stinging, pain, bruising, and erythema. The most common systemic adverse events include mild to severe hot flashes/sweats, malaise and fatigue, weakness, myalgia, dizziness, clamminess, testicular atrophy, and gynecomastia. As with other GnRH agonists, other adverse reactions, including decreased bone density and rare cases of pituitary apoplexy have been reported.

On May 18, 2020 Ryvu Therapeutics (WSE: RVU), a clinical stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology, reported that it will present data from its multiple oncology programs at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II taking place June 22 to June 24, 2020 (Press release, Ryvu Therapeutics, MAY 18, 2020, View Source [SID1234558263]).

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!

Data presented will include results from the small-molecule STING agonists, dual A2A/A2B adenosine receptors antagonist program, HPK1 inhibitors and SMARCA2 (BRM) degraders program.

Details of the e-poster presentations are as follows:

Title: In vivo and in vitro characterization of RVU330 best-in-class dual A2A/A2B adenosine receptor antagonist
Permanent Abstract Number: 5555

Title: Development of selective small molecule STING agonists suitable for systemic administration
Permanent Abstract Number: 4521A

Title: Development and characterization of small molecule HPK1 inhibitors
Permanent Abstract Number: 1947

Title: Development of novel, selective SMARCA2 (BRM) degraders for treatment of SMARCA4 (BRG1) mutated tumors
Permanent Abstract Number: 3656

The e-poster website will be launched on June 22, the first day of the AACR (Free AACR Whitepaper) Virtual Annual Meeting II. All e-posters will be made available for browsing on this date. Additional information is available at on the AACR (Free AACR Whitepaper) conference website View Source

On May 18, 2020 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported the offer document (the "Offer Document") for its voluntary tender offer (the "Tender Offer") for all of the ordinary shares of QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) at an offer price of €39 per share in cash, following approval of the publication by the German Federal Financial Supervisory Authority (Press release, Thermo Fisher Scientific, MAY 18, 2020, View Source [SID1234558262]).

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 period for acceptance of the Tender Offer commenced on May 18, 2020, and is scheduled to end at midnight Frankfurt am Main Local Time or 6:00 PM New York Local Time on July 27, 2020. The Tender Offer is subject to certain customary closing conditions, including, among others, the receipt of applicable regulatory approvals, the adoption of certain resolutions relating to the transaction at QIAGEN’s general meeting of shareholders (the "General Meeting"), and a minimum acceptance threshold of at least 75% of QIAGEN’s issued and outstanding ordinary share capital as of the end of the acceptance period. The conditions to the Tender Offer are set forth in their entirety in section 12 of the Offer Document.

The QIAGEN Managing Board and Supervisory Board have unanimously recommended that QIAGEN shareholders accept the Tender Offer by tendering their shares and vote in favor of each of the transaction resolutions at the General Meeting.

The transaction is expected to close in the first half of 2021 as previously announced.

The Offer Document, both in German and in English, is now available at View Source A copy of the Offer Document can also be obtained free of charge at the website maintained by the SEC at www.sec.gov or by contacting the U.S. and German information agents for the Tender Offer.

The German and U.S. information agents for the Tender Offer are, respectively:

Advisors

J.P. Morgan Securities LLC and Morgan Stanley & Co. LLC are serving as financial advisors to Thermo Fisher, and Wachtell, Lipton, Rosen & Katz is serving as legal counsel.

On May 18, 2020 MaxCyte, the global clinical-stage cell-based therapies and life sciences company, reported that clinical data from the first three cohorts of the ongoing Phase I dose-escalation trial demonstrating safety of MCY-M11 and feasibility of one-day manufacturing will be shared at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) upcoming annual meeting (Press release, MaxCyte, MAY 18, 2020, View Source [SID1234558261]). The ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program will be held May 29-31, 2020.

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 Poster Discussion presentation, entitled Feasibility and preliminary safety and efficacy of first-in-human intraperitoneal delivery of MCY-M11, anti-human-mesothelin CAR mRNA transfected into peripheral blood mononuclear cells, for ovarian cancer and malignant peritoneal mesothelioma, will be available in the Developmental Therapeutics: Immunotherapy session, which can be accessed on demand beginning at 8 a.m. ET on Friday, May 29, 2020.

MCY-M11 is a wholly-owned, non-viral, mRNA-based cell therapy candidate manufactured using un-manipulated peripheral blood mononuclear cells. It is under development for the treatment of ovarian cancer and peritoneal mesothelioma. The ongoing study so far demonstrates both the safety and of MCY-M11 as well as the feasibility of one-day manufacturing and intraperitoneal delivery of our cell product.

"This is a presentation of the preliminary results of our ongoing first-in-human study with the novel mRNA-based CARMA platform designed to treat malignancies expressing mesothelin," said Christina M. Annunziata, MD, PhD, Investigator at the Women’s Malignancies Branch and Head of the Translational Genomics Section at the National Cancer Institute Center for Cancer Research. "We have so far demonstrated the feasibility to deliver MCY-M11 CARMA cells intraperitoneally to treat patients, the acceptable overall safety of using a transient CAR expression approach and early evidence that supports moving forward with and further building on this strategy."

As previously announced, dosing began in October 2019 in the third cohort in MaxCyte’s Phase I dose-escalation trial with MCY-M11 and there have been no dose-limiting toxicities or related serious adverse events observed in the three completed cohorts. A fourth dosing cohort commenced in March 2020 as expected. Preliminary clinical results for the trial are expected to be announced in H2 2020. Clinical development of MCY-M11 continues now under the auspices of MaxCyte’s subsidiary CARMA Cell Therapies.

For more information about the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program and a link to the abstract, please visit: View Source

About CARMA Cell Therapies
Through its wholly owned subsidiary, CARMA Cell Therapies, MaxCyte is facilitating advancement of novel mRNA-based cell therapies for cancer and other diseases with serious unmet needs. MaxCyte has developed CARMA, a novel and proprietary platform for the development of non-viral, human messenger RNA (mRNA)-based, chimeric antigen receptor (CAR) or T-cell receptor (TCR) redirected immune cell therapies. CARMA [derived from CAR mRNA] utilizes MaxCyte’s Flow Electroporation technology for highly efficient, non-viral, delivery of one or more mRNA(s) into un-manipulated peripheral blood mononuclear cells (PBMCs) or isolated immune cells such as T- or NK-cells. CARMA offers the potential for a safer cell therapy, as a result of transient expression of receptor(s) and a non-viral delivery approach. Together, CARMA and MaxCyte’s EXPERT family of instruments also offer the potential for a significantly streamlined, scalable, and cost-effective GMP manufacturing process without the complexity of virus-based products. At the start of 2020, MaxCyte established CARMA Cell Therapies as a wholly owned subsidiary to facilitate independent investment and new partnerships to advance the CARMA platform. MaxCyte has retained Locust Walk, a global life science strategic advisory and transaction firm. The Company expects CARMA to be self-funded by end of 2020. For more information, visit View Source