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Personal Genome Diagnostics Appoints Megan Bailey as Chief Executive Officer

On April 21, 2020 Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, reported that appointed Megan Bailey as Chief Executive Officer (CEO), promoted from Chief Commercial Officer (CCO) (Press release, Personal Genome Diagnostics, APR 21, 2020, View Source [SID1234556473]). Bailey succeeds Douglas Ward, who has served as PGDx’s Chief Executive Officer since 2016.

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"PGDx is at the forefront of cancer genomics with a vision to fundamentally change oncology care by delivering products that enable local precision medicine," said Luis Diaz, MD, Co-Founder and Chairman, Personal Genome Diagnostics. "Megan has made significant contributions since joining the company, and her leadership will be critical as we prepare for the next phase of commercial success. Megan’s extensive knowledge of clinical diagnostics, along with business development and commercialization expertise, is perfectly aligned with the next stages of growth for the company."

Prior to her appointment to Chief Executive Officer, Bailey joined PGDx as the Vice President of Marketing and was promoted to Chief Commercial Officer, where she led the company’s marketing, sales, customer support, and communications in developing and executing global go-to-market strategies. During her tenure at PGDx, Bailey contributed to CE marks for both the elio tissue complete assay and elio plasma resolve products and played a key role in establishing strategic collaborations with organizations such as the Mayo Clinic and PathGroup.

Before joining PGDx, Bailey spent more than 14 years at Roche. Most recently, Bailey served as Senior Director of Commercial Operations, responsible for leading sales teams across Roche’s Clinical Chemistry/Immunoassay, Molecular, Tissue, and Point of Care divisions in the Southeast United States. Prior to that she held marketing leadership roles for the Tissue Diagnostics division where she led multiple product launches, developed and executed commercial strategies across a variety of product lines, and drove strategic collaborations with some of the nation’s largest Integrated Health Networks.

"I am honored to have the opportunity to lead PGDx at this point in the company’s evolution," said Megan Bailey, Chief Executive Officer, Personal Genome Diagnostics. "We’re on the cusp of enabling the scalability of precision medicine with a fast, reliable, and accurate system through the upcoming launch of PGDx elio tissue complete. I’m thrilled to continue to work with our world-class team to deliver diagnostic products to healthcare systems that empower the fight against cancer for patients and clinicians."

Dr. Diaz added: "On behalf of the PGDx Board of Directors, I would like to extend our sincere gratitude to Doug Ward for his vision, expertise and commitment to PGDx that enabled us to be a commercially oriented organization poised to deliver best-in-class products to healthcare systems worldwide."

Physicians’ Education Resource® Announces Transition of 11th Annual International Symposium on Ovarian Cancer and Other Gynecologic Malignancies™ to Live Webcast

On April 21, 2020 Physicians’ Education Resource (PER), a leading resource for continuing medical education, reported the return of the International Symposium on Ovarian Cancer and Other Gynecologic Malignancies (Press release, Physicians’ Education Resource, APR 21, 2020, View Source [SID1234556472]). The conference will be held May 2 as a live CME-accredited webcast.

"We are beyond excited to announce the return of our International Symposium on Ovarian Cancer and Other Gynecologic Malignancies conference," said Phil Talamo, president of PER. "To ensure the safety of our faculty and attendees during the global pandemic and support the oncology community in the treatment of their patients with gynecologic malignancies, we made the decision to transition our live meeting in San Diego to a virtual CME-certified webcast."

The meeting will be co-chaired by Robert L. Coleman, M.D., FACOG, FACS, gynecologic oncologist and chief scientific officer of the US Oncology Network; Ursula A. Matulonis, M.D., director and chief of the division of gynecologic oncology and Brock-Wilson Family chair at Dana-Farber Cancer Institute and professor of medicine at Harvard Medical School; and Bradley J. Monk, M.D., FACOG, FACS, professor and director of the division of gynecologic oncology at Creighton University School of Medicine at St. Joseph’s Hospital and Medical Center and medical director of gynecological oncology research at the US Oncology Network.

The 11th Annual International Symposium on Ovarian Cancer and Other Gynecologic Malignancies is a one-day educational and scientific webcast that will focus on key topics in the management of ovarian cancer, as well as endometrial, uterine and cervical malignancies. This historic meeting, led by leading experts in the field of gynecologic malignancies, will offer medical, surgical and radiation oncologists the chance to learn, debate and discuss the latest diagnostic, therapeutic and supportive care strategies for patients with gynecologic cancers. Case-based presentations will allow for vibrant discussion of the practical concerns of treating patients in the real world. Promising novel agents undergoing clinical trial evaluation will also be highlighted during the live discussion.

Accredited by the Accreditation Council for Continuing Medical Education and approved by the California Board of Registered Nursing, this live webinar will provide participants the opportunity to earn up to 6.5 AMA PRA Category 1 Credits and 6.5 nursing contact hours.

Tarveda Therapeutics to Present Data from First in Human Study of PEN-866 at the 2020 AACR Virtual Annual Meeting

On April 21, 2020 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company developing a new class of potent and selective precision oncology medicines, which it refers to as Pentarin miniature drug conjugates, for the treatment of patients with various solid tumor malignancies, reported that the company will present data from its first in human study of PEN-866 at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting, occurring April 27-28, 2020 (Press release, Tarveda Therapeutics, APR 21, 2020, View Source [SID1234556471]).

PEN-866 is the initial clinical program from Tarveda’s HSP90 binding miniature drug conjugate platform, which is designed to bind to activated Heat Shock Protein 90 (HSP90) to accumulate and release its potent topoisomerase 1 inhibitor (SN-38) payload in solid tumors.

Details of the poster presentation are as follows:

Title: Characterization of PEN-866, a Heat Shock Protein 90 (HSP90) binding conjugate of SN-38, in patient plasma and tumors from the first in human study
Date: Monday, April 27, 2020
Time: 9:00 AM – 6:00 PM ET
Location: AACR (Free AACR Whitepaper) Virtual Annual Meeting I accessible on the AACR (Free AACR Whitepaper) website at www.aacr.org

Blue Earth Diagnostics Continues to Expand Access to Axumin® (fluciclovine (18F)) with First Commercial Supply in Slovakia, Europe

On April 21, 2020 Blue Earth Diagnostics Ltd, a Bracco company focused on molecular imaging diagnostics, reported expanded access to Axumin (fluciclovine (18F)) in Europe (Press release, Blue Earth Diagnostics, APR 21, 2020, View Source [SID1234556470]). The first commercial delivery of Axumin was made in Slovakia in April 2020. This was possible through the Blue Earth Diagnostics’ distribution partner in Slovakia, MGP, spol. s r. o. Axumin is a PET imaging agent approved in the European Union for use in men with suspected recurrence of prostate cancer. Axumin is commercially available in Belgium, Luxembourg, Italy, France, Norway, the Czech Republic, The Netherlands, Austria and, now, Slovakia, with further European countries set to follow soon.

Prostate cancer is a leading cause of cancer death in men. While most primary prostate cancer can be successfully treated, recurrence occurs in up to one-third of patients. Recurrent disease is typically detected by a rise in PSA levels but often the location and extent of the disease cannot be detected by conventional imaging. Of those who suffer biochemical recurrence, approximately one-third develop metastatic prostate cancer. Axumin was developed to target the increased amino acid transport that occurs in many cancers, including prostate cancer. It is labelled with the radioisotope (18F), enabling it to be visualized in the body with PET imaging.

Dr. Jonathan Allis, Chief Executive Officer of Blue Earth Diagnostics said, "We are very pleased that Axumin is now available in Slovakia. Expansion of supply into this new European country demonstrates the productive relationships that we have with our manufacturing and distribution partners, and supports our mission to make Axumin commercially available to clinicians and their patients across Europe."

Karel Zeleny, Chief Executive Officer of MGP commented, "We are proud of our continuing partnership with Blue Earth Diagnostics, and are happy to be able to distribute Axumin to another new market, contributing to the management of patients with prostate cancer recurrence."

Myovant Sciences Submits New Drug Application (NDA) to the FDA for Once-Daily, Oral Relugolix for the Treatment of Men with Advanced Prostate Cancer

On April 21, 2020 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women’s health and prostate cancer, reported that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer (Press release, Myovant Sciences, APR 21, 2020, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-submits-new-drug-application-nda-fda-once-daily [SID1234556469]). Myovant also announced that it expects to submit its NDA for once-daily, oral relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for women with heavy menstrual bleeding associated with uterine fibroids in May 2020.

TWEET THIS: "The submission of our NDA for prostate cancer is a major step towards providing a one pill, once a day potential new treatment option for men with advanced prostate cancer," said Lynn Seely, M.D., chief executive officer of Myovant Sciences. "Based on the robust efficacy and safety data from the Phase 3 HERO study, we believe relugolix, if approved, could provide men an important oral alternative to leuprolide injections, the current standard of care."

The NDA submission is supported by positive results from the Phase 3 HERO study, a randomized pivotal study comparing relugolix versus leuprolide acetate. Relugolix met the primary efficacy endpoint with 96.7% of men achieving sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks. Six key secondary endpoints demonstrated superiority to leuprolide acetate, including sustained testosterone suppression to castrate levels through 48 weeks, rapid suppression of testosterone at Day 4 and at Day 15, profound suppression of testosterone (< 20 ng/dL) at Day 15, rapid suppression of prostate-specific antigen (PSA) at Day 15, and suppression of follicle-stimulating hormone (FSH) at Week 24 (all p-values < 0.0001). The overall incidence of adverse events in the relugolix and leuprolide acetate groups was comparable (92.9% vs. 93.5%, respectively). Major adverse cardiovascular events were reported in 2.9% of men in the relugolix group versus 6.2% of men in the leuprolide acetate group. These events included non-fatal myocardial infarction, non-fatal stroke, and all-cause mortality.

"We made the decision to prioritize this NDA submission and potentially accelerate the availability of an oral treatment option for men with advanced prostate cancer," said Juan Camilo Arjona, M.D., chief medical officer of Myovant Sciences. "This is of particular importance in the current environment and for the foreseeable future due to COVID-19 and the need for men with advanced prostate cancer to go to a clinic to receive injections in person."

About the Phase 3 HERO Program in Advanced Prostate Cancer
Myovant’s Phase 3 clinical program for advanced prostate cancer consisted of a randomized, open-label, parallel-group, multinational clinical study designed to evaluate the safety and efficacy of relugolix in men with androgen-sensitive advanced prostate cancer who required at least one year of continuous androgen deprivation therapy. Men enrolled in the study were randomized 2:1 to receive a single loading dose of relugolix 360 mg followed by relugolix 120 mg once daily, or to treatment with leuprolide acetate 3-month depot injection, respectively.

Approximately 1,100 men are planned to be enrolled in this study, including approximately 430 men with metastatic prostate cancer to support the analysis of a secondary endpoint of castration resistance-free survival, data which are expected in the third quarter of 2020, and 90 Chinese men (enrolled in China and Taiwan) to support registration in China.

About Prostate Cancer
Prostate cancer is the second most prevalent form of cancer in men and the second leading cause of death due to cancer in men in the U.S. Cardiovascular mortality is the leading cause of death in men with prostate cancer and accounts for 34% of deaths in men with prostate cancer in the U.S. Approximately three million men in the U.S. are currently living with prostate cancer, and approximately 170,000 men are estimated to be newly diagnosed in 2019. Advanced prostate cancer is prostate cancer that has spread or come back after treatment and may include men with biochemical recurrence (rising PSA in the absence of metastatic disease on imaging), locally advanced disease, or metastatic disease. Treatment for advanced prostate cancer typically involves androgen deprivation therapy, which reduces testosterone to very low levels, commonly referred to as castrate levels. GnRH receptor agonists, such as leuprolide acetate, or slow-release injections are the current standard of care for androgen deprivation therapy. However, GnRH receptor agonists may be associated with mechanism-of-action limitations, including the potentially detrimental initial rise in testosterone levels that can exacerbate clinical symptoms, which is known as clinical or hormonal flare, and delayed testosterone recovery after the drug is discontinued.

About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces testicular testosterone production, a hormone known to stimulate the growth of prostate cancer, and ovarian estradiol production, a hormone known to stimulate the growth of uterine fibroids and endometriosis. Myovant is developing relugolix as a monotherapy tablet (120 mg once daily) for men with advanced prostate cancer. Myovant is also developing a relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for women with uterine fibroids and for women with endometriosis.