On December 30, 2019 Myovant Sciences (NYSE: MYOV), a healthcare company focused on developing innovative treatments for women’s health and prostate cancer, reported the closing of the previously announced landmark, low-interest (3-month LIBOR plus 3%) loan facility from Sumitomo Dainippon Pharma Co., Ltd. (TSE: 4506), now increased to $400 million (Press release, Myovant Sciences, DEC 30, 2019, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-announces-closing-400-million-loan-facility [SID1234552631]). The closing of the loan facility is concurrent with the transfer by Roivant Sciences of a majority of Myovant’s shares and four additional biopharmaceutical "Vant" companies to Sumitovant Biopharma Ltd. ("Sumitovant"), a newly-formed subsidiary of Sumitomo Dainippon Pharma as a result of the completion of their transaction for the creation of a significant multi-national Sumitomo Dainippon Pharma-Roivant Alliance. With the increase in its loan facility with Sumitomo Dainippon Pharma, Myovant will repay its pre-existing loans from NovaQuest Capital Management and Hercules Capital (NYSE: HTGC). Concurrent with the transfer of Myovant’s shares, Hiroshi Nomura and Adele Gulfo have joined Myovant’s Board of Directors, while Vivek Ramaswamy and Frank Torti, M.D., have transitioned off.

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"It is with great pleasure that we welcome Hiroshi Nomura and Adele Gulfo to join our Board of Directors. They will bring valuable financial, strategic, and commercial expertise as Myovant approaches multiple potential commercial launches," said Lynn Seely, M.D., CEO of Myovant Sciences. "I sincerely thank Vivek Ramaswamy for his role in the formation and launch of Myovant, and both Vivek and Frank Torti for their contributions to Myovant’s success. Myovant is now in a much stronger financial position with the increased, low-interest loan facility from Sumitomo Dainippon Pharma, which enables us to repay the NovaQuest and Hercules loans and thereby substantially lower our cost of capital and reset our debt maturities to 5 years."

Mr. Nomura has been President, CEO, and Representative Director of Sumitomo Dainippon Pharma since April 2018. Prior to his current role, Mr. Nomura served in a number of executive leadership roles at Sumitomo Dainippon Pharma, including Board of Directors, Senior Executive Officer, and Chief Financial Officer from 2014 to 2018. From 2003 to 2014, he held various other positions with increasing responsibilities at Sumitomo Dainippon Pharma. He also served on the Board of Directors and as Vice Chairman, Executive Vice President, and Chief Financial Officer of Sunovion Pharmaceuticals Inc. from 2012 to 2014. Mr. Nomura received a Bachelor of economics from the University of Tokyo.

Ms. Gulfo serves as the Chief Business and Commercial Development Officer at Sumitovant. Prior to joining Sumitovant, from May 2018 to December 2019, Ms. Gulfo served as Chief of Commercial Development at Roivant Sciences. Previously, from 2014 to 2018, she was Chief Strategy Officer, Executive Vice President, and Head of Global Commercial Development at Mylan. From 2009 to 2014, she served in a number of executive leadership roles at Pfizer, including President and General Manager of the U.S. primary care business and President of Latin America. She also currently serves on the Board of Directors of EnPro Industries and Medexus Pharma. Ms. Gulfo received a B.S. from Seton Hall University and a M.B.A. from Fairleigh Dickinson University.

Myovant also announced the promotions of Frank Karbe to President and Chief Financial Officer and Matthew Lang to Chief Administrative and Legal Officer and Corporate Secretary.

Mr. Karbe joined Myovant in 2017 as Chief Financial Officer. He previously served as Executive Vice President and Chief Financial Officer for Exelixis from 2004 to 2014. Earlier in his career, he worked as an investment banker for Goldman Sachs & Co. Frank currently serves on the Board of Directors of Aduro Biotech. He received his Diplom-Kaufmann from the WHU-Otto Beisheim Graduate School of Management, Koblenz, Germany.

Mr. Lang joined Myovant in 2017 as General Counsel and Corporate Secretary. Previously, from 2009 to 2017, he worked at Gilead Sciences where he served most recently as Vice President, Head of Global Litigation, Investigations, Employment Law and Information Governance. Prior to Gilead, he practiced law at Dechert LLP in New York City. Mr. Lang received his B.A. in classical studies from Queen’s University at Kingston, Canada and his J.D. from the University of Pennsylvania Law School.

On December 30, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, reported that it will participate in the 38TH Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2020 (Press release, Five Prime Therapeutics, DEC 30, 2019, View Source [SID1234552632]). William Ringo, who is Five Prime’s Chairman and interim Chief Executive Officer, will represent the company and respond to questions from investors. He is scheduled to present at 7:30 a.m. PT (10:30 a.m. ET).

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Investors and other interested parties will be able to access a live audio webcast of the presentation by visiting View Source A replay of the presentation will also be available on the Five Prime website for 30 days after the conference.

On December 30, 2019 Castle Biosciences, Inc. (Nasdaq: CSTL) reported that results from a study designed to perform a systematic review of the literature and establish the level of evidence for the Company’s DecisionDx-Melanoma gene expression profile test were published in the December 2019 issue of the American Journal of Clinical Dermatology (Press release, Castle Biosciences, DEC 30, 2019, View Source [SID1234552633]). The results show that the DecisionDx-Melanoma test achieves a higher level of evidence than determined by major organizations that publish guidelines on melanoma management.

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DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors. In this independent study by Dubin, et al. titled, "Level of Evidence Review for a Gene Expression Profile Test for Cutaneous Melanoma," the researchers conducted a review of seven development and validation studies for the DecisionDx-Melanoma test. They then applied attributes of each study to the level of evidence criteria for the American Joint Committee on Cancer (AJCC), National Comprehensive Cancer Network (NCCN) and American Academy of Dermatology (AAD). The AJCC, NCCN and AAD are considered major authoritative organizations that many dermatologists rely upon to provide skin cancer guidelines, and each employs a unique ranking system to assign a level of evidence to the management of melanoma.

Key Findings:

The evaluation of seven development and validation studies led the authors to classify DecisionDx-Melanoma as level I/II, I–IIIB and IIA according to AJCC, NCCN and AAD criteria, respectively, which are higher than the official unrated status conferred by the AJCC and NCCN and the II/IIIC rating designated by the AAD in the latest version of their melanoma guidelines.
The authors note that the differences between the study’s findings and official published ratings may be attributed to chronological issues, as many of the studies were not yet published when the organizations conducted their reviews. There was also difficulty in applying the National Comprehensive Cancer Network criteria to this prognostic test, as their guidelines were intended for evaluation of therapeutic response markers.
Based on current published data, the authors find integration of the DecisionDx-Melanoma test to be useful for patients with invasive melanoma, particularly older patients with T1/T2 (tumor depth of 2 mm or less) melanomas:
For patients with invasive melanoma, DecisionDx-Melanoma may help guide the frequency of skin examinations and utilization of a sentinel lymph node biopsy (SLNB) surgical procedure or imaging following diagnosis of melanoma.
DecisionDx-Melanoma may benefit patients aged older than 65 years diagnosed with T1/T2 melanomas in the assessment of the risks and benefits of a SLNB surgical procedure.
Three additional prospective peer-reviewed clinical validity studies published in 2019 were not included in the Dubin study, due to publication after the systematic review was completed.

The full published study can be accessed at the journal’s website.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 3,900 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and five prospective risk of recurrence studies including more than 780 patients. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter study cohorts that included more than 2,000 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.

On December 29, 2019 Starpharma (ASX:SPL, OTCQX:SPHRY) reported that AstraZeneca (LSE/STO/NYSE:AZN) has commenced a phase 1 clinical trial of AZD0466 (DEP Bcl2/xL conjugate) and the first patient has been successfully dosed (Press release, Starpharma, DEC 29, 2019, View Source [SID1234552623]). The trial will recruit patients with a range of cancers and will be conducted at 4-5 US sites.

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The development of AZD0466, is being progressed under a multi-product license whereby Starpharma is eligible to receive development, launch and sales milestones of up to US$124 million, plus tiered royalties on net sales. The first dose of AZD0466 administered in the phase 1 trial has triggered a milestone payment to Starpharma of US$3 million. AstraZeneca also funds the development costs of DEP AstraZeneca products under the license.

AstraZeneca describes AZD0466 as having the potential to be a ‘best-in-class’ agent in this field with a broad opportunity in solid and haematological tumours (blood cancers) due to its ability to target both Bcl2 and Bcl/xL1.

Bcl2 is a clinically validated oncology target with the Bcl2 inhibitor, venetoclax (Venclexta – AbbVie/Genentech), being approved by the US FDA in 2016 with estimated peak global sales projected to be between US$2-3 billion2.

Dr Jackie Fairley, Starpharma CEO, commented: "It is really exciting to achieve this important milestone both for our collaboration with AstraZeneca and for Starpharma’s DEP platform. This is our first partnered DEP product to enter the clinic, alongside our three internal DEP products, DEP docetaxel, DEP cabazitaxel and DEP irinotecan. AZD0466 is a great illustration of the benefits that can be created for novel agents using Starpharma’s DEP platform and we look forward to further updates as the trial progresses."

On December 28, 2019 Elpiscience Biopharma reported the completion of Series B financing of 100 million USD (Press release, Elpiscience, DEC 28, 2019, View Source;id=1336 [SID1234552621]). The round was led by Hyfinity Investments, with participation from Tencent, GTJA Investment Group, Dyee Capital, Oriza Holdings, Ming Bioventures, WisdoMont, Parkway Global and others. Existing investors, including Lilly Asia Ventures, Hillhouse Capital Group, and CDH Investments continued to invest in this round of financing. The proceeds from Series B will primarily be used to advance highly innovative immunotherapy candidates such as ES101, ES102 and ES002 through pre-clinical and clinical development. The Company will also use these funds to expand its innovative product pipeline through internal discovery and global partnering.

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Elpiscience is a biopharmaceutical research and development company that strives to lead the next revolution of cancer immunotherapies. Built on its deep understanding of tumor biology and immunology, and with its highly efficient execution capabilities, Elpiscience has developed a globally competitive pipeline of 12 products in just two years, which is highly recognized not only by institutional investors but also by the commercial banks. Two weeks ago in Suzhou, Elpiscience announced the signing of a 150 million RMB collaboration with two major banks, Bank of China and Agricultural Bank of China. The fund will be used to establish Elpiscience’s GMP manufacturing capabilities. This signifies a major milestone of Elpiscience towards late stage and commercial development of antibody therapeutics.

Dr. Darren Ji, Elpiscience’s co-founder and CEO, commented, "We are pleased to be recognized by top investors during this round of financing. Their trust is truly appreciated, especially in this challenging year of private investment. We are particularly grateful towards Hyfinity Capital for their leading role and warmly welcome many other seasoned investors who participated in this Series B round. The participation of these top-notch investors greatly empowers us to continuously pursue the exciting journey of developing innovative drugs. We will stay committed to carefully exploring new scientific discovery towards finding effective therapies for cancer patients."

Dr. Sylvia Xin He, Hyfinity Investments’ Managing Partner, commented, "Elpiscience has a deep understanding of immunotherapy and focuses on the truly global innovative targets. The team at Elpiscience excels in execution, international collaboration, and innovative drug discovery and research in the field of tumor immunology. The rapid progress from preclinical to clinical development, the establishment of an integrated R&D team and the system, and their global network and collaboration with leading academic institutions and industry partners testify to the team’s strength. Immunotherapy is one of the vertical foci for Hyfinity Investments, a field that we have already deeply cultivated for the last two years. We are honored to join and support Elpiscience in its pursuit of innovative cancer immunotherapy and Hyfinity is committed to assisting Elpiscience in its great endeavors."