On April 10, 2020 Genetron Holdings Limited ("Genetron Health"), a China-based precision oncology company, reported the appointment of Dr. Yun-Fu Hu as Chief Medical Officer (Press release, Genetron Health Technologies, APR 10, 2020, View Source [SID1234556246]). A former deputy director with the US Food and Drug Administration (FDA), Dr. Hu will be tasked to steer the company forward in its in vitro diagnostic (IVD) devices registration and regulatory affairs as well as bio-pharmaceutical services business.

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. Hu has over two decades of experience in regulatory and managerial capacities related to medical devices and pharmaceutical industries. During his tenure at FDA, he has led a team of staff in premarket reviews and post-market compliance of IVD products and laboratory-developed tests (LDTs) for genetic testing, molecular cancer diagnostics, companion diagnostics, radiodosimetry, digital pathology and artificial intelligence devices. Some of his notable authorizations include: the first next generation sequencing (NGS)-based LDT as companion diagnostics (CDx) (Foundation Medicine FoundationFocus CDxBRCA); the first NGS-based CDx kit (ThermoFisher Oncomine Dx Target Test); the first NGS-based LDT for tumor profiling (MSK-IMPACT) and later on FoundationOne CDx); the first liquid biopsy test for NSCLC (Roche Cobas EGFR Mutation Test v2); and FDA’s only two approved cancer screening tests in the last decade (Exact Sciences’ Cologuard and Epigenomics’ Epi ProColon). Dr. Hu and his team have also won over 10 FDA-level group awards for outstanding contributions in FDA authorization of many such first-of-its-kind devices.

Prior to joining FDA, Dr. Hu has more than 10 years of product development experience in diagnostic and pharmaceutical industries, leading his teams to achieve outstanding results in biomarker discovery and diagnostic development.

Sizhen Wang, Genetron Health’s co-founder and CEO, said, "Dr. Hu’s caliber and depth of experience in molecular cancer diagnostics and pharmaceutical R&D is nothing short of exceptional. Hailed with outstanding regulatory background and solid industry experience, he is a perfect hybrid talent in the global biopharmaceutical field. With Dr. Hu joining our leadership team, he will value-add to our molecular diagnostic business with international best practices in technical R&D, product design, clinical approval and policy and regulatory matters. I believe he will be an asset to Genetron Health and the industry in driving high quality and high efficiency clinical adoption of more innovative technologies."

Dr. Hu said, "China has a unique advantage in precision oncology clinical data. We have witnessed the emergence of many outstanding companies, related technologies and products in recent years. I am truly impressed with the global vision shown by the leadership at Genetron Health. I believe Genetron has massive growth potential, driven by the company’s continuous innovation capabilities. I am delighted to be part of this team and I look forward to assisting the clinical adoption of Genetron’s innovative technologies and the establishment of a global one-stop bio-pharmaceutical service platform. It is our hope to bring high quality China biotechnology to the world."

On April 10, 2020 Pelican Therapeutics, Inc. ("Pelican"), reported that it was awarded $15.2 million to fund preclinical and certain clinical activities from Cancer Prevention Institute of Texas (CPRIT) grant (the "CPRIT Grant") (Filing, 8-K, Heat Biologics, APR 10, 2020, View Source [SID1234556244]). The CPRIT Grant is subject to customary CPRIT funding conditions.

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 CPRIT Grant initially covered a three-year period from June 1, 2017 through May 31, 2019. On April 12, 2019, CPRIT notified Pelican that it agreed to a six-month extension of time in order to conclude the approved scope of work, such that the completion date was extended from May 31, 2019 to November 30, 2019. On November 20, 2019, CPRIT notified Pelican that it agreed to a six-month extension of time in order to conclude the approved scope of work, such that the completion date was extended from November 30, 2019 to May 30, 2020. On April 9, 2020, CPRIT notified Pelican that it agreed to a six-month extension of time in order to conclude the approved scope of work, such that the completion date was extended from May 30, 2020 to November 30, 2020. All other terms and conditions of the CPRIT arrangement remained the same.

On April 9, 2020 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it recently participated in a constructive meeting with the U.S. Food and Drug Administration (FDA) as scheduled, to discuss the clinical section of the New Drug Application (NDA) for oral paclitaxel and encequidar for the treatment of metastatic breast cancer (Press release, Athenex, APR 9, 2020, View Source [SID1234573880]). The Company is on track to submit the NDA in accordance with the FDA’s guidance, and will provide a further update when the FDA’s official response to the filing becomes available.

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!

On April 9, 2020 Notable, a technology leader redefining cancer treatment through rapid drug development via a clinically validated platform, reported its board has appointed veteran life science executive Laurie Heilmann as Chief Executive Officer (Press release, Notable Labs, APR 9, 2020, View Source [SID1234556909]). She succeeds founder Matt De Silva who will remain a member of Notable’s Board of Directors and continue to serve as the company’s Executive Chairman.

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!

"Laurie has a proven track record transforming life science startups into established global brands. We are delighted to welcome her to the team during this critical inflection point in our trajectory," said Matt De Silva, Founder and Executive Chairman. "Notable’s experienced and diverse team has spent over five years focused on developing our clinical platform and building partnerships with top academic institutions and leading pharmaceutical companies. We will continue to expand the reach of our technology to power functional precision medicine with Laurie at the helm."

Heilmann brings more than 30 years of executive leadership experience. She joins Notable from CrownBio, where she served as President of Global Life Science and Diagnostic Solutions and led the strategic development and commercialization of products and services to treat oncology, cardiovascular, and metabolic diseases. Her efforts helped transform the company into a prominent global player in the pre-clinical oncology, cardiovascular, and metabolic disease markets. Prior to CrownBio, Laurie held leadership roles at Strong-Bridge Consulting, Image Metrix-American College of Radiology and the Ockham Development Group.

"It’s an exciting time to join the talented team at Notable. As the company enters the next stage of growth we will focus on advancing the awareness of our scientific technology platform and continue our revolutionary innovation in functional precision medicine," said Laurie Heilmann, CEO of Notable. "I look forward to advancing the incredible work that Matt and the Notable team has accomplished to accelerate drug discovery for cancer patients."

Notable’s automated technology platform is built to help predict patient responses to cancer treatment therapies in as little as seven days. As a precision oncology company, Notable matches patients with effective therapies and accelerates the drug development process for novel therapeutics. The company can help patients and their physicians make better-informed decisions about which treatments and clinical trials might be most effective. A feasibility study conducted at the Stanford University School of Medicine demonstrated that Notable achieved an 84 percent overall accuracy rate in retrospectively predicting patient therapeutic responses. The most recent data from this collaboration was presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December of 2019.

On April 9, 2020 Rexahn Pharmaceuticals terminated a nearly two-year-old agreement with Merck that paired the company’s experimental phosphorylated-p68 inhibitor with Keytruda as a potential treatment for metastatic triple-negative breast cancer (Press release, Merck & Co, APR 9, 2020, View Source [SID1234556249]).

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!

Rexahn disclosed the decision in a filing with the U.S. Securities and Exchange Commission this week, Seeking Alpha first reported. Rexahn said it notified Merck on April 7 of its decision to discontinue the development of RX-5902 for the treatment of metastatic triple-negative breast cancer. The two companies initially struck the agreement in 2018. At the time the deal was struck, Rexahn’s RX-5902 was already being studied as a monotherapy for triple-negative breast cancer. The companies intended to pair Keytruda with RX-5902 to treat patients with metastatic TNBC who have progressed following at least one prior treatment. Rexahn was intended to be the sponsor of the Phase II study.

In preclinical studies, RX-5902 had been shown to inhibit the growth and proliferation of multiple human cancer cell lines, including triple-negative breast cancer, decrease tumor growth in patient-derived xenograft models and potentiate the activity of immune checkpoint inhibitors and other anti-tumor agents, Rexahn said at the time of the deal.

In its disclosure this week, Rexahn provided little reason for the discontinuation of the Phase II program. The company said it had previously disclosed that it was evaluating the development strategy for RX-5902, including whether to proceed with the trial. In September, Rexahn announced it was exploring strategic alternatives to enhance shareholder value. Those options included the potential sale or licensing of assets. In that announcement, Rexahn said it would not disclose any developments of its strategy until "the evaluation of strategic alternatives has been completed or the board of directors has concluded that disclosure is appropriate or legally required."

While Rexahn has been somewhat silent on the state of its exploration of strategic alternatives, the company has continued to conduct business. In an SEC filing last month, the company said it amended its 2019 license agreement for its oncology asset RX-3117 with BioSense Global to use in Singapore, China, Hong Kong, Macau and Taiwan. BioSense initially aimed at developing the cancer treatment for China.

In February, Rexahn entered into a licensing agreement with China-based Zhejiang HaiChang Biotechnology for RX-0201, an asset that is a "nano-liposomal formulation of RX-0201 known as RX-0301, and RX-0047, a proprietary compound currently in preclinical development." HaiChang intends to develop one product comprising RX-0301 and one product comprising RX-0047, Rexahn said in the filing. Under terms of the deal, Rexahn could earn nearly $100 million if certain developmental and regulatory milestones are met.