On March 31, 2020 Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM) reported that it has initiated a Phase II study of HMPL-453, its novel small molecule inhibitor targeting fibroblast growth factor receptors ("FGFR"), in patients with advanced malignant mesothelioma (Press release, Hutchison China MediTech, MAR 31, 2020, https://www.chi-med.com/chi-med-initiates-a-phase-ii-trial-of-hmpl-453-in-patients-with-advanced-malignant-mesothelioma-in-china/ [SID1234556026]).

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The clinical study is a single-arm, multi-center, open-label study, evaluating the efficacy, safety and pharmacokinetics of HMPL-453 in historically confirmed patients with advanced malignant mesothelioma that failed at least one line of systemic therapy.

The primary outcome measure is overall response rate (ORR). Secondary outcome measures include preliminary efficacy such as disease control rate (DCR), time to response (TTR), duration of response (DoR), progression-free survival (PFS), and overall survival (OS). The lead investigator of the study is Shun Lu, Professor at Shanghai Chest Hospital, Jiao Tong University. Additional details may be found at clinicaltrials.gov, using identifier NCT04290325.

About Fibroblast Growth Factor Receptors (FGFR)
FGFRs are a sub‑family of receptor tyrosine kinases. Activation of FGFR signaling pathways is central to several biological processes. In normal physiology, FGF/FGFR signaling is involved in embryonic development (organogenesis and morphogenesis), tissue repair, angiogenesis, neuroendocrine and metabolism homeostasis. Given its complexity and critical role in a number of important physiological processes, aberrant FGFR signaling has been found to be a driving force in tumor growth, promotion of angiogenesis, as well as conferring resistance to anti‑tumor therapies.

About HMPL‑453
HMPL‑453 is a novel, highly selective and potent small molecule inhibitor targeting fibroblast growth factor receptors 1, 2 and 3. In pre‑clinical studies, HMPL‑453 demonstrated superior potency and better kinase selectivity as compared to other drugs in the same class, as well as a favorable safety profile. Enrollment has been completed for the dose escalation of the Phase I study of HMPL-453 in China, for which additional details can be found at clinicaltrials.gov, using identifier NCT03160833.

On March 31, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has submitted the regulatory application for FoundationOne Liquid CDx (overseas product name) to the Ministry of Health, Labour and Welfare (MHLW), as a liquid biopsy (LB) test that provides a comprehensive genomic profiling (CGP) for solid tumors (Press release, Chugai, MAR 31, 2020, View Source [SID1234556025]).

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"Since the national health insurance coverage for genomic testing has started in June 2019, cancer genomic medicine has become widely and increasingly recognized in our society as a new approach in cancer treatment. However, there is an increasing need for blood-based genomic testing in some patients who are unable to undergo invasive tumor biopsy," said Chugai’s President and COO, Dr. Osamu Okuda. "FoundationOne Liquid CDx is a new tool that can help a physician determine treatment options by conducting comprehensive genomic profiling based on genomic alterations in a wider range of patients. We will continue our efforts to obtain approval for the product as soon as possible, and contribute to precision medicine."

Developed by Foundation Medicine Inc. based in Cambridge, USA, FoundationOne Liquid CDx is a next-generation sequencing based in vitro diagnostic device for advanced cancer patients with solid tumors. It is to identify genomic alterations in oncogenes through detection of blood circulating tumor DNA (ctDNA). In the U.S., Foundation Medicine received Breakthrough Device designation from the U.S. Food and Drug Administration for the LB test in April 2018.

As a leading company in the field of oncology, Chugai is committed to realize precision medicine in oncology and contribute to patients and healthcare professionals through improving access to CGP.

On March 31, 2020 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") reported that it has fully placed the new shares from the capital increase resolved on March 30, 2020 of up to EUR 3,602,154.00 at a price of EUR 1.11 per new share (Press release, Epigenomics, MAR 31, 2020, View Source [SID1234556024]). Accordingly, the Company’s share capital will be increased from currently EUR 43,527,692.00 by EUR 3,602,154.00 to EUR 47,129,846.00 by issuing up to 3,602,154 new registered no par value shares of the Company against cash contributions.

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The new shares were fully subscribed by institutional investors from Germany and the U.S.A. by way of a private placement with the exclusion of the shareholders’ subscription rights and carry full dividend rights as of January 1, 2019.

The gross proceeds from the capital increase amount to approximately EUR 4.0 million.

Subject to the registration of the entry of the capital increase in the commercial register and any delays caused by the COVID 19 pandemic, the Company assumes that the admission of the new shares to the regulated market (Prime Standard) of the Frankfurt Stock Exchange will probably take place on or around April 3, 2020.

Epigenomics AG intends to use the net proceeds from the capital increase primarily to finance its ongoing operations.

On March 30, 2020 Diverse Biotech, Inc. www.diversebiotech.com reported it has signed an initial partnership agreement with The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center to study its potential new therapeutic candidates in glioblastoma (Press release, Diverse Biotech, MAR 30, 2020, View Source [SID1234576456]). The research will be performed in animal models of the disease to evaluate the efficacy and tissue distribution of Diverse Biotech’s new drug compounds.

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"We are honored to be partnering with this world-renowned center for the study and treatment of brain cancer. Glioblastoma is a disease with a large unmet patient need. Our team at Diverse Biotech wants to develop and study new drugs that could change the standard of care in this disease," said Stella Vnook, Diverse Biotech’s Chief Executive Officer.

"We are excited to be collaborating with Diverse Biotech and to evaluate their cannabidiol compounds in our GBM models. One of the main goals of our lab is to find new therapies that might improve the outcomes for patients living with this disease. Preclinical testing of novel agents is the first step in this process," said Steve Keir, DrPH, MPH, MMCI, Research Professor and Director of Translational Research at The Preston Robert Tisch Brain Tumor Center, Duke University.

On March 30, 2020 Vaccitech Ltd, a clinical stage biopharmaceutical company developing immunotherapies to treat infectious diseases and cancer, reported that its Chief Executive Officer, Bill Enright, will present an update on the Company’s progress at the upcoming Solebury Trout Virtual Investor Conference (Press release, Vaccitech, MAR 30, 2020, View Source [SID1234556135]). The presentation will include recent encouraging Phase 2 efficacy data for Vaccitech’s prostate cancer therapeutic combined with an anti-PD-1 checkpoint inhibitor in metastatic castration resistant prostate cancer patients. The presentation will also outline ongoing COVID-19 vaccine efforts using Vaccitech’s proprietary ChAdOx1 vector.

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Vaccitech is one of the few companies in the world that has data in humans demonstrating neutralizing antibodies against a coronavirus with its MERS (Middle Eastern Respiratory Syndrome) vaccine candidate.

Date of presentation: Tuesday, 31 Tuesday, 2020

Time: 10:00 am – 10:30 am ET