On February 6, 2020 Zetagen Therapeutics, Inc., a private, clinical-stage, biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions, reported the close of $5.34M Series A funding round (Press release, Zetagen Therapeutics, FEB 6, 2020, View Source [SID1234643690]). The financing will accelerate the growth of the Company’s ongoing clinical programs for ZetaMet (Zeta-BC-003), a synthetic, small-molecule, inductive biologic being developed to target and resolve metastatic lesions while inhibiting future tumor growth.

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"We are extremely pleased to have reached such an important milestone in Zetagen’s advancement as a biopharmaceutical company, " said Joe C. Loy, CEO of Zetagen Therapeutics, Inc. "This funding is paramount to accelerating our clinical programs around ZetaMet (Zeta-BC-003) by adding the necessary scientific infrastructure that will allow us to prepare for future human clinical trials."

ZetaMet (Zeta-BC-003) is a novel molecular pathway paired with a proprietary, drug-eluting implant technology. The novel therapy is designed to resolve tumor growth, inhibit pain, and regenerate bone. Zetagen exclusively licensed the platform technology from the State University of New York in 2016.

On February 5, 2020 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that Mr. Saiid Zarrabian, Chief Executive Officer of DelMar will attend the 22nd Annual BIO CEO & Investor Conference being held on February 10 and 11, 2020, at the New York Marriott Marquis in New York City (Press release, DelMar Pharmaceuticals, FEB 5, 2020, View Source [SID1234553865]). Mr. Zarrabian will be available for one-on-one meetings during the two-day event.

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Investors or others interested in meeting with management are encouraged to request a meeting through the conference’s one-on-one meetings system.

About the BIO CEO & Investor Conference

The BIO CEO & Investor Conference is one of the largest investor conferences focused on established and emerging publicly traded and select private biotech companies. Each year, the BIO CEO & Investor Conference provides a forum where institutional investors, industry analysts, and senior biotechnology executives have the opportunity to meet.

On February 5, 2020 Naveris reported a novel blood test can detect recurrent Human Papilloma Virus (HPV)-related head and neck (oropharyngeal) cancers, according to a study published online in the Journal of Clinical Oncology by researchers at the University of North Carolina School of Medicine (Press release, Naveris, FEB 5, 2020, View Source [SID1234553899]). The multi-year, prospective study underscores the test’s potential to allow patients with recurrent disease to begin earlier treatment and spare disease-free patients from repeated invasive testing.

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The technology underlying the research is licensed from the University of North Carolina to Naveris, which has designed and validated NavDx, a laboratory developed test for cancer-associated HPV detection. NavDx identifies minute fragments of tumor-modified viral HPV DNA, which is distinct from native viral HPV DNA. The company recently began providing the test through its CLIA laboratory to leading head and neck oncology treatment centers.

"This study shows how an exceptionally accurate, DNA-based blood test can be used to enhance the clinical management of patients with HPV-related cancers," said Piyush Gupta, PhD, CEO of Naveris. "The test identified all patients who recurred, doing so earlier than the current standard of care for most patients, while all patients that tested negative remained disease free for the duration of the study."

This study is timely as the incidence of HPV-related head and neck cancer has increased exponentially in recent decades and it is now the most prevalent HPV-related cancer in the United States, surpassing cervical cancer.

The prospective study at UNC was led by Associate Professor Dr. Bhisham Chera and Assistant Professor Dr. Gaorav Gupta. 115 patients treated for HPV-related head and neck cancers, with no evidence of disease post-therapy, were monitored for the development of recurrence for up to 3.5 years with radio-imaging and fiberoptic nasopharyngeal endoscopy. Patients also received the blood test prior to and during treatment, and at post-treatment follow up visits. All patients who eventually developed a recurrence had positive blood tests (sensitivity of 100%), while no patient with a negative blood test developed a recurrence (negative predictive value of 100%). Of the patients with two consecutive positive blood tests, all but one developed a biopsy-proven recurrence (positive predictive value of 94%). A positive blood test preceded the detection of recurrence by imaging for 91% of patients, with a median lead-time of 3.9 months.

The publication, by Chera et al., is entitled, Plasma Circulating Tumor HPV DNA for the Surveillance of Cancer Recurrence in HPV-associated Oropharyngeal Cancer, and is available Open Access.

On February 5, 2020 SIRION Biotech GmbH ("SIRION"), a world leader in viral vector-based gene delivery technologies for gene and cell therapy, and Hervolution Aps ("Hervolution"), a Danish start up supported by Novo Nordisk Foundation’s BioInnovation Institute (BII), reported a broad licensing agreement which includes coverage of SIRION’s adenovirus technologies to cancer vaccines encoding Endogenous Retrovirus (ERV)-derived antigens for active immunotherapy (Press release, SIRION Biotech, FEB 5, 2020, View Source [SID1234637209]). In addition, the companies have agreed to the assignment of ownership rights in a patent application for an adenoviral vector capable of encoding a virus-like particle (VLP), which displays an inactive immune-suppressive domain (ISD). This vaccine shows an improved immune response from either or both of the response pathways initiated by CD4 T cells or CD8 T cells. SIRION and Hervolution have been collaborating for over five years in the fields of HPV vaccine development and ERVs.

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Hervolution is an immunotherapy company that is applying adenovirus technologies both for cloning large nucleic acids and increasing the yield of replication-incompetent adenoviruses. The goal is to develop the world’s first adaptive immune therapy capable of targeting immunosuppressive genes of ancient retroviruses that normally are dormant in the human genome. The retroviral genes are reactivated in cancer and essential for tumor development. Hervolution’s proprietary combination of novel technologies is designed to break tolerance to this unique antigen family, thus providing broad anti-cancer efficacy.

As part of this agreement, SIRION Biotech will receive shares of Hervolution Aps, as well as representation on their Board of Directors. The parties have also agreed on milestones and royalties should Hervolution’s developments pass clinical development hurdles.

"This innovative cancer vaccine approach holds great promise, and our adenovirus was initially developed for such a vaccination. We congratulate Hervolution as they prepare to enter clinical development with the support of the BII," said Dr. Christian Thirion, Chief Executive Officer of SIRION.

Peter J. Holst, Ph.D., Interim CEO and CSO of Hervolution, is a former Associate Professor at the University of Copenhagen with long-standing experience in immunology, having made pivotal discoveries in the field. "Hervolution’s proprietary combination of novel technologies is designed to break tolerance to this unique antigen family, thus providing broad anti-cancer efficacy. SIRION has been a creative, loyal and responsive partner over the years, and their adenovirus technology is ideally suited to our needs."

On February 5, 2020 GlaxoSmithKline reported (Press release, GlaxoSmithKline, FEB 5, 2020, View Source [SID1234553866])

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2019 financial and product highlights
Pharmaceuticals £17.6 billion +2% AER, flat CER; Vaccines £7.2 billion +21% AER, +19% CER; Consumer Healthcare £9 billion +17% AER, +17% CER (Pro-forma +2% CER*)
Shingrix sales £1.8 billion +>100% AER, +>100% CER driven by strong execution in the US
Total Respiratory sales £3,081 million +18% AER, +15% CER. Trelegy £518 million +>100% AER, +>100% CER. Nucala £768 million +36% AER, +33% CER
Total HIV sales £4.9 billion, +3% AER +1% CER. Two-drug regimen sales £422 million
Total Group operating margin 20.6%. Adjusted Group operating margin 26.6% reflecting increased R&D spending and impact of generic Advair in the US partly offset by improved Vaccines and Consumer Healthcare performance. (Pharmaceuticals 26.2%; Vaccines 41.4%; Consumer Healthcare 20.8%)
Total EPS 93.9p +27% AER; +23% CER primarily reflecting reduced contingent consideration charges
Adjusted EPS 123.9p +4% AER, +1% CER reflecting operating performance and lower effective tax rate, partly offset by increased profit allocation to non-controlling interests
Net cash flow from operations £8.0 billion. Free cash flow £5.1 billion
23p dividend declared for the quarter, 80p for FY19

Pipeline highlights
Continued strengthening of R&D pipeline in 2019: eight submissions, six positive pivotal trial results and four new assets progressed into pivotal trials
In 2020 expect at least six potential approvals in oncology, HIV, specialty and respiratory
Expect proof of concept readouts on several key pipeline assets including four oncology medicines and vaccines for COPD and RSV
2020 guidance
Expect Adjusted EPS to decline -1% to -4% CER
Expect 80p dividend for 2020
Preparing for two new companies

New programme initiated to prepare for separation of GSK into two companies: New GSK, a biopharma company with an R&D approach focused on science related to the immune system, use of genetics and new technologies; and a new leader in Consumer Healthcare

As GSK increases investment in R&D and new product launches, the two-year separation programme aims to:
Drive a common approach to R&D across modalities with improved capital allocation
Align and improve capabilities and efficiencies of global support functions to support New GSK
Further optimise supply chain and portfolio, including divestments of non-core assets. Strategic review of prescription dermatology underway

Prepare Consumer Healthcare to operate as a standalone company
Programme to target delivery of £0.7 billion of annual savings by 2022 with total costs estimated at £2.4 billion (of which £1.6 billion cash). Programme expected to deliver improved operating performance, with meaningful improvements from 2022. Anticipated divestment proceeds largely expected to cover programme cash costs
Additional one-time costs to prepare Consumer Healthcare for separation estimated at £600-700 million

Emma Walmsley, Chief Executive Officer, GSK said:
"GSK delivered a good performance in 2019 with growth in sales and earnings, together with strong cash generation. We also made excellent progress in all three of our long-term priorities: Innovation, Performance and Trust, strengthening our pipeline, improving operational execution and reshaping the company.

"In 2020, our first priority remains Innovation, to progress our pipeline and support new product launches. Recent data readouts underpin our decision to further increase investment in R&D and these new products. At the same time, we are again focused on operational execution, including delivering a successful integration in Consumer Healthcare, and we are also preparing for the future, starting a new two-year programme to get GSK ready for separation.

"All of this aims to support future growth, deliver significant value creation, and set up two new leading companies in biopharma and consumer healthcare, each with the opportunity to improve the health of hundreds of millions of people."