On July 2, 2019 Sandoz reported the launch of the generic oncology medicine gefitinib indicated for adult patients with locally advanced or metastatic non-small cell lung cancer with activating mutations of EGFR-TK[1], which is recommended by ESMO (Free ESMO Whitepaper) as first-line treatment[4] (Press release, Novartis, JUL 2, 2019, View Source [SID1234537355]). The medicine will become available immediately in 13 countries across Europe on the day the reference medicine loses market exclusivity. Sandoz will continue to expand to other countries through a phased rollout.

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"Generics help expand access to medicine, sometimes as much as doubling the amount of patients treated without any increase in cost[5]," said Francesco Balestrieri, ad interim CEO, Sandoz. "At Sandoz, we recognize that oncology still lags behind seven other therapeutic areas that already benefit from considerable generic competition. The day one launch of generic gefitinib, seen by oncology experts as an essential treatment[8], is part of a wider Sandoz effort to change that equation."

In Europe lung cancer is the fourth most common cancer in both women and men, only exceeded by breast, prostate and colorectal cancer. Each year approximately 312,000 patients are diagnosed with lung cancer[2]. Non-small-cell lung carcinoma (NSCLC) is any type of epithelial lung cancer other than small cell lung carcinoma (SCLC) and accounts for approximately 80% to 85% of all lung cancers cases[6].

Sandoz is the #1 provider of generic oncology medicines worldwide[7] with a broad portfolio of more than 50 products, ranging from chemotherapy, hormones and supportive care to biologics[3]. Its growing oncology portfolio covers an industry-leading 75% of molecules on the WHO’s global Oncology Essential Medicines List[8],[9]. It invests in research and development to improve the lives of cancer patients and liberate healthcare resources through increased access to high-quality, affordable medicines.

About Gefitinib
Gefitinib is a once-daily, oral, non-chemotherapy medicine indicated for monotherapy treatment of adult patients with locally advanced or metastatic NSCLC with activating mutations of EGFR-TK[1]. It has been shown to potently inhibit EGFR, a protein involved in the growth and development of this type of cancer[1]. The ESMO (Free ESMO Whitepaper) guidelines recommend gefitinib as a first-line treatment option for patients with EGFR-activating mutation metastatic NSCLC[4]. Gefitinib is part of the national essential medicines list for cancer[8]. European regulatory approval was received for the generic molecule in July 2018, but generic products can only be made available at loss of market exclusivity of the reference product, provided that the patent protection has already expired.

On July 2, 2019 GNS Healthcare (GNS), a leading precision medicine company, together with the Alliance for Clinical Trials in Oncology (Alliance), is reported discoveries of predictive biomarkers for metastatic colorectal cancer (mCRC) patient response to receiving different treatments of cetuximab, bevacizumab, and panitumumab this week at the ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer 2019 conference held in Barcelona, Spain (Press release, GNS Healthcare, JUL 2, 2019, View Source [SID1234537371]). Patient subpopulation-specific prognostic factors of overall survival (OS) were also discovered. The in silico patient models identified AST level, primary side of tumor, intra-abdominal metastasis status as ubiquitous predictors of OS. KRAS status and hemoglobin levels were found to be predictors specific to the side of tumor location.

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The study titled "Bayesian machine learning on CALGB/SWOG 80405 (Alliance) and PEAK data identifies heterogeneous landscape of clinical predictors of overall survival (OS) in different populations of metastatic colorectal cancer (mCRC)" was selected to be presented in a poster discussion session, Friday July 5 from 10 am–5:15 pm local time.

Identification of prognostic factors of OS for subpopulations of patients with colorectal cancer is the key to better risk stratification at treatment initiation and identifying predictive factors for treatment response is crucial for making personalized treatment decisions.

In this study, one of several conducted by GNS and the Alliance, Bayesian machine learning approach was applied to the CALGB/SWOG 80405 (Alliance) and PEAK clinical trials datasets to discover gender and primary side specific predictors of OS in mCRC and patient subpopulations with better response to a given treatment.

Using clinical data from more than 2,000 patients with mCRC and GNS’ powerful causal AI platform, Reverse Engineering & Forward Simulation (REFS), nine independent predictive model ensembles were built to understand predictive biomarkers for patient response to receiving different treatments (cetuximab, bevacizumab, or panitumumab) and to identify patient subpopulation-specific prognostic factors of OS.

The study also identified gender-specific predictors, specifically creatinine level, intra-abdominal metastasis status, and the interaction of albumin and neutrophil levels. Urine protein levels were shown to be predictive of better efficacy from cetuximab treatment in patients with mCRC and left-sided tumors.

"We have never been in a better position to unravel drivers of disease and patient response to specific drugs. We built an in silico patient model of colorectal cancer and were able to uncover biomarkers that tell us which patients will respond to which treatment, and most importantly, why. This is what will get us to the point of delivering personalized medicine and eradicating disease," said Colin Hill, GNS Chairman, CEO, and Co-Founder.

"There is no such thing as a one-size-fits-all approach," said Alan P. Venook, MD, Study Chair for the CALGB/SWOG 80405 (Alliance) study, Madden Family Distinguished Professor of Medical Oncology and Translational Research at the University of California-San Francisco, and Shorenstein Associate Director for Program Development at the Helen Diller Family Comprehensive Cancer Center. "The better we understand how this disease progresses and which biomarkers predict treatment response, the closer we will get to curing it. We are committed to leveraging the best tools at hand – GNS’ powerful AI, comprehensive data, and the best minds in research – to cure cancer."

Previous results from these collaborations were presented in June 2018 at the ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois and at ESMO (Free ESMO Whitepaper) 2018 in Munich, Germany.

As one of the most common cancers in the U.S., there are an estimated 140,000 new cases of colorectal cancer diagnosed each year. There is still much to learn about the factors that drive progression and for patients with mCRC, the optimal treatment is still unknown.

About the Alliance for Clinical Trials in Oncology
The Alliance for Clinical Trials in Oncology develops and conducts clinical trials with promising new cancer therapies, and utilizes the best science to develop optimal treatment and prevention strategies for cancer, as well as research methods to alleviate side effects of cancer and cancer treatments. The Alliance is part of the National Clinical Trials Network (NCTN) sponsored by the National Cancer Institute (NCI) and serves as a research base for the NCI Community Research Oncology Program (NCORP).
To learn more about the Alliance, visit www.AllianceforClinicalTrialsinOncology.org.

On July 2, 2019 Oxford Vacmedix UK Limited (OVM), the UK-based biopharma company focused on the development of cancer vaccines, reported the award of an Innovate UK grant to CHAIN Biotechnology Ltd (CHAIN) and the University of Oxford to develop live biotherapeutics that support oral delivery for OVM’s recombinant overlapping peptide (ROP) cancer vaccines (Press release, Oxford Vacmedix, JUL 2, 2019, View Source/cancer-vaccine-firm-oxford-vacmedix-announces-collaboration-and-innovate-uk-grant/" target="_blank" title="View Source/cancer-vaccine-firm-oxford-vacmedix-announces-collaboration-and-innovate-uk-grant/" rel="nofollow">View Source [SID1234537356]). The research will use CHAIN’s proprietary microbiome technology and the world-class research facilities in the University’s department of Oncology.

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The project will initially focus on OVM-100 in a research project titled "Mucosal delivery of Clostridium spores encoding recombinant overlapping peptides (ROPs) of HPV antigen as therapeutic vaccines for cervical cancer". This will bring together University of Oxford’s expertise and CHAIN’s innovative microbial delivery platform to establish the effectiveness of delivering ROPs to the colon for the treatment of cervical cancer.

Spun out from the University of Oxford, OVM holds an exclusive licence for the ROP technology. The technology uses the novel, proprietary platform of ROPs to design and develop therapeutic cancer vaccines and diagnostics with the potential for increased efficacy, lower costs, simpler regulatory pathways and synergy when used in combination with other immune-oncology agents. OVM is developing two cancer vaccines, OVM-100 and OVM-200, focusing on unmet clinical need. OVM-100 is an HPV vaccine targeted at cervical cancer. OVM-200 represents a new type of vaccine utilising survivin, a protein inhibitor of apoptosis, to target solid tumours.

Dr Shisong Jiang, Principal Investigator in the Department of Oncology and Founder of OVM, said:

"We are delighted to have this opportunity to work with CHAIN on this exciting project. The importance of effective and controlled delivery is key to the development of new cancer vaccine and we are very pleased to have support and funding from Innovate UK for this work on our immunotherapy cancer vaccines"

Dr Edward Green, Chief Executive and Founder of CHAIN added:

"This project provides a further opportunity to exemplify our Clostridium-Assisted Drug Development (CADDTM) platform for targeted gut delivery of therapeutic peptides. We look forward to a successful collaboration with OVM and to establishing a combination approach that simplifies and accelerates the development of oral cancer vaccines providing significant patient benefits."

For more information or to arrange an interview, please contact:
William Finch, CEO, Oxford Vacmedix
T: +44 (0) 1865 742087 | M: +44(0)7769 903711 | E: [email protected]
View Source

On July 2, 2019 Immunicom, Inc., a biotechnology company awarded FDA Breakthrough Device Designation for its non-pharmaceutical solution for treating late-stage metastatic cancer, reported that raised $11 million in a Series B investment round (Press release, Immunicom, JUL 2, 2019, View Source [SID1234537372]). Several private equity family offices participated in the Series B financing which now increases Immunicom’s overall capital raised to $20 million.

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"Proceeds from this financing will help fund the 170-patient, randomized, multi-center, triple-negative breast cancer clinical trial we began May 31, while also fueling continued expansion of Immunicom’s global strategic partnerships," said Amir Jafri, the company’s Founder and CEO. "We are making great strides towards our vision of introducing a cancer immunotherapy that has the potential to be safer than most presently available treatments and very cost-effective. We truly appreciate the ongoing support of our investment partners for enabling us to achieve a rapid growth trajectory."

The revolutionary new immunotherapy treatment Immunicom has developed is called Immunopheresis and offers the potential to revitalize a cancer patient’s immune system to naturally fight tumor cells without introducing any new chemicals, proteins or antibodies into the body. Performed utilizing out-patient procedures analogous to standard dialysis treatments for removing unwanted waste products from a patient’s bloodstream through external filtration, Immunopheresis uses Immunicom’s proprietary blood filtering device technology to extract tumor-produced proteins in the bloodstream that inhibit the body’s natural immune system from attacking and eradicating tumors. This approach provides for a potentially robust immune response against the tumor cells and is intended to function also as an ideal adjunct therapy to existing treatments.

"Immunicom is uniquely positioned to have a fundamental impact on improving the lives of cancer patients worldwide," added David Schlotterbeck, Chairman of Immunicom and the former Co-Chairman of Cardinal Health. "Successfully bringing to market a medical device that not only has strong potential to treat a wide variety of cancer types, but with relatively straightforward design modifications may be reconfigured to treat other major illnesses as well, would be an industry game-changer. And that is precisely the objective our organization strives to achieve."

On July 1, 2019 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), (hereinafter "Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR) in oncology, in particular against rare or resistant cancers, reported the publication of an initiation report by KEPLER CHEUVREUX, a leading independent European financial services company specialized in research, execution and advisory services (Press release, Onxeo, JUL 1, 2019, View Source [SID1234537341]).

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KEPLER CHEUVREUX will now cover the ONXEO share on the stock exchange*.

The financial analysis published on June 28, 2019 by Kepler Cheuvreux is available on the website View Source, section "Research Public Access".

* This information does not constitute an offer to sell or subscribe, or the solicitation of an order to buy or subscribe for securities in France, Europe, the US or any other country. ONXEO and KEPLER CHEUVREUX have agreed on a service for the production and distribution of financial analyses.