On January 26, 2022 Sysmex Inostics, a global leader in the liquid biopsy revolution for oncology, reported the use of their HPV-SEQ test in the prospective University of Chicago clinical trial,1 "Pilot Study of Chemotherapy for HPV-Associated Oropharyngeal Cancer (Press release, Sysmex Inostics, JAN 26, 2022, View Source [SID1234607397])."

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"The ability to reliably detect HPV-DNA in plasma at such low frequency shows HPV-SEQ could be a promising non-invasive biomarker test for effectively assessing treatment response, appropriately de-intensifying treatment using real-time dynamic HPV quantification, and monitoring HPV-positive OPC patients’ post-treatment," said Dr. Nishant Agrawal, Professor of Surgery at the University of Chicago. "Therefore, the HPV-SEQ test has the potential to be an important tool for oncologists in treating patients with HPV-associated head and neck cancer," he concluded.

Current standard therapy used to treat OPC patients is associated with acute and long-term toxicities from chemotherapy, radiation, and surgery.2 In the trial, Dr. Agrawal and team will dynamically assess the level of cfHPV-DNA in patients’ blood and use this information to de-intensify treatment which would improve therapeutic outcome while minimizing treatment-associated toxicity.

Sysmex Inostics senior director of medical affairs, Fred Jones, noted, "The University of Chicago trial is a strong step forward in showing the clinical utility of HPV-SEQ test as a tool in treating patients with HPV-associated head and neck cancer. We look forward to the results of the trial."

HPV-associated OPC has increased dramatically over the last decade. In the United States HPV is thought to cause 70% of oropharyngeal cancers, back of the throat, including the base of the tongue and tonsils.3

Approximately 10 percent of men and 3.6 percent of women in the U.S. have HPV in their mouths and HPV infection is more commonly found with older age. While most people clear the infections on their own within a year or two, in some people HPV infection persists.4 Patients with HPV-driven disease respond better to treatment and demonstrate a more favorable prognosis, compared to patients with HPV negative head and neck cancer.

HPV-SEQ, Sysmex Inostics ultra-sensitive quantitative, CLIA-validated, blood test for the detection of cell-free HPV 16/18 DNA (cfHPV-DNA), will be used in the trial to monitor personalized treatment and de-escalation of HPV positive oropharyngeal cancer (OPC) patients. HPV-SEQ, which can detect as few as 5 HPV 16/18 molecules in a background of 20,000 wild-type molecules (0.025% allele frequency), empowers this ground-breaking trial. The protocol was published in the recent BMC Cancer paper,5 "Prospective study evaluating dynamic changes of cell-free HPV-DNA in locoregional viral-associated oropharyngeal cancer treated with induction chemotherapy and response-adaptive treatment."

The trial is a follow-on to the poster6 presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting in which Dr. Agrawal described how HPV-SEQ exhibits robust quantitative detection of cfHPV-DNA across a broad dynamic range, thus enabling high-resolution monitoring for patients with HPV positive OPC.

HPV-SEQ is available as a testing service provided by the Sysmex Inostics CLIA lab in Baltimore. MD.

January 26, 2022 Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, Epizyme, JAN 26, 2022, View Source [SID1234607415]). Epizyme also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of common stock offered in the offering. All of the shares in the proposed offering are to be sold by Epizyme.

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Epizyme anticipates using the net proceeds from the offering, together with its existing cash, cash equivalents and marketable securities, to fund global development and commercialization costs of tazemetostat outside of Japan, including the costs of conducting the Company’s ongoing and planned clinical trials of tazemetostat, including the Company’s confirmatory Phase 1b/3 trials in epithelioid sarcoma and follicular lymphoma (FL), the Company’s clinical trials of tazemetostat in additional FL populations and the Company’s clinical trials of tazemetostat across multiple types of hematological malignancies and solid tumors; to fund the Company’s Phase 1/1b trial of its SETD2 inhibitor, EZM0414 and the discovery and identification of additional product candidates to expand the Company’s pipeline of novel epigenetic therapies; to fund initiatives to accelerate commercial adoption of TAZVERIK; and for working capital and other general corporate purposes, which may include the acquisition of companies or businesses or licensing of other products, businesses or technologies, and repayment and refinancing of debt.

Jefferies is acting as lead bookrunner for the proposed offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The shares are being offered by Epizyme pursuant to a shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission ("SEC") on May 6, 2021 and declared effective by the SEC on May 13, 2021. The offering will be made only by means of the written prospectus and prospectus supplement that form a part of the registration statement. The preliminary prospectus supplement relating to and describing the terms of the offering is expected to be filed with the SEC and, if and when filed, copies of the preliminary prospectus supplement relating to the offering may be obtained for free by visiting the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388, or by email at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On January 26, 2022 Servier, an independent international pharmaceutical company, reported that it has partnered with French start-up Epigene Labs to develop an artificial intelligence-based application that prioritizes new cancer drug targets to determine the best therapeutic pathway to treat cancer patients (Press release, Servier, JAN 26, 2022, View Source;utm_medium=rss&utm_campaign=oncology-servier-collaborates-to-create-innovative-application-for-researchers [SID1234607399]). The application will be deployed within Servier R&D in the first quarter of 2022.

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Founded in January 2019, French startup Epigene Labs has developed the mCUBE platform with augmented intelligence for aggregating and analyzing genomic data in oncology to derive biomarkers and prioritize new cancer drug targets.

Based on Epigene Labs’ mCUBE platform, the application is perfectly suited for oncology projects and Servier R&D users. The mCUBE platform allows users to cross-analyze clinical and molecular data (omics data) through a suite of dynamic dashboards, accelerating the decision-making process in the early phases of oncology projects.

Epigene Labs has developed this application based on specifications provided by Servier’s teams from several fields of expertise (Bioinformatics, IT/data, oncology, Digital Information and Data System – DIDS). The mCUBE platform is widely deployed among Servier R&D users. In order to ensure continuous improvement, users will regularly share their feedback with Epigene Labs teams.

According to Céline Lefebvre, Ph.D., who leads the computational medicine team at Servier R&D and who is in charge of this project: "Epigene Labs has delivered a solution that is perfectly adapted to Servier’s projects in the field of oncology and that is in line with Servier’s Data&IA R&D strategy. The mCUBE platform will accelerate our decision making. It is a great lever for improving our working methods for the benefit of cancer patients.

Akpéli Nordor, Pharm.D., Ph.D., co-founder and CEO of Epigene Labs, added, "Epigene Labs is pleased to work with Servier to demonstrate the utility of its tools. As oncologists, we have a unique understanding of the tools other oncologists need to accelerate data-driven drug discovery, biomarker identification and patient selection. We look forward to continuing our collaboration with Servier to rapidly deliver the best treatments to cancer patients."

The partnership with Epigene Labs illustrates Servier’s open and collaborative innovation dynamic, which aims to surround itself with a network of diversified partners to accelerate therapeutic innovation and offer patients innovative and personalized treatments.

Céline Triquel, Open Innovation Project Manager at Servier, concludes: "This project called for collaborative work methods, agility, courage and perseverance, with the objective of developing innovations for the patient. I would like to thank all the contributors to this project, which illustrates our willingness and ability to access and integrate cutting-edge technologies, driven by open innovation and supported by the startup@servier program. "*

* The startup@servier program aims to create value for the startup and Servier with the objective of accelerating therapeutic innovation for the benefit of patients. A first phase of joint work allows the startup to conduct a key study or pilot application of a technology, before entering into a classic collaboration.

On January 26, 2022 Aptus Clinical reported A new trial opens in Greater Manchester which is to test cutting-edge wearable technologies involving patients who have received cancer treatment (Press release, Aptus Clinical, JAN 26, 2022, View Source [SID1234607418]).

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The commercially-available health sensors and devices produce a digital fingerprint of vital signs that could allow doctors to assess the progress of their patients.

Called, EMBRaCE, (Enhanced Monitoring for Better Recovery and Cancer Experience), the trial is a collaboration between Manchester University NHS Foundation Trust, The Christie NHS Foundation Trust and The University of Manchester.

The trial opens initially for blood cancer, lung, and colorectal cancer patients and will run across Greater Manchester.

The technologies under investigation include:

a smart ring, worn on any finger made by the company Oura
the Withings ScanWatch, a hybrid smartwatch
the Isansys system, which is worn on the chest.
The technologies can assess a range of vital signs, including electrocardiogram (ECG), heart rate, temperature, physical activity levels and sleep.

Dr Anthony Wilson, Consultant in Anaesthesia and Critical Care at Manchester Royal Infirmary (MRI), part of MFT, is the clinical lead for the project.

He said: "Cancer places a huge burden on the lives of people everywhere. This study uses cutting-edge technology that can monitor people during their treatment, with devices that they can wear all the time.

"We hope that it will provide new insights into how people cope with cancer treatment and what we can do to improve their recovery."

Dr Michael Merchant, Senior Lecturer in Proton Therapy Physics, at The University of Manchester, said: "This trial will assess if the latest wearable technology has a role in cancer care.

"It will help us to identify ways that clinical staff can individualise treatment before, during, and after therapy.

"We will find out if 24/7 data from these wearable sensors can be used to support patient recovery and provide accurate measurement outside clinic.

"It could even support the development of new cancer treatments by developing a digital platform for clinical trials in cancer involving wearable devices or fitness trackers."

Thomas Westworth, 70, is from South Lakeland in the Lake District. Now retired, he was self-employed within the building trade for 40 years, and has been receiving care for lymphoma at Manchester Royal Infirmary, part of Manchester University NHS Foundation Trust (MFT), for three months.

Mr Westworth will be taking part in the trial in the next couple of weeks when he receives his first infusion of CAR-T (Chimeric Antigen Receptor T-cell) therapy – a personalised medicine used to treat patients with certain types of leukaemia and lymphoma.

Mr Westworth said he is ‘fascinated by technology’, and was happy to consent to taking part in EMBRaCE when he was approached by the study team.

"I said if could be of any help I’d be happy to take part," said Mr Westworth.

"I think the actual idea behind the trial is fantastic, I think it should help people.

"All the staff here at Manchester Royal Infirmary and other hospitals where I have been cared for have been fantastic, everyone is absolutely brilliant."

EMBRaCE is funded by the GM Cancer Digital Innovation Fund, UK Research and Innovation and the National Institute for Health Research (NIHR) in collaboration with Aptus Clinical and Zenzium Ltd.

This trial will assess if the latest wearable technology has a role in cancer care. It will help us to identify ways that clinical staff can individualise treatment before, during, and after therapy. We will find out if 24/7 data from these wearable sensors can be used to support patient recovery and provide accurate measurement outside clinic. It could even support the development of new cancer treatments by developing a digital platform for clinical trials in cancer involving wearable devices or fitness trackers.
Dr Michael Merchant

Steve McConchie, CEO of Aptus Clinical, a clinical contract research organisation based in Alderley Park, Cheshire, said: "We are delighted that the clinical data collection and curation infrastructure we initially created to support an important piece of exploratory research into COVID-19 is being expanded to assess the utility of patient wearables to improve the care of cancer patients across Manchester.
"We look forward to continuing this collaboration with our partners at MFT , The Christie, and Zenzium and are pleased to be supporting research with the potential to make a real difference to patient’s care."

EMBRaCE is partnered with the health and biomedical data science company Zenzium Ltd to harness the power of Artificial Intelligence (AI) to analyse and identify key patterns within patient data.

Anthony D. Bashall, Managing Director of Zenzium, said: "We firmly believe the future of healthcare will be driven by continuous rather than episodic measurements to improve patient outcomes on an individual basis.

"We are excited to be part of this ground-breaking collaboration with some of the best entities in the field, which gives us the opportunity to bring our technology, knowledge and expertise in wearable devices enabled by AI to potentially make a real difference in the lives of patients."

Mr Steve Sweeney, cancer survivor and chair of the group of patients who have advised the project commented: "A cancer diagnosis is fraught with a variety of challenges for patients, way beyond the clinical treatment pathway itself.

"We know patients have anxiety around ongoing monitoring and the gap between GP and hospital cancer care, issues with fatigue and sleep disturbance, problems maintaining fitness and the need for greater psychological support.

"The EMBRaCE programme addresses these challenges head on, allowing participants to take more proactive control of their cancer journey through wearables and the data they provide clinicians. These patient pioneers will help shape the future of cancer care in the UK."

Professor Dave Shackley, Director of Greater Manchester Cancer Alliance and the Senior Responsible Officer for Cancer in Greater Manchester said: "We are delighted in Greater Manchester to have such a fantastic study taking place. The smart use of digital technology is going to be pivotal for high quality, personalised cancer care for our patients. We look forward to hearing the outcomes of this exciting research project and in particular implementing any key findings."

On January 26, 2022 CellCentric, a clinical stage, private biotechnology company pioneering small molecule inhibition of p300/CBP to treat cancer, reported it has received funding from BrightEdge, the impact venture capital fund of the American Cancer Society (Press release, CellCentric, JAN 26, 2022, View Source [SID1234607400]). The funding will be used to further progress the clinical development of its ground-breaking, targeted treatment, inobrodib (formerly known as CCS1477) and are accompanied by additional significant investment from existing lead investor, Morningside Investments Limited.

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Inobrodib is a first-in-class small molecule inhibitor that impacts twin regulatory proteins p300 and CBP and thus affects a number of established, yet elusive to treat oncogenes (including Myc, IRF4 and the Androgen Receptor). The orally bioavailable drug is transitioning into Phase II clinical trials in multiple indications; castration resistant prostate cancer (mCRPC), haematological malignancies as well as specifically targeted tumours driven by genomic alterations.

CellCentric recently received confirmation from the World Health Organisation for inobrodib as a new International Non-proprietary Name (INN) for CCS1477. The -brodib suffix represents the new class of drug; p300/CBP bromodomain inhibitors. Any subsequent follower drugs with a similar mechanism of action will bear the same novel drug class stem, -brodib.

Alice Pomponio, Managing Director of the American Cancer Society’s BrightEdge said: "We are delighted to be supporting CellCentric’s mission to bring a novel targeted therapy to people with cancer. At BrightEdge we invest in ground-breaking cancer research with the goal to translate them into commercially accessible solutions that put patients front and centre."

Jason Dinges of Morningside Technology Advisory, and CellCentric Board member, added: "We are proud to continue our support of CellCentric and its mission to bring the first p300/CBP inhibitor to patients. At Morningside we are committed to investing in companies with strong teams and clear plans to deliver on their goals."

Will West, Chief Executive Officer of CellCentric, commented: "We are very pleased to welcome BrightEdge, alongside our cornerstone investor Morningside, as we continue to pioneer targeted cancer treatment through inhibiting p300/CBP. We now know that our drug can be well tolerated and deliver clear signals of efficacy. The task ahead is to build on that, maximising its impact as a monotherapy and in combination with existing standard of care agents, to treat specific cancer types."