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."

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 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company dedicated to delivering targeted therapies for rare cancers, reported the pricing of an upsized underwritten public offering of 4,074,075 shares of its common stock and, in lieu of shares of common stock, to a certain investor, pre-funded warrants to purchase up to 925,925 shares of common stock pursuant to its existing shelf registration statement (Press release, Sierra Oncology, JAN 26, 2022, View Source [SID1234607414]). The shares of common stock are being offered at a public offering price of $27.00 per share and the pre-funded warrants are being offered at a public offering price of $26.999 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.001 per share exercise price for each pre-funded warrant. The expected gross proceeds to Sierra Oncology from the offering is approximately $135.0 million, before deducting underwriting discounts and commissions and other offering expenses. In addition, Sierra Oncology has granted to the underwriters a 30-day option to purchase up to 750,000 of additional shares of its common stock at the public offering price less underwriting discounts and commissions. Sierra Oncology intends to use the net proceeds of the offering to prepare for potential commercialization of momelotinib, clinical development of its other product candidates, research, clinical and process development and manufacturing of its product candidates, working capital, and capital expenditures and other general corporate purposes. All of the securities are being offered by Sierra Oncology. The offering is expected to close on or about January 31, 2022, subject to customary closing conditions.

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Jefferies and Cantor are acting as the joint book-running managers and representatives of the underwriters for the offering. LifeSci Capital, Oppenheimer & Co. and H.C. Wainwright & Co. are acting as lead managers for the offering.

A shelf registration statement on Form S-3 relating to the securities offered in the public offering described above was filed with the SEC on November 5, 2021 and declared effective by the SEC on November 12, 2021. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may also be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, New York, New York 10022, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, 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 TYME Technologies, Inc. (Nasdaq: TYME) (the Company or TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported the discontinuation of SM-88 with MPS in the Precision Promise trial in metastatic pancreatic cancer (mPDAC) upon learning from the trial sponsor, Pancreatic Cancer Action Network (PanCAN), that it terminated the arm due to futility compared to the control of standard of care chemotherapy in second-line mPDAC (Press release, TYME, JAN 26, 2022, View Source [SID1234607413]). Based on the information provided by PanCAN, the overall survival for SM-88 with MPS in monotherapy was lower compared to standard of care chemotherapies with either Gemcitabine and Abraxane or modified FOLFIRINOX.

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The Precision Promise trial is an adaptive randomized Phase 2/3 trial in mPDAC for patients treated in both first-line and second-line therapies. SM-88 (racemetyrosine) with MPS (10 mg methoxsalen, 50 mg phenytoin, and 0.5 mg sirolimus) was the first therapy to join this trial and was being studied as a standalone monotherapy in second-line patients versus control arms of standard of care regimens of either Gemcitabine and Abraxane or modified FOLFIRINOX.

"Given pancreatic cancer’s high mortality rate, we wanted to make a difference in the lives of these patients. Our team understood that many efforts before us have failed, but based on SM-88’s prior activity and safety profile, we were hopeful we could provide an effective new option for those fighting against this devastating disease," said Richie Cunningham, Chief Executive Officer of TYME. "I want to express my sincerest appreciation to the patients, their loved ones, the researchers, and the principal investigators involved in this trial, as well as thank PanCAN and Precision Promise for their passionate dedication to exploring new treatment options for pancreatic cancer patients."

"Given our prior promising results with SM-88 plus MPS in a subset of patients in second-line pancreatic cancer1, we are disappointed that we couldn’t make an impact in this very difficult to treat population. We will work with PanCAN and Precision Promise leadership to further analyze the data with the SM-88 arm, as it becomes available," said Dr. Jan M. Van Tornout, MD, MSC, Acting Chief Medical Officer of TYME.

TYME remains committed to advancing its current pipeline and the continued research and development of SM-88.

On January 26, 2022 Flatiron HealthⓇ reported a partnership with Japan’s National Cancer Center Hospital East (NCCHE) to build a real-world database of patients with gastro-intestinal cancers (Press release, Flatiron Health, JAN 26, 2022, View Source [SID1234607412]).

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"Insights from Flatiron’s U.S.-derived real-world data have brought important treatment alternatives to patients with cancer around the world," said Carolyn Starrett, Flatiron CEO. "Adding more patient experiences into the evidence that supports treatment, development and regulatory decisions is the best hope for truly transforming global cancer research and care. This agreement marks a major milestone in our commitment to bring Flatiron’s real-world data expertise into partnerships with hospitals and health networks in Asia and Europe."

Under the agreement signed with Flatiron Health K.K., real-world data (RWD) chronicling the aggregated and de-identified experiences of consented NCCHE patients will be curated into top-quality datasets for use by NCCHE to support its research and treatment decisions, and by other researchers and regulatory decision-makers to help answer previously unanswerable questions.

Founded in 2012, Flatiron brings together the boldest and most creative minds in medicine and technology to transform how cancer is understood and treated. The treatments and outcomes of only a small percentage of cancer patients are captured in the clinical trials that have traditionally formed the evidence base for most treatment, development and regulatory decisions. Flatiron helps to fill this gap with high-quality real-world evidence (RWE) derived from aggregated, de-identified patient information captured during routine care.

Flatiron’s U.S.-derived data have helped expand treatment alternatives for people around the world with gastric, colorectal, esophageal, breast, and head and neck cancer. Now, Flatiron International subsidiaries in Japan, Germany and the United Kingdom will partner with hospitals and health networks in RWD collaborations that produce more top-quality datasets for use by the partners who provide them, in research collaborations and under license, with specific terms and conditions, to biopharma companies, to accelerate cancer research.

"Each Flatiron International partnership is tailored to local legal, regulatory, data privacy and compliance standards and requirements, and designed to help local healthcare providers and partners generate and utilize high-quality RWD to advance oncology research and care," said Nathan Hubbard, Vice President, Head of Business Development and Flatiron International.

The datasets created in the Flatiron-NCCHE project will also be made available for analyses by SCRUM-Japan, an industry-academia collaborative whose members include NCCHE and other leading hospitals in Japan.

"We are honored to partner with NCCHE, one of Japan’s most influential cancer centers, and to collaborate with SCRUM-Japan, one of the most important cancer genomic screening national projects in the world," said Hiroshi Kojima, Head of Market Development, Flatiron Health K.K. "We look forward to expanding this partnership beyond gastro-intestinal cancers in due course."