On August 27, 2020 ViewRay, Inc. (Nasdaq: VRAY) reported that the GenesisCare Foundation’s Compassionate Access Programme is now accepting patients for treatment on the MRIdian MRI-Guided Radiation Therapy System (Press release, ViewRay, AUG 27, 2020, View Source [SID1234564133]). The program, in collaboration with the University of Oxford, is available to eligible National Health Service (NHS) patients with localized pancreatic cancer and is designed to improve access to precision radiotherapy in the United Kingdom, where patients have variable access to this innovative treatment. This is particularly relevant for patients as the COVID-19 pandemic has reduced the availability and safety of surgery and chemotherapy.

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Eligible NHS patients who have medically inoperable, borderline operable, locally advanced and locally recurrent pancreatic cancer will be treated at GenesisCare’s center in Oxford using stereotactic ablative radiotherapy (SABR) on the U.K.’s first MRIdian machine free of charge. In addition, UK charity, the Pancreatic Cancer Research Fund is providing support for the cost of travel or accommodations associated with treatment.

Unlike conventional radiation therapy systems, MRIdian combines an MRI scanner with the radiation therapy system. This feature, together with other technical innovations, offers advantages for the delivery of safe and effective radiotherapy. These include the ability to see the tumor and surrounding tissue before and during treatment, allowing to adapt the therapy in response to changes in patient anatomy and tumor size between treatments, and to continuously track the tumor in real-time during treatment and pause the radiation if the tumor moves out of position. As a result, the system can deliver very high ablative radiation doses to the tumor while protecting the surrounding healthy tissue from damage.

Patients will be cared for on MRIdian using SABR techniques, also known as MRIdian SMART therapy, which deliver a high dose of radiation just to the tumor. The course of treatment is typically five daily sessions.

"MRIdian is at the cutting-edge of what is possible in radiotherapy technology. The ability to visualize the tumor more accurately, to follow it while it’s being treated and to adapt the plan every day means we can deliver the best possible outcomes," said Dr. James Good, Clinical Oncologist and Clinical Director of SABR at GenesisCare. "Patients with localized pancreatic cancer have variable access to precision radiotherapy, and during the COVID-19 pandemic, patients have been further disadvantaged by the reduced availability and safety of surgery and chemotherapy. The Compassionate Access Programme has two significant purposes. Firstly, to provide patients who otherwise would have limited, or sadly, no options with a viable treatment option. Secondly, to help demonstrate the effectiveness of this treatment, with the ambition to make it available for all patients in the future."

"We are thrilled to support this ground-breaking program, working with GenesisCare and the University of Oxford," said Dr. Martin Fuss, Chief Medical Officer at ViewRay. "Facilitating pancreatic cancer patient access to the MRIdian SMART therapy provides a safe and effective treatment for this deadly disease and the hope for longer survival for patients in the U.K."

The program is made possible through charitable funding from the GenesisCare Foundation, the Pancreatic Cancer Research Fund and ViewRay, the manufacturer of the MRIdian system. The initiative is also supported by a team of expert clinicians and the University of Oxford, who share a commitment to expanding the role of MRI-guided radiotherapy for pancreatic cancer through clinical trials.

More information about the program, eligibility criteria and paperwork to refer patients can be found at genesiscare.com/uk/cap.

Currently 38 MRIdian systems are installed at hospitals around the world, where they have treated nearly 10,000 patients with a wide variety of solid tumors. MRIdian is also the focus of numerous ongoing research efforts and has been the subject of hundreds of peer-reviewed publications, scientific meeting abstracts and presentations. For a list of treatment centers, please visit: View Source

On August 27, 2020 Sirtex Medical ("Sirtex"), a leading manufacturer of targeted liver cancer therapies, reported that Sirtex and its shareholders, China Grand Pharmaceutical and Healthcare Holdings Limited (CGP), have been issued a "Notice of Drug Clinical Trial Approval" by the National Medical Products Administration (NMPA) of the People’s Republic of China (Press release, Sirtex Medical, AUG 27, 2020, View Source [SID1234564132]).

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The notice confirms that SIR-Spheres Y-90 resin microspheres meet the relevant requirements for drug registration in China. With this confirmation, Sirtex is approved to file a New Drug Application (NDA) in the country.

"We are grateful to the members of CGP, Sirtex China and our Global Regulatory, Quality Assurance, Operations and Medical teams for their dedicated work in achieving this approval from the NMPA and navigating the complex regulatory process," said Kevin R. Smith, Chief Executive Officer of Sirtex. "This is a critical milestone toward allowing us to provide a valuable treatment option to people with liver cancer in China."

The announcement marks an important step in Sirtex’s journey to gain market entry into China, thanks to the company’s collaboration with its shareholder, CGP.

"We are proud of our team’s accomplishment and work to achieve this goal," said Weikun Tang, Ph.D., General Manager of Sirtex China. "We are excited for the opportunity to work together with CGP to bring SIR-Spheres Y-90 resin microspheres to our country’s patients."

On August 27, 2020 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the pace, risk and cost of oncology drug discovery and development, and identify patients who will benefit from its targeted oncology drug candidates, reported that Panna Sharma, CEO and President, will provide company updates at the following investor events in September (Press release, Lantern Pharma, AUG 27, 2020, View Source [SID1234564131]):

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The LD Micro 500
Date/Time: September 1, 2020 at 2:40 p.m. ET

MedInvest AI, Big Data & Digital Health Conference
Date/Time: September 9, 2020 at 10:40 a.m. ET

Colliers Institutional Investor Conference
Date/Time: September 10, 2020 at 9:00 a.m. ET to 5:00 p.m. ET (1×1 only; no presentation)

H.C. Wainwright 22nd Annual Global Investor Conference
Date/Time: September 15, 2020 at 4:30 p.m. ET

AI 2020, 13th Annual BioPharm America Conference
Fireside Chat: Using AI to Optimize Drug Selection and Development, hosted by Zacks Investment Research John Vandermosten
Date/Time: September 21, 2020 at 11:45 a.m. ET
All meetings and presentations will be held virtually. Investors and media interested in meeting with Panna Sharma should contact Marek Ciszewski, J.D., at: [email protected] or +1.628.777.3167. Registered conference attendees may also request meetings through the respective conference registration system.

On August 27, 2020 Sysmex Inostics, Inc., a global leader and pioneer in blood-based circulating tumor DNA (ctDNA) analysis for oncology, reported the publication of a clinical study evaluating RAS mutation status in circulating tumor DNA (ctDNA) of colorectal cancer (CRC) patients undergoing anti-EGFR antibody therapy (cetuximab or panitumumab) rechallenge using the OncoBEAM RAS CRC test in two different multicenter Japanese retrospective trials, JACCRO CC-08 and JACCRO CC-09.

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OncoBEAM RAS CRC is a test that uses BEAMing technology, an enhanced digital PCR method optimized for high sensitivity blood-based mutation detection for metastatic colorectal cancer (mCRC) patients. In this study, investigators utilized the highly sensitive nature of OncoBEAM testing to explore the clinical value of monitoring changes in plasma RAS mutations in CRC patients during treatment with anti-EGFR antibody therapy.

Colorectal cancer continues to be one of the leading causes of cancer-related deaths globally. Treatment of mCRC patients with anti-EGFR monoclonal antibodies have demonstrated significant improvements in the survival of patients with wild-type RAS tumors. mCRC patients being considered for anti-EGFR therapy rechallenge could greatly benefit the overall patient survival by undergoing initial plasma testing to establish RAS mutation status at baseline, as well as performing subsequent tests to monitor RAS mutation dynamics during treatment. By receiving regular blood draws throughout the anti-EGFR rechallenge treatment, patients would benefit from periodic OncoBEAM RAS testing, which would in turn deliver valuable insights for clinicians in assessing therapy response.

The study published in JCO Precision Oncology by Sunakawa et al., demonstrated that RAS mutations were found in 38% of CRC patients after receiving the first course of anti-EGFR mAb therapy, but prior to rechallenge treatment. The disease control rate (DCR) was 33% in patients with RAS mutations in ctDNA, whereas it was 80% in patients without RAS mutation detected by OncoBEAM at baseline. The data also showed that patients with RAS mutations detected just before anti- EGFR mAb rechallenge had no survival benefit from rechallenge treatment. Moreover, post-progression survival time after rechallenge was worse in patients with RAS mutations than in patients without mutations at disease progression. The emergence of RAS mutations during rechallenge treatment at disease progression is therefore useful for predicting outcomes of anti- EGFR mAb therapy rechallenge.

"We found that the OncoBEAM RAS CRC assay was not only effective in monitoring the resistance to anti-EGFR therapy, but was also important in helping us determine the efficacy of the rechallenge treatment and therefore predict patients who would have favorable outcomes. Overall, our novel findings support the value of using the ultrasensitive OncoBEAM RAS liquid biopsy test in the clinical management of CRC patients receiving anti-EGFR mAb as rechallenge treatment," stated Dr. Yu Sunakawa, MD, PhD, Department of Clinical Oncology, St Marianna University School of Medicine, Kawasaki, Japan.

Besides results of this publication, a new prospective observational trial "REMARRY (UMIN000036424)" has been initiated with over 100 patients recruited as of June 2020. This clinical trial, supported by SCRUM-Japan MONSTAR-SCREEN, will expand the evaluation of patient-specific dynamics in ctDNA RAS mutational status as a predictor of anti-EGFR mAb rechallenge efficacy. Overall, the aggregate results from these trials should strongly support the clinical utility of performing longitudinal plasma OncoBEAM RAS testing in monitoring tumor response during anti-EGFR antibody therapy.

The publication, titled "RAS Mutations in Circulating Tumor DNA and Clinical Outcomes of Rechallenge Treatment with Anti-EGFR Antibodies in Patients with Metastatic Colorectal Cancer," was published in JCO Precision Oncology, July 28, 2020, by Yu Sunakawa et al.: View Source

The poster, titled "REMARRY and PURSUIT trials: Liquid biopsy-guided rechallenge of anti-EGFR monoclonal antibody for patients with RAS/BRAF V600E wild-type metastatic colorectal cancer" was presented at ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer 2020 by Hiromi Nakajima et al.: View Source
(Press release, Sysmex Inostics, AUG 27, 2020, View Source [SID1234564129])

On August 27, 2020 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that its Senior Vice President and Chief Financial Officer, Jonathan Guarino, will deliver a corporate presentation at the LD Micro Conference, held virtually September 1-4, 2020 (Press release, Soligenix, AUG 27, 2020, View Source [SID1234564127]). The presentation will be delivered on Friday, September 4 at 9:40 AM ET.

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For more information about the LD Micro Conference, please refer to the conference website at View Source

For further information regarding Soligenix, Inc., please visit the Company’s website at www.soligenix.com.