On May 28, 2020 RefleXion Medical, a therapeutic oncology company pioneering biology-guided radiotherapy* (BgRT) for treating all stages of cancer, reported a clinical collaboration with Merck (known as MSD outside the U.S. and Canada) to evaluate the safety and efficacy of KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with BgRT in multiple late-stage cancers, including non-small cell lung cancer (NSCLC), in two randomized controlled clinical trials (Press release, RefleXion Medical, MAY 28, 2020, View Source [SID1234558638]).

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"It is exciting to see these companies from different fields collaborating to investigate immuno-radiotherapy approaches for patients with metastatic cancer," said Jason Luke, MD, director of the Cancer Immunotherapeutics Center at UPMC Hillman Cancer Center and associate professor of medicine at the University of Pittsburgh School of Medicine. "Several published clinical and translational studies laid the foundation for combining immunotherapy and radiotherapy, but despite their promise, available conventional radiotherapy techniques are limited in their general ability to reach more than 1-2 tumors.

"We hypothesize that BgRT may improve treatment efficacy and expand the immunologic impact of therapy by overcoming this limitation and treating more tumors," continued Dr. Luke. "This expanded treatment potential allows the field to pose new questions such as: What outcomes can combination therapy achieve when BgRT treats 5, 10 or even more sites of disease?"

This clinical collaboration reflects interest by researchers, clinicians and industry in exploring external beam radiotherapy to potentially expand the application of immunotherapy and improve outcomes for patients with advanced-stage cancer. Worldwide, over 1,000 clinical trials registered with the National Institutes of Health seek to determine the effect of combining immunotherapy and radiotherapy. Currently, very few of these trials reflect collaboration between radiotherapy and pharmaceutical companies.1

The aim of the clinical collaboration between RefleXion and Merck is to establish whether treating multiple tumors with BgRT, a novel external beam radiotherapy treatment modality in development, is safe and amplifies KEYTRUDA’s therapeutic effect. The RefleXion X1 machine with BgRT is designed to overcome the technical limitations that restrict radiotherapy delivery to one or two sites of disease, and instead allow it to reach multiple sites during the same treatment session, even those sites that move due to breathing or digestion.

"We believe BgRT will one day treat all visible tumor sites, which could lead to better patient outcomes, particularly when used with immunotherapy," said Todd Powell, CEO and president of RefleXion. "The collaboration with Merck will allow us to explore this combined effect in randomized controlled clinical trials that, if successful, may lead to significant changes in the way physicians approach cancer care for patients with late-stage disease."

RefleXion recently announced the close of a $100M equity financing round, the sale of their first commercial system and FDA clearance for the X1 machine for conventional radiotherapy applications. The X1 is the only platform that includes high quality computed tomography (CT) imaging to reduce motion artifacts during patient setup and x-ray treatment delivery, resulting in accurate targeting of the radiation dose to a patient’s tumor.

About Combining Immunotherapy and External Beam Radiotherapy

External Beam Radiotherapy (EBRT) by itself treats a discrete target to provide local tumor control; however, clinical evidence suggests that EBRT potentially converts the locally radiated tumor into an in situ vaccine that contributes to systemic control of the cancer.2 The exploration of EBRT with immunotherapy began in earnest after a rapid succession of advances led to a corresponding acceleration of clinical trials and FDA approvals of different drugs for various cancer indications. Ongoing clinical trials for this combined approach are aimed at confirming safety and demonstrating clinical efficacy, determining the appropriate dosing and sequencing of each treatment, and developing biomarkers to identify the patients most likely to benefit.3

On May 28, 2020 Daiichi Sankyo, Inc. (hereafter, Daiichi Sankyo) reported that it has entered into a strategic agreement with Syneos Health (Nasdaq:SYNH) (Press release, Daiichi Sankyo, MAY 28, 2020, https://www.businesswire.com/news/home/20200528005466/en/Daiichi-Sankyo-Syneos-Health%C2%AE-Form-Strategic-Coalition [SID1234558637]). The companies are coming together to form a coalition to accomplish their shared goal of bringing promising cancer therapies to patients as safely, effectively and efficiently as possible .

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Under the agreement, Syneos Health will provide both strategic and operational solutions for three lead Daiichi Sankyo DXd antibody drug conjugates (ADC): DS-1062, U3-1402 and DS-8201 (known as ENHERTU). The coalition expands a strong, pre-existing relationship between the two companies, further leveraging Syneos Health’s insights-driven Syneos One product development model to de-risk and accelerate development.

The coalition will enable early strategic engagement of Syneos Health teams to inform critical drug development decision making from the start. Cross-functional teams from both companies will share therapeutic expertise and product development insights to shape optimal study designs and create a consistent quality clinical delivery process across a portfolio of studies. Adding to the world-class scientific and technological expertise at Daiichi Sankyo, Syneos Health brings strong clinical site-level relationships and field experts located across the globe who can engage more closely and effectively with investigator teams.

"We quickly recognized that our three flagship ADCs have transformative potential that our in-house structure and current CRO engagements could not deliver as fast as we feel obligated to for patients," said Marielle Cohard Radice, Global Head of Development Operations, Daiichi Sankyo. "The ‘one-team and patient-first’ philosophy we have built with Syneos Health will enable evaluation of our development candidates in more therapeutic settings, more swiftly and more effectively."

The combined end-to-end knowledge from the Daiichi Sankyo and Syneos Health teams will provide a robust understanding of how patients are cared for, which workflows exist, and how cutting-edge clinical investigation can best be embedded in the clinic setting. Shared insights will also enable optimized site selection and engagement to best address patient needs. By leveraging this coalition approach, Daiichi Sankyo expects deeper synergies, particularly at the clinical site level, across projects with common indications and patient populations.

"High unmet patient need and rapid scientific discovery in the oncology space are driving the need for a faster and more predictable approach to clinical development," said Paul Colvin, President, Syneos Health Clinical Solutions. "We’re pleased to collaborate with an innovative company like Daiichi Sankyo, using our unique outsourced product development model to improve clinical trial performance for their advanced oncology portfolio."

On May 28, 2020 City of Hope reported that it has acquired a 190,000-square-foot, four-story building and adjacent land for $108 million from Five Point Office Venture I, LLC, a joint venture of Five Point Holdings, LLC (NYSE: FPH), in the FivePoint Gateway campus. The campus is part of FivePoint’s Great Park community (Press release, City of Hope, MAY 28, 2020, View Source [SID1234558636]).

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City of Hope plans to immediately begin converting the building at 15161 Alton Parkway into its first comprehensive cancer center outside of its main campus in Duarte, California. This is the beginning of a $1B investment by City of Hope to build a world-class comprehensive cancer center. The center, along with a future acute care cancer hospital to be built by City of Hope on the same site, will anchor what FivePoint and City of Hope believe will one day become a regional hub for a larger wellness campus in the heart of Irvine with blue-chip physician groups, wellness specialists and related research and innovation activities. It is a healthcare model FivePoint eventually plans to introduce in partnership with City of Hope into its other California communities.

"City of Hope is second to none when it comes to delivering on the vision of cutting-edge care and research. The outpatient cancer treatment and research center and the cancer hospital will be world-class additions to the campus and the wider community," said Lynn Jochim, FivePoint’s Chief Operating Officer. "We are honored and excited to join hands with such a renowned partner."

The cancer center is intended to offer diagnostic imaging and screenings, precision medicine and early detection, medical oncology, chemotherapy, radiation therapy, surgical oncology and ambulatory surgery. In addition, a clinical research center for Phase 1-3 clinical trials will be located in the building. The adjacent hospital, which City of Hope plans to construct, will be Orange County’s only specialty cancer hospital focused exclusively on treating and curing cancer.

"Orange County called out to us for our presence, and we are responding in a big way. We are ‘all in’ for the region, fulfilling a promise that will deliver pioneering research and lifesaving treatment in 21st century, next-generation patient-centered settings," said Annette Walker, President, City of Hope Orange County. "As we begin to break ground, we are energized by our FivePoint partnership and the tremendous support of local leaders, community members, and philanthropic friends."

The growing partnership between FivePoint and City of Hope positions two of the biggest and most respected names in their industries as leaders on a singular mission to accelerate the future of healthcare in FivePoint’s Great Park community and the region. Together, FivePoint and City of Hope will design and facilitate innovate health services, programs, products and a re-engineered patient and family experience. However, the vision for a wellness and health centric community, one that offers equal access for all to vital care, treatment and research, goes well beyond Orange County. It is now powering FivePoint’s planning for the future of its communities.

"There has never been a moment in history more important than now to act boldly to make wellness and health care the foundation of every sustainable community of the future. This partnership with our trusted partner, City of Hope, is truly a game changer," said Emile Haddad, FivePoint Chairman and CEO. "One day, we will look back at this moment and remember those who took a leap of faith to help ensure the future health and well-being of others through innovation. I believe FivePoint and City of Hope are taking a vital step to be part of this story."

Robert Stone, President and Chief Executive Officer, City of Hope agreed: "It takes visionary partners to bring about incredible change, and we are fortunate to have found collaborators with an aligned mission. This is not about buildings. It’s about developing a nexus of unsurpassed medical expertise, future-focused communities, groundbreaking technology, and innovation."

On May 28, 2020 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported that two abstracts will be published at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Meeting to be held from May 29 to May 31 (Press release, TYME, MAY 28, 2020, View Source [SID1234558635]).

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CMBTs are proprietary investigational compounds that leverages cancer’s altered metabolism and associated vulnerabilities to specifically disrupt fundamental cellular processes. This can include altering protein synthesis, increasing oxidative stress, decreasing pH levels, and compromising protein or lipid barriers. In addition, CMBTs may target select survival mechanisms including autophagy, as well as altering the tumor microenvironment to improve immune recognition of the cancer.

In clinical trials, our lead cancer metabolism-based compound, SM-88 (racemetyrosine), has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, prostate, sarcoma, breast, lung, and lymphoma cancers with minimal serious grade 3 or higher adverse events.

Radiomics Abstract:

SM-88 is an oral dysfunctional tyrosine derivative. Previous studies reported a well-tolerated profile with encouraging efficacy. Recently, advances in image analysis using quantitative textural analysis have uncovered noninvasive biomarkers that correlate with molecular drivers of cancer and prognostic signatures of response. Earlier radiomic data from patients treated with SM-88 showed a positive correlation between circulating tumor cells and tumor radiomics at baseline. This study extends those findings to focus on radiomic changes associated with SM-88 in a Phase II dose escalation trial (NCT03512756).

Health Economic Outcomes Research Abstract:

Over the past 20 years, innovative cancer medicines have contributed to increased life expectancy, reduced mortality, decreased hospitalization and decreased use of medical services. Recently, a health economic study presented at ASCO (Free ASCO Whitepaper) GI 2020 cited that for every additional $1 spent on innovative medicines for pancreatic cancer between 2009 and 2016, there was a reduction in non-medicine spending of $8 to $9, thereby lowering the total cost of care for pancreatic cancer patients. Accordingly, the commercial opportunity of a new disease-altering therapy should be measured by some combination of the clinical, economic and social value created. This study demonstrates the value of a novel pancreatic cancer therapy from this perspective.

Additional information on the meeting can be found on the ASCO (Free ASCO Whitepaper) website at: View Source

Details for the abstracts are as follows

Title: Radiomic texture analysis correlates with PDAC patient outcomes on SM-88
Virtual Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic and Hepatobiliary
Virtual Session Date: May 29-31, 2020
Virtual Session Location: ASCO (Free ASCO Whitepaper) Virtual Scientific Program
Abstract Number: e16776

Title: Value-Based Estimate of Market Size and Opportunity for Economic Benefit Through Innovative Pancreatic Cancer Therapies
Virtual Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic and Hepatobiliary
Virtual Session Date/Time: May 29-31, 2020
Virtual Session Location: ASCO (Free ASCO Whitepaper) Virtual Scientific Program
Abstract Number: e16790

About SM-88

SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events.

On May 28, 2020 bluebird bio, Inc. (NASDAQ: BLUE) reported that the company will host a live webcast to review new data presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting on Friday, June 12 at 8:00 am ET (Press release, bluebird bio, MAY 28, 2020, View Source [SID1234558634]).

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Investors may listen to the call on June 12, 2020 at 8:00 am ET by dialing (844) 825-4408 from locations in the United States or +1 (315) 625-3227 from outside the United States. Please refer to conference ID number 2796099.

In addition, members of the management team will participate in the following upcoming investor conferences:

Jefferies Virtual Healthcare Conference, Thursday, June 4, at 3:30 pm ET
Goldman Sachs 41st Annual Global Healthcare Conference, Wednesday, June 10, at 9:40 am ET
To access the live webcasts of bluebird bio’s presentations, please visit the "Events & Presentations" page within the Investors & Media section of the bluebird bio website at View Source Replays of the webcasts will be available on the bluebird bio website for 90 days following the events.