On July 7, 2021 Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, reported the publication of an analysis highlighting that Bladder EpiCheck can reduce both patient burden and healthcare system costs in the U.S. and European countries for low grade intermediate risk non-muscle invasive bladder cancer (NMIBC) (Press release, Nucleix, JUL 7, 2021, View Source [SID1234584678]). The analysis, titled "Alternating Cystoscopy with Bladder EpiCheck in the Surveillance of Low-Grade Intermediate-Risk NMIBC: A Cost Comparison Model," was published in the peer-reviewed journal Bladder Cancer.

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This analysis was performed in an effort to better understand the economic impact of such an approach across 10 different countries with varied healthcare cost structures. Researchers developed a decision analysis model to compare standard surveillance with a modified surveillance that alternated between standard methods and use of Bladder EpiCheck every three to six months. The alternating schedule saved 8-14% of the cost for the system in 70% of the countries and resulted in a negligible cost increase in the other countries.

"Bladder cancer is the fifth most common cancer across the world, yet surveilling its recurrence remains one of the most invasive, intensive and costly processes across the oncology landscape. This includes cystoscopy: a painful procedure patients must undergo every few months," said Aharona Shuali, M.D., vice president of medical at Nucleix. "The findings of this analysis show that Bladder EpiCheck can be used to help reduce this burden to patients with a cost saving in most countries and a negligible cost increase in remaining countries."

Authors attributed the cost-effectiveness of this alternative strategy to Bladder EpiCheck’s high specificity of 86%. This is because lower specificity often results in patients receiving additional cystoscopies, ultimately leading to higher overall costs to the healthcare system. Importantly, for such an alternating schedule to be clinically acceptable, high sensitivity for high-grade disease is key to ensure patients with a high-grade recurrence, who are at risk of disease progression, are detected promptly and treated.

"We are currently over-monitoring low-grade NMIBC patients, which creates an enormous burden on the patients and the system, however, eliminating surveillance of these patients altogether is not an option, due to the small but significant risk of progression to high-grade disease," said Yair Lotan, M.D., Professor of Urology at University of Texas Southwestern Medical Center. "This analysis demonstrates that a robust urine marker, such as Bladder EpiCheck, can be used to reduce the frequency and burden of cystoscopies without additional costs to the healthcare system and patients."

About Bladder EpiCheck

Bladder EpiCheck provides patients and clinicians with a simple, objective urine test to detect recurrence of bladder tumors. The test analyzes subtle disease-specific changes in DNA methylation markers, allowing for the detection of 92% of the high-risk (non Ta-LG) cancers. Bladder EpiCheck demonstrated negative predictive value (NPV) of 99% for high-risk cancer, meaning that when receiving a negative Bladder EpiCheck result, there is 99% chance that no high-risk cancer is present1. Bladder EpiCheck is intended for use as a noninvasive method for monitoring of tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer. Bladder EpiCheck is CE-marked and available in Europe. The test is not available for sale in the United States.

On July 7, 2021 Inceptor Bio, a Research Triangle Park, North Carolina-based cell and gene therapy biotechnology company, reported that it has launched FastBack Bio, the first of multiple next-generation cell and gene therapy platform companies that Inceptor Bio is building (Press release, Inceptor Bio, JUL 7, 2021, View Source [SID1234584677]).

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FastBack Bio’s core technology is the M-STIM platform, from which multiple co-stimulatory domains may be derived. M-STIM co-stimulatory domains are powerful modulators of T cell responses and endow CAR-T cells with a number of beneficial characteristics. In vitro data show that the first M-STIM co-stimulatory domain, M83, provides CAR-T cells with differentiated expansion kinetics and a balanced mix of effector memory and central memory phenotypes compared to CAR-T cells made with commonly used co-stimulatory domains including CD28 and 4-1BB. Additionally, M83-based CAR-T cells are resistant to exhaustion in vitro and exhibit an enhanced metabolism that may be beneficial in the tumor microenvironment (TME).

Dr. Mike Nicholson, Chief Science Officer at Inceptor Bio, said, "CAR-T therapy has demonstrated impressive results fighting liquid tumors, but the field hasn’t been as successful treating solid tumors. In murine models of renal cell carcinoma, M83-based CAR-T cells are far superior to CD28 or 4-1BB-based CAR-T cells. Those data, coupled with in vitro characterization, lead us to believe that M83-based CAR-T cells will be more efficacious against solid tumors."

FastBack Bio launches with technology licensed from Dr. Lishan Su’s laboratory at the University of North Carolina at Chapel Hill. Dr. Su earned his Ph.D. in virology from Harvard and held a post-doctoral position in immunology and stem cell biology at Stanford. Dr. Su spent 24 years at UNC Chapel Hill, with appointments in the UNC Lineberger Cancer Center and the Department of Microbiology & Immunology. In October 2020, he was appointed Head of the Maryland Institute of Human Virology.

Dr. Su, who will continue to support development of the M83 platform through sponsored research and as an advisor to FastBack Bio, said, "I am excited to support FastBack Bio as an Inceptor Bio portfolio company. FastBack Bio will have access to world-class facilities and a team with an exceptional track record that will allow us to accelerate the development of T cell-based therapeutics with our novel co-stimulatory domain."

Abe Maingi, Co-Founder, Board Member, and VP of Business Operations at Inceptor Bio, noted, "At Inceptor Bio, we are committed to building therapeutic companies with the leading innovators in cell and gene therapy to progress treatments that have potential to cure difficult-to-treat cancers. We are thrilled to announce that the University of North Carolina and Dr. Su are the first partners in our mission to advance cell and gene therapies to cure cancer."

Inceptor Bio was established to pursue a diversified portfolio of cell therapy platforms across multiple cell types, including CAR-T, CAR-M, and NK/NKT, with novel mechanisms that enhance immune cell performance within the tumor microenvironment. Inceptor Bio has a new website at www.inceptor.bio to provide information on the company’s vision and activities.

On July 7, 2021 Adcendo, a biotech company developing innovative antibody-drug conjugates (ADCs) for the treatment of underserved cancers, reported the appointment of Michael Pehl as Chief Executive Officer (CEO) (Press release, ADCendo, JUL 7, 2021, View Source [SID1234584676]). Henrik Stage, co-founder of Adcendo, will move to the role of Chief Financial Officer.

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Michael Pehl has over 25 years of international biotechnology and oncology leadership experience in both the US and Europe. He joins Adcendo from GEMoaB, where he served as CEO and led the recent formation and launch of a globally leading allogeneic CAR-T company together with Blackstone Life Sciences and Intellia Therapeutics. Prior to this, he was CEO of Immunomedics Inc., leading the development of sacituzumab govitecan in metastatic triple negative breast cancer, which was approved in the U.S. in 2020. Immunomedics was acquired by Gilead in 2020 for $21 billion. Previously, Michael Pehl was President of Oncology at Celgene, responsible for the global commercial, clinical development, medical strategy and operations. His responsibilities included overseeing global clinical programs and commercial launches of several drugs including Lenalidomide (Revlimid), Pomalidomide (Pomalyst; Imnovid), Enasidenib (IDHIFA), Nab-paclitaxel (Abraxane) and Luspatercept (Reblozyl). Prior to this he held commercial leadership roles in Oncology and Nephrology at Amgen.

John Haurum, Chairman of the Board of Adcendo, said: "We are delighted to welcome Michael to Adcendo. This comes at a critical inflection point in Adcendo’s development and we are very pleased to have someone with such a unique blend of proven scientific and commercial experience, including taking drugs from bench to market, to build on the company’s momentum and help maximize the potential of our unique biologic insights and novel ADCs."

Michael Pehl, Chief Executive Officer of Adcendo, added: "I am incredibly excited to join Adcendo and help advancing our ADCs into the next wave of development. The company has a unique scientific understanding of its novel targets and I have been genuinely impressed by the progress achieved in such a short period since inception. I look forward to working with Henrik, the excellent team in Copenhagen and our Board to unlock the full potential of our science and bring a pipeline of next generation ADCs to underserved cancer patients."

These appointments follow the company’s recent EUR 51 million Series A round, which was one of the largest such financings for a Nordic biotech company. The company is working to bring the lead program targeting the novel cancer target uPARAP/Endo180 to proof of concept in patients. In addition to this program, Adcendo aims to build a pipeline of additional novel cancer targets ideally suited to ADC approaches.

On July 7, 2021 ViewRay, Inc. (NASDAQ: VRAY) reported that the Miami Cancer Institute, part of Baptist Health South Florida, has enrolled the first patients in its "Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction for Inoperable Primary or Metastatic Carcinoma" clinical study – referred to as the SMART ONE trial (NCT#04939246) (Press release, ViewRay, JUL 7, 2021, View Source [SID1234584675]). This single-arm prospective study that was developed and led by Dr. Michael Chuong, MD, FACRO, radiation oncologist and Medical Director of Proton Therapy and MR-guided Therapy at Miami Cancer Institute, is exploring the feasibility and tolerability of single-fraction stereotactic ablative body radiation therapy (SABR) for primary or metastatic carcinoma involving the lung, liver, adrenal gland, abdominal/pelvic lymph node, pancreas, and kidney.*

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The use of MRI instead of CT for daily image guidance offers several important advantages in the delivery of SABR including superior visualization of the internal anatomy prior to and uniquely continuously during treatment delivery.

SABR is an advanced and technically complex procedure in which very high radiation dose is delivered using steep dose gradients with millimeter precision and accuracy. The most common delivery schedule is daily treatment for five total days to each targeted tumor. While completing treatment in only one day may be possible, it is not commonly done using CT-guided radiation delivery machines because of safety concerns due to limitations in visual confirmation of tumor and nearby critical organ position throughout treatment.

MRIdian’s design allows clinicians the ability to safely deliver an ablative dose and expand single-fraction SABR to tumors that would not have been previously considered. The design includes diagnostic-quality anatomic imaging prior to treatment delivery, the ability to perform on-table adaptive planning and continuous intrafraction visualization, soft tissue tracking and automatic beam gating. These features facilitate tighter planning target volume margins to spare healthy tissue, especially in immediate proximity to the target, which allow for reduction or elimination of higher-grade toxicities often associated with SABR dose delivery.

"With MRIdian, we’re giving clinicians the clinical confidence to safely deliver ablative radiation doses while also reducing the number of treatments," said Martin Fuss, M.D., chief medical officer at ViewRay. "MRI-guidance and on-table adaptive delivery ensure that these powerful radiation doses are reaching the target but avoid highly sensitive surrounding critical structures. We believe this treatment concept has the potential to alleviate toxicity risks associated with SABR while improving outcomes for cancer patients around the world."

A growing body of clinical literature has led to the initiation of the SMART ONE trial design. This evidence describes favorable outcomes of image-guided SABR for various cancers, including tumors in the pancreas, liver, lung, breast, adrenal gland, kidney, lymph nodes, and prostate; however, the peer-reviewed, published body of data has nearly exclusively been based on multi-fraction SABR.

"Published experience suggests that delivery of single-fraction SABR using MRIdian should be at least isotoxic and isoeffective as compared to multi-fraction SABR, as supported by its on-table adaptive planning capabilities and continuous soft-tissue tracking with automatic beam gating," said Dr. Chuong. "We believe the study will demonstrate the feasibility to safely and effectively deliver SABR in only one fraction across these indications that will not only shorten overall treatment time, but also reduce cost and improve increase patient convenience."

The MRIdian system provides oncologists outstanding anatomical visualization through diagnostic-quality MR images and the ability to adapt a radiation therapy plan to the targeted cancer with the patient on the table. This combination allows physicians to define tight treatment margins to avoid unnecessary radiation exposure of vulnerable nearby organs-at-risk and allows the delivery of ablative radiation doses in five or fewer treatment sessions, without relying on implanted markers. By providing real-time continuous tracking of the target and surrounding healthy tissues, MRIdian enables automatic gating of the radiation beam if the target moves outside the user-defined margins. This allows for delivery of the prescribed dose to the target, while sparing surrounding healthy tissue and critical structures, which results in minimizing toxicities typically associated with conventional radiation therapy.

More than 12,500 patients have been treated with MRIdian. Currently, 44 MRIdian systems are installed at hospitals around the world where they are used to treat a wide variety of solid tumors and are the focus of numerous ongoing research efforts. MRIdian 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

*ViewRay has provided grant funding to Miami Cancer Institute in support of the SMART ONE trial.
Dr. Michael Chuong has served on advisory boards of, and received honoraria from, ViewRay.

On July 7, 2021 Pathios Therapeutics Limited ("Pathios"), an innovative biotech company focused on the development of first-in-class therapies for cancer, reported the presentation of preclinical data establishing in vivo proof of concept for its small molecule GPR65 inhibitor programme (Press release, Pathios Therapeutics, JUL 7, 2021, View Source [SID1234584674]). The data will be presented during the Immuno Week meeting which is being held virtually from July 6-9th, 2021, and will form part of a session entitled "Macrophage Drug Development".

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In the research presented, Pathios evaluated the impact of PTT-3196, an orally bioavailable, potent and selective GPR65 inhibitor, on expression of key immune-related genes and tumor growth in a highly glycolytic RCC PDX model implanted in NCG mice that had been reconstituted with human immune cells. The key findings of the study were:

A dose-dependent increase in a host of genes known to be predictive of a successful response to T cell checkpoint inhibitors in the clinic including CD3D, CD3E, IL2RG, CCL5 and CXCl10
Prominent increases in a range of other genes comprising a Type I/II interferon signature including CD40, STAT1, TAP1, TAP2 and components of the inducible immunoproteasome (PSMB8, PSMB9 and PSMB10)
A reduction in tumor volume commensurate with the gene expression changes highlighted above
A suppression of pro-tumorigenic genes including TGFB, IL10 and ADORA2A
"We are extremely excited about these results. PTT-3196 is able to robustly activate the human innate immune system in a highly glycolytic, patient derived tumor microenvironment, reversing many of the pro-tumorigenic macrophage gene expression changes that result from chronic exposure to an acidic environment. The ability to bring about a gene expression signature that is predictive of clinical success with T cell checkpoint inhibitors is especially encouraging and fully validates the concept that GPR65 inhibitors counteract a critical innate immune checkpoint that we believe prevents the majority of solid cancers being able to respond to currently approved immunotherapies." Stuart Hughes, Chief Executive Officer of Pathios Therapeutics

About Pathios Therapeutics
Launched in 2017, Pathios is a drug discovery and development company focused on translating innovative science into new medicines. Pathios was founded by a team of experienced biotech and pharmaceutical industry professionals, entrepreneurs and clinicians. To date, Pathios has secured a total of US$13.2M in Series A funding from the leading venture capital firms, Canaan Partners and Brandon Capital. The Company is focused on developing small-molecule inhibitors of the pH-sensing G protein-coupled receptor GPR65 to target immunosuppressive macrophages