RefleXion Receives FDA Clearance for SCINTIX Biology-Guided Radiotherapy; Cutting-edge Treatment Applicable for Early and Late-stage Cancers

On February 2, 2023 RefleXion Medical, a therapeutic oncology company, reported the U.S. Food and Drug Administration (FDA) has granted the first marketing clearance for its SCINTIX biology-guided radiotherapy, a cutting-edge treatment applicable for early and late-stage cancers (Press release, RefleXion Medical, FEB 2, 2023, View Source [SID1234626803]). The company will host a live-stream event featuring both its co-founder and CEO discussing the breakthrough significance of SCINTIX therapy for cancer treatment.

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SCINTIX is the first and only radiotherapy that allows each cancer’s unique biology to autonomously determine where and how much radiation to deliver, second-by-second, during actual treatment delivery. This expands the RefleXion X1 into the only dual-treatment modality platform that can treat patients with indicated solid tumors of any stage. The SCINTIX biologic modality tracks tumor motion from all types of movement, including expected motion from internal processes such as breathing and digestion or unexpected movement by a patient. The X1 also has a state-of-the-art anatomic modality previously cleared by the FDA for solid tumors located anywhere in the body.

"SCINTIX ushers in a new era of external-beam radiotherapy by harnessing data produced from the biologic process of cancer cells, which until now has been untapped," said Terence Williams, M.D., Ph.D., chair of City of Hope’s Department of Radiation Oncology. "We are excited to be among the early adopters of SCINTIX and to help develop this therapy for all cancer patients, especially those with stage 4 disease, where treatment options often remain very limited."

"With SCINTIX, the X1 machine and the tumor communicate continuously via a live data stream produced during patient treatment," continued Dr. Williams. "This precision should enable us to treat less surrounding tissue and may enable the treatment of more tumors in the same course of therapy."

The FDA cleared SCINTIX biology-guided radiotherapy to treat patients with lung and bone tumors. These tumors may arise from primary cancers or from metastatic lesions spread from other cancers in the body. Previously granted Breakthrough Device designation by the FDA for treating lung tumors, the breakthrough nature of SCINTIX technology lies in its ability to detect and then treat multiple moving tumors. Initially cleared for use with the radiopharmaceutical fluorodeoxyglucose F 18—commonly known as FDG—the company plans to adapt SCINTIX therapy to work with the full array of novel radiopharmaceuticals under development for different cancer types.

"From its inception, the novel nature of SCINTIX therapy demanded that we fundamentally rethink how to design a machine capable of delivering cancer treatment to patients that were not considered candidates for radiotherapy because of the extent of their disease," said Todd Powell, CEO and president of RefleXion. "Likewise, our regulatory pathway encompassed unprecedented hurdles as medical device and pharmaceutical teams within the FDA worked together to create a new classification regulation for this breakthrough device and therapy.

"With initial clearance for SCINTIX therapy behind us, we will begin full commercialization and patient treatments in the coming weeks."

SCINTIX therapy (formerly referred to as BgRT) is delivered through the RefleXion X1 machine, which combines positron emission tomography (PET) with a linear accelerator (LINAC) to deliver a radiation dose that tracks the cancer’s motion. Immediately prior to treatment, the patient is injected with a radiopharmaceutical that interacts with cancer cells to produce signals or emissions. The X1 continuously constructs a map from the detected emissions data that determines where to aim beamlets of radiation. This crosstalk between the tumor and the X1 requires the system to rotate at 60 rpm—making it the first and only radiotherapy machine to spin at this speed.

"Autonomous radiotherapy was just a concept over a decade ago, but now for the first time in the history of cancer treatment, the individual biology of the cancer itself guides its own destruction," said Sam Mazin, Ph.D., founder and CTO of RefleXion. "Today, I want to acknowledge and thank the many talented people who have contributed over the years to translate SCINTIX therapy to the clinic."

Combined, tumors in the lung or bone, including those that metastasize from other primary cancers, arise in approximately 430,000 patients.1 In metastatic cancer, where patients can present with both lung and bone tumors, radiotherapy is often not considered as a treatment option due to the cumbersome clinical workflow and toxicity of treating more than one tumor in a treatment session.

RefleXion is hosting a brief live stream event from its headquarters in Hayward, Calif., about the SCINTIX therapy clearance. The live stream can be accessed on RefleXion’s YouTube channel today at 10:30 AM PST.

PacBio to Report Fourth Quarter and Full Year 2022 Financial Results on February 16, 2023

On February 2, 2023 PacBio (NASDAQ: PACB) reported that it will hold its quarterly conference call to discuss its fourth quarter and full year 2022 financial results on Thursday, February 16, 2023, at 4:30 pm Eastern Time (Press release, Pacific Biosciences, FEB 2, 2023, View Source [SID1234626802]).

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The call will be webcast and may be accessed at PacBio’s website at: View Source." target="_blank" title="View Source." rel="nofollow">View Source

Date: Thursday, February 16, 2023 at 4:30 pm ET (1:30 pm PT)
Listen live via internet or replay: View Source
Toll-free: 866-652-5200
International: 412-317-6060

If using the dial-in option, please dial into the call five to ten minutes prior to start time using the appropriate number above and ask to join the "PacBio Q4 Earnings Call."

BriSTAR Immunotech to Present at the BIO CEO & Investor Conference

On February 2, 2023 BriSTAR Immunotech, a clinical-stage cell therapy company, reported that its Chief Executive Officer, James Pan, Ph.D., will be presenting at the 25th BIO CEO & Investor Conference (Press release, Bristar Immunotech, FEB 2, 2023, View Source;investor-conference-301737314.html [SID1234626800]). The conference will take place at the New York Marriott Marquis during February 6-9, 2023.

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Dr. Pan’s presentation will focus on how BriSTAR’s STAR-T platform is used to formulate novel cell therapy candidates that better address the challenges in treating solid tumors. These challenges include overcoming tumor heterogeneity, antigen escape, tumor infiltration, and the immunosuppressive microenvironment.

Dr. Pan will also discuss the latest developments for the Company’s novel T cell immunotherapy candidates, including lead candidates CD19/CD20 STAR-T and LILRB4 STAR-T. CD19/CD20 STAR-T is currently in clinical trials targeting relapsed/refractory B-cell non-Hodgkin lymphoma and LILRB4 STAR-T is indicated for acute myeloid leukemia (AML).

Details of Dr. Pan’s Presentation are as follows:

Date and Time: February 7, 2023 from 1:45 PM – 2:00 PM (EST)

Location: Winter Garden Room, 6th floor, New York Marriott Marquis

Please visit the website of BIO for more information.

CoImmune Announces Novel Engineered CAR T Cells Improve Anti-Tumor Activity and Reverse Immunosuppression in Preclinical Models

On February 2, 2023 CoImmune, Inc., a clinical stage immuno-oncology company working to redefine cancer treatment using best-in-class cellular immunotherapies, reported that preclinical models show CAR T cells engineered with OrexiCAR technology to secrete a CD47-SIRPα checkpoint blocker have improved anti-tumor activity and reverse myeloid immunosuppression in tumors (Press release, CoImmune, FEB 2, 2023, View Source [SID1234626799]). The results are published in Blood, the most highly cited peer-reviewed publication in the field of hematology.

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The work was directed by David Scheinberg, M.D., Ph.D., Chairman of the Sloan Kettering Institute’s Center for Experimental Therapeutics at Memorial Sloan Kettering Cancer Center (MSK). Dr. Scheinberg and colleagues invented the OrexiCAR technology that is licensed to CoImmune. Researchers engineered CAR T cells to locally secrete a high affinity CD47-blocker, CV1, at the tumor site (OrexiCAR T cells), and treated human lymphoma-bearing xenograft mice in combination with an orthogonally targeted monoclonal antibody (rituximab).

Results demonstrate that OrexiCAR T cells plus rituximab were additive in effect on lymphoma tumor regressions and mouse survival without new toxicities:

80 percent of mice treated with OrexiCAR T cells had no detectable tumor at day 86 post tumor engraftment, as compared to only 25 percent treated with wild type CAR T cells, in conjunction with rituximab.
Mice treated with OrexiCAR T cells had significantly improved median overall survival compared to those treated with wild type CAR T cells in combination with rituximab or CV1 plus rituximab.
OrexiCAR-secreted CV1 reversed tumor immunosuppression of myelomonocytoid cells, both in vitro and within the tumor microenvironment.
OrexiCAR T cells were not toxic in mice.
"While traditional CAR T therapies have reported high response rates in hematopoietic cancers, we also see a high level of relapses and a relative lack of efficacy in solid tumor settings due to multiple tumor escape mechanisms including the overexpression of CD47," said Charles Nicolette, Ph.D., Chief Executive Officer of CoImmune. "We are collaborating with MSK to engineer these technologies into our CAR-CIK platform to deliver additional agents locally to tumor sites to mitigate tumor escape by loss of targeted antigens and tumor induced immunosuppression. We now have an exciting opportunity to advance the science of immunotherapy with fundamentally new approaches to broadly target a range of cancers that have been up to now largely refractory."

In October 2021, CoImmune acquired the rights to several technologies developed at MSK including Synthetic Enzyme-Armed Killer (SEAKER) cells that combine the target-seeking power of immune cells with the ability to locally generate a potent anticancer drug at the tumor site without systemic toxicity, also referred to as a "micropharmacy."

"This research proves that human T cells can be engineered to co-express both a CAR and a CD47 checkpoint blocker while maintaining T cell function, and that we can simultaneously equip T cells with a secondary orthogonal mechanism for activating the immune system," said Dr. Scheinberg. "Importantly, the local secretion of the CD47 inhibitor bypasses the CD47 sink found on all cells in the body and should prevent systemic toxicities. This combination of CAR T cell therapy, local CD47 blockade, and orthogonal antibody may be a strategy to overcome the limitations of tumor antigen loss and heterogeneity and immunosuppression of the CAR T cell."

Varian Receives FDA 510(k) Clearance for Halcyon and Ethos Radiotherapy Systems Featuring HyperSight Imaging Solution and Announces First Patient Treatment

On February 2, 2023 Varian, a Siemens Healthineers company, reported that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as well as CE mark, for Halcyon and Ethos radiotherapy systems featuring Varian’s HyperSight imaging solution (Press release, Varian Medical Systems, FEB 2, 2023, View Source [SID1234626798]). On February 1, a cancer patient at Penn Medicine became the first person in the world to be treated on a Halcyon system equipped with HyperSight.

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HyperSight enables clinicians to capture high-quality images of patients during their daily radiation treatments. These images are used for daily localization of patient tumors, and HyperSight now enables them to be used for replanning and adaptation to patient and tumor changes. HyperSight’s cone-beam computed tomography (CBCT) technology delivers larger images with better contrast, and is 10 times faster than conventional linear accelerator-based imaging systems, saving time for patients and creating the potential to significantly enhance the patient experience.

Traditional CBCT imaging can take up to 60 seconds and may require patients with tumors that move with breathing — including lung, liver, and left breast tumors — to hold their breath several times to acquire a full, clear image. HyperSight can acquire images in six seconds, potentially minimizing patient discomfort and anxiety and contributing to clearer images due to reduction of motion related image blurring.

The quantitative information about patient anatomy (Hounsfield Units) contained within HyperSight images allows, for the first time, for radiation dose distributions to be calculated directly on CBCT images. This calculation previously required a patient to make an additional trip to a separate CT scanner used for treatment simulation and planning. With HyperSight, this calculation can be performed directly on the linac-based CBCT image during the normal course of treatment. As a result, this technology may help adapt treatment to adjust to anatomical changes to the tumor and surrounding organs, which can change from day to day during treatment.

"Varian has long been focused on pioneering innovations that can enhance the radiotherapy experience and outcomes for both patients and cancer care teams. Becoming a Siemens Healthineers company has given us an opportunity to sharpen and accelerate these efforts, with a focus on connecting the power of imaging inside and outside the treatment room," said Kevin O’Reilly, President of Radiation Oncology Solutions at Varian. "HyperSight reflects the power of our expanded view of the patient journey and robust imaging technology. We look forward to working with our clinical partners and the broader radiotherapy community to drive adoption and further advancement of this technology, as we continue our work to transform the patient pathway and deliver on our mission to create a world without fear of cancer."

As a longtime collaborator and the first cancer center in the world to adopt Varian’s Halcyon system, Penn Medicine has played a key role in supporting the advancement of radiation therapy innovations, including HyperSight.

"Bringing this technology to patients is another step forward in our work to help develop and assess cutting-edge treatment technologies that improve care for cancer patients," said James Metz, MD, chair of Radiation Oncology and leader of the Roberts Proton Therapy Center at Penn.

Editor’s note: Dr. Metz has served on the Varian advisory board.