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.

Arcellx to Participate in Upcoming Investor Conferences

On February 2, 2023 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported the company’s participation in the following investor conferences (Press release, Arcellx, FEB 2, 2023, View Source [SID1234626797]).

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Guggenheim Oncology Conference 2023
Fireside chat on Thursday, February 9, 2023, at 11:20 a.m. ET

SVB Securities Global Biopharma Conference (Virtual)
Fireside chat on Thursday, February 16, 2023, at 3:00 p.m. ET
A live webcast of these discussions will be accessible from Arcellx’s website at www.arcellx.com in the Investors section. A replay of the webcasts will be archived and available for 30 days following the event.

ESSA Pharma to Participate in the Guggenheim Healthcare Talks 5th Annual Oncology Conference

On February 2, 2023 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported that the Company will participate in a fireside chat at the Guggenheim Healthcare Talks 5th Annual Oncology Conference in New York City on Thursday, February 9, 2023, at 9:00 a.m. Eastern Time (Press release, ESSA, FEB 2, 2023, View Source [SID1234626796]).

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David R. Parkinson, President and Chief Executive Officer of ESSA Pharma; Peter Virsik, ESSA’s Chief Operating Officer; and David S. Wood, ESSA’s Chief Financial Officer, will host and participate in one-on-one meetings.

A live webcast of the presentation can be accessed in the Investors/Events & Presentations section of ESSA’s website at www.essapharma.com. An archived replay of the event will be available for 30 days.

Y-mAbs and the European Medicines Agency Reach Agreement on the Pediatric Investigation Plan for Naxitamab

On February 2, 2023 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that the European Medicines Agency ("EMA") has agreed to the Company’s proposed Pediatric Investigation Plan ("PIP") for naxitamab (Press release, Y-mAbs Therapeutics, FEB 2, 2023, View Source [SID1234626793]). The decision follows a positive opinion from EMA’s Pediatric Committee ("PDCO"). Naxitamab is being developed by Y-mAbs for the treatment of patients with relapsed/refractory high-risk neuroblastoma, which is the indication targeted by the PIP, as well as osteosarcoma.

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A PIP outlines a pharmaceutical company’s strategy for investigation of the new medicinal product in the pediatric population and is a required submission as part of the regulatory process for the registration of new medicines in Europe. An approved PIP is a prerequisite for filing a Marketing Authorization Application ("MAA") for any new medicinal product in Europe.

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs. MSK has institutional financial interests related to the compound and Y-mAbs.

About DANYELZA (naxitamab-gqgk)

DANYELZA (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved in the United States by the FDA under accelerated approval based on overall response rate and duration of response. Continued approval for this indication is contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information (View Source) for complete Boxed Warning and other important safety information.

Investor presentation

On February 2, 2023 Verrica Pharmaceuticals presenting its investor presentation (Filing, 8-K, Verrica Pharmaceuticals, FEB 2, 2023, View Source [SID1234626792]).

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