On February 4, 2021 Varian (NYSE: VAR) reported that it has started the installation of the cyclotron and gantry for its ProBeam 360° single-room proton therapy system at Penn Medicine Lancaster General Health’s Ann B. Barshinger Cancer Institute (Press release, Varian Medical Systems, FEB 4, 2021, View Source [SID1234574663]). The cyclotron and gantry are core pieces of equipment of the ProBeam 360° system.

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The Ann B. Barshinger Cancer Institute, which is part of Penn Medicine Lancaster General Health, has become the first treatment center in the world to have a ProBeam 360° system from Varian. The center is expected to treat its first patients in 2022.

"Varian is proud of our longstanding collaboration with Penn Medicine, which goes back decades and encompasses joint innovation, clinical research, training and education, and bringing new technologies to cancer patients," said Kolleen Kennedy, Chief Growth Officer and President of Proton Therapy Solutions at Varian. "We’re especially pleased to be taking this next step with them, delivering the latest innovations in proton therapy technology for the cancer patients of South Central Pennsylvania."

The cyclotron is a particle accelerator that accelerates protons to extremely fast speeds; roughly 100,000 miles per second or roughly two thirds the speed of light, to create a beam that can precisely reach tumors wherever they are in the body. The finished ProBeam 360° system will incorporate the fully rotational gantry that rotates around the patient to target tumors from virtually any angle, robotic patient positioning tools, integrated iterative cone-beam CT imaging and pencil-beam scanning for delivery of high-definition intensity-modulated proton therapy (IMPT).

Proton therapy makes it possible to treat certain types of cancer more precisely and with potentially fewer side effects than is possible with conventional radiation therapy. With proton therapy, the risk of damage to healthy tissues and potential side effects is reduced because a proton beam deposits dose within the tumor site rather than passing all the way through the patient. Proton therapy can be used for many of the most common types of cancer.

In addition to the ProBeam 360° system, Varian will also provide its ARIA information management system and Eclipse treatment planning—software that can be used to enable a cloud-based "hub and spoke" operations model for managing key functions centrally to avoid costly duplication of resources across the larger University of Pennsylvania Health System. The Eclipse software will also incorporate RapidPlan PT— the first clinical application of machine learning in proton treatment planning. RapidPlan PT is a knowledge-based treatment planning software that enables clinicians to leverage knowledge and data from previous cases in order to develop high-quality, personalized plans for patients.

"This is yet another key milestone in a multi-year journey that will marry the extensive research and clinical protocols we’ve developed over the past 11 years at Penn Medicine’s Roberts Proton Therapy Center with the considerable expertise at Lancaster General," said James Metz, MD, Chair of Radiation Oncology, Perelman School of Medicine.

On February 4, 2021 CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), reported the start of an expansion of the ongoing Phase 1 study with its lead RNA-based cancer drug candidate, CV8102 (Press release, CureVac, FEB 4, 2021, View Source [SID1234574608]). Initial results from the dose-escalation part in four solid cancer types were presented at the SITC (Free SITC Whitepaper) conference in 2020. CV8102 had shown promising evidence of efficacy after intratumoral application as a single agent, and in combination with systemic anti-PD-1 antibody treatment. Translation of a locally induced immune response into a systemic immune response was observed in several patients, showing the ability of CV8102 to impact injected as well as distant lesions. The objective of the expansion is to confirm safety, tolerability, and efficacy of CV8102 in patients with advanced melanoma at 600µg, the selected dose to be advanced in a Phase 2 clinical trial. Furthermore, the trial expansion will evaluate the effects of CV8102 on systemic and intratumoral immune markers, which will provide additional clinical insights on CV8102’s mode of action.

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"Initial clinical data in cancer has demonstrated the ability of our RNA immunomodulator to trigger a systemic immune response attacking cancer not only at the site of injection but also in other areas of the body," said Ulrike Gnad-Vogt, Senior Vice President Area Head Oncology at CureVac. "The CV8102 trial expansion is expected to provide further insights into clinical efficacy and mechanism of action in patients with advanced PD-1 refractory melanoma, an indication with a high unmet medical need. We are very pleased to see CV8102 progress to the next stage, an important step to further leverage the potential of immunostimulating RNA therapeutics in oncology."

The expansion part of the trial will enrol 30 patients with PD-1 refractory melanoma, who will receive intratumoral injections of CV8102 in combination with PD-1 antibodies, as well as 10 patients who will be treated with CV8102 only. Initially, CV8102, with or without co-administration of anti-PD-1 treatment, will be injected weekly for five weeks, followed by three injections at two- or three-week intervals depending on the anti-PD-1 antibody schedule. Patients showing evidence of clinical benefit are eligible for further injections for up to 12 months.

About CV8102

CV8102 is a noncoding single stranded RNA complexed with a cationic peptide and functions as a strong immunomodulator based on TLR (toll-like receptor) 7/8 and RIG-1 (retinoic-acid-inducible protein 1) activation. It is designed to modulate the tumor microenvironment following intratumoral injection and to translate a local immune response towards released tumor antigens into a systemic immune response to control both injected as well as distant lesions. The currently ongoing Phase 1 dose escalation study is assessing tolerability as well as activity of CV8102 in the dose range of 25 to 900 µg. It is administered as both a single agent and in combination with systemic anti-PD-1 antibodies for the intratumoral treatment of four types of solid tumors: cutaneous melanoma, adenoid cystic carcinoma, squamous cell carcinoma of the skin, and squamous cell carcinoma of the head and neck. Initial results from the dose-escalation study presented at the SITC (Free SITC Whitepaper) conference in November 2020 showed that the 600µg dose was tolerated without dose limiting toxicities as a single agent and in combination with anti-PD-1 antibodies. Preliminary evidence of efficacy was observed in the single agent and combination group, with several patients showing responses of distant noninjected lesions.

On February 4, 2021 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company" or "Pulse Biosciences"), a novel bioelectric medicine company progressing Nano-Pulse Stimulation (NPS) technology, reported that it has filed a prospectus supplement with the Securities and Exchange Commission ("SEC"), under which it may offer and sell shares of its common stock (the "Shares") having an aggregate offering price of up to $60,000,000 from time to time through an "at the market equity" offering program (the "Offering") (Press release, Pulse Biosciences, FEB 4, 2021, View Source [SID1234574625]). The Company currently intends to use the net proceeds from sales of Shares under the Offering for general working capital purposes, including the ongoing investment in current and future clinical and pre-clinical studies evaluating the safety and efficacy of the Company’s proprietary NPS technology including applications outside of dermatology, the development and enhancement of its CellFX System, obtaining further regulatory clearances for its CellFX System, sales and marketing activities, and general corporate operations. The timing of any sales will depend on a variety of factors to be determined by the Company.

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The Shares will be offered through Stifel, Nicolaus & Company, Incorporated, as sales agent (the "Sales Agent"). The Sales Agent may sell Shares by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415 of the Securities Act of 1933, as amended.

The prospectus supplement filed today adds to, updates or otherwise changes information contained in the accompanying prospectus contained in a shelf registration statement on Form S-3 (File No. 333-246346) for the offering of Shares. Prospective investors should read the prospectus, the prospectus supplement and other documents the Company has filed with the SEC (some of which are incorporated by reference into the prospectus and prospectus supplement) for more complete information about the Company, the Offering and the risks the Company is currently facing. You may obtain copies of the prospectus supplement and accompanying prospectus relating to the offering without charge by visiting the SEC’s website at www.sec.gov.

This press release is for informational purposes only and is not an offer to sell or the solicitation of an offer to buy any Shares of the Company, which is made only by means of a prospectus supplement and related prospectus. There will be no sale of Shares in any jurisdiction in which the offer, solicitation of an offer to buy or sale would be unlawful.

On February 4, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported it will report financial results for the fourth quarter and full year 2020 after market close on Wednesday, February 24, 2021 (Press release, Guardant Health, FEB 4, 2021, View Source [SID1234574643]). Company management will be webcasting a corresponding conference call beginning at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time.

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Live audio of the webcast will be available on the "Investors" section of the company website at: www.guardanthealth.com. The webcast will be archived and available for replay after the event.

On February 4, 2021 Cerus Corporation (Nasdaq: CERS) reported that William ‘Obi’ Greenman, Cerus’ president and chief executive officer, and Kevin D. Green, Cerus’ chief financial officer, are scheduled to participate in two conferences (Press release, Cerus, FEB 4, 2021, View Source [SID1234574664]):

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BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference on Wednesday, February 17th at 1:30 P.M. ET.
The Cowen 41st Annual Health Care Conference on Monday, March 1st at 2:40 P.M. ET.
A live webcast of the events will be available on the Investor Relations page of the Cerus web site at View Source A replay will be available for approximately two weeks following the completion of the event.