Minerva Biotechnologies Announces Opening 1st-In-Human Phase I/II Trial of a MUC1* Targeting CAR T for Metastatic Breast Cancers at City of Hope

On February 1, 2022 Minerva Biotechnologies Corporation reported that its trial of huMNC2-CAR44 T cells (NCT04020575) has now opened at City of Hope, Duarte, California (Press release, Minerva Biotechnologies, FEB 1, 2022, View Source [SID1234607589]). This is a first-in-human trial targeting the tumor-associated form of MUC1, called MUC1* (muk 1 star). MUC1* is the transmembrane cleavage product that is a growth factor receptor that drives growth of an estimated 93% of breast cancers. The antibody that targets Minerva’s CAR T to the tumor binds to an ectopic site that is only exposed after cleavage and release of the tandem repeat domain. Other attempts at targeting MUC1 with antibodies, ADCs, or CAR Ts have targeted the tandem repeat domain, which is cleaved in the tumor microenvironment and shed from the cell surface.

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The huMNC2-CAR44 therapy was developed by, and is proprietary to, Minerva Biotechnologies. The targeting head of the CAR, the antibody MNC2, recognizes a unique conformation of MUC1 after cleavage by a specific enzyme in the tumor microenvironment. "The ability of our antibody to bind specifically to the cancerous form of MUC1 without binding to MUC1 on normal tissues is a real breakthrough," said Dr. Cynthia Bamdad, CEO of Minerva Biotechnologies.

"Demonstration of safety and early signs of efficacy of huMNC2-CAR44 represent a significant milestone for Minerva. We have a broad, deep pipeline that includes next generation CAR Ts, with enhanced in vivo persistence, and the ability to target cells with much lower antigen density, allowing us to challenge the persistence issues seen elsewhere in the field. We can now progress these to the clinic with increased confidence. We are also developing therapeutics that target the onco-embryonic growth factor, NME7, that activates the MUC1* growth factor receptor across many different types of solid tumors and the preclinical results are very encouraging," said Minerva Chief Business Officer, Michael Crowther.

We would like to express our gratitude to our collaborators, our scientists, and the patients and their physicians for their support and participation in this trial.

About the trial

NCT04020575 is a first-in-human trial of huMNC2-CAR44, an autologous CAR T therapy targeting MUC1* in metastatic breast cancer in patients with MUC1* reactive tumors. For more information about the trial, including the study description, inclusion/exclusion criteria, and intake contact information, visit: View Source or contact Dr. Yuan Yuan 1-800-826-4673 or email [email protected]

Personalis to Present at the BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference

On February 1, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that its management team will present at the BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference on Tuesday, February 15, 2022 at 2:00 p.m. Eastern Time (Press release, Personalis, FEB 1, 2022, View Source [SID1234607588]).

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The webcast link is available only for those who are attending the BTIG conference.

Guardant Health to Report Fourth Quarter and Full Year 2021 Financial Results on February 23, 2022

On February 1, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported it will report financial results for the fourth quarter and full year 2021 after market close on Wednesday, February 23, 2022 (Press release, Guardant Health, FEB 1, 2022, View Source [SID1234607587]). Company management will be webcasting a corresponding conference call beginning at 1:30 p.m. Pacific Time / 4:30 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.

Gilead Sciences Announces 2.8 Percent Increase in First Quarter 2022 Dividend

On February 1, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) reported that the company’s Board of Directors has declared an increase of 2.8% in the company’s quarterly cash dividend, beginning in the first quarter of 2022 (Press release, Gilead Sciences, FEB 1, 2022, View Source [SID1234607586]). The increase will result in a quarterly dividend of $0.73 per share of common stock. The dividend is payable on March 30, 2022, to stockholders of record at the close of business on March 15, 2022. Future dividends will be subject to Board approval.

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Blue Earth Diagnostics Highlights Upcoming Presentation of Key Results from Phase 3 SPOTLIGHT Study of Targeted PET Imaging Agent 18F-rhPSMA-7.3 in Biochemically Recurrent Prostate Cancer

On February 1, 2022 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported the upcoming oral presentation of key results from its Phase 3 SPOTLIGHT trial of 18F-rhPSMA-7.3 in recurrent prostate cancer, at the upcoming ASCO (Free ASCO Whitepaper) 2022 Genitourinary Cancers Symposium (ASCO GU) (Press release, Blue Earth Diagnostics, FEB 1, 2022, View Source [SID1234607585]). The conference will be held in-person in San Francisco, Calif. and online from February 17 to 19, 2022. 18F-rhPSMA-7.3 is an investigational Prostate-Specific Membrane Antigen-targeted radiohybrid (rh) PET imaging agent. The SPOTLIGHT study (NCT04186845) is a Phase 3, multi-center, single-arm imaging study, conducted in the United States and Europe, to evaluate the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy.

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Details of the presentation are listed below.

Highlighted 18F-rhPSMA-7.3 Oral Presentation

Date: Thursday, February 17, 2022
Track: Prostate Cancer
Title: Detection Rates of 18F-rhPSMA-7.3 PET in Patients with Suspected Prostate Cancer Recurrence: Results from a Phase 3, Prospective, Multicenter Study (SPOTLIGHT)
Presenter: David M. Schuster, MD, FACR, Winship Cancer Institute of Emory University, Atlanta, Ga.
Session: General Session – Evolution of Multidisciplinary Management Across the Spectrum of Prostate Cancer
Abstract: 9
Location: In-person and online/Level 3, ballroom
Session Time: 6:00 PM ET– 7:30 PM ET (3:00 PM PT – 4:30 PM PT)
Presentation: 7:00 PM ET (4:00 PM PT)

Blue Earth Diagnostics invites participants at the ASCO (Free ASCO Whitepaper) 2022 Genitourinary Cancers Symposium to attend the presentation above. Participants on-site are also invited to visit Blue Earth Diagnostics’ Medical Affairs booth (#50). For full session details and scientific presentation listings, please see the ASCO (Free ASCO Whitepaper) GU online program here.

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)
rhPSMA compounds consist of a radiohybrid ("rh") Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells and they may be radiolabeled with 18F for PET imaging, or with isotopes such as 177Lu or 225Ac for therapeutic use – creating a true theranostic technology. The radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA imaging technology from Scintomics GmbH in 2018, followed by acquisition of exclusive rights to therapeutic applications in 2020. Blue Earth Diagnostics has two Phase 3 clinical studies evaluating the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in prostate cancer: ("SPOTLIGHT," NCT04186845), in men with recurrent disease and ("LIGHTHOUSE," NCT04186819), in men with newly diagnosed prostate cancer. rhPSMA compounds are investigational and have not received regulatory approval.