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.

SQZ Biotechnologies Announces Publication of Comprehensive Preclinical Research on SQZ® APC’s Ability to Overcome Fundamental Biological Barrier to Effective and Efficient Killer T Cell Activation

On February 1, 2022 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported the publication of comprehensive preclinical research on the company’s ability to engineer multiple immune cell types to drive MHC-I antigen presentation, a critical advance in the ability to drive a patient’s killer T cells to fight multiple diseases (Press release, SQZ Biotech, FEB 1, 2022, View Source [SID1234607584]). The cell engineering findings, published online and in the February 15th edition of the Journal of Immunology, are part of the body of work supporting the development of SQZ Antigen Presenting Cell (APC) and SQZ Enhanced Antigen Presenting Cell (eAPC) cancer vaccine therapeutic programs currently in clinical development.

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The journal publication follows the December 2021 oral presentation at the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) congress reporting that the company’s lead APC therapeutic candidate induced a radiographic, symptomatic, histologic response as a monotherapy in a late line head and neck cancer patient.

"We are excited to publish the comprehensive dataset that has long underpinned our conviction in the SQZ APC platform’s potential for patient impact," said Armon Sharei, Ph.D., Chief Executive Officer and Founder of SQZ Biotechnologies. "These data demonstrate the ability of microfluidic squeezing to engineer antigen presentation in T cells, B cells, NK cells, and monocytes, thereby empowering these immune cells to activate endogenous CD8 killer T cells – a powerful and highly specific arm of the immune system. Our early clinical trial data presented at ESMO (Free ESMO Whitepaper)-IO demonstrated our multi-cell engineering mechanism at work, and we are excited about the potential to implement this approach across multiple tumor types."

CD8, or Killer, T cells play a critical role in combating diseases, however, a major bottleneck for CD8 T cell activation is displaying the desired disease associated antigen(s) to these T cells through the MHC-I pathway. In this journal article, SQZ scientists and their collaborators describe how they overcome this fundamental biological problem through the delivery of antigens directly into the cytosol of immune cells by microfluidic squeezing.

"What’s exciting about our platform is the ability to efficiently insert many types of antigen cargo directly into a cell’s cytosol for presentation to killer T cells, and the ability to engineer other immune system cells to target disease," said Howard Bernstein, M.D., Ph.D., chief scientific officer at SQZ Biotechnologies. "Our enhanced APCs, which recently received FDA IND clearance to commence a clinical trial, represent a further advancement of the concept by delivering five different mRNAs into a patient’s monocytes, B cells, T cells, and NK cells in a single step. We are exploring an exciting frontier in cell therapy and look forward to assessing its potential for patient impact in our clinical trials."

Major Journal Study Findings

Enabling Cancer Vaccine Development

In this study, the authors demonstrate preclinically that cytosolic delivery of antigens through microfluidic squeezing enables direct MHC-I antigen presentation to CD8 T cells by diverse immune system cell types, overcoming a major challenge in the development of cancer vaccine therapeutics
Study authors also showed they could expand beyond the more commonly used dendritic cells to induce T cell activation. MHC-I presentation was demonstrated in engineered T cells, B cells, Natural Killer cells, and monocytes – broadening their potential use and impact in therapeutic design
Tumor Protection and Immunization

In vivo study findings showed that engineered B cells, T cells, or mixed peripheral blood mononuclear cells (PBMCs), were all capable of activating endogenous immune responses across multiple antigens
These immune responses were able to protect mice in prophylactic studies, drive tumor regression in therapeutic studies, and form long-term memory that protects against future tumor challenge
Authors further found that this protection correlates with tumor infiltration of antigen-specific cells with nearly 90 percent of infiltrating CD8 T cells being specific for the tumor antigen delivered using the Cell Squeeze technology
Efficient, Scaled Manufacturing

Study authors compared the viability and delivery of engineered cells using research-scale and manufacturing-scale Cell Squeeze chips. They found that delivery of different cells types within PBMCs was similar across research-scale and manufacturing-scale chips, and study authors demonstrated successful increase from millions to billions of cells processed using manufacturing-scale chips

Abcam Collaborates With Twist Bioscience to Enhance Antibody Discovery for Diagnostic and Research Applications

On February 1, 2022 Twist Bioscience Corporation (NASDAQ:TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, and Abcam (AIM:ABC; NASDAQ:ABCM), a global innovator in life sciences reagents and tools, reported a licensing agreement under which Abcam will use a proprietary Twist VHH phage library for antibody discovery, development and commercialization for diagnostic and research applications (Press release, Abcam, FEB 1, 2022, View Source [SID1234607583]).

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Phage display complements other antibody discovery methods, and offers several benefits for tackling challenging targets. The synthetic nature and the diversity of each Twist library (up to 10 billion variants) enable the rapid identification of antibodies against challenging targets that would otherwise fail due to toxicity or lack of immunogenicity. The recombinant format enables easier genetic engineering and maximizes in vitro manufacturing ensuring batch-to-batch reproducibility and scalability from bench to bedside.

Alejandra Solache, Ph.D., SVP R&D at Abcam said, "Twist’s phage library complements our leading recombinant antibody discovery capabilities, adding further scale and diversity and increasing the likelihood of identifying antibodies with the desired properties against emerging or established targets. The partnership supports Abcam and Twist’s commitment to deliver antibodies that have the potential to accelerate the development of innovative research tools, diagnostics and therapeutics."

Under the terms of the agreement, Twist Bioscience grants Abcam the right to engage in research and development activities using Twist single domain (VHH) synthetic antibody library. Abcam has the option to nominate, license and commercialize antibody sequences for diagnostic and research use, in return for license fees and commercial milestone payments. Twist retains the rights to the same sequences for therapeutic application.

Emily M. Leproust, Ph.D., CEO and co-founder of Twist said, "This partnership is an important milestone in Twist’s journey as it allows us to access the research and diagnostic market through Abcam’s commitment to advance discovery, development and commercialization of the resulting antibodies. In addition, this agreement lays the foundations for a long term collaboration with Abcam to drive new commercial opportunities. Importantly, because Twist retains the rights to develop the sequences for therapeutic uses, this partnership has the potential to benefit our internal pipeline as well."

VHH Antibody Libraries

Antibodies contain two variable domains, the heavy and the light chains. A VHH antibody, also known as a nanobody or single domain antibody, is the antigen binding domain of the heavy chain, with three complementary determining regions (CDRs), or areas where antigens bind to the antibody. Twist’s VHH library uses novel methods that combine synthetic and natural approaches to maximize diversity in the 10 billion antibody library, creating high quality VHH libraries for use against any protein target. The small size of the VHH antibodies allow them to access targets that traditional antibodies cannot, with tight binding affinity. The modular nature of VHH antibodies supports creation of bi- or multi-specific antibodies ideal for developing next generation therapies specific to oncology, autoimmune disease and virology.