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GRAIL to Present New Multi-Cancer Early Detection Data at the 2023 ASCO Annual Meeting

On May 22, 2023 GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, reported that it will present new data evaluating the use and potential of its methylation-based multi-cancer early detection (MCED) platform at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, June 2-6 (Press release, Grail, MAY 22, 2023, View Source [SID1234631935]). Presentations include interim results from SYMPLIFY, the first large-scale prospective study to evaluate GRAIL’s MCED test in symptomatic patients referred for cancer suspicion, as well as Galleri real-world clinical surveillance data and subset analyses from the PATHFINDER clinical implementation study. An evaluation of Galleri implementation using a centralized model within Mercy’s multi-state health system will also be presented.

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"If we hope to bend the cancer mortality curve, we need a new, population-scale approach for screening people that finds many more cancers than we do today, in earlier stages when treatments are often more effective," said Josh Ofman, MD, MSHS, president at GRAIL. "We believe that adding multi-cancer early detection testing to recommended screening is the best chance to address the growing burden of late-stage cancer in an aging population. We are excited to present new data at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting supporting the use of GRAIL’s MCED technology in adults at elevated risk of cancer, as well as initial findings from SYMPLIFY, a study evaluating patients presenting with signs and symptoms who are referred for a cancer evaluation."

Initial results from SYMPLIFY will be presented during an oral session. SYMPLIFY is the first prospective study assessing the clinical performance of GRAIL’s MCED Methylation Platform in individuals with signs and symptoms that may indicate cancer. Researchers will also present an analysis of the early real-world clinical experience using the Galleri MCED test to detect a shared cancer signal and predict cancer signal of origin (CSO) to guide targeted diagnostic workup. Additionally, doctors from Mercy will present a preliminary analysis of an MCED test implementation model within a large health system utilizing a patient navigation system. A follow-up analysis to the PATHFINDER study assessing clinical implementation of the test following a cancer signal detected result and CSO-guided workups will also be presented. Results from the PATHFINDER study were previously reported during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022.

Abstracts will be available on the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting website. Updated analyses will be presented at the Annual Meeting.

Oral Sessions

Title: Large-scale observational prospective cohort study of a multi-cancer early detection (MCED) test in symptomatic patients referred for cancer investigation
Session Title: Care Delivery and Regulatory Policy
Date/Time: June 3, 2023, 1:27 to 1:39 PM CDT
Location: S100a
Abstract Number: 1501

Title: Methylated DNA biomarkers and incident cancer in the American Cancer Society (ACS) Cancer Prevention Study-3 (CPS-3) cohort
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Date/Time: June 5, 2023, 9:12 to 9:24 AM CDT
Location: Hall D2
Abstract Number: 3004

Posters

Title: Early real-world (RW) experience with a multi-cancer early detection (MCED) test
Session Title: Prevention, Risk Reduction and Hereditary Cancer
Date/Time: June 3, 2023, poster session from 1:15 to 4:15 PM CDT; panel discussion from 5:04 to 5:14 PM CDT
Location: S102
Abstract Number: 10519

Title: Clinical evaluation of cancer signal origin prediction and diagnostic resolution following multi-cancer early detection testing
Session Title: Prevention, Risk Reduction and Hereditary Cancer
Date/Time: June 3, 2023, poster session from 1:15 to 4:15 PM CDT; panel discussion from 5:04 to 5:14 PM CDT
Location: S102
Abstract Number: 10520

Title: Preclinical circulating tumor DNA (ctDNA) shedding duration and prognostic implications of modeling 3669 participants from American Cancer Society Cancer Prevention Study-3 (CPS-3) and Circulating Cell-free Genome Atlas substudy 3 (CCGA3)
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Date/Time: June 3, 2023, 8:00 to 11:00 AM CDT
Location: Hall A
Abstract Number: 3060

Title: Elevated cancer risk among individuals with combinations of cancer-related risk factors: A large claims database analysis
Session Title: Prevention, Risk Reduction and Hereditary Cancer
Date/Time: June 3, 2023, 1:15 to 4:14 PM CDT
Location: Hall A
Abstract Number: 10561

Title: Examining the potential for lead-time bias by estimating stage-specific proportions of deaths due to diagnosed cancer
Session Title: Prevention, Risk Reduction and Hereditary Cancer
Date/Time: June 3, 2023, 1:15 to 4:15 PM CDT
Location: Hall A
Abstract Number: 10535

Title: Overall and non-lung cancer incidence in the National Lung Screening Trial (NLST) as indicators of potential for multi-cancer screening
Session Title: Prevention, Risk Reduction and Hereditary Cancer
Date/Time: June 3, 2023, 1:15 to 4:15 PM CDT
Location: Hall A
Abstract Number: 10633

Title: Methylation-based prediction of myelodysplastic syndrome survival outcomes
Session Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes and Allotransplant
Date/Time: June 5, 2023, 8:00 to 11:00 AM CDT
Location: Hall A
Abstract Number: 7058

Title: Implementation of a multi-cancer early detection (MCED) test using a centralized model within (w/i) a multi-state health system
Session Title: Care Delivery and Regulatory Policy
Date/Time: June 5, 2023, 1:15 to 4:15 PM CDT
Location: Hall A
Abstract Number: 1526

Guardant Health Announces Proposed Public Offering of Common Stock

On May 22, 2023 Guardant Health, Inc. (Nasdaq:GH), a leading precision oncology company, reported that it has commenced an underwritten public offering of $250.0 million of its common stock (Press release, Guardant Health, MAY 22, 2023, View Source [SID1234631933]). In addition, Guardant Health intends to grant the underwriters a 30-day option to purchase up to $37.5 million of its common stock at the public offering price, less underwriting discounts and commissions. All of the shares of common stock in this offering will be sold by Guardant Health. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the proposed offering.

J.P. Morgan, Goldman Sachs & Co. LLC, TD Cowen and SVB Securities are acting as joint book-running managers for the proposed offering.

The shares of common stock are being offered by Guardant Health pursuant to an automatic shelf registration statement on Form S-3 that was previously filed with the U.S. Securities and Exchange Commission, or the SEC, and automatically became effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the proposed offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov.

Copies of the preliminary prospectus supplement and accompanying prospectus may be obtained by contacting:

J.P. Morgan Securities LLC
c/o Broadridge Financial Solutions
1155 Long Island Avenue, Edgewood, NY 11717
Telephone: (866) 803-9204, or email: [email protected];

Goldman Sachs & Co. LLC
Attention: Prospectus Department
200 West Street, New York, NY 10282
Telephone: (866) 471-2526, or email: [email protected];

Cowen and Company, LLC
599 Lexington Avenue, New York, NY 10022
Telephone: (833) 297-2926, or email: [email protected];

SVB Securities LLC
Attention: Syndicate Department
53 State Street, 40th Floor, Boston, MA 02109
Telephone: (800) 808-7525, ext. 6105, or email: [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Acepodia Announces First Patient Dosed in Phase 1 Clinical Trial of ACE1831, an Anti-CD20 Armed Allogeneic Gamma Delta T-cell Therapy in Development to Treat Patients with Non-Hodgkin’s Lymphoma

On May 22, 2023 Acepodia, a clinical stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) platform to address gaps in cancer care, reported that the first patient has been dosed with ACE1831 in a Phase 1, first-in-human clinical trial for patients with non-Hodgkin’s lymphoma (Press release, Acepodia, MAY 22, 2023, View Source [SID1234631932]). ACE1831 is Acepodia’s first gamma delta T cell therapy to enter clinical development from its proprietary ACC platform technology derived from 2022 Nobel Prize laureate Dr. Carolyn Bertozzi’s pioneering work in the development of bioorthogonal chemistry which moves click chemistry into living organisms.

"As we continue to validate our Antibody-Cell Conjugation (ACC) technology in humans, this trial marks the beginning of a new chapter in the field of allogeneic cell therapy," said Sonny Hsiao, Ph.D., chief executive officer of Acepodia. "Currently available cell therapies still present challenges in effectively engaging cancer cells due to immunosuppression caused by the tumor microenvironment. By utilizing potent gamma delta T cells with our novel tumor-targeting mechanisms, we are committed to identifying a safe and therapeutic dose in this Phase 1 trial and to advancing this study in larger patient cohorts."

The Phase 1 trial is a multi-center, dose escalation trial that will evaluate the safety of ACE1831 in patients with non-Hodgkin’s lymphoma. The goal of the study is to determine the maximum tolerated dose of ACE1831, which is administered intravenously via a single infusion following completion of lymphodepleting chemotherapy. The study is expected to enroll up to 42 patients in the United States.

ACE1831 is an off-the-shelf gamma delta T cell therapy candidate developed from Acepodia’s proprietary ACC platform. ACE1831 targets CD20-expressing hematological cancers using anti-CD20 antibody conjugated gamma delta T cells. Taking advantage of the high expression of NK activating receptors of the gamma delta T cells to scavenge the malignant blood cells, ACE1831 has demonstrated in models enhanced cytotoxicity against cancer cells both in vitro and in vivo.

About Gamma-Delta T Cells
Acepodia’s gamma delta T cell program harnesses the unique properties of gamma delta T cells to develop a new class of off-the-shelf cell therapies for the treatment of cancer. Gamma delta T cells have characteristics of both the innate and adaptive immune systems that make them an ideal chassis for the development of cell therapies. This cell type can recognize and attack cancerous cells as well as coordinate a broad antitumor immune response by recruiting other immune factors and cells to the site of disease. Gamma delta T cells have also been shown to preferentially traffic to distinct tissues and could be ideally suited for more targeted treatment of certain types of cancers.

Rakuten Medical to Start a Global Phase 3 Trial of Alluminox™ Treatment using ASP-1929 for Recurrent Head and Neck Cancer in India

On May 22, 2023 Rakuten Medical, Inc. (Rakuten Medical), a global biotechnology company developing and commercializing precision, cell-targeting therapies based on its proprietary Alluminox platform, reported that the Company has been granted permission from the Indian Central Drugs Standard Control Organization (CDSCO) to conduct its global, pivotal Phase 3 clinical trial (ASP-1929-301/ClinicalTrials.gov Identifier: NCT03769506) evaluating Alluminox treatment (photoimmunotherapy) using ASP-1929 in patients with locoregional, recurrent head and neck squamous cell carcinomas (HNSCC) in India, and the registration of clinical trial information with the Clinical Trial Registry of India (CTRI) has been completed (CTRI Identifier: CTRI/2023/05/052728) (Press release, Rakuten Medical, MAY 22, 2023, View Source [SID1234631931]). The study sites will include several leading medical institutions in India such as the Tata Memorial Centre and Narayana Health, and the treatment will be administered to enrolled patients once ready. This ASP-1929-301 study is currently underway in several countries such as the U.S. and Taiwan, and will enroll 275 patients globally including Indian patients.

In India, more than 200,000 new cases of head and neck cancer are diagnosed each year, which accounts for approximately 25% of all new head and neck cancer cases worldwide1. One of the reasons for this is the widespread use of chewing tobacco. More than 28% of all adults (15 years and above) in India are users of tobacco, and approx. 75% of them use smokeless tobacco, including chewing tobacco2. It has been reported that more than half of oral cancer (a type of head and neck cancer) in India is attributable to smokeless tobacco, including chewing tobacco3. In addition to the high occurrence of head and neck cancer, it is known that the majority of these patients present with advanced disease, which also corresponds with poorer outcomes 4. Such high volumes of advanced stage patients can present many challenges for the surgeons and medical oncologists who treat head and neck cancer. Time and treatment options are limited. Surgery, radiation, and chemotherapy are all commonly used to manage this patient population – but more options are needed.

The multi-center, randomized, open-label, global Phase 3 study of Alluminox treatment using ASP-1929 will evaluate the efficacy and safety of ASP-1929 in patients with locoregional, recurrent HNSCC who have previously failed or progressed on or after at least two lines of therapy, of which at least one line must be systemic therapy, and are not eligible for surgery or radiation. Participants will be randomized to receive experimental therapy or investigator’s choice of systemic therapy (2:1). The dual-primary endpoints of the study are progression-free survival and overall survival, and a key secondary endpoint includes objective response rate.

"We are very pleased to be conducting the pivotal Phase 3 study of Alluminox treatment using ASP-1929 in India, where there is a high unmet need for head and neck cancer treatment," said Mickey Mikitani, Co-CEO of Rakuten Medical. "The addition of India to this important study will help to accelerate the development of this drug. We will continue to do our utmost to bring a new treatment option to patients with head and neck cancer around the world as soon as possible, working closely with medical institutions and regulatory authorities in each country."

ASP-1929 is a conjugation of an antibody cetuximab and IRDye 700DX, a light activatable dye, and is Rakuten Medical’s first pipeline drug developed on its Alluminox platform. It binds to epidermal growth factor receptor (EGFR), which is highly expressed in head and neck cancers. After binding to cancer cells, ASP-1929 is locally activated by non-thermal red light (690 nm) illumination, which leads to selective cell killing inpre-clinical observations. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the drug in January 2018. In Japan, in September 2020, ASP-1929 received marketing approval from the Ministry of Health, Labour and Welfare for unresectable locally advanced or recurrent head and neck cancer as brand name Akalux, together with BioBlade Laser System, the medical device used in combination with the drug under the Conditional Early Approval System. Outside of Japan, ASP-1929 and the laser device system have not yet been approved by any regulatory authority.

IDEAYA Announces IND Clearance Enabling Phase 1/2 Clinical Trial for Combination of IDE397 and AMG 193 in MTAP-Deletion Solid Tumors

On May 22, 2023 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that the U.S. Food and Drug Administration (FDA) has completed its review of the Amgen-sponsored Investigational New Drug (IND) application and concluded that the proposed clinical study may proceed to evaluate IDE397 in combination with AMG 193 in solid tumors having MTAP deletion (Press release, Ideaya Biosciences, MAY 22, 2023, View Source [SID1234631930]).

"We are pleased to collaborate with Amgen to clinically evaluate the IDE397 and AMG 193 combination as a potential first-in-class treatment for patients having solid tumors with MTAP deletion. We believe that evaluation of this combination represents an exciting and highly rational clinical study for patients with MTAP-deletion tumors, based on the observed preclinical efficacy, tolerability and selectivity," said Dr. Darrin M. Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.

"We have a deep understanding of the underlying biological rationale for this combination of a MAT2A inhibitor and an MTA-cooperative PRMT5 inhibitor. As presented at AACR (Free AACR Whitepaper) 2023, gene expression analysis of hallmark pathways, alternative splicing analysis and retained intron analysis collectively demonstrate that combined pharmacological inhibition of MAT2A and PRMT5 deepens the biological response through maximal pathway suppression. The enhanced combination effect was observed selectively in MTAP-null models," said Dr. Michael White, Ph.D., Chief Scientific Officer, IDEAYA Biosciences.

IDE397 is a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2a (MAT2A). IDEAYA is clinically evaluating IDE397 as monotherapy in a Phase 1/2 clinical trial in patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion, with ongoing enrollment into Phase 2 monotherapy expansion cohorts in selected indications, including squamous cell NSCLC, esophagogastric cancer, and bladder cancer. AMG 193 is the Amgen investigational methylthioadenosine- (MTA-) cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor. The clinical evaluation of IDE397 with AMG 193 represents a novel and potential first-in-class synthetic lethality combination. Targeting two mechanistically distinct nodes of the MTAP methylation pathway – MAT2A and PRMT5 provides a synergistic approach for targeting MTAP-null tumors.

IDEAYA is collaborating with Amgen to clinically evaluate the IDE397 and AMG 193 combination in patients having tumors with MTAP deletion in an Amgen-sponsored clinical trial pursuant to a Clinical Trial Collaboration and Supply Agreement, or CTCSA. The Phase 1/2 clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of IDE397 in combination with AMG 193.

IDEAYA and Amgen co-presented preclinical data at the 2023 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), or AACR (Free AACR Whitepaper) 2023, demonstrating deep and durable anti-tumor efficacy for the IDE397 and AMG 193 combination in a NSCLC MTAP-null CDX model. These data showed complete responses following approximately 30 days of combination treatment at doses below the maximally efficacious preclinical dose for each compound, which were durable from approximately study-day 40 to study-day 100. The IDE397 and AMG 193 combination was well tolerated, with no observed body weight loss through the approximate 30 days of combination treatment in these models. Additionally, the results of gene expression analysis of hallmark pathways, alternative splicing analysis and retained intron analysis collectively demonstrated that combined pharmacological inhibition of MAT2A and PRMT5 deepens the biological response through maximal pathway suppression. The enhanced combination effect was observed selectively in MTAP-deleted relative to MTAP wild-type models.

Pursuant to the mutually non-exclusive CTCSA, Amgen is the sponsor of the IDE397 and AMG 193 combination clinical trial and each of IDEAYA and Amgen will supply their respective compounds, IDE397 and AMG 193. Each party will pay fifty percent (50%) of the external third-party costs for conducting the clinical trial and be wholly responsible for their respective own internal costs and expenses in support of the clinical trial. The companies will jointly own clinical data and all intellectual property, if any, relating to the combined use of IDE397 and AMG 193 from the clinical trial. Each party retains commercial rights to its respective compounds, including with respect to use as a monotherapy or combination agent. The companies have formed a joint oversight committee responsible for coordinating all regulatory and other activities in support of the clinical trial.