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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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.

On May 22, 2023 City of Hope, one of the largest cancer research and treatment organizations in the United States, reported that one of its researchers will present results from a SWOG Cancer Research Network Phase 3 study comparing nivolumab and brentuximab vedotin in patients with advanced stage classic Hodgkin lymphoma at an ASCO (Free ASCO Whitepaper) press briefing (Press release, City of Hope, MAY 22, 2023, View Source [SID1234631929]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Alex Herrera, M.D., City of Hope associate professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation, will present the findings on Saturday, June 3, for Abstract LBA4 and at a plenary session on Sunday, June 4. The embargo for this abstract lifts on Sunday, June 4, at 7 a.m. CT/8 a.m. ET.

Other innovative City of Hope-led research on a natural killer cell engager for relapsed or difficult to treat acute myeloid leukemia, a City of Hope-developed CAR T for prostate cancer, pediatric cancer survivorship and precision medicine for breast cancer will also be presented during the conference, which attracts oncology professionals from around the world to discuss the latest clinical cancer research impacting patient care.

Title: A first-in-human study of CD123 NK cell engager SAR443579 in relapsed or refractory acute myeloid leukemia, B-cell acute lymphoblastic leukemia, or high-risk myelodysplasia
Abstract Number: 7005
Session Type: Oral
Session Title: Hematologic Malignancies — Leukemia, Myelodysplastic Syndromes and Allotransplant
Session Date and Time: Friday, June 2, 1 to 4 p.m. CT
Presentation Time: Friday, June 2, 2:24 to 2:36 p.m. CT
Presenter: Anthony Stein, M.D., City of Hope professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation

Title: Lisocabtagene maraleucel (liso-cel) in R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): Primary analysis of TRANSCEND CLL 004
Abstract Number: 7501
Session Type: Oral.
Session Title: Hematologic Malignancies — Lymphoma and Chronic Lymphocytic Leukemia
Session Date and Time: Tuesday, June 6, 9:45 a.m. to 12:45 p.m. CT
Presentation Time: Tuesday, June 6, 9:57 to 10:09 a.m. CT
Presenter: Tanya Siddiqi, M.D., City of Hope associate professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation

Title: Real-world outcomes of brexucabtagene autoleucel (brexu-cel) for relapsed or refractory (R/R) mantle cell lymphoma (MCL): A CIBMTR subgroup analysis by prior treatment
Abstract Number: 7507
Session Type: Oral.
Session Title: Hematologic Malignancies — Lymphoma and Chronic Lymphocytic Leukemia
Session Date and Time: Tuesday, June 6, 9:45 a.m. to 12:45 p.m. CT
Presentation Time: Tuesday, June 6, 11:57 a.m. to 12:09 p.m. CT
Presenter: Swetha Kambhampati, M.D., City of Hope assistant professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation

Title: Carvedilol for prevention of heart failure in anthracycline-exposed survivors of childhood cancer: Results from COG ALTE1621
Abstract Number: 10013
Type: Oral.
Session Title: Pediatric Oncology
Session Date and Time: Monday, June 5, 8 to 11 a.m. CT
Presentation Time: Monday, June 5, 9:12 to 9:24 a.m. CT
Presenter: Saro Armenian, D.O., M.P.H., Barron Hilton Chair in Pediatrics, professor and chair, Department of Pediatrics

Title: Final results from phase I study of PSCA-targeted chimeric antigen receptor (CAR) T cells in patients with metastatic castration resistant prostate cancer (mCRPC)
Abstract Number: 5019
Type: Poster
Session Title: Genitourinary Cancer — Prostate, Testicular and Penile
Session Date and Time: Saturday, June 3, 1:15 to 2:45 p.m. CT
Presenter: Tanya Dorff, M.D., City of Hope professor, Department of Medical Oncology & Therapeutics Research

Title: Healthcare utilization among individuals diagnosed with hereditary breast-ovarian cancer syndrome through a universal germline genetic testing program
Abstract Number: 10604
Session Type: Poster
Session Title: Prevention, Risk Reduction and Hereditary Cancer
Session Date and Time: Saturday, June 3, 1:15 to 2:45 p.m. CT
Presenter: Stacy W. Gray, M.D., A.M., City of Hope professor and chief, Division of Clinical Cancer Genomics, Department of Medical Oncology & Therapeutics Research

Title: Efficacy and safety of atezolizumab plus cabozantinib vs cabozantinib alone after progression with prior immune checkpoint inhibitor (ICI) treatment in metastatic renal cell carcinoma (RCC): Primary PFS analysis from the phase 3, randomized, open-label CONTACT-03 study
Abstract Number: LBA4500
Session Type: Oral
Session Title: Genitourinary Cancer — Kidney and Bladder
Session Date and Time: Monday, June 5, 11:30 a.m. to 2:30 p.m. CT
Senior Author: Sumanta Kumar Pal, M.D., City of Hope professor, Department of Medical Oncology & Therapeutics Research

Title: Effect of CBM588 in combination with cabozantinib plus nivolumab for patients (pts) with metastatic renal cell carcinoma (mRCC): A randomized clinical trial
Abstract Number: LBA104
Session Type: Clinical Science Symposium
Session Title: Role of the Microbiome in Immune Checkpoint Inhibitor Response and Resistance
Session Date and Time: Sunday, June 4, 9:45 to 11:15 a.m. CT
Presentation Time: 10:21 to 10:33 a.m. CT
Presenter: Heydeh Ebrahimi, M.D., M.P.H., City of Hope postdoctoral fellow