On May 13, 2024 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that it will share new research from across its innovative portfolio of approved and investigational cancer therapies during the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 31 – June 4 (Press release, Astellas, MAY 13, 2024, View Source [SID1234643133]). A total of 16 abstracts will be presented, including new data from pivotal trials supporting ongoing regulatory reviews. The volume of data being presented by Astellas reinforces its commitment to changing the course of cancer treatment through targeted therapies for hard-to-treat cancers like prostate, urothelial, and gastric/gastroesophageal junction (GEJ) cancers.

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Tadaaki Taniguchi, MD, PhD, Chief Medical Officer, Astellas
"The data at ASCO (Free ASCO Whitepaper) demonstrate the strength and breadth of our growing oncology portfolio and provide new insights into our transformative therapies for patients living with some of the most devastating cancers. Recent regulatory achievements mean our oncology medicines are reaching more patients than ever worldwide, and we are continuing to pursue novel targets and invest in research to improve overall survival and raise quality of life."

Highlights at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting include:

Further data from the Phase 3 EV-302 trial evaluating enfortumab vedotin in combination with pembrolizumab versus chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC), including data in cisplatin-eligible and cisplatin-ineligible populations. These results support the combination as a landmark advancement in the care of patients with la/mUC, regardless of cisplatin eligibility, and serve as the basis of ongoing regulatory reviews by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), Japan’s Ministry of Health, Labour and Welfare (MHLW), and the China National Medical Products Administration (NMPA).
Final overall survival (OS) results from the Phase 3 SPOTLIGHT study, evaluating the efficacy and safety of zolbetuximab – a first-in-class claudin (CLDN) 18.2-targeted monoclonal antibody approved by Japan’s MLHW and currently in review by multiple regulatory authorities for approval worldwide. In this abstract, zolbetuximab is evaluated in combination with mFOLFOX6 (a combination chemotherapy regimen that includes oxaliplatin, leucovorin, and fluorouracil) for the first-line treatment of patients with CLDN18.2 positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. These results underpin the strength of the zolbetuximab clinical data supporting the pursuit of regulatory approvals worldwide.
Two new post-hoc analyses of the Phase 3 EMBARK trial, which evaluated enzalutamide plus leuprolide, placebo plus leuprolide, and enzalutamide (single agent) in patients with nonmetastatic hormone- (or castration-) sensitive prostate cancer (nmHSPC or nmCSPC) with high-risk biochemical recurrence (BCR), including an oral presentation on the impact of treatment suspension on health-related quality of life and a poster presentation on sexual activity patient-reported outcomes.
Astellas Presentations at 2024 ASCO (Free ASCO Whitepaper) Annual Meeting

Enfortumab Vedotin

Presentation Title

Lead Author

Presentation Details

Impact of exposure on outcomes with enfortumab vedotin in patients with locally

advanced or metastatic urothelial cancer

D. Petrylak

Type: Oral

Presentation

Abstract

Number: 4503

Date: June 3, 2024

8:00-11:00 AM

CDT

Patient-reported outcomes (PROs) from a randomized, phase 3 trial of enfortumab

vedotin plus pembrolizumab (EV+P) versus platinum-based chemotherapy (PBC) in

previously untreated locally advanced or metastatic urothelial cancer (la/mUC)

S. Gupta

Type: Oral

Presentation

Abstract

Number: 4502

Date: June 3, 2024

8:00-11:00 AM

CDT

Enfortumab vedotin (EV) in triple-negative breast cancer (TNBC) and HR+/HER2-

breast cancer (BC) cohorts of EV-202

A. Giordano

Type: Oral

Presentation

Abstract

Number: 1005

Date: June 1, 2024

3:00-6:00 PM

CDT

Enfortumab vedotin (EV) with pembrolizumab (P) versus chemotherapy (chemo) in

previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC): Analysis of

cisplatin (cis)-eligible population from EV-302/KEYNOTE-A39

J. Bedke

Type: Poster

Presentation

Abstract

Number: 4562

Date: June 2, 2024
9:00 AM-12:00

PM CDT

Enfortumab vedotin (EV) with pembrolizumab (P) versus chemotherapy (chemo) in

previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC): Analysis of

the cisplatin (cis)-ineligible population from EV-302/KEYNOTE-A39

M. Van Der Heijden

Type: Poster

Presentation

Abstract

Number: 4563

Date: June 2, 2024

9:00 AM-12:00

PM CDT

Enfortumab vedotin (EV) in non-squamous and squamous non–small cell lung cancer

(NSCLC) cohorts of EV-202

K. Muro

Type: Poster

Presentation

Abstract

Number: 8585

Date: June 3,2024

1:30-4:30 PM

CDT

Enfortumab vedotin (EV) in previously treated gastric/esophageal cancers cohorts of

EV-202

K. Muro

Type: Poster

Presentation

Abstract

Number: 4046

Date: June 1, 2024

1:30-4:30 PM

CDT

Study EV-103: Neoadjuvant treatment with enfortumab vedotin monotherapy in

cisplatin-ineligible patients with muscle invasive bladder cancer (MIBC): 2-year event-

free survival and safety data for Cohort H

P. O’Donnell

Type: Poster

Presentation

Abstract

Number: 4564

Date: June 2, 2024

9:00 AM-12:00

PM CDT

Enfortumab vedotin and pembrolizumab as first-line treatment in recurrent or

metastatic head and neck squamous cell carcinoma: a cohort of the EV-202 trial

P. Swiecicki

Type: Poster

Presentation

Abstract

Number: TPS6116

Date: June 2, 2024

9:00 AM-12:00

PM CDT

Systematic Literature Review and Network Meta-Analysis of First-Line Therapies for

Locally Advanced/Metastatic Urothelial Carcinoma

L. Bloudek

Type: Online

publication

Abstract

Number: e16547

Real-world first-line treatment patterns and outcomes in patients with locally advanced

or metastatic urothelial carcinoma in the United States

R. Chen

Type: Online

Publication

Abstract

Number: e23287

Enzalutamide

Presentation Title

Lead Author

Presentation Details

EMBARK post-hoc analysis of impact of treatment suspension (TxS) on health-

related quality of life (HRQoL)

S. Freedland

Type: Oral Presentation

Abstract Number: 5005

Date: June 1, 2024

3:00-6:00PM CDT

EMBARK post hoc analysis of sexual activity (SA) patient-reported outcomes

(PROs) in patients (pts) who were sexually active or interested in sex at baseline (BL)

S. Freedland

Type: Poster Presentation

Abstract Number: 5084

Date: June 2, 2024

9:00 AM-12:00 PM CDT

Physicians use of first-line treatment intensification in metastatic castration-

sensitive prostate cancer (mCSPC): A discrete choice experiment

S. Loeb

Type: Poster Presentation

Abstract Number: 5087

Date: June 2, 2024

9:00 AM-12:00 PM CDT

Characteristics and treatment (Tx) patterns (TxP) of high-risk biochemically

recurrent (HR-BCR) non-metastatic castration-sensitive prostate cancer in the

real-world by race, age, and prostate-specific antigen (PSA) doubling time

(PSADT)

A. Morgans

Type: Online-Only Abstract

Abstract Number: e17071

Zolbetuximab

Presentation Title

Lead Author

Presentation Details

Final overall survival results from phase 3 SPOTLIGHT study evaluating

zolbetuximab + mFOLFOX6 as first-line (1L) treatment for patients (pts) with

claudin 18 isoform 2 (CLDN18.2)+, HER2−, locally advanced (LA) unresectable or

metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma

K. Shitara

Type: Poster Presentation

Abstract Number: 4036

Date: June 1, 2024

1:30-4:30 PM CDT

About PADCEV and the Astellas, Pfizer and Merck Collaboration
Astellas and Pfizer have a clinical collaboration agreement with Merck to evaluate the combination of Astellas’ and Pfizer’s PADCEV (enfortumab vedotin-ejfv) and Merck’s KEYTRUDA (pembrolizumab) in patients with previously untreated metastatic urothelial cancer. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada).

About XTANDI and the Pfizer/Astellas Collaboration
In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE:PFE), and Astellas (TSE: 4503) entered into a commercial agreement to jointly develop and commercialize XTANDI (enzalutamide) in the United States, while Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing the product outside the United States. Pfizer receives alliance revenues as a share of U.S. profits and receives royalties on sales outside the U.S.

On May 13, 2024 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea" or the "Company"), a clinical stage biopharmaceutical company focused on precision oncology through synthetic lethality, reported that management will attend the 2024 RBC Capital Markets Global Healthcare Conference that will take place May 14-15, 2024 in New York, NY. Details are as follows (Press release, Aprea, MAY 13, 2024, View Source [SID1234643132]):

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2024 RBC Capital Markets Global Healthcare Conference
Date: May 14-15, 2024
Location: New York, NY

Management will be available for one-on-one meetings. To request a meeting, please contact your conference representative.

On May 13, 2024 Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA), a leader in PCR-based DNA technologies, and the Institute of Hematology and Blood Transfusion (ÚHKT/IHBT) reported that an abstract relating to the development of a fully enzymatic, non-viral manufacturing workflow to enable the rapid and cost-effective production of clinical-grade (GMP) CAR T-cell therapies has been accepted for presentation at the prestigious European Hematology Association (EHA) (Free EHA Whitepaper) 2024 Hybrid Congress to be held in Madrid, Spain from June 13 – 16, 2024 (Press release, Applied DNA Sciences, MAY 13, 2024, View Source [SID1234643131]). Accepted abstracts will be available on the Congress’ website starting on May 14, 2024. This current study extends the successful results previously published on the virus-free preparation of CD19-specific CAR T-cells against refractory B cell malignancies utilizing Applied DNA’s Linea DNA.

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The current study was designed to address the high cost of conventional CAR T-cell therapies, which is primarily due to conventional manufacturing processes that utilize difficult-to-manufacture viral vectors. By generating CD123-specific CAR T-cells in a non-viral workflow via piggyBac transposons made from Linea DNA at substantial and cost-efficient yields with no risk of antibiotic-resistance gene transfer, we believe the study could offer a promising solution for the rapid manufacture of CAR T-cell therapies. IHBT is currently seeking SÚKL-EMA approval to initiate clinical trials using its Linea DNA-enabled CD123-specific CAR T-cells in patients with refractory acute myeloid leukemia.

Details of the oral presentation:
Abstract Title: "Linear DNA Platform For The Non-Viral Point-Of-Care Production Of Car-T Cells"
Abstract Number: P1722
Presenting Author: Dr. Pavel Otáhal

About the Linea DNA and Linea IVT Platforms
The Linea DNA platform is a completely cell-free DNA production platform founded on Applied DNA’s long-standing expertise in the large-scale enzymatic production of DNA. Capable of producing DNA in quantities ranging from milligrams to grams, the Linea DNA platform can produce high-fidelity DNA constructs ranging from 100bp to 20kb in size. The DNA produced via the Linea DNA platform is free of the adventitious DNA sequences found in other sources of DNA, is rapidly scalable, and provides for simple chemical modification of DNA constructs.

The Linea IVT platform combines DNA IVT templates manufacturing via the Linea DNA platform with a proprietary Linea RNAP to enable mRNA and sa-mRNA manufacturers to produce what Applied DNA believes to be better mRNA faster, with advantages over conventional mRNA production, including: 1) the elimination of plasmid DNA as a starting material; 2) the prevention or reduction of double-stranded DNA (dsRNA) contamination; and 3) simplified mRNA production workflows.

Learn more about the Linea DNA and Linea IVT platforms: LineaRx, an Applied DNA Sciences company

On May 13, 2024 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that its first patient with liver cancer metastases has been treated in a feasibility and safety study of Alpha DaRT at the McGill University Health Center in Montreal, Canada (Press release, Alpha Tau Medical, MAY 13, 2024, View Source [SID1234643130]).

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The trial seeks to recruit up to 10 patients who are eligible for a two-staged hepatectomy to resect liver metastases of colorectal cancer. Specifically, in the first stage, as many metastatic tumors as possible will be surgically removed in a non-curative intervention, while Alpha DaRT sources will be inserted into a separate tumor in the second liver lobe, and in the second stage, after allowing for the resected liver to regenerate naturally, the portion of the liver with the Alpha DaRT sources will be surgically removed.

The study primarily aims to examine the feasibility of delivering Alpha DaRT sources into the liver metastases, as well as the safety of utilizing the Alpha DaRT sources in the liver by assessing the frequency and severity of related adverse events. The study also aims to examine Alpha DaRT’s efficacy in terms of radiological response, assessed after insertion of the Alpha DaRT sources, and via pathological response, assessed after the second stage of surgery. Additional information about the trial can be found at View Source

Alpha Tau CEO Uzi Sofer commented, "The start of this trial marks a big milestone towards addressing the urgent need for new therapeutic options in treating patients with liver metastases. This trial is part of our overall strategy to showcase the broad use and potential of the Alpha DaRT in other hard-to-treat indications such as cancers of the brain, lung, vulva and pancreas. We would like to thank Dr. Peter Metrakos and his team at the McGill University Health Center for enrolling and treating the first patient in this highly significant feasibility and safety trial."

Peter Metrakos, MD, CM, FACS, FRCSC, Professor of Surgery, Pathology and Anatomy and Cell Biology, Director of Hepato-Pancreato-Bilary Surgery and Senior Scientist, McGill University Health Centre -Research Institute, Cancer Research Program, Department of Surgery at McGill University, and the principal investigator of the trial, commented "Liver Metastases associated with colorectal cancer is of major concern and a leading cause of patient mortality with limited effective treatment options. We are encouraged by the early results of Alpha DaRT treatment in other tumor types and are hopeful that the Alpha DaRT treatment will offer better outcomes to these patients with such a challenging disease."

Robert Den MD, Alpha Tau CMO commented, "While we continue to accrue patients with cutaneous recurrent SCC to the ongoing pivotal ReSTART trial, we also look to expand the use of the Alpha DaRT technology to high unmet medical need indications in internal organs such as liver metastases. This trial is particularly exciting for us in light of previous preclinical work that has demonstrated the ability of Alpha DaRT to generate an observed systemic immune response when used to treat a colorectal tumor model, and we hope to better understand the effect of Alpha DaRT on liver metastases and immune cell populations in human patients. We look forward to the preliminary results of this trial, which we hope will further our goal of advancing the use of Alpha DaRT across a range of indications and helping patients worldwide."

This clinical study is the next phase of a multi-year research collaboration program between the McGill University Research Center and the Alpha Tau Medical research team. This collaboration started with translation experiments using orthotopic animal models that mimic human liver colorectal metastatic disease, showing a reduction in tumor growth rate when using Alpha DaRT compared to control and changes in the hepatic immune microenvironment.

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

On May 13, 2024 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported the pricing of an underwritten offering of 37,931,035 shares of its common stock at a price of $2.90 per share (Press release, Allogene, MAY 13, 2024, View Source [SID1234643129]). The gross proceeds from this offering are expected to be approximately $110 million, before deducting the underwriting discount and commissions and estimated offering expenses payable by Allogene.

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The offering is anchored by mutual funds and large institutional investors and includes leading healthcare specialists as well as certain members of the Allogene Board of Directors and Executive Management Team. The offering is expected to close on or about May 16, 2024, subject to customary closing conditions.

Goldman Sachs & Co. LLC is acting as sole book-running manager for the offering.

The securities described above are being offered by Allogene pursuant to a shelf registration statement (including a prospectus) filed on March 14, 2024 with the Securities and Exchange Commission (SEC), which was declared effective on April 25, 2024. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website at View Source Copies of the final prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at [email protected].

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