On September 11, 2024 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that it will highlight new data from across its approved and investigational cancer therapies during the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress being held in Barcelona, Spain on 13-17 September (Press release, Astellas, SEP 11, 2024, View Source [SID1234646508]). Eight abstracts across a broad range of cancer types will be presented, reinforcing Astellas’ commitment to making a meaningful difference to people living with advanced and hard-to-treat cancers. Six abstracts include data spanning prostate, urothelial, gastric and gastroesophageal junction (GEJ), and pancreatic cancers. Two abstracts feature Phase 1 data presented for the first time from immuno-oncology and targeted protein degradation assets.

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Tadaaki Taniguchi, MD, PhD, Chief Medical Officer, Astellas:
"The data presented at ESMO (Free ESMO Whitepaper) are an exciting demonstration of the strength of our portfolio and the transformative potential of our pipeline to help deliver outcomes that matter for patients. Astellas has made a long-term commitment to helping people living with hard-to-treat cancers by both investing in next-generation modalities like targeted protein degradation and immuno-oncology, and by maximizing the number of patients that could benefit from our approved medicines."

Highlights at the ESMO (Free ESMO Whitepaper) Congress 2024 include:

Data from the Phase 3 EV-302 study, evaluating Nectin-4 expression and response to first-line treatment of enfortumab vedotin in combination with pembrolizumab in previously untreated locally advanced or metastatic urothelial cancer (la/mUC). These results support the combination as a first-line advancement across la/mUC patient subgroups, regardless of Nectin-4 expression.
Five-year follow-up data from the Phase 1/2b EV-103 DE/A study, analyzing durable responses and meaningful survival to enfortumab vedotin in combination with pembrolizumab in patients with first-line cis-ineligible la/mUC. These results further support the broad suitability, regardless of cis-eligibility, and long-term benefits of this regimen in la/mUC.
Final pooled overall survival data from the Phase 3 SPOTLIGHT and GLOW trials, evaluating zolbetuximab plus chemotherapy as a first-line treatment in patients with HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma whose tumors are Claudin 18.2-positive.
Updates involving a Phase 2 trial in progress assessing zolbetuximab in combination with gemcitabine and nab-paclitaxel (GN) versus GN monotherapy as first-line treatment of Claudin 18.2-positive metastatic pancreatic cancer.
Phase 3 EMBARK post-hoc analyses, evaluating enzalutamide in combination with leuprolide and as monotherapy versus leuprolide alone in patients with high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer. These results support the benefits of enzalutamide both in combination with leuprolide and as monotherapy in patients aged <70 and ≥70 years.
Clinical data from lead pipeline assets: Phase 1 data from ASP3082, the first protein degrader targeting KRAS G12D mutant to enter clinical trials, in patients with advanced pancreatic, colorectal, and non-small cell lung cancer; and preclinical, translational/early clinical data from ASP1570, a novel DGKζ inhibitor, in patients with advanced solid tumors. The results support continued study of these investigational therapies for the treatment of various cancer types.

Astellas Presentations at 2024 ESMO (Free ESMO Whitepaper) Congress

Enfortumab vedotin

Presentation title

Speaker

Presentation details

EV-302: Exploratory Analysis of Nectin-4 Expression and Response to 1L Enfortumab Vedotin (EV) + Pembrolizumab (P) in Previously Untreated Locally Advanced or

Metastatic Urothelial Cancer (la/mUC)

T. Powles

Type: Mini Oral Session
Abstract Number: 1966MO
Date: September 15

Study EV-103 Dose Escalation/Cohort A (DE/A): 5y Follow-Up Of First-Line (1L)

Enfortumab Vedotin (EV) + Pembrolizumab (P) in Cisplatin (cis)-Ineligible Locally

Advanced Or Metastatic Urothelial Carcinoma (la/mUC)

J. Rosenberg

Type: Poster
Abstract Number: 1968P
Date: September 15

Epidemiology and treatment patterns of patients with locally advanced or metastatic

urothelial cancer in France: a non-interventional database study

F. Joly

Type: Poster
Abstract Number: 2001P
Date: September 15

Zolbetuximab

Presentation title

Speaker

Presentation details

First-line (1L) zolbetuximab + chemotherapy in patients (pts) with claudin 18.2 (CLDN18.2) +, HER2–, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma: A pooled final analysis of SPOTLIGHT + GLOW

Y-K Kang

Type: Poster
Abstract Number: 1438P
Date: September 16

Zolbetuximab With Gemcitabine + Nab-Paclitaxel (GN) in First-Line Treatment of Claudin 18.2–Positive Metastatic Pancreatic Cancer (mPC): Phase 2, Open-Label, Randomized Study

W. Park

Type: Poster
Abstract Number: 1532TiP
Date: September 16

Enzalutamide

Presentation title

Speaker

Presentation details

Enzalutamide (enza) with or without leuprolide in patients (pts) with high-risk biochemically recurrent (hrBCR) prostate cancer (PC): EMBARK post-hoc analysis by age

N. D. Shore

Type: Poster
Abstract Number: 1638P
Date: September 15

Pipeline

Presentation title

Speaker

Presentation details

Phase 1/2 Trial of ASP1570, a Novel Diacylglycerol Kinase ζ Inhibitor, in Patients With Advanced Solid Tumors

D. Olsen

Type: Poster
Abstract Number: 1004P
Date: September 14

Preliminary safety and clinical activity of ASP3082, a first-in-class, KRAS G12D selective protein degrader in adults with advanced pancreatic (PC), colorectal (CRC), and non-small cell lung cancer (NSCLC)

W. Park

Type: Proffered Paper Session
Abstract Number: 608O
Date: September 15

On September 11, 2024 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company’s novel pyruvate kinase (PK) activator tebapivat (AG-946) for the treatment of myelodysplastic syndromes (MDS) (Press release, Agios Pharmaceuticals, SEP 11, 2024, View Source [SID1234646507]).

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"Receiving orphan drug designation for tebapivat in MDS underscores the importance of bringing new oral treatment options to patients suffering from this rare disease," said Sarah Gheuens, M.D., Ph.D., chief medical officer and head R&D at Agios. "We aim to deliver the first oral therapy that addresses anemia due to ineffective erythropoiesis in lower-risk MDS, which affects approximately 75,000-80,000 patients in the U.S. and EU5 and accounts for approximately 70% of MDS cases."

Agios completed a Phase 2a study of tebapivat in lower-risk MDS late last year and is currently initiating a Phase 2b study of tebapivat in lower-risk MDS.

The FDA’s Office of Orphan Drug Products grants orphan drug designation to support the development of medicines for rare disorders that affect fewer than 200,000 people in the U.S. Under the Orphan Drug Act, orphan drug designation qualifies a company for incentives, including tax credits, exemptions from certain FDA fees for clinical trials, and the potential for seven years of market exclusivity following drug approval.

Mitapivat, the company’s lead PK activator, was previously granted FDA orphan drug designation for the treatment of PK deficiency, thalassemia, and sickle cell disease.

Tebapivat is not approved for use by any regulatory authority.

On September 10, 2024 ICE Bioscience and NanoTemper Technologies reported an exciting new partnership to establish a Biophysical Joint Innovation Platform (Press release, ICE Bioscience, SEP 10, 2024, View Source;catname=icenews [SID1234647432]). The signing and unveiling ceremony took place at ICE Bioscience’s headquarters in Beijing, with senior leadership from both companies in attendance, including Dr. TJ Bing, Senior Vice President of ICE Bioscience, Dr. Qiang Xia, Vice President of ICE Bioscience, and Barrett Lee, NanoTemper’s Head of APAC Commercial.

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Dr. Bing and Mr. Lee officially signed the cooperation agreement and jointly unveiled the new platform, marking the beginning of an innovative collaboration aimed at advancing biophysics research and applications in drug discovery.

During the event, Dr. Bing welcomed the NanoTemper team and emphasized ICE Bioscience’s commitment to innovation and technology in drug discovery. He highlighted the company’s significant investment in R&D and the strategic alignment of NanoTemper’s Spectral Shift technology with ICE’s goals of exploring new targets, new technologies, and new assays.

Barrett Lee expressed NanoTemper’s appreciation for ICE Bioscience’s trust and enthusiasm for bringing cutting-edge technologies to global researchers. He shared his confidence that this partnership would support ICE Bioscience in becoming a leader in binding affinities and protein stability services, providing essential tools for high-throughput screening.

Following the unveiling, ICE Vice President Xia Qiang led the NanoTemper representatives on a tour of the newly established innovation platform, showcasing the company’s advancements in biophysical assays and outlining future objectives for the platform.

On September 10, 2024 PDX Pharma reported that it has successfully met all the milestones of our Phase I SBIR and has received approval from the National Cancer Institute (NCI) to advance to the Phase II project, valued at $2 million (Press release, PDX Pharmaceuticals, SEP 10, 2024, View Source [SID1234646513]). This project (R44CA285233) focuses on the development of our nanotherapeutic, PETTRA (PLK1 and EGFR Targeted Therapy and Radiation Sensitizer). PETTRA is built upon our patented nanoparticle delivery platform, Pdx-NP, which enables the co-delivery of an anti-EGFR antibody (serving as both a cancer-homing agent and an EGFR inhibitor) and PLK1 siRNA (killing cancer cells and sensitizing them to radiation). We have overcome the limitations of traditional nanoparticle delivery systems, achieving a long circulation half-life (e.g., 25 hours in monkeys), a tenfold increase in siRNA accumulation in tumors, and specific delivery to target cells (by 5 to 8-fold over normal cells). Additionally, we have demonstrated excellent PLK1 gene knockdown (e.g., 84%) and significant tumor inhibition (e.g., 91%) in mouse models. We would like to extend our gratitude to the NCI for their continued support and congratulate our team on this achievement!

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On September 10, 2024 Xcell Biosciences Inc. (Xcellbio), an instrumentation company focused on cell and gene therapy applications, reported it has advanced its collaboration with Labcorp with the installation of a new AVATAR Foundry system at the healthcare company’s Ann Arbor, Michigan site (Press release, Xcell Biosciences, SEP 10, 2024, View Source [SID1234646497]). This installation, part of the beta access program for Xcellbio’s latest instrument, allows scientists at Labcorp to extend the potency benefits observed in small-scale workflows on the previously installed AVATAR Odyssey platform up to large-scale automated cell therapy manufacturing workflows.

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Xcellbio has developed the AVATAR incubator system for cell and gene therapy research and development with the AVATAR Odyssey system designed for small-scale research and process development needs. Its latest platform, the AVATAR Foundry system, is a current good manufacturing platform (cGMP) that delivers novel capabilities for improving the potency of cell and gene therapies. These capabilities are especially important for cell therapies targeting solid tumors, which often face overwhelming challenges in the hostile tumor microenvironment (TME).

"After using the AVATAR Odyssey system for more than two years, we have seen results demonstrating benefits for both cell therapy expansion rates and anti-tumor potency. We are eager to scale our workflows with the new AVATAR Foundry instrument, which could allow us to support customers early in their development of novel manufacturing techniques for cell and gene therapies," said Maryland Franklin, Ph.D., vice president and enterprise head of cell and gene therapy at Labcorp. "This technology complements our strong capabilities in analytical testing and our commitment to using potency assays and downstream analytics for monitoring and release of candidate therapies to provide delivery of only the most effective and reliable products."

Labcorp scientists have used AVATAR incubation technology to study the effectiveness and performance of cell therapy candidates grown in standard culture conditions versus those grown in customized levels of oxygen and pressure. The use of these custom conditions during cell expansion metabolically rewires therapeutic cells to improve their survival and persistent tumor killing activity in the harsh TME. Labcorp scientists have been going beyond in vitro studies with ongoing in vivo experiments to further evaluate this approach.

"Labcorp has long been one of Xcellbio’s closest collaborators, and we are pleased to include them as early members of our beta access program for the AVATAR Foundry," said Brian Feth, co-founder and CEO at Xcellbio. "We look forward to seeing the innovative ways they will use this platform to enhance their already impressive cell and gene therapy work."