On April 25, 2022 Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T-cell therapies to treat solid tumors, reported that Dr. Cheng Liu, President and CEO, to participate in person at the PEGS Boston Conference and Expo at Hynes Convention Center on May 2-6, 2022 (Press release, Eureka Therapeutics, APR 25, 2022, View Source [SID1234612926]).

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!

Dr. Liu will be participating in two engagements. He will be hosting a roundtable discussion on the challenges and opportunities of targeting intracellular antigens and presenting Eureka’s approach of using TCR-mimic antibodies to target intracellular antigens, both in the Oncology Stream – Antibodies for Cancer Therapy Track.

On April 25, 2022 Suzhou Porton Advanced Solutions Ltd. (‘Porton Advanced’) and Guizhou Sinorda Biomedicine Co. Ltd (‘Sinorda Biomedicine’) reported a long-term strategic partnership in cell and gene therapy R&D and platform development (Press release, Jiangsu Sinorda Biomedicine Co, APR 25, 2022, View Source [SID1234612925]).

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!

Porton Advanced offers an end-to-end gene and cell therapy CDMO service platform covering plasmids, cell therapy, gene therapy, oncolytic virus, mRNA therapy and Bacterial Therapy. With broad experience in domestic and international new drug filing, Sinorda Biomedicine focuses on the R&D of innovative drugs for digestive tract diseases, tumor immunotherapy and oncolytic virus therapy, and has several new drug projects in clinical stage. Its subsidiary, Jiangsu Tairui Sinorda Biomedicine Pharmaceutical Technology Co. Ltd., provides pre-clinical and clinical research services for tumor immune pharmacology and efficacy.

Under the agreement, Porton Advanced will provide services to accelerate the development, production and registration of breakthrough cell therapies currently being developed by Sinorda Biomedicine, including its T-cell immunotherapy product for colorectal cancer, SND002 (Sentinel lymph node T cell) and other pipelines. Porton Advanced will also work with Sinorda Biomedicine to support its cell and gene therapeutic R&D and production.

SND002 (SLN-T), the first collaborated project, has received approval for the initiation of Phase II clinical trials in Europe. Previously, the product was also designated as a ‘Breakthrough New Drug’ by the Chinese National Science and Technology Major Project. The launch of this critical first project allows the integration of resources and capabilities from both Porton Advanced and Sinorda and promises greater synergy to accelerate the clinical development and approval of Sinorda’s SLN-T program.

Dr. Yangzhou Wang, CEO of Porton Advanced, said, "Sinorda Biomedicine has a proven track record in drug development in China, US and Europe. The company possesses great expertise in immunology and oncolytic viruses, as well as cutting-edge immune functional assays, technologies, and capabilities. I am excited to see how our end-to-end cell and gene therapy CDMO platforms and quality systems can complement these capabilities and enhance Sinorda’s pipeline. Supporting Sinorda’s development, production and regulatory filing and accelerating its cell therapy drugs to market is a great cause and a great opportunity. We look forward to the opportunity to help Sinorda establish advanced therapies that benefit patients globally."

Dr. Pingsheng Hu, founder of Sinorda Biomedicine, said, "The entering of the strategic collaboration between Sinorda and Porton Advanced is a significant milestone to speed up the clinical development of our novel immunotherapies for solid tumors. Sinorda has long-term experience in clinical application of immunotherapy in solid tumors. In addition, Sinorda has rich resources in clinical research, in clinical bio-bank for real world data study with cutting edge technologies for evaluation of immunotherapy. Porton Advanced brings an integrated CDMO platform, innovative technologies and an international team, with experience from R&D stage to market approval and commercial production. Those capabilities from both sides will bring great opportunities in future development, that will contribute to value creation in the long term for both companies."

On April 25, 2022 Hologic, Inc. (Nasdaq: HOLX) reported that the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) has published an update which expands the utility of Breast Cancer Index (BCI) within its Clinical Practice Guideline: "Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer (Press release, Hologic, APR 25, 2022, View Source [SID1234612924])." Specifically, ASCO (Free ASCO Whitepaper) now recognizes BCI as the only genomic test to help guide extended endocrine therapy decisions in early-stage, HR+ breast cancer patients with node negative or node positive (one-three positive nodes) disease when treated with five years of primary endocrine therapy without evidence of recurrence. A special article highlighting the new ASCO (Free ASCO Whitepaper) guidelines was recently published in the Journal of Clinical Oncology on this subject.1

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!

"The clinical decision to either extend or end adjuvant endocrine therapy after five years is a challenging decision for healthcare providers and their patients. I am pleased to see updated guidelines from ASCO (Free ASCO Whitepaper) affirming the use of a data-driven biomarker like Breast Cancer Index to predict likelihood of benefit from extended endocrine therapy, helping to better inform decision-making processes around treatment plans," said Mark Pegram, MD, Chief Medical Consultant for Breast Oncology at Biotheranostics, a subsidiary of Hologic. "There is an extensive body of clinical evidence consistently proving the utility of BCI, and its addition to major oncology clinical guidelines like those from ASCO (Free ASCO Whitepaper) further underscores the test’s potential in clinical decision-making regarding extended adjuvant endocrine therapy."

BCI is a proprietary molecular gene expression-based test that is uniquely positioned to provide information to help physicians individualize treatment plans beyond five years. It is also the only test to be recognized by other major clinical practice guidelines for prediction of which early-stage, HR+ breast cancer patients are likely to benefit from extended endocrine therapy.2 Extended endocrine therapy has been demonstrated to help reduce the risk of recurrence in some women with early-stage, HR+ breast cancer. However, for breast cancer patients on extended endocrine therapy, the potential side effects and toxicities of treatment often have significant negative effects on health and quality of life, such as osteoporosis, bone fractures and joint pain.3-6 As a result, it’s important to know if a patient is unlikely to benefit from extended endocrine therapy to help reduce these challenging side effects and health consequences.

"We are pleased to see that ASCO (Free ASCO Whitepaper) updated its clinical practice guidelines to include BCI as the only genomic test to predict the value of extended endocrine therapy, reaffirming other guidelines within clinical oncology," said Kevin Thornal, Hologic’s president, Diagnostic Solutions Division. "We look forward to continuing to improve women’s health by giving healthcare providers the information they need to make the best treatment decisions for their patients."

According to the ASCO (Free ASCO Whitepaper) Guideline Update, the purpose was to "update recommendations on appropriate use of breast cancer biomarker assay results to guide adjuvant endocrine and chemotherapy decisions in early-stage breast cancer.1" An updated literature search identified 24 randomized clinical trials and prospective-retrospective studies published from January 2016 to October 2021, which were evaluated by an Expert Panel to develop evidence-based recommendations.

About Breast Cancer Index
Breast Cancer Index is a molecular, gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early-stage, HR+ breast cancer. This breakthrough test helps oncologists and patients navigate the difficult trade-offs between taking steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to unnecessary treatment. Breast Cancer Index has guideline designation from the American Joint Committee on Cancer for cancer staging based on molecular profile. ASCO (Free ASCO Whitepaper), the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), the European Group on Tumor Markers (EGTM) and St. Gallen acknowledge Breast Cancer Index as a biomarker to inform the chemotherapy decision; and ASCO (Free ASCO Whitepaper) and EGTM acknowledge BCI as a biomarker to inform the extended endocrine treatment decision. It is the only validated, commercially available test that predicts benefit from extended endocrine therapy. Breast Cancer Index is intended for routine clinical use, and treatment decisions based on results are the responsibility of the physician. It is a laboratory developed test (LDT) performed in a single CLIA-certified and CAP-accredited diagnostic laboratory and is not required to be cleared or approved by the US Food and Drug administration. For more information, visit www.breastcancerindex.com.

On April 25, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with solid and hematological cancers and other serious diseases, reported the results of a new study demonstrating the potential impact of access to omidubicel on health disparities in allogeneic hematopoietic stem cell transplant in a poster presentation at the 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings (TCT), being held in Salt Lake City, UT, April 23-26, 2022 (Press release, Gamida Cell, APR 25, 2022, View Source [SID1234612923]).

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!

The study, titled "Projected Impact of Omidubicel on Racial and Ethnic Disparities in Allogeneic Hematopoietic Cell Transplant Access and Outcomes for Patients with Hematologic Malignancies in the US," leveraged a decision-tree model to project allo-HCT access and clinical outcomes in a hypothetical population of 10,000 allo-HCT–eligible patients in the U.S. with hematologic malignancies without an available match-related donor. The study concluded that broad use of omidubicel will extend access for allo-HCT-eligible patients, decrease time to transplant and improve clinical outcomes, notably among racial and ethnic groups with worse status quo outcomes. Projected increases in one-year overall survival ranged (with 20% omidubicel use among allo-HCT–eligible patients) from 2.5% for whites patients to 6.3% for Black patients. The study also concluded that higher levels of modeled omidubicel uptake were associated with greater improvements in clinical outcomes and greater reductions in racial disparities.

Previous studies indicate that non-white patients have a lower likelihood of finding an appropriate match in the U.S. public donor registries, with Black patients have a 16-20% chance of finding an appropriate match. Given that an allogeneic stem cell transplant is intended as a curative option, if patients cannot find an appropriate match they will not have access to allogeneic stem cell transplant, a potentially curative treatment. The Phase 3 study of omidubicel demonstrated the ability of the therapy to be used as a donor source for racially and ethnically diverse patients with 40% of patients enrolled in the study being non-white.

"Today, minority groups comprise only about 30% of all allogeneic hematopoietic stem cell transplant transplants, indicating that lack of access to a matched donor is a significant barrier to treatment in the current landscape," said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell. "This study is encouraging in that it projects that broad access to omidubicel has the potential to open up allo-HSCT as an effective treatment for more patients and address the barriers that have contributed to this alarming health disparity. These data are particularly encouraging as we continue to advance our rolling BLA submission to the FDA and move closer to bringing the therapy to more patients in need."

Gamida Cell initiated a rolling Biologics License Application (BLA) submission for omidubicel in the first quarter of 2022 and is on-track to complete submission of all modules of the BLA in the second quarter of 2022.

In addition to this poster, two oral presentations and four additional poster presentations on omidubicel and a poster presentation on GDA-201, the company’s leading NK cell therapy program, will be shared during the conference. All poster presentations will be publicly available at www.ASTCT.org. Details below:

Title (Oral Presentation): Hematopoietic Stem Cell Transplantation (HSCT) with Omidubicel is Associated with Enhanced Circulatory Plasmacytoid Dendritic Cells (pDC), NK Cells and CD4+ T Cells with Lower Rates of Severe Infections Compared to Standard Umbilical Cord Blood Transplantation (Part of Best Abstract Award Session)
Presenting Author: Paul Szabolcs, M.D., Division of Blood and Marrow Transplantation and Cellular Therapy, UPMC Children’s Hospital of Pittsburgh, Pittsburg, PA
Session Title: Tandem Meetings Best Abstracts Session in the Scientific Track
Session Date / Time: Monday, April 25, 2022, 6:00 PM – 6:15 PM MT, SPCC, Ballroom D
Title (Oral Presentation): Allogeneic HSCT with Omidubicel demonstrates sustained clinical improvement versus standard myeloablative UCBT: Final results of a Phase III randomized multicenter study
Presenting Author: Mitchell Horwitz, M.D., Professor of Medicine, Duke Cancer Institute
Session Title: Oral Abstract – Session L – Consider the Source: Stem Cell Grafts and Donors
Session Date / Time: Tuesday, April 26, 2022, 3:15 PM – 3:30 PM MT
Title: (Poster): Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) With Omidubicel: Long-Term Follow-Up From A Single Center (ASH Encore)
Lead Author: Chenyu Lin, M.D., Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University Medical Center, Durham, NC
Title (Poster): Total Costs of Care and Complication Rates Among Patients with Hematologic Malignancies Who Receive Allogeneic Hematopoietic Cell Transplants in the US
Lead Author: Richard Maziarz, M.D., Professor of Medicine, Medical Director Adult Blood and Marrow Stem Cell Transplant Program, Oregon Health and Science University, Portland, OR
Title (Poster): Hospitalization and Healthcare Resource Use of Omidubicel Vs Umbilical Cord Blood (UCB) for Hematological Malignancies in a Global Randomized Phase III Clinical Trial Setting
Lead Author: Navneet Majhail, M.D., Taussig Cancer Institute, Department of Hematology and Oncology, Cleveland Clinic, Cleveland, OH
Title (Poster): HRQOL following transplantation with omidubicel versus UCB in patients with hematologic malignancies: Results from a Phase III randomized , multicenter study
Lead Author: Mitchell Horwitz, M.D., Professor of Medicine, Duke Cancer Institute
Title (Poster): Transcriptional and Metabolic Profiling of Nicotinamide-Enhanced Natural Killer (NAM-NK) Cells (GDA-201)
Lead Author: Dima Yackoubov, Scientist, Gamida Cell
About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell transplant for patients with hematologic malignancies (blood cancers), for which it has been granted Breakthrough Status and orphan drug designation by the FDA. Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). For more information on clinical trials of omidubicel, please visit the Gamida Cell website.

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About NAM Technology

Our NAM-enabling technology is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we are able to enhance, expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. This allows us to administer a therapeutic dose of cells that may help cancer patients live longer better lives.

On April 25, 2022 Turnstone Biologics Corp., a clinical-stage biotechnology company developing next-generation tumor-infiltrating lymphocyte ("TIL") therapy and viral immunotherapy designed to treat and cure solid tumors, reported a research collaboration with the University of Montreal Hospital Research Centre [Centre de recherche du Centre hospitalier de l’Université de Montréal, ("CRCHUM")], to drive advancements in TIL therapy using tumor-reactive T-cells (Press release, Turnstone Biologics, APR 25, 2022, View Source [SID1234612922]). The goal of the collaboration is to identify genome alterations and tumor-specific antigens from different tumor types and to further streamline the process for identification, direct selection and expansion of Turnstone’s tumor-reactive TILs, with the potential to expand this work into future clinical trials at CRCHUM.

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!

Dr. Simon Turcotte, associate professor of surgery at the Université de Montréal and lead of CRCHUM’s adoptive T-cell cancer immunotherapy program, has agreed to spearhead the collaboration research efforts and plans to provide key access to tumor and blood derivatives essential to conduct this research. Dr. Turcotte completed his medical and surgical training at the Université de Montréal, his post-doctoral research training on TIL immunotherapy at the National Cancer Institute, Bethesda, MD, in the laboratory of Dr. Steven A. Rosenberg, and a hepatobiliary and pancreatic surgical oncology fellowship at the Memorial Sloan Kettering Cancer Center in New York, NY.

"Considering all the different types of T-cell-based immunotherapies being studied to treat advanced solid cancers, TILs have shown the best potential for efficacy to date. This collaboration between CRCHUM and Turnstone Biologics, the first of its kind in Canada, engages us on the exciting path of developing next-generation TILs aimed at better recognizing cancer cells," said Dr. Turcotte. "By bringing together CRCHUM’s unique capabilities with Turnstone’s technology platform, and by applying our own complementary cell therapy research efforts, we see significant potential to improve treatment outcomes for cancer patients."

"Our TIL platform has transformative potential across a wide range of solid tumors," said Stewart Abbot, Ph.D., Chief Scientific Officer, Turnstone. "Establishing this collaboration with Dr. Turcotte and CRCHUM is a tremendous opportunity to advance our vision to unlock the full potential of TILs. We continue to seek innovative technologies and the field’s best minds in support of our development programs. We believe Dr. Turcotte’s extensive expertise and our combined scientific team will allow us to accelerate the development of our tumor-reactive selected TIL product candidates and lead to more effective medicines."