On April 25, 2022 Quantum Leap Healthcare Collaborative (Quantum Leap) and Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, reported the selection of Ambrx’s antibody drug conjugate (ADC) ARX788 for a new investigational treatment arm in the I-SPY 2.2 TRIAL for the treatment of HER2-positive breast cancer in the neoadjuvant setting (Press release, Ambrx, APR 25, 2022, View Source [SID1234612928]). Sponsored by Quantum Leap, the I-SPY 2.2 TRIAL is a continuation of the I-SPY 2 TRIAL that seeks to create personalized treatments by adapting therapies for each patient to optimize the clinical outcome.

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"We are particularly excited about this collaboration," stated Dr. Laura J. Esserman, MD, MBA, Director of the Breast Care Center at the UCSF Helen Diller Family Comprehensive Cancer Center, and Principal Investigator of I-SPY Family of Trials. "We hope this will usher in an era of more targeted, effective and less toxic therapies for people with HER2-positive breast cancers, leveraging decades of investment in science and drug development, and delivering better treatment to patients when they need it most. This is the right drug, for the right patient at the right time."

I-SPY 2.2 is an adaptive Phase 2 clinical trial that evaluates emerging targeted agents, allowing those agents to either be combined with less toxic chemotherapeutic regimens or to replace cytotoxic chemotherapy entirely. ARX788 will be evaluated as a monotherapy, and in combination with the PD-1 targeting checkpoint inhibitor cemiplimab, in HER2-positive early-stage breast cancer in the neoadjuvant setting. Ambrx anticipates the ARX788 arms to begin enrolling patients in May 2022.

Quantum Leap, sponsor of the I-SPY 2.2 TRIAL, leads a pre-competitive consortium that includes the U.S. Food & Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from more than 16 major U.S. cancer research centers.

"I am thrilled that Quantum Leap has selected Ambrx’s antibody drug conjugate, ARX788, to be evaluated in the I-SPY 2.2 TRIAL," said Feng Tian, Ph.D., Chairman of the Board, President, and CEO of Ambrx. "We are encouraged by the favorable anti-tumor activity and safety profile of ARX788 for the treatment of early-stage breast cancer. It may provide a less toxic treatment option for patients through the precision conjugation of cytotoxic payloads targeting HER2 receptors. I look forward to collaborating with Quantum Leap and exploring the potential of our antibody drug conjugate in enabling effective chemo-free therapeutic treatments to patients."

ARX788 is an anti-HER2 antibody drug conjugate (ADC) that is being studied broadly in breast cancer, gastric/GEJ cancer and other solid tumors. ARX788 is a homogeneous and highly stable ADC that maximizes potential anti-tumor activity by optimizing the number and position of its payloads and the chemical bonds that conjugate the payloads to the antibody. The United States Food and Drug Administration (FDA) has granted ARX788 the Fast Track Designation for the treatment of HER2-positive metastatic breast cancer.

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 that updated infection data on omidubicel in comparison to umbilical cord blood transplantation (UCB), was shared in an oral 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 [SID1234612927]).

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The presentation, which received a TCT Best Abstract Award, titled "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," was presented by Paul Szabolcs, M.D., Division of Blood and Marrow Transplantation and Cellular Therapy, UPMC Children’s Hospital of Pittsburgh, Pittsburg, PA. The data from a sub-study of the Phase 3 randomized trial of omidubicel showed early and enhanced recovery of variety of immune cells, including circulatory dendritic cell subtypes, NK cells and CD4+ T cells within the first 28 days and sustained B-cell recovery from Day 28 onwards, and such immune recovery was associated with lower rates of severe infection. The data from an additional analyses of CD4+ subsets, T-cell receptor repertoire diversity and recent thymic emigrants support the long-term durability and functionality of the omidubicel graft.

"These data provide mechanistic support for the reduced infection rates seen with omidubicel-treated patients in the Phase 3 study, and clear demonstration of the benefits of omidubicel over standard cord blood transplantation, which can be associated with immune and hematopoietic recovery challenges that are devastating to patients," said Ronit Simantov, M.D., Chief Medical Officer of Gamida Cell. "As we advance omidubicel through the FDA review process, these data demonstrate that the therapy has the potential to change the outlook for patients suffering from blood cancer, who all too often struggle with post-transplant recovery complications."

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 total, Gamida Cell is presenting two oral and six poster presentations at TCT 2022. All poster presentations are publicly available at www.ASTCT.org.

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 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]).

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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]).

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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

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"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.