On December 9, 2021 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, reported enrollment of the first patient in its open-label phase 1 trial of IMU-935, a highly potent and selective inverse agonist of the transcription factor RORγt, in metastatic castration-resistant prostate cancer (mCRPC) (Press release, Immunic, DEC 9, 2021, View Source [SID1234596713]).

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The trial’s Principal Investigator is Johann Sebastian de Bono, M.D., Ph.D., Regius Professor of Cancer Research and Professor in Experimental Cancer Medicine, The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, London. The trial has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA), the Research Ethics Committee (REC) and the Health Research Authority (HRA) in the United Kingdom.

"After receiving available established treatments, many of which are being given soon after diagnosis, few effective treatments remain for men suffering from mCRPC with this disease being invariably fatal. There is therefore an urgent need to find alternative therapeutic options," stated Professor de Bono. "Preclinical data indicate that IMU-935 may suppress the expression of the mutated AR-V7 receptor, which is a hallmark and progression driver of CRPC. In addition, by repressing pro-tumorigenic Th17 cells and IL-17 cytokines, IMU-935 may further impact tumor growth. I look forward to exploring the anticancer activity of this agent against mCRPC."

"As one of world’s leading experts on the subject of castration-resistant prostate cancer, Professor de Bono’s expertise and deep understanding of the unique mechanism of action of IMU-935 provides important corroboration of this key pipeline program within the scientific and clinical communities," noted Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "Based on the compelling preclinical data highlighting the therapeutic potential of IMU-935 to affect mCRPC, which is the second leading cause of cancer-related death among men, we recognize the potential importance of this program. We are pleased to have enrolled the first patient on plan and look forward to continuing to progress the trial."

The phase 1 trial is structured in two portions: a dose-escalation part and an optional expansion part. A total of between 18 and 24 patients are planned to be enrolled in the dose-escalation part at three dose levels of IMU-935 to be given for three cycles of 28 days each. At each of the three dose levels, a safety analysis after 28 days and an interim analysis after three months of treatment will be performed. The main analysis for this trial is planned after the last patient has received six months of study treatment. The primary objective is to evaluate the safety and tolerability of increasing doses of IMU-935 to establish the maximum tolerated dose and the recommended phase 2 dose. The trial will also evaluate the anti-tumor activity of IMU-935 by means of prostate-specific antigen (PSA) levels, circulating tumor cell (CTC) numbers, and radiographic response assessments of tumor progression. Patients who receive a benefit from IMU-935 will have the option to continue treatment until progression. Following completion of all dose-escalation cohorts, an expansion cohort at one or two therapeutically active dose levels with up to 18 additional patients may be performed to support selection of a recommended phase 2 dose. Initial clinical data is expected to be available in the third quarter of 2022.

The company also re-iterates its prior guidance that data from the multiple ascending dose part of the ongoing phase 1 trial of IMU-935 is expected in the fourth quarter of 2021, with initial clinical data in psoriasis expected in the second quarter of 2022, and that regarding vidofludimus calcium (IMU-838), phase 2 top-line data in ulcerative colitis is expected to be available in the second quarter of 2022.

For more information on the phase 1 clinical trial of IMU-935 in mCRPC, please visit: www.clinicaltrials.gov, NCT05124795.

About Castration-Resistant Prostate Cancer
Castration-resistant prostate cancer (CRPC) is a form of advanced prostate cancer. Approximately 200,000 new cases of prostate cancer are diagnosed each year in the United States, with roughly 40,000 cases progressing to CRPC. Because early stages of prostate cancer rely on testosterone to grow, approaches to lower testosterone can be employed therapeutically. With CRPC, the cancer no longer completely responds to treatments that lower testosterone, significantly limiting available treatment options in these patients. Common sites of metastasis are lymph nodes, bones, bladder, rectum, lung, or liver. Although metastatic CRPC may be asymptomatic, typical signs/symptoms include problems urinating, pain while passing urine or blood in the urine, tiredness, weakness, weight loss, shortness of breath, or bone pain. The main goal in treating metastatic CRPC is to control symptoms and slow progression.

About IMU-935
IMU-935 is a highly potent and selective inverse agonist of RORγt (retinoic acid receptor-related orphan nuclear receptor gamma truncated) with additional activity on DHODH (dihydroorotate dehydrogenase). The nuclear receptor RORγt is believed to be the main driver for the differentiation of Th17 cells and the expression of cytokines involved in various inflammatory and autoimmune diseases. This target is believed to be an attractive alternative to approved antibodies for targets such as IL-23, IL-17 receptor and IL-17, itself. IMU-935 shows strong cytokine inhibition targeting both Th17 and Th1 responses in preclinical testing, as well as indications of activity in animal models for psoriasis and inflammatory bowel disease. Preclinical experiments indicate that, while leading to a potent inhibition of Th17 differentiation and cytokine secretion, IMU-935 did not affect thymocyte maturation. IMU-935 is an investigational drug product that has not been approved in any jurisdiction.

On December 9, 2021 Exai Bio, a next-generation liquid biopsy company, reported it has raised a $67.5 million Series A financing to accelerate development of its non-invasive, RNA-based liquid biopsy platform for early cancer detection (Press release, Exai Bio, DEC 9, 2021, View Source [SID1234596709]). The financing was led by leading life sciences and tech investors Section 32 and Casdin Capital, with participation from Two Sigma Ventures, who have been integral to advancing cancer diagnostics and artificial intelligence/machine learning technologies.

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Exai Bio’s platform delivers unprecedented clinical insight into cancer biology from non-invasive blood samples enabling early and accurate diagnosis of cancer to inform personalized care treatments. Unlike first generation liquid biopsy tests which measure circulating tumor DNA (ctDNA) mutations and/or epigenetic markers (such as ctDNA methylation or fragmentation patterns), Exai Bio’s proprietary platform measures cell-free RNA profiles, analyzing them using advanced artificial intelligence and machine learning algorithms. Specifically, Exai Bio is focused on orphan non-coding RNA (oncRNA), small RNA sequences not seen in normal tissue but abundant in tumors. In liquid biopsy samples, these tumor-specific oncRNAs translate to higher sensitivity and specificity, ultimately enabling a more accurate diagnosis as compared to ctDNA-based liquid biopsy tests. Exai Bio’s approach is applicable across multiple unmet needs in cancer.

"Exai Bio is the first company founded to explore the important role of oncRNA in early and more accurate cancer detection and its important impact on improved patient outcomes and health economics," said Patrick Arensdorf, chief executive officer, Exai Bio. "Combining oncRNA technology with cutting-edge machine learning and artificial intelligence to decipher tumor signals and understand the active biology of disease, Exai Bio’s next generation liquid biopsy platform provides actionable information to help inform accurate clinical decisions."

Exai Bio’s next generation liquid biopsy platform was developed based on groundbreaking research conducted by Hani Goodarzi, PhD, assistant professor of Biochemistry and Biophysics, a member of the Bakar Computational Health Sciences Institute and the Helen Diller Family Comprehensive Cancer Center at the University of California, San Francisco (UCSF), and co-founder and scientific advisor for Exai Bio. Dr. Goodarzi’s research, published in Nature, 2018, was the first to identify breast cancer-specific oncRNA and its role as a robust promoter of breast cancer metastasis. The paper also identified the opportunity to utilize oncRNA for early cancer detection via liquid biopsy.

Since 2018, Dr. Goodarzi’s research into oncRNA has continued, and today, Exai Bio’s liquid biopsy platform has been utilized in multiple studies, most notably including the I-SPY 2 study collaboration with UCSF. I-SPY 2 is a neoadjuvant, adaptive clinical trial designed to improve outcomes in individuals with high-risk breast cancer.

Dr. Goodarzi will present data from I-SPY 2 at the San Antonio Breast Cancer Symposium in San Antonio, Texas. The poster, "Tumor-released circulating orphan non-coding RNAs reflect treatment response and survival in breast cancer," demonstrates that the changes in tumor-released oncRNA content of the blood are a significant predictor of clinical outcomes. The study results show that oncRNA "fingerprints" are blood-accessible and enable building predictive models of tumor response. These data will be presented on Thursday, December 9th, 2021 at 7:00 AM Central Time.

Dr. Goodarzi commented, "It’s incredibly rewarding that our early research and the discovery of tumor specific-RNA can have such a meaningful impact on early cancer detection and therapy selection, and potentially improve health outcomes for so many people diagnosed with cancer. The data in the neoadjuvant breast cancer setting is significant, as early stage breast cancer has been a difficult target for ctDNA-based liquid biopsy approaches. I look forward to the continued development of our platform and its exploration in a broad range of cancers."

Exai Bio holds the exclusive license for the development and commercialization of its next generation liquid biopsy platform from the UCSF Innovation Ventures’ Office of Technology Management & Advancement, which leads licensing and business development efforts on behalf of the university.

Exai Bio is led by an experienced founding management team and advisors including:

Patrick Arensdorf, founder and chief executive officer, formerly Chan Zuckerberg Biohub, Bluestar Genomics, ImmuMetrix (acquired by CareDx), Intersect ENT (acquired by Medtronic)
Babak Alipanahi, PhD, founder and chief scientific officer, formerly Google Health, 23andMe, Deep Genomics
Nelson Lee, chief administrative officer, formerly Lawrence J. Ellison Institute for Transformative Medicine (USC), Evidation Health, Crescendo Bio (acquired by Myriad)
Kimberly Chau, vice president clinical operations, formerly CELLective Dx, Kyphon (acquired by Medtronic), Scios (acquired by Johnson & Johnson), Corgentech
Hani Goodarzi, PhD, founder and scientific advisor, UCSF, Rockefeller, Princeton, 2021 Vilcek Prize for Creative Promise in Biomedical Sciences
Robert Warren, MD, clinical advisor, UCSF Surgical Oncology Research Lab
Michael Pellini, MD, managing partner at Section 32, commented, "Exai Bio is delivering clinically meaningful advances in liquid biopsy approaches with the potential to significantly improve cancer care. The ability of Exai Bio’s platform to detect and utilize oncRNA as a cancer signal reveals important insights into cancer biology that can lead to earlier and more accurate cancer detection and diagnosis and better inform personalized treatment options."

On December 9, 2021 Seattle Cancer Care Alliance (SCCA), the only National Comprehensive Cancer Network (NCCN)-designated cancer center in Washington state, reported that more than 20 of the organization’s clinicians will showcase new research at the 63rd Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), taking place December 11-14, 2021, in Atlanta (Press release, Seattle Cancer Care Alliance, DEC 9, 2021, View Source [SID1234596708]).

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SCCA clinicians and researchers will unveil findings on areas of investigation into treatments for patients with various hematological malignancies, including lymphoma, leukemia and myeloma. Clinicians will discuss findings on CAR-T therapies targeting CD20 cells, multiple myeloma and chronic lymphocytic leukemia. Key research also includes findings on hematopoietic stem cell transplant (HCT) and outcomes and utilization for a range of treatments.

"Our team at Seattle Cancer Care Alliance is committed to understanding, developing and advancing cutting-edge cancer treatments," said Nancy Davidson, MD, president and executive director of SCCA. "Our researchers and clinicians are known leaders in the hematological clinical research space; we are proud of their work and continued contributions to this space. We look forward to energized discussion on the implications of the research presented and the role the research plays in contributing to expanded treatment options for patients."

For more information about SCCA physician-researchers presenting their pioneering research at the 63rd ASH (Free ASH Whitepaper) annual meeting, visit View Source

Below is a list of SCCA’s lead abstracts and presentations:

CAR-T Therapies:

Abstract: 3872 – Safety and Efficacy of Third Generation CD20 Targeted CAR-T (MB-106) for Treatment of Relapsed/Refractory B-NHL and CLL

SCCA Author: Mazyar Shadman, MD, MPH
Abstract: 2815 – Pharmacodynamic Analysis of CAR-T Cell Persistence in Patients with Hematologic Malignancies Treated with NKTR-255, an IL-15 Receptor Agonist That Enhances CD8+ T-Cells: Preliminary Results from a Phase 1 Study

SCCA Author: Alexandre V. Hirayama, MD
Abstract: 1749 – Long-Term Follow-up and Single-Cell Multiomics Characteristics of Infusion Products in Patients with Chronic Lymphocytic Leukemia Treated with CD19 CAR-T Cells

SCCA Author: Alexandre V. Hirayama, MD
Abstract: 551 – Safety and Efficacy of Fully Human BCMA CAR T Cells in Combination with a Gamma Secretase Inhibitor to Increase BCMA Surface Expression in Patients with Relapsed or Refractory Multiple Myeloma

SCCA Author: Andrew J. Cowan, MD
Abstract: 905 – Clinical Translation of SC-DARIC33: A Pharmacologically Controlled CD33-Targeted Anti-AML CAR T Cell Product Regulated By Low Nanomolar Concentrations of Rapamycin

SCCA Author: Jacob S. Appelbaum, MD, PhD
Abstract: 470 – SCRI-CAR19x22v2 T Cell Product Demonstrates Bispecific Activity in B-ALL

SCCA Author: Corinne Summers, MD
Hematopoietic Stem Cell Transplant (HCT):

Abstract: 645 – Donor Bone Marrow Derived Macrophage Engraftment into the Central Nervous System of Allogeneic Transplant Patients

SCCA Author: Keith R. Loeb, MD, PhD
Abstract: 646 – Non-Genetic Determinants of Clonotypic T Cell Expansion Following Allogeneic Stem Cell Transplant

SCCA Author: Albert C. Yeh, MD
Abstract: 2868 – COVID-19 in Pediatric Hematopoietic Cell Transplant Recipients: A CIBMTR Study

SCCA Author: Neel S. Bhatt, MBBS, MPH
Abstract: 648 – Early Cytomegalovirus Reactivation after Allogenic Bone Marrow Transplantation Is Associated with the Loss of Recipient-Derived Humoral Immunity and Is Reduced By IL-6 Inhibition

SCCA Author: Ping Zhang, MD
Treatments of Hematological Malignancies:

Abstract: 1208 – The Efficacy and Safety of Low-Dose Inotuzumab Ozogamicin in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia: Interim Results of a Phase 4 Study

SCCA Author: Ryan D. Cassaday, MD
Abstract: 34 – A Phase 1/2 Trial of Cladribine, High-Dose Cytarabine, G-CSF, and Dose-Escalated Mitoxantrone (CLAG-M) Plus Gemtuzumab Ozogamicin in Adults with Newly-Diagnosed Acute Myeloid Leukemia (AML) or Other High-Grade Myeloid Neoplasm

SCCA Author: Roland B. Walter, MD, PhD, MS
Abstract: 813 – Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Follicular Lymphoma: Primary Analysis from a Phase 2 Study (CITADEL-203)

SCCA Author: Ryan C. Lynch, MD
Abstract: 233 – Concurrent Pembrolizumab with AVD for Untreated Classical Hodgkin Lymphoma

SCCA Author: Ryan C. Lynch, MD
Abstract: 1410 – Phase 2 Study of Zanubrutinib in BTK Inhibitor-Intolerant Patients (Pts) with Relapsed/Refractory B-Cell Malignancies

SCCA Author: Mazyar Shadman, MD, MPH
Abstract: 1363 – Oral Ixazomib in Untreated Follicular Lymphoma Permits COVID-19 Vaccine Response and Its Efficacy Is Associated with Clinical Factors and Gene Expression Signatures

SCCA Author: Solomon A. Graf, MD
Abstract: 799 – Global Proteomic Profiling Identifies Novel Prognostic Factors in Undifferentiated Leukemia Blasts from Patients with NPM1 Mutations: A Previously Unreported Approach to Biomarker Discovery from the Fred Hutch and SWOG

SCCA Author: Derek L. Stirewalt, MD
Abstract: 403 – CD22 CAR Optimization for Improved in-Human Activity Following Inadequate CD22 CAR Activity in Phase 1 Clinical Trial PLAT-04

SCCA Author: Corinne Summers, MD
Abstract: 2339 – Infectious Complications after Intensive Chemotherapy with CLAG-M or ‘7+3’ for Adults with Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms

SCCA Author: Anna B. Halpern, MD
Abstract: 3341 – Development of Astatine-211 (211At)-Based Anti-CD123 Radioimmunotherapy for Acute Leukemias and Other CD123+ Hematologic Malignancies

SCCA Author: Johnnie J. Orozco, MD, PhD
Abstract: 2745 – TIG-007: Study of EOS884448/GSK4428859A Alone, and in Combination with Iberdomide with or without Dexamethasone, in Participants with Relapsed or Refractory Multiple Myeloma

SCCA Author: Leona Holmberg, MD, PhD
Abstract: 3909 – Patient-Reported Outcomes (PROs) Among Patients with Steroid-Refractory or -Dependent Chronic Graft-vs-Host Disease (cGVHD) Randomized to Ruxolitinib (RUX) vs Best Available Therapy (BAT)

SCCA Author: Stephanie J. Lee, MD, MPH
Abstract: 2094 – Absence of Hyperactivation of Fibrinolysis Explains the Lack of Hemostatic Efficacy of Prophylactic Tranexamic Acid (TXA) in Hypoproliferative Thrombocytopenia

SCCA Author: Terry B. Gernsheimer, MD
Abstract: 1609 – The IL-2/IL-15 Mimetic NL-201 Prevents Myeloma Relapse after ASCT By Expanding Highly Cytolytic T Cells in the Bone Marrow That Are Resistant to Exhaustion

SCCA Author: Simone A. Minnie, PhD
Abstract: 328 – The Combination of Anti-Tigit and Lenalidomide Promotes Synergistic Myeloma-Specific Immunity after ASCT

SCCA Author: Simone A. Minnie, PhD

On December 9, 2021 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported that a study demonstrating the ability of its CNSide assay to identify HER2 and other actionable tumor alterations in the cerebrospinal fluid of patients with breast cancer and leptomeningeal disease (LMD) (Press release, Biocept, DEC 9, 2021, View Source [SID1234596707]). The poster was chosen for a Spotlight Presentation at the San Antonio Breast Cancer Symposium on Dec. 8, 2021.

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LMD is a devastating complication in which cancer spreads to the membrane surrounding the brain and spinal cord. The current standard of care for diagnosing LMD is through clinical evaluation, imaging and cytology, which have limited sensitivity and are unable to identify important tumor biomarkers such as HER2. HER2-targeted treatment for patients with breast cancer and LMD may provide substantial survival advantages over the expected median survival of less than three months.

In this analysis, cerebrospinal fluid (CSF) of 63 patients with stage IV breast cancer and LMD was collected, and CSF tumor cells were captured and characterized using CNSide. HER2 amplification was detected in 56% of all patients. HER2 status differed between the primary tumor and LMD in 38% of cases, with more than 80% of those patients exhibiting a switch from a HER2-negative primary tumor to HER2-positive LMD.

"Knowing if a patient’s tumor is HER2 positive or negative, and especially whether HER2 status has changed from primary tumor to LMD, allows us to more precisely treat those patients and achieve a better response," said Amir Azadi, M.D., a neuro-oncologist at Banner MD Anderson, who participated in a key opinion leader webcast event earlier this year discussing the advantages of CNSide in detecting central nervous system metastases. "Patients with brain metastases and leptomeningeal disease have a very poor prognosis. CNSide provides new information to help guide treatment decisions that may extend life expectancy and improve quality of life for these patients."

"Our CNSide assay can be used both to confirm the presence of tumors and to identify important biomarkers in LMD such as HER2," said Michael Dugan, M.D., Chief Medical Officer and Medical Director of Biocept. "Finding HER2 amplification in breast cancer tumor cells in the CSF is critical because anti-HER2 targeted therapy provides one of the best options for physicians treating patients with breast cancer who have developed the life-threatening complications of LMD."

The CNSide CSF assay is designed to help physicians better detect and manage treatment of metastatic cancers involving the central nervous system. It provides a timely and accurate method to help diagnose these tumors, identify actionable biomarkers and assess response to therapy, with the goal of improving patient survival and quality of life. The assay is based on Biocept’s proprietary quantitative tumor cell capture and detection method, paired with assays to identify actionable molecular treatment targets. CNSide has the ability to answer key questions that may help inform treatment decisions: Is there involvement by tumor? Is there a target for treatment? Is there a trend with respect to treatment response?

The poster, titled, "Characterization of HER2 Amplification in the Cerebrospinal Fluid of Patients with Leptomeningeal Disease in Stage IV Patients with Breast Cancer," can be accessed here.

On December 9, 2021 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that its collaborator, BeiGene, Ltd., has dosed the first patient in South Korea in the HERIZON‑GEA‑01 trial (Press release, Zymeworks, DEC 9, 2021, View Source [SID1234596706]). As a result of this development milestone, Zymeworks will receive a US$8 million payment under its zanidatamab collaboration agreement with BeiGene.

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Zymeworks and BeiGene continue to work to expedite the opening of approximately 300 clinical trial sites across 38 countries in support of the global Phase 3 pivotal trial. With a 24-month projected enrollment period, this study may enable the submission of a supplemental Biologics License Application by Zymeworks in the United States as early as 2024.

About the HERIZON-GEA-01 Clinical Trial

HERIZON-GEA-01 is a global, randomized, Phase 3 clinical trial [NCT05152147] designed to evaluate the efficacy and safety of zanidatamab in combination with physician’s choice chemotherapy [CAPOX (capecitabine/oxaliplatin) or FP (5FU/cisplatin)] with or without the PD-1 inhibitor, tislelizumab, compared to trastuzumab plus physician’s choice chemotherapy for first-line treatment in subjects with advanced or metastatic HER2-positive gastroesophageal adenocarcinomas. Primary endpoints are progression-free survival per RECIST 1.1 criteria, as assessed by blinded independent central review, and overall survival. The trial is expected to enroll approximately 700 patients at approximately 300 sites across 38 countries. Zymeworks’ collaborator, BeiGene, will oversee trial sites in Asia (excluding Japan), Australia and New Zealand, and Zymeworks will oversee trial sites in the rest of the world, including North and South America, Japan, Europe, Middle East and Africa.

About the Zymeworks-BeiGene Collaboration

In November 2018, Zymeworks and BeiGene entered into license and collaboration agreements in which BeiGene was granted an exclusive license for the research, development, and commercialization of zanidatamab and ZW49 in Asia (excluding Japan), Australia, and New Zealand. The companies are collaborating on joint global development for selected indications, with the goal of developing zanidatamab and ZW49 worldwide across multiple HER2-expressing cancers and lines of therapy.

About Zanidatamab

Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. Zanidatamab’s unique binding properties result in multiple mechanisms of action including HER2-receptor clustering, internalization, and downregulation; inhibition of growth factor-dependent and -independent tumor cell proliferation; antibody-dependent cellular cytotoxicity and phagocytosis; and complement-dependent cytotoxicity. Zanidatamab is currently being evaluated in two pivotal clinical trials, one for the first-line treatment of advanced or metastatic HER2-positive gastroesophageal adenocarcinoma (HERIZON-GEA-01) and one for previously treated HER2-amplified biliary tract cancer (HERIZON-BTC-01). Zanidatamab is also being evaluated in several Phase 2 clinical trials for HER2‑expressing gastroesophageal, colorectal, and breast cancers. The FDA has granted zanidatamab with Breakthrough Therapy designation for patients with previously treated HER2 gene-amplified biliary tract cancer, as well as two Fast Track designations, one as monotherapy for refractory biliary tract cancer and one in combination with standard of care chemotherapy for first-line gastroesophageal adenocarcinoma. These designations mean zanidatamab is eligible for Accelerated Approval, Priority Review and Rolling Review, as well as intensive FDA guidance on an efficient drug development program. Zanidatamab has also received Orphan Drug designations from the FDA as well as the European Medicines Agency for the treatment of biliary tract and gastric cancers.