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.

On December 9, 2021 Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to discover and develop Engineered Precision Biologics (EPBs), reported that NovoCodex Pharmaceuticals Ltd. (NovoCodex), Ambrx’s partner in China, presented positive safety and efficacy data from its ongoing ACE-Breast-01 Phase 1 clinical study of ARX788 at the San Antonio Breast Cancer Symposium (SABCS) (Press release, Ambrx, DEC 9, 2021, View Source [SID1234596704]).

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ACE-Breast-01 is a Phase 1 clinical study of ARX788 in HER2-positive metastatic breast cancer patients whose disease is resistant/refractory to HER2 targeted agents including trastuzumab, ADCs (antibody drug conjugates), TKIs (tyrosine kinase inhibitors) and bispecific antibodies. The updated data, presented during a spotlight poster session (PD8-04), demonstrates ARX788’s robust anti-tumor activity.

Study Highlights

ARX788 at 1.5 mg/kg Q3W demonstrated robust treatment effect as illustrated by objective response rate (ORR) in 29 patients in all prior anti-HER2 treatments groups:
Prior Anti-HER2 Therapy

Confirmed ORR

Trastuzumab containing regimens*

19/29 (66%)

HER2 ADC regimens (T-DM1, DX126-262, A166, BAT8001, HS630)**

4/5 (80%)

HER2 TKI regimens (lapatinib, pyrotinib, neratinib, AST-1306, Hemay-022)

15/23 (65%)

Both HER2 ADC and HER2 TKI regimens

3/4 (75%)

Bispecific antibody containing regimens (KN026 and M802)

3/4 (75%)

Table represents subsets of a total of 29 evaluable patients in the 1.5 mg/kg Q3W cohort, treatment groups are not mutually exclusive

* All patients at 1.5 mg/kg Q3W received prior trastuzumab-containing regimens

** One patient who received prior pertuzumab also achieved confirmed partial response (PR)

The disease control rate among evaluable patients in the 1.5 mg/kg cohort was 100% (29/29)
ARX788 demonstrated low systemic toxicity and was generally well tolerated with most adverse events being grade 1 or 2
No dose limiting toxicity or drug-related deaths occurred
"As the ACE-Breast-01 data for ARX788 continues to develop, we are encouraged by the ADC’s anti-tumor activity and safety profile. ARX788’s ability to continually deliver anti-cancer activity in patients with prior anti-HER2 therapies including ADCs, TKIs and bispecifics, truly highlights the potential of our drug candidate," said Feng Tian, Ph.D., Chairman of the Board, President and CEO of Ambrx. "I look forward to working with NovoCodex to realize the full potential of ARX788."

The Phase 1 clinical study being conducted by our partner, NovoCodex, is a dose escalation study designed to evaluate the safety and anti-tumor activity of ARX788 administered every three weeks in heavily pretreated patients with HER2-positive metastatic breast cancer. The 29 evaluable patients in the 1.5 mg/kg Q3W dose cohort who participated in the study were heavily pretreated with, and had failed, a median of seven prior lines of therapy (median of six for the 69 patients in all cohorts) in the advanced disease setting.

Additionally, Ambrx presented a poster on ACE-Breast-03 in a SABCS ongoing trial poster session (OT1-02-02). The poster details ARX788 in its ongoing global ACE-Breast-03 Phase 2 clinical study in patients with HER2-positive metastatic breast cancer whose disease is resistant or refractory to T-DM1, and/or T-DXd, and/or tucatinib-containing regimens. The study is currently enrolling up to 200 patients and will assess the efficacy, safety and pharmacokinetics of ARX788, with confirmed objective response rate as the primary endpoint.

Dr. Tian continued, "Ambrx’s proprietary EuCODE technology enables ARX788 to maximize the delivery efficiency of the therapeutic’s cytotoxic payload AS269 into HER2-expressing tumor cells. I am looking forward to our on-going global ACE-Breast-03 phase 2 study designed for patients with HER2-positive metastatic breast cancer whose disease is resistant or refractory to T-DM1, T-DXd, and tucatinib-containing regimens."