On June 4, 2021 Sarah Cannon reported it will present its latest cancer research insights at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) Annual Meeting being held virtually June 4-8, 2021 (Press release, Sarah Cannon Research Institute, JUN 4, 2021, View Source [SID1234583598]). This year, Sarah Cannon’s drug development, molecular profiling, and clinical care expertise is featured through 119 abstracts and presentations, including data from 70 phase 1 studies. Throughout the weekend, Sarah Cannon experts will engage in 113 oral presentations, poster discussion sessions, and poster presentations as well as more than 10 invited lectures.

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"From early-phase drug development to breaking down barriers in oncology care, Sarah Cannon leaders will discuss a variety of key topics that are helping to accelerate progress in patient care," said Howard A. "Skip" Burris III, MD, FACP, FACSO, President, Clinical Operations & Chief Medical Officer, Sarah Cannon. "Our ability to match targeted therapies to the molecular drivers of tumor expressions is generating greater insights into how we can personalize medicine for every individual."

In addition to representing Sarah Cannon during the Annual Meeting, Dr. Burris currently serves as Chair of the ASCO (Free ASCO Whitepaper) Board of Directors and Conquer Cancer, the ASCO (Free ASCO Whitepaper) Foundation.

June 4 Highlights

Dee Anna Smith, Chief Executive Officer, Sarah Cannon, will present "The Empowerment of Female Leaders" in the "Dismantling Gender Disparities in the Global Oncology Workforce Together" Education Session on June 4 at 8 a.m. CDT.
Andrew Kennedy, MD, Physician-in-Chief, Radiation Oncology, Sarah Cannon; Director, Radiation Oncology Research, Sarah Cannon Research Institute, will present "Radiation Oncology Perspective" in the "Barriers to Comprehensive Multidisciplinary Head and Neck Cancer Care in a Community Oncology Practice" Education Session on June 4 at 8 a.m. CDT.
Andrew McKenzie, PhD, Director, Personalized Medicine, Sarah Cannon; Scientific Director, Genospace, will present "Integrating Molecular Insights into Multidisciplinary Planning" as part of the "Reaching More Patients: The Challenges and Opportunities of Bringing Multidisciplinary Care to Communities" Education Session on June 4 at 8 a.m. CDT.
Gerald Falchook, MD, MS, Director, Drug Development, Sarah Cannon Research Institute at HealthONE, will present "A First-In-Human Phase 1 Study of a Novel PARP7 Inhibitor RBN-2397 in Patients with Advanced Solid Tumors" in an oral presentation on June 4 from 10 a.m. – 1 p.m. CDT.
Erika Hamilton, MD, Director, Breast Cancer and Gynecologic Cancer Research, Sarah Cannon Research Institute, will present "Hunting HER2 in Solid Tumors: Margetuximab-Cmkb, Tucatinib, and Trastuzumab Deruxtecan" in the "FDA Approvals and Their Incorporation into Clinical Practice" Education Session on June 4 at 10 a.m. CDT.
Dax Kurbegov, MD, Vice President & Physician-in-Chief, Clinical Programs, Sarah Cannon, will present "Highlights of Health Services Research and Quality Improvement" in the "Health Services Research and Quality Improvement" Highlights of the Day Session on June 4 at 5 p.m. CDT.
Meredith McKean, MD, MPH, Associate Director, Melanoma and Skin Cancer Research, Sarah Cannon Research Institute, will present "Highlights of Developmental Therapeutics-Molecularly Targeted Agents and Tumor Biology" in the "Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology Highlights" Highlights of the Day Session on June 4 at 5 p.m. CDT.
Poster Discussion Highlights (Available Online June 4)

Howard A. "Skip" Burris, III, MD, will present "A First In Human Study of AO-176, a Highly Differentiated Anti-CD47 Antibody, in Patients with Advanced Solid Tumors."
Todd Bauer, MD, Senior Investigator, Drug Development, Sarah Cannon Research Institute at Tennessee Oncology, will present "Phase IB Study of The Anti-TGF-β Monoclonal Antibody NIS793 Combined with Spartalizumab, a PD-1 Inhibitor, in Patients with Advanced Solid Tumors."
Elisa Fontana, MD, PhD, Translational Oncologist & Research Fellow, Sarah Cannon Research Institute – UK, will present "Early-Onset Stage II/III Colorectal Adenocarcinoma in the IDEA Database: Treatment Adherence, Toxicities, and Outcomes From Adjuvant Fluoropyrimidine and Oxaliplatin."
Erika Hamilton, MD, will present "Phase I/II Study of H3B-6545, a Novel Selective Estrogen Receptor Covalent Antagonist, in Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced Breast Cancer."
Manish Patel, MD, Director, Drug Development, Sarah Cannon Research Institute at Florida Cancer Specialists, will present "BDB001, an Intravenously Administered Toll-Like Receptor 7 and 8 Agonist, in Combination with Pembrolizumab in Advanced Solid Tumors: Phase 1 Safety and Efficacy Results."
Debra Richardson, MD, FACOG, FACS, Associate Professor, Gynecologic Oncology, Stephenson Cancer Center | Sarah Cannon Research Institute, will present "A Tale of Three PARP Inhibitors."
David Spigel, MD, Chief Scientific Officer, Sarah Cannon Research Institute, will present "Five-Year Survival Outcomes with Durvalumab after Chemoradiotherapy in Unresectable Stage III NSCLC: An Update from the PACIFIC Trial."
Poster Highlights (Available Online June 4)

Gerald Falchook, MD, MS, will present "A Phase 1 Dose-Escalation Study of Intravenously Administered TAK-676, a Novel STING Agonist, Alone and in Combination with Pembrolizumab in Patients with Advanced or Metastatic Solid Tumors."
Erika Hamilton, MD, will present "LIO-1: Lucitanib + Nivolumab in Patients with Advanced Solid Tumors – Updated Phase 1b Results and Initial Experience in Ph2 Ovarian Cancer Cohort."
Maen Hussein, MD, Principal Investigator, Sarah Cannon Research Institute at Florida Cancer Specialists, will present "Platform Trial of Ezabenlimab, an Anti-PD-1 Antibody, in Patients with Previously Treated Advanced Solid Tumors: Combination with BI 836880, a VEGF/Ang2-Blocking Nanobody."
Melissa Johnson, MD, Director, Lung Cancer Research, Sarah Cannon Research Institute, will present "Phase 1 & Phase 2a, First-In-Human Study, of DRP-104, a Broad Glutamine."
Carissa Jones, PhD, Senior Program Specialist, Personalized Medicine, Sarah Cannon, will present "Impact of Immune Checkpoint Inhibitor and EGFR Tyrosine Kinase Inhibitor Sequence on Time to Treatment Failure among EGFR+ NSCLC Treated in a Community-Based Cancer Research Network."
Meredith McKean, MD, MPH, will present "Association of Combined Phase I/II Study of a Novel Bicyclic Peptide and MMAE Conjugate BT8009 in Patients with Advanced Malignancies with Nectin-4 Expression."
Manish Patel, MD, will present "A Phase 1/2 Open-Label Study of KY1044, an Anti-ICOS Antibody with Dual Mechanism of Action, as Single Agent and in Combination with Atezolizumab, in Adult Patients with Advanced Malignancies."
Emma Sturgill, PhD, Program Specialist, Personalized Medicine, Sarah Cannon, will present "Concordance of Blood and Tissue TMB from NGS Testing in Real World Settings and Their Ability to Predict Response to Immunotherapy."
Michael Tees, MD, Hematologist/Oncologist, Colorado Blood Cancer Institute, a part of Sarah Cannon Cancer Institute at Presbyterian/St. Luke’s Medical Center, will present "Safety and PK/PD of ALLO-647, an Anti-CD52 Antibody, with Fludarabine/Cyclophosphamide for Lymphodepletion in the Setting of Allogeneic CAR-T Cell Therapy."
June 7 Highlights

Gerald Falchook, MD, MS, will chair "Developmental Therapeutics—Immunotherapy Track" on June 7 from 2-5 p.m. CDT.
Judy Wang, MD, Associate Director, Drug Development, Sarah Cannon Research Institute at Florida Cancer Specialists, will present "Novel Strategies for Overcoming Resistance to Immune Checkpoint Inhibitors" as part of "Developmental Therapeutics—Immunotherapy Track" on June 7 from 2-5 p.m. CDT.
Tara Gregory, MD, Unrelated Donor Program Director; Multiple Myeloma Program Co-Director, Colorado Blood Cancer Institute, a part of Sarah Cannon Cancer Institute at Presbyterian/St. Luke’s Medical Center, will present "CD20-Directed CAR T" as part of "Developmental Therapeutics—Immunotherapy Track" on June 7 from 2-5 p.m. CDT.
June 8 Highlights

Jesus Berdeja, MD, Director, Myeloma Research, Sarah Cannon Research Institute, will present "Updated Results of a Phase 1, First-In-Human Study of Talquetamab, a G Protein-Coupled Receptor Family C Group 5 Member D × CD3 Bispecific Antibody, in Relapsed/Refractory Multiple Myeloma" in an oral presentation on June 8 from 7-10 a.m. CDT.
Marlana Orloff, MD, Assistant Professor, Department of Medical Oncology, Sidney Kimmel Cancer Center at Jefferson Health | Sarah Cannon Research Institute, will present "Mutation Landscape and Emerging Therapies in Uveal Melanoma" in the "Beyond BRAF: Targeted Therapy for Non-BRAF Melanoma" Education Session on June 8 at 10:30 a.m. CDT.
The researchers are a part of Sarah Cannon’s global network of strategic sites, including:

Sarah Cannon Research Institute at Tennessee Oncology, Sarah Cannon Research Institute at Florida Cancer Specialists, Colorado Blood Cancer Institute, Sarah Cannon Blood Cancer Center at St. David’s South Austin Medical Center, Sarah Cannon Center for Blood Cancer at TriStar Centennial, Sarah Cannon Research Institute at HCA Midwest Health (Kansas City), Sarah Cannon Research Institute at HealthONE (Denver), Sarah Cannon Research Institute – United Kingdom, Sidney Kimmel Cancer Center at Jefferson Health, and The Stephenson Cancer Center at the University of Oklahoma.

On June 4, 2021 InnoCare (HKEX: 09969), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, reported the latest clinical data for the pan-FGFR inhibitor gunagratinib today at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting (Press release, InnoCare Pharma, JUN 4, 2021, View Source [SID1234583597]). This is the first time InnoCare has presented gunagratinib’s clinical data at an international academic conference, showing good safety and tolerability.

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Updated Results from the Phase I Study of a highly selective irreversible FGFR inhibitor ICP-192 (gunagratinib) for patients with advanced solid tumors with abnormal FGFR gene

Abstract Number: 4092

ICP-192 (gunagratinib), developed by InnoCare Pharma, is a novel pan-FGFR (fibroblast growth factor receptors) inhibitor that potently and selectively inhibits FGFR activities irreversibly by covalent binding. Preclinical data showed that gunagratinib overcomes the acquired resistance to the first-generation reversible FGFR inhibitors.

Gunagratinib is currently in clinical phase I/II. The safety and tolerability as well as pharmacokinetics/pharmacodynamics (PK/PD) of gunagratinib were evaluated in patients with advanced solid tumors, and the preliminary anti-tumor activity was evaluated by RECIST1.1 in patients with FGF/FGFR gene aberrations.

As of February 2021, a total of 30 patients had received the treatment of gunagratinib. Gunagratinib performed well in safety and tolerance, the maximum tolerated dose (MTD) had not been reached. Among the 12 patients with FGF/FGFR gene aberrations who have completed at least one tumor assessment, the overall response rate (ORR) was 33.3%, including 1 patient (8.3%) of cholangiocarcinoma with complete response (CR) and 3 patients (25%) with partial response (PR), 7 patients achieved SD. The disease control rate (DCR) was 91.7%.

Professor Ye Guo, the Deputy Director of Oncology Medical Department of Shanghai Oriental Hospital and the Director of Clinical Center for PhaseⅠsaid, "Gunagratinib is safe and well-tolerated in patients with advanced solid tumors. Anti-tumor activity was demonstrated in patients with FGF/FGFR geneaberrations in multiple tumor types, including cholangiocarcinoma. Better response is expected with the increase of treatment durations."

The 2021 ASCO (Free ASCO Whitepaper) Annual Meeting will be held online from June 4th to 8th, 2021. The ASCO (Free ASCO Whitepaper) annual meeting is the most important and professional academic event in the global oncology field, which will showcase the international cutting-edge clinical oncology research results and tumor treatment technologies.

On June 4, 2021 Tachyon Therapeutics, Inc. ("Tachyon" or "the Company"), a research and development biotechnology company, reported two abstract presentations of the Company’s lead product candidate, TACH101, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting. ASCO (Free ASCO Whitepaper) is being held virtually from June 4-8, 2021 (Press release, Tachyon Therapeutics, JUN 4, 2021, View Source [SID1234583596]).

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"We are excited about the emerging preclinical profile of TACH101, the first inhibitor of KDM4 histone demethylase to be in clinical studies," stated Frank Perabo, MD, PhD, CEO of Tachyon Therapeutics. "Epigenetic processes play a fundamental role in regulation of cellular biology, but when unregulated, can lead to cancer development and progression. Data presented at ASCO (Free ASCO Whitepaper) show favorable pharmacologic properties for TACH101, compelling efficacy data in animal models, and broad applicability as a potential anti-cancer agent. We look forward to advancing this molecule into first-in-human trials later this year."

Highlights from the two ASCO (Free ASCO Whitepaper) abstracts are summarized below:

Abstract #3105

TACH101 demonstrated potent increase in H3 methylation levels (H3K36me3), showing on-target activity.
TACH101 triggered effective tumor control in xenograft models including colorectal, esophageal, gastric, breast, and lymphoma with tumor growth inhibition of up to 100%.
Further evaluation using a panel of patient-derived colorectal models and patient-derived organoids showed a strong correlation of TACH101 sensitivity with MSI-H status (IC50 ranges 1-150 nM).
TACH101 reduced tumorigenic potential by 4.4-fold, suggesting that reduction of cancer stem cells by TACH101 may be effective in therapy-resistant settings.
The poster presentation of Abstract #3105 is available for viewing on the ASCO (Free ASCO Whitepaper) Annual Meeting website at View Source

Abstract #e15067

TACH101 showed potent KDM4 inhibition without significant off-target activity in in vitro and in vivo studies.
Pharmacokinetic studies showed TACH101 exhibited low clearance, moderate volume of distribution, and good oral bioavailability in mouse, rat, and dog.
TACH101 had little or no inhibitory effects on CYP enzyme activities.
The exposure from oral administration in rats and dogs was dose proportional and was not affected by food intake in dogs.
Presentation of Abstract #e15067 is available for viewing on the ASCO (Free ASCO Whitepaper) Annual Meeting website at View Source

On June 4, 2021 Guardant Health, Inc. (Nasdaq: GH) reported that presents new data at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held from June 4-June 8, 2021, showing that its LUNAR-2 blood test is a highly sensitive test that can detect colorectal cancer (CRC) in early-stage cancer patients (Press release, Guardant Health, JUN 4, 2021, View Source [SID1234583594]). This largest ever cohort continues to demonstrate the performance and robustness of the LUNAR-2 assay.1,2

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Today, it is estimated that only 68% of adults, 50 years and older, are screened for CRC despite the Centers of Disease Control (CDC) target compliance goal of 80%.3-5 A patient-friendly blood testing option with high sensitivity could finally bridge the gap to this compliance goal, and bend the mortality curve for the second leading cause of cancer death in the U.S.6

The data (N=705) show that the LUNAR-2 assay achieved overall sensitivity of 91% in early-stage CRC (stage I, II, and III), and specificity of 94%. The performance in this new cohort of CRC cases, and cancer-free controls, is consistent with previously reported data.1-2 Notably, no differences in sensitivity for CRC detection were observed in patients presenting with asymptomatic disease, compared to those patients who were symptomatic, despite the lower cell-free DNA (cfDNA) tumor fractions observed in asymptomatic patients, suggesting the test will have clinically meaningful performance in an average-risk screening population. Further, an expanded multi-cohort analysis of over 1,300 cases of patients with CRC, demonstrated that the LUNAR-2 assay consistently delivers clinical meaningful sensitivity for the detection of early-stage cancer.

The LUNAR-2 assay achieves industry-leading performance for detecting early-stage CRC by simultaneously interrogating somatic, methylation, and fragmentomic signals from circulating tumor DNA (ctDNA) in the blood.

"It’s exciting to see the latest data on Guardant Health’s LUNAR-2 assay, which are consistent with prior data, but most importantly deliver the performance necessary for clinical adoption in average-risk colorectal cancer screening," said Jeeyun Lee, MD, Professor, Division of Hematology/Oncology, Samsung Medical Center. "It’s great to see the momentum Guardant Health has achieved since the introduction of their best-in-class liquid biopsy technology in 2014. Now, they are at the precipice of delivering a highly sensitive colorectal cancer screening test, and I look forward to seeing the outcome of their registrational study."

"What makes this data particularly exciting is that our LUNAR-2 assay continues to show clinically meaningful performance in increasingly larger cohorts of patients with early-stage cancer," said Helmy Eltoukhy, Guardant Health CEO. "Furthermore, our assay delivered comparable sensitivity in both asymptomatic and symptomatic patients, despite the significantly reduced signals in asymptomatic patients. We’re pleased with the test performance which exceeds the benchmark required for clinical adoption in an average-risk patient population."

The ECLIPSE trial, a 10,000-patient registrational study, is currently underway to evaluate the performance of LUNAR-2 to detect CRC in an average-risk adult population. If successful, Guardant Health expects data from the trial will support a premarket approval (PMA) submission to the FDA. The trial is expected to complete enrollment by the end of 2021.

On June 4, 2021 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that presented interim results from the Phase II SUMMIT basket trial, assessing the efficacy of neratinib in patients with EGFR exon 18-mutant non-small cell lung cancer (NSCLC), including patients with central nervous system (CNS) involvement, at the virtual 2021 ASCO (Free ASCO Whitepaper) Annual Meeting (Press release, Puma Biotechnology, JUN 4, 2021, View Source [SID1234583593]). The presentation, entitled "Neratinib efficacy in a subgroup of patients with EGFR exon 18-mutant non-small cell lung cancer and central nervous system involvement: findings from the SUMMIT basket trial," is included in the Lung Cancer—Non-Small Cell Metastatic Poster Session (#9068).

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The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study that includes a cohort evaluating the safety and efficacy of neratinib administered daily to patients with EGFR exon 18-mutant non-small cell lung cancer (NSCLC). Patients received 240 mg of neratinib daily as a single agent with mandatory loperamide prophylaxis.

A cohort of 11 patients with EGFR exon 18-mutant NSCLC from the Phase II SUMMIT basket trial, including patients with central nervous system involvement, were evaluated for safety and efficacy. Prior lines of therapies included EGFR tyrosine kinase inhibitors (TKIs) (91%), chemotherapy (55%) and checkpoint inhibitors (IOs) (27%). Patients with stable, asymptomatic CNS metastasis were enrolled. Of the 11 patients, 3 patients had baseline CNS metastasis.

Of the 10 evaluable patients who had previously been treated with an EGFR tyrosine kinase inhibitor, 6 patients (60%) experienced a partial response (PR), and 4 patients (40%) demonstrated a confirmed partial response. Four additional patients showed stable disease (SD) lasting ≥16 weeks – bringing the experienced clinical benefit that includes confirmed complete response or partial response or stable disease for at least 16 weeks to 80%. The median duration of response (DOR) was 7.5 months, and the median progression-free survival (PFS) was 9.1 months with some patients remaining on treatment. Of the 3 patients who had CNS metastases, best responses were 2 PR and 1 SD and individual PFS times were 1.9 to 9.1 months. These results suggest that neratinib can be a potential treatment option for patients with NSCLC and hard-to-treat CNS metastases.

Neratinib was well tolerated in this study, with no occurrences of grade 3 diarrhea reported and there was no incident of any patient requiring a dose hold, dose reduction, hospitalization, or discontinuation of treatment due to diarrhea.

Jonathan W. Goldman, MD, Associate Professor of Hematology & Oncology, Associate Director of Drug Development and Director of Clinical Trials in Thoracic Oncology at UCLA, an investigator on the trial, said, "EGFR exon 18-mutant lung cancer patients have no effective targeted options after first-line FDA-approved EGFR TKI therapy. This study shows that neratinib has the potential to be an efficacious and safe option to treat their disease, possibly with CNS activity as well."

Alan H. Auerbach, Chief Executive Officer and President of Puma, added, "The descriptive findings from this study indicate that neratinib may have a role as a treatment option for rare cancers. We are excited to explore the full potential of neratinib and help patients with difficult to treat conditions."