City of Hope presents new research on cancer immunotherapies at 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 22, 2023 City of Hope, one of the largest cancer research and treatment organizations in the United States, reported that one of its researchers will present results from a SWOG Cancer Research Network Phase 3 study comparing nivolumab and brentuximab vedotin in patients with advanced stage classic Hodgkin lymphoma at an ASCO (Free ASCO Whitepaper) press briefing (Press release, City of Hope, MAY 22, 2023, View Source [SID1234631929]).

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Alex Herrera, M.D., City of Hope associate professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation, will present the findings on Saturday, June 3, for Abstract LBA4 and at a plenary session on Sunday, June 4. The embargo for this abstract lifts on Sunday, June 4, at 7 a.m. CT/8 a.m. ET.

Other innovative City of Hope-led research on a natural killer cell engager for relapsed or difficult to treat acute myeloid leukemia, a City of Hope-developed CAR T for prostate cancer, pediatric cancer survivorship and precision medicine for breast cancer will also be presented during the conference, which attracts oncology professionals from around the world to discuss the latest clinical cancer research impacting patient care.

Title: A first-in-human study of CD123 NK cell engager SAR443579 in relapsed or refractory acute myeloid leukemia, B-cell acute lymphoblastic leukemia, or high-risk myelodysplasia
Abstract Number: 7005
Session Type: Oral
Session Title: Hematologic Malignancies — Leukemia, Myelodysplastic Syndromes and Allotransplant
Session Date and Time: Friday, June 2, 1 to 4 p.m. CT
Presentation Time: Friday, June 2, 2:24 to 2:36 p.m. CT
Presenter: Anthony Stein, M.D., City of Hope professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation

Title: Lisocabtagene maraleucel (liso-cel) in R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): Primary analysis of TRANSCEND CLL 004
Abstract Number: 7501
Session Type: Oral.
Session Title: Hematologic Malignancies — Lymphoma and Chronic Lymphocytic Leukemia
Session Date and Time: Tuesday, June 6, 9:45 a.m. to 12:45 p.m. CT
Presentation Time: Tuesday, June 6, 9:57 to 10:09 a.m. CT
Presenter: Tanya Siddiqi, M.D., City of Hope associate professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation

Title: Real-world outcomes of brexucabtagene autoleucel (brexu-cel) for relapsed or refractory (R/R) mantle cell lymphoma (MCL): A CIBMTR subgroup analysis by prior treatment
Abstract Number: 7507
Session Type: Oral.
Session Title: Hematologic Malignancies — Lymphoma and Chronic Lymphocytic Leukemia
Session Date and Time: Tuesday, June 6, 9:45 a.m. to 12:45 p.m. CT
Presentation Time: Tuesday, June 6, 11:57 a.m. to 12:09 p.m. CT
Presenter: Swetha Kambhampati, M.D., City of Hope assistant professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation

Title: Carvedilol for prevention of heart failure in anthracycline-exposed survivors of childhood cancer: Results from COG ALTE1621
Abstract Number: 10013
Type: Oral.
Session Title: Pediatric Oncology
Session Date and Time: Monday, June 5, 8 to 11 a.m. CT
Presentation Time: Monday, June 5, 9:12 to 9:24 a.m. CT
Presenter: Saro Armenian, D.O., M.P.H., Barron Hilton Chair in Pediatrics, professor and chair, Department of Pediatrics

Title: Final results from phase I study of PSCA-targeted chimeric antigen receptor (CAR) T cells in patients with metastatic castration resistant prostate cancer (mCRPC)
Abstract Number: 5019
Type: Poster
Session Title: Genitourinary Cancer — Prostate, Testicular and Penile
Session Date and Time: Saturday, June 3, 1:15 to 2:45 p.m. CT
Presenter: Tanya Dorff, M.D., City of Hope professor, Department of Medical Oncology & Therapeutics Research

Title: Healthcare utilization among individuals diagnosed with hereditary breast-ovarian cancer syndrome through a universal germline genetic testing program
Abstract Number: 10604
Session Type: Poster
Session Title: Prevention, Risk Reduction and Hereditary Cancer
Session Date and Time: Saturday, June 3, 1:15 to 2:45 p.m. CT
Presenter: Stacy W. Gray, M.D., A.M., City of Hope professor and chief, Division of Clinical Cancer Genomics, Department of Medical Oncology & Therapeutics Research

Title: Efficacy and safety of atezolizumab plus cabozantinib vs cabozantinib alone after progression with prior immune checkpoint inhibitor (ICI) treatment in metastatic renal cell carcinoma (RCC): Primary PFS analysis from the phase 3, randomized, open-label CONTACT-03 study
Abstract Number: LBA4500
Session Type: Oral
Session Title: Genitourinary Cancer — Kidney and Bladder
Session Date and Time: Monday, June 5, 11:30 a.m. to 2:30 p.m. CT
Senior Author: Sumanta Kumar Pal, M.D., City of Hope professor, Department of Medical Oncology & Therapeutics Research

Title: Effect of CBM588 in combination with cabozantinib plus nivolumab for patients (pts) with metastatic renal cell carcinoma (mRCC): A randomized clinical trial
Abstract Number: LBA104
Session Type: Clinical Science Symposium
Session Title: Role of the Microbiome in Immune Checkpoint Inhibitor Response and Resistance
Session Date and Time: Sunday, June 4, 9:45 to 11:15 a.m. CT
Presentation Time: 10:21 to 10:33 a.m. CT
Presenter: Heydeh Ebrahimi, M.D., M.P.H., City of Hope postdoctoral fellow

HanX Biopharmaceuticals announces HX009 IND approval from FDA

On May 22, 2023 Hanx Biopharmaceuticals, Inc. (HanxBio), reported that the company has received Investigational New Drug (IND) approval to start clinical trial of the potentially first-in-class recombinant anti-CD47/PD-1 bispecific antibody (BsAb), HX009, in Patients with relapsed/refractory Lymphoma (Press release, HanX Biopharmaceuticals, MAY 22, 2023, View Source [SID1234631928]). This is a Phase IB/II clinical study to be conducted in the United States to evaluate HX009 in the treatment of lymphoma patients who have failed standard therapy.

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This is another important milestone of HX009 development as well as in the company’s drug development program. HX009 has been studied in Australia and China in both solid tumor and lymphoma indications. The approval by FDA to start clinical trial in US strengthens the development of HX009 globally, and enhances the company’s position in the field of bispecific antibody research.

Dr. Lei Zhang, CMO of HanxBio, said: "We are very pleased that our HX009 program has received clinical trial research approval from the US FDA. Although immune checkpoint inhibitors (ICIs) have shown great promises in a wide range of oncology indications, there still remains many challenges including in lymphoma. Therefore, it is of great value to develop the next generation of ICIs, including BsAb, such as dual targeting CD47 and PD-1 BsAb like HX009. We look forward to rapidly advancing the clinical development of HX009, bringing new treatment options to patients to meet unmet medical needs."

Actinium Pharma Announces Six Abstracts Accepted for Oral and Poster Presentation at the SNMMI 2023 Annual Meeting, Demonstrating Actinium’s Leadership in Targeted Radiotherapy for Hematologic and Solid Cancers

On May 22, 2023 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, reported that six abstracts have been accepted for oral and poster presentation at the upcoming Society for Nuclear Medicine & Molecular Imaging (SNMMI) 2023 Annual Meeting, which will be held in Chicago, June 24-27, 2023 (Press release, Actinium Pharmaceuticals, MAY 22, 2023, View Source [SID1234631927]). These abstracts exhibit the breadth of Actinium’s technological and clinical endeavors over the past year that are now culminating in targeted radiotherapies that improve the outcomes of cancer patients.

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Details of the SNMMI oral presentation:

Presentation Title: Machine learning applications to optimize dosimetric imaging of I131-apamistamab for bone marrow conditioning in relapsed/refractory acute myeloid leukemia (R/R AML)
Session Type/Title: Oral / New developments in radiopharmaceutical therapy
Date and Time: June 25, 5:00pm – 6:15pm ET

Details of the SNMMI poster presentations:

All posters will be accessible for viewing for the entirety of the conference. The general session is Science Pavilion – Meet the Authors Session: June 26, 5:15pm – 6:15pm

Abstract Title: Relative biological effectiveness of antibody radioconjugates (ARCs): In vitro dosimetric evaluation to streamline pre-clinical decision-making
ID: P86
Track: Oncology, Basic and Translational

Abstract Title: Streamlining personalized dosimetry for I131-apamistamab using a Co-57 sheet source to circumvent the need for radionuclide-specific attenuation correction
ID: P715
Track: Molecular Targeting Probes-Radioactive & Nonradioactive

Abstract Title: Organ-specific dosimetry to estimate potential toxicity thresholds of Actimab-A (lintuzumab-Ac225) used in combination with venetoclax in relapsed/refractory AML
ID: P88
Track: Oncology, Basic and Translational

Abstract Title: Individualized dosing for high-dose targeted radiation of hematopoietic cells with Iomab-B (I131-apamistamab) prior to HCT in relapsed/refractory acute myeloid leukemia (R/R AML): Safety and efficacy results from the pivotal phase 3 SIERRA trial
ID: P685
Track: Oncology Clinical Diagnosis & Therapy

Abstract Title: Administration and radiation safety of high-dose Iomab-B (I131-apamistamab) demonstrated in multiple clinical settings: Experience from the large multicenter phase 3 SIERRA trial for targeted conditioning of patients with relapsed/refractory AML
ID: P730
Track: Oncology Clinical Diagnosis & Therapy

Autolus Therapeutics to hold Analyst call to highlight data at ASCO from the Pivotal Phase 2 FELIX study of obe-cel data in adult r/r B-ALL

On May 22, 2023 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that it will hold an analyst call to highlight data at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from the Pivotal Phase 2 FELIX study of obe-cel data in adult r/r B-ALL (Press release, Autolus, MAY 22, 2023, View Source [SID1234631926]). The event will be held on June 2 at 4.00 pm ET/9.00 pm BST. Conference call participants should pre-register using this link to receive the dial-in numbers and a personal PIN, which are required to access the conference call.

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A simultaneous audio webcast and replay will be accessible on the events section of Autolus’ website.

ASCO Oral Presentation, abstract #7000:

Title: Safety and efficacy of Obecabtagene autoleucel (obe-cel, AUTO1), a fast-off rate CD19CAR in relapsed/refractory adult B-Cell acute lymphoblastic leukemia (r/r B-ALL): Topline results of the pivotal FELIX study

Session Title: Hematologic Malignancies — Leukemia, Myelodysplastic Syndromes, and Allotransplant
Session date and time: Friday, June 2, 2023, 14:00 – 17:00 EDT, 19:00 – 22:00 BST
Presenting Author: Dr. Claire Roddie, MD, PhD, FRCPath, Consultant Haematologist and Honorary Senior Lecturer, Cancer Institute, University College London (UCL)

VerImmune Announces Positive Pre-IND Meeting with FDA

On May 22, 2023 VerImmune Inc ("VerImmune"), an early-stage biotechnology company specializing in the development of innovative products based on a novel Virus-inspired Particle (ViP) technology platform, reported the successful completion of a Type B pre-IND meeting with the US Food and Drug Administration (FDA) for its groundbreaking VERI-101 immuno-oncology lead product for the treatment of multiple solid tumors (Press release, VerImmune, MAY 22, 2023, View Source [SID1234631923]).

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The primary objective of the pre-IND meeting was to seek FDA concurrence on VerImmune’s manufacturing, control strategies and development plans, the design of non-clinical IND-enabling studies, and guidance on the proposed first-in-human clinical trial in cancer patients for VERI-101. The FDA provided clear and constructive feedback in the form of written responses to the Pre-IND package and questions submitted by VerImmune. This feedback from the FDA on the overall development strategy empowers VerImmune to advance towards the IND preparation and submission of VERI-101.

Joshua Wang, Ph.D., Founder and CEO of VerImmune Inc., commented, "This milestone for our startup is of paramount importance as it provides regulatory clarity, paving the way for our new ViP-based modality as well as our highly novel immunotherapy approach to advance to clinical trials. We are thrilled by the positive and valuable feedback received from the FDA, which enables us to efficiently execute the necessary steps for IND approval. I want to express my gratitude to our exceptional team and dedicated advisors who have worked tirelessly to reach this stage."

VerImmune’s primary focus lies in the field of Oncology, wherein the ViP technology enables a pioneering first-in-class cancer immunotherapy approach known as Anti-tumor Immune Redirection (AIR). This innovative method harnesses the body’s pre-existing immune system, specifically by leveraging the immune memory from past infections or childhood vaccination to combat cancer. By taking a highly orthogonal approach, VerImmune’s technology holds immense potential to revolutionize the Immuno-Oncology market, offering new treatment possibilities for patients facing limited options or resistance to current cancer therapies.