On May 20, 2021 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune T-cell activating technology, reported publication of abstract #2501 by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, PDS Biotechnology, MAY 20, 2021, View Source [SID1234580369]). The abstract summarizing interim data from the National Cancer Institute (NCI)-led phase 2 trial has been accepted for oral presentation at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting taking place June 4-8. The presentation, scheduled for June 7, is expected to include results from a larger sample than the 14 patients included in the abstract.

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Additional data highlights from abstract #2501 include:

An overall objective response rate of 71% (10/14) in patients with refractory HPV16-associated cancers
1 complete response (anal cancer)
9 partial responses (3 cervical cancer, 2 vulvar/vaginal cancer, 2 anal cancer, 2 oropharyngeal cancer)
90% of these of these responses are ongoing after a median 5 months of follow up (9/10)
The NCI Center for Cancer Research’s Laboratory of Tumor Immunology and Biology (LTIB) and Genitourinary Malignancies Branch (GMB) are jointly leading this Phase 2 trial (NCT04287868), which studies PDS0101 in combination with two investigational immune-modulating agents: bintrafusp alfa (M7824), a bifunctional "trap" fusion protein targeting TGF-β and PD-L1, and NHS-IL12 (M9241), a tumor-targeting immunocytokine. Bintrafusp alfa is being jointly developed by Merck KGaA, Darmstadt, Germany, and GlaxoSmithKline; NHS-IL12 is being developed by Merck KGaA, Darmstadt, Germany.

The trial is evaluating the treatment combination in both checkpoint inhibitor naïve and refractory patients with advanced human papillomavirus (HPV)-associated cancers that have progressed or returned after treatment. Objective response is measured by radiographic tumor responses according to RECIST 1.1. These reported data validate the preclinical studies published by the NCI demonstrating that the complementary mechanisms of action of the three immunotherapies which involve potent in-vivo HPV16-specific killer and helper T-cell induction with effective T-cell tumor infiltration, blocking of immune checkpoints as well as targeting of TGF-β resulted in superior tumor regression.

"The achievement of a 71% objective response rate in a difficult to treat patient population continues to strengthen the evidence of our novel Versamune platform’s potential ability to induce high levels of tumor-specific CD8+ killer T-cells that attack the cancer resulting in strong synergy with Bintrafusp alfa and NHS-IL12, thus leading to effective tumor regression," commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. "The initial data solidifies our belief that PDS0101’s published preclinical efficacy, when combined with these two immune-modulating agents, demonstrates the potential to significantly improve clinical outcomes for patients with advanced, refractory HPV-associated cancers who have limited treatment options."

There are more than 630,000 cases of HPV-associated malignancies including cervical, oropharyngeal and anal cancer worldwide annually. HPV 16 is responsible for most of these cases. About 15-20% of HPV-associated malignancies respond to PD-(L)1 inhibitors. However, for the overwhelming majority of patients who progress on these immunotherapies there is no effective standard of care therapy.

The abstract is now available online on the ASCO (Free ASCO Whitepaper) conference website: View Source

Abstract Number: 2501
Abstract Title: Phase II evaluation of the triple combination of PDS0101, M9241, and bintrafusp alfa in patients with HPV 16 positive malignancies.

Presenting Author: Julius Strauss, MD, National Cancer Institute
Session: Developmental Therapeutics—Immunotherapy
Date: June 7, 2021
Time: 3:00 PM-6:00 PM EDT

Dr. Julius Strauss, Staff Clinician, LTIB, is serving as the Principal Investigator of this phase 2 clinical trial in advanced HPV-associated cancers. For patients interested in enrolling in this clinical study, please call NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email [email protected], and/or visit the website: View Source

On May 20, 2021 NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, reported that new data from two clinical trials evaluating the company’s lead asset NT-I7 (efineptakin alfa) will be presented during poster sessions at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, to be held in a virtual platform June 4-8, 2021 (Press release, NeoImmuneTech, MAY 20, 2021, View Source [SID1234580386]). The data come from clinical studies evaluating NT-I7, a novel long-acting human IL-7, 1. in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) as a treatment for advanced solid tumors, and 2. given concurrently with adjuvant chemotherapy in patients with high-grade gliomas.

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Details related to the poster presentations are as follows:

Title: Safety, Pharmacokinetics, Pharmacodynamics Profiles and Preliminary Antitumor Activity of Phase 1b/2a Study of NT-I7, a Long-Acting Interleukin-7, plus Pembrolizumab in Patients with Advanced Solid Tumors: The Phase 1b Data Report
Lead Author: Aung Naing, MD, The University of Texas MD Anderson Cancer Center
Abstract Number: 2594
Poster Session: Developmental Therapeutics—Immunotherapy, on demand starting at 9:00am ET, June 4, 2021

Title: A phase I/II study to evaluate the safety and efficacy of a novel long-acting interleukin-7, NT-I7, for patients with newly diagnosed high-grade gliomas after chemoradiotherapy: the interim result of the phase I data
Lead Author: Jian Li Campian, MD, PhD, Washington University School of Medicine in St. Louis/Siteman Cancer Center
Abstract Number: 2040
Poster Session: Central Nervous System Tumors, on demand starting at 9:00am ET, June 4, 2021

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and enhanced functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On May 20, 2021 Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that its Board of Directors declared a quarterly cash dividend of $0.62 per share, payable on July 21, 2021 to shareholders of record of Quest Diagnostics common stock on July 7, 2021 (Press release, Quest Diagnostics, MAY 20, 2021, View Source [SID1234580402]).

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On May 20, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing onvansertib to treat cancers with the greatest medical needs for new treatment options, including KRAS-mutated colorectal cancer, pancreatic cancer and castrate-resistant prostate cancer, reported that Dr. Mark Erlander, chief executive officer of Cardiff Oncology, will present and participate in one-on-one investor meetings at the Jefferies Virtual Healthcare Conference taking place June 1-4, 2021 (Press release, Cardiff Oncology, MAY 20, 2021, View Source [SID1234580354]).
Presentation details can be found below.
Date: Tuesday, June 1, 2021 Time: 4:00 PM ET Webcast Link:
View Source

A replay of the presentation will be available by visiting the "Events" section of the Cardiff Oncology website after the conclusion of the presentation and will be archived on the Company website for 30 days.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On May 20, 2021 Foundation Medicine, Inc. reported that the company and its collaborators will present a total of 29 studies, including two clinical science symposia presentations and two poster discussions, at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program (ASCO21) from June 4-8 (Press release, Foundation Medicine, MAY 20, 2021, View Source [SID1234580387]). Among the presentations are data reinforcing the role of comprehensive genomic profiling (CGP) in increasing equitable patient access to precision medicine tools, as well as studies highlighting the clinical utility of CGP and the power of real-world data to inform treatment decisions and better understand disparities in care.

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Highlights of these presentations include:

new data emphasizing how the lack of early CGP testing and clinical trial enrollment in patients of African ancestry may help explain disparities in prostate cancer;
clinical data reinforcing the value of tissue- and liquid-based CGP as tools for oncologists to identify predictive biomarkers and enable precision medicine; and
additional evidence of the power of real-world data from Foundation Medicine and Flatiron Health’s joint clinico-genomic database (CGDB) to inform treatment decisions.
"At our core, Foundation Medicine is focused on using the highest quality insights to transform cancer care for everyone, and the breadth of data we’re presenting at ASCO (Free ASCO Whitepaper) in collaboration with our research and industry partners reflects that commitment," said Brian Alexander, M.D., M.P.H., CEO at Foundation Medicine. "The data we’ll share with the oncology community will help us continue moving the needle on changing clinical care by showing the clinical value of CGP across the spectrum of cancers, as well as highlighting the need to consistently and equitably improve access to genomic testing so that every person facing a cancer diagnosis has the insights needed to inform the best possible care."

Understanding Genomic Ancestry and CGP Utilization in Men with Prostate Cancer

In a study conducted in collaboration with Sylvester Comprehensive Cancer Center at the University of Miami, researchers investigated the genomic landscape and therapeutic implications of CGP in prostate cancer across men of European and African ancestry. Researchers believe this is the largest known cohort of its kind that describes CGP utilization, the genomic landscape from CGP, and treatment patterns in prostate cancer across ancestry groups. The analysis revealed men of African ancestry were less likely to receive CGP earlier in their treatment course and less likely to be treated in clinical trials. The findings potentially advance the field’s understanding of ancestry-based disparities in prostate cancer.

[Ancestral characterization of the genomic landscape, comprehensive genomic profiling utilization, and treatment patterns may inform disparities in advanced prostate cancer: A large-scale analysis. Abstract #5003.]

Clinical Utility of Comprehensive Genomic Profiling

In a study exploring the genomic and immunologic profile of intrahepatic cholangiocarcinoma (IHCC) with IDH1/2 genetic alterations in partnership with The University of Texas MD Anderson Cancer Center and others, researchers found significant differences in alterations between IDH1+/IDH2+ IHCC and IDH wild-type IHCC. The data suggest these alterations are IHCC driver oncogenes and support investigation of IDH inhibitors in these patients.

[IDH1 and IDH2 driven intrahepatic cholangiocarcinoma (IHCC): A comprehensive genomic and immune profiling study. Abstract #4009]

In a real-world clinical outcomes study of alpelisib in patients with PIK3CA-mutated breast cancer conducted in partnership with UCSF Helen Diller Family Comprehensive Cancer Center, researchers validated the effectiveness of alpelisib in a diverse, real-world population. Results showed these patients had longer progression-free survival with alpelisib plus fulvestrant than with fulvestrant alone. The study also showed liquid biopsy CGP detected PIK3CA mutations at a similar rate to tissue biopsy, reinforcing the clinical utility of both testing types depending on the patient’s unique situation.

[Real world (rw) clinical outcomes on alpelisib (ALP) in patients (pts) with breast cancer (BC) and PIK3CA mutations (PIK3CAm). Abstract #1068]

As the cancer community works to expand access to precision medicine trials to more patients, the need for decentralized trials has become increasingly apparent. In the Alpha-T study, a clinical trial sponsored by Roche using Foundation Medicine’s precision enrollment services, researchers at multiple institutions, including UCSD Moores Cancer Center and Vanderbilt University Medical Center, are investigating patients with ALK-positive solid tumors, identified through either liquid or tissue biopsy, being treated with alectinib. Through remote support, patients are participating in the trial from their local care setting, demonstrating the potential of decentralized trials to increase broader and more diverse enrollment in clinical trials.

[Alpha-T: An innovative decentralized (home-based) phase 2 trial of alectinib in ALK-positive (ALK+) solid tumors in a histology-agnostic setting. Abstract #TPS3155]

Power of Real-World Data to Advance Personalized Medicine

Using the CGDB, researchers assessed outcomes for metastatic breast cancer patients with somatic BRCA or other homologous recombination (HR)-pathway mutations treated with a PARP inhibitor. Results suggested these patients had similar benefit from PARP inhibitor treatment compared to patients with germline BRCA mutations, supporting future studies of this targeted treatment approach for these patients.

[Analysis of real-world (RW) data for metastatic breast cancer (mBC) patients (pts) with somatic BRCA1/2 (sBRCA) or other homologous recombination (HR)-pathway gene mutations (muts) treated with PARP inhibitors (PARPi). Abstract #10512]

Leveraging routine CGP testing of metastatic castrate resistant prostate (mCRPC) cancer tissue samples, researchers discovered that patients with biomarkers routinely assessed by CGP, including AR amplification, may help predict which patients are likely to benefit from taxane chemotherapy instead of novel hormonal therapy.

[Using real-world outcomes to evaluate the predictive power of tissue-assessed genomic biomarkers for taxane versus novel hormonal therapy (NHT) outcomes in metastatic castration-resistant prostate cancer (mCRPC). Abstract #5054]

The following is a list of select abstracts that will be presented at the meeting. To access all abstracts being presented by Foundation Medicine and its collaborators, please visit: meetinglibrary.asco.org.

Abstract #

Title

Collaborator

Clinical Science Symposia

5003

Ancestral characterization of the genomic landscape, comprehensive genomic profiling utilization, and treatment patterns may inform disparities in advanced prostate cancer: A large-scale analysis.

University of Michigan Cancer Center, Sylvester Comprehensive Cancer Center, Harvard Medical School

4009

IDH1 and IDH2 Driven Intrahepatic Cholangiocarcinoma (IHCC): A comprehensive genomic and immune profiling study.

MD Anderson

Poster Discussions

10512

Analysis of real-world (RW) data for metastatic breast cancer (mBC) patients (pts) with somatic BRCA1/2 (sBRCA) or other homologous recombination (HR)-pathway gene mutations (muts) treated with PARP inhibitors (PARPi).

Beth Israel Deaconess Medical Center; Dana Farber Cancer Institute, Flatiron

3009

Prevalence of inferred clonal hematopoiesis (CH) detected on comprehensive genomic profiling (CGP) of solid tumor tissue or circulating tumor DNA (ctDNA).

Poster Presentations

5054

Using real-world outcomes to evaluate the predictive power of tissue-assessed genomic biomarkers for taxane versus novel hormonal therapy (NHT) outcomes in metastatic castration-resistant prostate cancer (mCRPC).

MD Anderson

5567

Assessment of predictive biomarker prevalence in molecularly defined adult-type ovarian granulosa cell tumors.

MD Anderson

TPS3143

TCF-001 TRACK (Target Rare Cancer Knowledge): A national patient-centric precision oncology trial for rare cancers.

University of California San Diego, TargetCancer Foundation​

TPS3155

Alpha-T: An innovative decentralized (home-based) phase 2 trial of alectinib in ALK-positive (ALK+) solid tumors in a histology-agnostic setting.

Roche,​ UCSD Moores Cancer Center, Vanderbilt University Medical Center

2599

Real-world pan-cancer landscape of frameshift mutations (FSM) and their role in predicting responses to immune checkpoint inhibitors (ICI) in patients (pts) with tumors with low tumor mutational burden (TMB).

​Huntsman Cancer Institute

1068

Real-world (rw) clinical outcomes on alpelisib (ALP) in patients (pts) with breast cancer (BC) and PIK3CA mutations (PIK3CAm).

University of California, San Francisco

2541

Genomic immunotherapy (IO) biomarkers detected on comprehensive genomic profiling (CGP) of tissue and circulating tumor DNA (ctDNA).

National Cancer Center Hospital East; Kashiwa, Japan

1036

Concordance of HER2+ status by IHC/ISH and ERBB2 status by NGS in a real-world clinicogenomic database and analysis of outcomes in patients (pts) with metastatic breast cancer (mBC).

Flatiron

539

Comprehensive genomic profiling (CGP) of 275 male breast cancer (BC) tissue (TBx) and liquid (LBx) biopsies: Comparative analysis to a female cohort (FBC) and therapeutic considerations.

Dana Farber Cancer Institute

9101

Identification of potential germline (GL) variants by routine clinical comprehensive genomic profiling (CGP) and confirmatory GL testing in 24 tumor types.

Dana Farber Cancer Institute