On November 15, 2021 The V Foundation for Cancer Research, a top-rated cancer research charity, reported that it has awarded grants worth more than $21 million for cutting-edge cancer research in 2021 (Press release, The V Foundation for Cancer Research, NOV 15, 2021, View Source [SID1234595654]). The total grant funding by the Foundation has now reached nearly $290 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Each year, the Foundation invites NCI-designated cancer centers nationwide to nominate researchers for each grant category, Translational and V Scholar, for funding consideration. The V Foundation’s Scientific Advisory Committee (SAC), made up of world-class researchers from leading cancer centers, reviews and recommends the most promising projects for funding. This rigorous process ensures proposals meet the highest standards of scientific merit.

"After many difficult months during which the COVID-19 pandemic affected not just fundraising but also disrupted research at many institutions, we are delighted to report a strong funding year to drive critical cancer research forward and nurture young research talent through these difficult times," said Carole Wegner, Ph.D., senior vice president of research and grants administration.

The V Foundation awarded 18 Translational grants and 37 V Scholar grants in 2021. Translational grants are a three-year commitment of $200,000 per year. These grants support "bench to bedside" research, whose endpoint is often planning or initiation of a clinical trial. V Scholar grants provide researchers with $200,000 of funding over a two-year commitment and are awarded to innovative young scientists establishing their research careers.

A total of $3.7 million was awarded through the Stuart Scott Memorial Cancer Research Fund in 2021. The Stuart Scott Fund was created in 2015 in memory of beloved ESPN sportscaster Stuart Scott. Scott was a cancer research advocate, especially for minority populations, even before his own cancer diagnosis. The Fund is dedicated to reducing inequalities in both cancer care and cancer research, as well as supporting early career researchers from underrepresented minorities.

A total of $5 million was awarded through the Dick Vitale Fund for Pediatric Cancer. Funded studies include research for brain, blood and bone cancers, among others. Nearly $60 million has been awarded through the fund named for V Foundation board member Dick Vitale, a tireless champion for pediatric cancer research.

The Translational research project that receives one of the highest ratings by the SAC is annually designated as the Nick Valvano Translational Research Grant. Nick Valvano, Jim Valvano’s brother, served as CEO for 13 years and has been a V Foundation Board Member since 1993. This year, Steven Reiner, M.D., from Columbia University, received the distinction.

"Support from the V Foundation for our research will be transformative," said Reiner. "When we began studying blood samples from cancer patients, we quickly realized the test we developed might predict which patients will respond to immunotherapy, something important to patients and their doctors. I am honored to receive the Nick Valvano Translational Research Grant, which could help make immunotherapy even more effective for a greater number of cancer patients."

An additional Translational research project receiving one of the highest ratings by the SAC is annually designated as the Bob Bast Translational Research Grant. Bob Bast, M.D., chaired the V Foundation’s SAC for over 20 years and continues to serve on the SAC and V Foundation board. Shivani Srivastava, Ph.D., from Fred Hutchinson Cancer Research Center, received the honor.

Andrew Venteicher, M.D., Ph.D., from Masonic Cancer Center, and Yuxuan Miao, Ph.D., from the University of Chicago, tied for the Martin D. Abeloff Scholar Award, recognizing the highest reviewer-scored V Scholar grant recipient.

The V Foundation holds 10 consecutive 4-star (highest) ratings from Charity Navigator, America’s largest evaluator of charities, making the Foundation among the top 2% of all charities evaluated. The V Foundation is also a GuideStar Platinum-rated charity.

For more information about the V Foundation, its grants program, the Scientific Advisory Committee or to donate, please visit v.org. A complete list of the 2021 grant recipients can be found here.

On November 15, 2021 StacheStrong, a non-profit devoted to raising funds and awareness for brain cancer research, reported the launch of the Glioma Connectome Project (GCP), a newly-established consortium of neurosurgery centers to advance clinical research and treatment for patients with glioblastoma, an aggressive form of brain cancer (Press release, StacheStrong, NOV 15, 2021, View Source [SID1234595653]). The mission is to generate groundbreaking brain connectomics research to drive clinical and practice changes at neurosurgical centers across the U.S.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The nascent field of connectomics is a global interdisciplinary effort to study brain connectivity which has helped identify and understand individual brain networks responsible for functions such as language, emotion, and cognition. This new consortium will translate breakthrough neuroscience into real-world applications and potential new therapies for patients with glioblastoma and other types of brain cancer.

"We are excited to launch this consortium of leading institutions in the United States, to provide hope for patients diagnosed with brain cancer, and serve as a catalyst for change," said Colin Gerner, President and Co-Founder of StacheStrong. "This promising new study brings together top neurosurgeons and neuroradiologists to better learn about brain connectomics to perform more successful glioma surgeries, as well as how to better treat and rehabilitate after surgery."

The GCP consortium, which includes the University of Pennsylvania, University of Miami, Mount Sinai, Henry Ford Health System, Northwestern University and University of Nebraska Medical Center, will launch a series of prospective observational studies that harness large-scale multi-institution clinical data produced in the routine care of glioma patients. The study will collect patient data from MRI scans, to produce personalized brain maps. Harnessing machine learning techniques and cutting-edge software, the project will be structured to maximize the quality and volume of data, while minimizing the time and resources needed from physicians and patients.

"The GCP is a critical effort to translate the breakthrough findings of connectomics into neurological care. It embodies the common cause of these leading institutions to properly equip physicians fighting this devastating disease," said Dr. Michael Sughrue, a global thought leader in connectomics and Chief Medical Officer of Omniscient Neurotechnology.

About the Glioma Connectome Project (GCP)

The Glioma Connectome Project is a consortium of leading brain tumor centers dedicated to studying and exploring the wiring of the human brain, or "connectome", to further our understanding of the origins and progression of glioblastomas as well as developing and evaluating surgical, radiation, medical and immunological therapies. The consortium’s objectives include improving current treatment paradigms, developing new biomarkers and endpoints in glioma therapy, measuring the benefits and risks of glioma therapy including surgery, radiation, chemotherapy, electrical field therapy, and others. The consortium includes the University of Pennsylvania, University of Miami, Mount Sinai, Henry Ford Health System, University of Nebraska, and Northwestern University.

On November 15, 2021 Cytovation AS, a clinical stage immune-oncology company focused on the development of its first-in-class targeted tumor membrane immunotherapy, reported that the first patient has been dosed in the expansion phase of its Phase I/IIa CICILIA clinical trial (Press release, Cytovation, NOV 15, 2021, View Source [SID1234595652]). In this phase of the trial, CyPep-1 is being administered in combination with KEYTRUDA (pembrolizumab) in patients with a range of solid tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Lars Prestegarden, MD, PhD, CEO of Cytovation, commented: "We are very pleased to report the dosing of our first patient with CyPep-1 in combination with MSD’s leading anti-PD-1 therapy KEYTRUDA. This marks a further important milestone in our journey to bring this exciting potential new therapy to patients, where preclinical data suggest its mode of action is highly synergistic with checkpoint inhibitors. We believe CyPep-1 could have broad utility in treating a range of solid tumors and we look forward to reporting further data as we progress this study."

This new part of the planned expansion phase follows the successful conclusion of the initial monotherapy trial (Part 1) previously announced on September 23rd, 2021 and aims to evaluate the safety of CyPep-1 in combination with KEYTRUDA in 15 patients with a variety of advanced solid tumors.

Upon successful completion of this Phase I tranche of patients, the combination trial will move to a three arm, Phase II open-label, multi-center trial of CyPep-1 in combination with KEYTRUDA to evaluate the efficacy and safety of intratumoral CyPep-1 in patients with advanced HNSCC (head and neck squamous cell carcinoma), melanoma, or TNBC (triple negative breast cancer) receiving prior standard of care.

Initial results from Phase 1 of the combination arm safety study are expected early in 2022 with the Phase II combination trial scheduled to start shortly thereafter.

Previously in Part 1 of the CICILIA trial 12 patients were recruited with a range of solid tumors, each patient having received a minimum of three intra-tumoral injections of CyPep-1. Safety and tolerability in this first part of the monotherapy study were encouraging with no serious adverse events or dose-limiting toxicities, while early efficacy signals were positive and remain consistent with the preclinical proof-of-concept data previously generated.

Both the Phase I part of the combination program with KEYTRUDA and the three Phase II arms are part of a clinical trial collaboration and supply agreement with MSD.

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

About CyPep-1

CyPep-1 is a proprietary first-in-class targeted tumor membrane immunotherapy engineered to selectively target tumor cell membranes based on their altered molecular composition relative to normal cells. CyPep-1 eliminates cancer cells by forming pores in the plasma membrane, releasing cancer specific antigens to the immune system, promoting an inflammatory microenvironment, and inducing a tumor-specific immune response by in situ vaccination.

Preclinical data suggest this mode of action is highly synergistic with checkpoint inhibitors.

On November 15, 2021 Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, reported that an abstract highlighting clinical design for their lead drug candidate, Pidnarulex (CX-5461), in patients with solid tumors and BRCA2 and/or PALB2 mutation, has been accepted for trial in progress poster presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (2022 ASCO (Free ASCO Whitepaper) GI) in San Francisco, 20-22 January, 2022 (Press release, Senhwa Biosciences, NOV 15, 2021, View Source [SID1234595651]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Inherited mutations in BRCA genes predispose to various early onset cancers. Approximately 10% and 19% of pancreatic cancer patients harboring BRCA1 and BRCA2 mutations respectively and FDA has approved Lynparza (olaparib), the first poly ADP-ribose polymerase inhibitor (PARPi) as frontline maintenance in pancreatic cancer in late 2019. Unfortunately, resistance to PARPi associated with multiple mechanisms can be observed over time, suggesting a prominent unmet need for the development of new treatment options.

"Pidnarulex alone, has shown efficacy in tumor cells resistant to PARPi in the preclinical studies. When Pidnarulex was in combination with other chemotherapeutics, it even delayed the development of PARPi resistance. Therefore, we believe Pidnarulex demonstrates great potential as a treatment for pancreatic or other cancer patients who have acquired resistance to PARPi or other chemotherapies," said Tai-Sen Soong, Chief Executive Officer of Senhwa Biosciences.

The full abstract will be made available online via View Source at 5:00 PM (EST) on 18 January, 2022.

About Pidnarulex (CX-5461)

Specific mutations within the Homologous Recombination (HR) pathway may be exploited by Pidnarulex through a "synthetic lethality" approach by targeting the DNA repair defects in HR Deficient tumors. Specifically, Pidnarulex is designed to stabilize DNA G-quadruplexes of cancer cells, which leads to disruption of the cell’s replication fork. While acting in concert with HR pathway deficiencies, such as BRCA1/2 mutations, replication forks stall and cause DNA breaks, ultimately resulting in cancer cell death. On the other hand, PMCC postulates a different mechanism of action. Specifically, it is thought that Pidnarulex acts as a RNA Pol I Inhibitor.

On November 15, 2021 PACT Pharma, Inc., a clinical-stage company developing transformational personalized neoTCR-T cell therapies for the eradication of solid tumors, reported that new data related to its PACTImmune Database were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting (Press release, PACT Pharma, NOV 15, 2021, View Source [SID1234595650]). The results were featured in a poster presentation (#820) entitled, "Machine learning significantly improves neoantigen-HLA predictions utilizing > 26,000 data points from the PACTImmune Database," at the SITC (Free SITC Whitepaper) conference, which was held November 10-14, 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The presented results reported findings from a study in which PACT applied machine learning to more than 26,000 manufactured polypeptides consisting of the initially predicted neoE peptide together with Beta-2-Microglobulin and the HLA heavy chain for 62 different HLA alleles. Data demonstrated that PACT’s approach significantly improved neoE-HLA predictions, resulting in a 22% improvement in success rates on prospective data as compared to the widely used netMHCpan4.1 predictions. Additionally, the presentation outlined key elements of PACT’s strategy for continued enhancements to its approach to further improve its predictive power.

"The PACTImmune Database enables us to tune and continue to learn from our platform and its growing data assets. Based on retrospective analysis we know that higher predicted neoE-HLA success corelates with more TCRs captured per patient. Ultimately, these improved predictions should give us more actionable neoTCR options for patients in our clinical trial," said Eric Stawiski, Vice President of Bioinformatics at PACT and presenter of the SITC (Free SITC Whitepaper) poster.

The abstract related to this presentation is available on the SITC (Free SITC Whitepaper) website and can be accessed at: View Source

About PACTImmune Database
PACT has developed a proprietary approach to validate predicted neoepitopes (neoEs) and their cognate T cell receptors (neoTCRs) by capturing neoepitope-specific T cells from peripheral blood. This neoTCR discovery and validation process is being applied in a clinical trial (NCT03970382) evaluating personalized neoTCR-T cell therapy to treat patients across eight solid tumor types. Extensive pre-, on- and post-treatment data related to this trial has been accumulated in the PACTImmune Database (PIDB) which represents a growing data asset for patient-specific tumor immunogenicity in solid tumors.