On November 15, 2021 RenovoRx, Inc. (Nasdaq: RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, reported its unaudited financial results for the third quarter ended September 30, 2021 (Press release, Renovorx, NOV 15, 2021, View Source [SID1234595664]).

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"The third quarter of 2021 marked an important juncture in the growth of our company as we completed our IPO in late August and our seventh U.S. patent was issued for our RenovoTAMP (RenovoRx Trans-Arterial Micro-Perfusion) therapy platform. Our team remains patient-focused, supporting the clinical sites, their patients and families enrolled in our Phase 3 TIGeR-PaC clinical trial for the treatment of locally advanced pancreatic cancer (LAPC)," said Shaun Bagai, Chief Executive Officer of RenovoRx.

Mr. Bagai added, "At two recent pancreatic cancer-focused meetings, we presented incremental positive study data from our foundational clinical trials that support the potential for more tolerable and targeted treatment of LAPC through intra-arterial delivery of chemotherapy. Through preliminary pharmacokinetic data (data describing the absorption, distribution, metabolism, and excretion of chemotherapy) from five patients in the TIGeR-PaC study, we found an approximate two-thirds reduction in systemic gemcitabine, when compared to systemic levels in historical control patients receiving traditional IV infusion of gemcitabine. This finding reinforces the potential for intra-arterial delivery to improve tolerability, reduce typical, and often debilitating, side effects associated with systemic chemotherapy, and ultimately improve quality of life. In addition, the final data we presented from our RR2 Observational Registry Study suggests that when RenovoTAMP is used in combination with radiation therapy, it may reduce arterial microvasculature, which minimizes leakage during chemotherapy delivery, and thereby increases the chemotherapy directly reaching the tumor."

GAAP Financial Results

For the Third Quarter Ended September 30, 2021 (Unaudited)

Net loss for the third quarter of 2021 was $1.5 million, compared to $1.1 million for the third quarter of 2020.
Research and development expenses for the third quarter of 2021 were $0.8 million, compared to $0.7 million for the same period in 2020. The increase was primarily due to higher clinical development personnel costs.
General and administrative expenses for the third quarter of 2021 were $0.6 million, compared to $0.2 million for the same period of 2020. The increase was primarily due to higher professional and consulting expenses related to preparing for our IPO in August 2021, including personnel costs and insurance costs for directors and officers liability insurance.
For the Nine Months Ended September 30, 2021 (Unaudited)

Net loss for the nine months ended September 30, 2021 was $4.0 million, compared to $2.9 million for the same period in 2020.
Research and development expenses for the nine months ended September 30, 2021 and 2020 were each $1.9 million. Research and development expenses during the 2021 period were higher overall, primarily due to higher clinical development personnel costs, but were offset by lower leased software expenses and payments received from clinical sites for the use of our RenovoCath delivery system in our Phase 3 clinical trial.
General and administrative expenses for the nine months ended September 30, 2021 were $1.4 million, compared to $0.6 million for the same period of 2020. The increase was primarily due to higher professional and consulting expenses related to preparing for our IPO in August 2021, including personnel costs and insurance costs for directors and officers liability insurance.
As of September 30, 2021, the Company had cash and cash equivalents of $17.7 million and no outstanding debt obligations.

About the Phase 3 TIGeR-PaC Clinical Trial

The TIGeR-PaC clinical trial is a randomized multi-center study using the RenovoTAMP platform to evaluate RenovoRx’s first product candidate, RenovoGem to treat unresectable LAPC through the intra-arterial delivery of gemcitabine, an approved chemotherapeutic agent. TIGeR-PaC is currently enrolling locally advanced, unresectable pancreatic cancer patients. To learn more about the study and the participating clinical trial sites, visit View Source

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.

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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.

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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.

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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]).

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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.