On June 1, 2023 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing targeted combination therapies, reported that the University of Texas (UT) Southwestern Medical Center is now enrolling pancreatic cancer patients in the open label, randomized Phase III TIGeR-PaC clinical trial (Press release, Renovorx, JUN 1, 2023, View Source [SID1234632376]). The study is investigating RenovoGem which utilizes RenovoRx’s proprietary therapy platform, TAMP, to provide improved and targeted intra-arterial delivery of FDA-approved gemcitabine chemotherapy to treat Locally Advanced Pancreatic Cancer (LAPC).

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The study is comparing RenovoGem with standard of care treatment (intravenous gemcitabine and nab-paclitaxel). RenovoRx recently announced interim analysis data that suggested a 6-month improvement in median overall survival and a 65% reduction in side effects versus standard of care.

"Pancreatic cancer is expected to be the second largest cause of cancer-related deaths before 2030*," said Principal Investigator, Salwan Al Mutar, MD, MSc, Assistant Professor at UT Southwestern Medical Center. "Systemic, intra-venous chemotherapy uses blood vessels to deliver treatment. However, pancreatic cancer tumors have poor blood supply so systemic chemotherapy may not reach the tumor. This clinical trial is evaluating targeted, intra-arterial chemotherapy that is singularly focused on the tumor."

Ramtin Agah, M.D., RenovoRx’s Founder and Chief Medical Officer, commented, "UT Southwestern Medical Center is one of the world’s premier academic medical organizations, integrating research with exceptional clinical care. We are excited Dr. Al Mutar and his team are enrolling patients in this important and transformative study. Our shared vision is providing cancer patients with novel therapies to enhance survival and quality of life."

UT Southwestern is the most recent clinical trial site to join the Phase III TIGeR-PaC study which continues enrolling patients at U.S. sites. UT Southwestern’s staff of more than 2,800 providers is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments. Physicians there provide medical care in about 80 specialties to more than 105,000 hospitalized patients, nearly 370,000 emergency room cases and oversee approximately three million outpatient visits annually.

About the TIGeR-PaC Study

TIGeR-PaC is a randomized multi-center Phase III open label clinical trial designed to investigate the Company’s first product candidate, RenovoGem, which utilizes RenovoRx’s proprietary therapy platform, TAMP, to provide targeted intra-arterial delivery of FDA-approved chemotherapy, gemcitabine, to treat locally advanced pancreatic cancer (LAPC) following stereotactic body radiation therapy (SBRT). The study is comparing treatment with TAMP versus standard of care systemic intravenous (IV) administration of gemcitabine and nab-paclitaxel. The study is designed to randomize 114 patients (57 in each arm) with all patients receiving upfront induction chemotherapy and SBRT. Final analysis will be conducted after 86 protocol-specified events have occurred in the SBRT population with two planned interim analyses: the first analysis when 30% of the specified events has been reported and the second analysis when 60% of the events have been reported (expected in mid-2024).

TIGeR-PaC is currently enrolling unresectable LAPC patients at several sites across the US. To learn more about the study and the participating clinical trial sites, visit View Source

On June 1, 2023 Seven and Eight Biopharmaceuticals Inc., a clinical stage biotechnology company focused on developing proprietary novel immuno-oncology therapies to activate the immune system against cancer, reported that it has signed an exclusive licensing agreement with Eikon Therapeutics (Press release, Seven and Eight Biopharmaceuticals, JUN 1, 2023, View Source [SID1234632375]). As part of the agreement, Eikon Therapeutics is awarded global rights to develop and commercialize the company’s novel immune modulator agonists targeting toll-like receptor 7 and 8 (TLR7/8).

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"We have made great progress in the field of TLR7/8 agonists and advanced our molecules to industry leading positions," said Walter Lau, Ph.D., Chief Executive Officer of Seven and Eight Biopharmaceuticals. "We are delighted to have the Eikon team continue the clinical development and ultimate commercialization of these molecules. Eikon and its highly experienced immuno-oncology team has a proven track record of developing and commercializing industry leading anti-PD-1 therapies, and we believe they will be uniquely positioned to advance our first-in-class TLR7/8 agonists as potential treatments for multiple tumor types."

"The Seven and Eight Biopharma novel TLR7/8 agonists have, in Phase I trials, shown an acceptable safety profile in over 150 patients treated in mono- or in combination with anti-PD-(L)1 therapy," said Robert H.I. Andtbacka, M.D., C.M., Chief Medical Officer of Seven and Eight Biopharmaceuticals. "In addition, encouraging clinical responses have been seen in both mono- and combination therapy in multiple heavily pre-treated tumor types. We are excited to see the development of these novel TLR7/8 agonist continue under Eikon’s leadership."

The exclusive licensing agreement also includes development of novel Toll-like receptor ligand antibody conjugation (TLAC) molecules. "Over the years, Seven and Eight Biopharma has built not only TLR7/8 agonist programs from the ground up but also an innovative TLAC platform, and we are glad to see the continued development of these promising molecules" said Lixin Li, M.D., Ph.D., Chief Technical Officer of Seven and Eight Biopharmaceuticals.

On June 1, 2023 BostonGene reported that four abstracts have been accepted for poster presentations and two abstracts have been accepted for online publication for the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), which will be held June 2 – 6, 2023, at McCormick Place Convention Center in Chicago, IL (Press release, BostonGene, JUN 1, 2023, View Source [SID1234632374]). BostonGene will also exhibit at booth 28155.

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"We look forward to sharing results from our research analyzing genomic and transcriptomic classifications and our analysis demonstrating the added benefit of comprehensive genomic profiling in a thousand diverse cancer patients at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting. These presentations reflect our scientific expertise and commitment to bringing innovative solutions into clinical practice," said Nathan Fowler, MD, Chief Medical Officer at BostonGene.

Details about the abstracts selected for presentation can be found below:

Abstract Number: 3076
Title: Aggregated analysis of 1,000 patients with cancer to assess the benefits of integrated whole exome and whole transcriptome sequencing
Date and Time: Saturday, June 3 | 8:00 AM – 11:00 AM CT
Location: McCormick Place Convention Center
Poster Number: 274
Speaker: Anna Ogloblina, PhD, BostonGene

The deep interrogation of BostonGene’s comprehensive approach to molecular profiling demonstrates the advantages of integrated RNA sequencing (RNA-seq) and whole exome sequencing (WES) analysis, including an increase in clinically significant biomarkers and matched clinical trials, which can ultimately lead to more effective personalized treatments for cancer patients.

Abstract Number: 11547
Title: Novel genomic alterations and transcriptomic-based tumor microenvironment classification of sarcoma and their impact on treatment decision-making
Date and Time: Saturday, June 3 | 1:15 PM – 4:15 PM CT
Location: McCormick Place Convention Center
Poster Number: 481
Speaker: Krystle Nomie, PhD, BostonGene

This presentation demonstrates the ability of the BostonGene’s Tumor PortraitTM test to identify genomic alterations and classify tumor microenvironment (TME) subtypes of sarcomas that ultimately provide insights on potential immunotherapy and specific gene-related treatment strategies.

Research conducted in collaboration with The University of Texas MD Anderson Cancer Center

Abstract Number: 579
Title: Differential genomic and transcriptomic analysis of invasive lobular and ductal carcinomas
Date and Time: Sunday, June 4 | 8:00 AM – 11:00 AM
Location: McCormick Place Convention Center
Poster Number: 409
Speaker: Jason Mouabbi, MD, MD Anderson

In this study, the use of BostonGene’s integrated analysis platform provided an in-depth understanding of the molecular differences between two breast cancer subtypes, invasive lobular carcinoma (ILC) and invasive ductal carcinoma (IDC), revealing mechanistic insights for both subtypes that can be used to tailor ILC-specific interventional clinical trials.

Abstract Number: 1039
Title: Genomic characterization of the GATA3 mutational landscape in breast cancer
Date and Time: Sunday, June 4 | 8:00 AM – 11:00 AM
Location: McCormick Place Convention Center
Poster Number: 260
Speaker: Jason Mouabbi, MD, MD Anderson

This presentation highlights the use of integrated genomic and transcriptomic analysis to understand further the mutational landscape of GATA3, a broadly used biomarker in breast cancer, to guide future prospective clinical studies.

Online publication abstracts:

Abstract Number: e15058
Title: RNA sequencing as a confirmatory assay and its impact on patient care in multiple cancer types

This presentation describes the advantage of RNA sequencing (RNA-seq) to confirm the pathological detection of biomarkers, demonstrating the utility of RNA-seq analysis to drive treatment decisions in 4 cancer types.

Research conducted in collaboration with Weill Cornell Medicine, Englander Institute of Precision Medicine, MD Anderson, Oncology Consultants, and Cancer Centers of South Florida

Abstract Number: e14691
Title: Tumor immunity portrait: An AI-driven molecular predictor combining tumor microenvironment and tumor mutational burden for immune checkpoint inhibitor response prediction

This study highlights the ability of BostonGene’s Tumor Immunity PortraitTM, an integrated approach combining the tumor’s characteristics and TME, to provide an accurate prediction of ICI non-response in 3 cancer types for personalized treatment decision-making.

For more information, please visit the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting website. The abstracts will be published online in the Journal of Clinical Oncology supplement for the ASCO (Free ASCO Whitepaper) Annual Meeting Proceedings.

On June 1, 2023 Shasqi, Inc. ("Shasqi"), a clinical-stage biotech company, whose mission is to revolutionize cancer treatment with click chemistry, reported that it has entered into a research collaboration with Johnson & Johnson Enterprise Innovation Inc (Press release, Shasqi, JUN 1, 2023, View Source [SID1234632373]). Through the collaboration, Shasqi will apply its novel tumor-targeted Click Activated Protodrugs Against Cancer (CAPAC) platform to the development of new cancer therapies.

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Shasqi’s CAPAC platform relies on chemistry, not biology, for activation of drugs at the tumor. The platform is made up of two separate components: a tumor-targeting agent and a cancer therapeutic. These come together at the site of the tumor, and the cancer therapeutic is activated via click chemistry, a Nobel Prize winning technology. Using this platform, Shasqi is targeting high doses of cancer drugs directly to the site of the tumor, while minimizing toxicity to healthy cells. Shasqi is the first company to use click chemistry in humans.

"This is a compelling opportunity to expand our platform," said José M. Mejía Oneto, MD, PhD, founder and chief executive officer of Shasqi. "We are excited to collaborate and apply click chemistry for potential new therapies in areas of significant unmet medical need."

The use of click chemistry to activate cancer drugs at the tumor has been clinically validated. In a phase 1 study, click chemistry was used to activate a dose of doxorubicin that is 12-times a conventional dose, with a favorable toxicity profile. Tumor localization of click chemistry was achieved through an intratumorally injected biopolymer. A phase 2a study is currently enrolling patients with soft tissue sarcoma and head and neck cancer.[1]

The collaboration will focus on Shasqi’s intratumorally injected biopolymer (SQL70) and a co-development committee has been formed with the aim of identifying the next clinical candidate.

"This marks the start of Shasqi’s ambition to advance our platform and collaboratively develop the next generation of tumor-targeted therapies, expanding on the foundation built by antibody drug conjugates," said Mukul Agarwal, chief business officer at Shasqi. "The reliance on chemistry, not biology for drug activation, allows for the use of small molecules, peptides, and antibody fragments to target tumor antigens, creating unprecedented flexibility."

On June 1, 2023 Sengenics Corporation LLC, driving the discovery of next-gen biomarkers through its immunoproteomics platform, reported that Dr. Iman Osman, Director of the Interdisciplinary Melanoma Program at New York University Grossman School of Medicine, will be presenting groundbreaking findings at the American Association of Clinical Oncologists (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, June 2nd – 6th, 2023 (Press release, Sengenics, JUN 1, 2023, View Source [SID1234632372]). Her poster, titled "Determinants of racial disparities in immune-related adverse events (irAE) with checkpoint inhibition (ICI) in melanoma" (Abstract #9549, Poster Board # 312), sheds light on the prediction of irAEs in patients treated with checkpoint inhibitors. The predictive antibody data were generated with the Sengenics immunoprofiling platform.

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The emergence of immune checkpoint inhibitors has revolutionized cancer treatment by effectively countering cancer cells’ suppression of the cytotoxic T-cell response. They have revolutionized the field and brought hope to many patients. However, these inhibitors often give rise to immune-related adverse events (irAEs). The ability to predict the occurrence of irAEs would significantly enhance clinicians’ decision-making in treatment protocols.

Dr. Osman’s research investigates the hypothesis that patients susceptible to irAEs may exhibit baseline antibody profiles that hold predictive value for their response. Notably, she is extending her investigation to identify predictive signatures within underrepresented minority populations.

"I believe it is of utmost importance to develop predictive models that can be universally applicable, encompassing all patients and not solely the majority population," stated Dr. Osman. "Recognizing the diversity in immune responses and avoiding the oversimplification of assuming what works for one group will work for another is crucial."

Jerry Williamson, President, and CEO of Sengenics, expressed enthusiasm for promoting Dr. Osman’s critical work, stating, "We are thrilled to support Dr. Osman’s groundbreaking research, as it contributes to the growing body of evidence supporting the value of antibody biomarkers."

Dr. Osman currently serves as the Associate Dean for Clinical Research Strategy and Director of the Interdisciplinary Melanoma Program at New York University Grossman School of Medicine. Her primary focus revolves around conducting translational research in melanoma where she spearheads the Melanoma Research Enterprise at NYU.