On October 17, 2023 OncoNano Medicine, Inc. reported that it will be presenting positive preclinical data detailing delivery of interleukin-12 (IL-12) with the ON-BOARD platform at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), taking place November 1-5, 2023 in San Diego, California (Press release, OncoNano Medicine, OCT 17, 2023, View Source [SID1234636110]).

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ON-BOARD is an ultra pH-sensitive tumor delivery platform designed to minimize systemic exposure and toxicity by protecting oncology intervention payloads and releasing them specifically in the acidic tumor microenvironment. The poster presentation will detail encapsulation and delivery of IL-12, a potent pleiotropic cytokine, using ON-BOARD in immunocompetent mice.

Presentation Overview

TITLE: Encapsulation of IL-12 with an ultra pH-sensitive tumor delivery platform improves tolerability and promotes antitumor response in a preclinical model
PRESENTER: Jason Miller, Ph.D., Associate Director, Research Pipeline Development, OncoNano Medicine
DATE: Friday, November 3, 2023
TIME: 9:00 a.m. – 7:00 p.m. PT
LOCATION: Exhibit Hall B – San Diego Convention Center
POSTER NUMBER: 1147-B

On October 17, 2023 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that the company will present two poster presentations at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 taking place October 20-24, 2023, in Madrid, Spain (Press release, ORIC Pharmaceuticals, OCT 17, 2023, View Source [SID1234636098]). The presentations will highlight the initial Phase 1b clinical data for ORIC-114 in EGFR/HER2 exon 20 mutated cancers and new preclinical data for ORIC-114 demonstrating activity against additional atypical mutations in EGFR.

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In conjunction with the ESMO (Free ESMO Whitepaper) presentations, ORIC will host a conference call and webcast on Saturday, October 21, 2023, at 9:00 a.m. ET. Management will be joined by Dr. Alexander Spira, Clinical Director, NEXT Oncology-Virginia, who will share his perspective on the initial data from the Phase 1b study and the potential of ORIC-114 to treat EGFR/HER2 exon 20 mutated cancers.

Details of the ESMO (Free ESMO Whitepaper) poster presentations are as follows:

Title: A Global Phase 1b Study of ORIC-114, a Highly Selective, Brain Penetrant EGFR and HER2 Inhibitor, in Patients with Advanced Solid Tumors Harboring EGFR Exon 20 or HER2 Alterations
Poster #: 1333P
Poster Session: NSCLC, metastatic
Date & Time: Monday, October 23, 2023, at 9:00 a.m. CEST

Title: Preclinical Activity of ORIC-114, a Highly Selective, Brain Penetrant,
Irreversible Kinase Inhibitor, Against Atypical Mutations in EGFR
Poster #: 1345P
Poster Session: NSCLC, metastatic
Date & Time: Monday, October 23, 2023, at 9:00 a.m. CEST

Full abstracts are available for public viewing via the ESMO (Free ESMO Whitepaper) website. ePosters will be available Saturday, October 21, 2023, at 9:00 a.m. CEST.

Conference Call and Webcast Details

To join the conference call via phone and participate in the live Q&A session, please pre-register online here to receive a telephone number and unique passcode required to enter the call. A live webcast and audio archive of the conference call will be available through the investor section of the company’s website at www.oricpharma.com. The webcast will be available for replay for 90 days following the presentation.

On October 17, 2023 Nucleus RadioPharma, the world’s first fully integrated development, manufacturing, and supply chain organization for radiopharmaceuticals reported an oversubscribed $56 million Series A funding round led by Eclipse and GE HealthCare with participation from Echo Global, Fox Chase Cancer Center, Granger Management, Mayo Clinic, Mercy Health, and University of Missouri (Press release, Nucleus RadioPharma, OCT 17, 2023, View Source [SID1234636096]). With this round of funding, Nucleus RadioPharma will establish multiple new manufacturing facilities around the country, including Rochester, Minnesota, near Mayo Clinic, and build novel technology for the development, manufacturing, and distribution of radiopharmaceuticals.

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Radiopharmaceuticals offer a highly targeted approach to a wide variety of cancer types and stages. "Conceivably, many cancers have the potential to be treated with a properly designed radiopharmaceutical and yet, very few patients with cancer are receiving this kind of treatment," said Geoff Johnson, M.D., Ph.D., Chair of Nuclear Medicine, Mayo Clinic, and Chief Scientific Officer of Nucleus RadioPharma. Despite their promise, only a small fraction of patients are able to obtain these drugs due to limited production capacity and an outdated, fragmented supply chain. Nucleus RadioPharma was founded and built to ensure cancer patients can access potentially lifesaving radiopharmaceuticals by developing technologies to modernize the clinical development, manufacturing, and supply chain of these promising new therapies.

"Theranostic radiopharmaceuticals are offering promise for millions who currently have limited treatment options," said Charles S. Conroy, CEO of Nucleus RadioPharma. "As truly targeted therapies, these drugs are proving not only to be highly effective but also to maintain a superior safety profile. This funding advances the reach and impact of these life-saving agents, allowing for therapies that can be mass-produced, and offers hope to those with few alternatives."

In addition to its manufacturing capabilities, Nucleus RadioPharma will shape the development of a new supply chain network designed to move, track, and deliver materials to patients faster and more efficiently. This network will cover the entire process, from identifying target molecules and testing treatments to supporting regulatory approvals and delivering patient-ready medication. Nucleus will bring life-saving treatments to an even broader patient base with the completion of multiple large regional sites. To enable global logistics and distribution of these therapies, the company is developing novel software and hardware technologies.

"We co-founded Nucleus RadioPharma, and are leading their Series A, to propel the radiopharmaceutical industry forward," said Justin Butler, Partner at Eclipse. "Nucleus RadioPharma distinguishes itself as the first to offer an accelerated development platform, full-scale commercial manufacturing, and enhanced distribution through streamlined patient delivery systems. The company sets new standards for innovation in the industry, uniquely positioning Nucleus RadioPharma to unlock the full potential of the radiopharmaceutical sector."

Nucleus RadioPharma is positioned to expedite the availability of targeted radiopharmaceutical therapies through several ongoing partnerships and collaborations. These will enable rapid initiation of clinical trials, full support for formulation, analytical method development, regulatory guidance, and commercial manufacturing.

"Radiopharmaceuticals are a powerful tool in the fight against cancer," said Kevin O’Neill, President & CEO of GE HealthCare’s Pharmaceutical Diagnostics (PDx) segment. "Nucleus RadioPharma has made tremendous progress in the field in a short period of time. We are excited to partner with them to expand development, supply, and commercial manufacturing capabilities to make targeted radiotherapies and theranostics more accessible to patients globally."

On October 17, 2023 Diakonos Oncology Corporation ("Diakonos"), a clinical stage immuno-oncology company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s unique dendritic cell vaccine, DOC1021 (Press release, Diakonos Oncology, OCT 17, 2023, View Source [SID1234636095]). The designation was based on positive preliminary safety and efficacy data from a Phase 1 clinical trial enrolling patients with glioblastoma multiforme (GBM).

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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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FDA Fast Track designation is intended to speed development and review of drugs that show early clinical promise in treating severe or life-threatening conditions. This pivotal designation can help propel Diakonos closer to delivering DOC1021 to GBM patients, of which only 7% survive more than five years.

"The FDA’s decision acknowledges the potential of this new treatment approach for a very challenging disease," said Mike Wicks, Chief Executive Officer of Diakonos, "Our protocol represents a first for cancer immunotherapy and could be viable for many types of cancers beyond GBM."

Developed at the Texas Medical Center in Houston, DOC1021 represents a novel approach to fighting cancer that harnesses the body’s natural anti-viral immune response. By mimicking a viral infection with the patient’s cancer markers, DOC1021 leverages the body’s innate ability to detect and eliminate infected cells.

At the core of DOC1021 is Diakonos’ proprietary "double-loading" technique, which stimulates a previously undiscovered pathway for viral recognition and response. Using a patient’s dendritic cells, a type of white blood cell that detects threats, the unique cancer markers are loaded both internally and externally into the immune cells, which would simultaneously occur in a viral infection. Once the patient’s individualized treatment is prepared, it is administered through three precise injections targeting the deep cervical lymph node chains. This approach results in immune responses that directly target the central nervous system.

This revolutionary approach has shown remarkable outcomes, as the earliest patients have all exceeded survival expectations. DOC1021 also maintains an impressive safety profile. As the treatment enters the final stages of the clinical trial, no serious adverse events have been linked to it. In addition, without the need of genetic modification or artificial stimulation, DOC1021 further stands apart from other cancer immunotherapies.

"Because Phase I clinical trials are generally not statistically powered to demonstrate efficacy, detection of a statistically significant efficacy signal is very promising," said William Decker, Associate Professor of Immunology at Baylor College of Medicine and inventor of the DOC1021 technology.

Dr. Joseph Georges, FDA Sponsor-Investigator of the DOC1021 phase 1 clinical trial and Assistant Professor of Neurosurgery at the University of Arizona College of Medicine-Phoenix, said, "Historically, glioblastoma outcomes have been notoriously challenging to improve upon. From a clinical and scientific standpoint, the results we are observing with DOC1021 are encouraging. The vaccine’s mechanism of action and its unique route of administration showcase the potential of harnessing the body’s immune system to combat glioblastoma."

The Phase 1 open-label trial of DOC1021 (NCT04552886) is underway at the MD Anderson Cancer Center at Cooper University Health Care in Camden, NJ, and at the University of Texas Health Science Center in Houston. The trial is expected to complete this year.

GBM is the most common and lethal malignant brain tumor with an annual incidence of 3.19 per 100,000 persons in the U.S. About 61% of patients have the unmethylated subtype, which has demonstrated median survival of 15 months compared to 21.7 months for methylated GBM patients when treated with the standard of care.

On October 17, 2023 BostonGene, a leading provider of AI-based molecular and immune profiling solutions, reported that it will present three abstracts at ESMO (Free ESMO Whitepaper) Congress 2023 (Press release, BostonGene, OCT 17, 2023, View Source [SID1234636094]). This highly influential oncology event brings together clinicians, researchers, patient advocates, journalists and healthcare industry representatives from around the world to exchange and debate translational cancer science, present potentially practice-changing data and stimulate multidisciplinary discussions to improve treatment options for our patients. The event will be held on October 20 – 24, 2023, in Madrid, Spain, at the IFEMA MADRID. BostonGene will also exhibit in Hall 5, booth 550.

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BostonGene session details are below:

Abstract: 1215P
Title: Comparative analysis of cfDNA liquid biopsy and tumor-based next-generation sequencing (NGS) approaches
Date: Sunday, October 22
Presenter: Chris Davitt, PhD, BostonGene

This study compared the utility of cell-free DNA (cfDNA) liquid biopsy with tumor-based next-generation sequencing approaches, revealing a 66.2% and 31.4% increase in the detection of single nucleotide variants and insertions and deletions, respectively, in clinically actionable gene panels using cfDNA.

Abstract: 1963P
Title: Comprehensive profiling of chordoma reveals tumor microenvironment subtypes and unique molecular findings
Date: Monday, October 23
Presenter: Alexander Bagaev, PhD, BostonGene

Whole exome and whole transcriptome sequencing of chordoma patients identified distinct tumor microenvironment (TME) subtypes. In total, 89% of patients had immune-enriched (IE and IE/F) TMEs, highlighting potential avenues for targeted therapies, particularly immune checkpoint inhibitors, in the management of advanced chordomas.

Abstract: 1982P
Title: Transcriptomic analysis and tumor microenvironment (TME) classification reveals unique immune biology in HIV patients with Kaposi Sarcoma (KS)
Date: Monday, October 23
Presenter: Krystle Nomie, PhD, BostonGene

Transcriptomic analysis of HIV-positive and HIV-negative Kaposi Sarcoma (KS) patients revealed unique tumor microenvironment (TME) characteristics related to treatment response, suggesting potential avenues for novel therapeutic strategies in KS and emphasizing the importance of understanding the interplay between immune status and the TME.

To learn more or to schedule a meeting with BostonGene during the event, please contact Maria Proia at [email protected].

For more information, please visit the ESMO (Free ESMO Whitepaper) Congress 2023 website.