On June 2, 2022 ANP Technologies, Inc. (ANP) reported that its drug master file (DMF) on its novel, nano-encapsulating polymer-based drug excipient, ANP001B has been accepted and published by the U.S. Food & Drug Administration (FDA) (Press release, ANP Technologies, JUN 2, 2022, View Source [SID1234615462]). The DMF#36513 demonstrates ANP’s success in the development of its "Plug and Play" drug delivery platform that can be broadly applicable for many active pharmaceutical ingredients (API’s) – particularly those that are poorly soluble, need better pharmacokinetics, improved safety or tolerability, enhanced biodistribution or those requiring targeted delivery.

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The novel nano-encapsulating polymer, ANP001B, is a proprietary polymer composition developed by ANP and has been successfully used in the chemotherapy drug, FID-007 during the clinical trial conducted by ANP and its Partner Fulgent Pharma for the treatment of solid tumors in pre-treated cancer patients. The clinical trial was performed at the University of Southern California (USC) Norris Comprehensive Cancer Center and the results were published in 2021 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO FID-007).

"This is a significant validation and confirmation of ANP’s nano-encapsulating polymer drug delivery platform," said Dr. Ray Yin, President, and CTO of ANP. "Based on the data from the clinical trial, ANP001B is safe for intravenous (IV) injection in humans. In addition to FID-007, we are also working on a number of other drug candidates using the same nano-drug delivery platform with the goal to provide next generation formulation solutions by tackling age old problems associated with poor solubility, efficacy and tolerability. Our strong intellectual property (IP) position and low-cost manufacturing advantages have uniquely positioned ANP within the highly competitive drug development field, as it allows the rapid and vertical integration of our nano-drug delivery platform with various APIs seamlessly."

On June 2, 2022 InterVenn Biosciences, a clinical technology company leveraging glycoproteomics to transform the future of healthcare, reported new data showing that its new DAWN IO Melanoma test accurately assesses and classifies advanced melanoma patients as likely or unlikely to benefit from immune checkpoint inhibitor therapies: either pembrolizumab alone or ipilimumab in combination with nivolumab (Press release, InterVenn Biosciences, JUN 2, 2022, View Source [SID1234615461]). This test was developed on InterVenn’s perspectIV platform, which can directly interrogate the blood glycoproteome, for its own development or on behalf of partners.

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InterVenn conducted the validation study of the new DAWN IO Melanoma test in collaboration with Mass General Hospital (MGH), on a cohort of 205 advanced melanoma patients. The company was able to develop a signature based on the blood glycoproteome. The test is designed to guide clinicians in accurately assessing individual likelihood of benefit to the commonly used therapies nivolumab and ipilimumab, given in combination, or pembrolizumab. The test showed strong discriminatory power with a hazard ratio of 4.93 and high statistical significance.

DAWN IO Melanoma is the first in a series of liquid biopsy-based assays that InterVenn plans to develop under the DAWN IO brand to address a variety of cancers. InterVenn is building a robust pipeline of liquid biopsy tests to unlock the untapped, rich layer of biology called the glycoproteome, which is, in simple terms, the entire set of sugars on proteins. Because of the essential roles glycoproteins play in physiological functions, the glycoproteome has the potential to be highly significant for real-time clinical decision-making.

"Immune checkpoint inhibitors simply don’t work on everyone. The launch of DAWN IO Melanoma helps physicians and patients with advanced melanoma plan the best treatment path based on their likelihood to benefit from these therapies," said Aldo Carrascoso, CEO of InterVenn. "The DAWN IO Melanoma validation study confirms that the perspectIV platform can identify glycoproteomic biomarkers that perform consistently and accurately, with the potential to support oncologists treating patients with advanced melanoma and other complex cancers."

The Problem that DAWN IO Melanoma Solves

Approximately 100,000 cases of melanoma are diagnosed a year in the United States, with 5% of those diagnosed at a late stage. While cancer immune therapies are powerful treatments for many types of cancer, including melanoma, they are effective only in subsets of patients. Reliable tests to assess a patient’s likelihood of benefit before starting immunotherapy are limited, which can lead to sub-optimal clinical decisions.

Patients who gain no health benefit miss out on alternative options for treatment, losing valuable time. As a result, there is a significant unmet medical need for tests that can guide physician selection of the appropriate treatment, including the recommendation to enroll in an appropriate clinical trial.

Built to meet clinical requirements, DAWN IO Melanoma interrogates the blood glycoproteome at an unprecedented speed and scale. Unlike other non-invasive methods, it does not depend on detecting material shed by tumors, and it requires a significantly lower blood sample volume than conventional methods. In addition, the groundbreaking ability to process significantly large amounts of highly complex post-translational information enables clinical applications of glycosylation in ways that clinicians have not previously seen.

The Validation Study

Results of the retrospective validation study demonstrated a glycoproteomic biomarker signature successfully identified metastatic melanoma patients as likely or not to benefit from ICIs, where the "Unlikely to Benefit" group displayed a median progression-free survival of 2.5 months versus 17.34 months for the Likely to Benefit group, p<1.29 x 10-5. The study’s results confirm that DAWN IO Melanoma determined 12% of patients were "Unlikely to Respond" while 10% were classified as "Indeterminate."

"Our validation study is an important milestone in InterVenn’s ongoing efforts to build high-quality clinical tests and the supporting clinical evidence that its innovative glycoproteomic biomarkers can enable," said Tillman Pearce, M.D., Chief Medical Officer at InterVenn.

InterVenn’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists (CAP). The DAWN IO Melanoma test was developed, and its performance characteristics were determined by InterVenn. The DAWN IO Melanoma test has not been cleared or approved by the U.S. Food and Drug Administration. InterVenn’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The DAWN IO Melanoma test is intended for clinical purposes.

Lung Registry: Enrollment Begins

To further support clinical evidence for DAWN IO, InterVenn is starting recruitment for its HEaLth through I/O therapy Success Registry (HELIOS-001), focused on individuals diagnosed with advanced malignancies who will begin ICI treatment. The HELIOS-001 Registry will support current and future discovery of InterVenn’s DAWN IO product portfolio. Individuals who consent to participate will be asked to provide an initial blood sample, as well as clinical data pertaining to their diagnosis and treatment. For more information about the Registry, please contact [email protected].

Poster Presentation at ASCO (Free ASCO Whitepaper) 2022

The validation results will be presented in a poster session on June 6 at 1:15-4:15 p.m. CT in Hall A, Abstract # 9545, Poster #138 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting at McCormick Place in Chicago.

Additional Information

For more information about DAWN IO Melanoma, go to www.intervennoncology.com. InterVenn will also have a stand at the ASCO (Free ASCO Whitepaper) conference and will be available for in-person meetings during the event.

On June 2, 2022 RenovoRx, Inc. (Nasdaq: RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, reported that it will participate in the Gateway to Translation Webinar Series hosted by the University of Cambridge’s Academy of Therapeutic Sciences (CATS) on Wednesday, June 8, 2022 at 1:00 PM ET (Press release, Renovorx, JUN 2, 2022, View Source [SID1234615460]). Dr. Ramtin Agah, Chief Medical Officer and Co-Founder of RenovoRx, will present a seminar, "Localized Intra-arterial Drug Delivery for Treatment of Solid Tumors." To register for this seminar, click here.

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During his presentation, Dr. Agah will discuss current available treatment options for pancreatic tumors and why they can fall short of providing an effective solution for treating this deadly disease. He will also discuss how the RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP) therapy platform re-envisions the treatment of pancreatic and other difficult-to-treat cancers, as well as the scientific rationale underlying its development. The seminar will be chaired by Prof. Saeb-Parsy, Professor of Transplantation at the University of Cambridge, and will be followed by a live Q&A session.

"It is an honor to present at the upcoming Gateway to Translation Seminar Series at the University of Cambridge. I would like to thank Prof. Saeb-Parsy, Cambridge’s Academy of Therapeutic Sciences (CATS) and the University for the opportunity to share RenovoRx’s progress in this vital area of research," said Dr. Agah. "The development of our therapy platform was the result of challenging the traditional boundaries in medicine – we identified a gap in the standard of care for pancreatic and similar difficult-to-treat cancers and designed the RenovoTAMP therapy platform, which is now in a Phase 3 clinical trial. Our Phase 1/2 and observational registry studies have demonstrated the potential for localized treatment of pancreatic cancer to decrease side effects typical of systemic chemotherapy, and importantly, improve patient survival. RenovoRx represents the mission of CATS and the potential for innovation through collaboration across medical disciplines and between academics and industry."

A recording of this presentation will be posted to the RenovoRx Website Events page when it becomes available.

On June 2, 2022 Kiyatec, a leader in functional precision oncology, reported that new clinical evidence of its proprietary ex vivo 3D cell culture technology use in high-grade glioma will be presented at ASCO (Free ASCO Whitepaper) 2022 (Press release, KIYATEC, JUN 2, 2022, View Source [SID1234615459]). As a first-time ASCO (Free ASCO Whitepaper) presenter and exhibitor, Kiyatec will present its Clinical Services and Drug Development Services capabilities at ASCO (Free ASCO Whitepaper)’s first-ever Innovation Hub at kiosk #IH01. The ASCO (Free ASCO Whitepaper) meeting will be held in Chicago June 3-7, 2022.

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In this updated cohort of 42 patients with high grade glioma, 3D Predict Glioma prospectively predicted patient response to standard of care temozolomide (TMZ), regardless of MGMT methylation status. In a subgroup analysis of the 23 MGMT unmethylated patients, test-predicted responders had a relative median progression-free survival advantage of 5.9 months versus test-predicted non-responders (p = 0.0018). This data provides additional evidence of 3D Predict Glioma predictivity and its potential to provide additional information for glioma patient treatment options including clinical trial enrollment, alternative therapies indicated for use in glioma or combination therapy with TMZ.

Kiyatec Chief Executive Officer Matthew Gevaert, PhD, said, "This enhanced cohort adds to our body of clinical evidence demonstrating the predictive insights 3D Predict Glioma can provide to neuro-oncologists planning treatment for glioblastoma patients. With it, we’ve advanced our mission is to disrupt cancer care by accurately predicting patient-specific response and non-response before treatment begins."

High grade gliomas, including glioblastoma, are among the most aggressive brain cancers, with patients exhibiting highly variable treatment responses in both newly diagnosed and recurrent disease. TMZ with radiation therapy is the guideline-directed standard of care in the newly-diagnosed setting, which has remained relatively unchanged for over 15 years despite variable patient responses.

Kiyatec’s ex vivo KIYA-Predict pre-clinical platform and 3D Predict clinical assays are leading the functional precision oncology space with published, clinically-correlated evidence to prospectively predict glioma patient therapeutic response prior to initiation of therapy.

Clinical application of a functional 3D ex vivo test to predict therapeutic response in patients with HGG: A progression-free survival analysis

On June 2, 2022 GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, reported a broad strategic collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN) to develop and commercialize companion diagnostic (CDx) assays for use with AstraZeneca’s therapies (Press release, Grail Bio, JUN 2, 2022, View Source [SID1234615458]). The collaboration will initially focus on developing companion diagnostic tests to identify patients with high-risk, early-stage disease, with plans to embark on numerous studies across multiple indications over the next several years. The parties are additionally planning to use GRAIL’s technology to enable recruitment of patients with early-stage cancer for AstraZeneca’s clinical studies.

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"GRAIL has developed a novel approach to detect cancer signals in blood, regardless of whether or not the patient has clinical symptoms. We are excited to embark on this work with AstraZeneca to transform cancer outcomes through a broad, strategic collaboration," said Sir Harpal Kumar, President, Biopharma Business and Europe at GRAIL. "Through our collaboration, we hope to provide critical information to improve the identification of patients who may be eligible for clinical trials and change clinical paradigms for the treatment of early-stage cancers."

Across the projects within this collaboration, GRAIL will use its methylation platform to perform testing for patients enrolled in AstraZeneca’s clinical trials. GRAIL will seek regulatory approval in key markets for the liquid biopsy companion diagnostics.

Susan Galbraith, Executive Vice President of Oncology R&D, AstraZeneca, said: "Identifying and treating cancer early is at the heart of this strategic collaboration. Combining GRAIL’s innovative blood-based methylation profiling platform with AstraZeneca’s leadership in Oncology, we hope to accelerate the adoption of circulating tumor DNA across clinical trials and make our cancer medicines available at an earlier stage of disease when there is greater potential to transform patient outcomes, and even cure."

GRAIL is developing its proprietary methylation platform for use in multiple post-diagnostic settings to identify patients at high risk of future cancer recurrence, detect the presence or absence of residual disease, and to inform treatment decisions, including identifying patients with cancer who may be eligible for neoadjuvant or adjuvant therapy. GRAIL’s technology platform is designed to optimize circulating tumor DNA testing to enable detection of early stage disease and minimal residual disease (MRD).