On June 2, 2022 National Resilience, Inc. (Resilience) and The University of Texas MD Anderson Cancer Center reported the launch of a joint venture, the Cell Therapy Manufacturing Center, to accelerate the development and manufacturing of innovative cell therapies for patients with cancer (Press release, National Resilience, JUN 2, 2022, View Source [SID1234615464]). Uniting the strengths of Resilience and MD Anderson, the joint venture will advance its work within a culture of academic innovation alongside industrial expertise.

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The Cell Therapy Manufacturing Center will be based in a state-of-the art 60,000-square-foot manufacturing facility in the Texas Medical Center, with a team of 70 employees focused on process and analytical development as well as early-phase and clinical-stage Good Manufacturing Practices (GMP).

The joint venture combines MD Anderson’s expertise in immunotherapy and cell therapies as well as a leading clinical trials infrastructure, with Resilience’s innovative biomanufacturing technologies, advanced analytics and a national network for developing and producing cell therapies. Together, the parties aim to accelerate the path of cell therapies to the clinic, while enabling scalability and a smooth transition to late-phase clinical and commercial activities.

"Cell therapies have had a dramatic impact for patients with certain cancers, but progress has been hampered by structural challenges," said Jason Bock, Ph.D., Chief Executive Officer of the Cell Therapy Manufacturing Center. "This novel joint venture was conceived to address those challenges by harnessing the complementary capabilities of two world-class organizations, allowing us to advance innovative programs to deliver impactful therapies to patients."

The joint venture will engage with MD Anderson researchers and external industry collaborators to advance new therapies through preclinical and clinical development, ensuring consistent and safe products that can be evaluated rapidly in clinical trials led by MD Anderson physicians. Resilience customers will be able to leverage this offering as part of the company’s growing network of biomanufacturing facilities that are flexible enough to scale projects from small-batch pre-clinical to large-scale commercial production. Resilience has 10 facilities across North America, with more than 1 million square feet of manufacturing space.

"The promise of cell therapies to help patients in need has been limited by a lack of innovation in biomanufacturing," said Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience. "This collaboration aims to overcome those hurdles by extending our network with this unique partnership, creating opportunities to incubate innovative ideas and provide cutting-edge biomanufacturing technologies and processes to researchers, with a goal of bringing more cell therapies to patients."

The joint venture will advance the most promising cell therapy modalities to answer unmet clinical needs, including engineered tumor infiltrating lymphocytes (TILs), chimeric antigen receptor (CAR)-modified T cells, endogenous T cells (ETCs), engineered natural killer (NK) cells and other emerging technologies, for patients with hematological and solid tumors. MD Anderson researchers are leaders in the field of cancer cell therapy, responsible for advancing the translational and clinical development of many of the currently approved and experimental cell therapies.

The joint venture is built upon MD Anderson’s Biologics Development platform, formerly part of the institution’s Therapeutics Discovery division. Current strategic collaborations with MD Anderson’s Biologics Development platform will continue; collaborative relationships with MD Anderson’s Therapeutics Discovery division, as well as physicians and scientists across the institution, also will be maintained.

"We believe in the tremendous potential of cell therapies to deliver solutions that offer cures, not merely prolonged survival. Resilience offers unique capabilities that make it an ideal choice for unlocking that potential and accelerating impactful cell therapies," said Ferran Prat, Ph.D., J.D., senior vice president for Research Administration and Industry Relations at MD Anderson. "Our mission at MD Anderson is to end cancer, and this joint venture is a strategic step toward realizing that goal."

On June 2, 2022 Immunicom, Inc., a privately held clinical-stage biotechnology company with a transformative immuno-oncology platform, reported data from its ongoing clinical investigation [NCT04004910] at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting (Press release, Immunicom, JUN 2, 2022, View Source [SID1234615463]). The trial data, detailed by principal investigator Prof. Piotr Wysocki, show that the Company’s Immunopheresis LW-02 Column is a safe, promising immunotherapy that helps spur upregulation of a patient’s TNF-α pathway—an endogenous cytokine broadly recognized for its anticancer characteristics.

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As part of Immunicom’s ongoing clinical study, 28 patients with advanced triple negative breast cancer (TNBC) underwent 862 LW-02 Column Immunopheresis procedures. 10 patients received Immunopheresis LW-02 Column as a monotherapy, and 18 patients received it in addition to various chemotherapy regimens. As reflected in the trial data, subtractive therapy with the LW-02 Colum as a monotherapy or adjunct to chemotherapy is safe and achieves effective depletion of soluble TNF-α receptors from plasma. It was also noted that no serious device-related adverse events related to the LW-02 Column have been reported in the trial.

Therapy with the LW-02 Column was performed three times a week for at least 16 weeks by processing two plasma volumes via apheresis per treatment. After 30 minutes of therapy, the mean capture efficiencies for sTNF-R1 and sTNF-R2—the proteins shed by tumors that suppress endogenous TNF-α—were 95.2% and 79.6%, respectively. The LW-02 Column was also found to be highly selective in removing sTNF-R1 and sTNR-R2 from total plasma proteins. The mean total amount of sTNF-R1 & sTNF-R2 that leeched from the LW-02 Column was 109 ng per apheresis session, many orders of magnitude lower than TNF-α concentrations known to trigger clinically meaningful effects.

Commenting on the trial data presentation, Immunicom Chief Clinical Officer Dr. Victoria Manax revealed, "LW-02 Column Immunopheresis data suggest that removing these factors is an increasingly promising modality for cancer patients. The ASCO (Free ASCO Whitepaper) abstract highlights both the LW-02 column’s efficacy and safety profile. Coupled with our AACR (Free AACR Whitepaper) presentation last month, which shared results of the ongoing clinical benefit to patients, even patients with advanced stage cancers, we continue to find evidence that this is an exciting new option in immuno-oncology."

Through the Company’s three ongoing global clinical trials, Immunicom continues to evaluate the safety and efficacy of LW-02 Column Immunopheresis for advanced TNBC as well as other solid tumor types. You can learn more about Immunopheresis and TNBC in Immunicom’s ASCO (Free ASCO Whitepaper) 2022 Abstract presentation.

Subtractive Therapy – Immunopheresis and the LW-02 Column

Immunicom employs a proprietary, high-affinity, molecular capture-ligand binding matrix within the LW-02 Column to remove specific cytokine receptors, soluble TNF-Receptors 1 and 2 (sTNFR-1/2), that are shed by cancer cells into the extracellular tumor microenvironment. sTNF-Rs serve as decoys, binding to tumor necrosis factor alpha (TNF-α) before it can bind to its membrane-embedded sTNF-R receptors to trigger several cell death pathways. The selective removal of decoy sTNF-Rs by the LW-02 Column allows the patient’s immune system to identify and aggressively attack the cancer.

Immunopheresis, like dialysis, is a subtractive therapy that occurs outside the body, in contrast to conventional drugs and biologics that are infused into the patient. Immunopheresis is thus intended to be much better tolerated than chemo- and immunotherapies, allowing for its use as an adjunct with these therapies, possibly in lower doses to reduce their toxicity.

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.