On March 22, 2022 Paige, the global leader in AI-based diagnostic software in pathology, reported that launched its latest product, Paige Breast Lymph Node, an AI medical device software that helps pathologists detect if breast cancer has metastasized to lymph nodes, concurrent with pathologists’ own interpretive review* (Press release, Paige AI, MAR 22, 2022, View Source [SID1234610613]). The product was unveiled at the United States and Canadian Academy of Pathology (USCAP) Annual Meeting taking place March 19-24, 2022.

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Determining whether cancer in the breast has spread to the lymphatic system is critical to a patient’s diagnosis and planned treatment. Due to the size of the tissue area and size of the small micro-metastases, a pathologist’s accurate assessment of a lymph node slide can be tedious and time-consuming.

Designed to increase the accuracy and efficiency in the detection of breast cancer metastases that are most at-risk for being missed, Paige Breast Lymph Node leverages AI to empower pathologists to identify tumor metastases of any size, including small micrometastases, more efficiently and reliably. It is designed to enhance diagnostic accuracy for the most subtle metastatic foci and has over 98% slide level sensitivity to detect metastases of any size. A positive indication of metastatic breast cancer will be displayed at the individual lymph node level with Paige’s proprietary TissueMap, which highlights all regions on a slide that are suspicious for cancer. In addition, both slides and cases with suspected positive lymph nodes are highlighted, facilitating their prioritization and efficient review by the pathologist.

"Accurate detection of breast cancer metastases is paramount for physicians and their patients, but it can be a laborious, manual task for pathologists," said David Klimstra, M.D., Founder and Chief Medical Officer at Paige. "Paige Breast Lymph Node offers pathologists a quicker and more efficient way to analyze large quantities of lymph node tissue, as well as peace of mind for them and their patients."

Paige Breast Lymph Node will be available immediately as part of the Paige Breast Suite. This software uses the same underlying AI technology as Paige Prostate, which can work with a broad range of data, staining techniques, and scanning artifacts, resulting in a generalizable AI that can be quickly deployed in a variety of laboratory and hospital settings.

"Paige Breast Lymph Node bolsters the value of the Paige Breast Suite to clinical pathologists," said Andy Moye, Ph.D., Chief Executive Officer at Paige. "This product launch is an important step in our overall commercialization strategy as we bring the power of our AI platform to new disease areas. Alongside our FDA-approved Paige Prostate, the generalizability of the AI further validates the broader use of Paige’s software in assisting pathologist to diagnose cancer."

Paige will host a webinar on March 30 to demonstrate how Paige Breast Lymph Node can be used in clinical practice. For more information about Paige Breast Lymph Node, visit View Source or contact [email protected].

*Paige Breast Lymph Node is available for research use only in United States and in other regions where research use is permitted. Research use only products should not be used in diagnostic procedures.

On March 22, 2022 Proscia, a leader in digital and computational pathology solutions, and Visiopharm, a world leader in AI-driven precision pathology software, reported a strategic partnership to deliver integrated AI-enabled solutions that aim to improve clinical decision making for cancer care (Press release, Proscia, MAR 22, 2022, View Source [SID1234610612]). Through the collaboration, the partners will advance the use of AI-enabled solutions to deliver new insights to pathologists for two of the most common cancer diagnoses.

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Driven by a growing base of evidence on the economic and clinical benefits of adoption, leading laboratories are increasingly looking to adopt AI in routine practice to optimize operations and improve patient care. In a Nature survey of pathologists, 75% expressed interest in using AI to facilitate workflow and quality improvements, and 80% expected to be using AI by 2028. Powerful computational applications such as Visiopharm’s portfolio of breast and colon solutions have highlighted the role that AI could play in improving diagnosis for an increasingly large portion of lab volume. However, a key barrier to deriving the full value of AI is the lab’s ability to seamlessly integrate this diverse range of applications into routine operations.

Proscia and Visiopharm have joined forces to deliver a unified solution that combines Visiopharm’s suite of CE-IVD* clinical AI applications – including breast IHC markers, breast metastasis detection, and colon metastasis detection – with Proscia’s CE-IVD Concentriq Dx platform** for image-based data and workflow management. Users of Concentriq Dx can now leverage the full suite of Visiopharm’s AI applications directly in the routine workflow, helping pathologists quantify the expression of biomarkers aiming to accelerate treatment decisions for patient care. This marks an expansion of the companies’ existing collaboration integrating AI-enabled solutions which have successfully driven breakthroughs in translational research and advance precision medicine for life sciences companies.

"We are excited about expanding our successful partnership in the research market to include the clinical market," said Michael Grunkin, CEO of Visiopharm. "With Visiopharm’s commitment to AI-driven Precision Pathology, and Proscia’s commitment to interoperability and digital workflow solutions for pathology labs, this integrated solution combines efficient workflows and support for optimal treatment decisions to our clinical customers." *

"Our unified solution will equip pathologists with powerful AI applications to quantify expression of biomarkers aiming to significantly improve treatment decisions," said David West, CEO of Proscia. "Ultimately, this will enable pathologists to fully realize AI’s potential in unlocking insights that remain hidden to the human eye, helping to advance the way we understand and treat disease, driving accuracy in diagnosis, and establishing prognosis and personalized therapies for patients."

Click here to learn more about how Visiopharm and Proscia are helping organizations to realize the full promise of their digital pathology data.

*Visiopharm’s clinical AI IVDs are certified under IVDR in Europe only. These are not for diagnostic purposes in US.

**Concentriq Dx is CE-marked for in-vitro diagnostic use in Europe and available for primary diagnosis in the US during the COVID-19 public health emergency.

On March 22, 2022 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported the successful closing of an equity investment totaling EUR 33 million from the Indigenous Critical Infrastructure Fund Canada (ICIF) and from a private equity fund managed by Portland Investment Counsel Inc., a related and connected party to Portland Holdings (Press release, ITM Isotopen Technologien Munchen, MAR 22, 2022, View Source [SID1234610611]). The capital increase follows the recently announced EUR 25 million equity investment from ITM’s strategic partner, Grand Pharma, bringing the total amount of cash raised to date in 2022 to EUR 58 million in this financing round. The proceeds will primarily be used for the finalization of the late-stage development of the company’s lead candidate ITM-11 (n.c.a. 177Lu-edotreotide), a targeted radiopharmaceutical currently being evaluated in two phase III clinical trials for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs), a high-need cancer indication, as well as for any future commercialization and market launch efforts, if approved. In addition, the funding will be used to accelerate the strategic development of additional radiopharmaceutical candidates in ITM’s broad proprietary pipeline and the expansion of ITM’s radioisotope supply capabilities.

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"The ICIF is pleased to invest in ITM’s Targeted Radionuclide Therapy initiative as both an exciting economic opportunity as well as a way to potentially positively impact Indigenous health outcomes globally, particularly with regards to cancer," added Chief Keith Matthews, Chairman of ICIF.

"I am thrilled that ITM and ICIF have reached this significant milestone. The need to improve health care globally and address the unmet needs of cancer patients through innovative therapies, particularly targeted radionuclide therapy, has never been more critical. ITM is central to this industry and is disrupting traditional forms of treatments like chemotherapy and external beam radiation, with new diagnostic and therapeutic solutions that we believe will help improve outcomes and quality of life of cancer patients. We believe ICIF’s support of nuclear medicine initiatives should have a meaningful impact on communities affected by cancer, domestically and worldwide," said Michael Lee-Chin, Supervisory Board Member of ITM and founder and chairman of Portland Holdings. "Portland’s mantra of ‘Doing Well and Doing Good’ and our unwavering commitment through investments to democratize health care for all is reflected in our continuous support to ITM and the precision oncology industry."

"The financing by ICIF and Portland Holdings emphasizes our efforts to build a global community towards a paradigm shift in precision oncology combining ITM’s deep technology, global network and manufacturing expertise in producing high-quality radiopharmaceuticals with the insights to advance a broad diagnostic and therapeutic pipeline and we are, together with Portland Holdings, very happy and honored to be able to welcome the Indigenous Critical Infrastructure Fund to the growing global community of our investors," commented Steffen Schuster, Chief Executive Officer of ITM.

ITM is a global leader in the production and supply of high-quality medical radioisotopes for the precise diagnosis and targeted treatment of various cancer indications and has established a wide-reaching international supply network. The company has integrated its expertise to developing a broad proprietary pipeline of targeted radiopharmaceutical diagnostics and therapeutics designed to address hard-to-treat cancer indications. ITM combines its first-class medical radioisotopes with targeting molecules capable of reaching a range of tumors, including gastroenteropancreatic neuroendocrine tumors (GEP-NETs), which severely lack treatment options. ITM is working toward validating its approach with its lead candidate, ITM-11, in two phase III clinical trials, COMPETE (NCT03049189) and COMPOSE (NCT04919226).

About Targeted Radionuclide Therapy
Targeted Radionuclide Therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to normal tissue. Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope to a targeting molecule (e.g., peptide, antibody, small molecule) that can precisely recognize tumor cells and bind to tumor-specific entities such as receptors which are expressed on the cell surface. As a result, the radioisotope accumulates at the tumor site and decays, releasing a small amount of ionizing radiation, thereby destroying tumor tissue. The highly precise localization potentially enables targeted treatment with minimal impact to healthy surrounding tissue.

About ITM-11 (n.c.a. 177Lu-edotreotide)
ITM-11, ITM’s therapeutic radiopharmaceutical candidate being investigated in the phase III clinical studies COMPETE and COMPOSE, consists of two components: the medical radioisotope no-carrier-added lutetium-177 (n.c.a. 177Lu) and the targeting molecule edotreotide, a synthetic form of the peptide hormone somatostatin that targets neuroendocrine tumor-specific receptors. Edotreotide binds to these receptors and places the medical radioisotope n.c.a. lutetium-177 directly onto the diseased neuroendocrine cells so that it accumulates at the tumor site. N.c.a. lutetium-177 is internalized into the tumor cells and decays, releasing medical radiation (ionizing β-radiation) with a maximum radius of 1.7 mm and destroying tumor tissue. The highly precise localization can result in the healthy tissue surrounding the targeted tumor being minimally affected.

On March 22, 2022 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported that CEO Mark Erlander, Ph.D., has been invited to present at the 2022 Virtual Growth Conference, presented by Maxim Group LLC and hosted by M-Vest, on March 28th – 30th from 9:00 AM – 5:00 PM EDT (Press release, Cardiff Oncology, MAR 22, 2022, View Source [SID1234610610]).

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Details on the presentation can be found below.

In addition to the fireside chat, Dr. Erlander will also provide a pre-recorded overview of Cardiff Oncology’s clinical and corporate strategy. The pre-recorded presentation will be available throughout the duration of the conference, which will be streamed live on M-Vest. To attend, sign up to become an M-Vest member here.

A replay of the fireside chat will be available by visiting the "Events" section on the investor page of the Cardiff Oncology website after the conference’s conclusion.

On March 22, 2022 PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has successfully completed a 24-month product stability study required by the U.S. Food and Drug Administration (FDA) for its clinical trial product candidate, CypCaps (Press release, PharmaCyte Biotech, MAR 22, 2022, View Source [SID1234610609]). The significance of this timepoint is that CypCaps has now demonstrated that it has a shelf life of at least 24 months when stored at -80oC.

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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the completed 24-month stability study, "While we continue to establish a maximum shelf life for our clinical trial product candidate, CypCaps, reaching the 24-month timepoint is highly significant in allowing PharmaCyte to store a biologic at -80oC. We demonstrated that frozen CypCaps maintain their viability, enzymatic activity and cell potency after 2 years of storage at -80oC in a cryopreserved state. This is a major milestone not only for PharmaCyte but also for the cell therapy field."

After 24 months storage of the Cell-in-a-Box encapsulated cell product, CypCaps, at -80oC, the product was thawed and analyzed for cell viability, enzyme activity and cell potency as well as being examined for pH, label integrity, capsule appearance, capsule integrity and container closure integrity.

Notably, over the entire 24-month period, there was no significant change in the number and viability of the encapsulated cells, or, most importantly, in the biological activity that is key to activating the anti-cancer mechanism PharmaCyte uses for its cancer therapy. The successfully completed stability study was initiated prior to the submission of the company’s IND to the FDA, and the information and data obtained from the study will form part of the updated package of information that will be provided to the FDA, together with data from additional studies requested by this regulatory agency.

This formal study, performed under GMP conditions, confirms previous laboratory data generated by PharmaCyte’s partner, Austrianova, showing cell viability and activity of a similar Cell-in-a-Box cell encapsulation product upon storage in the frozen state for over 6 years.

This data is remarkable and stands in stark contrast with data obtained after cryopreservation of alginate encapsulated cells where one study showed viability after 2 weeks storage (Nicola Cagol, Walter Bonani, Devid Maniglio, Claudio Migliaresi, Antonella Motta (2018) Effect of cryopreservation on cell-laden hydrogels: comparison of different cryoprotectants. Tissue Eng. Part C Methods 24:20-31) and another using alginate encapsulated islets showed viability when thawed after 4 weeks storage in a frozen state (Greg G Kojayan, Antonio Flores, Shiri Li, Michael Alexander, and Jonathan RT Lakey (2019) Cryopreserved alginate-encapsulated islets can restore euglycemia in a diabetic animal model better than cryopreserved non-encapsulated islets. Cell Medicine 11: 1-6). Another study using cryopreserved cardiosphere-derived cells encapsulated in alginate-poly-L-lysine-alginate microcapsules showed viability of the cells after being revived 60 days after storage in a frozen state (Paz-Artigas L, Ziani K, Alcaine C, Báez-Díaz C, Blanco-Blázquez V, Pedraz JL, Ochoa I, Ciriza J. (2021) Benefits of cryopreservation as long-term storage method of encapsulated cardiosphere-derived cells for cardiac therapy: A biomechanical analysis. Int J. Pharm. 607:121014).

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced, inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source