On March 16, 2022 Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, reported its Bladder EpiCheck test has been included in the 2022 European Association of Urology (EAU) Clinical Guidelines for non-muscle invasive bladder cancer (NMIBC) (Press release, Nucleix, MAR 16, 2022, View Source [SID1234610187]). The EAU guidelines aim to provide practical recommendations on the clinical management of NMIBC, to assist physicians in making informed treatment decisions with available scientific data.

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The EAU guidelines state that urinary biomarker tests with high sensitivity and negative predictive values for high-grade disease, including a specific reference to Bladder EpiCheck, might be used to replace and/or postpone cystoscopies in low- and intermediate-risk NMIBC, and reduce the number of cystoscopies in this patient population.

Bladder cancer is the fifth most common cancer in the western world, but the costliest to care for, due to the need for prolonged surveillance. Because of high recurrence rate of the disease, patients undergo up to four follow-ups each year, which usually include cystoscopies that are invasive and painful.

"In follow up, many cystoscopies are negative, meaning the procedure was unnecessary. Apart from that, even when there is a high-grade recurrence, sensitivity of cystoscopies is certainly not 100%. The updated EAU guidelines illustrate that clinicians can improve NMIBC monitoring by replacing some of the cystoscopies with high-performing, non-invasive urinary markers," said Professor Fred Witjes, Professor of Medical Sciences at Radboud University Medical Center and chair of the MIBC EAU guidelines. "In our hospital we have implemented such an alternating schedule with Bladder EpiCheck which benefits the patients and is cost effective."

A comprehensive meta-analysis, entitled "Diagnostic Accuracy of Novel Urinary Biomarker Tests in Non-Muscle Invasive Bladder Cancer: A Systematic Review and Network Meta-Analysis," was recently published in European Urology Oncology. Pooled data from five studies on Bladder EpiCheck reported an overall specificity of 85%, and a sensitivity of 91% and negative predictive value (NPV) of 99% for high grade disease. Importantly, Bladder EpiCheck demonstrated the best performance out of the guideline-recommended markers as measured by diagnostic odds ratios.

"Inclusion in the European Association of Urology’s guidelines for NMIBC will revolutionize patient care and drive adoption of Bladder EpiCheck, a non-invasive measure for surveilling the disease, which is a significant milestone for the Nucleix technology," said Aharona Shuali, M.D., vice president of medical affairs at Nucleix.

About Bladder EpiCheck

Bladder EpiCheck provides patients and clinicians with a simple, objective urine test to detect recurrence of bladder tumors. The test analyzes subtle disease-specific changes in DNA methylation markers, allowing for the detection of 91% of high-grade cancers. Bladder EpiCheck demonstrated negative predictive value (NPV) of 99% for high-grade cancer, meaning that when receiving a negative Bladder EpiCheck result, there is 99% chance that no high-grade cancer is present1. Overall specificity of Bladder EpiCheck is 85%, ensuring a low rate of false positive results. Bladder EpiCheck is intended for use as a non-invasive method for monitoring of tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer. Bladder EpiCheck is CE-marked and available in Europe. The test is not available for sale in the United States.

On March 16, 2022 Helix BioPharma Corp. (TSX: "HBP"), ("Helix" or the "Company"), a clinical-stage biopharmaceutical company developing unique therapies in the field of immuno-oncology based on its proprietary technological platform DOS47, reported fiscal 2022 second quarter results for the period ending January 31, 2022 (Press release, Helix BioPharma, MAR 16, 2022, View Source [SID1234611326]).

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On March 16, 2022 Clovis Oncology, Inc. (NASDAQ: CLVS) reported the initiation of a development, manufacturing, and services agreement with Evergreen Theragnostics to develop actinium-225-labeled-FAP-2286 (225Ac-FAP-2286) (Press release, Clovis Oncology, MAR 16, 2022, View Source [SID1234610168]). Under the agreement, Clovis and Evergreen intend to develop radiolabeling chemistry and analytical methods for use in potential future pre-clinical and clinical studies.

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"This agreement with Evergreen Theragnostics represents an important step forward for Clovis in our efforts to optimize our clinical development program for FAP-2286," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We are enthusiastic about exploring the potential of FAP-2286 labeled with actinium-225 in our targeted radiopharmaceuticals program. Actinium-225 represents an emerging radionuclide that is generating significant interest for its potential for therapeutic use."

Actinium-225 (225Ac) is an alpha particle-emitting radionuclide uniquely suited to targeted radiotherapeutic applications based on its half-life of approximately 10 days, balancing the ability to deliver a meaningful dose of radiation to target tumors while allowing central manufacturing and distribution of 225Ac-FAP-2286. The high-energy radioactive decay emitted from tumor-targeted 225Ac delivery causes double-stranded DNA damage and cell death, however, given the limited distance traveled by alpha particles, damage is minimized to cells in the tumor mass and systemic toxicity is potentially limited. i,ii

Under the terms of the agreement, Evergreen will develop 225Ac-FAP-2286 at its facility in Springfield, N.J. The facility was purpose-built to develop and manufacture a variety of therapeutic radiopharmaceuticals, including those based on alpha-emitting isotopes such as 225Ac, from early development to commercial scale manufacturing.

"We are excited to support Clovis and its targeted radionuclide development program with the development of an actinium-225-labeled FAP-2286. Actinium-based radiotherapies offer the potential to play an important role in the fight against cancer," said James Cook, CEO of Evergreen Theragnostics. "We seek to provide a robust and efficient radiopharmaceutical manufacture, testing, and supply process for our partners from early-stage development through commercialization."

FAP-2286 is the first peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP) to enter clinical development. In the Phase 1/2 LuMIERE study (NCT04939610), the investigational therapeutic agent is linked to lutetium-177 labeled FAP-2286 (177Lu-FAP-2286). Lutetium-177 (177Lu) is a beta-particle-emitting radionuclide with established supply and distribution networks ideally suited for clinical development of a PTRT. FAP-2286 labeled with gallium-68 (68Ga-FAP-2286) is being used as an investigational imaging agent to identify patients with FAP-positive tumors appropriate for treatment with the therapeutic agent. FAP-2286 is the lead candidate in Clovis Oncology’s targeted radionuclide therapy (TRT) development program.

For more information about FAP-2286, targeted radionuclide therapy, or Clovis’ TRT development program, please visit targetedradiotherapy.com.

About FAP-2286

FAP-2286 is a clinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use. High FAP expression has been shown in pancreatic ductal adenocarcinoma, cancer of unknown primary, salivary gland, mesothelioma, colon, bladder, sarcoma, squamous non–small cell lung, and squamous head and neck cancers. High FAP expression was detected in both primary and metastatic tumor samples and was independent of tumor stage or grade. Clovis holds US and global rights for FAP-2286 excluding Europe, Russia, Turkey, and Israel.

FAP-2286 is an unlicensed medical product.

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 delivery of radiation to normal tissue. Targeted radionuclides are created by linking radioactive isotopes, also known as radionuclides, to targeting molecules (e.g., peptides, antibodies, small molecules) that can bind specifically to tumor cells or other cells in the tumor environment. Based on the radioactive isotope selected, the resulting agent can be used to image and/or treat certain types of cancer. Agents that can be adapted for both therapeutic and imaging use are known as "theranostics." Clovis, together with licensing partner 3B Pharmaceuticals, is developing a pipeline of novel, targeted radiotherapies for cancer treatment and imaging, including its lead candidate, FAP-2286, an investigational peptide-targeted radionuclide therapeutic (PTRT) and imaging agent, as well as three additional discovery-stage compounds.

On March 16, 2022 Proscia, the leader in digital and computational pathology solutions, reported a multi-year OEM agreement with Siemens Healthineers (Press release, Proscia, MAR 16, 2022, View Source [SID1234610190]). Under the agreement, Siemens Healthineers will expand its Enterprise Imaging offering towards the global digital pathology market using Proscia’s Concentriq Dx platform.

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The partnership comes amid a tipping point for the digital pathology market. Demand for digital pathology has surged as systemic challenges long threatening the traditional laboratory model centered around pathologists and microscopes in physical spaces have intensified in the pandemic and post-pandemic era. Mounting pressures created by a shrinking pathologist population, rising biopsy volume, and industry consolidation have been exacerbated by the pandemic-driven shift to remote work. Laboratories are now rapidly seeking to modernize their pathology operations, but legacy software systems lack the necessary enterprise-wide capabilities, preventing labs from achieving true digitization.

With Proscia’s Concentriq Dx platform, Siemens Healthineers is entering the digital pathology market to satiate the rampant demand and expand its Enterprise Imaging offering with industry-leading technology to realize the full value of digital pathology operations. Siemens Healthineers is a global leader in healthcare IT, with solutions that span nearly all major departments and disease states at the world’s leading health systems. The agreement with Proscia enables Siemens Healthineers to expand into one of the few remaining areas of healthcare that has just started to experience the full benefits of digitization.

Siemens Healthineers selected Proscia after conducting an extensive evaluation process. Several key aspects of Proscia’s technology that Siemens Healthineers cited in its decision include product maturity, superior end-user experience, open platform, future-proof capabilities, and recognized brand with in-depth domain knowledge. Siemens Healthineers’ Syngo Carbon Enterprise Imaging Solution offers a wide range of possibilities with image interpretation, reporting, AI implementation, data management, archiving and migration, including unique access to innovation platforms through seamless integration.

"Healthcare’s rapid digital transformation has emphasized the value of data in reshaping the way clinicians and researchers understand, diagnose, and fight disease," said Christian Zapf, Head of Imaging Software & IT at Siemens Healthineers. "The traditional practice of pathology is on the verge of the biggest transformation the field has seen since the introduction of light microscopy, and we’re excited to accelerate pathology’s digital transformation and pioneer breakthroughs with a strong partner complementing our core strength in enterprise reading and reporting resulting in higher efficiency and improved patient outcomes."

Proscia’s Concentriq Dx in combination with Syngo Carbon offers a best-of-breed solution for digitizing pathology operations at scale alongside diagnostic radiology imaging for healthcare enterprises. By entering the rapidly growing digital pathology market with Concentriq, Siemens Healthineers is expanding its position as one of the industry leaders in healthcare with solutions covering the entire clinical pathway, providing a full spectrum of enterprise services across digital, data, and AI.

"Our partnership with Siemens Healthineers represents a seminal moment for Proscia and a monumental leap for digital pathology on a global scale," said David West, CEO of Proscia. "We’re honored to work together with the worldwide leader in medical imaging to accelerate pathology’s digital transformation, improve the quality of care with more precise and personalized diagnoses, and ensure improved patient outcomes."

Proscia’s Concentriq is a singular, scalable platform that enables laboratory networks to unify pathology operations and eliminate the geographic silos to realize a truly connected and collaborative global practice. The platform sits at the lab’s center of gravity, connecting a diverse ecosystem of hardware and software into a single solution. Concentriq’s pathologist-centric design was developed by and for pathologists to deliver an interface that feels natural, is highly responsive, supports real-time collaboration for consults and second opinions, and makes digital image viewing as smooth as possible. The platform’s future-proof design is ready now for pathology’s computationally driven future, with an integration layer capable of supporting plug-and-play adoption of AI applications.

On March 16, 2022 Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT), a company focused on the discovery and development of next-generation synthetically lethal therapies for cancer, reported financial results for the fourth quarter and full year ended December 31, 2021 and provided an update on recent operational highlights (Press release, Cyteir Therapeutics, MAR 16, 2022, View Source [SID1234610169]).

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"In 2021, we made significant progress towards our goal of advancing our lead program CYT-0851 in the clinic with the completion of a dose escalation study and identification of the recommended Phase 2 dose. Our interim analysis demonstrated anti-tumor effects with disease control and responses in heavily pretreated and progressing lymphoma and solid tumor patients, with a safety profile consisting primarily of mild adverse events," said Markus Renschler, MD, President and Chief Executive Officer of Cyteir. "We are now dosing patients in the Phase 2 monotherapy expansion cohorts and have begun Phase 1 combination therapy cohorts. We expect interim safety and efficacy data read-outs from these cohorts this year that may allow us to design one or more potentially registrational trials. We continue to invest in our pipeline and are advancing two new targets from our synthetic lethality DNA damage response platform toward the clinic."

Fourth Quarter and Full Year 2021 Accomplishments

Advanced CYT-0851 Clinical Program

Cyteir completed the dose-escalation portion of the first-in-human Phase 1/2 trial of CYT-0851 up to the maximum feasible daily dose of 1200 mg and determined the maximum tolerated dose of 600 mg per day. The recommended Phase 2 dose was identified as 400 mg per day. An interim analysis of the Phase 1 portion was presented in an oral session at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting. In a heavily pretreated and progressing patient group typical of Phase 1 studies, we demonstrated disease control in 20 of 46 response evaluable patients, including three responses in non-Hodgkin lymphoma and soft tissue sarcoma. No patient at or below the recommended Phase 2 dose discontinued treatment for treatment-related adverse events. The three most common treatment-related adverse events were fatigue (21% of patients), hyperuricemia (11%), and nausea (11%). There was no clinically significant myelosuppression.
We began enrolling patients in six disease-specific Phase 2 expansion cohorts with monotherapy in hematologic malignancies and solid tumors. In January 2022, the first patient was dosed. Completion of stage 1 of this study is expected before the end of 2022.
Simultaneously, we initiated a Phase 1 combination study of CYT-0851 with three standard-of-care regimens: rituximab plus bendamustine, gemcitabine and capecitabine, in both hematologic malignancies and solid tumors. In January 2022, we dosed the first patient in the study, and we are currently enrolling additional patients. Initial safety data from this combination study is expected before the end of 2022.
In total for our CYT-0851 Phase 1/2 trial, we are now actively enrolling nine patient cohorts in both monotherapy and combination therapy with interim safety results expected in 2022.
Advanced DNA Damage Response (DDR) Platform

In 2021, we initiated two additional drug discovery projects focused on identifying inhibitors of DNA damage repair. The first of these undisclosed targets (Target 2) plays a key role in Non-Homologous End Joining (NHEJ) and the second (Target 3) in Microhomology-Mediated End Joining (MMEJ) DNA repair pathways. For both targeted drug discovery projects, we have identified subsets of cancers that, we believe, uniquely depend on the target of interest for their survival and we are working to identify patient selection biomarkers to identify these cancer subsets for use in drug candidate development. Both undisclosed target projects are currently in lead generation, and we anticipate reaching the drug candidate nomination stage in 2023.
We expect to complete IND-enabling studies for CYT-1853 in the first half of 2022 and if the data supports an overall risk-benefit improvement and differentiation from CYT-0851, we plan to file an IND application with the FDA before the end of 2022.
Efficient execution of research and clinical strategy with cash runway into 2024

Ended 2021 with approximately $190 million in cash and cash equivalents with cash runway expected to extend into 2024
Continued investment in our clinical and preclinical portfolio
Progress achieved in key clinical milestones, including advancing CYT-0851 monotherapy to Phase 2 and initiating Phase 1 combination therapy study
Continuing to build management and research teams while maintaining low employee turnover
2022 Key Milestones Completed

Dose first patient in the Phase 1 CYT-0851 combination therapy cohorts
Dose first patient in the Phase 2 CYT-0851 monotherapy expansion cohorts
2022 Expected Key Milestones Completed

Present data from Phase 1 CYT-0851 monotherapy dose escalation study
Announce top line safety data from Phase 1 CYT-0851 combination therapy study
Announce top line interim results from stage 1 of CYT-0851 Phase 2 monotherapy study
Design potential registrational trial for one or more indications with CYT-0851
File IND for CYT-1853
Continue to elucidate CYT-0851’s molecular target and mechanism of action
Lead optimization of NHEJ inhibitor leading to potential target nomination in 2023
Lead optimization of MMEJ inhibitor leading to potential target nomination in 2023
Fourth Quarter and Full Year 2021 Financial Results

Cash and cash equivalents: Cash and cash equivalents as of December 31, 2021 were $189.7 million, which are expected to fund planned operations into 2024.

Research and development (R&D) expenses: R&D expenses were $8.3 million for the fourth quarter of 2021 versus $3.9 million for the same period in 2020 and $31.0 million for the full year 2021 versus $16.8 million for full year 2020. The year-over-year increase in R&D spending in the comparative periods was due primarily to increased research activity, clinical trial expenses and headcount, including initiation of Phase 1 and Phase 2 studies for our product CYT-0851.

General and administrative (G&A) expenses: G&A expenses were $3.6 million for the fourth quarter of 2021 compared to $1.5 million for the same period in 2020 and $11.3 million for the full year 2021 compared to $4.2 million for full year 2020. The year-over-year increase in G&A expenses in the comparative periods was primarily due to employee-related costs, as well as other administrative expenses associated with company growth and operating as a public company.

Net loss: Net loss was $11.8 million, or $0.34 per share, in the fourth quarter of 2021 compared to $5.4 million, or $2.92 per share, for the same period in 2020. For the full year 2021, net loss was $42.1 million, or $2.16 per share compared to $20.8 million, or $13.60 per share for full year 2020.

Fourth Quarter and Full year 2021 Conference Call and Webcast Information

Cyteir will host a conference call to discuss the fourth quarter and full year of 2021 financial and operational results on Wednesday, March 16, 2022, at 4:30 p.m. ET. The conference call will be available by webcast on the Investor Relations page at www.cyteir.com. An audio replay of the call will be available on the website after 9:00 p.m. ET the same day.