On March 16, 2022 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported that results for the fourth quarter and full year 2021 (Press release, MorphoSys, MAR 16, 2022, View Source [SID1234610193]).

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"In 2021, we accelerated our vision to become a leader in hematology/oncology with the acquisition of Constellation Pharmaceuticals which expanded our late-stage pipeline," said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "We are proud that approximately 2,000 patients have been treated with Monjuvi in the U.S. since launch and continue to have the leading market share of second line new patient starts."

Jean-Paul Kress continued, "Looking ahead, we are focused on continued execution of the Monjuvi commercialization and rapidly progressing our pivotal studies of pelabresib in myelofibrosis and tafasitamab in 1L DLBCL, FL, and MZL. We are committed to bringing innovative medicines to people with cancer and are well positioned to deliver on our growth strategy to create long-term shareholder value."

Tafasitamab Highlights:

Monjuvi (tafasitamab-cxix) U.S. net product sales of € 20.5 million (US$ 23.6 million) for the fourth quarter of 2021 and € 66.9 million (US$ 79.1 million) for the full year of 2021.

Minjuvi Royalty revenue of € 0.6 million for sales outside of the U.S. in the fourth quarter of 2021. Full year 2021 Minjuvi royalty revenue of € 0.7 million.

Enrollment of first patient in Phase 3 trial evaluating the safety and efficacy of tafasitamab compared to placebo in combination with lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL). In January 2021, FDA granted orphan drug designation to tafasitamab for the treatment of follicular lymphoma (FL), and the first patient was dosed in the phase 3 inMIND study in April 2021.

Enrollment of first patient in Phase 3 trial evaluating tafasitamab and lenalidomide in addition to R-CHOP in first-line DLBCL patients. In May 2021, the first patient was dosed in the pivotal Phase 3 frontMIND study evaluating tafasitamab and lenalidomide in addition to rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) compared to R-CHOP alone as first-line treatment for high-intermediate and high-risk patients with untreated diffuse large B-cell lymphoma (DLBCL).

Health Canada and European Commission approve Minjuvi in combination with lenalidomide for DLBCL. In August 2021, Health Canada granted conditional marketing authorization for Minjuvi (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, who are not eligible for autologous stem cell transplant (ASCT) and the European Commission granted conditional marketing authorization for Minjuvi (tafasitamab) in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Announcement of real-world evidence for tafasitamab in combination with lenalidomide for patients with DLBCL. In December 2021, MorphoSys presented additional real-world evidence results from the RE-MIND2 study comparing tafasitamab in combination with lenalidomide against the most frequently used treatments in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). These treatments include polatuzumab vedotin plus bendamustine and rituximab (Pola-BR), rituximab plus lenalidomide (R2), and CD19 chimeric antigen receptor T-cell (CAR-T) therapies. The data was presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH 2021).

National Comprehensive Cancer Network updates guidelines for Monjuvi. On March 15, 2022, the National Comprehensive Cancer Network updated the designation of Monjuvi (tafasitamab-cxix) to preferred regimen in its Clinical Practice Guidelines in oncology for B-cell Lymphomas.

Pelabresib Highlights:

Announcement of data from Phase 2 MANIFEST study in patients with myelofibrosis. In December 2021, MorphoSys presented the latest data from the ongoing MANIFEST study, an open-label, Phase 2 clinical trial of pelabresib, an investigational BET inhibitor, in patients with myelofibrosis, a rare bone marrow cancer for which only limited treatment options are available. The data confirm and corroborate previously reported data, including updated data for the primary endpoint spleen volume reduction at week 24 for the combination arm 3 with ruxolitinib in frontline myelofibrosis and a reduction in total symptom score. The data increased MorphoSys’ confidence in the probability of success for the phase 3 MANIFEST-2 study. These findings were presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH 2021).

Other Program Highlights:

Enrollment of first patient in felzartamab Phase 2 trial for Immunoglobulin A Nephropathy (IgAN). In October 2021, the first patient has been dosed in the Phase 2 IGNAZ clinical trial evaluating felzartamab for patients with (IgAN).

Announcement of first data from felzartamab Phase 1b/2a study. In November 2021, MorphoSys presented interim results from M-PLACE, the ongoing Phase 1b/2a, proof of concept study with felzartamab in patients with membranous nephropathy (MN) at the 2021 Annual Meeting of the American Society of Nephrology (ASN).

Corporate Updates:

MorphoSys acquires Constellation Pharmaceuticals. In June 2021, MorphoSys entered into a definitive agreement to acquire Constellation Pharmaceuticals with its late-stage product candidate Pelabresib (CPI 0610) for treating myelofibrosis and CPI-0209, a mid-stage EZH2 inhibitor, for treating both hematologic and solid tumors.

MorphoSys enters into funding agreement with Royalty Pharma. MorphoSys secured from Royalty Pharma a US$ 1.425 billion upfront payment, access to Development Funding Bonds up to US$ 350 million, and up to US$ 150 million in milestone payments. As part of the agreement, Royalty Pharma Investments 2019 ICAV, a subsidiary of Royalty Pharma plc, purchased US$ 100 million in shares (1,337,552 shares) of MorphoSys at a price of € 63.35 per share on July 16, 2021.

Financial Results for the Fourth Quarter of 2021 (IFRS):

Total revenues for the fourth quarter of 2021 were € 52.9 million compared to € 36.0 million for the same period in 2020.

Cost of Sales: In the fourth quarter of 2021, cost of sales was € 9.5 million compared to € 9.4 million for the comparable period in 2020.

Research and Development (R&D) Expenses: In the fourth quarter of 2021, R&D expenses were € 87.0 million (Q4 2020: € 52.8 million). The increase in R&D expenses is primarily due to the inclusion of R&D expenses from Constellation and higher investment to support the advancement of clinical programs.

Selling, General and Administrative (SG&A) Expenses: Selling expenses decreased in the fourth quarter of 2021 to € 32.5 million (Q4 2020: € 32.8 million) and general and administrative (G&A) expenses amounted to € 18.2 million (Q4 2020: € 14.2 million). The increase in G&A expense in the fourth quarter was driven mainly by transaction costs for the acquisition of Constellation and the inclusion of Constellation’s G&A expenses.

Impairment of Goodwill: In the fourth quarter, MorphoSys accounted for a non-cash impairment charge on goodwill in the amount of € 230.7 million, due to the decision to discontinue all US-based drug discovery and biology activities of Constellation which MorphoSys acquired in July 2021. MorphoSys will continue to focus its research activities on the most advanced programs at its German research hub in Planegg.

Operating Loss: Operating loss amounted to € 325.0 million in the fourth quarter of 2021 (Q4 2020: operating loss of € 75.2 million).

Consolidated Net Profit / Loss: For the fourth quarter of 2021, consolidated net loss was € 381.0 million (Q4 2020: consolidated net loss of € 16.5 million).

Financial Results for the Full Year 2021 (IFRS):

Total revenues for the full year of 2021 were € 179.6 million compared to € 327.7 million in 2020. The year-over-year decline was driven by the upfront payment of the collaboration and license agreement with Incyte executed in 2020 for the out-licensing of tafasitamab outside the U.S. The Group revenues include revenues of € 66.9 million from the recognition of Monjuvi product sales in the US. Royalties in 2021 included € 0.7 million from the sale of Minjuvi outside of the U.S. by our partner Incyte and € 64.9 million from Tremfya sales. While Tremfya royalties will continue to be recorded on MorphoSys’ income statement, the payments for these royalties are passed onto Royalty Pharma starting in the second quarter of 2021. As such, € 53.4 million of Tremfya royalties were passed on to Royalty Pharma in 2021.

Cost of Sales: For full year 2021, cost of sales were € 32.2 million compared to € 9.2 million in 2020. The year-over-year increase was primarily driven by higher sales of Monjuvi in the U.S.

R&D Expenses: In 2021, R&D expenses were € 225.2 million compared to € 139.4 million in 2020. The R&D expenses increased due to higher development activity and the inclusion of expenses from the Constellation acquisition since July 15, 2021.

SG&A Expenses: Selling expenses increased in 2021 to € 121.5 million compared to € 107.7 million in 2020. The year-over-year increase was primarily driven by the first full year of commercialization activities for Monjuvi compared to the ramp up of activities in 2020.

G&A expenses amounted to € 78.3 million compared to € 51.4 million in 2020. The year-over-year increase was driven primarily by the transaction-related costs of € 37.3 million related to the Constellation and Royalty Pharma agreements. In addition, Constellation’s G&A expenses were included for the first time.

Operating Loss: Operating loss amounted to € 508.3 million in 2021 compared to an operating profit of € 18.0 million in 2020.

Consolidated Net Profit / Loss: For the full year of 2021, consolidated net loss was € 514.5 million compared to a net profit of € 97.9 million in 2020.

Cash and Other Financial Assets: As of December 31, 2021, the Company had cash and other financial assets of € 976.9 million compared to € 1,244.0 million on December 31, 2020.

Number of shares: The number of shares issued totaled 34,231,943 on December 31, 2021 compared to 32,890,046 at the end of 2020.

Full Year 2022 Financial Guidance:

Amounts in million

2022 Financial Guidance

2022 Guidance Insights

Monjuvi U.S. Net Product Sales

US$ 110m to 135m

100% of Monjuvi U.S. product sales are recorded on MorphoSys’ income statement and related profit/loss is split 50/50 between MorphoSys and Incyte.

Gross Margin for Monjuvi U.S. Net Product Sales

75% to 80%

100% of Monjuvi U.S. product cost of sales is recorded on MorphoSys’ income statement and related profit/loss is split 50/50 between MorphoSys and Incyte.

R&D expenses

€ 300m to 325m

2022 growth over 2021 will be driven primarily by investment in ongoing pivotal phase-3 studies, excluding transaction/restructuring/other charges related to Constellation acquisition recorded in 2021.

SG&A expenses

€ 155m to 170

51% to 56% of mid-point of SG&A expenses represents Monjuvi U.S. selling costs of which 100% are recorded in MorphoSys’ income statement. Incyte reimburses MorphoSys for half of these selling expenses.

For 2022, we anticipate a year-over-year decline in SG&A, excluding transaction/restructuring/other charges related to Constellation acquisition recorded in 2021.

Additional information related to 2022 Financial Guidance:

Tremfya royalties will continue to be recorded as revenue without any cost of sales in MorphoSys’ income statement. These royalties, however, will not contribute any cash to MorphoSys as 100% of the royalties will be passed on to Royalty Pharma.
MorphoSys anticipates receiving royalties for Minjuvi sales outside of the U.S. Guidance for these royalties is not being provided as MorphoSys does not receive any sales forecasts from its partner Incyte.
MorphoSys does not anticipate any significant cash-accretive revenues from the achievement of milestones in 2022. Milestones for otilimab are passed on to Royalty Pharma. Milestones from all other programs remain with MorphoSys at 100%.
MorphoSys anticipates sales of commercial and clinical supply of tafasitamab outside of the U.S. to its partner Incyte. Revenue from this supply is recorded in the "Licenses, milestones and other" category in MorphoSys’ income statement. These sales result in a zero gross profit/margin. As such, MorphoSys does not provide guidance for these sales.
While R&D expense is anticipated to grow year-over-year due to investments in three pivotal studies, the growth is partially being offset by the consolidation of research/discovery activities.
SG&A expense guidance range reflects savings from synergies following the acquisition of Constellation and streamlined commercialization efforts.
Anticipated foreign exchange (USD/EUR) to impact operating expenses (R&D and SG&A) negatively by approximately 3%.

Operational Outlook for 2022:

MorphoSys anticipates the following key development milestones in 2022:

First proof-of-concept data from the ongoing clinical phase 2 study of CPI-0209 in solid tumors and blood cancer;
Additional data from the phase 1/2 M-PLACE (proof-of-concept) study of felzartamab for the treatment of anti-PLA2R antibody positive membranous nephropathy (MN);
First data from the phase 2 study (IGNAZ) to evaluate felzartamab in patients with immunoglobulin A nephropathy (IgAN);
MorphoSys’ partner Roche expects a pivotal data readout of the GRADUATE 1 and GRADUATE 2 trials with gantenerumab in the second half of 2022. Roche initiated these phase 3 development program for patients with Alzheimer’s disease in 2018;
Initiation of a combination study (in collaboration with Incyte and Xencor) of tafasitamab, plamotamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), first-line DLBCL and relapsed or refractory follicular lymphoma (FL).

MorphoSys Group Key Figures (IFRS, end of financial year: December 31, 2021)

MorphoSys will hold its conference call and webcast tomorrow, March 17, 2022, to present the full year 2021 results the outlook for 2022.

Please dial in 10 minutes before the beginning of the conference.

A live webcast and slides will be made available at the Investors section under "Upcoming Events & Conferences" on MorphoSys’ website, View Source and after the call, a slide-synchronized audio replay of the conference will be available at the same location.

On March 16, 2022 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the ‘‘Company’’) (Paris:NANO) (NASDAQ:NBTX), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported that it will report its financial results for full-year ending December 31, 2021, on Wednesday, March 30, 2022, after the close of the US market (Press release, Nanobiotix, MAR 16, 2022, View Source [SID1234610192]).

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The announcement will be followed by a conference call and live audio webcast on Thursday, March 31, 2022, at 8:00 AM EDT / 2:00 PM CET, prior to the open of the US market. During the call, Laurent Levy, chief executive officer, and Bart Van Rhijn, chief financial officer, will briefly review the Company’s year-end results and an update on business activities before taking questions from analysts and investors. Investors are invited to email their questions in advance to [email protected].

A live webcast of the call may be accessed by visiting the investors section of the company’s website at www.nanobiotix.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the company’s website.

On March 16, 2022 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported full year 2021 financial results and recent portfolio updates (Press release, SQZ Biotech, MAR 16, 2022, View Source [SID1234610191]).

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"We have much to be proud of as 2021 was a year of significant milestones for SQZ—a major highlight was that our lead APC candidate demonstrated monotherapy clinical benefit in an advanced patient as well as favorable safety data and tolerability across all patients in the highest dose cohort," said Armon Sharei, Ph.D., Chief Executive Officer at SQZ Biotechnologies. "In addition, we received clearance of our enhanced APC IND, a multi-functional mRNA-engineered treatment, which is now our third cell therapy candidate to advance into the clinic. We continue to expand our technical and therapeutic capabilities across disease areas. In all, the continued evolution of our portfolio of Cell Squeeze powered cell therapy candidates give us confidence that we are on the right track to potentially drive broad patient impact through a new generation of cell therapies."

2021 Full Year and Recent Portfolio Updates

SQZ Antigen Presenting Cell ("APC") Platform in Oncology

Highest dose cohort of SQZ-PBMC-HPV-101 shown to induce radiographic, symptomatic, and immune response as a monotherapy in a post-checkpoint HPV+ solid tumor patient. The December 2021 EMSO-IO oral presentation of interim-data also showed:
Tumor conversion from desert to inflamed phenotype with 8-fold increase in CD8 T Cell tumor infiltration and 50-fold increase in tumor PD-L1 expression
Favorable safety data and that the investigational therapy was generally well tolerated with no dose-limiting toxicities observed
Independent Data and Safety Monitoring Board ("DSMB") recommended that the Phase 1/2 clinical trial of SQZ-PBMC-HPV-101 advance into the combination stage with immune checkpoint inhibitors
The combination stage of SQZ-PBMC-HPV-101 trial is enrolling, and the highest-dose monotherapy stage of the trial continues enrollment to further evaluate the investigational candidate in single agent settings
Comprehensive preclinical research on SQZ APC’s ability to overcome fundamental biological barrier to effective and efficient killer T Cell activation published by the Journal of Immunology
SQZ Enhanced Antigen Presenting Cell ("eAPC") Platform in Oncology

FDA IND clearance of the first eAPC clinical candidate, engineered with E6, E7, CD86, membrane bound IL-2 & IL-12, was received January 2022
New eAPC preclinical data demonstrating efficient delivery of multiple mRNA to engineer APC function was presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Congress in November 2021
SQZ Activating Antigen Carriers ("AAC") Platform in Oncology

New AAC preclinical data presented at SITC (Free SITC Whitepaper) demonstrated a synergistic benefit with SQZ AACs used in combination with cisplatin, an early-line chemotherapy agent for the treatment of multiple cancers
SQZ Tolerizing Antigen Carriers ("TAC") Platform in Immune Tolerance

New TAC preclinical data presented at the 2021 Federation of Clinical Immunology Societies meeting showed the ability to induce antigen-specific immune tolerance, including Treg induction, demonstrating potential for broad applicability across autoimmune diseases
TAC celiac disease program IND-enabling studies underway to support IND FDA submission planned for the first half of 2023 with our point-of-care system targeted to manufacture clinical batches
2021 Full Year and Recent Corporate Highlights

Raised $60 million in gross proceeds from a follow-on public equity offering in February 2021
Added key board members and advisors, including Bernard Coulie, M.D., Ph.D. and Patrick Vink, M.D. to the Board of Directors, and John Maraganore, Ph.D. as a strategic advisor
Accepted for membership in the Roche China Accelerator to support certain early activities in China
2021 Full Year Financial Highlights

Revenue for the year ended December 31, 2021, was $27.1 million compared to $21.0 million for the year ended December 31, 2020
Research and development expenses for the year ended December 31, 2021, were $70.1 million compared to $51.5 million for the year ended December 31, 2020; the increase was primarily due to higher development and manufacturing costs associated with translating our product candidates into the clinic, as well as increased personnel-related costs to support continued progress with the Company’s pipeline
General and administrative expenses for the year ended December 31, 2021, were $25.7 million compared to $20.5 million for the year ended December 31, 2020; the increase was primarily due to higher personnel and other corporate-related costs, including stock-based compensation expense and other costs related to operating as a public company
Net loss for the year ended December 31, 2021, was $68.7 million, compared to $50.5 million for the year ended December 31, 2020
As of December 31, 2021, the Company had cash and cash equivalents of $143.5 million and anticipates this will be sufficient to fund operating expenses and capital expenditure requirements into the second half of 2023

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 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.