On February 2, 2022 Medigene AG ( View Source) (Medigene, FSE: MDG1, Prime Standard), a clinical-stage immuno-oncology company focusing on the development of T-cell-based cancer therapies, reported that promising preliminary efficacy and immune monitoring data from the Phase I part of the Phase I/II clinical trial of Medigene’s T cell receptor-modified T cell (TCR-T) therapy MDG1011 in patients with advanced-stage blood cancers (ClinicalTrials.gov Identifier: NCT03503968 ( View Source)) (Press release, MediGene, FEB 3, 2022, View Source [SID1234607703]). Data demonstrating safety and tolerability, with no cases of dose-limiting toxicity (DLT) associated with MDG1011, were published in December 2021.

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MDG1011 is a TCR-T immunotherapy directed against the tumor antigen PRAME (PReferentially expressed Antigen in MElanoma). Patients with relapsed or refractory acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or multiple myeloma (MM) were included in the open-label, dose-escalation Phase I part of the study that was conducted at nine clinical centers in Germany. Following standard pre-conditioning, patients received MDG1011 as a single intravenous infusion at specified dose levels of 0.5, 1 or 5 million TCR-transduced T cells per kg body weight. The primary study objectives were to evaluate safety, tolerability, and feasibility to manufacture autologous MDG1011 TCR-T cells for heavily pretreated patients. In addition, preliminary signs of clinical efficacy and immune monitoring data were investigated.

Clinical and biological data analysis

MDG1011 contained CD8+ TCR-T cells showing recognition and killing of specific standardized target cells in vitro and was successfully manufactured for 13 patients. The group of patients included ten with AML, two with MM and one with MDS. Four patients succumbed to disease before treatment could be administered, in line with the severity of the underlying condition of study patients. Thus, nine patients received MDG1011 at one of the three specified dose levels.

Patient immune monitoring included detection of PRAME-specific T cells (MDG1011 TCR-T cells) in blood to determine persistence over time and biomarker tracking of PRAME in bone marrow and/or blood (as an indicator for remaining cancer cells) by qPCR.

* One patient with AML treated at the lowest dose experienced complete remission at week 4 after treatment; however, this clinical response was not sustained, and the patient’s disease progressed 8 weeks thereafter. PRAME expression was slightly increased from baseline at week 4 whereas MDG1011 TCR-T cells were below the detection level.
* Two patients with AML, treated at the intermediate and highest dose respectively, experienced transient grade 1 or 2 cytokine release syndrome (CRS) within 3 days of drug administration, providing evidence of biological activity of MDG1011 therapy in vivo. MDG1011 TCR-T cells were still detectable in both patients at week 4.
* One patient with multilineage MDS and myeloproliferative neoplasm (MPN) treated at the highest dose, remained without apparent progression to secondary AML 3 and 6 months after MDG1011 administration and is still monitored. MDG1011 TCR-T cells were found at weeks 4, 8 and 12 and were still present at lower levels at month 6 after treatment. Bone marrow could not be evaluated in this patient. PRAME signals in blood were no longer detected at week 4 but gradually increased thereafter at 2, 3 and 6 months, remaining clearly below the baseline level. In concordance, blast counts both in blood and bone marrow remained well below baseline.
* MDG1011 TCR-T cells were detected in six of eight evaluable patients at one or more time points within four weeks after administration. TCR-T cells were also present in two patients at later time points, albeit at decreased levels.
* The biomarker PRAME was assessed in bone marrow samples from five patients four weeks after MDG1011 administration compared to baseline. PRAME decreases occurred in three AML and one MM patient while a slight increase was noted in another patient with MM. PRAME decreased in blood at week 4 for two patients treated at the highest dose but increased thereafter.

The preliminary clinical observations in two patients and occurrence of CRS in a further two of the nine heavily pretreated cancer patients are both encouraging and consistent with expectations of an adoptive T cell therapy. These observations are corroborated by the immune monitoring data.

Prof. Simone Thomas, from the Department of Internal Medicine III of the University Hospital Regensburg and Leibniz Institute for Immunotherapy, Principal Investigator of the study: "No immune effector cell-associated neurotoxicity syndrome (ICANS) or DLTs were detected, so MDG1011 appears to be safe and well-tolerated at all three doses. The aforementioned clinical observations taken together with the effect on PRAME levels and the persistence of MDG1011 strongly support the hypothesis of biological activity of MDG1011."

Prof. Dolores Schendel, Chief Executive Officer and Chief Scientific Officer at Medigene: "We are very pleased that all MDG1011 TCR-T drug products manufactured from such heavily pre-treated patients with a substantial disease burden showed strong functional activity in vitro, leading to detectable biological and/or clinical activity in four patients.

The effects of PRAME-specific TCR-T immunotherapy on cancer cells should be further investigated based on this safe and well-tolerated treatment. The use of higher cell numbers as well as the treatment of patients with less advanced disease stages could further increase the clinical benefit in the future. Based on our strategic shift to development of TCR-T immunotherapy for solid cancer, Medigene has announced previously that the Phase II part of this study will only be conducted with or by a partner; based on overall results from the Phase I part of the study.

Our current development programs in solid cancer concentrate on TCR discovery for novel tumor-specific antigens and implementation of innovative tools to enhance efficacy and improve safety of T-cell-based immunotherapies."

On February 3, 2022 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (the "Company") reported that the company will deliver a corporate presentation at the 11th Annual Leerink Global Healthcare Conference (February 14-18, 2022) (Press release, Aurinia Pharmaceuticals, FEB 3, 2022, View Source [SID1234607701]). The presentation will take place virtually on Wednesday, February 16, 2022 at 8 am ET. Interested parties can register to listen to the presentation via the public link here or access via the Investor section of the Aurinia corporate website – www.auriniapharma.com, under "News/Events."

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On February 3, 2022 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that the U.S. Patent and Trademark Office has issued to Kintara United States Patent No. 11,234,955 covering a method of treating brain tumors including glioblastoma (GBM), medulloblastoma, and cancer brain tumor stem cells that has O6-methylguanine-DNA methyltransferase (MGMT)-driven drug resistance (Press release, Kintara Therapeutics, FEB 3, 2022, View Source [SID1234607699]).

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The patent allows for claims recognizing the unique anti-neoplastic activity of VAL-083 on malignant brain tumor cells, in particular those cells that express the DNA repair enzyme MGMT. The MGMT repair enzyme is the principal resistance mechanism that limits significant therapeutic benefit for GBM patients receiving temozolomide (TMZ), the current first line therapy. VAL-083’s activity is independent of MGMT and provides clinical treatment opportunities for newly-diagnosed patients who express the enzyme as well as recurrent patients who fail TMZ treatment. Moreover, MGMT is a biomarker used in the diagnosis of a patient’s brain tumor and helps clinicians to understand the patient’s prognosis.

In addition to the antiproliferative activity in GBM, the patent covers the significant activity of VAL-083 for medulloblastoma, another deadly form of brain tumor, as well as the opportunity to target brain tumor stem cells, perhaps the ultimate cause of brain tumor therapy resistance. Medulloblastomas are invasive, rapidly growing, and are a common type of brain tumor in children.

"The effect of VAL-083 on brain tumor stem cells represents a unique advance," Dennis Brown, Ph.D., Kintara’s Chief Scientific Officer said. "These undifferentiated stem cells are resistant to radiation and chemotherapy and are thought to represent the source of most brain tumor recurrences. We believe the ability to target these stem cells with VAL-083 may offer clinicians additional approaches to improve patient treatment outcomes."

On February 3, 2022 Cardinal Health (NYSE: CAH) reported second quarter fiscal year 2022 revenues of $45.5 billion, an increase of 9% from the second quarter of last year. Second quarter GAAP operating loss was $950 million due to a non-cash, pre-tax goodwill impairment of $1.3 billion related to the Medical segment (Press release, Cardinal Health, FEB 3, 2022, View Source [SID1234607698]). GAAP diluted earnings per share (EPS) were $0.17, primarily due to this impairment, net of tax effects. Second quarter non-GAAP operating earnings decreased 26% to $467 million and non-GAAP diluted earnings per share (EPS) decreased 27% to $1.27, primarily due to inflationary impacts and global supply chain constraints in the Medical segment.

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Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. (PRNewsfoto/Cardinal Health)

"Consistent with our January update, we continue to experience significant inflationary impacts and global supply chain constraints in our US Medical Products and Distribution business. We’re taking action to drive performance in the Medical segment, including evolving our commercial contracting strategies and driving mix, simplifying our operating model, and investing in our growth businesses," said Mike Kaufmann, chief executive officer of Cardinal Health. "Our second quarter results demonstrate continued performance in other areas, including: growth in the Pharma segment, progress towards our $750 million enterprise cost savings target, strong cash flow generation, and efficient capital deployment."

Second-quarter revenue for the Pharmaceutical segment increased 11% to $41.4 billion, driven primarily by branded pharmaceutical sales growth from large Pharmaceutical Distribution and Specialty customers.

Pharmaceutical segment profit increased 3% to $426 million in the second quarter driven by generics program performance. This was partially offset by investments in technology enhancements and higher operations expenses.

Second-quarter revenue for the Medical segment decreased 5% to $4.1 billion, primarily due to the divestiture of the Cordis business.

Medical segment profit decreased 79% to $50 million in the second quarter, primarily due to inflationary impacts and global supply chain constraints in products and distribution. This also reflects the timing of selling higher cost PPE, including the net positive impact in the prior year, and to a lesser extent, the divestiture of the Cordis business.

Fiscal year 2022 outlook1
The company updated its fiscal year 2022 guidance range for non-GAAP diluted earnings per share attributable to Cardinal Health, Inc. to $5.15 to $5.50, from $5.60 to $5.90.

This guidance reflects the previously announced additional $150 million to $175 million impact from increased inflation and global supply chain constraints, and a lower-than-expected offset from pricing actions. Accordingly, the company announced updated Medical segment profit outlook of thirty to forty-five percent decline, from mid-single to low-double digit percentage decline.

Additionally, the company updated expectations for its fiscal year 2022 non-GAAP effective tax rate to 23% to 24.5%, from 23% to 25%, and its Interest and Other to $140 million to $160 million, from $150 million to $180 million.

The company does not provide forward-looking guidance on a GAAP basis as certain financial information, the probable significance of which cannot be determined, is not available and cannot be reasonably estimated. See "Use of Non-GAAP Measures" following the attached schedules for additional explanation.

Recent highlights

Cardinal Health recently announced a partnership with Ember Technologies to deliver a cold chain solution that ensures product integrity and security throughout the supply chain, while significantly reducing shipping waste in the transport of temperature-sensitive medicines.
Cardinal Health participated as a strategic investor in a new round of funding for Medically Home, a technology company that enables health systems to safely care for their patients at home, across the care continuum, including hospital-level care.
For the 14th consecutive year, Cardinal Health was honored as one of the "Best Places to Work for LGBTQ Equality" by the Human Rights Campaign (HRC) Foundation, achieving 100% on the HRC’s 2021 Corporate Equality Index (CEI).
Webcast
Cardinal Health will host a webcast today at 8:30 a.m. Eastern to discuss second quarter results. To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required.

Presentation slides and a webcast replay will be available until February 3, 2023.

On February 3, 2022 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Quest Diagnostics, FEB 3, 2022, View Source [SID1234607697]).

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"In another unprecedented year, Quest provided critical COVID-19 testing to our country and delivered record revenues, earnings and cash from operations for full year 2021," said Steve Rusckowski, Chairman, CEO and President. "At the same time, our base business revenues grew more than 19 percent year over year, achieving record levels.

"Quest is well positioned in 2022 to deliver on our commitments. Our guidance for 2022 reflects lower demand for COVID-19 testing services; growth in the base business; and the impact of the previously announced one-year delay of PAMA cuts; partially offset by investments to accelerate growth.

"I am proud of the incredible accomplishments of our 50,000 Quest employees throughout the pandemic. They have risen to the challenge of bringing COVID-19 testing to millions of patients – all the while innovating, persevering, and remaining committed to our vision of empowering better health. Our team is strong, the business has momentum, and Quest’s future is bright."

(a) Excludes COVID-19 testing.

(b) For further details impacting the year-over-year comparisons related to operating income, operating income as a percentage of net revenues, net income attributable to Quest Diagnostics, and diluted EPS, see note 2 of the financial tables attached below.

(c) The sum of reported and adjusted diluted EPS for the four quarters of 2021 did not equal the total for the year ended December 31, 2021 due to both quarterly fluctuations in our earnings and in the weighted average common shares outstanding throughout the year as a result of the impact of accelerated share repurchase agreements ("ASR") that we entered into during April 2021.

Dividend Increased

Quest Diagnostics’ Board of Directors authorized a 6.5% increase in its quarterly dividend from $0.62 to $0.66 per share, or $2.64 per share annually, starting with the dividend payable on April 20, 2022 to shareholders of record of Quest Diagnostics common stock on April 6, 2022. This dividend increase is the company’s eleventh since 2011.

Guidance for Full Year 2022

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP operating performance measures that exclude special items such as restructuring and integration charges, certain financial impacts resulting from the COVID-19 pandemic, amortization expense, excess tax benefits ("ETB") associated with stock-based compensation, a gain on remeasurement of an equity interest, costs associated with donations, contributions, and other financial support through Quest for Health Equity, our initiative with the Quest Diagnostics Foundation to reduce health disparities in underserved communities, a gain on sale of an ownership interest in a joint venture, gains associated with changes in the carrying value of our strategic investments, and other items.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables attached below include reconciliations of non-GAAP adjusted measures to GAAP measures.

Conference Call Information

Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, passcode: 7895081; or via live webcast on our website at www.QuestDiagnostics.com/investor. We suggest participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or, from approximately 10:30 a.m. Eastern Time on February 3, 2022 until midnight Eastern Time on February 17, 2022, by phone at 800-839-9317 for domestic callers and 203-369-3605 for international callers. Anyone listening to the call is encouraged to read our periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.