On December 8, 2021 Onxeo S.A. (Euronext Growth Paris: ALONX, First North Copenhagen: ONXEO), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage response (DDR), reported the presentation of new preclinical data confirming the differentiated antitumoral properties of AsiDNA, its first-in-class DNA Damage Response (DDR) inhibitor, in poster and oral sessions during the EACR-AstraZeneca Virtual Conference organized by the European Association for Cancer Research and AstraZeneca on the theme of "Drug Tolerant Persister Cells" (7-8 December, 2021) (Press release, Onxeo, DEC 8, 2021, View Source [SID1234596601]).

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Several studies have shown that a small population of tumor cells, treated by targeted therapies, evade cell death by entering a reversible dormancy state known as the Drug-tolerant persister (DTP) state. These DTP cells are identified as major source of targeted therapy failures, thus leading to cancer relapse.

The data presented by Onxeo show that the addition of AsiDNA to targeted therapies prevents the regrowth of the DTP cells, thereby completely and irreversibly abolishing the emergence of resistance in tumor cells. The Company first discovered this unique property of AsiDNA in combination with PARPi (see Poster at AAC virtual meeting 2020). The most recent preclinical studies presented at EACR-AstraZeneca Virtual Conference, confirmed the prevention of resistance in other relevant tumor models where AsiDNA was combined with targeted therapies such as KRASi and EGFRi.

Judith Greciet, Chief Executive Officer of Onxeo, stated: "As already demonstrated in our previous studies, drug-tolerant persister cells are a well-established cause of resistance to targeted therapies such as TKIs and PARPi. Our new data provide further evidence that these cells are a major source of resistance to different cancer treatments, and that AsiDNA could be a therapeutic strategy of choice to specifically address this therapy failure. From a medical perspective, this is a major achievement as it paves the way for multiple combination strategies with our leading drug candidate in order to abolish tumor resistance. We are pleased that our pioneering approach has gained strong interest of the international medical and research community at the EACR-AstraZeneca Virtual Conference."

On December 8, 2021 McKesson Corporation (NYSE: MCK) reported that it will host an Investor Day beginning at 1:00 p.m. ET, where executive leadership will provide an overview of the company’s progress towards its goal of delivering sustainable growth and details around the company’s long-term financial outlook (Press release, McKesson, DEC 8, 2021, View Source [SID1234596621]).

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The Investor Day event will showcase how McKesson will deliver long-term growth:

Highlighting significant progress in executing against its priorities by focusing on people and culture, sustainable core growth, streamlining the portfolio, and expanding its oncology and biopharma services ecosystems. The success is evidenced by its strong financial performance and outstanding operational excellence.
Reaffirming its commitment to the growth pillars of oncology and biopharma services. The company’s differentiated set of assets and capabilities uniquely positions the company to win in these growing markets and improve the health outcomes of patients.
Providing a financial overview and long-term outlook that highlights the focus on shareholder value creation and supports a compelling investment thesis.
Increasing fiscal 2022 Adjusted Earnings per Diluted Share guidance range to $22.35 to $22.95, from the previous range of $21.95 to $22.55, to reflect an additional $0.40 related to the U.S. government’s COVID-19 vaccine distribution program.
Announcing a new $4.0 billion increase to the share repurchase program authorized by the Board of Directors.
"We are excited to share our vision and strategy with the investment community. As we focus on the next chapter of growth and innovation, McKesson will leverage the breadth and depth of its core growth to further develop and build differentiated oncology and biopharma services ecosystems," said Brian Tyler, chief executive officer. "We remain committed to delivering superior shareholder returns through sustainable earnings growth and a disciplined approach to capital deployment."

Webcast and Presentations

The video webcast will be available live from 1:00 p.m. to 4:00 p.m. ET on Wednesday, December 8, 2021 at investor.mckesson.com/events-and-presentations. After the event, the archived video webcast will be available on McKesson’s Investor Relations website, along with the company’s slide presentation, at investor.mckesson.com.

Non-GAAP Financial Measure

This press release includes a forecast of Adjusted Earnings per Diluted Share, which is not a financial measure calculated in accordance with U.S. generally accepted accounting principles (GAAP). The company is unable to provide a quantitative reconciliation of this forward-looking Non-GAAP measure to the equivalent forward-looking GAAP measure without unreasonable effort, because the company does not forecast GAAP earnings per share and cannot reliably forecast LIFO inventory-related adjustments, certain litigation loss and gain contingencies, restructuring, impairment and related charges, and other adjustments, which are difficult to predict and estimate. These items are inherently uncertain and depend on various factors, many of which are beyond the company’s control, and as such, any associated estimate and its impact on GAAP performance could vary materially. Refer to investor.mckesson.com and the company’s slide presentation noted above for definitions and explanations of the Company’s Non-GAAP financial measures.

On December 8, 2021 Almac Diagnostic Services, a member of the Almac Group, reported that its unique software driven solution for gene expression data analysis – claraT – has assisted oncology researchers at The University of Arkansas for Medical Sciences (US) and Queen’s University Belfast (UK) in the study of brain and breast cancers (Press release, Almac, DEC 8, 2021, View Source [SID1234596586]). The studies, recently published in the MDPI Cancer Journal and the British Journal of Cancer, have the potential to lead to better therapeutic outcomes for patients.

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The research teams, led by Dr Analiz Rodriguez at the University of Arkansas for Medical Sciences and Dr Stuart McIntosh at Queen’s University Belfast, cite use of Almac’s claraT report as a key method used to uncover new findings in their oncology studies.

Almac’s claraT report assists in the analysis of gene expression data by classifying the most biologically relevant gene expression signatures into a comprehensive easy-to-interpret report that covers all 10 Hallmarks of Cancer.

In Dr Analiz Rodriguez’s study, claraT was utilised as a method to facilitate the molecular profiling of brain metastases. Together with other genomic and transcriptomic tools, claraT helped identify novel molecular subtypes and new drivers of brain cancer progression in parallel to novel drug targets. These findings have been published in the MDPI Cancer Journal.

Dr Rodriguez said "We are grateful for the Almac Group’s claraT platform as it allowed us to evaluate hundreds of gene expression signatures and single gene targets that correlated to the Hallmarks of Cancer. Transcriptome data can be difficult to analyze, especially in our heterogenous dataset which included brain metastases samples from various primary cancer subtypes. The claraT software solution immensely simplified our workflow and helped us identify a novel subgroup of brain metastases which warrants further investigation."

Dr McIntosh’s study at Queen’s University Belfast demonstrated that the Almac DNA-damage immune-response (DDIR) assay could be used to identify a group of breast cancer patients more likely to benefit from DNA damaging chemotherapy prior to surgery. The team then used transcriptome profiling and the claraT report to demonstrate that patients with low baseline immune signalling or "cold" tumours could be immune primed through the prior use of DNA damaging chemotherapy, potentially sensitizing these tumours to immune checkpoint therapy. Taken together, these results could help refine the treatment of breast cancer patients and lead to better therapeutic outcomes. These results have been published in the British Journal of Cancer.

Dr McIntosh said "The increasing use of neoadjuvant chemotherapy for breast cancer has great potential to benefit patients, but there is a real need for validated biomarkers to identify those patients who will benefit from it. Furthermore, although there is increasing interest in the use of immune checkpoint therapies in breast cancer, we still don’t know which patients are likely to respond, nor what the best accompanying chemotherapeutic regimen is to sensitise patients to these. The use of Almac’s claraT report in our study has given us a valuable insight into the underlying biology of breast tumours before and during neoadjuvant chemotherapy, allowing us the potential to develop studies with a sound scientific rationale to further improve outcomes for these women."

Professor Richard Kennedy, Global VP and Medical Director, Almac Diagnostic Services stated: "We are delighted to be able to equip leading cancer researchers like Professor Rodriguez and Dr McIntosh with a valuable gene expression analysis platform which has supported the identification of exciting new data in their studies. We congratulate them and their teams on their recent publications and look forward to seeing how their studies progress towards new therapeutic interventions in both brain and breast cancer."

To see the current list of publications, posters and presentations that Almac’s claraT report has assisted research institutions with. Please see: View Source

On December 8, 2021 OPKO Health, Inc. (NASDAQ: OPK) reported that the U.S. Food and Drug Administration (FDA) has approved OPKO’s 4Kscore Test (Press release, Opko Health, DEC 8, 2021, View Source [SID1234596602]). This test is approved for use in men age 45 and older who have not had a prior prostate biopsy or are biopsy negative and have an age-specific abnormal total PSA and/or abnormal digital rectal exam (DRE). The 4Kscore Test provides a numerical value to assess the presence of aggressive prostate cancer before a decision is made to perform a prostate biopsy.

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The 4Kscore Test is currently available at BioReference Laboratories, an OPKO Health Company, through its specialty oncology and urology division, GenPath.

"The 4Kscore Test has been available as a Laboratory Developed Test (LDT) since 2014. The FDA approval provides further validation of its value as an important tool in the diagnostic paradigm for prostate cancer," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories, Inc.

The FDA approval is based on data from two prospective clinical studies carried out in the United States. Annually, about 20 million total PSA tests are performed in the United States and 10-15% of the results are found to be abnormal. The 4Kscore Test is calculated using a proprietary algorithm that includes values of a subject’s four different prostate specific kallikrein biomarkers, age, prior biopsy history and DRE status. The algorithm was developed by a team at Memorial Sloan Kettering, based on more than 30,000 cryopreserved blood samples, including assessment of the relationship of the 4Kscore Test to the subjects’ long-term prostate health outcome.

The 4Kscore Test has been used by more than 7,700 health care providers including approximately 4,200 urologists. Over 300,000 tests have been performed since its launch as an LDT in 2014. The test has been included in the National Comprehensive Cancer Network Guidelines (NCCN) since 2015 and European Association of Urology Prostate Cancer Guidelines since 2016. OPKO has offered the 4Kscore Test in the U.S., Europe and elsewhere.

About the 4Kscore Test

The 4Kscore Test is an in vitro serum or plasma test that combines four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA and human kallikrein 2) into a single numerical score that also incorporates a patient’s age, previous biopsy status and digital rectal exam results. The 4Kscore Test is indicated for use with other patient information as an aid in the decision for prostate biopsy in men 45 years of age and older who have an abnormal age-specific total PSA and/or abnormal DRE. The 4Kscore Test is intended to aid in detection of aggressive prostate cancer (Gleason score ≥7/Gleason Grade Group ≥2) for whom a biopsy would be recommended by a urologist, based on current standards of care before consideration of the 4Kscore Test. A 4Kscore <5.0 is associated with decreased likelihood of a Gleason score ≥7 on biopsy.

The intended use population are:

Men 45-54 years old and total PSA ≥2 ng/mL and/or abnormal DRE
Men 55-75 years old and total PSA ≥3 ng/mL and/or abnormal DRE
Men ≥76 years old and total PSA ≥4 ng/mL and/or abnormal DRE
Prostate biopsy is required for the diagnosis of cancer. The test is not recommended more than once every 6 months. The test is intended for professional use only. For more information about the 4Kscore Test, please visit www.4Kscore.com.

On December 8, 2021 City of Hope, a world-renowned, National Cancer Institute (NCI)-designated comprehensive cancer research and treatment organization, reported it has entered into a definitive agreement to acquire Cancer Treatment Centers of America (CTCA), a network of oncology hospitals and outpatient care centers across the United States (Press release, City of Hope, DEC 8, 2021, View Source [SID1234596622]). City of Hope’s strategic acquisition of CTCA will advance the missions of both organizations, building a national, integrated cancer research and treatment system to transform the future of cancer care.

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"This is a defining moment in the fight against cancer and a powerful opportunity to reach more cancer patients with the leading treatments, care and advanced research they critically need," said Robert Stone, president and CEO of City of Hope and the Helen and Morgan Chu Chief Executive Officer Distinguished Chair. "CTCA has a strong commitment to patient-centric cancer care, and combining its network and services with City of Hope’s scientific expertise, clinical trials and patient care strengths will significantly increase the number of people who can access the latest lifesaving treatments."

City of Hope’s acquisition expands and accelerates the organization’s ability to rapidly translate research and science into lifesaving care through its unique model — connecting breakthrough discoveries and academic medicine expertise with excellent, community-based specialized cancer care to the benefit of patients and families served. This acquisition also expands the portfolio, reach and impact of City of Hope’s leading-edge cancer services and capabilities, including research and development, into more communities across the country.

"Building on more than three decades of unparalleled patient experience and quality care, we’re excited to become a part of City of Hope, and to take a step closer to reaching so many more cancer patients with our unique, patient-centered model," said Pat Basu, M.D., M.B.A., president and CEO of CTCA. "Through the shared, patient-centric values of both organizations and expanded access as a result of the collaboration, cancer patients across the nation will be the ultimate beneficiaries of this relationship."

City of Hope is a national leader in advancing cancer research and treatment protocols, conducting nearly 1,000 clinical trials annually that can enroll approximately 25% of its patients. With more than 450 patent portfolios, 95 active investigator-initiated investigational new drugs (INDs) and approximately 50 IND applications submitted to the U.S. Food & Drug Administration every year, City of Hope is among the leading innovators in cancer research. The organization is also a pioneer in bone marrow and stem cell transplants with one of the largest, most successful programs of its kind in the U.S., having performed more than 17,000 procedures.

With CTCA, City of Hope builds on and accelerates its vision to forge partnerships and find new avenues for its expertise to positively impact as many lives as possible. In addition to the ongoing, significant expansion of its clinical network in Southern California, City of Hope previously acquired Translational Genomics Research Institute (TGen), which provides breakthrough genomics research. TGen’s capabilities are fully leveraged to provide highly specialized care and precision medicine treatment to City of Hope patients across its clinical care network. And in 2019, City of Hope launched AccessHopeTM to extend the reach of its clinical and research expertise directly to partner employers, including 17 of the Fortune 500 companies, so they can provide their employees with cancer information and expert clinical decision support.

Combined, City of Hope and CTCA will include approximately 11,000 team members, comprising the collaborative expertise of 575 physicians across a network of locations in California, including a new campus in Irvine opening in summer 2022, as well as Arizona, Illinois and Georgia. Basu will remain CEO of CTCA and report to Robert Stone.

"Cancer treatment is changing rapidly. Today, through advances such as immunotherapy, precision medicine and other treatments available through clinical trials, there are better survival rates and fewer side effects than ever before. A critical part of cancer care is closing the gap to access that exists for too many patients, particularly in underserved communities," continued Stone. "By joining forces with CTCA, we’re taking a major step forward in our mission to democratize cancer care and bring today’s treatments and tomorrow’s discoveries to even more people who need them now."

The transaction is expected to close in early 2022, subject to regulatory approvals. After close, City of Hope intends to convert CTCA to a nonprofit organization.