On April 22, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported participation in the Dermatology Nurses’ Association 2021 Annual Convention (Press release, Castle Biosciences, APR 22, 2021, View Source [SID1234578373]). Castle presented posters highlighting each of the company’s three skin cancer gene expression profile (GEP) tests.

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Poster information is as follows:

DecisionDx-Melanoma:

The poster is entitled, "31-gene expression profiling improves risk stratification in patients with T1 cutaneous melanoma."

DecisionDx-Melanoma is Castle’s 31-gene expression profile test that uses an individual patient’s tumor biology to predict risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node (SLN) positivity, independent of traditional staging factors.

Study methods and findings:

Nearly 70% of melanomas are diagnosed with tumor thickness that is less than or equal to 1.0 mm (T1 tumors), and recurrence-free survival (RFS) is generally good among these patients. However, up to 15% of patients with T1 tumors may experience a recurrence. Moreover, due to the large number of patients with T1 tumors, 27-30% of melanoma-related deaths occur in patients originally diagnosed with a T1 tumor, suggesting better identification of T1 patients at high risk of recurrence or metastasis is needed.
DecisionDx-Melanoma is designed to classify a patient’s recurrence risk as low (Class 1: Class 1A lowest) or high (Class 2: Class 2B highest) and has been validated in multiple prospective and retrospective studies.
Univariate analysis of the study data shows DecisionDx-Melanoma to be a stronger predictor of RFS than SLN status.
Multivariable analysis shows DecisionDx-Melanoma to be a strong, independent predictor of RFS.
With Class 2B RFS status similar to SLN positive status, Class 2B patients warrant follow-up strategies similar to SLN positive patients.
DecisionDx-SCC:

The poster is entitled, "Clinical utility of the 40-gene expression profile (40-GEP) for improved patient management decisions and disease related outcomes when combined with current clinicopathological risk factors for cutaneous squamous cell carcinoma (cSCC): Case Series."

DecisionDx-SCC is Castle’s prognostic 40-gene expression profile test for patients diagnosed with high-risk cutaneous squamous cell carcinoma (SCC) designed to use a patient’s tumor biology to predict individual risk of metastasis for patients with SCC and one or more risk factors.

Study methods and findings:

Two SCC cases were presented that highlight DecisionDx-SCC’s utility in stratifying risk in SCC.
The cases were very similar at diagnosis, both presenting with a history of immunosuppression along with identical staging (T2a per Brigham and Women’s Hospital staging; T1 per American Joint Committee on Cancer staging), but had divergent outcomes:
Case 1 did not recur, despite incomplete resection.
Case 2 developed local recurrence and regional metastasis, and died from SCC, despite clear surgical margins, radiation and chemotherapy treatments.
Subsequent DecisionDx-SCC test results yielded risk level assignments that correlated with the two patients’ outcomes:
Case 1 had a retrospective low-risk (Class 1) DecisionDx-SCC result.
Case 2 had a highest-risk (Class 2B) DecisionDx-SCC result.
The authors concluded that incorporating DecisionDx-SCC as a prognostic factor with traditional clinicopathological risk factors can improve stratification of high-risk SCC patients with at least one risk factor, thereby informing risk-appropriate management strategies.
DecisionDx DiffDx-Melanoma:

The poster is entitled, "Development, validation, and clinical utility of the 35-gene expression profile test for use as an adjunctive melanoma diagnostic tool."

DecisionDx DiffDx-Melanoma is designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions.

Study methods and findings:

DecisionDx DiffDx-Melanoma was developed using artificial intelligence methods trained on 200 benign nevi and 216 melanomas to select a panel of 32 discriminant and 3 control genes.
The test’s ability to differentiate accurately between benign and malignant pigmented skin lesions was characterized.
The test provides a high technical success rate at 96.6% with a modest intermediate-risk zone of 3.6%.
The analytical validity data of the DecisionDx DiffDx-Melanoma test demonstrates high precision as an indication of technical success.
Dermatopathologists utilized the DecisionDx DiffDx-Melanoma result to refine their diagnoses and their diagnostic confidence increased by 51%.
Dermatologists utilized the DecisionDx DiffDx-Melanoma result, which in the majority of responses, led to altered treatment plans in agreement with the DecisionDx DiffDx-Melanoma result.
About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. To predict likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithm, i31-GEP, to produce an integrated test result. i31-GEP is an artificial intelligence-based neural network algorithm (independently validated in a cohort of 1,674 prospective, consecutively tested patients with T1-T4 cutaneous melanoma) that integrates the DecisionDx-Melanoma test result with the patient’s traditional clinicopathologic features. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through December 31, 2020, DecisionDx-Melanoma has been ordered more than 68,920 times for use in patients with cutaneous melanoma.

More information about the test and disease can be found at www.CastleTestInfo.com.

About DecisionDx DiffDx-Melanoma

DecisionDx DiffDx-Melanoma is designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions. Of the approximately 2 million suspicious pigmented lesions biopsied annually in the U.S., Castle estimates that approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. DecisionDx DiffDx-Melanoma classifies these lesions as: benign (gene expression profile suggestive of benign neoplasm); intermediate-risk (gene expression profile cannot exclude malignancy); or malignant (gene expression profile suggestive of melanoma). Interpreted in the context of other clinical, laboratory and histopathologic information, DecisionDx DiffDx-Melanoma is designed to add diagnostic clarity and confidence for dermatopathologists while helping dermatologists deliver more informed patient management plans.

More information about the test and disease can be found at www.CastleTestInfo.com.

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1, 2A or 2B risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

More information about the test and disease can be found at www.CastleTestInfo.com.

On April 22, 2021 Mission Therapeutics ("Mission"), a drug discovery and development company focused on selectively inhibiting deubiquitylating enzymes (DUBs), reported that members of its management will be attending the upcoming SVB Leerink Biopharma Private Company Connect Event (Press release, Mission Therapeutics, APR 22, 2021, View Source [SID1234578340]).

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The event, which will take place virtually on 6-7 May 2021, is intended to bring together private companies with institutional investors and to facilitate discussions on the trends and opportunities shaping the future of healthcare.

For individuals interested in attending the conference, please contact SVB Leerink for more information.

On April 22, 2021 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that financial results for the first quarter ended March 31, 2021 (Press release, Quest Diagnostics, APR 22, 2021, View Source [SID1234578358]).

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"Quest had a very strong first quarter, with our base business continuing its recovery to near pre-pandemic levels," said Steve Rusckowski, Chairman, CEO and President, Quest Diagnostics. "Contributions from acquisitions and Professional Lab Services relationships accelerated growth in the base business and helped offset the reduction in demand for COVID-19 testing, which was in line with industry trends. In March, for the first time since the pandemic began, monthly organic revenue in the base business grew versus our 2019 baseline. As we noted at our recent Investor Day, Quest is well positioned to grow as the U.S. exits the pandemic and people return to normal activities and address the routine care issues that have been neglected over the past year."

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.

Share repurchase update

The company expects to launch an accelerated share repurchase in the amount of approximately $1.5 billion in the coming days.

As of March 31, 2021, $2.5 billion remained available under the company’s share repurchase authorization, reflecting a $1 billion increase by the Board of Directors in March. Also, as previously announced, the Board of Directors increased the share repurchase authorization by $1 billion in February.

For the three months ended March 31, 2021, the company repurchased 3.4 million shares of its common stock for $410 million.

Updated outlook for first half of 2021

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, costs associated with donations, contributions, and other financial support through Quest for Health Equity, the company’s 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, 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 the company’s website at www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 888-566-0490 for domestic callers or 203-369-3053 for international callers. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on April 22, 2021 until midnight Eastern Time on May 6, 2021. Anyone listening to the call is encouraged to read the company’s 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.

On April 22, 2021 Candel Therapeutics, Inc., a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported it has completed enrollment for its Phase 1 clinical trial in patients with newly diagnosed high-grade glioma to evaluate the safety and efficacy of CAN-2409 in combination with immune checkpoint inhibitor Opdivo (nivolumab) and standard of care radiation therapy, as well as temozolomide for patients with methylated MGMT promoters (Press release, Candel Therapeutics, APR 22, 2021, View Source [SID1234578374]). The trial enrolled 35 evaluable patients and is being conducted in collaboration with Bristol Myers Squibb Company, manufacturer of Opdivo, and separately the Adult Brain Tumor Consortium at Johns Hopkins University.

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"The addition of CAN-2409 to immune checkpoint inhibitor treatment has the potential to train lymphocytes to specifically recognize tumor neoantigens and to change the ‘cold’, immunosuppressive tumor microenvironment, thereby synergizing with lymphocyte activation induced by nivolumab resulting in tumor cell destruction," said Paul Peter Tak, M.D., Ph.D., President and Chief Executive Officer of Candel Therapeutics. "With a significant number of patients affected each year and limited treatment options available, there remains a critical need for effective therapies in high-grade glioma. It is our hope that CAN-2409 can create new, more effective options for this patient population, and we look forward to the readout from this study next year."

The primary endpoints of the study are safety and tolerability of this combined treatment regimen. Secondary endpoints include overall survival, progression free survival and immunological biomarkers. For more information about this study, please visit: www.clinicaltrials.gov (NCT03576612).

Opdivo is a registered trademark of Bristol Myers Squibb.

About CAN-2409

CAN-2409, previously known as gene-mediated cytotoxic immunotherapy (GMCI), Candel’s most advanced oncolytic viral immunotherapy candidate, is a replication-deficient adenovirus that delivers the herpes simplex virus thymidine kinase (HSV-tk) gene to cancer cells. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. The intra-tumoral administration results in the release of tumor-specific neoantigens in the microenvironment, thereby training the immune system to recognize these antigens. The activated effector T cells have the potential to migrate to distant, uninjected metastases for broad anti-tumor activity. At the same time, the adenoviral capsid protein elicits a strong pro-inflammatory signal in the tumor microenvironment. This adjuvant effect helps create a better immune response against the tumor neoantigens released locally. This dual mechanism of antigen unmasking and immune activation may enable CAN-2409 to generate a powerful and lasting attack against a variety of the patient’s tumor-associated neoantigens, minimizing the possibility for antigen escape and tolerance development.

Because of its versatility, CAN-2409 may have the potential to treat a broad range of solid tumors. Combination activity with standard of care radiation therapy, surgery, immune checkpoint inhibitors

(ICI) and chemotherapy has already been shown in several preclinical and clinical settings. Candel has previously published preclinical data that supports combination of CAN-2409 with ICI. In a mouse model of glioblastoma unresponsive to ICI, addition of CAN-2409 was shown to modulate the immunosuppressive, unresponsive tumor microenvironment, resulting in a synergistic effect in vivo, with significantly improved survival in mice treated with CAN-2409 and ICI combination. Furthermore, CAN-2409 presents a favorable tolerability profile. More than 700 patients have been dosed to date, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events. Currently, Candel is evaluating the effects of treatment with CAN-2409 for brain, prostate, lung, and pancreatic cancers in clinical trials.

On April 22, 2021 Clinical Outcomes Solutions (‘COS’), a global leader in the collection, analysis and reporting of patient-centered outcomes data with offices in Tucson and Chicago (USA) and Folkestone (UK), reported a collaborative partnership with Carevive Systems (‘Carevive’), the leading oncology-focused health technology company (Press release, Carevive Systems, APR 22, 2021, View Source [SID1234578408]).

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The two organizations, both deeply experienced with the collection and analysis of oncology data, are proud to announce that Carevive is joining the Oncology Outcomes initiative, launched in February 2019, to deliver world-class data and analysis to improve the patient experience and enhance survival outcomes of cancer patients.

The partnership will leverage Carevive’s innovative digital oncology platform to capture the patient experience while on treatment, and COS’ deep experience in analyzing these types of data, providing invaluable insights for life science companies and regulatory authorities.

The Carevive platform PROmpt enables cancer care teams to monitor and manage their patients remotely, which improves survival outcomes and patient quality of life. The platform also enables large-scale digital data collection via the Oncology Pragmatic Trial Investigator Network (Carevive OPT-IN), merging electronic medical records (EMR) with patient reported outcomes (PRO) to offer cancer centers a holistic, longitudinal view of their patient population for quality improvement and pathway enhancement purposes.

COS is a global leader in delivering innovative science to capture and communicate the patient voice, in order to provide actionable evidence through qualitative and quantitative research, with a specific focus on Clinical Outcomes Assessments in the oncology space. Through the partnership, COS will apply this expertise to providing data analytic support to generate insights from these novel patient experience datasets.

Stacie Hudgens, Chief Executive Officer at COS, said: "We are very excited to announce this partnership with Carevive, an organization that shares our deep-rooted passion for world-class oncology research to improve the patient experience.

"The depth and breadth of the Carevive datasets provide access to a host of data on solid tumors and liquid cancers, and will enhance our ability to improve the patient journey."

Bruno Lempernesse, Chief Executive Officer at Carevive, said: "Carevive is committed to reshaping the way cancer care is delivered so that therapies can become more personalized through the use of real-world patient data. We are delighted to announce this partnership with COS, an organization that has supported the development of our patient experience data collection efforts from its inception. By combining COS’ FDA and industry expertise with Carevive data, this partnership provides a model of how to approach real-world evidence and patient-reported outcomes with cancer care teams, regulatory authorities and life science companies."

Tara Symonds, Chief Science Officer at COS, added: "We have seen the benefit from monitoring patient symptoms over time while on treatment across numerous cancer types. Oncology treatments are highly toxic and can cause significant side effects. Thus, effective, real-time monitoring enables far quicker intervention and the opportunity to improve the patient experience and enhance symptom management.

"Research conducted by renowned medical oncologist and PRO expert Ethan Basch M.D., has shown that such intervention can add six months to survival, a significant finding for the benefit of patients with cancer. Digital Health Solutions, such as the Carevive platform, are the key to demonstrating the extent to which patients’ symptoms and quality of life are improved by particular treatments, and are rapidly becoming a critical tool for our clients when conducting real-world assessments of the impact of their drugs.

"The platform also offers additional benefits, such as the opportunity to design real-world studies for our clients, which would not be possible without access to Carevive’s database."