On May 27, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported that it has been selected as the winner of the "Best New Technology Solution – Dermatology" award in the sixth annual MedTech Breakthrough Awards program for its innovative DecisionDx-Melanoma gene expression profile (GEP) test (Press release, Castle Biosciences, MAY 27, 2022, View Source [SID1234615204]). DecisionDx-Melanoma leverages Castle’s advanced technologies to identify the risk of metastasis, recurrence and sentinel lymph node (SLN) positivity for patients diagnosed with invasive cutaneous melanoma. In 2021, Castle was awarded "Best New Technology Solution – Oncology" by MedTech Breakthrough for its DecisionDx-SCC and DecisionDx DiffDx-Melanoma GEP tests, both of which were launched in the second half of 2020.

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The mission of the MedTech Breakthrough Awards is to honor excellence and recognize the innovation, hard work and success in a range of health and medical technology categories. This year’s program attracted more than 3,900 nominations from over 15 different countries throughout the world.

DecisionDx-Melanoma is Castle’s proprietary risk stratification GEP test that is designed to use a patient’s tumor biology to predict individual risk of metastasis or recurrence for patients diagnosed with invasive cutaneous melanoma, a deadly skin cancer, as well as the risk of SLN positivity, independent of traditional staging factors. Unlike traditional treatment plans that are developed using clinical and pathologic factors alone (e.g., a patient’s age, tumor thickness, ulceration, etc.), incorporating the patient’s primary tissue biology can help physicians and patients make more informed disease management decisions aligned with each patient’s unique biologic risk.

"Having an accurate picture of whether melanoma is likely to recur or spread is critical to making the right treatment and disease management decisions, and though risk indicators like clinicopathological factors and patient history are important, they have their limitations," said James Johnson, managing director, MedTech Breakthrough. "Genomic testing can supplement these traditional factors, and Castle’s GEP test has been shown to accurately and independently predict individual risk of recurrence or metastasis, and can provide clinically actionable and personalized information to inform the treatment plan for each patient. Congratulations to the Castle team for being our choice for ‘Best New Technology Solution – Dermatology.’"

In 2021, Castle incorporated two new proprietary, independently validated algorithms into its DecisionDx-Melanoma test: i31-SLNB (designed to predict SLN positivity) and i31-ROR (designed to predict an individual patient’s risk of recurrence). These algorithms combine a patient’s clinical and pathologic risk factors with their DecisionDx-Melanoma class result to provide an Integrated Test Result with precise and personalized risk information specific to each patient, including his/her:

Personalized likelihood of SLN positivity, thus informing consideration of the SLN biopsy surgical procedure.
Personalized, patient-specific risk of recurrence predictions, including five-year outcomes for melanoma-specific survival, distant metastasis-free survival and recurrence-free survival, to give guidance for patient follow-up and treatment intensity decisions.
"The choices that clinicians and patients make immediately after a diagnosis of invasive melanoma can be critical and ultimately determine the outcome of a patient’s disease," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "Thus, it was important to us at Castle that our DecisionDx-Melanoma test provided the most precise and personalized information possible to help inform potentially life-changing decisions around the management and treatment of a patient’s cancer. We are thrilled to win this award, recognizing our innovative DecisionDx-Melanoma test that we believe is transforming the management of melanoma and guiding improved patient care."

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 (CM) metastasis or recurrence, as well as the risk of sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 6,300 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. Additionally, Castle has an ongoing collaboration with the National Cancer Institute (NCI) to link DecisionDx-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on CM cases. This collaboration has resulted in Castle’s analysis of 5,226 samples (clinically tested through December 31, 2018) in a study to evaluate melanoma-specific survival and overall survival; in this study, patients tested with DecisionDx-Melanoma had better survival rates than untested patients, and the data suggested that DecisionDx-Melanoma can accurately risk-stratify for disease progression to aid in risk-aligned treatment plans for improved patient outcomes and survival. 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. Additionally, impact on patient management plans for one of every two patients tested has been shown in five multi-center/single-center studies including more than 800 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. To predict risk of recurrence and likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an Integrated Test Result. Through March 31, 2022, DecisionDx-Melanoma has been ordered 97,288 times for patients with cutaneous melanoma.

On May 27, 2022 Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, reported that it will be presenting a poster at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held at McCormick Place in Chicago and virtually from June 3-7, 2022 (Press release, Bolt Biotherapeutics, MAY 27, 2022, View Source [SID1234618688]). The poster is titled "Characterization of tumor antigen expression and myeloid immune profiles to inform the development of immune-stimulating antibody conjugates (ISACs)."

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"The data being presented at ASCO (Free ASCO Whitepaper) demonstrate that myeloid cells are consistently present in solid tumors. We believe this represents an attractive cellular target to address cancer more broadly. Myeloid cells are key cell types that serve as immunologic sentinels within the tumor microenvironment and can directly kill tumor cells or activate long-lasting cytotoxic T cells," said Edith A. Perez, M.D., Chief Medical Officer of Bolt Biotherapeutics. "Myeloid-targeted therapies, as single-agents or in combination with approved therapies, have the potential to benefit patients who may or may not have previously benefited from T cell-targeted approaches."

Bolt Biotherapeutics is currently developing a pipeline of myeloid-targeting therapies, including immune-stimulating antibody conjugates (ISACs) and BDC-3042 (a Dectin-2 agonistic antibody), designed to kill tumors through activation of myeloid cells and subsequent recruitment of T cells. Bolt researchers characterized the myeloid immune landscape of tumor microenvironments from five solid tumor types. The data demonstrate that myeloid cells are present in all tested tumor microenvironments, including those with low T cell infiltration. These findings support the potential for myeloid-directed therapies to activate the innate immune system as a bridge to adaptive immunity, including patient populations who have demonstrated resistance to T cell-mediated immune checkpoint blockade. The data also validate the tumor cell expression of tumor antigens HER2, CEA, and PD-L1, all of which are targets of Boltbody ISAC candidates.

The ASCO (Free ASCO Whitepaper) abstract and poster presentation can be found on the Bolt website under Events & Presentations. Details regarding the presentation are as follows.

Title: Characterization of tumor antigen expression and myeloid immune profiles to inform the development of immune stimulating antibody conjugates (ISACs)
Presented by: Jason Ptacek, Ph.D.
Poster Session: Developmental Therapeutics – Immunotherapy
Time: Sunday, June 5, 8:00 a.m. – 11:00 a.m. CDT
Abstract Number: 2557
Poster Number: 212

On May 27, 2022 NEX-I reported the company has established 20 types of mouse models for refractory factors, and developed ‘NX-101,’ a candidate for an immunotherapy agent targeting solid tumors (Press release, NEX-I, MAY 27, 2022, View Source;mode=VIEW&num=18&category=&findType=&findWord=&sort1=&sort2=&page=3 [SID1234643435]). "We plan to complete non-clinical trials within next year and enter phase 1 clinical trials in the fourth quarter of next year."

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NEX-I was founded in April last year by CEO Kyung-Wan Yoon, who served as Chief Scientific Officer (CSO) and Vice President at Genome & Company. Currently, about 15 people are working at Nexi, including Chief Operating Officer (COO) Vice President Son Jin-beop, and Chief Technology Officer (CTO) Professor Kim Tae-woo of Korea University, who are former DM Bio employees, and plans to add about 10 more people this year.

NexI was selected for the TIPS and Korea New Drug Development Foundation (KDDF) ​​project last year, and attracted 4 billion won in pre-Series A. In particular, we will cooperate in the mid- to long-term with Daewoong Pharmaceutical, which participated as a strategic investor in Pre Series A, to develop pipelines such as non-small cell lung cancer (NSCLC) antibody candidate ‘NXI-101’ and metastatic melanoma antibody candidate ‘NXI-201’. We plan to continue research and development.

On May 27, 2022 Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its bacterial Mimicry drug discovery platform, reported the publication of three abstracts related to its OncoMimcs pipeline, including EO2401, its first-in-class off-the-shelf OncoMimics cancer immunotherapy, ahead of poster presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 3-7, 2022 in Chicago and virtually (Press release, Enterome, MAY 27, 2022, View Source [SID1234615168]).

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Enterome will present clinical proof-of-concept data from its most advanced OncoMimics drug candidate, EO2401, a therapeutic cancer vaccine candidate currently in clinical development for the treatment of patients with first progression/recurrence of glioblastoma (ROSALIE trial, EOGBM1-18) and for the treatment of patients with locally advanced or metastatic adrenocortical carcinoma, or malignant pheochromocytoma/paraganglioma (SPENCER trial, EOADR1-19).

A third poster describing the Phase 1/2 trial (SIDNEY, EONHL1-20) with Enterome’s second OncoMimics vaccine, EO2463, in non-Hodgkin lymphoma will also be presented at ASCO (Free ASCO Whitepaper).

Details of the poster presentations and session are as follows:

ROSALIE Trial (EOGBM1-18)

Title: EO2401, a novel microbiome-derived therapeutic vaccine for patients with recurrent glioblastoma
Track: Central Nervous System Tumors
Abstract number: #2034
Date and Time: Sunday, June 5, 8:00 AM-11:00 AM CDT
Presenter: Professor Wolfgang Wick, Universitätsklinikum Heidelberg and German Cancer Research Center, Heidelberg, Germany
Authors: Wick, W. et al
SPENCER Trial (EOADR1-19)

Title: EO2401, a novel microbiome-derived therapeutic vaccine for patients with adrenocortical carcinoma (ACC)
Track: Genitourinary Cancer—Kidney and Bladder
Abstract number: #4596
Date and Time: Saturday, June 4, 1:15 PM-4:15 PM CDT
Presenter: Professor Vivek Subbiah, The University of Texas MD Anderson Cancer Center (MDACC), Houston, TX
Authors: Baudin, E. et al
SIDNEY Trial (EONHL1-20)

Title: A novel microbial-derived peptide therapeutic vaccine (EO2463) as monotherapy and in combination with lenalidomide and rituximab, for treatment of patients with indolent non-Hodgkin lymphoma
Poster session: Hematologic Malignancies/Lymphoma and Chronic Lymphocytic Leukemia
Poster number: #TPS7586
Date and Time: Saturday, June 4, 8:00 -11:00 AM CDT
Authors: Zinzani, P.L et al

About OncoMimics Peptides

OncoMimics peptides are gut microbiome-derived peptides that closely mimic antigens expressed by tumor cells. In contrast to tumor antigens, however, OncoMimics peptides are recognized by the immune system as "non-self" and can generate a strong human cytotoxic CD8+ response steming from memory T cells, offering enormous potential to create a new class of cancer vaccines targeting solid and liquid tumors.

Enterome’s pioneering work on its OncoMimics pipeline leverages the fundamental understanding that the gut is the largest lymphoid organ in the body and is home to most of its memory T-cells. As a result, there is constant interaction and presentation of peptides and proteins secreted by gut bacteria to the body’s immune system, resulting in the formation of a pool of effector memory T cells protecting the human body against bacterial invasion. In the event that the bacterial antigens are mimics of tumor antigens, this process leads to the generation of circulating effector memory T cells with a preserved ability to recognize tumor antigens.

On May 27, 2022 Exact Sciences Corp. (NASDAQ: EXAS), a leader in advanced cancer diagnostics, reported new data supporting its cancer tests and treatment guidance tools will be showcased in nine poster presentations and five e-abstracts at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held June 3-7 in Chicago, Illinois (Press release, Exact Sciences, MAY 27, 2022, View Source [SID1234615186]).

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"As the leading cause of death worldwide,1 cancer creates tremendous human suffering and staggering health care costs. Tests to help catch the disease earlier and guide more effective treatment are necessary to improve outcomes," said Kevin Conroy, chairman and CEO of Exact Sciences. "Together with our collaborators from leading medical institutions, Exact Sciences is proud to present extensive data at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting. These presentations highlight the breadth of our pipeline and portfolio of tests as part of our relentless efforts to advance the field of cancer diagnostics."

Studies supporting Exact Sciences’ screening and earlier detection efforts include a comparison of simulated outcomes between stool- and blood-based colorectal cancer screening tests. The modeled outcomes suggest blood-based tests result in detecting fewer colorectal cancer cases compared to stool-based tests due to differences in colorectal cancer sensitivity and specificity and lower advanced adenoma detection rates.2 A cost-effectiveness analysis that assumed adherence to stool-based screening and/or follow-up colonoscopy increased when coinsurance was waived showed improvement in outcomes including life years gained and CRC incidence and mortality reductions.3 Another study indicated a shorter time to diagnosis for screenable versus symptom-driven cancers, supporting an expanded use of multi-cancer testing.4

Also being presented are findings from Mayo Clinic as part of the academic center’s ongoing collaboration with Exact Sciences to advance the use of methylated DNA markers in detecting a range of cancer types, including cutaneous melanoma, prostate cancer, and lymphoma.5

Data highlighting Exact Sciences’ precision oncology portfolio of tests will also be presented. The analyses support use of Oncomap and Oncomap ExTra, comprehensive genomic profiling tests formerly known as the Oncotype Map Pan-Cancer Tissue and GEM ExTra tests, respectively, to inform targeted therapy selection and clinical trial options for patients with advanced solid tumors.6 Also being presented is an overview of the ongoing CORRECT-MRD II study, designed to generate clinical validation data for the company’s minimal residual disease assay in Stage II and III colorectal cancer patients.7

Following are details for the fourteen abstracts that have been accepted at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. All abstracts are now available in the ASCO (Free ASCO Whitepaper) Meeting Library.

Saturday, June 4

NSABP C-14: CORRECT-MRD II – Second colorectal cancer clinical validation study to predict recurrence using a circulating tumor DNA assay to detect minimal residual disease
Authors: Salem, M., et al.
Session: Gastrointestinal Cancer ‒ Colorectal and Anal
Poster Discussion: 8:00-11:00 a.m. CT
Abstract Number: TPS3632

Methylated DNA markers in early detection of lymphoma: Discovery, validation, and clinical pilot
Authors: Witzig, T., et al.
Session: Hematologic Malignancies ‒ Lymphoma and Chronic Lymphocytic Leukemia
Poster Discussion: 8:00-11:00 a.m. CT
Abstract Number: 7562

Sunday, June 5

Comprehensive genomic profiling to identify gene alterations in DNA repair pathway across solid tumors
Authors: McDonnell, K., et al.
Session: Developmental Therapeutics ‒ Molecularly Targeted Agents and Tumor Biology
Poster Discussion: 8:00-11:00 a.m. CT
Abstract Number: 3124

Monday, June 6

Comprehensive whole-exome and transcriptome profiling to identify actionable alterations associated with response to PARP inhibitors in breast cancer
Authors: Dombrowski, S., et al.
Session: Breast Cancer ‒ Metastatic
Poster Discussion: 8:00-11:00 a.m. CT
Abstract Number: 1096

BRAF mutation classes and co-occurring mutations in NSCLC
Authors: Niu, J., et al.
Session: Lung Cancer ‒ Non-Small Cell Metastatic
Poster Discussion: 8:00-11:00 a.m. CT
Abstract Number: 9083

Characterization of time to diagnosis indicates shorter interval for screenable versus symptom-driven cancers
Authors: Gainullin, V., et al.
Session: Prevention, Risk Reduction, and Hereditary Cancer
Poster Discussion: 1:15-4:15 p.m. CT
Abstract Number: 10526

Comparison of simulated outcomes between stool- and blood-based colorectal cancer screening tests
Authors: Fendrick, A. M., et al.
Session: Prevention, Risk Reduction, and Hereditary Cancer
Poster Discussion: 1:15-4:15 p.m. CT
Abstract Number: 10529

Plasma methylated DNA markers of cutaneous melanoma: Association with PET/CT-positive disease
Authors: Meves, A., et al.
Session: Melanoma/Skin Cancers
Poster Discussion: 3:15-6:15 p.m. CT
Abstract Number: 9567

Methylated DNA markers in urine aid in the selective identification of patients with prostate cancer as well as clinically significant pathology
Authors: Shah, P., et al.
Session: Genitourinary Cancer ‒ Prostate, Testicular, and Penile
Poster Discussion: 3:15-6:15 p.m. CT
Abstract Number: 5091

Online Publications

Cost-effectiveness of mt-sDNA vs mailed FIT outreach for Medicare Advantage enrollees using the CRC-AIM microsimulation model
Authors: Bhatt, J., et al.
Abstract Number: e18827

Cost-effectiveness of waiving coinsurance for follow-up colonoscopy after a positive stool-based colorectal screening test in a Medicare population
Authors: Fendrick, A. M., et al.
Abstract Number: e13624

Modeling analysis of COVID 19-related delays in colorectal cancer screening on simulated clinical outcomes
Authors: Wilson, L., et al.
Abstract Number: e13631

Plasma methylated DNA markers detect recurrence and response to therapy in colorectal cancer
Authors: Zhu, M., et al.
Abstract Number: e15567