Expert Panel Provides Framework for Incorporating DecisionDx-SCC Results Into Clinical Decision Making for Cutaneous Squamous Cell Carcinoma Patients With One or More Risk Factors

On May 20, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to inform treatment decisions, reported a publication describing the findings of a squamous cell carcinoma (SCC) gene expression profiling (GEP) expert panel in the Journal of Drugs in Dermatology (Press release, Castle Biosciences, MAY 20, 2021, View Source [SID1234580388]). The publication provides a framework for integrating DecisionDx-SCC into clinical practice.

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Treatment plan decisions in SCC are based upon the likelihood of an individual patient’s tumor to metastasize. Data from previous studies has demonstrated that DecisionDx-SCC, Castle’s prognostic 40-GEP test designed to use a patient’s tumor biology to predict individual risk of metastasis for patients with SCC and one or more risk factors, is a significant, independent predictor of risk, compared to existing traditional clinical and pathologic staging systems.

The article, titled "Clinical Considerations for Integrating Gene Expression Profiling into Cutaneous Squamous Cell Carcinoma Management," describes the findings of a multidisciplinary expert panel, representing backgrounds from academic medical centers and community practices. The panel also included specialties clinicians, such as Mohs surgeons, surgical oncologists and a radiation oncologist. The panel reviewed traditional risk assessment practices, guidelines and expert recommendations on DecisionDx-SCC. The panel also focused on decision-making points, where information from DecisionDx-SCC might inform the clinical management of patients with SCC and one or more risk factors.

Study findings:

Decision points supported by DecisionDx-SCC test results include:
nodal evaluation
adjuvant radiation therapy
follow-up and surveillance
The panel determined that the additional information provided by DecisionDx-SCC could:
help avoid unnecessary treatment and surveillance
allow healthcare providers to increase treatment intensity or follow-up as needed
inform if and when to refer a patient for medical, surgical, or radiation oncology
"This is an exciting time in the management of high-risk squamous cell carcinoma patients," said study author, Sherrif Ibrahim, M.D., Ph.D., Mohs surgeon and associate professor in the department of dermatology at The University of Rochester Medical Center. "Progress has been made with clinicopathologic risk factor assessment. However, potential remains for these assessments to overestimate or underestimate risk. Gene expression profile testing assists us in assessing the biologic risk of individual tumors and providing personalized care for our patients, which may lead to risk appropriate reduction of treatment or increased treatment intensity and more appropriate referrals."

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.

AIkido Pharma Announces Phase 1 Data To Be Presented at the American Society of Clinical Oncology ("ASCO") Annual Meeting

On May 20, 2021 AIkido Pharma Inc. (Nasdaq: AIKI) ("AIkido" or the "Company") reported that Phase 1 testing data will be presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting June 4, 2021 (Press release, AIkido Pharma, MAY 20, 2021, View Source [SID1234580404]). The presentation of the data will be by Dr. Scott Tagawa, a Professor of Medicine & Urology at Weill Cornell Medicine and an AIkido Pharma Scientific Advisory Board member.

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ASCO Presentation Details:

Title: "Phase I study of 225Ac-J591 for men with metastatic castration-resistant prostate cancer (mCRPC)"
Tract: Genitourinary Cancer—Prostate, Testicular, and Penile
Presenter: Dr. Scott Tagawa MD, MS, FACP
Abstract Number: 5015
Date and Time: Available Starting June 4, 2021, 9:00 am (EST)

The Abstract from this study has been released on the ASCO (Free ASCO Whitepaper) Annual Meeting website (View Source), a portion of which states: "PSMA-targeted alpha-emitter 225Ac utilizing intact antibody J591 is tolerable with early evidence of clinical activity. Based upon these results, a follow up study [NCT04506567] testing multiple and fractionated dosing of 225Ac-J591 is underway. Clinical trial information: NCT03276572 (View Source )

The full ASCO (Free ASCO Whitepaper) meeting program is available at: www.asco.org

NovalGen presents data at American Society of Clinical Oncology for novel ROR1xCD3 bispecific antibody for non-Hodgkin lymphoma

On May 20, 2021 NovalGen Ltd ("NovalGen"), a biopharmaceutical company developing breakthrough cancer therapies, reported the company will give a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual meeting 2021, taking place June 4-8, 2021 (Press release, UCLB, MAY 20, 2021, View Source [SID1234580421]).

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NovalGen has developed an ROR1xCD3 bispecific antibody T cell engager, NVG-111, that is currently entering Phase 1/2 development for patients with non-Hodgkin lymphoma; initially focused on Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic Leukemia (CLL), but with the potential to target >20 different hard-to-treat solid and liquid cancers. NVG-111 is a first in class bispecific antibody T cell engager targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1). ROR1 is a tumor-associated antigen that is overexpressed in a broad range of cancers, but has negligible expression in healthy adult tissues, making it an ideal candidate for novel, targeted cancer therapies.

"These data presented in our poster at ASCO (Free ASCO Whitepaper) show preclinical data supporting our Phase 1/2 first in human study for NVG-111," said Professor Amit Nathwani, CEO of NovalGen. "The data demonstrates NVG-111 eliciting potent killing at low concentrations of the drug. Additionally, cytokine release appears lower than other T cell engagers. Overall, it advances the scientific understanding of the potential of NVG-111 in a range of hard-to-treat cancers."

Poster Presentation Details:

Abstract Number for Publication: 7549

Abstract Title: NVG-111, a novel ROR1xCD3 bispecific antibody for non-Hodgkin lymphoma

Session Title: Poster Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

The abstract is available on the ASCO (Free ASCO Whitepaper) meeting library.

GeneQuantum Completes C Round for Novel ADC Candidates

On May 20, 2021 GeneQuantum Healthcare (Suzhou) reported that it completed a Series C funding to develop its portfolio of site-specific antibody drug conjugate molecules (Press release, GeneQuantum Healthcare, MAY 20, 2021, View Source [SID1234580472]). According to the company, the C round raised several hundreds of millions of RMB, which puts the funding at least in the $50 million range, but the exact amount was not disclosed. GeneQuantum says it has built a differentiated ADC platform that addresses the major problems of ADC drugs: high heterogeneity, narrow therapeutic window and high manufacturing cost. The Series C was led by China Life Private Equity Investment.

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Chugai Obtains Approval for FoundationOne Liquid CDx Cancer Genomic Profile to be used as a Companion Diagnostic for Olaparib in BRCA-Mutated Prostate Cancer

On May 20, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on May 19, 2021 for FoundationOne Liquid CDx Cancer Genomic Profile to be used as a companion diagnostic for the PARP inhibitor, Lynparza (generic name: olaparib) for the treatment of BRCA-mutated castrate-resistant prostate cancer (mCRPC) with distant metastasis (Press release, Chugai, MAY 20, 2021, View Source [SID1234580339]). With this approval, patients with advanced prostate cancer who may be eligible for the treatment with olaparib can be identified through both tissue-based and liquid-based comprehensive genomic profiling (CGP) tests. Since tissue availability can be an issue for some metastatic prostate cancer patients, blood-based testing is an important option to consider and critically important for informing patient care.

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"We are pleased that the FoundationOne Liquid CDx Cancer Genomic Profiletest was approved as a companion diagnostic for olaparib for advanced metastatic prostate cancer, following the tissue-based FoundationOne CDx Cancer Genomic Profile approval in December last year," said Chugai’s President and CEO, Dr. Osamu Okuda. "Precision cancer medicine is rapidly changing the treatment strategy for mCRPC and it is very important to understand the genomic profile of a patient’s tumor in order to select the optimal treatment. The availability of both liquid and tissue-based companion diagnostics helps to identify patients who may be eligible for olaparib. We are committed to advancing personalized healthcare in cancer treatment."

The approval aims to expand the use of FoundationOne Liquid CDx Cancer Genomic Profile as a companion diagnostic for olaparib in advanced prostate cancer which progressed after treatment with enzalutamide or abiraterone. It identifies patients who my be eligible for the treatment by detecting BRCA1/2 gene alterations. The efficacy and safety of olaparib in mCRPC patients with BRCA1/2 alterations were investigated in the Phase III PROfound study and AstraZeneca K.K. received approval from the MHLW on December 25, 2020. Olaparib is jointly developed and commercialized by AstraZeneca (LSE/STO/Nasdaq: AZN) and MSD (Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA).

As a leading company in the field of oncology, Chugai is committed to realize advanced personalized healthcare in oncology and contributing to patients and healthcare professionals through improving access to CGP.

Approval information The underlined part has been newly added.

Intended uses or indications

The Product is used for comprehensive genomic profiling of blood samples in patients with solid tumors.
The Product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
Activated EGFR alterations Non-small cell lung cancer (NSCLC) afatinib dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesilate
EGFR exon 20 T790M alterations osimertinib mesilate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib
ROS1 fusion genes entrectinib
NTRK1/2/3 fusion gene Solid tumors entrectinib
BRCA1/2 alterations Prostate cancer olaparib
About FoundationOne Liquid CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc. based in Cambridge, USA, FoundationOne Liquid CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device using blood samples for advanced cancer patients with solid tumors. It is intended to identify genomic alterations in 324 cancer-related genes through detection of circulating tumor DNA (ctDNA) in blood. The test is approved by the MHLW for use in cancer genome profiling to report substitutions, insertion and deletion alterations, and select gene rearrangements for short variants in 324 genes. It is also indicated for use as a companion diagnostic to identify patients who may benefit from treatment with specific targeted therapies (listed in Table above of Intended uses or indications). For the latest information about the product, including companion diagnostic indications, please refer to the prescribing information.

About BRCA alterations
BRCA1 and BRCA2 are human genes that produce proteins responsible for repairing damaged DNA and play an important role in maintaining the genomic stability of cells. When either of these genes is mutated or altered, such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genomic alterations that can lead to cancer and confer sensitivity to PARP inhibitors including Lynparza.1-4

Trademarks used or mentioned in this release are protected by laws.