On March 8, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported that DecisionDx-Melanoma, Castle’s prognostic gene expression profile test for cutaneous melanoma, now utilizes an Integrated Test Result (ITR), designed to provide a more precise risk prediction in patients with stage I, II or III melanoma (Press release, Castle Biosciences, MAR 8, 2021, View Source [SID1234576248]). The Company plans to launch an app later in 2021 for dermatology clinicians, featuring an interactive algorithm using the 31-GEP test score and traditional clinicopathologic factors to predict risk.

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DecisionDx-Melanoma now outputs an ITR. The ITR is calculated by an independently validated algorithm (i31-GEP), designed to provide a more precise and personalized prediction of sentinel lymph node (SLN) positivity in order to guide discussions and recommendations, within current risk-based guidelines, for the SLN biopsy (SLNB) surgical procedure. 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.

"We have demonstrated our ability to bring high value, clinically actionable genomic tests to market," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We start by identifying dermatologic diseases with high unmet clinical need. We then use the gene expression profile of the patient’s tumor biology to provide clinicians and their patients with precise, personalized risk prediction, better informing management decisions to optimize health outcomes and reduce healthcare costs.

"We recognize the complexity of cancer and the necessity of diagnostics to utilize advanced approaches to provide actionable results, as exemplified in the use of artificial intelligence for our i31-GEP and updated integrated patient test result. Castle continues to evolve, as we advance our expertise in dermatologic diagnostics, in alignment with our commitment to inform treatment decisions and improve health outcomes along the patient care continuum."

In addition to the likelihood of SLN positivity, the updated DecisionDx-Melanoma patient report includes predictions of 5-year outcomes of melanoma specific survival, distant metastasis free survival and recurrence free survival, updated with an expanded dataset, by DecisionDx-Melanoma class result: lowest risk (Class 1A), increased risk (Class 1B/2A) or highest risk (Class 2B). This personalized risk information supports clinicians and their patients in making cancer management decisions, such as intensity of surveillance and follow-up frequency.

The Company expects to launch an app based on i31-GEP and the ITR later in 2021. The app’s first phase is expected to provide dermatologic clinicians an interactive experience to determine the risk of SLN positivity for an individual patient, based on the clinicopathologic factors and i31-GEP score entered.

DecisionDx-Melanoma is Castle’s gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, independent of traditional staging factors. The personalized information provided on the ITR is designed to help clinicians and their patients make more informed decisions about the sentinel lymph node biopsy (SLNB) surgical procedure and follow-up management and care plans.

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.

On March 8, 2021 Pathios Therapeutics reported that it will team up with researchers at The University of Oxford to accelerate cancer immunotherapies targeting GPR65 on immunosuppressive macrophages (Press release, Pathios Therapeutics, MAR 8, 2021, View Source [SID1234576178]).

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Pathios Therapeutics Limited ("Pathios"), an innovative biotech company focused on the development of first-in-class therapies for cancer, reported that it has been awarded £350K (approximately US$475K) in the form a Smart Grant from Innovate UK, the UK Government’s innovation agency, to accelerate their cancer immunotherapy programme targeting the innate immune checkpoint, GPR65. Pathios will collaborate on this project with researchers from the Department of Oncology at The University of Oxford to develop the key tools required to enable the rapid translation of small-molecule GPR65 inhibitors for treatment-resistant melanoma.

The advent of immunotherapy agents targeting T-cell checkpoints (PD-1/CTLA-4) has brought about significant improvements in the long-term survival of many melanoma patients. However, only a subset of patients receive sustained benefit from these treatments and it remains an ongoing challenge to identify additional therapies for the remaining non-responsive population.

Recent ground-breaking science suggests a key reason that some melanoma patients that do not respond well to anti-PD-1 therapies relates to the disarming of innate immune cells called tumour-associated macrophages (TAMs) by the acidic microenvironment that is inherent to advanced tumours. Activation of the pH-sensing receptor, GPR65, on TAMs by acidic pH leads to the suppression of a host of pro-inflammatory genes thereby shifting the characteristics of these cells from immune-stimulating to immunosuppressive(1). The importance of the GPR65 pathway in cancer is underscored by a small proportion of the population with inactivating polymorphisms showing stratified association with survival when analysed in The Cancer Genome Atlas (TCGA). Pathios’ ‘Macrophage Conditioning’ approach aims to deploy small-molecule GPR65 inhibitors to reverse pH-dependent immunosuppressive signalling in the vast majority of patients who do not carry this genetic change.

With this grant, Pathios will develop a range of tools to expedite the translation of small molecule GPR65 inhibitors for use in cancer immunotherapy. This will include the development of early clinical target engagement biomarkers as well as employing a range of bioinformatics techniques to identify those patients most likely to benefit from Pathios’ GPR65-targeted approach.

Stuart Hughes, Chief Executive Officer of Pathios: "We are delighted to have secured this highly competitive funding from Innovate UK to accelerate our programme against GPR65 and to continue to build our scientific links with cancer researchers at The University of Oxford. This award boosts our ongoing programme and is a significant endorsement of our novel approach to targeting the innate immune system in hard-to-treat cancers. We look forward to developing the tools that will drive forward our GPR65-based ‘Macrophage Conditioning’ technology and help deliver on the company’s goal to provide a first-in-class treatment approach for those melanoma patients who currently have limited treatment options".

On March 8, 2021 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that Anixa’s Chief Executive Officer, Dr. Amit Kumar, has been invited to present at the Inaugural Emerging Growth Virtual Conference, presented by M Vest LLC and Maxim Group LLC (Press release, Anixa Biosciences, MAR 8, 2021, View Source [SID1234576199]). The conference will take place on March 17 and 18 from 9:00 am-5:00 pm ET featuring roundtable discussions with C-suite executives moderated by Maxim Research Analysts, fireside chats with live Q&A, and presentations from hundreds of issuers both domestically and internationally.

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During this virtual conference, Anixa will present along with other important voices in the biotech industry. Dr. Kumar will provide an overview of Anixa’s business and an update on the Company’s programs. To attend the conference, sign up to become an M-Vest member here: https://www.m-vest.com/events/2021-emerging-growth-virtual-conference.

On March 8, 2021 IMV Inc. ("IMV" or the "Corporation") (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies, reported that it will hold a conference call and webcast on Wednesday, March 17, 2021 at 8:00 a.m. Eastern Time to discuss the Company’s 2020 fourth quarter and full year financial and operational results (Press release, IMV, MAR 8, 2021, View Source [SID1234576216]).

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Financial analysts are invited to join the conference call by dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (international) using the conference ID: 8998652.

Other interested parties will be able to access the live audio webcast at this link: View Source The webcast will be recorded and will then be available on the IMV website for 30 days following the call.

On March 8, 2021 NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer cell-based therapeutics company, reported that its stockholders approved by the required vote each of the proposals related to the pending merger of NantKwest and ImmunityBio, Inc (Press release, NantKwest, MAR 8, 2021, View Source [SID1234576249]). presented at the special meeting of stockholders held earlier in the day, including approval of the merger by a majority of unaffiliated stockholders of NantKwest. Final voting results for NantKwest’s special meeting of stockholders will be disclosed in a Form 8-K to be filed by NantKwest with the Securities and Exchange Commission.

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The merger is expected to close on March 9, 2021, subject to the satisfaction of customary closing conditions. Following the closing of the transaction, the combined company will assume the ImmunityBio name and its shares of common stock are expected to trade on NASDAQ under the symbol "IBRX" commencing on March 10, 2021.