On April 15, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported that Keith Kennedy, chief financial officer and chief operating officer, will retire from the company, effective May 15, 2021, following the company’s release of its full quarterly financial results and the filing of its Form 10-Q for the first quarter 2021 (Press release, Veracyte, APR 15, 2021, View Source [SID1234578078]). Jane Alley, vice president and corporate controller, will become acting CFO until a replacement is named. Veracyte is conducting a search for a new CFO.

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"Keith has played a key role in Veracyte’s growth and success over the last four years and the board and I deeply appreciate his many contributions. These include building a strong financial infrastructure and team that we believe will help position us for continued success. Keith will be missed and we wish him the very best in his next chapter," said Bonnie Anderson, Veracyte’s chairman and chief executive officer.

Veracyte also announced preliminary results for the first quarter ended March 31, 2021.

The company expects to report total revenue of between $36 million and $37 million, including between $3.5 million and $3.8 million for urologic cancers, for the first quarter ended March 31, 2021, an increase of 17.3% at the midpoint of the total range, compared to the first quarter of 2020. The company expects product and reported testing volume of between 14,000 and 14,500 tests, including between 1,400 and 1,500 tests in urologic cancers, for the first quarter of 2021, an increase of 9.3% at the midpoint of the total range, compared to prior year. The foregoing amounts are preliminary, have not been audited or reviewed and are subject to change in connection with the completion of Veracyte’s financial statements for the first quarter ended March 31, 2021.

"We are off to a strong start for the year. Revenue and genomic testing and product volume continued to gain momentum in the first quarter and were further boosted by our acquisition in mid-March of Decipher Biosciences, with its market-leading prostate cancer test. We also remain on track to launch key pipeline products in the second half of the year, including our Percepta Nasal Swab test and Genomic Atlas in lung cancer and our Envisia classifier on the nCounter Analysis System in international markets," said Ms. Anderson.

Veracyte expects to announce full first quarter 2021 financial results on May 10, 2021, after market close. Management will host a conference call and webcast to discuss the company’s financial results and to provide a general business update, later that same day. Additional details on the call will be released in a separate press release.

On April 15, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, presented new data on the integration of the DecisionDx-Melanoma test with clinicopathologic features (i31-GEP) at the 10th World Congress of Melanoma and 17th European Association of Dermato-Oncology (EADO) Congress (Press release, Castle Biosciences, APR 15, 2021, View Source [SID1234578095]). DecisionDx-Melanoma is Castle’s prognostic gene expression profile test for cutaneous melanoma with an Integrated Test Result (ITR) designed to provide a more precise risk prediction in patients with stage I, II or III melanoma.

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The ITR is calculated by the independently validated integrated 31-GEP, or i31-GEP, algorithm, 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 that integrates the DecisionDx-Melanoma test result with the patient’s traditional clinicopathologic features. The algorithm has been validated in a cohort of 1,674 prospectively tested patients with T1-T4 cutaneous melanoma.

The poster, titled "Integration of the 31-gene expression profile test with clinicopathologic features (i31-GEP) to assess sentinel lymph node positivity risk in patients with cutaneous melanoma," highlights the i31-GEP validation study data and demonstrates that the algorithm provides a more precise, personalized likelihood of sentinel lymph node positivity. The poster can be accessed here.

Study methods and findings:

DecisionDx-Melanoma, using the categories of Class 1A, 1B, 2A and 2B, age and tumor thickness was previously validated in an independent, prospective, multi-center study of 1,421 patients to predict SLNB positivity rates.
An integrated DecisionDx-Melanoma test result (i31-GEP) was developed to integrate DecisionDx-Melanoma’s output, a risk assignment based on gene expression profile analysis, with clinicopathologic risk factors.
The study reviewed the development and validation of the i31-GEP, which deploys a neural network algorithm to integrate the continuous DecisionDx-Melanoma score as well as other histologic and clinical features on a development cohort of 1,398 patients. The i31-GEP algorithm was locked using these 1,398 patients and was then independently validated on an independent, U.S. based cohort of 1,674 patients.
The development phase identified that the DecisionDx-Melanoma score was the most important variable in predicting SLN positivity under both the variable importance assessment function (DecisionDx-Melanoma score = 100, Breslow thickness = 56, Mitotic rate = 25, ulceration = 83 and Age = 0; with 100 being the highest possible value) and log-likelihood value (DecisionDx-Melanoma score = 91.3, Breslow thickness = 53.5, Mitotic rate = 20.7, ulceration = 19.1 and Age = 10.5; with 100 being the highest possible value).
The independent validation phase showed that the i31-GEP provides a highly concordant prediction of SLN positivity rate compared to observed rates(linear regression slope of 0.999, with 1.0 representing complete concordance).
Of patients originally classified with 5-10% SLN positivity risk, i31-GEP reclassified 63% of those patients, whose actual risk of SLN positivity was outside that range in either direction (less than 5% or greater than 10%).
i31-GEP had a high negative predictive value of 98% in patients with T1-T4 tumors.
"Most patients who undergo a sentinel lymph node biopsy procedure receive negative results, indicating that other tools may be needed to better understand and stratify risk for patients with melanoma and define groups who may be able to avoid SLNB entirely," said study author Eric Whitman, M.D., surgical oncologist and medical director at Atlantic Health System Cancer Care in New Jersey. "DecisionDx-Melanoma and i31-GEP can help refine patient classification with respect to the likelihood of sentinel node positivity. These clinical validation data show that the ITR result, which reflects a combination of gene expression analysis and standard clinicopathologic features, can be used to provide a more precise risk prediction and potentially help improve patient selection for SLNB."

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 April 15, 2021 Alchemab Therapeutics, a biotech company developing novel products for patients with hard-to-treat diseases by harnessing the power of naturally protective antibodies, reported the completion of a £60 million ($82 million) Series A financing round (Press release, Alchemab Therapeutics, APR 15, 2021, View Source [SID1234578119]).

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The international investment syndicate is led by RA Capital Management, with participation from Lightstone Ventures, Data Collective VC (DCVC), DHVC, SV Health Investors and the Dementia Discovery Fund. The company was created by SV Health Investors who led the Seed round in 2019.

The proceeds will be used to advance Alchemab’s unique target-agnostic drug discovery platform. The approach interrogates the entire antibody repertoires of individuals from well-defined groups who show unexpected resistance to disease despite genetic disposition or other risk factors predicative of a poor prognosis. Using insights gained, Alchemab can identify naturally protective antibodies with therapeutic potential. Alchemab’s primary focus is the development of novel therapeutics for hard-to-treat neurodegenerative diseases and cancers, and the Company currently has several programs at the preclinical stage.

Alchemab’s approach was developed with support from scientific founders at Oxford University, Johns Hopkins University and Mount Sinai Hospital. Alchemab is amongst the first commercial group to access Illumina’s Cambridge, UK Accelerator.

"Our aim is to become a major player in the identification of novel targets and antibodies in the areas of neurodegeneration and cancer," noted Alex Leech, CEO at Alchemab. "The substantial financial commitment by this high-caliber group of US and European investors is a strong endorsement of our science and team."

His colleague and co-founder, Dr Jane Osbourn OBE, CSO at Alchemab, added: "Our approach to understanding the natural immunological response to disease and why some people are able to stay well has huge potential to identify antibody therapies across a range of indications. The Series A financing offers a great opportunity to accelerate our efforts to positively impact the lives of patients.

Dr Houman Ashrafian, Managing Partner at SV Health Investors, commented: "Alchemab is a brilliant company driven by science. The Company combines elements of traditional drug discovery techniques with advanced analytics, and in doing so turns the conventional biotech model upside down."

Dr Andrew Levin, Managing Director at RA Capital, added: "It is a privilege to work with this exceptional team. Alex, Jane and the scientists at Alchemab are offering a truly innovative, disease-agnostic approach that we believe has great potential for the development of novel therapeutics."

Last month, Alchemab announced the award of an Innovate UK grant to support the development of a novel disease-modifying antibody therapy for Huntington’s disease, in collaboration with the Medicines Discovery Catapult.

On April 15, 2021 Iktos’s AI technology, reported that based on deep generative models, helps bring speed and efficiency to the drug discovery process (Press release, Iktos, APR 15, 2021, View Source [SID1234580475]). Iktos’ technology automatically designs virtual novel molecules that have all of the characteristics of a successful drug molecule.

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Iktos AI is the first company to release user-friendly and high-performance de novo design software for multi-parameter optimization that can be used by any medicinal or computational chemist, whatever their level of expertise, in deep learning and computer programming.

BioExcel is partnering with Iktos on the application of advanced molecular modelling and simulation techniques to expedite drug design.

On April 14, 2021 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) reported that three projects have been selected to study oral decitabine (35 mg) and cedazuridine (100 mg) (Press release, Astex Pharmaceuticals, APR 14, 2021, View Source [SID1234578021]). The NCCN ORP convened a Scientific Review Committee to review, evaluate, and select awardees and will provide oversight for the two-year studies—which will commence later in 2021. Research funding will be provided by a grant from Taiho Oncology, who will also supply the decitabine and cedazuridine tablet.

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The selected projects are:

• Michael Byrne, DO, Vanderbilt-Ingram Cancer Center, Moffitt Cancer Center
o Phase 2 Study of Decitabine and Cedazuridine in Combination with Venetoclax for AML Relapse after Allogeneic Hematopoietic Cell Transplantation

• Gurkamal Chatta, MD, Roswell Park Comprehensive Cancer Center
o A Phase 1b Clinical Trial: Improving Outcomes with Androgen Pathway inhibitors by Targeting DNA Methyltransferase Activity

• Martin McCarter, MD, University of Colorado Cancer Center
o Oral Decitabine/Cedazuridine in Combination with Nivolumab as a Strategy to Enhance the Efficacy of Immune Checkpoint Blockade in Unresectable or Metastatic Mucosal Melanoma

"Congratulations to all of the selected investigators," said Wui-Jin Koh, MD, Chief Medical Officer, NCCN. "We look forward to their work advancing our understanding of this medication combination. The potential for oral medication in place of intravenous delivery is particularly worthy of exploration, as this may provide better options for outpatient therapy with reduced office visits, which in turn improves access to care and helps underserved patient populations.

"Taiho Oncology is pleased to continue our collaboration with the National Comprehensive Cancer Network to help broaden the understanding of oral decitabine and cedazuridine for patients with solid tumors and hematologic malignancies," said Terri L. Washington, DNP, RN, Vice President, Scientific Partnerships and Medical Affairs Operations, Taiho Oncology, Inc. "These grants will help advance critical research and represent a step forward in exploring the full potential of oral decitabine and cedazuridine for patients to help improve outcomes."

The NCCN ORP fosters innovation and knowledge discovery that improves the lives of people with cancer and supports preclinical, translational, clinical research and quality improvement projects in oncology at NCCN Member Institutions. In an effort to improve collaboration in cancer research, the NCCN ORP also maintains a shared resources website and an informed consent database. For more information, visit NCCN.org/orp.