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.

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 Seres Therapeutics, Inc. (Nasdaq: MCRB) reported that the Company, in collaboration with study partners, The Parker Institute for Cancer Immunotherapy (PICI) and The University of Texas MD Anderson Cancer Center, has voluntarily discontinued further enrollment in the Melanoma Checkpoint and Gut Microbiome Alteration With Microbiome Intervention (MCGRAW) study evaluating the safety and drug activity of SER-401 or fecal microbiota transplant (FMT) in combination with nivolumab in patients with metastatic melanoma (Press release, Seres Therapeutics, MAR 8, 2021, View Source [SID1234576247]).

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"While we are disappointed to discontinue enrollment, we are encouraged by the opportunity to apply the learnings from this study towards future development programs at Seres that can directly benefit the oncology community in search of new treatment options," said Matthew Henn, Ph.D., Chief Scientific Officer at Seres. "We want to thank the patients, their care partners, our collaborators and the medical professionals who participated in this study, despite the COVID-19 pandemic, and helped further advance our understanding of the role microbiome therapeutics play in the treatment of cancer."

A preliminary analysis of results from 10 subjects who received either SER-401 or placebo in combination with nivolumab indicated that SER-401 was safe and well-tolerated. There were no patients enrolled in the FMT portion of the study. Subjects currently enrolled in the study will complete the study protocol. Given challenges in enrollment due to the COVID-19 pandemic, subsequent anticipated time to study completion, and progress in its preclinical oncology pipeline, Seres has decided to deprioritize further development of SER-401. The Company will continue to advance its research and development efforts in cancer, applying learnings from the SER-401 trial.

Evidence continues to emerge that suggests gut microbiome modulation may augment responses to cancer immunotherapy, including improving responses in PD-1 refractory patients1.

Seres and its collaborators continue to be excited about the opportunity to develop next-generation therapeutics targeting gut microbes for the treatment of individuals living with cancer. Seres will continue to engage with MD Anderson and PICI to advance the development of medicines in this field, and maintains a robust preclinical program in oncology as well as a collaboration with Memorial Sloan Kettering Cancer Center centered on advancing microbiome therapeutics in various settings of oncology. Seres’ immuno-oncology patent portfolio includes the option to exclusively license foundational intellectual property from MD Anderson, based upon the work of Jennifer Wargo, M.D., professor of Surgical Oncology and Genomic Medicine.

On March 8, 2021 Oncoinvent AS, a clinical stage company advancing a pipeline of radiopharmaceutical products across a variety of solid cancers, reported the advancement of its ongoing Phase 1 clinical study of Radspherin in ovarian cancer patients suffering from peritoneal carcinomatosis to the third level dose cohort following approval from the trial Safety Monitoring Committee (Press release, Oncoinvent, MAR 8, 2021, https://www.oncoinvent.com/press-release/oncoinvent-announces-progression-of-radspherin-to-third-dose-level-cohort-in-ongoing-rad-18-001-phase-1-trial-in-platinum-sensitive-recurrent-ovarian-cancer-patients-with-peritoneal-carcinomatos/?utm_source=mailpoet&utm_medium=email&utm_campaign=oncoinvent-announces-progression-of-radspherin-r_32 [SID1234576246]). In this cohort, patients will receive 4MBq of Radspherin, and enrollment is expected to begin imminently. Radspherin, a versatile α-emitting radionuclide therapy, is also being evaluated in an ongoing Phase 1 study in colorectal cancer patients with peritoneal carcinomatosis.

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"Peritoneal carcinomatosis is a very serious complication of ovarian cancer, often leaving patients with a poor prognosis, and we believe that Radspherin represents a potentially safe and transformative product candidate, offering patients a new treatment option," said Jan A. Alfheim, Chief Executive Officer of Oncoinvent. "Radspherin leverages the unique properties of alpha-emitting microparticles to safely deliver localized radiation to cancer cells, while also minimizing off-target effects and the killing of healthy tissue. We are excited by our continued progress, and look forward to reporting dose-ranging data in the second quarter of 2021."

"I am pleased to see how, when administered, Radspherin is well tolerated and seems quite evenly distributed in the abdominal cavity of the patients that have been recruited to the RAD-18-001 study here at the Radium Hospital. With the safety results that have been seen in both the RAD-18-001 and RAD-18-002 studies, I am looking forward to initiating treatment of patients at the 4 MBq dose level." Said Dr. Yun Wang, Principle Investigator for the RAD-18-001 study at the Radium Hospital.

About RAD-18-001
RAD-18-001 is an ongoing phase 1 open-label, dose-escalation clinical trial is designed to assess the dose, safety and tolerability of Radspherin, an α-emitting radionuclide therapy, administered into the intraperitoneal cavity in subjects with peritoneal carcinomatosis from ovarian cancer following complete cytoreductive surgery. Key objectives in the study include determining maximum tolerated dose, abdominal biodistribution, and preliminary anti-tumor activity. Please refer to www.clinicaltrials.gov for additional clinical trial details.

About Radspherin
Radspherin is a novel alpha-emitting radioactive microsphere suspension designed for treatment of metastatic cancers in body cavities. The radium-224 based therapeutic, Radspherin has shown strong and consistent anticancer activity at doses being essentially non-toxic in preclinical studies. It is anticipated that the product can potentially be used to treat several forms of metastatic cancer.

On March 8, 2021 Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported that Bill Lundberg, M.D., Chief Executive Officer, will participate in a fireside chat at the 33rd Annual Roth Conference on Monday, March 15 at 2:00 p.m. ET (Press release, Merus, MAR 8, 2021, View Source [SID1234576245]).

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The live webcast of the presentation will be available on the Investors page of the Company’s website, View Source An archived presentation will be available on the Merus website for a limited time.