On January 13, 2022 On Target Laboratories, Inc., a privately-held biotechnology company developing intraoperative molecular imaging agents to target and illuminate cancer during surgery, reported the completion of the Phase 3, randomized, multi-center, single dose, open-label ELUCIDATE (Enabling LUng Cancer IDentification Using FolATE Receptor Targeting) Trial, which investigated the use of CYTALUX (pafolacianine) injection in patients scheduled to undergo thoracic surgery for confirmed or suspected cancer in the lung (Press release, On Target Laboratories, JAN 13, 2022, View Source [SID1234605473]).

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The study (NCT04241315) assessed the efficacy of CYTALUX and near-infrared imaging (NIR) to intraoperatively identify pulmonary nodules and detect positive margins. It also evaluated the safety and tolerability of single intravenous doses of CYTALUX. The trial successfully achieved its primary endpoint and full results will be shared in the future.

"Lung cancer is the number one cancer killer of men and women globally," said Inderpal (Netu) Sarkaria, MD, MBA, FACS Associate Professor of Cardiothoracic Surgery and Chair in Minimally Invasive Thoracic Surgery and Director of Thoracic Robotic Surgery at UPMC and ELUCIDATE trial investigator. "There is opportunity for emerging technologies to enhance our ability to find and remove cancer during surgery to improve the lives of lung cancer patients."

CYTALUX was approved by FDA on November 29, 2021 for adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions. CYTALUX is the first targeted molecular imaging agent that illuminates ovarian cancer intraoperatively, enabling the detection of more cancer for removal. CYTALUX, administered by standard IV prior to surgery, binds to folate receptors that are overexpressed in most epithelial ovarian cancersi and illuminates intraoperatively under near-infrared light.

"ELUCIDATE was completed ahead of schedule, which was a monumental achievement during a pandemic," said Chris Barys, President and Chief Executive Officer of On Target. "We are grateful to the trial patients, the Investigators and their teams who helped us move yet another step closer to bringing CYTALUX to more patients fighting cancer."

About Intraoperative Molecular Imaging

To date, there have been limited ways for surgeons to confidently assess the location and full extent of cancerous tissue while operating. Intraoperative Molecular Imaging (IMI) is an emerging category of technology for surgical oncology in which targeted imaging agents are injected into patients to highlight cancer cells making them visible during surgery.

On January 13, 2022 Bold Therapeutics, a clinical-stage biopharmaceutical company developing BOLD-100, reported an extension of the option agreement with an undisclosed publicly traded South Korean biopharmaceutical company, originally executed in May 2020, for development and commercialization rights to BOLD-100 in South Korea (Press release, Bold Therapeutics, JAN 13, 2022, View Source [SID1234605472]). The extension is expected to further solidify cooperation between these companies, as well as support the addition of five clinical trial sites in South Korea: Seoul National University Hospital (PI: Do-Youn Oh); Samsung Medical Center (PI: Joon Oh Park); Severance Hospital (PI: Sun Young Rha); National Cancer Center (PI: Yongjun Cha); and Kangbuk Samsung Hospital (KBSMC) (PI: Dong-Hoe Koo).

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Bold Therapeutics’ BOLD-100 is a first-in-class ruthenium-based small molecule therapeutic that (1) alters the unfolded protein response (UPR) through selective GRP78 inhibition; and (2) induces reactive oxygen species (ROS) which causes DNA damage and cell cycle arrest. Collectively, these effects result in cell death in both sensitive and resistant cancers, giving BOLD-100 the potential to significantly improve outcomes in a wide range of both solid and liquid tumors in combination with other anti-cancer therapies ranging from traditional chemotherapies to targeted therapies to immuno-oncology agents. BOLD-100 has been granted Orphan Drug Designations (ODDs) by the FDA in both gastric (stomach) and pancreatic cancers, and Bold Therapeutics expects to receive one or more Breakthrough Therapy Designations (BTDs) for BOLD-100 in 2022. Preclinical experiments have repeatedly shown that BOLD-100 improves outcomes in combination with a wide range of existing anti-cancer therapies, with particular synergy evident in drug-resistant cell lines.

"As our partner is one of the fastest growing and most respected pharmaceutical companies in South Korea, we are honored to extend this option agreement that allows us to further leverage their substantial expertise in oncology development," said E. Russell McAllister, CEO of Bold Therapeutics. "We expect to complete our Phase 1b trial of BOLD-100 in combination with FOLFOX in the treatment of advanced gastrointestinal cancers imminently and immediately transition into a Phase 2a study at six sites in Canada, two sites in the U.S., and now five sites in South Korea. We look forward to continuing to work with our partner’s team to advance this revolutionary cancer therapy."

On January 13, 2022 SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals Co., Ltd., an innovative global pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to study SKL27969 as a potential treatment of advanced solid tumors (Press release, SK biopharmaceuticals, JAN 13, 2022, View Source [SID1234605471]).

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SK life science will conduct a Phase 1/2 open-label, non-randomized, multicenter, dose escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SKL27969 in adult patients with solid tumors.

"We look forward to learning more about the potential of SKL27969 as a treatment option for a range of advanced solid tumors," said Marc Kamin, MD, chief medical officer at SK life science. "We are excited to expand our R&D efforts into discovering potential new therapies for cancer."

"This milestone enables SK life science and SK Biopharmaceuticals to explore and begin to address unmet medical needs in oncology," said Jeong Woo Cho, PhD, President and CEO of SK Biopharmaceuticals and SK life science. "We look forward to advancing the development of this novel candidate using our already established clinical development capabilities in an effort to deliver a potential therapy to patients."

About SKL27969
SKL27969 is a protein arginine methyltransferase 5 (PRMT5) inhibitor candidate that has shown activity in preclinical models of solid tumors, such as glioblastoma (GBM), non-small cell lung cancer (NSCLC), and triple negative breast cancer (TNBC).

On January 13, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will report its fourth quarter and full year 2021 financial and operating results on Friday, February 4, 2022, before the U.S. financial markets open (Press release, Regeneron, JAN 13, 2022, https://www.prnewswire.com/news-releases/regeneron-to-report-fourth-quarter-and-full-year-2021-financial-and-operating-results-and-host-conference-call-and-webcast-on-301460682.html [SID1234605470]). The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

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Conference Call Information
Participants may access the conference call live via webcast on the ‘Investors and Media’ page of Regeneron’s website at View Source To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

On January 13, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a leader in transforming disease management and improving patient outcomes through innovative diagnostics, reported the publication of clinical performance study data demonstrating that DecisionDx-SCC provides significant and independent prognostic value for stratifying metastasis risk in patients with cutaneous squamous cell carcinoma (SCC) with one or more risk factors (high risk) (Press release, Castle Biosciences, JAN 13, 2022, View Source [SID1234605469]). The study, titled "Enhanced Metastatic Risk Assessment in Cutaneous Squamous Cell Carcinoma with the 40-Gene Expression Profile Test," is available online in Future Oncology.

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"As the criteria for high-risk SCC is broad, it can be challenging for clinicians to appropriately manage a patient’s disease using only their clinicopathologic risk factors," said the study’s first author, Sherrif Ibrahim, M.D., Ph.D., dermatologist and Mohs surgeon at Rochester Dermatologic Surgery, Victor, New York, and associate professor, Department of Dermatology at University of Rochester Medical Center, Rochester, New York. "DecisionDx-SCC is designed to provide powerful prognostic information regarding a patient’s risk of metastasis, based on the biology of the individual patient’s tumor. As a physician, I rely on this information to help me make informed and personalized decisions in the management and follow-up care of patients with SCC."

Study background:

The annual incidence of SCC is high (approximately 2 million diagnosed cases/year in the U.S.) and continues to grow, resulting in a substantial number of patients with poor outcomes.
An estimated 200,000 patients per year with SCC are broadly classified as having high-risk disease, based on clinicopathologic factors associated with increased likelihood of poor outcomes; while these and other factors are used to stratify patient risk, low accuracy, histopathologic discordance and lack of standardized reporting limit clinical utility of this clinicopathologic factor-based approach.
DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of metastasis in patients with SCC with one or more risk factors.
The test result, in which patients are stratified into a Class 1 (low), 2A (moderate) or 2B (high) risk category, predicts individual metastatic risk to inform risk-appropriate management decisions.
Study methods and findings:

A retrospective cohort of 420 cases of primary SCC tumors with known patient outcomes underwent testing with DecisionDx-SCC; test results were assessed using Kaplan-Meier and Cox regression analyses with traditional clinicopathologic factor-based assessment, including National Comprehensive Cancer Network (NCCN) classification, and current staging methods, including Brigham and Women’s Hospital (BWH) and American Joint Committee on Cancer Eighth Edition (AJCC8) staging.
DecisionDx-SCC stratified the clinical validation cohort for metastatic risk: 212 cases received a Class 1 result (low risk), 185 cases received a Class 2A result (moderate risk) and 23 cases received a Class 2B result (high risk), with metastasis rates of 6.6%, 20.0% and 52.2%, respectively. Kaplan-Meier analyses demonstrated statistically significant differences in three-year metastasis-free survival (MFS) rates for the overall cohort; 93.9%, 80.5% and 47.8% for Class 1, Class 2A and Class 2B, respectively (log-rank, p<0.001). MFS rates were also significantly different across Class 1, Class 2A and Class 2B for subsets of the cohort with one risk factor and >2 risk factors.
DecisionDx-SCC further stratified risk within high-risk and very high-risk subgroups classified according to the current NCCN guidelines: for the high-risk subgroup, MFS rates were 95.9%, 84.3% and 62.5% for Class 1, Class 2A and Class 2B, respectively (p=0.0001); for the very high-risk subgroup, MFS rates were 89.6%, 75.9% and 40.0% for Class 1, Class 2A and Class 2B, respectively (p<0.001).
When compared to the accuracy metrics for AJCC8 and BWH T staging, the positive predictive value of a DecisionDx-SCC Class 2B result (high risk) was 52.2% compared to 30.0% and 39.9% for high-stage AJCC8 (T3/T4) and BWH (T2b/T3), respectively, while maintaining similar negative predictive value (87.2% compared to 88.5% and 87.9%, respectively).
The specificity of a DecisionDx-SCC Class 2B result (96.9%) and the sensitivity of a Class 2 result (77.8%) were significantly greater than the corresponding metrics for high-stage BWH and AJCC8. Together, these metrics demonstrated that DecisionDx-SCC identified tumors at high risk for metastasis with improved accuracy compared to BWH and AJCC8 tumor staging, while distinctly stratifying these cases from those with Class 1 tumors which have risk levels similar to the general SCC patient population.
The addition of DecisionDx-SCC results to binary T stage status identified subpopulations ranging from 5.7% to 71.4% (BWH) and 5.6% to 83.3% (AJCC8), compared to 12.1% to 33.9% (BWH) and 11.5% to 30.0% (AJCC8) for binary staging alone, which demonstrated that risk assessment was refined by combining DecisionDx-SCC results with tumor staging.
Overall, the data demonstrated that:
DecisionDx-SCC enhanced clinicopathologic risk factor-based assessment and identified a group of SCC patients within a high-risk cohort with metastasis rates similar to the general SCC population (Class 1 result with one risk factor).
Patients identified by DecisionDx-SCC as having the highest risk for metastasis (Class 2B) consistently had metastasis rates ≥50%, regardless of having one or two or more risk factors.
Combining DecisionDx-SCC with clinicopathologic factor-based risk assessment, regardless of whether it is based on risk factor count or T stage, further stratified risk for metastasis in SCC patients and improved the accuracy of risk predictions to better inform risk-appropriate patient management decisions.
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 (low), 2A (moderate) or 2B (high) 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.