On August 29, 2024 NuCana plc (NASDAQ: NCNA) reported that the NuTide:323 study is being discontinued following a pre-planned initial analysis and recommendation from the NuTide:323 Study Steering Committee (Press release, Nucana, AUG 29, 2024, View Source [SID1234646205]). While there were prognostic imbalances favoring the control arm, the Steering Committee believed that the combination of NUC-3373 with leucovorin, irinotecan and bevacizumab (NUFIRI+bev) was unlikely to achieve the study’s primary objective of superior Progression Free Survival (PFS) compared to the control arm of 5-FU, leucovorin, irinotecan and bevacizumab (FOLFIRI+bev) in the final analysis. In all three arms, the treatment regimens were observed to have a favorable safety profile and to be generally well tolerated, with only 12 of the 175 patients (four patients in each arm) discontinuing treatment due to adverse events.

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"While we are disappointed with this unexpected outcome, especially for people living with colorectal cancer, we gained valuable knowledge from the NuTide:323 study which will inform our ongoing development programs. We are extremely grateful to the study participants, their families, the investigators and study teams for their participation and efforts," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "These results highlight the challenges associated with developing new medicines for patients with complex and heterogenous cancers such as metastatic colorectal cancer. We will leverage insights from these data to identify future potential development options for NUC-3373 in colorectal cancer."

Professor Josep Tabernero, MD, PhD, Head of the Medical Oncology Department at the Vall d´Hebron University Hospital, Barcelona and Chair of the NuTide:323 Study Steering Committee, stated: "In the NuTide:323 study, we were aiming to develop NUC-3373 as a replacement for 5-FU, in combination with leucovorin, irinotecan and bevacizumab in patients with second-line colorectal cancer. The premise of this ambitious goal was based on robust non-clinical and clinical data and the NuTide:323 study team are very disappointed with this outcome."

Mr. Griffith continued: "NuCana remains committed to improving survival outcomes for patients with cancer. The results of the NuTide:323 study do not impact the ongoing NuTide:303 study, in which NUC-3373 is being combined with either pembrolizumab in solid tumors or docetaxel in patients with lung cancer. Furthermore, we are excited about the potential of NUC-7738, a novel agent that profoundly impacts gene expression in cancer cells and targets multiple aspects of the tumor microenvironment. We look forward to sharing the latest data from the Phase 2 part of the NuTide:701 study of NUC-7738 in combination with pembrolizumab in patients with melanoma at the ESMO (Free ESMO Whitepaper) annual conference in September 2024."

On August 29, 2024 Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, reported that Chief Executive Officer Masoud Toloue and Chief Financial Officer Vandana Sriram will take part in a fireside chat at the Morgan Stanley 22nd Annual Global Healthcare Conference on September 6, 2024 at 1:50 p.m. ET (Press release, Quanterix, AUG 29, 2024, View Source [SID1234646223]). The presentation will be available virtually and participants can register here. The presentation will be available for viewing following the conference on Quanterix’s website here: ir.quanterix.com.

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To learn more about Quanterix, visit www.quanterix.com/company/. To learn more about Quanterix’s Simoa technology, visit: www.quanterix.com/simoa-technology/.

On August 29, 2024 2seventy bio, Inc. (Nasdaq: TSVT), reported that members of the management team will participate in a fireside chat at the upcoming Morgan Stanley 22nd Annual Global Healthcare Conference on September 6, 2024 at 12:20 p.m. ET in New York (Press release, 2seventy bio, AUG 29, 2024, View Source [SID1234646190]).

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A live webcast of the fireside chat will be available via the Investors and Media section of the company’s website at View Source Replays will be archived on the 2seventy bio website for 30 days following the events.

On August 29, 2024 Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, reported that NXP800 was granted Orphan Drug Designation by the United States Food and Drug Administration ("FDA") for the treatment of AT-rich interactive domain-containing protein 1a (ARID1a) ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers (Press release, Nuvectis Pharma, AUG 29, 2024, View Source [SID1234646206]).

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Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "We are very pleased to have received this designation from the FDA for NXP800. The prevalence of ovarian cancer, which is comprised of ovarian, fallopian tube and primary peritoneal cancers, exceeds the 200,000 patient threshold below which drugs may be eligible to receive orphan drug designation in the United States and in ovarian cancer it has been uncommon to receive this designation for the treatment of a subset of the disease. We therefore believe that this Orphan Drug Designation granted by the FDA for NXP800 for the treatment of a subset of ovarian cancer, specifically for patients with an ARID1a deficiency, provides further validation for NXP800’s mechanism of action and the target patient population in our ongoing Phase 1b clinical trial in patients with platinum resistant, ARID1a-mutated ovarian cancer. We expect to provide a data update from this study this coming fall."

About Orphan Drug Designation

Orphan Drug Designation is granted by the FDA to drugs or biologics intended to treat a rare disease or condition, defined as one that affects fewer than 200,000 people in the United States. Orphan Drug Designation provides certain financial incentives to support clinical development, and the potential for up to seven years of marketing exclusivity for the product for the designated orphan indication in the United States if the product is approved for its designated indication.

On August 29, 2024 Median Technologies (FR0011049824, ALMDT, PEA/PME scheme eligible, "Median" or "The Company") reported that eyonis LCS, its proprietary Artificial Intelligence (AI)/machine learning (ML) powered Software as Medical Device (SaMD) for lung cancer screening (LCS), met the primary and all secondary endpoints in REALITY, the first of two pivotal studies required for marketing authorizations in U.S. and Europe (Press release, MEDIAN Technologies, AUG 29, 2024, View Source [SID1234646224]).

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Median’s eyonis LCS SaMD is designed for improving the detection and diagnostic accuracy of low-dose computed tomography (LDCT). LDCT imaging is the standard of care globally and is currently the only approved lung cancer screening modality in U.S. and Europe.

Fredrik Brag, CEO of Median Technologies said: "These data met our ambition for improving the performance of LDCT with eyonis LCS. Now, we are even more excited to report the upcoming RELIVE pivotal data and file for marketing authorizations in H1 2025. We believe that broad implementation of LDCT with eyonis LCS has the potential to vastly improve early detection and lead to far more cures, dramatically reducing lung cancer mortality."

The average five-year survival rate for all lung cancer patients is 18.6 percent because only 16 percent of lung cancers are diagnosed at an early stage2. Conversely, Stage 1 lung cancer can be cured when detected, with an 80% survival rate after 20 years, where many die from other causes. For Stage 1A cancers that measure 10 mm or less, the 20-year survival rate has been shown to be 92%.

Consequently, there is tremendous momentum behind efforts in the U.S., Europe and Asia to increase lung cancer screening and improve its accuracy. Enabling the accurate early detection of lung cancer with eyonis LCS could dramatically improve lung cancer survival.

Thomas Bonnefont, COO and CCO eyonis Business Unit said: "The high performances of our device can not only save lives but also prevent healthy patients undergoing unnecessary medical procedures. This will avoid unnecessary distress for patients and reduce healthcare costs."

Lung cancer screening is recommended by the U.S. Preventive Services Task Force (USPSTF) in adults aged 50 to 80 years who have a 20 pack-year smoking history. The market opportunity includes a population of 14.5 million people in the US alone, currently eligible for a lung cancer screening exam, with an existing potential reimbursement of $650 per exam with a SaMD postprocessing for characterization of malignant vs benign nodules. This represents a total addressable annual market of over $9 billion. The eligible U.S. patient number is expected to rise in the coming years, driven by planned broadening of the eligibility criteria. Similarly, new lung screening program deployments are planned in Europe and Asia. Around $230bn were spent on cancer medical care in 2023 in the US. The vast majority of cancer care costs are incurred in treating advanced cancer patients, versus preventive care such as screening that can save patients’ life.

Definitive results from REALITY show that eyonis LCS can accurately detect and characterize cancerous nodules. The novel SaMD achieved exceptional results, with an area under the curve (AUC) value of 0.904 at patient level versus an AUC of 0.80 – the minimum value set as a primary endpoint for REALITY. Importantly, 80% of the cancers in the analyzed cohort of REALITY were difficult-to-diagnose Stage 1 cancers. Moreover, the REALITY cohort was enriched compared to real life with small non-spiculated cancers, and large spiculated benign nodules, both of which are challenging for radiologists to diagnose.

The pivotal REALITY study (Clinicaltrials.gov identifier: NCT0657623), initiated in July 2023, collected retrospective imaging and clinical data from 1,147 patients from five major cancer centers and hospitals in the US and Europe and two clinical data providers. REALITY evaluated eyonis LCS ability to diagnose lung cancer. The objectives were to assess eyonis LCS standalone performance in characterizing cancerous vs non-cancerous patients (i.e. "performance at patient level"), and in detecting and characterizing suspicious versus malignant nodules. The primary endpoint of REALITY was determined after consultation with the U.S. regulatory authorities and the primary endpoint was selected to show that eyonis LCS would achieve an AUC superior to 0.8.

The second pivotal trial, RELIVE, is a Multi-Reader Multi-Case (MRMC) study that will offer clinical validation of eyonis LCS to complement the analytical validation already achieved and communicated today with REALITY. All the patient recruitment and relevant patient clinical data for the RELIVE study have already successfully been collected from the participating sites. RELIVE is scheduled for completion in the coming months, with an anticipated data read-out in Q1 2025 and regulatory filings in H1 2025.

About eyonis LCS: eyonis Lung Cancer Screening (LCS) is an artificial intelligence (AI) powered diagnostic tool that uses machine learning (ML) to help analyze imaging data generated with low-dose computational tomography (LDCT) to diagnose cancer at the earliest stages, when it can still be cured in the majority of patients. eyonis LCS has been classified by regulators as "Software as Medical Device", or SaMD, and is the subject of two pivotal studies required for marketing approvals in the U.S. and Europe: REALITY (successfully completed – Clinicaltrials.gov identifier: NCT0657623) and RELIVE (ongoing). Filing applications including these pivotal data are scheduled to be submitted for FDA 510(k) premarket clearance and CE marking in H1 2025. In the interim, eyonis technology is being used in at clinical research centers. Separately, Median’s AI technology is being sold and deployed via Median’s iCRO business unit, to biopharmaceutical companies performing clinical trials of experimental therapeutics, including the world’s leading pharmaceutical companies in cancer.