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 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 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that Robert M. Davis, chairman and chief executive officer, and Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories, are scheduled to participate in a fireside chat at the Morgan Stanley 22nd Annual Global Healthcare Conference on Thursday, Sept. 5, 2024, at 2:35 p.m. EDT (Press release, Merck & Co, AUG 29, 2024, View Source [SID1234646204]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink.

On August 29, 2024 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, reported that William Ho, CEO and co-founder, will be presenting at the (Press release, In8bio, AUG 29, 2024, View Source [SID1234646203]):

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H.C. Wainwright 26th Annual Global Investment Conference
Format Fireside Chat
Date/Time Monday, September 9, 2024, at 2:30 p.m. ET.

A live webcast and replay will be available under "Events and Presentations" in the News & Presentations section of the IN8bio website at View Source

On August 29, 2024 Flamingo Therapeutics ("Flamingo") reported its participation in the following upcoming investor conferences (Press release, Flamingo Therapeutics, AUG 29, 2024, View Source;utm_medium=rss&utm_campaign=flamingo-therapeutics-announces-participation-in-upcoming-investor-conferences [SID1234646202]):

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Wells Fargo Annual Healthcare Conference, September 4-6, 2024, Boston, MA
PA Life Sciences Future Conference, September 18-19, 2024, Philadelphia, PA
8th Annual Chardan Genetic Medicines Conference, September 30-October 1, 2024, NY
4thAnnual Needham Private Biotech Company Virtual 1×1 Forum, October 8-9, 2024

During these events, Company management will participate in one-on-one meetings with investors.