On October 1, 2024 Owkin, the first end-to-end AI-biotech that uses cutting-edge causal AI to unlock precision drug discovery, development and diagnostics, reported a new partnership with AstraZeneca, a global biopharmaceutical company, to develop an AI-powered tool to pre-screen for gBRCA mutations (gBRCAm) in breast cancer directly from digitized pathology slides (Press release, Owkin, OCT 1, 2024, View Source [SID1234646987]). As part of Owkin’s ongoing collaboration with Gustave Roussy and The Centre Léon Bérard through PortrAIt, a French consortium to accelerate precision medicine through AI-enabled digital pathology, this tool aims to significantly accelerate and expand access to gBRCA testing that too many patients may not be considered for.

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Thomas Clozel, MD, CEO of Owkin, said: "We are excited to collaborate with AstraZeneca to bring the benefits of AI to BRCA testing with the gBRCA Pre-Screen solution. During Breast Cancer Awareness Month, it’s especially important to highlight how by streamlining the diagnostic process for determining BRCA mutation status, we can expand access to BRCA testing and identify more gBRCAm patients more rapidly. Our goal is to generate the best possible medical evidence through multiple clinical studies, making genetic testing more accessible and precise, and therefore reduce the inequity of care by allowing more patients to benefit from tailored care."

BRCA testing, which identifies mutations in the BRCA1 and BRCA2 genes, plays a vital role in determining an individual’s risk for developing certain cancers, including breast and ovarian cancers. Knowing the BRCA status of breast cancer patients is important to help identify familial risk and guide treatment options, including responses to targeted therapies. While many professional bodies have released guidelines recommending broader BRCA testing, it is not always consistently offered to eligible individuals, and implementation varies between countries. This is causing an inadvertent exclusion of individuals who may benefit from these tests. If routinely used, this gBRCA pre-screening solution could lead to the identification of thousands more gBRCAm HR-positive early breast cancer patients in France, Germany, Italy, Spain, and the United Kingdom by 2030.

Kristina Rodnikova, Head of Global Commercial Diagnostics, Oncology at AstraZeneca, said: "On average, a woman with a BRCA1 or BRCA2 gene mutation has up to a 7 in 10 chance of being diagnosed with breast cancer by age 80. This collaboration with Owkin underscores our commitment to advancing precision medicine, helping address the unmet need and identifying patients at risk of harboring BRCA mutations to improve their outcomes."

The typical BRCA testing journey for a patient can take several months and involve several healthcare professionals, from initial consultation to results, strongly impacting the patient’s outcomes. The gBRCA pre-screening solution has the potential to significantly enhance the efficiency of BRCA mutation identification. In less than one hour, the solution could identify a patient at high risk of harboring gBRCA mutation by leveraging existing material, including H&E slides. This could greatly streamline the gBRCA testing process, allowing oncologists and genetic counsellors to accelerate the gBRCA genetic testing for high-risk patients and incorporate these genetic test results into the treatment planning process without delays.

The solution is currently in development and undergoing validation.

On October 1, 2024 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, reported that the first patient has been enrolled in its Phase 2 dose expansion study evaluating ST316, the Company’s first-in-class antagonist of β-catenin (Press release, Sapience Therapeutics, OCT 1, 2024, View Source;catenin-antagonist-in-colorectal-cancer-302263343.html [SID1234646985]). Enrollment of the study’s Phase 1 monotherapy dose escalation portion was completed in July 2024.

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ST316 is designed to selectively shut down the Wnt/β-catenin signaling pathway in tumor cells but not in normal cells, allowing for anti-cancer activity without the toxicity related to broad inhibition of this pathway. The Wnt/β-catenin signaling pathway is one of the most active pathways in several cancers and drives more than 80% of colorectal cancers (CRCs), the first indication to be evaluated in the ST316 Phase 2 expansion. There are more than 1 million people living with CRC in the United States, with another 150,000 expected to be diagnosed this year alone.

Dr. Abi Vainstein-Haras, Sapience’s Chief Medical Officer, stated, "The promising results seen in our Phase 1 study demonstrate ST316’s potential to be an effective therapy for Wnt pathway-driven cancers, including CRC among others. Given ST316’s favorable safety and tolerability profile, together with robust pre-clinical data, Sapience is committed to maximizing the potential of ST316 in various therapeutic combinations across lines of treatment."

"CRC patients who are refractory to current therapies desperately need new options like ST316," said Dr. Barry Kappel, Sapience’s founder and Chief Executive Officer. "With CRC being the second-leading cause of cancer death in the United States, and with alarming increases in incidence among younger Americans, we are dedicated to widening the treatment options for this devastating disease."

ST316-101 (NCT05848739) is a first-in-human, open-label, Phase 1-2 dose-escalation and expansion study designed to determine the safety, tolerability, PK, PD and early efficacy of ST316. The Phase 1 dose escalation portion of the study tested various dose levels of ST316 in patients with select advanced solid tumors that are known to harbor abnormalities of the Wnt/β-catenin signaling pathway, including CRC. The Phase 1 portion completed enrollment in July 2024. In the Phase 2 dose expansion portion of the study, ST316 is being tested in CRC patients in combination with relevant standards of care and in multiple lines of treatment. Sapience is conducting the Phase 2 study across several sites in the United States.

About ST316

ST316 is a first-in-class peptide antagonist of the interaction between β-catenin and its co-activator, BCL9, a complex responsible for driving oncogene expression in multiple cancers where aberrant Wnt/β-catenin pathway signaling is observed. ST316 exposure in cancer cells prevents BCL9-driven nuclear localization of β-catenin and inhibits formation of the Wnt enhanceosome protein complex. Disruption of this interaction selectively suppresses the transcription of oncogenic Wnt target genes that regulate proliferation, migration, invasion and the metastatic potential of tumor cells, as well as genes that regulate the immunosuppression of the tumor microenvironment. ST316 creates a pro-immune tumor microenvironment and in preclinical models has shown to be synergistic with checkpoint inhibition. Due to its selectivity and downstream modulation of the Wnt/β-catenin pathway, ST316 presents an opportunity to safely and effectively target Wnt/β-catenin driven cancers without the toxicities previously seen with other Wnt pathway agents.

On October 1, 2024 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that members from the Replimune management team will present and host investor meetings at the following two conferences (Press release, Replimune, OCT 1, 2024, View Source [SID1234646982]):

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BMO 2024 Oncology Summit
Date: Tuesday, October 8, 2024

3rd Annual Roth Healthcare Opportunities Conference
Date: Wednesday, October 9, 2024

On October 1, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported the completion of the acquisition of CN201 from Curon Biopharmaceutical (Curon), a novel investigational clinical-stage bispecific antibody for the treatment of B-cell associated diseases (Press release, Merck & Co, OCT 1, 2024, View Source [SID1234646981]).

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"By actively depleting B-cells, CN201 offers applications spanning both B-cell malignancies and autoimmune diseases. We look forward to building upon the foundational work started by the Curon team," said Dr. Dean Y. Li, president, Merck Research Laboratories.

CN201 is currently being investigated in Phase 1 and Phase 1b/2 clinical trials for the treatment of patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL) and relapsed or refractory B-cell acute lymphocytic leukemia (ALL), respectively. Preliminary data suggest CN201 has activity in patients with relapsed or refractory B-cell hematologic malignancies and is well tolerated, potentially leading to significant and sustained reductions in B-cell populations.

Transaction details

Under the agreement, Merck, through a subsidiary, has acquired full global rights to CN201. As previously disclosed, the transaction is being accounted for as an asset acquisition. Merck is recording a pre-tax charge of approximately $750 million (reflecting the upfront payment and other related costs), or approximately $0.28 per share, which will be included in third-quarter non-GAAP results and was not included in Merck’s full-year financial outlook issued on July 30. As a matter of policy, Merck provides updates to its financial outlook once each quarter and will provide an update to its full-year financial outlook when it reports third-quarter 2024 results on October 31.

About CN201

CN201 is a novel CD3xCD19-targeting T-cell-engager bispecific antibody, designed to target B cells for elimination by T cells. CN201 is currently being evaluated in Phase 1 and Phase 1b/2 clinical trials for the treatment of relapsed or refractory non-Hodgkin’s lymphoma and relapsed or refractory acute lymphocytic leukemia, respectively.

On October 1, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported good safety and favorable ongoing efficacy results from the 10-month follow-up visit of the first patient treated in its Deltacel-01 Phase 1 clinical trial (Press release, Kiromic, OCT 1, 2024, View Source [SID1234646980]). This trial is evaluating Deltacel (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies.

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In this patient, the tumor size was reduced by approximately 27% compared with the pre-treatment size, and no new sites of disease were identified. As a result, the progression-free survival (PFS) has reached 10 months with no reported adverse events. These results follow an approximate 20% reduction in tumor size detected at eight months post-treatment and an approximate 13% reduction at six months post-treatment. This patient is being treated at the Beverly Hills Cancer Center (BHCC).

"As this patient is the most advanced in our ongoing Deltacel-01 clinical trial, we are particularly encouraged by these latest follow-up results that continue to validate the potential of Deltacel as a safe and effective treatment for patients with later-stage cancers," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. "We believe these findings underscore the promise of our allogeneic GDT therapy in providing durable clinical benefit."

"The latest results from this patient are highly promising, particularly given the durable progression-free survival and tumor reduction we observed," said Afshin Eli Gabayan, M.D., Medical Oncologist, Medical Director and Deltacel-01 Principal Investigator at BHCC. "This patient’s response to Gama Delta T-Cell Treatment continues to provide optimism as we evaluate Deltacel’s therapeutic potential. Continued meaningful results could represent a significant breakthrough for these late-stage cancer patients with limited treatment options."

Kiromic expects to report additional follow-up results from the fourth patient enrolled in this study in October.

About Deltacel-01

In Kiromic’s open-label Phase 1 clinical trial, titled "Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer" (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the Deltacel-01 trial is to evaluate safety, while secondary measurements include objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rates.