On February 15, 2024 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the company will participate in the following investor conferences (Press release, Guardant Health, FEB 15, 2024, View Source [SID1234640169]).

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Citi 2024 Unplugged Medtech and Life Sciences Access Day in New York
Fireside Chat on Thursday, February 29 at 1:00 p.m. Eastern Time / 10:00 a.m. Pacific Time
TD Cowen 44th Annual Health Care Conference in Boston
Fireside Chat on Tuesday, March 5 at 9:50 a.m. Eastern Time / 6:50 a.m. Pacific Time

Interested parties may access live and archived webcasts of the sessions on the "Investors" section of the company website at: www.guardanthealth.com.

On February 15, 2024 Kurome Therapeutics Inc. reported that the U.S. Food and Drug Administration (FDA) has cleared the IND for KME-0584, allowing the company to proceed with a Ph1 clinical trial in relapsed/refractory (R/R) AML and high-risk (HR) MDS patients (Press release, Kurome Therapeutics, FEB 15, 2024, View Source [SID1234640168]). Kurome plans to initiate the clinical trial in the latter half of 2024.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"This is a major milestone for the Kurome team and our collaborators and validates our unique approach to AML and MDS as well as the suitability of KME-0584 for initial clinical testing," said Jan Rosenbaum, Ph.D., CEO and CSO at Kurome. "We look forward to getting our clinical trial underway and testing our approach of targeting dysregulated immune signalling in the setting of AML and HR-MDS by targeting both IRAK1 and IRAK4 together to improve efficacy in this difficult to treat R/R patient population."

About KME-0584
KME-0584 is a potent and highly selective small molecule inhibitor of interleukin 1 receptor associated kinases (IRAK)1, IRAK4, and all mutations of FMS-like receptor tyrosine kinase-3 (FLT3), for the treatment of R/R AML or HR-MDS. KME-0584 is intended for oral administration as a monotherapy, and as combination therapy with azacitidine or venetoclax.

About the Phase 1 Clinical Trial
The Phase I study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of KME-0584 alone or in combination with venetoclax or azacitidine in patients with AML and HR MDS. The study will include a dose escalation and an expansion phase with up to 100 total participants. Kurome Therapeutics is planning to start the study in 2024 across multiple investigative sites in the US.

On February 15, 2024 Pharus Diagnostics ("PharusDx") reported a global exclusive license agreement with City of Hope cancer center for proprietary biomarkers to be used in early screening of individuals at risk for pancreatic ductal adenocarcinoma (PDAC) (Press release, Pharus Diagnostics, FEB 15, 2024, View Source [SID1234640167]). This license agreement marks a pivotal step with PharusDx to develop and commercialize a version of its OncoSweep liquid biopsy screening for the early detection of PDAC. OncoSweep aims to improve on the current standard for early diagnosis of PDAC, offering a non-invasive solution that has been shown in laboratory studies to be highly accurate.

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PDAC is predicted to become the second leading cause of cancer-associated mortality within the next decade in the United States, with a five-year relative survival rate of approximately 8.5%. The poor survival rate is mainly due to late-stage diagnosis, attributed to the pancreas’ deep location within the abdominal cavity. Early-stage PDAC often exhibits no noticeable symptoms that could indicate the disease.

City of Hope, one of the largest cancer research and treatment organizations in the United States, is a pivotal leader in advancing research in the diagnosis of PDAC. The research breakthrough led by Ajay Goel, Ph.D., AGAF, chair of City of Hope’s Department of Molecular Diagnostics and Experimental Therapeutics, is poised for further development and then commercialization into a liquid biopsy test that surpasses the accuracy of conventional PDAC screening. The agreement covers a set of microRNA (miRNA) biomarkers that have been shown to greatly improve sensitivity, specificity, positive predictive value and negative predictive value.

"We are excited about what we can bring to market using the licensed technology. An accurate diagnostic tool can greatly improve PDAC patient outcome, especially when surgical resection remains an option," said PharusDx Chairman Bowei Lee. Lee is also Chairman of LCY Group, one of the major investors backing PharusDx, along with CK Life Sciences and CK Hutchison.

Goel, director of Biotech Innovations at City of Hope, added, "We are thrilled to collaborate with PharusDx on this important step in City of Hope’s quest to bring blood-based, noninvasive tests to people for the early detection of gastrointestinal cancers. This specific licensing opportunity is particularly meaningful given the increased burden of pancreatic cancer worldwide and the lethality of this disease." (Goel is a compensated PharusDx advisory board member.)

The current challenge of asymptomatic early diagnosis of PDAC is anticipated to be addressed by PharusDx’s liquid biopsy miRNA test: OncoSweep. This test is expected to offer a critical improvement to screening options for at-risk individuals, particularly asymptomatic adults with risk factors such as diabetes, older age, cigarette smoking, obesity, and a history of chronic pancreatitis. Using machine learning, OncoSweep distinguishes specific biomarker signatures unique to cancer patients, offering higher specificity and sensitivity than the conventional analytes alone. The test is cost-effective and can be integrated into existing health screening protocols.

OncoSweep is a near painless, accessible, and easily repeatable screening option. It is designed to detect asymptomatic disease early and preempt unnecessary invasive procedures, reducing the physical, emotional, and financial impact that PDAC has on patients. The anticipated highly accurate results could provide actionable insights for personalized treatments and better outcomes. Furthermore, early cancer diagnosis may significantly reduce long-term medical costs in the healthcare industry and ease the financial burden on payers, including governments, insurance companies, and individuals.

PharusDx is dedicated to advancing single and pan-cancer liquid biopsy screenings using cutting-edge proprietary technology. The company aims to commercialize a portfolio of products targeted to improve cancer screening. PharusDx is committed to a future where all cancers can be managed early for improved outcomes.

On February 14, 2024 iNtRON Biotechnology ("iNtRON", www.intodeworld.com) reported that New Drug Part has secured a potent anti-cancer candidate, PHAGERIA, with broad antimicrobial activity against ETBF (Enterotoxigenic B. fragilis), a harmful microbe associated with colorectal cancer (Press release, iNtRON Biotechnology, FEB 14, 2024, View Source [SID1234640166]).

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iNtRON stated that following the proprietary development of the Robot Bacteriophage 2nd generation technology, additional in-vitro evolution technology was applied. The Company previously secured the technology to customize and edit bacteriophage genomes as desired using tailored CRISPR/Cas technology and Random Transposon Mutagenesis in 2022. Recently, the Company has advanced this technology further to develop a more potent anti-cancer candidate, PHAGERIA.

According to the Company, in-vitro Evolution technology was employed to induce the evolution of specific genes of ETBF bacteriophages under specialized experimental conditions, resulting in the selection of PHAGERIA anti-cancer candidates with enhanced antimicrobial activity. This achievement is significant as it is the first instance of applying in-vitro Evolution technology to ETBF bacteriophages, demonstrating the excellence of the bacteriophage gene editing technology (CRISPR/Cas) and Robotic Bacteriophage improvement platform technology of the Company.

Additionally, iNtRON identified the mutation patterns of tail fiber genes closely associated with antimicrobial activity, extracting and securing core sequences along with information about variable or invariant regions. The Company anticipates effectively utilizing this to further enhance the antimicrobial activity of future PHAGERIA anti-cancer candidates.

Dr. SON, Ji-soo, the head of the BD Department emphasized, "As ETBF is known to have a direct correlation with the occurrence and progression of colorectal cancer, it was the primary target of this screening for PHAGERIA anti-cancer candidates." He added, "We plan to gradually expand the application of this technology to other bacteriophages to improve the broad antimicrobial properties against harmful gut microbiomes and further advance the Robotic Bacteriophage improvement platform technology."

Mr. YOON, Kyung-won, CEO of iNtRON said that "The Robotic Bacteriophage Improvement Platform technology is the core technology that underpins not only PHAGERIA but also PHAGERUS for developing antiviral agents and PHAGERIARUS for developing immune-modulating agents. He further stated, "We will focus more on related research and development and enhance technological capabilities to achieve success in the development of new drugs based on bacteriophage technology, solidifying our position as a global leader in the bacteriophage field."

About PHAGERIA Platform

iNtRON’s PHAGERIA is a technical term for iNtRON, synthesized from bacteriophages and bacteria. In simple terms, PHAGERIA is a platform for researching the impact of bacteriophages on intestinal bacteria and their effect on human health. When bacteriophages consume intestinal bacteria, it can lead to changes in the intestinal flora. These changes may have an impact on human immunity and overall health.

On February 15, 2024 Dragonfly Therapeutics, Inc., a clinical stage biotechnology company developing novel immunotherapies reported a new clinical collaboration designed to evaluate and combine DF1001, a HER-2 immune engager developed using Dragonfly’s TriNKET technology platform and Dragonfly’s lead clinical asset, with Trodelvy, Gilead’s Trop-2-directed antibody drug conjugate (ADC), in metastatic breast cancer (mBC) and non-small cell lung cancer (NSCLC) (Press release, Dragonfly Therapeutics, FEB 15, 2024, View Source [SID1234640165]).

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"DF1001 is the first of eight Dragonfly-developed drugs in the clinic and has shown clinical benefit in mBC, NSCLC and colorectal cancer (CRC) in a heterogeneous Phase 1 population with 22% RECIST responders and 39% clinical benefit in mBC patients at active dose levels, with no DLTs, even in a heavily-pre-treated population," said Joseph Eid, Dragonfly President of R&D. "It has been demonstrated to be well tolerated across all dose levels in the Phase 1 study as monotherapy, and pharmacodynamic activity was demonstrated in 28/42 (67%) paired biopsies from 0.5-15mg/kg, where increase in CD8 and NK cell infiltration was observed consistent with preclinical models and supporting the TriNKET immune modulating MoA. Our preclinical work has shown the powerful combinatorial effect of TriNKETs with ADCs, and highlighted the potential benefits to patients of using Gilead’s Trodelvy in combination with DF1001."

"We are delighted to further strengthen our partnership with Gilead by launching this new clinical stage collaboration," said Bill Haney, CEO and Dragonfly co-founder. "Dragonfly has promising pre-clinical data that highlights the potential for synergistic efficacy when DF1001 is combined with Trodelvy in mBC and NSCLC. We are excited to work with our colleagues at Gilead to bring this combination to patients in need."

Dragonfly will have operational control of the study and first patients are expected to receive this combination in Q2 2024. Clinical trial sites are currently open in the U.S., France, Belgium, Denmark and the Netherlands. Additional sites in North America, Europe and Asia Pacific will open in 2024. Additional information about the trial, including eligibility criteria, can be found at: View Source (ClinicalTrials.gov Identifier: NCT04143711).

About DF1001

DF1001 is an investigational first-in-class drug candidate that targets natural killer (NK) cells and T-cell activation signals to co-activating NK receptors, where NKG2D and CD16 co-stimulation yields distinctive and potent NK cell activation. DF1001 is being evaluated in adult patients for the treatment of advanced solid HER-2 positive tumors. DF1001 was discovered and developed using Dragonfly’s TriNKET platform. DF1001 has the potential to stimulate effective anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies. DF1001 is the most advanced in a pipeline of TriNKETs that Dragonfly is developing to address high unmet needs for patients across a broad range of disease areas.