On June 5, 2024 Pierre Fabre Laboratories reported the filing of an investigational new drug ("IND") application to the U.S. Food and Drug Administration ("FDA") to initiate a first-in-human (FIH) Phase I/II clinical trial with PFL-002/VERT-002 for solid tumors including non-small cell lung cancer (NSCLC) (Press release, Pierre Fabre, JUN 5, 2024, View Source [SID1234644149]).

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The PFL-002/VERT-002 Phase I/II trial is a multi-center, international study aimed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of PFL-002/VERT-002 in NSCLC patients with MET alterations, including those acquired as resistance mechanism to other treatments. The FDA will review the application and determine its acceptability.

"We are looking forward to initiating the first-in-human trial of PFL-002/VERT-002 later this year. We are confident that this new drug holds significant promise, as a novel therapeutic option with a differentiated mechanism of action, for patients facing MET-altered solid tumors, including NSCLC" said Francesco Hofmann, Head of Research and Development for Medical Care at Pierre Fabre Laboratories.

About PFL-002/VERT-002

PFL-002/VERT-002 is a monoclonal antibody developed by Vertical Bio, offering a unique and differentiating mechanism of action, acting as a degrader of c-MET, a known disease driver in patients with solid tumors, including non-small cell lung cancer (NSCLC) presenting mutations or amplification of MET. The antibody has been optimized preclinically by Vertical Bio, which has been acquired by Pierre Fabre Laboratories.

Pierre Fabre Laboratories is progressing PFL-002/VERT-002 into clinical development and hope to enroll a first patient in the FIH trial by end 2024.

On June 5, 2024 Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company developing novel, investigational engineered cytokine therapies designed to address areas of unmet need for patients with a variety of cancers, reported that Caroline Loew, Ph.D., CEO, will present at the East Coast IDEAS Investor Conference on June 13 at 9:15 a.m. EST (Press release, Mural Oncology, JUN 5, 2024, View Source;1-investor-meetings-14th-annual-east [SID1234644128]). A webcast will be available at www.threepartadvisors.com/east-coast and ir.muraloncology.com.

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About IDEAS Investor Conferences

The mission of the IDEAS Conferences is to provide independent regional venues for quality companies to present their investment merits to an influential audience of investment professionals. Unlike traditional bank-sponsored events, IDEAS Investor Conferences are "SPONSORED BY INVESTORS. FOR INVESTORS" and for the benefit of regional investment communities. Conference sponsors collectively have more than $200 billion in assets under management and include: 1102 Partners, Adirondack Research and Management, Allianz Global Investors: NFJ Investment Group, Ariel Investments, Aristotle Capital Boston, Ascend Wealth Advisors, Barrow Hanley Mewhinney & Strauss, BMO Global Asset Management, Constitution Research & Management, Inc., Diamond Hill, First Wilshire Securities Management, Inc., Granahan Investment Management, Great Lakes Advisors, Greenbrier Partners Capital Management, LLC, Hodges Capital Management, Ironwood Investment Management, Keeley Teton Advisors, Luther King Capital Management, Marble Harbor Investment Counsel, North Star Investment Management, Perritt Capital Management, Punch & Associates, Shepherd Kaplan Krochuk, Westwood Holdings Group, Inc., and William Harris Investors. The IDEAS Investor Conferences are held annually and are produced by Three Part Advisors, LLC. Additional information about the events can be located at View Source

On June 5, 2024 GC Genome Corporation, a leading diagnostics company, reported new data from its AI-based liquid biopsy platform for non-invasive colorectal cancer (CRC) detection at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, GC Genome, JUN 5, 2024, View Source [SID1234644150]). Conducted in collaboration with Genece Health Inc., a strategic partner based in San Diego, the study demonstrated significant promise for accurate non-invasive CRC and advanced adenoma (AA) detection by analyzing cell-free DNA (cfDNA) whole genome sequencing (WGS) data.

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The poster presentation highlighted the potential implementation of its liquid biopsy platform using multimodal deep learning technology to detect colorectal cancer in clinical data. The study incorporates 1,506 colonoscopy-verified normal samples, 130 AA patients, and 302 CRC patients (with a breakdown of stages). This innovative approach demonstrated high sensitivity for CRC detection across all stages, including early-stage lesions, while maintaining high specificity.

"The development of non-invasive screening methods for colorectal cancer is crucial for improving early detection and patient outcomes," said Eun-Hae Cho M.D., Ph.D., Chief Scientific Officer at GC Genome. "By emphasizing the necessity for a non-invasive approach, this research brings us nearer to the development of a convenient, accessible screening option for patients. It has the potential to bridge the current screening gap and surpass the limitations of traditional methods. And we are excited to continue our work to bring this technology to patients as soon as possible."

Key Findings of the Study:

The multimodal deep learning algorithm achieved high sensitivity for CRC detection, ranging from 80.2% to 84.0% across all stages.
The algorithm also demonstrated promising accuracy in detecting AA lesions, with a sensitivity of 63.0%.
The use of colonoscopy-verified normal samples strengthens the study’s foundation and paves the way for future clinical translation.

On June 4, 2024 Crown Bioscience, a global contract research organization (CRO) and a JSR Life Sciences company, reported the completion of a global collaboration agreement with the Shanghai Model Organisms Center (SMOC) (Press release, Crown Bioscience, JUN 5, 2024, View Source [SID1234644095]). This five-year agreement extends the existing partnership and will provide unique immuno-oncology platforms and services from all Crown Bioscience facilities worldwide.

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This strategic alliance includes:

The purchase and supply of a broad range of genetically engineered mouse models, including thousands of knock-in and knock-out humanized models,

Genetically engineered cell line development services,

Custom development of GEMM models and MuPrimeTM (Crown Bioscience’s tumor homograft models) leveraging SMOC-engineered mice.
Globally, Crown Bioscience research affiliates will benefit from uniform pricing, comprehensive IP protection, and licensing rights. This uniformity is accompanied by a shared commitment to research excellence, unrivaled quality standards, and scientific innovation.

Key advantages for Crown Bioscience customers include:

Unprecedented Access: Immediate access to SMOC’s extensive library, featuring over 6,000 off-the-shelf mouse models and more than 11,000 established genetically engineered mouse prototypes.

Consistent Supply Chain: A reliable source of genetically engineered cell lines and murine models, alongside highly translational humanized models.

Global Strategic Synergy: Fostering a global strategic partnership, extending beyond procurement, that enhances both entities’ capabilities and offerings.
Through this collaboration, Crown Bioscience and SMOC will help bridge the gap between scientific discovery and clinical application and foster the continuous growth and evolution of global research initiatives.

Click here for more information on our innovative immuno-oncology platforms and services.

On June 5, 2024 Amgen (NASDAQ:AMGN) reported that it will present at the Goldman Sachs 45th Annual Global Healthcare Conference at 9:20 a.m. ET on Monday, June 10, 2024 (Press release, Amgen, JUN 5, 2024, View Source [SID1234644114]). Peter Griffith, executive vice president and chief financial officer at Amgen, and Jay Bradner, executive vice president of Research and Development and chief scientific officer at Amgen, will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.