DiaCarta Reports Positive Clinical Trial Data For Its Blood Based Test to Triage FIT-Positive Patients Enrolled in CRC Screening Programs

On January 3, 2025 DiaCarta Inc., a precision molecular diagnostic company, reported the publication of its prospective clinical trial data on its blood-based test for triaging FIT (fecal immunochemical test)-positive patients in colorectal cancer (CRC) screening (Press release, DiaCarta, JAN 3, 2025, View Source [SID1234649408]).The study data was published in the Journal of Molecular Pathology on December 13, 2024. The findings reveal that in triaging FIT-positive patients in CRC screening, the QuantiDNA test from patients’ plasma reduces the need for colonoscopy examinations by 33% and is non-inferior to the standard of care in detecting significant colorectal lesions.

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The prospective clinical trial was designed for the Triage of FIT+ Patients Enrolled in a Colorectal Cancer Screening Program. During the period 2019–2022, 711 individuals of both genders, aged 50–74, participating in a CRC screening program organized by the ASL NA 3 SUD, a public healthcare company operating in the district of Naples (Italy), were enrolled in a cross-sectional study aimed at investigating the possible role of the plasma-based test. According to the study protocol, all participants with a FIT+ (or FOBT+) test, willing to sign an informed consent and eligible for the study, received both the blood-based test and a colonoscopy. Data analysis strategy ensured a comparison between the standard of care and the alternative approach. The study was approved by the Ethical Committee in December 2018. Statistical analysis was conducted internally and independently validated by TechnoSTAT Clinical Services (Bnei Brak, Israel). The database was provided and held by Mednet, Inc. (Minnetonka, MN, USA).

"In Europe, all patients diagnosed as FIT positive are referred for colonoscopy, but, according to data collected from within the screening programs, 75% of them turn out to be negative afterward," said Dr. Mauro Scimia, DiaCarta’s Medical Director and Senior Business Director in Italy, as well as one of the senior authors of this paper. "We utilized the straightforward, non-invasive, and well-tolerated blood-based test to triage FIT+ patients, significantly reducing the number of patients who truly require colonoscopy. This approach helps alleviate the burden on healthcare providers and reduces patients’ anxiety while they wait for long colonoscopy queues."

"We are very pleased with the clinical trial results. The clinical performance of the simple blood-based test in triaging CRC screening aligns perfectly with our mission to advance cancer testing through liquid biopsy," Dr. Adam (Aiguo) Zhang, President and CEO of DiaCarta, added. "This clinical trial represents a major milestone in "bringing the test into clinical practice."

General Proximity De-Stealths with $16M to Pioneer Next-Gen Induced Proximity Medicines for ‘Undruggable’ Targets

On January 3, 2025 General Proximity, a breakthrough biotech platform company, reported its emergence from stealth, unveiling its proprietary OmniTAC platform designed to pioneer the next generation of induced proximity medicines (Press release, General Proximity, JAN 3, 2025, View Source [SID1234649815]). The company has raised $16 million to accelerate the development of treatments targeting undruggable proteins associated with cancer, cardiometabolic disease, neurodegeneration, and longevity.

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"We believe proximity medicines are the future of small-molecule drug discovery and have the potential to lower global disease burden more than any other current therapeutic modality," said Armand B. Cognetta III, PhD, Founder and CEO of General Proximity. "Biological proximity—the nearness or interaction of two or more (macro)molecules—is a master regulator of biology. By achieving precise control of proximity through our OmniTAC platform, we are able to modulate ‘undruggable’ targets more effectively than other approaches. Control of proximity equals control of biology."

The oversubscribed seed round was led by Aydin Senkut, founder and managing partner at Felicis, a firm renowned for backing biotech trailblazers such as Recursion, Ginkgo Bioworks, and BioAge.

"It was clear from our first meeting with Armand that General Proximity is going to be one of the technologies that propels us towards cures for cancer and many other diseases," said Senkut. "We quickly became convinced that their cutting-edge proximity approach would enable them to solve some of the most ambitious and consequential challenges in drug discovery, paving the way for a bold new era of human healthspan and longevity extension."

Other notable investors include Y Combinator, age1, Modi Ventures, Wilson Sonsini, as well as a number of prestigious angel investors including Jeff Dean (Head of Google AI), Uri Lopatin (Khosla, YC, Pardes), Ben Mann (Co-Author GPT-3, Co-Founder Anthropic), Alec Nielsen (CEO Asimov), Trevor Martin (CEO Mammoth), Juan Benet (Founder Filecoin), Nish Bhat (Co-Founder Color Health), Jim Dahl (Rock Creek Capital), and De Thompson V (Legends Capital).

General Proximity is the brainchild of Armand, a veteran of renowned chemical biologist Benjamin Cravatt’s research group. The founding team behind General Proximity includes an array of top scientists from institutions such as Scripps Research Institute, the Broad Institute of Harvard/MIT, Yale, Oxford, Cambridge, UPenn, Johns Hopkins, Columbia, and UCSF, with deep experience from top pharmaceutical companies (Novartis, Merck, GSK, Genentech, Roche, and Alnylam), as well as multiple veterans from the labs of induced proximity pioneers Craig Crews and Amit Choudhary.

General Proximity has assembled a world-class Scientific & Strategic Advisory Board featuring key opinion leaders from top biotechnology and pharmaceutical companies such as Martin Babler (Genentech, Principia, Alumis), Lawrence Hamann (Bristol-Myers Squibb, Novartis, Celgene, Takeda, Interdict), and Andy Crew (Astellas, Arvinas, Siduma) alongside a number of academic experts in cancer biology and neurodegeneration.

In total, the team is responsible for hundreds of peer reviewed articles and patents and has been a driving force behind over 200 clinical programs and 36 FDA approved medicines.

The team has also attracted significant interest from the pharmaceutical industry, securing a record five ‘Golden Ticket’ awards from major pharma pitch competitions (AbbVie, Servier, Astellas, Ono, Bristol-Myers Squibb) and winning a coveted spot in Johnson & Johnson’s JLabs biotech incubator.

Children’s Hospital of Philadelphia Researchers Develop New Tool with Potential to Advance Precision Medicine Treatment for Cancer

On January 3, 2025 Researchers at Children’s Hospital of Philadelphia (CHOP) and the Perelman School of Medicine at the University of Pennsylvania reported a new screening technology, Aptamer-based T Lymphocyte Activity Screening and SEQuencing (ATLAS-seq), to better identify antigen-reactive T cells that are more likely to offer greater immune responses against cancer cells (Press release, CHOP, JAN 3, 2025, View Source [SID1234649409]). The findings were reported this week in the journal Nature Communications.

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Researchers continuously work to develop immunotherapy treatments that help the immune system recognize and attack specific protein targets on cancer cells, also known as tumor antigens, thereby training the body to fight cancer more effectively and precisely. Discovering antigen-reactive T cell receptors (TCRs) is essential to this precision medicine approach.

TCRs are protein complexes located on the surface of T cells that recognize and bind to antigen peptides presented by major histocompatibility complex (MHC) molecules, triggering a cascade of cellular responses that lead to T cell activation. However, standard methods for isolating antigen-reactive TCRs often fail to identify TCRs that effectively activate T cells.

"TCRs identified by ATLAS-seq tend to be more efficient in target cell killing than those identified by conventional technologies," said Lan Lin, PhD, senior author of the study and Assistant Professor in Pathology and Laboratory Medicine at Children’s Hospital of Philadelphia and Penn Medicine. "Overall, ATLAS-seq improves TCR screening to more effectively identify antigen-reactive TCRs with high functional activity."

The ATLAS-seq technology combines a single-cell approach with an aptamer-based fluorescent molecular sensor that emits a fluorescence signal when a T cell is activated. In the study, the researchers designed a microfluidic system to isolate individual T cells that react to stimulation by an antigen peptide of interest and determined their unique TCR sequences using single-cell sequencing.

"We envision that ATLAS-seq can play a pivotal role in identifying TCRs targeting tumor antigens, driving the development of novel T cell immunotherapies for a broad range of hard-to-treat cancers," said Lin, who is also a researcher in the Raymond G. Perelman Center for Cellular and Molecular Therapeutics and the Center for Computational and Genomic Medicine at CHOP.

This work was supported by National Institutes of Health grant R01GM121827, W.W. Smith Charitable Trust grant C2004 and a CHOP Research Institute Cell & Gene Therapy Collaborative seed grant.

Novocure to Participate in 43rd Annual J.P. Morgan Healthcare Conference

On January 3, 2025 Novocure (NASDAQ: NVCR) reported that management will participate in the 43rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025. Ashley Cordova, Chief Executive Officer, and William Doyle, Executive Chairman, will speak on behalf of the company and address questions at 9:00 a.m. PST (Press release, NovoCure, JAN 3, 2025, View Source [SID1234649410]). Ms. Cordova and Mr. Doyle will be joined by Christoph Brackmann, Chief Financial Officer, for one-on-one meetings with investors throughout the conference.

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A live audio webcast of this presentation can be accessed from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for replay for at least 14 days following the event.

Agios to Present at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025

On January 3, 2025 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, reported that its management team is scheduled to present at the 43rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025, at 7:30 a.m. PT / 10:30 a.m. ET (Press release, Agios Pharmaceuticals, JAN 3, 2025, View Source [SID1234649392]).

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The live webcast will be accessible on the Investors section of the company’s website (www.agios.com) under the "Events & Presentations" tab. A replay of the webcast will be archived on the company’s website for at least two weeks following the presentation.