On January 6, 2025 Norgine reported that it completed its marketing authorisation application filing to European Medicines Agency (EMA) for eflornithine in high-risk neuroblastoma (HRNB) (Press release, Norgine, JAN 6, 2025, View Source [SID1234649445]). This follows the submissions in April 2024, via Project Orbis, in Australia, Switzerland and the United Kingdom.

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This milestone further supports Norgine’s efforts to give patients access to eflornithine and bring a further treatment option in the field of paediatric oncology.

Norgine and USWM, LLC (dba US WorldMeds), a Kentucky-based specialty pharmaceutical company, have an exclusive licensing agreement by which Norgine will register and commercialise eflornithine, also referred to as DFMO, in Europe, Australia and New Zealand.

On 13 December 2023, the US Food and Drug Administration (FDA) approved eflornithine as the first oral maintenance therapy for HRNB, indicated to reduce the risk of relapse in adult and paediatric patients who have received certain prior therapies.[1] The approval decision was based on findings from a trial comparing outcomes from patients treated with eflornithine in Study 3b (NCT02395666)[2],[4] to control patients derived from Study ANBL0032 (NCT00026312; clinical-trial-derived external control arm)[3],[4] . The study with eflornithine treated patients showed improved event-free survival and overall survival when compared to outcomes for patients with HRNB treated with the standard of care (SoC).[1]

Dr David Gillen, Chief Medical Officer at Norgine, added, "This submission via the EU Centralised Procedure represents another important step in the regulatory process for eflornithine and further emphasises Norgine’s passion and commitment in attempting to secure additional treatment options for patients living with HRNB, a condition with a high level of unmet medical need."

Janneke van der Kamp, CEO of Norgine added "Submitting this marketing authorisation to the EMA marks a pivotal step for patients facing this challenging cancer. We are committed to advancing innovative therapies that address the unmet needs of young patients and their families, and this milestone brings us closer to offering hope where it’s most needed".

On January 5, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that the company will participate in the 43rd Annual J.P. Morgan Healthcare Conference (Press release, Innovent Biologics, JAN 5, 2025, View Source [SID1234649417]). During the conference, Dr. De-Chao Michael Yu, the Founder, Chairman and CEO of Innovent, will deliver a company presentation highlighting the organization’s business update, strategic priorities and future outlook. Dr. Yu will also participate in a panel discussion session.

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The 43rd J.P. Morgan Annual Healthcare Conference will be held from January 13 to 16, 2025 in San Francisco, CA. Recognized as the largest and most influential health care investment symposium in the industry, the conference will gather over 8,000 investors, industry leaders and representatives from 550 global healthcare companies to explore the latest market trends and medical innovations.

Company Presentation

Time: Thursday, January 16, at 08:30 a.m. PST

Speaker: Dr. De-Chao Michael Yu, the Founder, Chairman and CEO of Innovent

Live audio webcast:

View Source;kiosk=true

Presentation slides：

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* will be available on the Innovent website – Investors & Media section after the live presentation

Panel Discussion

Time: Wednesday, January 15, at 2:15 p.m. PST

Theme: China Biopharma Industry Global Expansion Strategy

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.

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.

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.