On October 26, 2023 Circio reported the first generation circVec 1.0 genetic cassette based on "Nature´s best design" for human circRNA expression. Following rational, targeted optimization of specific sequences and regulatory elements, Circio has been able to further improve the circRNA biogenesis and translation rate, resulting in up to 10-fold increase in protein payload expression (Press release, Circio, OCT 26, 2023, View Source [SID1234636337]). To Circio´s knowledge, circVec 2.0 far exceeds any other known intra-cellular circRNA expression system, both in terms of circRNA biogenesis efficiency and protein yield.

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Thomas Birkballe Hansen, VP and head of Research at Circio said: "We are continuing to evolve our circVec platform, and the enhanced 2.0 design drives potent and persistent protein expression. Durability and toxicity are major issues facing today´s gold-standard gene therapy approaches, which we believe can be overcome by switching from current mRNA-based expression to our circVec system. We have not reached the full potential of our technology yet, and we are continuously exploring further optimization strategies towards circVec 3.0 and beyond."

The data presented at ESGCT 2023 demonstrates the importance of optimizing both the DNA genetic cassette and the circRNA design to maximize protein payload expression. By modifying the flanking inverted repeat elements (IR), circRNA biogenesis was improved by 2-3 -fold vs. circVec 1.0. Screening and selecting novel internal ribosome entry site (IRES) elements increased the protein translation rate by 2-6 -fold. Combining these modifications, the resulting protein payload expression was enhanced by 3-10-fold vs. circVec 1.0 (depending on cell type), and outcompeted mRNA already at early time points.

Furthermore, bioinformatic modelling of long-term dynamics, based on Circio´s experimental results and externally published data, showed substantially elevated and more durable expression levels from circRNA compared to conventional mRNA vectors. This characteristic can enable improved therapeutic potency, lower dosing, and reduced toxicity. As such, circRNA is expected to replace mRNA as the preferred expression system for all viral and DNA-based therapeutics in the future.

Please see the poster here: 2023 ESGCT poster

On October 25, 2023 SparX Biopharmaceutical reported its Investigational New Drug (IND) submission to the U.S. Food and Drug Administration (FDA) for SPX-303, a First-in-Class anti-LILRB2/PD-L1 bispecific antibody drug candidate. This monumental step underscores SparX’s steadfast commitment to unveiling groundbreaking solutions for patients grappling with advanced or refractory solid tumors.

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Dr. Gui-Dong Zhu, Chief Executive Officer of SparX Biopharmaceutical, expressed his enthusiasm: "This IND submission marks a crucial juncture in our determined pursuit to revolutionize cancer treatment. The initial data for SPX-303 is not only promising but fortifies our resolve to materialize its therapeutic potential in a clinical milieu, especially for those patients constrained by limited treatment avenues."

Upon the greenlight from the agency, SparX Biopharmaceutical is poised to commence a Phase 1 clinical study, evaluating the safety, tolerability, and preliminary efficacy of SPX-303 in patients beleaguered by advanced or refractory solid tumors. This inaugural human trial stands as a critical endeavor in assessing the unprecedented therapeutic capacities of SPX-303, setting an era of innovative and enhanced healthcare solutions..

Developed by SparX, SPX-303 emerges as a novel bispecific antibody therapy, designed to concurrently engage two fundamental immune checkpoint proteins, LILRB2 and PD-L1. Both proteins are quintessential regulators in upholding the immune system’s homeostasis and robustness, forestalling autoimmune malfunctions. LILRB2 predominantly mitigates excessive innate immune responses, preserving the body’s inherent defensive balance, while PD-L1, frequently amplified in tumor cells, judiciously regulates T cell activation, ensuring a precise and restrained immune response. Cancer, with its deceptive mechanisms, often exploits these checkpoints, thereby gaining a defensive shield against immune attacks and proliferating unrestrained. SPX-303 is meticulously crafted to breach this shield, enabling the immune system to identify and robustly obliterate malignant cells, marking a new epoch in cancer therapy.

(Press release, Sparx Therapeutics, OCT 25, 2023, View Source [SID1234661037])

On October 25, 2023 myNEO, a biotech company focused on exploiting "dark genome" targets to develop novel therapeutic cancer vaccines, reported its new name – myNEO Therapeutics (Press release, myNEO Therapeutics , OCT 25, 2023, View Source [SID1234640211]). The new name reflects the company’s transition from an immunogenomic profiling expert towards an integrated drug discovery company focused on the development of a pipeline of therapeutic cancer vaccines.

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Since the company was founded in 2018, it has developed and patented proprietary Artificial Intelligence (AI) algorithms that are state-of-the art in identifying novel cancer antigens, allowing optimal selection of the best cancer targets for use in immunotherapies.

Building on this deep knowledge, internal research efforts have revealed a novel class of lncRNA-derived "dark genome" antigens which myNEO Therapeutics has named "camyotopes". These tumor-derived epitopes originate from the non-coding part of the genome, or dark genome, which is increasingly associated with a variety of diseases including cancer. Preclinical validation of these targets has reinforced the company’s belief that camyotopes are a potentially game changing class of tumor antigens for cancer immunotherapy for the many patients currently lacking sufficient actionable immunogenic targets.

Following the discovery and validation of a number of camyotopes, myNEO Therapeutics has made rapid progress in advancing its first therapeutic product, CAMYO-01, towards the clinic. CAMYO-01 incorporates a pool of colorectal cancer-specific camyotopes formulated into an mRNA-based vaccine.

Unlike personalized vaccines that require patient-unique targets and upfront genomic analysis of each patient’s tumor, camyotopes are conserved in more than 95% of the target cancer patient population. As such, treatments based on these targets can be made readily available off-the-shelf with no need for expensive and time-consuming tumor screening thereby improving access and providing a significant benefit to patients.

In addition, myNEO Therapeutics has shown that selected camyotopes are specifically translated as well as highly abundant in cancer cells which is expected to limit off-target toxicity and de-risk immune escape which can render treatment ineffective.

myNEO Therapeutics is currently performing additional pre-clinical validation experiments to prepare for the first phase of clinical development for CAMYO-01, which is expected to start before the end of 2024.

Cedric Bogaert, co-founder and CEO of myNEO Therapeutics commented: " This evolution of our corporate identity to myNEO Therapeutics marks a pivotal milestone in our strategic development and illustrates the significant progress we are making in realizing our vision. CAMYO-01 is only the start of our plan to develop a robust pipeline of therapeutic cancer vaccines based on our unique technology platform and insights into the dark genome which we believe can unlock the future of cancer immunotherapy for the benefit of a broad population of patients. "

On October 25, 2023 AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), reported a new service agreement with Medigene AG (Medigene, the "Company", FSE: MDG1, Prime Standard) (Press release, MediGene, OCT 25, 2023, View Source [SID1234636354]). Under the agreement, AGC Biologics is providing autologous production for a next-generation-therapy product focused on the treatment of solid cancers, supporting Medigene’s IND filing and clinical trials.

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With the product currently in the pre-clinical phase, AGC Biologics will perform a process transfer and clinical manufacturing of Medigene’s product candidate at the CDMO’s Cell and Gene Center of Excellence in Milan.

"The growth of T cell immunotherapies in recent years has been astonishing. Although complex to manufacture, they offer unique therapeutic effects for patients in need," said Luca Alberici, General Manager of AGC Biologics Milan. "Intricate cell therapy projects are not unique to our team, and we are eager to take on this challenge and help produce this cell therapy product with Medigene, a company truly focused on innovation in the field of solid tumor treatments."

According to recent industry research from Roots Analysis, T cell immunotherapies are poised for greater than 30 percent growth rate over the next decade, thanks to their unique ability to target cancer cells and promising early clinical data. Being a living therapy, T cell therapies are complex drug products to manufacture at GMP scales. AGC Biologics’ Milan location has 30 years of experience in the cell and gene field and expertise with complex advanced cell therapy projects, such as these. The core team has guided three cell therapy products from development to commercial stages and has manufactured hundreds of batches of cell therapies for clinical and commercial usage.

"This is a critical first step in ensuring that our lead product candidate MDG1015, a third generation TCR-T therapy combining our optimal affinity TCR targeting NY-ESO-1/LAGE-1a with our PD1-41BB costimulatory switch protein, is ready for GMP clinical evaluation," said Selwyn Ho, CEO at Medigene. "We are delighted to partner with AGC Biologics as we advance towards MDG1015’s phase I clinical milestone and look forward to its further development and delivering a potentially best-in-class, differentiated TCR-T therapy for patients with solid tumors."

To learn more about AGC Biologics’ global cell therapy services visit www.agcbio.com/capabilities/cell-therapy, go to www.agcbio.com/capabilities/viral-vector and learn more about the CDMO’s viral vector offerings.

On October 25, 2023 Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent" or the "Company"), a technology-based company with a well-established clinical diagnostic business and a therapeutic development business, reported two upcoming poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting, to be held virtually and at the San Diego Convention Center from November 1 to 5, 2023 (Press release, Fulgent Genetics, OCT 25, 2023, View Source [SID1234636353]).

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Details on Fulgent’s poster presentations at SITC (Free SITC Whitepaper) are as follows:

Title: Critical clinical evaluation of plasma to tumor tissue concordance by cancer type using Illumina’s cell-free ctTSO500 commercial liquid biopsy assay
Date and Time: Saturday, November 4 from 9:00 a.m. to 8:30 p.m. PDT
Abstract/Poster #: 222-B

Title: FID-007: Nanoencapsulated Paclitaxel Derived from a Novel Nano-Drug Delivery Platform
Date and Time: Saturday, November 4 from 9:00 a.m. to 8:30 p.m. PDT
Abstract/Poster #: 782-B

The posters will be available following the presentations on the Investor Relations section of the company’s website at View Source

About FID-007

FID-007 consists of paclitaxel encapsulated in a polyethyloxazoline (PEOX) polymer excipient designed to enhance PK, biodistribution, and tolerability. In addition to allowing the drug to remain in solution until it can enter a cancer cell, the PEOX nanoparticle is designed to preferentially deliver paclitaxel to the tumor through the leaky hyperpermeable vasculature.