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.

On October 25, 2023 Flashpoint Therapeutics, a company developing nanotechnology-enabled therapeutics for cancer and other diseases, reported a $10M seed financing round led by Beta Lab, a leading deep tech venture capital firm headquartered in Riyadh, Saudi Arabia, with participation from leading private equity investor Russell Carson’s CS Venture Opportunities Fund (Press release, Flashpoint Therapeutics, OCT 25, 2023, View Source [SID1234636352]).

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The funding will be used to advance its first therapeutic candidate in oncology, nominate a second development candidate, and advance multiple internal and partnered discovery programs. Flashpoint will also use the funds to expand its team and enhance the platform to develop best-in-class multi-targeted RNA, CRISPR and peptide therapeutics with unique characteristics.

Flashpoint nanostructures are all-in-one formulations that kinetically tune and co-deliver precise combinations of therapeutic components. This approach overcomes limitations of current technologies that rely on mixing therapeutic components with little control over their co-delivery or structural presentation. The company’s proprietary discovery platform is founded on nanotechnology research developed over the past 10 years in the laboratory of Chad Mirkin, Director of the International Institute for Nanotechnology at Northwestern University.

Validated in numerous in-vivo models, this technology enables the development of therapeutic candidates with superior product profiles by co-delivering diverse payloads to the right target cells with precise stoichiometry, optimized structure-function relationship, and synchronized activation kinetics. This capability overcomes many major limitations of current therapeutics that have focused on defining potent components but cannot control how they work together.

"We are thrilled to announce a $10 million seed financing round led by Beta Lab, a leading deep tech venture capital firm," said Adam Margolin, Ph.D., CEO & Founder, Flashpoint Therapeutics. "Biotechnology has created tools capable of modulating any disease process. To translate these tools into cures, we need to get the right combinations into the right cells in the right structure to induce their function at the right time. By solving these challenges for the first time, Flashpoint’s technology has consistently transformed ineffective components into highly effective therapies based on preclinical studies. This substantial investment will allow us to move our candidates into the clinic."

The company’s initial candidate will be a first-in-class cancer immunotherapy that delivers precise cocktails of immune stimulatory molecules with nanoscale architecture and activation kinetics optimized to induce robust, coordinated anti-tumor immune response. This approach yields 35 times increased co-delivery of therapeutic components to immune cells, 80 times stronger immune activation, and 650% greater tumor killing.

Using the same drug components that are ineffective in conventional formulations, Flashpoint immunotherapies have shown promise for treating breast cancer, lymphoma, cervical cancer, melanoma, colon cancer, glioma, and prostate cancer. Based on these studies, the company will advance the best of these candidates into clinical trials.

"Effective cancer therapy requires co-activating multiple pathways in the same cell. But current drugs just mix together components and hope they randomly come together at the right place and time. Flashpoint overcomes limitations of this approach by integrating therapeutic components within nanostructures that control their co-delivery and coordinated activation of the multiple pathways required for the immune system to kill tumors," said Mirkin.

Preclinical studies beyond immuno-oncology have demonstrated that Flashpoint’s technology can enhance virtually all therapeutic modalities – including RNA, peptide, and CRISPR – by enabling superior uptake by target cells outside of the liver, cargo co-delivery, stability in circulation, target activation, and reduced immunogenicity.

A proof of concept clinical study using Flashpoint’s technology has demonstrated delivery of nucleic acid cargo to the brain. Flashpoint plans to partner with leading companies in nucleic acid and peptide therapeutics to develop best-in-class therapeutic candidates in these areas.

"Flashpoint’s technology stands out from other treatment modalities in the market. Extensive data shows its ability to consistently improve therapy effectiveness, and the platform’s elegant design allows it to be added to existing candidates. Any company partnering with Flashpoint stands to gain a unique advantage over the competition. It would be almost negligent not to test if Flashpoint’s platform can enhance candidates in their pipeline," said Abdulrahman Al-Olayen, Managing Director of Beta Lab. Adam brings a deeply personal mission to the company. Motivated by the loss of his mother to cancer at a young age, he has dedicated his career to developing novel cancer therapies. We are eager to support Adam in his passionate mission to develop a new class of breakthrough therapies to benefit patients."

"We invest in transformative technologies and Flashpoint’s superior technologies have the potential to transform the way that therapeutics are developed, said Quinten Stevens, General Partner of CS Venture Opportunities Fund. Professor Chad Mirkin is a visionary, and this marks our second Chad founded company portfolio investment. We are delighted to partner with Chad and Adam and support them in successfully growing Flashpoint and developing their technologies, which will have a material benefit to society.

On October 25, 2023 TriSalus Life Sciences Inc., (Nasdaq: TLSI), an oncology company integrating its novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors, reported that it will present a variety of new data from its innovative clinical development pipeline at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting being held November 1-5, 2023, in San Diego, California (Press release, TriSalus Life Sciences, OCT 25, 2023, View Source [SID1234636351]).

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Presentation details for SITC (Free SITC Whitepaper) 2023 are as follows:

Late Breaker Oral Presentation: Clinical Activity of SD-101 with Immune Checkpoint Inhibition (ICI) in Metastatic Uveal Melanoma Liver Metastasis (MUM-LM) from the PERIO-01 Phase 1 Trial
Presenter: Sapan P. Patel, M.D., Director of the Uveal Melanoma Program, The University of Texas MD Anderson Cancer Center
Abstract: 1534
Session: Late-Breaking Abstract Session
Time: Saturday, November 4, 11:25 a.m. PDT
Poster Presentation also available in the Poster Hall and in the Virtual ePoster Hall

Poster Presentation: PERIO-03: Pressure Enabled Intrapancreatic Delivery of SD-101 with Checkpoint Blockade for Locally Advanced Pancreatic Adenocarcinoma – Initial Safety and Feasibility Experience
Abstract: 647
Presenter: Michael S. Lee, M.D., Associate Professor, The University of Texas MD Anderson Cancer Center
Time: Friday, November 3, 9:00 a.m. – 7:00 p.m. PDT

Poster Presentation: Checkpoint Inhibitor Administered Either Systemically of Subcutaneously Enhances the Anti-Tumor Immunity of SD-101 Delivered by Pressure-enabled Drug Delivery (PEDD) Device in Treating Liver Metastasis (LM)
Abstract: 1123
Presenter: Chandra C. Ghosh, Ph.D., TriSalus Life Sciences
Time: Friday, November 3, 9:00 a.m. – 7:00 p.m. PDT

The presentations will be available here following their respective sessions.

On October 25, 2023 Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, reported financial results and provided a corporate update for the third quarter of 2023 (Press release, MediGene, OCT 25, 2023, View Source [SID1234636349]). The Company’s Quarterly Statement Q3 2023 is available on Medigene’s website: View Source

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"In the past quarter, we continued to successfully execute our corporate strategy and deliver on our commitments. We have further progressed our lead candidate, MDG1015 with our IND / CTA enabling work and also expanded our pipeline into neoantigens with the annoucement of the lead for MDG2011, which targets KRAS G12V A*11, and the first pre-clinical data presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October. Here, MDG2011 showed significantly enhanced anti-tumor activity and tumor killing of our optimal affinity T cell receptor (TCR) when combined with the PD1-41BB costimulatory switch protein," said Selwyn Ho, Chief Executive Officer at Medigene.

"On our End-to-End Platform, we expanded the license for our PD1-41BB and CD40L-CD28 costimulatory switch proteins to include uses in additional cell types and in Chimeric Antigen Receptor T cell (CAR-T) therapies. Backed by a growing T cell receptor engineered T cell (TCR-T) therapy pipeline, additional armoring, enhancement and optimization technologies, as well as a solid IP-portfolio, we are advancing towards our ambition of developing first-in-class / best-in-class TCR-T therapies for patients suffering from solid tumors. We are confident that by fully leveraging the capabilities of our End-to-End Platform, we will deliver significant value to patients and shareholders."

Financial and Corporate Highlights:

The financial performance in the third quarter of 2023 was in line with the Executive Management Board’s expectations. Revenues in the third quarter 2023 amounted to EUR 1.6 million compared to EUR 1.4 million in the previous year period (9-month period 2023: EUR 4.6 million), primarily from the partnership with BioNTech. Reflecting our commitment towards advancing and expanding the pipeline, R&D expenses for the quarter were EUR 3.2 million compared to EUR 3.3 million in the prior year period (9-month period 2023: EUR 8.4 million).
The Executive Management Board, therefore, maintains its guidance for the fiscal year 2023 published in the annual report 2022 on March 29, 2023, in its entirety. Accordingly, the Executive Management Board expects revenue in 2023 to be between EUR 5 and 7 million. The Company expects R&D costs ranging from EUR 13 to 16 million. As of September 30, 2023, cash and cash equivalents and time deposits amounted to EUR 21.2 million (December 31, 2022: EUR 33.2 million). Based on current planning, the Company is financed until the fourth quarter of 2024.
In September, the Company’s partner 2seventy bio, together with JW Therapeutics, has announced the acceleration of their T cell-based immunotherapy projects in Greater China. Specifically, the program containing Medigene’s MAGE-A4-targeted TCR is on track to initiate an investigator-initiated study in China by the end of 2023.
Due to the prolonged funding and development pause by Hongsheng Sciences of the partnered program that included Medigene’s NY-ESO-1-targeted TCR, the parties have mutually agreed to terminate the partnership agreement as it relates to the NY-ESO-1 asset in Q3 2023. The return of this asset to Medigene allows Medigene to find a new strategic development partner in Asia, but now for our first-in-class MDG1015 program containing the Company’s optimal affinity NY-ESO-1-targeted TCR.

Research & Development Highlights:

In August, Medigene announced the expansion of the intellectual property (IP) license for its PD1-41BB and CD40L-CD28 costimulatory switch proteins, enabling their application to additional cell types and for use in Chimeric Antigen Receptor T cell (CAR-T) therapies.
In September, the Company was granted a patent by the European Patent Office protecting its PD1-41BB costimulatory switch protein technology. The patent complements the PD1-41BB IP-portfolio with similar patents already granted in the United States, China and Japan.
In September, Medigene delivered on its commitment to select a lead candidate for the second TCR-T therapy program in solid tumors, MDG2011, targeting KRAS (Kirsten rat sarcoma viral oncogene homologue) G12V with HLA-A*11 (HLA, human leukocyte antigen) and being developed in combination with Medigene’s PD1-41BB costimulatory switch protein Medigene’s End-to-End Platform has successfully generated not one but three KRAS G12V-HLA-A*11-directed TCRs, of which the Company has prioritized one as the lead to move forward to the pre-clinical stage for the MDG2011 program.
Subsequent to the quarter, first pre-clinical data on MDG2011 was presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 held in Madrid in October 2023. The pre-clinical data presented showed significantly enhanced T cell activity and tumor killing when combining the PD1-41BB costimulatory switch protein with recombinant TCRs not only when directed at the cancer-testis antigen NY-ESO-1/LAGE-1a (MDG1015), but also, presented for the first time, against the neoantigen mutant KRAS G12V.
Describing in detail our End-to-end Platform approach, the paper Evolution by Innovation as a Driving Force to Improve TCR-T Therapies, by Dolores J. Schendel, was published in Frontiers in Oncology, section Molecular and Cellular Oncology in September 2023.