On September 25, 2023 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported that it has closed the Share Purchase Plan (SPP, see ASX Announcement 18 August 2023) component of its capital raising in conjunction with the acquisition of the exclusive licensing rights to azer-cel, raising a further $18.2 million (Press release, Imugene, SEP 25, 2023, View Source [SID1234635350]).

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Under the SPP, approximately 325 million shares will be issued at $0.056 per share, representing the lower of $0.084 and a 2.5% discount to the 5-day VWAP up to and including the closing date of the SPP (21 September 2023).

Under the SPP, Eligible Shareholders will also receive one free option for every New Share subscribed for. The New Options will have an exercise price of $0.118 per option with an expiration of 31 August 2026 and will be subject to shareholder approval. It is intended that the New Options will be quoted on the ASX.

The new ordinary shares subscribed for under the SPP are expected to be issued on Tuesday, 26 September 2023.

Imugene’s Executive Chairman Paul Hopper said: "I want to thank our existing shareholders for their support of the SPP on behalf of the Board and management of Imugene. With a portfolio of world-class assets, backed by an outstanding balance sheet, Imugene is well placed to continue its development and provide shareholder value to our loyal investors in due course."

On September 23, 2023, oncologists and experts from more than 60 clinical research centers across the country gathered in Guangzhou to participate in the YL201 Phase I/II Investigators Meeting hosted by Suzhou MediLink Therapeutics Co., Ltd (Press release, Suzhou Medilink Therapeutics, SEP 23, 2023, View Source [SID1234635352]). The chair of this meeting was Professor Li Zhang, from the Cancer Center of Sun Yat-sen University, who gathered the wisdom and experience of experts, to discuss the development strategy of the clinical trial protocol in depth, and lay a solid foundation for the efficient drug development of YL201.

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Presentation by the Chairperson of the Meeting, Lead Investigator Professor Li Zhang, said that "ADC is currently a highly anticipated field, and the data generated from the early international multi-center clinical trial of YL201 project by MediLink is exciting. There is hope for a breakthrough therapy in the future, and it has provided a solid foundation for the rapid advancement into Phase I/II. Sincere wishes for further progress and breakthroughs in this project, bringing better data and outcomes to the field of cancer treatment".

At the meeting, Professor Hongyun Zhao shared the exciting clinical trial data of the recent successful dose exploration stage.

Sponsor representative, Dr. Tongtong Xue, Chairman and CEO of MediLink Therapeutics, said in his opening remarks that "it is a great honor to invite experts in the field of oncology from all over China to witness the growth and progress of MediLink. As a dynamic young company, through the joint efforts of the team, researchers and collaborators in the past 1.5 years, the YL201 project has been initially confirmed for safety, and the convening of this Investigator’s Meeting marks the initial success of the original TAMLIN antibody conjugation technology of MediLink". Dr. Xue also noted that "MediLink has made great strides to help patients and still has a long way to go", underscoring the belief of MediLink to continue to accelerate the pace of development for YL201, and contribute to new cancer treatment solutions to benefit more patients.

On September 22, 2023 Incurix reported that its development substance ‘ICX-301’, a transcription factor targeting treatment for castration-resistant prostate cancer (CRPC), was selected as the second national candidate for 2023 by the National New Drug Development Project (Director Muk Hyun-sang) (Press release, Incurix, SEP 22, 2023, View Source;idx=93&page=1&code=news [SID1234643589]). It was announced on the 22nd that it was selected as a project to study the establishment of a new drug R&D ecosystem for the new drug development project.

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According to Incurix, castration-resistant prostate cancer develops within 13 to 30 months, depending on the progression of general prostate cancer. It is known that the expression of the AR mutation ‘AR splice variant-7’ (AR-V7) during the AR-DNA binding process causes drug resistance, low response rates to existing anticancer drugs, repeated recurrences, and ultimately leads to death. Incurix explains that prostate cancer has a large unmet need for which existing anticancer drugs can only extend survival in the short term.

‘ICX-301’ is a small molecule compound designed to address the unmet needs of castration-resistant prostate cancer. It is designed to inhibit the expression of transcription factors through direct inhibition of DNA binding at the site where the androgen receptor (AR) and mutant AR-V7 can bind.

Through this national new drug development project, Incurix will begin developing transcription factor-targeted treatments that not only have drug resistance but also have fewer side effects due to MOA (Mechanism of The Action) specificity over the next two years. The goal is to optimize the lead substances already secured and ultimately derive candidate substances that can enter non-clinical research.

Incurix is ​​a company specializing in the development of new targeted anticancer drugs. It was founded by Kyeong-Chae Jeong, a senior researcher at the National Cancer Center, who has conducted research on the development of direct transcription factor inhibitors for 20 years. We are currently developing small molecule targeted anti-cancer drugs and have a pipeline targeting direct inhibition of c-Myc, STAT3, and AR transcription factors.

The National New Drug Development Project is a pan-ministerial national R&D (research and development) project to strengthen the global competitiveness of the domestic pharmaceutical and bio industry. For 10 years from 2021, we will support the entire cycle of new drug development with the goal of strengthening the domestic R&D ecosystem for new drug development, creating global commercialization results, and creating public outcomes in the health and medical field.

On September 22, 2023 TME Pharma N.V. (Euronext Growth Paris: ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported that two abstracts on the ongoing NOX-A12 GLORIA Phase 1/2 trial in first-line brain cancer (glioblastoma) were selected for presentation at upcoming international scientific conferences (Press release, TME Pharma, SEP 22, 2023, View Source [SID1234635346]).

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The oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress taking place in Madrid, Spain, on October 20-24, 2023, will highlight an in-depth analysis of how the combination of radiotherapy and NOX-A12 remodels the immune tumor microenvironment in first-line glioblastoma patients, featuring clinical data from the GLORIA Phase 1/2 trial. The full abstract will be published online via the ESMO (Free ESMO Whitepaper) Congress website at 00.05 CEST on Monday, October 16, 2023. It will be available concurrently on the TME Pharma website.

Title: Spatial remodeling of the immune tumor microenvironment after radiotherapy and CXCL12 inhibition in glioblastoma in the Phase 1/2 GLORIA trial.
Speaker: Dr. Julian Layer
Session: Mini Oral 508MO
Lecture Time and Date: 11.15-11.20 a.m. CEST, Saturday, October 21, 2023

The 2023 Society for Neuro-Oncology (SNO) Annual Meeting, taking place in Vancouver, Canada, on November 15-19, 2023, will feature a poster presentation with a clinical update from the ongoing GLORIA Phase 1/2 trial studying NOX-A12, TME Pharma’s CXCL12 inhibitor, in combination with radiotherapy and anti-VEGF (bevacizumab). The full abstract will be published and made available on the SNO official journal Neuro-Oncology on Friday, November 10, 2023. It will be available concurrently on the TME Pharma website.

Title: Interim data on dual inhibition of post-radiogenic angio-vasculogenesis by olaptesed pegol (NOX‑A12) and bevacizumab in glioblastoma from the first expansion arm of the Phase 1/2 GLORIA trial.
Presenter: Prof. Frank Giordano, MD
Session: Poster Session
Session Time and Date: 7.30-9.30 p.m. PT, Friday, November 17, 2023

On September 22, 2023 Coya Therapeutics, Inc. (Nasdaq: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company developing biologics and cell therapies intended to enhance the function of Tregs, reported licensing of the exclusive, worldwide rights of a proprietary Exosome Engineering Technology from CMU with potential applications across multiple indications, including neurodegeneration, autoimmune, and oncology (Press release, Coya Therapeutics, SEP 22, 2023, View Source [SID1234635345]).

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This technology is versatile, permitting the modification of exosomes from different biological sources while overcoming several of the scale-up and manufacturing challenges encountered with exosomes, including not requiring genetic manipulation. In addition, the ability to customize the surface of the exosome with a protein of interest while loading the interior of the exosome with cargo opens possibilities across multiple therapeutic areas beyond neurodegenerative diseases.

Data was recently presented at the 5th Exosome Based Therapeutic Development Summit in Boston, MA on September 7, 2023, demonstrating that Treg exosome membranes could be engineered to controllably immobilize CTLA-4, a membrane surface active protein, onto the Treg exosome surface resulting in stable CTLA-4-Treg exosomes. CTLA-4-Treg exosomes dramatically increased targeting of, binding to, internalization of, and uptake into immune cells including macrophages and T cells. Previously, using the same technology, CMU demonstrated applications in Oncology by engineering mesenchymal derived exosomes with an immunomodulatory apoptotic inducing protein, Fas Ligand (FAS-L).

This novel proprietary EET platform extends Coya’s pipeline beyond Neurodegenerative disorders to include autoimmune disorders and cancer while expanding Coya’s optionality for potential non-dilutive business development and strategic partnerships with companies seeking novel ways to deliver cargo/drugs in a targeted fashion.

Fred Grossman, President and CMO said "The science behind the technology is strong and has focused on overcoming the limitations of exosomes. We believe this technology can shape the future of targeted delivery of desired agents to address multiple conditions."