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 Hillstream BioPharma Inc., (NASDAQ:HILS), a biotechnology company developing innovative therapeutic candidates in rare immune, inflammatory and oncologic diseases reported a corporate name change to Tharimmune, Inc., ("Tharimmune"). The corporate name change is based on the Greek word "thárros", translated to mean courage and reflects the transformation of the Company into a patient-focused, clinical development organization (Press release, Hillstream Biosciences, SEP 22, 2023, View Source [SID1234656413]). The Company’s common stock will trade on The Nasdaq Capital Market under a new ticker symbol, THAR, effective as of Monday, September 25, 2023.

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"Over the past few months, we have made significant progress in shifting the focus of the Company to align with our future vision to impact patients in serious need of new treatment options," said Randy Milby, Chairman and CEO of Tharimmune, Inc. Our new name, dedicated to the courage of all people diagnosed with diseases of high unmet need, aligns with this focus as we shift into a patient-centric organization striving towards developing impactful and accessible products."

Tharimmune is progressing towards acquiring a clinical stage asset, TH104, with a recently approved IND. TH104 has a dual mechanism of action by affecting multiple receptors, known to suppress chronic, debilitating pruritis or "uncontrollable itching". The Company expects to close the acquisition in the fourth quarter as well launch and complete a phase 1 pharmacokinetic trial by year-end. The clinical data package is strengthened by the phase 1 clinical trials already conducted ex-US, which showed reliable bioavailability of the active ingredient in TH104 via transmucosal film technology in both healthy volunteers as well as people diagnosed with liver disease, including primary biliary cholangitis.

On September 22, 2023 Chime Biologics, a leading CDMO that enables biologic therapeutics development reported a strategic cooperation agreement with Panolos Bioscience, a South Korean biotech company to accelerate multi-specific protein development, at a signing ceremony held in Optics Valley Wuhan, Hubei Province on the 19th of September (Press release, Panolos Bioscience, SEP 22, 2023, View Source [SID1234656258]). Dr. HyeSeong Lim, Founder and CEO of Panolos Bioscience, and Mr. YoungHoon Cho, Chief Business Officer of Panolos Bioscience, as well as Chime Biologics’ team attended the signing ceremony.

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Panolos Bioscience, located in the suburb of Seoul, Korea, is a biopharmaceutical company focused on the development of multi-specific therapeutics to treat cancer, auto-immune diseases and rare diseases. Panolos Bioscience has entered into a collaboration with Chime Biologics for a novel multi-specific protein drug, PB203, for solid tumors (PDAC/ICC), which is in the preclinical stage with plans to conduct clinical trial Phase I in the US. Chime Biologics will provide an one-stop biologic CMC solution for the development and manufacturing of PB203 from cell line development, process development, and GMP manufacturing service. And it will be based on the unique Chime’s CHOrus platform, which has a highly productive, rapid, and stable cell line development capability to select the optimal stable expression clones based on expression titer and quality.

The leaders from the Consulate General of the Republic of Korea, Wuhan, Foreign Affairs Office of Wuhan Municipal People’s Government, Wuhan East Lake High-tech Development Zone, and Wuhan National Bio-Industry Base Construction Management Office witnessed the signing ceremony, and this agreement underlines the strong collaboration between China and Korea.

Dr. HyeSeong Lim, Founder and CEO of Panolos Bioscience, said, "We are pleased to be a global strategic partner with Chime Biologics, and the co-development of PB203 is an important start in establishing our long-term strategic cooperation in Wuhan, China, covering commercial manufacturing. This is the first step in our shared mission to the commercialization of innovative medicines, starting from China and spreading to the world. By partnering with global CDMO Chime Biologics, we will do our best to bring hope and a new life to our patients."

Dr. Jimmy Wei, President of Chime Biologics, said, " We are very excited to work with Panolos Bioscience to drive the project to Wuhan, China, taking unique advantage of Chime’s CHOrus cell line development platform that enables the US clinical trials and global sampling. This is not only a recognition of Chime Biologics’ new business model and international quality system, but also an important development journey for Chime Biologics to go globally. We believe that Chime Biologics’ high-quality platform and rich experience will facilitate the global R&D, clinical trials and future commercial manufacturing of multi-specific therapeutic proteins."

About PB203
PB203, a multi-specific protein targeting VEGF, PIGF, and PD-L1, is currently in pre-clinical development as a potential remedy for solid tumors, notably pancreatic cancer. Its promising efficacy, published in Nature Communication in 2022, was further accentuated during an oral presentation at this year’s Immuno-Oncology Summit in the US. This notable discourse emphasized its clear therapeutic mechanism and potential impact on pancreatic cancer treatment.

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