On September 25, 2023 Chime Biologics, a leading CDMO that enables its partners’ success in biologics, announced a strategic cooperation with Kings Pharm (Press release, Chime Biologics, SEP 25, 2023, View Source [SID1234635395]).

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According to the agreement, Chime Biologics will leverage its rich experience in biosimilar projects to provide cell line development, early process development, global clinical and commercial manufacturing, and registration services to Kings Pharm. Chime Biologics will be the exclusive CDMO service provider and will help Kings Pharm to bring the asset to global markets.

The signing ceremony was accompanied by delegates of the Consulate General of the Republic of Korea in 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 as this agreement underlines the strong collaboration between both countries.

Jaehee Lee, Advisor of Kings Pharm, commented, "Kings Pharm is committed to developing new drugs for oncology and metabolic diseases for aging. We believe that life must be respected and that human life goes on. This anti-tumor biosimilar is the first collaboration project between Kings Pharm and Chime Biologics, and we are very pleased to enter into a strategic partnership with Chime for such an important project. Chime Biologics has a proven track record of quality systems with international quality standards, rich experience in biologics marketing and filing, and a flexible business model to ensure the global development and production of this project. We are willing to authorize the exclusive cooperation with Chime Biologics and look forward to further expanding the cooperation in the future for the benefit of patients."

Dr. Jimmy Wei, President of Chime Biologics, said, "We are pleased to establish a strong partnership with Kings Pharm to accelerate the development and commercialization of this anti-tumor biosimilar. The biosimilar program is Chime Bio’s strength, our team has successful experience in developing several biosimilars and has a proprietary platform for high-expression cell line development, which allows us to provide low-cost biosimilar development services to clients all over the world. This collaboration is the beginning of our one-stop solution for biosimilars, we are proud to make every effort to support Kings Pharm to promote its biosimilars to market and increase the accessibility of biologics to patients globally."

Chime Biologics is launching a global one-stop solution for biosimilars. Clients start a project with a product idea, then Chime will leverage its rich experience in biosimilar development to support the client’s biosimilar IND-filing, clinical sampling, commercial manufacturing and regulatory service.

On September 25, 2023 CytoMed Therapeutics Limited (NASDAQ: GDTC) ("CytoMed" or "Company"), a Singapore-based biopharmaceutical company focused on harnessing its proprietary technologies to develop novel donor-derived cell-based allogeneic immunotherapies for the treatment of various cancers, reported that its exclusively licensed induced pluripotent stem cell (iPSC)-based technology has been granted a patent by the China National Intellectual Property Administration (CNIPA) (Press release, Cytomed Therapeutics, SEP 25, 2023, View Source [SID1234635394]).

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"We’re thrilled to strengthen our existing suite of patents," said Peter Choo, Chairman of CytoMed. "Now this novel iPSC-based technology has been granted patent in China and Japan (where the iPSC technology was pioneered in 2006). Such progress further expands the Company’s current patent portfolio to three countries, consisting of and including patents granted in the US and China for our licensed allogeneic chimeric antigen receptor gamma delta T cell (CAR-γδ T cell) technology which is expected to start phase I clinical trial in Singapore soon."

For cancer treatment, immune cells such as γδ T cells and natural killer (NK) cells are invaluable therapeutic cells due to their ability to express an array of built-in receptors that recognize stress-induced cancer antigens naturally.

By combining the iPSC technology and directed differentiation, CytoMed can generate a novel type of synthetic hybrid immune cells, γδ NKT cells, that express cancer recognition receptors of both γδ T cells and NK cells to recognize a wide range of cancers without genetic modification or use of viral vectors. As an allogeneic cell source, the Company’s iPSC-derived γδ NKT cells may potentially become an "off-the-shelf" cell therapy that is applicable to a large pool of patients.

The patent titled "Methods and Kits for Generating Mimetic Innate Immune Cells from Pluripotent Stem Cells" with Patent No. ZL201880022790.X, published as CN 110691844 B, covers technologies to derive novel synthetic γδ NKT cells for the treatment of various types of cancers including hematological malignancies and solid tumors. This asset is currently under preclinical development. The Company holds an exclusive, worldwide license to use this patent pursuant to the Licence Agreement dated June 1, 2018, which was filed with the Securities and Exchange Commission as an exhibit to the registration statement on Form F-1 (File No.: 333-268456) on March 30, 2023.

On September 25, 2023 Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT), reported receipt of written responses to questions submitted for a Type B pre-Investigational New Drug Application (PIND) meeting with the U.S. Food and Drug Administration (FDA) (Press release, Shuttle Pharmaceuticals, SEP 25, 2023, View Source [SID1234635393]). The FDA’s positive feedback and guidance on the Company’s Chemistry, Manufacturing, and Controls (CMC) and clinical protocol design for Ropidoxuridine provides a pathway to IND application submission in the fourth quarter of 2023 to initiate the Phase 2 clinical trial.

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"The FDA’s written responses provide clarification and guidance on key aspects to our Phase 2 clinical design and CMC protocols, paving the way to Shuttle’s clinical development of Ropidoxuridine as a radiation sensitizer for treating glioblastoma," commented Shuttle Pharma’s Chairman and CEO, Anatoly Dritschilo, M.D.

Ropidoxuridine (IPdR) is Shuttle’s lead candidate radiation sensitizer for use in combination with RT to treat brain tumors (glioblastoma), a deadly malignancy of the brain with no known cure. Shuttle has received Orphan Drug Designation from the FDA, providing potential marketing exclusivity upon first FDA approval for the disease.

On September 25, 2023 Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") reported the completion of enrollment of 120 patients in the Phase III registration clinical trial of ASC40 combined with bevacizumab for treatment of recurrent glioblastoma (rGBM) (Press release, Ascletis, SEP 25, 2023, View Source [SID1234635392]). ASC40 is an oral, selective small molecule inhibitor of fatty acid synthase (FASN), a key enzyme which regulates de novo lipogenesis (DNL). ASC40 inhibits energy supply and disturbs membrane phospholipid composition of tumor cells by blocking de novo lipogenesis [1].

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The Phase III registration clinical trial (ClinicalTrials.gov Identifier: NCT05118776) is a randomized, double-blind, placebo-controlled, multi-center clinical trial in China to evaluate progression-free survival (PFS), overall survival (OS) and safety of patients with rGBM. Approximately 180 patients will be randomized at the ratio of 1:1 to Cohort 1 (oral ASC40 tablet, once daily + Bevacizumab) and Cohort 2 (matching placebo tablet, once daily + Bevacizumab). Based on prespecified interim analysis condition, 120 patients are likely to lead sufficient events for interim analysis of PFS. The interim analysis will be conducted after 93 PFS events are observed.

Glioblastoma (GBM) is the most aggressive diffuse glioma of astrocytic lineage and is considered a grade IV glioma based on the World Health Organization (WHO) classification [2]. Research shows that glioblastoma (GBM) accounts for 57% of gliomas and has an incidence rate of approximately 2.85 to 4.56 per 100,000 population in China per year, suggesting approximately 40,000 to 64,000 new cases of GBM per year [3]. In the U.S., GBM represents 56.6% of gliomas and has an incidence rate of approximately 3.21 per 100,000 population per year [4]. Over 90% GBM patients will relapse after surgery, radiation and chemotherapies. Effective treatments are extremely limited for patients with rGBM.

"Lipid metabolism is now recognized as an important pathway in cancer [1]. The pivotal role of FASN in lipid metabolism makes it an attractive target in the clinic research." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis. "With 120 patients enrolled in the Phase III clinical trial of FASN inhibitor ASC40, we are likely to have sufficient events for the interim analysis of PFS. It’s a milestone of the Phase III study and we are looking forward to the results."

On September 25, 2023 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company developing targeted and transformative cancer therapies using its proprietary AI and machine learning (ML) platform, RADR, with multiple clinical stage drug programs, reported the dosing of the first patient in the Phase 1 clinical trial evaluating Lantern’s investigational new drug LP-184 in patients with advanced solid tumors (Press release, Lantern Pharma, SEP 25, 2023, View Source [SID1234635391]).

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"The first patient dosing in our Phase 1 trial of LP-184 is a critical milestone and underscores the commitment of our team to advancing our pipeline of therapies to patients," stated Panna Sharma, Lantern’s President and CEO. "This milestone is about more than advancing a novel drug candidate. It also validates our unique approach of leveraging AI and machine learning to expedite drug development. Insights from our proprietary AI and ML platform, RADR, were instrumental in our development of LP-184 and aided in understanding its mechanism of action, identifying and prioritizing its cancer indications, and generating machine learning biomarker signatures to assist with patient selection in future clinical trials. The rapid advancement of LP-184 into a first-in-human Phase 1 trial underscores the immense potential that we see in this drug candidate, as well as for our approach to AI-enabled drug development. We believe LP-184 has blockbuster potential for patients with multiple types of advanced solid tumors and CNS cancers, many of which have no or limited effective therapeutic options, and we are excited to envision the impact this could have in transforming the lives of patients."

The single arm multicenter Phase 1 trial (NCT05933265) is assessing the safety and tolerability of escalating doses of LP-184 to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) in patients with advanced solid tumors and recurrent high-grade gliomas, including glioblastoma (GBM). The study has been designed as a 35 patient trial with patients receiving LP-184 infusion on Day 1 and Day 8 of each 21-day cycle, for a minimum of two cycles. Patients will be monitored for safety, pharmacokinetics, and clinical activity, and dose escalation is planned with minimum of three patient cohorts. Lantern has already activated two clinical trial sites and plans to activate multiple additional sites in the US over the next 100 days. Lantern anticipates the Phase 1A portion of the trial to be completed in the first half of 2024.

After the Phase 1 trial is completed, Lantern plans to advance LP-184 into additional clinical trials for multiple solid tumor indications, and Lantern’s subsidiary, Starlight Therapeutics, will advance the clinical development of LP-184 for all brain and CNS indications under the name STAR-001. Globally, the aggregate annual market potential of LP-184/STAR-001’s programs is estimated to be approximately $11-13 billion, consisting of $6-7 billion for solid tumors and $5-6 billion for CNS cancers.

About LP-184:

LP-184 is a unique small molecule that utilizes its powerful mechanism of action, known as synthetic lethality, to exploit common vulnerabilities in solid tumor and CNS cancers with DNA damage repair (DDR) deficiencies. The anti-tumor potential of LP-184 has been demonstrated across an extensive number of in-vitro and in-vivo cancer models, including pancreatic, bladder, triple-negative breast cancer (TNBC), glioblastoma (GBM), brain metastases, and ATRT. In addition to LP-184’s promise as a single agent, its antitumor potency has the potential to be enhanced when used in combination with existing FDA-approved agents and other treatment modalities including spironolactone, PARP inhibitors, and radiation therapy. Results validating LP-184’s anti-tumor potential have been published at leading conferences and journals including, the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, the Society for Neuro-Oncology annual meeting, the San Antonio Breast Cancer Symposium, and the Frontiers in Drug Discovery Journal.