QuantumPharm's AI Platform Validated as Portfolio Companies Achieve IND Approvals and Secure Significant Funding

Since June, five companies including QuantumPharm (“晶泰科技”),2228.HK) Partnering Company——LemanMETiS TechBioSIGNETMETA、ReviR Therapeutics, respectively announced IND and other pipeline milestones or significant financing progress. The small molecule pipelines discovered by the XtalPi platform are comprehensively moving into the clinical stage, showcasing AI-driven pharmaceutical innovation.Capabilities Continuously ValidatedPowered by quantum physics, artificial intelligence (AI), and robotics, METiS TechBio's drug discovery platform serves not only global pharmaceutical giants like Pfizer and Eli Lilly but also supports cutting-edge biotech companies in accelerating pipeline breakthroughs. Innovative drug molecules discovered and designed through this platform are progressively gaining regulatory approval for clinical translation, expediting the delivery of higher-quality and more effective treatment options to patients.

Among them,AI+ Immune Metabolism Reprogramming Biopharmaceutical CompanyLeman（Leman Biotech）Announced Completion of a Total of 50 Million Yuan in Financing, its metabolically enhanced ultra-low-dose CAR-T cell therapy has helped more than 20 adult and pediatric patients be discharged, and will accelerate the advancement.New Drug Research Application(IND) application and clinical trials in the treatment of adult solid tumors and pediatric leukemia;A Global Leader in AI-Driven Precision Targeted Drug Delivery and Drug DiscoveryMETiS TechBio（METiS Pharmaceutical）Announces Completion of $100 Million Series C Financing, for the construction of AI-driven drug delivery platforms and the development of proprietary pipelines. One of its small-molecule drugs has entered Phase III clinical trials, and the mRNA immunotherapy pipeline is also expected to enter clinical trials this year.The First Cancer Innovative Targeted Drug R&D Company in China Based on Organoid Disease Models + AISignet TherapeuticsAnnounced that the first targeted drug for diffuse gastric cancer, discovered in collaboration with METiS TechBio, has been obtained.U.S. Food and Drug Administration (FDA IND Approval, which will soon enter clinical trials;An innovative pharmaceutical company focusing on the research and development of drugs for autoimmune and metabolic diseases.META（META Pharmaceuticals ）METiS TechBio announces that a globally pioneering small molecule drug for Primary Hyperoxaluria, co-developed with XtalPi, has received FDA Rare Pediatric Disease Designation., and plans to conduct a Phase I clinical safety assessment in healthy subjects in Australia in the first half of 2025; AI-driven targeted RNA small molecule drug discovery companyReviR TherapeuticsRecently announced the completion of a $30 million Series A financing round, will continue to advance the development of multiple pipelines related to nervous system diseases, including the collaboration project with XtalPi, in preclinical and clinical stages, and further enhance its AI-driven drug discovery platform.

METiS TechBio is committed to building an AI and robot-empowered efficient R&D platform, collaborating with partners to focus on hotspots,Difficult Issues andUnmet clinical needs, discovering and developing innovative drug molecules with competitive edge and significant value potential. XtalPi currently serves over 300 biopharmaceutical companies and research institutions. As the platform continues to accumulate high-precision R&D data in molecular design and synthetic experiments, its capabilities in de novo drug design, automated chemical synthesis, and analysis are continuously improving.To lay a solid foundation for improving the innovation, efficiency, and return on investment in biopharmaceutical R&D,Accelerate the transformation of scientific research achievements into pipeline assets.

● Leman Biotech: Achieved Complete Remission and Discharge for Over 20 Cancer Patients, Raised 50 Million to Accelerate Clinical Translation of Ultra-Low Dose Metabolism-Enhanced CAR-T

On June 18, 2024, Leman Biotech Co., Ltd. announced the completion of two rounds of new financing, totaling 50 million yuan in its Angel+ and Angel++ rounds. To date, Leman has cumulatively raised approximately 150 million yuan in financing and project funding. The new funds will primarily be used for the IND application of its metabolically enhanced CAR-T cell therapy drug, accelerating the clinical translation of its solid tumor treatment.

Leman Biotech, with the technical support from METiS TechBio, has developed three core drug R&D pipelines: metabolic reprogramming biologics, anti-exhaustion cell therapy drugs, and super-factor drugs. It has also established a proprietary technology platform for the discovery, R&D, and production of biologics and novel immunotherapy cell drugs. The AI super-factor R&D platform MetaAI-10, jointly developed by the two companies, was23 YearsAchieve Milestone Breakthrough, obtaining thousands of ultra-high affinity immune metabolic regulators (biomacromolecules) and filing patents. Some super-factor mutants and their natural receptorsThe affinity is hundreds of times higher than that of a similar superfactor from Stanford University, which was reported in Science during the same period., is expected to become a new generation of immunotherapy drugs with higher bioactivity specificity, lower side effects, and better efficacy.

Leman Biotech Co., Ltd. at the 2024 American Society of Gene & Cell Therapy (ASGCT) Annual Meeting

Share the IIT clinical progress of its metabolism-enhanced immune new therapy,

All 18 patients who had completed the dosing were within three months of receiving the dose.

Start responding and achieve sustained efficacy, with a CR (Complete Response) rate of 100%.

The metabolic-enhanced CD19 CAR-T cell therapy, which is the most advanced in Leman's pipeline, is currently undergoing investigator-initiated clinical (IIT) studies at the First Affiliated Hospital of the University of Science and Technology of China and the First Affiliated Hospital of Zhejiang University School of Medicine.More than 20 adult patients with relapsed/refractory leukemia/lymphoma have achieved complete remission (CR) and been discharged after treatment.At the same time,The IIT for this therapy targeting children with relapsed or refractory CD19-positive B-cell hematologic malignancies has also been initiated at the Children's Hospital of Zhejiang University School of Medicine.The first pediatric patient hasAchieveAchieved CR andRecentlyDischarge from Hospital。This achievementIt is an important advancement for Leman Biotech Co., Ltd. in the clinical research of pediatric malignant hematological tumors, offering new treatment options and hope for more children suffering from related malignant blood cancers. (This clinical research is still recruiting patients for free; for more details, please refer to the article on the "Leman Biotech" WeChat Official Account.)

Notably, this treatment can reduce the drug dosage to 1% of the existing commercialized CAR-T.Thereby greatly shortening the production cycle of drugs, significantly reducing the cost of CAR-T therapy, and having relatively fewer side effects.SHANGNo significant observation of common side effects such as cytokine storms in existing CAR-T treatments.In the future, it is expected to significantly reduce the originally "astronomical" prices of cell therapy drugs, making it possible for Leman Biotech Co., Ltd.'s metabolism-enhanced CD19 CAR-T to be included in the national medical insurance directory.

● METiS TechBio: Completed Financing of $300 Million, Driving World-Leading Drug Delivery Platform with AI, Advancing Phase III and Phase I Clinical Trials for Small Molecule and Nucleic Acid Drugs

On June 21, 2024, METiS TechBio announced the completion of its $100 million Series C financing, bringing the total financing to nearly $300 million.This round of financing will be used to continue advancing the AI + drug delivery platform construction and the development of its self-research pipeline, supporting METiS TechBio in continuous innovation in the field of drug delivery.

METiS TechBio, incubated by XtalPi, was co-founded by Dr. Hongmin Chen, a member of the US National Academy of Engineering, Dr. Caida Lai, and Dr. Wenshou Wang, both top scientists from MIT. The company leverages AI-driven precision-targeted drug delivery and drug discovery, focusing on the development of innovative nanomaterials.，And has developed more effective therapeutic drugs for patients, now becoming one of the world's leading drug delivery platforms.

METiS TechBio has independently developed three major AI+ core technology platforms: AI-driven nucleic acid delivery system design platform (AiLNP), AI-driven mRNA sequence design platform (AiRNA), and AI-driven small molecule formulation design platform (AiTEM). It has also established a proprietary technical route for METiS TechBio that deeply integrates dry and wet lab experiments, thereby achieving efficient drug delivery and drug discovery.

Based on the AI drug delivery platform,METiS TechBio has achieved best-in-class global leadership in liver-targeting., with delivery efficiency surpassing industry giants by more than 20 times. In fields such as lung targeting, it has achieved an order-of-magnitude improvement in efficacy compared to top overseas pharmaceutical companies. In addition, METiS TechBio has pioneered targeted delivery technologies for systemic muscles, the brain, immune organs, and tumors, successfully leading the world in overcoming the "bottleneck" challenges of multi-organ and tissue targeting, bringing opportunities for nucleic acid gene drugs in areas such as cancer, metabolic diseases, autoimmune diseases, and neurodegenerative diseases.

Relying on its self-developed technology platform, METiS TechBio has established several R&D pipelines, focusing on disease areas such as oncology, central nervous system disorders, and liver diseases, covering small molecule drugs and nucleic acid drugs primarily based on mRNA.The small molecule pipeline, which is currently the most advanced, has successfully entered Phase III clinical trials in June 2023, and the mRNA immunotherapy pipeline is also expected to enter clinical trials this year.In addition to independent research and development, METiS TechBio also actively seeks external cooperation, adopting a dual-driven model of "independent R&D + co-development" to promote corporate growth and gain wide recognition in the industry.

● SIGNET: The World's First AI + Organoid-Developed Drug, in Collaboration with METiS TechBio, Receives FDA IND; Diffuse Gastric Cancer Sees Its First Targeted Drug Enter Clinical Trials

On June 26, 2024, SIGNET announced that its self-developed pipeline for the world's first targeted drug for the treatment of diffuse gastric cancer had received the IND approval from the U.S. FDA ahead of schedule.

SIGNET, based on organoid disease models, is committed to identifying new targets and developing effective therapies for cancer. They have discovered a novel potent target based on diffuse gastric cancer and collaborated with METiS TechBio to developThe world's first targeted drug for diffuse gastric cancer to receive FDA IND, and also the world's first innovative targeted drug developed by integrating organoid disease models + AI: sigx1094`, with hope`Filling the Gap: No Effective Drug for Diffuse Gastric Cancer WorldwideTheMarket Gap。

In the drug discovery and design of SIGNET-1094,SIGNET Collaborates Deeply with Metis TechBio, for the innovative target selected by SIGNET,Designed a preclinical candidate compound (PCC) with a novel molecular scaffold and superior comprehensive drug-like properties in just over six months., greatly improving the R&D efficiency; in efficacy evaluation, SIGNET utilizes its established organoid platform based on patient genomic characteristics to achieve better results.GroundScreen out molecules that closely mimic patients' actual responses, thereby significantly increasing the potential for clinical trial success. From the discovery of a new target to the approval of the IND, SIGNET accomplished this in just over three years.At the same time, SIGNET and METiS TechBio have multiple innovative cancer-targeted drug research and development projects underway.。

Thus, SIGNET officially enters the clinical stage.And is about to launch the Phase I clinical trial of its first targeted drug for diffuse gastric cancer.In addition, the preclinical efficacy characterization of sigx1094 demonstrates its superior therapeutic effects in the treatment of highly metastatic cancers such as ovarian cancer, triple-negative breast cancer, and pancreatic cancer, as well as in combination with chemotherapy or targeted drugs for KRAS and EGFR mutations, showing potential to play a role in broader therapeutic fields.

● META:METiS TechBio CollaborationUnder Research NewDrug Receives FDA Pediatric Rare Disease Designation, First-of-its-kind Small Molecule Primary Hyperoxaluria Pipeline Poised for Accelerated Approval

2024August 5,METAMETA Announces FDA Rare Pediatric Disease Designation (RPDD) for META-001-PH, an Investigational New Drug for the Treatment of Primary Hyperoxaluria (PH), a Rare and Life-Threatening Genetic Disorder. The RPDD is expected to significantly advance the clinical development of META-001-PH.

METAFounded in 2021,Based on cutting-edge emerging biological theories, effectively regulate immune system functions and other physiological system functions by modulating the vitality of cellular metabolism, and develop safer and more effective treatments for autoimmune and metabolic diseases, focusing on the R&D of first-in-class innovative drugs.

META-001-PH is a first-in-class small molecule drug developed by META Pharmaceuticals Inc. in collaboration with Metis TechBio Co., Ltd. for the treatment of primary hyperoxaluria.From the initial scaffold screening to the nomination stage of preclinical candidate compounds, this novel molecule was completed in collaboration with the AI drug discovery team at XtalPi. XtalPi was also responsible for the chemical synthesis work of the related series. Preclinical animal disease model experiments showed that META-001-PH can significantly reduce urinary oxalate excretion by up to 80%.Compared with the insufficient long-term performance of existing treatment options,The once-daily oral META-001-PH can continuously maintain oxalate at normal levels.Showing potential for long-term control of kidney stone formation in patients, becoming the most promising therapy among current investigational drugs to fully control the disease.In preclinical animal models, META-001-PH also demonstrated good tolerability and safety, and is currently undergoing toxicology studies for clinical application.And plans to conduct a Phase I clinical trial for safety assessment in healthy subjects in Australia in the first half of 2025.

In the future,META-001-PH Will be eligible for a Priority Review Voucher (PRV) after the approval of a New Drug Application (NDA) or Biologics License Application (BLA) for rare pediatric diseases.PRV can shorten the review time by 4-6 months and can be used for the marketing application of any subsequent product.It can also be sold to third parties, with the average transfer price exceeding 100 million US dollars in recent years.

On July 26, 2024, ReviR Therapeutics (ReviR) announced the completion of a $30 million Series A financing round. The funds will be used to further develop ReviR's self-developed AI drug discovery platform, VoyageR, and to combine AI technology with the extensive drug development experience of the ReviR team. This will advance the existing pipeline for Huntington's disease (HD) as well as preclinical and clinical stage development of pipelines related to various neurological disorders, including Charcot-Marie-Tooth disease (CMT) and amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease).

ReviR is a biotechnology company that combines AI technology for the development of small-molecule drugs targeting RNA, focusing on innovative drug research and development for central nervous system diseases, cancer, and other rare genetic disorders. ReviRDeveloped by"Oral Gene Therapy"On the one hand, it can regulate gene expression and is applicable in a wide range of genetic disease fields.; on the other hand, it is easy to administer, highly accessible to patients, and the treatment is relatively reversible with lower risks.May bring new breakthroughs for various untreatable hereditary neurological diseases and cancers., benefiting hundreds of millions of patients worldwide.

METiS TechBio has established a close cooperative relationship with ReviR Therapeutics over the long term.In 2021, the two companies announced the joint development of an AI-powered targeted RNA small molecule drug discovery platform. Starting from 2022, the two parties have collaborated based on XtalPi's advanced AI + robotics drug discovery platform, combined with ReviR's VoyageR platform.RNA structure computation and target prediction capabilities, jointly developing small molecule drugs targeting RNA,In order to address unmet clinical needs。The current collaboration between the two parties has yielded pipeline results, with plans to advance to the clinical stage in the future.RNA targets possess broad development potential. We look forward to advancing RNA therapy innovation through the joint efforts of both parties, bringing more high-quality and efficient innovative drug options to patients worldwide.