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Artificial Intelligence (AI) field

InfiniAI Pharma publishes a paper on MolMiner, an automated molecular structure identification tool

In September 2022, Beijing InfiniAI Pharmaceutical Technology Co., Ltd. (InfiniAI Pharma) published a paper on MolMiner, an automated molecular structure identification tool, in the JCIM journal. MolMiner is a tool for automatically identifying chemical molecular structures, jointly developed by InfiniAI Pharma and Peking University, and is a functional module in the PharmaMind® innovative drug R&D platform. Currently, MolMiner has nearly 8,000 registered users, including 31 enterprise-level users, and the average daily active users remain above 60.

InfiniAI Pharma successfully selected as a "Specialized, Refined, and Unique" enterprise in 2022

On August 25, 2022, the Beijing Municipal Commission of Economy and Information Technology announced the list of the fourth batch of "Specialized, Refined, and Unique" enterprises in Beijing in 2022. InfiniAI Pharma was successfully selected for its outstanding achievements in technological innovation.

As of the third quarter of 2022, InfiniAI Pharma has made phased progress in several projects. Among them, the IIP009 project obtained a novel patentable molecule with a structure generated by AI 3D molecular generation, with an activity of 100 nM. Currently, the team is optimizing the molecule's activity and druggability through AI and computational methods. The IIP001 project, in cooperation with Wuhan University, conducted cell and animal experiments, preliminarily verifying the mechanism of action of a novel antiviral drug against influenza virus.

Company website: http://www.iipharma.com.cn/iipharma/

LungLB® approved for commercialization in New York State

On September 2, 2022, LungLife AI (AIM: LLAI.L) announced that it had successfully passed a New York State Department of Health ("NYSDOH") on-site audit with zero defects and was granted a license for its Clinical Laboratory Evaluation Program ("CLEP").

As a key step in Lunglife AI's commercialization plan, CLEP certification allows LungLife AI to conduct clinical utility studies and commercialize LungLB® in New York State. The company has also obtained Clinical Laboratory Improvement Amendments ("CLIA") certification, allowing it to conduct clinical utility studies in 46 other states. Following certification, Lunglife AI can recruit participants for utility studies at one of its key experimental centers – the Icahn School of Medicine at Mount Sinai in New York.

Company website: https://lunglifeai.com/

Sanmei Bio receives multiple awards and recognitions

On July 16, 2022, Zhuhai Sanmei Bio-diagnostic Technology Co., Ltd. (Sanmei Bio) won the "Golden Sieve Award for Future Unicorn Enterprises" at the ZAODX World Tumor Early Screening Conference.

On July 21, 2022, Sanmei Bio's "Overseas R&D Institution for Tumor Liquid Biopsy" was recognized by the 2022 Guangdong Provincial Science and Technology Innovation Strategic Project - External Scientific and Technological Cooperation Platform, becoming the only enterprise in Zhuhai to pass the provincial-level overseas R&D institution certification in 2022.

On September 18, 2022, Sanmei Bio participated in the 25th International Conference on Medical Image Computing and Computer-Assisted Intervention (MICCAI 2022). Sanmei's AI team won first place in the verification stage and fifth place overall in the MICCAI Airway Tree Modeling tracheal segmentation competition at this conference, signifying that Sanmei's AI technology team has entered the ranks of the world's top tier.

Company website: http://www.sanmedbio.com/

Gene editing field

Beam announces its 2022 Q2 R&D pipeline

and business highlights

On August 9, 2022, Beam Therapeutics (BEAM.NASDAQ) announced its quarterly results for the period ended June 30, 2022. 2022 is a key year for Beam's transformation into a multi-program clinical-stage company, with key updates including:

Patient enrollment in the Phase 1/2 BEACON clinical trial of BEAM-101 progressed smoothly in the second half of 2022; BEAM-201 has submitted an IND and is currently on clinical hold, awaiting further details from the FDA; IND submission for BEAM-102 and IND application research plan for BEAM-301 are planned for the second half of 2022; Dr. John Lo was appointed Chief Commercial Officer; $1.2 billion in cash, cash equivalents, and marketable securities.

Beam releases first in vivo data on multiple base editing therapy for hepatitis B, promising functional cure for hepatitis B

On September 19, 2022, Beam announced new preclinical data demonstrating the potential of its multiple base editing approach to reduce hepatitis B virus (HBV) markers, including hepatitis B surface antigen (HBsAg), and prevent HBV rebound in vivo. This data was generated in collaboration with the Fabien Zoulim laboratory at Lyon INSERM Cancer Research Center and presented at the 2022 International HBV Meeting in a poster titled "Cytidine base editing inhibits hepatitis B virus replication and reduces HBsAg expression in vitro and in vivo."

In HBV-infected cells, the research team used cytidine base editors (CBEs) to target integrated HBV DNA and cccDNA at multiple locations, introducing precise and permanent stop codons into the viral genome. These stop codons are designed to silence the HBV virus gene without the risk of chromosomal rearrangements.

Beam President and Chief Scientific Officer, Dr. Giuseppe Ciaramella, stated that they are very excited to share this new data, which for the first time addresses two disease drivers of HBV infection in an in vivo model, highlighting the potential of the multiple base editing approach. By blocking HBV replication and silencing viral protein expression, this multiple base editing approach may be a potential therapeutic option for the many HBV carriers worldwide. They look forward to further exploring its utility in more preclinical studies.

The research team conducted in vivo experimental evaluations of this method in a mouse model of HBV infection, and the results showed:

1) One or two doses of base editing therapy resulted in a sustained reduction of >2 log10 IU/ml in HBsAg in mice, while no significant reduction was observed in mice treated with entecavir or in the blank control group.

2) Base editing therapy resulted in a sustained reduction of 3 log10 copies/ml in serum HBV DNA, and no HBV rebound was observed after cessation of treatment. In contrast, the serum HBV DNA in the entecavir-treated group decreased after administration but rebounded after cessation of treatment.

In summary, these results suggest that base editing therapy has the potential to permanently inactivate cccDNA and integrated HBV DNA by introducing base mutations that prevent HBV replication and silence viral protein expression, offering new hope for a functional cure for hepatitis B patients.

Company website: https://beamtx.com/

Refuge focuses on the R&D of

next-generation cell therapies for the treatment of cancer

Refuge Biotechnologies, Inc. (Refuge), founded in California, USA in 2015 by Dr. David Parkinson, Dr. Stanley Qi, and Dr. Bing C. Wang, is a cancer immunotherapy company that leverages synthetic biology and genetic engineering to unlock the full potential of cell therapy. Refuge's proprietary receptor-dCas platform utilizes unique genetic engineering technologies based on precise CRISPR activation (CRISPRa) and CRISPR interference (CRISPRi). By linking ligand-specific receptors to dCas, Refuge enables cells to sense their surroundings and conditionally activate or repress multiple genes upon encountering specific external antigens—resulting in more effective and targeted therapies that go beyond single targets and functions.

Company website: https://refugebiotech.com/

Cell Therapy Field

Carisma and Sesen Bio Complete Merger Agreement Signing, Planning to List on Nasdaq After Merger

On September 21, 2022, Carisma Therapeutics Inc. (“Carisma”) announced the completion of the definitive merger agreement with Sesen Bio, Inc. (Nasdaq: SESN), planning to merge the two companies through an all-stock transaction. The combined company will operate under the name Carisma Therapeutics Inc. and trade on Nasdaq under the stock symbol “CARM.”

The headquarters of the merged company will be located in Philadelphia, Pennsylvania, led by Carisma's President and CEO, Steven Kelly, continuing to focus on the development of chimeric antigen receptor-macrophage (CAR-M) and monocyte therapy platforms, with the expectation of achieving multiple development milestones within the next 18 months, including supplemental Phase I clinical data for CT0508, technology transfer with Novartis regarding CT-0508 clinical trials, and Phase I clinical data for intraperitoneal injection of CT0508 to treat HER2+ peritoneal cancer patients.

At the same time, Carisma has also secured a $35 million financing commitment from 13 existing shareholders, including IP Group, HealthCap, AbbVie, Wellington Partners, Merck, and Lizhu Pharmaceutical, which is expected to close simultaneously with the merger. Upon completion of the merger and financing, the combined company is expected to have approximately $185 million in funds, which will be primarily used to advance Carisma's R&D pipeline to obtain key data from multiple clinical trials.

The merger and related financing are expected to be completed within the next 3 to 4 months. For more details on the proposed merger agreement, collaborations, R&D progress, forward-looking statements, and other disclosures, please refer to the official announcement link: https://carismatx.com/sesen-bio-and-carisma-therapeutics-announce-merger-agreement/.

Company website: https://carismatx.com/

Yizun Bio Continues to Advance Clinical Research and Development of Key Pipeline Products, Accelerating the Construction of an Industrial-Grade Cell Production Platform

Yizun Biopharmaceuticals (Zhejiang) Co., Ltd. (Yizun Bio) continues to optimize and upgrade its CNK-T platform technology, and advance clinical trials and registration applications for key pipeline products. The company has completed preclinical experiments demonstrating the potent killing effect and safety of CNK-UT002 against various advanced solid tumors. Simultaneously, the company has successfully developed CNK-UT003, a pipeline product targeting acute myeloid leukemia (AML), which has shown a strong tumor-clearing effect in in vitro cell experiments and animal experiments. The company further improved the construction of the GMP quality management system and the Mingdu Zhiyun digital R&D platform, laying an important foundation for IND application of cell drugs.

In terms of external cooperation, Yizun Bio has established strategic alliances with Dongfulong, Tiger Bio, and Easydixi to accelerate the construction of a large-scale cell production platform and clinical research of cell drugs. Currently, Yizun Bio has completed the development of IIT clinical CMC cell processes and large-scale GMP cell production, and has formally established clinical cooperation relationships with the First Affiliated Hospital of Zhejiang University and Shulan International Hospital, and is about to start recruiting patients and conducting cell infusions for IIT clinical trials targeting liver cancer and colorectal cancer.

Yizun Bio is a cutting-edge cell therapy company with several internationally leading and original platform technologies, specializing in the treatment of solid tumors and allogeneic universal cell technologies. The company has successfully established three core technology platforms: CNK-T, VAC-T, and UT, and preliminary results from exploratory clinical trials have confirmed the significant efficacy of CNK-UT in the treatment of advanced liver cancer.

Small Molecule Innovative Drug Field

Elicio Announces Preclinical Data for Lymph Node-Targeting Amphiphilic SARS-CoV-2 Vaccine ELI-005

On September 7, 2022, Elicio Therapeutics (Elicio) announced data from a preclinical study evaluating ELI-005 (a mixture of Elicio's amphiphilic (AMP) adjuvant AMP-CpG and the SARS-CoV-2 spike receptor-binding domain (RBD) immunogen) as a potential lymph node-targeting protein subunit vaccine. Results showed that ELI-005 administration safely promoted robust cellular and humoral immune responses through effective targeting of lymph nodes in mice and non-human primates (NHPs). Furthermore, these data demonstrate the prospect of lymph node adjuvant targeting to orchestrate innate immunity and generate robust adaptive responses crucial for vaccine efficacy. These results were published on bioRxiv and can be accessed via this link: https://www.biorxiv.org/content/10.1101/2022.05.19.492649v1.full.

Elicio Receives $2.8 Million Grant to Develop Cancer Vaccines

On September 20, 2022, Elicio announced that it had received a $2.8 million (approximately RMB 19.95 million) grant from the Chicago Gastrointestinal Research Foundation (GIRF) to develop two cancer vaccine candidates, ELI-007 and ELI-008. Both vaccines are immune vaccines developed on Elicio's proprietary AMP platform, capable of directly targeting lymph nodes, effectively activating, training, and expanding key immune cells to generate a lasting anti-tumor immune response.

Candidate vaccine ELI-007 targets cancer cells with the BRAF V600E gene mutation, which accounts for 10% of colorectal cancers. Candidate vaccine ELI-008 targets cancer cells with p53 hotspot gene mutations, such as those in colorectal cancer, non-small cell lung cancer, and melanoma, which account for 60% of solid tumors.

Elicio Publishes Preclinical Data Demonstrating AMP Platform Enhances Intranasal Vaccine Uptake

On October 4, 2022, Elicio announced the publication of preclinical data from the research laboratory of Dr. Darrell Irvine at the Massachusetts Institute of Technology (MIT), demonstrating that Elicio's AMP platform, when combined with protein antigens, promotes absorption in the nasal mucosa and enhances immune responses after intranasal immunization. The data presented represents a promising strategy to promote mucosal immunity against HIV, SARS-CoV-2, and other infectious diseases. The data was published in Science Translational Medicine and can be accessed via this link https://www.science.org/doi/10.1126/scitranslmed.abn1413.

Darrell J. Irvine, Howard Hughes Medical Institute Investigator and MIT Professor, stated "Delivery of vaccine components across the mucosal barrier has been a major challenge in mucosal vaccine development. These data show that AMP modification can improve nasal mucosal uptake of vaccine antigens through interactions with albumin and a neonatal Fc receptor termed a "mucosal gateway." This results in increased antigen concentration in the nasal-associated lymphoid tissue. Encouragingly, this approach has the potential to induce antibody production at other mucosal sites following intranasal immunization."

Dr. Peter DeMuth, Chief Scientist at Elicio, added: "This research demonstrates a novel mechanism of AMP vaccines, whereby small proteins modified with AMPs can be more effectively delivered to nasal-associated lymphoid tissue. This is a remarkable new application of the AMP platform and contributes to the development of novel mucosal immune vaccines. These mucosal responses are important for combating pathogens that invade the respiratory or urogenital mucosa and can prevent infection or reduce the number of pathogens at the mucosal site, thereby reducing the risk of transmission to others."

Company website: https://elicio.com/

Xinyuan continues to advance the global clinical research of its independently developed anti-gout drug ABP-671.

Jiangsu Xinyuan Pharmaceutical Technology Co., Ltd. (Xinyuan), founded in 2012, is dedicated to independently researching and developing first-in-class innovative drugs with global commercial value and global competitiveness. Its pipeline includes metabolic diseases such as gout and NASH, as well as oncology diseases. The company's core team members are mainly from the United States and have extensive experience in the research and development of innovative drugs. CEO Dr. Shi Dongfang has over 20 years of R&D experience in Europe and the United States, and has been engaged in the research and development of first-in-class innovative drugs for anti-tumor, anti-HCV, and type II diabetes treatment.

Xinyuan has announced positive results in China and the United States from a randomized, double-blind, placebo-controlled Phase 2a clinical trial of its investigational first-in-class drug ABP-671 for the treatment of patients with chronic gout. A pivotal global Phase 3 clinical trial is currently planned. There is a significant unmet clinical need in the global gout market. ABP-671 may offer significant advantages in safety, tolerability, and efficacy in the treatment of gout and hyperuricemia, bringing benefits to a large number of patients.

Company website: http://www.atombp.com/

Kenta focuses on the research and development of new generation kinase inhibitors.

Shanghai Kenta Biopharmaceutical Co., Ltd. (Kenta), founded in 2021, focuses on the development of new generation kinase inhibitor drugs. Its R&D strategy focuses on untargeted kinases, clinically resistant mutations, and non-catalytic function regulation of kinases. The company was founded by Dr. Ma Dawei, an academician of the Chinese Academy of Sciences. It has established a kinase inhibitor design and synthesis platform, a multi-dimensional kinase screening platform, a chemical proteomics target discovery and verification platform, and a kinase non-catalytic function discovery and regulation technology platform.

Large molecule innovative drug field

Milestone! Jinsen Bio's Bis5 project (China's first PD-1/TIM-3 bispecific antibody) initiates clinical trials.

On July 29, 2022, Shanghai Jinsen Biopharmaceutical Technology Co., Ltd. (Jinsen Bio) initiated Phase I clinical trials for its Bis5 project. The clinical trial is led by Professor Zhou Caicun, a renowned expert.

Bis5 is the first molecule from Jinsen Bio's pipeline to enter clinical trials, the first PD-1/TIM-3 bispecific antibody in China to enter clinical trials, and the second globally with this target. It is also the only publicly reported product with T, NK, and DC cell activity. It is expected that Bis5, based on the advantages conferred by the SBody platform and the unique activity characteristics of the molecule, will demonstrate efficacy in clinical trials to meet the clinical needs of patients with PD-1 treatment-ineffective and refractory tumors.

Jinsen Bio completes first patient dosing in Phase I clinical study of Bis5 in China.

On August 19, 2022, Jinsen Bio successfully completed the first patient dosing in a Phase I clinical trial of its independently developed bispecific antibody Bis5 at Shanghai Pulmonary Hospital. This clinical trial is a multicenter, open-label Phase I clinical study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of Bis5 in patients with advanced malignant tumors.

Company website: http://lnlbio.com/index.html

Aetio develops proprietary protein prodrug technology platform.

Aetio Biotherapy (Aetio), founded in Texas, USA in 2018, is an early-stage biotherapeutic company developing novel immunotherapies. Aetio is dedicated to developing clinically valuable drugs to improve quality of life by reducing drug-related mortality, treatment side effects, and dosing frequency.

Aetio focuses on cancer treatment, but believes that the potential of immunotherapy remains unrealized due to the widespread treatment side effects and systemic toxicity associated with treatment. Therefore, Aetio has developed novel antibody and cytokine fusion proteins that are traditionally considered "too effective." Aetio's first platform consists of locally activated prodrug forms with extended half-lives.

Company website: https://www.aetiobiotherapy.com/

Luzhu Bio's recombinant herpes zoster vaccine LZ901 receives FDA approval to enter clinical research.

On July 13, 2022, Beijing Luzhu Biotechnology Co., Ltd. (Luzhu Bio) received notification from the U.S. FDA that its recombinant herpes zoster vaccine (LZ901) can enter clinical research in the United States.

LZ901 was independently developed by Luzhu Bio's R&D team. After intramuscular injection, it actively presents the VZV gE antigen to the body's immune system, greatly enhancing the body's immune system's ability to produce humoral and cellular immunity. It is currently undergoing Phase II clinical trials in China.

To date, there are two main herpes zoster vaccines on the market globally: Merck's Zostavax (which has been withdrawn from the US market due to its technological approach and lower protection rate) and GSK's ShingrixÔ. In 2020, GSK's new recombinant herpes zoster vaccine, ShingrixÔ, achieved sales revenue of US$2.57 billion, making it the fifth-largest selling vaccine globally in 2020 and rising to the fourth-largest in 2021, a truly world-class blockbuster product.

Company website: http://www.luzhubiotech.com/

New medical materials field

Medpha's three major product pipelines are making progress

Zhuhai Medpha Biotech Co., Ltd. (Medpha) was founded in early 2019, focusing on the independent innovation and development of fourth-generation PHA biomaterials (the company currently holds more than ten independently developed patents for inventions and utility models) and the industrialization and commercialization of its downstream new products. Medpha integrates production and research, striving to explore emerging markets with broad commercial application prospects, such as low-carbon environmental protection, nutritional health management, and absorbable medical devices. The company's 1,000-ton PHA new factory was officially put into operation in Zhanjiang at the end of 2021. This new factory uses next-generation industrial biotechnology to produce and supply low-carbon, green, and environmentally friendly PHA materials on a large scale, and further processes downstream derivative nutritional and health active molecules, as well as high-purity medical PHA and microspheres.

Company website: http://www.medpha.cn/

Pharmaceutical industry big data Field

PharmaNex Cloud's five major databases are newly launched, Nine database groups have upgraded functions

In the third quarter of 2022, PharmaNex Cloud launched five major databases: the API-focused database, the customs import and export database, the formulation database, the medical consumables bidding database, and the domestic and foreign registered drug information database. At the same time, more than 20 important sub-databases under the nine database groups have been updated and functionally optimized. Significant improvements have been made in data integrity, relevance, timeliness, data retrieval convenience, and intelligence. This allows for more multi-dimensional data filtering and analysis functions, more intuitive, faster, and more accurate query and analysis of target data, meeting users' richer personalized retrieval needs, making enterprise decision-making more precise and work more efficient.

Among them, the API-focused database (API Intelligence) integrates the original enterprise version of API basic information, usage estimation, synthesis routes, customs import and export, suppliers, registration, etc., and is linked to global listed formulations, patents, and PharmaNex Cloud's small molecule compound design platform, Intsynth. The data coverage is wide, and the correlation and integration are high. It can present the global API supply and demand, market size, and synthesis information more comprehensively and systematically, providing customers with efficient and accurate one-stop retrieval services. IntSynth is a one-stop knowledge engineering system built around synthesis routes, based on chemical reaction data, for professionals in the chemical and pharmaceutical industries.

Company website: https://www.pharnexcloud.com/

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