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The field of Artificial Intelligence (AI)

PharmaMind V3.2｜InfiniPharma Innovative Drug

AI R&D platform client continuously upgraded

In May 2022, the automatic molecular structure recognition tool PharmaMind MolMiner V3.2 client of Beijing InfiniPharma Technology Co., Ltd. (InfiniPharma) was upgraded and launched. In addition, InfiniPharma passed the ISO three-system certification of information security management system, quality management system, and information technology service management system, providing strong support for the company's R&D and strategic development.

As the first software product independently developed and released by InfiniPharma, the PharmaMind® client V3.2 version has improved the accuracy of the algorithm and the convenience compared to the V3.0 version, and supports Chinese and English language switching following the system language. It can be downloaded and used for free via the following link:

Windows:

https://molminer-cdn.iipharma.cn/pharma-mind/artifact/latest/win/PharmaMind-win-latest-setup.exe

Mac:

https://molminer-cdn.iipharma.cn/pharma-mind/artifact/latest/mac/PharmaMind-mac-latest-setup.dmg

InfiniPharma and Shuimu Future reach a new drug development cooperation,

Self-developed project IIP009 also makes new progress

In June 2022, InfiniPharma signed a new drug development cooperation agreement with Shuimu Future, based on the principle of resource sharing and complementary advantages, aiming to obtain 1-2 preclinical candidate compounds with good in vivo efficacy and high safety within the shortest R&D cycle. In the same month, the new drug development project IIP009 also made significant progress. The R&D team obtained 4 novel molecules using 3D molecular generation technology, among which 3 showed cell proliferation inhibitory activity. The best compound has an IC50 value of about 600 nM, and the team is carrying out further molecular structure optimization of this compound.

Lunglife AI is committed to AI-enhanced

Early lung cancer clinical diagnostic solutions

LungLife AI (AIM: LLAI.L) was founded in 2008 and officially listed on the London Stock Exchange on July 8, 2021. Headquartered in California, USA, it is a cancer diagnostic company committed to using AI to perform molecular analysis of cancer biomarkers in blood for early lung cancer diagnosis and management. LungLife AI also develops a series of companion diagnostic solutions, from assisting in the diagnosis of patients with early-stage diseases to treatment stratification and monitoring of advanced lung cancer. LungLife AI's diagnostic technology, combined with machine learning and image analysis, improves workflow efficiency and performance, providing clinicians with actionable information. The company's developed LungLB® for early lung cancer detection provides clinicians with more information to effectively assist in the diagnosis of patients with nodules and shadows shown on lung CT scans, helping to reduce the number of unnecessary invasive surgeries and reduce treatment delays.

Company website: https://lunglifeai.com/

Sanmei Bio was shortlisted for the "Top 100 Future Medical Companies in China" double list

In June 2022, the first domestic series of Top 100 Future Medical Companies in the innovative medical field for non-listed companies, launched by Arterial Network, VB100, and Danshell Research Institute, was grandly unveiled. Zhuhai Sanmei Bio-diagnostic Technology Co., Ltd. (Sanmei Bio) was ranked on the main list of "Top 100 Future Medical Companies" and won the "Top 100 Future Medical Companies·Pengcheng Award" for annual innovative enterprises, demonstrating Sanmei Bio's core strength and social value in the field of innovative medical devices in China.

Founded in 2016, Sanmei Bio is an innovative enterprise focusing on tumor liquid biopsy. Currently, the company's products mainly focus on the early diagnosis of pulmonary nodules. It uses patented technology from MD Anderson Cancer Center in the United States to detect targets highly related to lung cancer specificity. It is one of the "three musketeers" currently recommended by the China Lung Cancer Prevention and Control Alliance.

Nature interviews Sanmei Bio:

Precise diagnostic technology applied to early lung cancer diagnosis

On June 30, 2022, Nature globally released the "Nature Focus·China Precision Medicine" special issue, summarizing, analyzing, and exploring the cutting-edge, innovative, and potential technologies in the field of precision medicine in China. Among them, Nature paid particular attention to Zhuhai Sanmei Bio's "liquid biopsy + artificial intelligence" early lung cancer diagnosis solution and interviewed Mr. Shi Jianfeng, CEO of Sanmei Bio, and Dr. Ye Xin, director of product development.

Sanmei Bio's circulating chromosome aberration cell (CAC) detection is a simple, safe, effective, and non-invasive detection method. By detecting cells with lung cancer-specific chromosome abnormalities, it achieves the diagnosis of benign and malignant pulmonary nodules, significantly improving the sensitivity and specificity of benign and malignant pulmonary nodule discrimination. This technology has been highly recognized by clinical experts through various methods such as scientific research cooperation and clinical research, verified by a large amount of data at home and abroad. In addition, Sanmei Bio has built the Sanmei Bio Pulmonary Nodule Analysis Platform through deep convolutional neural network and machine algorithm learning using large-sample clinical data, thus indicating the malignant risk of pulmonary nodules and assisting in benign and malignant judgment.

In March 2022, Frontiers in Oncology published the results of a multicenter study by Sanmei Bio nationwide. Combining clinical characteristics of nodules, LDCT artificial intelligence analysis data, and CAC liquid biopsy results, a lung cancer early diagnosis model with optimal diagnostic performance was constructed, which is superior to the traditional Mayo model and the US Veterans model.

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

Gene editing field

Beam releases 2022 Q1

Pipeline highlights and expected milestones

On May 9, 2022, Beam Therapeutics (BEAM.NASDAQ) released its pipeline highlights and expected milestones for the first quarter of 2022:

HSC project

Continue to advance its BEAM-101 program for the treatment of SCD, and it is expected to enroll patients in the Phase 1/2 clinical trial (code-named BEACON-101) in the second half of 2022 to evaluate the safety and efficacy of BEAM-101 in treating SCD.

The second project focusing on the treatment of SCD, BEAM-102, is expected to submit an IND application in the second half of 2022.

T cell project

The BEAM-201 project for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia/T-cell lymphocytic lymphoma is expected to submit an IND application in the second half of 2022.

In vivo studies of LNP liver-targeted projects

Plans to present the latest preclinical data from its BEAM-301 program at the American Society of Gene & Cell Therapy (ASGCT) meeting, showing high and sustained editing efficiency in a glycogen storage disease type 1a (GSDIa) mouse model for up to 35 weeks. The company plans to initiate an IND-enabling study for BEAM-301 in 2022, a liver-directed LNP formulation that base edits to correct the R83C mutation (a common causative mutation in GSDIa).

Also at ASGCT, the company will present new preclinical data for its base editing program targeting alpha-1 antitrypsin deficiency, highlighting optimizations to the editor and guide RNA that resulted in a 2-fold increase in editing efficiency in mice, enabling potentially clinically relevant increases in circulating alpha-1 antitrypsin at doses below 1 mg/kg.

Beam proposes the first

Development of a non-genotoxic conditioning regimen for sickle cell disease patients before autologous transplantation

On June 27, 2022, Beam announced at the Federation of American Societies for Experimental Biology (FASEB) Genome Engineering meeting its development of an improved transplant preconditioning regimen for sickle cell disease (SCD) patients undergoing hematopoietic stem cell transplantation (HSCT).

Beam is advancing two base editing therapies for the treatment of SCD: BEAM-101 and BEAM-102. BEAM-101 incorporates base editing designed to mimic the single nucleotide polymorphism seen in individuals with persistent hereditary fetal hemoglobin. BEAM-102 directly edits the disease-causing HbS point mutation to recreate the naturally occurring normal human hemoglobin variant HbG-Makassar. In the second half of 2022, Beam plans to initiate patient enrollment for the BEAM-101 clinical trial and submit an IND application for BEAM-102.

To develop broadly applicable base editing therapies for SCD patients and other hematologic patients, Beam has established a long-term strategy, a key component of which is improving the safety of preconditioning regimens. Current preconditioning regimens rely on non-specific chemotherapy or radiotherapy, associated with significant toxicity and a high incidence of treatment-related mortality. To overcome this, Beam has developed a non-genotoxic approach that combines a monoclonal antibody (targeting CD117) with multiplex base editing of HSCs to improve clinical outcomes in SCD. Simultaneously, Beam developed a CD117 base editing strategy with over 75% editing efficiency, compatible with the BEAM-102 program that corrects the sickle mutation and generates HbG-Makassar.

Company website: https://beamtx.com/

Refuge focuses on the research and development of next-generation cell therapies for the treatment of cancer.

Refuge Biotechnologies, Inc. (Refuge), founded in 2015 in California, USA by Dr. David Parkinson, Dr. Stanley Qi, and Dr. Bing C. Wang, is an immuno-oncology company leveraging synthetic biology and genetic engineering to unlock the full potential of cell therapies. Refuge's proprietary receptor-dCas platform utilizes unique gene 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 Presents Engineered Cell Therapy Data at AACR Annual Meeting

On April 8, 2022, Carisma Therapeutics (Carisma) announced research findings to be presented at the American Association for Cancer Research (AACR) Annual Meeting in New Orleans.

Chimeric Antigen Receptor Macrophages (CAR-M) Sensitizing solid tumors to PD1 immunotherapy

The results demonstrated a powerful synergistic effect between the CAR-M platform and T cell checkpoint inhibitor therapy. Carisma used preclinical solid tumor animal models resistant to PD1 blockade to demonstrate that the addition of CAR-M to the treatment regimen significantly enhanced tumor control, overall survival, and tumor microenvironment (TME) activation. Notably, while CAR-M monotherapy already reshaped the TME, the combination with anti-PD1 further increased the infiltration of T cells, dendritic cells, and other inflammatory immune cells. Carisma will seek to further evaluate CT-0508 (anti-human epidermal growth factor receptor 2 (HER2) CAR-M) in combination with pembrolizumab for the treatment of patients with HER2-overexpressing tumors.

CAR Monocytes for Solid Tumor Immunotherapy Preclinical Development of (CAR-Mono)

The results demonstrated that CAR-monocytes can be produced in a single day, inducing potent targeted anti-tumor activity in vitro and in vivo, differentiating into M1-polarized CAR-M within the tumor, and persisting for over 6 months in animal models. In this study, Carisma established an ultra-rapid, same-day CAR-monocyte manufacturing process with the potential to significantly reduce future commercialization costs and manufacturing turnaround times associated with autologous cell therapies.

Carisma Releases Updates on Phase 1 Clinical Trial of Engineered Macrophage Therapy

On June 5, 2022, Carisma Therapeutics (Carisma) released landmark updated data from its CT-0508 chimeric antigen receptor macrophage (CAR-M) trial at the American Society of Clinical Oncology (ASCO) Annual Meeting. Clinical data showed that the company's CAR-M platform demonstrated good safety, potential clinical feasibility, and potential applicability in other therapeutic areas in the treatment of HER2-overexpressing tumors. Clinical data supporting the mechanism of action of CAR-M, including its effects on tumor infiltration, tumor microenvironment remodeling, and T cell activation in subjects, were provided. Carisma also presented the overall design of its Phase 1 clinical trial of adenovirus-transduced autologous macrophages designed to contain an anti-HER2 chimeric antigen receptor, with an estimated completion date of February 2023.

Company website: https://carismatx.com/

Yi Zun Bio continues to advance clinical research and development of its robust pipeline,

Accelerating the construction of a digital R&D and production platform

Since completing Series A financing in January 2022, Yi Zun Biopharmaceutical (Zhejiang) Co., Ltd. (Yi Zun Bio) has continued to optimize and upgrade its CNK-T platform technology, and has advanced clinical trials and registration applications for key pipeline products. The company has completed in vitro cell experiments, animal experiments, and GVHD trials of the CNK-UT product in liver cancer and colorectal cancer, demonstrating the powerful killing effect and safety of the cell drug in vivo and in vitro. It is also continuously improving the construction of its quality management system, laying an important foundation for IND application. Yi Zun Bio has successfully completed the IIT clinical CMC cell process development and completed the first batch of large-scale GMP cell production at its Hangzhou production base. Pending completion of standard release testing, it is preparing to launch IIT clinical reinfusion. Simultaneously, Yi Zun Bio has launched a strategic cooperation with Mingdu Zhiyun, leveraging Mingdu's advantages and experience in pharmaceutical digitalization to provide the company with digital and standardized full-process management for R&D innovation and large-scale production, creating an international standard R&D and production platform.

Yi Zun Bio is a cutting-edge cell therapy company with a number of internationally leading and original platform technologies, specializing in the treatment of solid tumors and allogeneic universal cell technology. 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 Clinical Data for AMP Vaccine and TCR-T Cell Therapy

Preclinical data for the combination therapy of solid tumors

On April 29, 2022, Elicio Therapeutics (Elicio) presented preclinical data at the Keystone 2022 Symposium on the combination of an amphipathic (AMP) peptide vaccine and TCR-T cell therapy for the treatment of solid tumors. The data showed that AMP vaccine vaccination significantly enhanced the anti-tumor response of TCR-T cells, and also induced epitope spreading between endogenous T cell populations, resulting in durable efficacy in established syngeneic tumor models. The AMP vaccine was delivered to lymph nodes and expressed by activated antigen-presenting cells, thereby improving TCR-T cell survival and anti-tumor function. Results showed that AMP vaccine vaccination could increase the functional expansion of in vivo tumor-specific TCR-T cells by up to 46 times. Dr. Peter DeMuth, Chief Scientific Officer of Elicio, stated, "With our lymph node-targeted AMP vaccine, we can promote antigen presentation and activate complementary mechanisms crucial for TCR-T cell enhancement and broad immune activation. We have seen that this AMP vaccine effectively activates TCR-T cells and enhances their anti-tumor function." These studies provide direct rationale and evidence for combining AMP vaccines with TCR-T cell therapy to enhance clinical anti-tumor efficacy.

Elicio Presents Data on KRAS Mutation

AMPLIFY-201 Study Design for Cancer Driven by KRAS Mutation

On May 27, 2022, Elicio presented the AMPLIFY-201 study design for cancers driven by KRAS mutations at the ASCO 2022 Annual Meeting. AMPLIFY-201 is a Phase 1 clinical study of ELI-002 (a lymph node-targeted therapeutic cancer vaccine) in patients with mKRAS-driven cancers; it uses biomarkers to detect persistently circulating tumor DNA in patients; AMPLIFY-201 will increase the ratio of ELI-002-induced T cells to residual tumor cells, further enhancing its anti-tumor effect. The study used biomarkers to develop a new approach to accelerate the development of cancer immunotherapy.

Elicio at the 2022 Keystone Symposium

Showcased the latest R&D data

On July 6, 2022, Elicio presented preclinical data on the lymph node-targeted SARS-CoV-2 amphipathic vaccine ELI-005 at the 2022 Keystone Symposium. ELI-005 is an AMP vaccine targeting SARS-CoV-2 that contains the SARS-CoV-2 spike receptor-binding domain (RBD) protein and a lymph node-targeted CpG TLR-9 agonist (AMP-CpG). The results showed that ELI-005 elicited strong and durable cellular and humoral immune responses in mice, which were maintained at significantly higher levels than comparator vaccines for 32 weeks in mice. ELI-005 contains the lymph node-targeting amphipathic vaccine adjuvant AMP-CpG, which induces effective, comprehensive, and durable innate immune responses in draining lymph nodes of mice. Animals treated with AMP-CpG showed a significantly higher percentage of CD8+ T cells with a central memory phenotype, leading to a stronger recall response in mice one week after antigen challenge. ELI-005 rapidly induced potent cellular and antibody responses in non-human primates that were 5,000 times higher than baseline, exhibiting cross-reactive neutralizing activity specific to Beta, Delta, and Omicron SAR-CoV-2 variants.

Elicio also presented preclinical data on the combination of AMP-CpG adjuvant with an EBV vaccine. The data showed that co-administration of AMP-CpG with directly lymph node-delivered EBV gp350 and EBV polyproteins rapidly induced effective gp350-specific antibody (IgG), EBV neutralizing antibody responses, and EBV-specific T cell responses in HLA transgenic mice. Moreover, the effective humoral and cellular immunity induced by AMP-CpG was durable, with responses maintained for over 7 months.

Company website: https://elicio.com/

Xinyuan Continues to Advance Independent R&D

Global Clinical Study of ABP-671, a New Anti-Gout Drug

Established in 2012, Jiangsu Xinyuan Pharmaceutical Technology Co., Ltd. (Xinyuan) 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 oncological diseases. The company's core team members are mainly from the United States and have extensive experience in the R&D 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 R&D 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 huge unmet clinical need in the global gout market. ABP-671 may have significant advantages in safety, tolerability, and efficacy in the treatment of gout and hyperuricemia, and will bring good news to many patients.

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

Kohn Tai is dedicated to the research and development of new generation kinase inhibitors

Shanghai Conntec Biopharmaceutical Co., Ltd. (Conntec), founded in 2021, focuses on the development of new generation kinase inhibitor drugs. Its R&D strategy focuses on untargeted kinases, clinical drug resistance 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 kinase inhibitor design and synthesis platform, multi-dimensional kinase screening platform, chemical proteomics target discovery and verification platform, and kinase non-catalytic function discovery and regulation technology platform.

Macromolecule innovative drug field

Jinsen Bio focuses on the R&D of bispecific and multispecific antibody new drugs

Founded in 2015, Jinsen Bio is a high-tech enterprise focusing on the R&D of bispecific antibody new drugs. Focusing on the forefront of the tumor immunotherapy segment, based on the sequence-specific IgG-like bispecific antibody (SBody) technology platform, it is committed to the development of first-in-class (FIC) bispecific/multispecific antibody new drugs to address the clinical needs of the subpopulation where PD-1 treatment is ineffective or drug-resistant.

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

Aetio develops a proprietary protein prodrug technology platform

Aetio Biotherapy (Aetio) was founded in Texas, USA in 2018. It is an early-stage biopharmaceutical 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. However, due to the common side effects and systemic toxicity of treatments, Aetio believes that the potential of immunotherapy remains unrealized. Therefore, it has developed novel antibody and cytokine fusion proteins that were 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 enters Phase II clinical trial

On April 27, 2022, the NMPA Drug Clinical Trial Registration and Information Disclosure Platform showed that the recombinant herpes zoster vaccine (LZ901) developed by Beijing Luzhu Biotechnology Co., Ltd. (Luzhu Bio) has started Phase II clinical enrollment.

LZ901, independently developed by Luzhu Bio's R&D team, can actively deliver VZV gE antigen to the body's immune system after intramuscular injection, greatly enhancing the body's immune system's ability to produce humoral and cellular immunity. The entry of LZ901 into Phase II clinical trial will significantly accelerate the clinical research progress of the vaccine and is expected to further enrich Luzhu Bio's product pipeline, bringing more choices for herpes zoster patients.

To date, two major herpes zoster vaccines have been launched globally: Merck's Zostavax (currently delisted in the US due to its technology route and low protection rate) and GSK's ShingrixÔ (Shingrix). In 2020, GSK's new recombinant herpes zoster virus vaccine ShingrixÔ achieved sales revenue of US$2.57 billion, making it the fifth largest vaccine in global sales in 2020 and the fourth largest in 2021, a world-class blockbuster product.

Major News! Luzhu Bio submits application for Hong Kong Stock Exchange IPO

Valuation exceeds 4.42 billion yuan

On June 28, 2022, Beijing Luzhu Biotechnology Co., Ltd. (Luzhu Bio) announced the completion of a Series C (Crossover round) financing of approximately 218 million yuan, with investors including Huapu Haihe Biopharmaceutical Fund, Yizhuang Biopharmaceutical Fund, and Xinyin Zhenghua.

Luzhu Bio is a biotechnology company committed to providing high-quality and affordable human vaccines and therapeutic biologics to prevent and control infectious diseases and address major unmet medical needs in the treatment of cancer and autoimmune diseases. Since its establishment in 2001, it aims to leverage a deep understanding of immunology and protein engineering and has established innovative technology platforms. After 20 years of independent R&D and active introduction of innovative technologies, it has established an innovative precision protein engineering platform to empower the entire cycle of drug development. Its main development candidate human vaccines, monoclonal antibodies, and bispecific antibody product pipelines include 3 clinical products under development, including core products LZ901 and K3, and 4 pre-clinical products under development.

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

New medical materials field

Madefa completes tens of millions of RMB Series A financing

On June 6, 2022, Zhuhai Madefa Biotechnology Co., Ltd. (Madefa) announced that it had completed tens of millions of RMB in Series A financing in May, with participation from institutions and well-known investors. The funds will be used for further product development and production expansion, as well as domestic and international market expansion. Prior to this Series A financing, Zhuhai Madefa completed an angel round financing of 20 million yuan in early 2021, with participation from local industrial funds and several well-known investors; it has also received more than 20 million yuan in major scientific research and talent special funds from the local provincial and municipal governments.

Founded in early 2019, Madefa focuses on the independent innovation and development of the fourth-generation PHA biomaterials (the company currently owns more than ten independently developed invention patents, utility model patents, etc.) and the industrialization and commercialization of its downstream new products. Madefa integrates production and research, and is committed to developing 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 production in Zhanjiang at the end of 2021. This new factory uses the next generation of industrial biotechnology to produce and supply low-carbon green PHA materials on a large scale, and further deep-processes downstream derivative nutritional health active molecules, as well as high-purity medical PHA and microspheres.

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

Pharmaceutical industry big data field

Yaorong Cloud Data joins hands with well-known domestic pharmaceutical companies to reach strategic cooperation

In June 2022, Yaorong Cloud joined hands with Guobang Pharmaceutical, Seto Bio, Guangshengtang Pharmaceutical, Dino Pharmaceutical, Tuoxin Pharmaceutical, and Anglikon Pharmaceutical to reach strategic cooperation, signing service agreements on the service content of drug R&D, global listing, national hospital sales data, market information, rational drug use, consistency evaluation, production testing, and raw materials databases.

This strategic cooperation marks a new chapter for PharnexCloud. PharnexCloud will continue to focus on the deep integration of "data + AI" with the pharmaceutical industry, transforming data technology advantages into industrial advantages, using data to empower and lead the industry, promoting the digital upgrading of the industry, and helping more excellent Chinese pharmaceutical companies and drugs to go global.

PharnexCloud's biopharmaceutical big data one-stop search platform is a big data platform integrating global biopharmaceutical industry chain data. It has integrated upstream and downstream data of the pharmaceutical industry chain from more than 40 countries and regions, including China, the European Union, the United States, Japan, and India, covering innovative drugs, generic drugs, raw materials, pharmaceutical markets, and medical devices, etc. Combined with its unique pharmaceutical data retrieval system, it provides "one-stop" intelligent data retrieval services for global pharmaceutical professionals in various fields, including pharmaceutical R&D, production testing, market sales, and rational drug use.

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

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