Mediar Therapeutics, Inc.

Acepodia’s platform is based on the click chemistry work of Nobel laureate Carolyn Bertozzi, Ph.D., who is a scientific adviser for the company. Call it a case of good chemistry: Acepodia, a biotech based on Nobel Prize-winning science, is entering into a new partnership with Pfizer’s Ignite program to support development of the biotech's unique cell immunotherapies.Under the terms of the deal, Pfizer will provide resources, expertise and strategic advice to help Acepodia complete ongoing clinical development of two cancer treatments and expand its program into autoimmune diseases, according to a Sept. 3 release. No financial exchanges are tied to the deal, an Acepodia spokesperson told Fierce Biotech in an email. Acepodia will retain all rights related to the program’s progress and future partnerships, the release said. Acepodia’s antibody-cell conjugate (ACC) platform is based on the work of Nobel laureate Carolyn Bertozzi, Ph.D., who is a scientific adviser for the company. Bertozzi pioneered the use of modular chemical reactions, known as click chemistry, inside of living cells without disrupting other important processes, a technique she termed bioorthogonal chemistry. She won the 2022 Nobel Prize in Chemistry for this work.Acepodia uses these modular reactions to create modified T cells that express antigens targeting tumors; in other words, the company makes CAR T cells using chemistry rather than gene editing. ACC CAR T cells are easily scalable and avoid side effects seen in other CAR T-cell therapies, according to the release. With Pfizer’s support, Acepodia hopes to next create T cells for undisclosed autoimmune targets.“We see a significant opportunity to bring the benefits of our ACC platform to autoimmune diseases, and working with Pfizer Ignite will position us well to deliver our immunotherapies to patients in desperate need of new options,” Acepodia CEO Sonny Hsiao, Ph.D., said in the release. The chemistry-inclined company’s lead asset is ACE1831, a cell therapy for non-Hodgkin lymphoma currently in phase 1 trials. ACE1831 T cells target CD20, a protein commonly found on the surface of cancerous B cells. In May, Acepodia reported that a single dose at the lowest dosage levels of ACE1831 had stabilized disease in three out of five patients who received it, with another patient’s cancer disappearing entirely. The biotech reported no serious adverse events from the treatment.In addition to ACE1831, Pfizer will also help Acepodia advance its other oncology treatment, ACE2016. ACE2016 targets solid tumor cells that express epidermal growth factor receptor and is slated to enter phase 1 trials before the end of the year. The biotech raised $100 million in a series D last year to support its oncology pipeline. Through its Ignite program, Pfizer partners with biotechs to help them advance new drugs from preclinical development all the way to market. Ignite mainly focuses on oncology, inflammation and immunology, according to the program’s website.In 2023, Pfizer Ignite partnered with Mediar Therapeutics to advance two drug candidates for fibrosis; in May 2024, Swiss anti-allergy biotech Mabylon joined the program to advance an antibody treatment for peanut allergies.

Results Highlights for Interim Results ended 30 June 2024 Revenue reached RMB981.8 million Gross profit amounted to RMB339.1 million Net profit grew by 956.0 YoY to RMB144.2 million Adjusted non-IFRS net profit reached RMB168.2 million, increased by 15.1% YoY HONG KONG, Aug. 29, 2024 /PRNewswire/ -- On August 29, 2024, Viva Biotech Holdings Group ("Viva Biotech", "the Group" or "the Company", stock code: 1873.HK) announced that the Group achieved a revenue RMB981.8 million; and the Group's gross profit of RMB339.1 million. The Group's net profit amounted to RMB144.2 million, a significant improvement from the net profit of RMB13.7 million for the corresponding period of last year, mainly benefiting from the elimination of relevant financial adjustments due to the full repayment of convertible bonds; Adjusted non-IFRS net profit improved from RMB146.1 million for the corresponding period of last year to an adjusted non-IFRS net profit of RMB168.2 million, representing a year-on-year increase of nearly 15.1%. This was mainly attributable to the investment income from the group successful exit of certain portfolio companies as well as the positive contribution from initiatives to reduce costs and increase efficiency. In addition, since the Group completed the introduction of strategic investors such as Temasek, HighLight Capital, True Light Capital and Investment Corporation of Dubai in 2023, the strategic investors have brought synergies in corporate governance, business operations, investment and financing plans and strategic development of the Group. CRO Growth to Gradually Recover in the Future Despite Fluctuations in the Short to Medium Term In the first half of 2024, the Company's revenue from CRO business amounted to RMB385.9 million and achieved a corresponding adjusted gross profit of RMB167.2 million. The revenue for the first half of 2024 decreased compared to last year, primarily due to the short-term impact from challenges in global biopharmaceutical investment and financing on the R&D of innovative drugs, as well as the strategic contraction of the Company's EFS business last year. Nevertheless, the Company effectively implemented measures such as cost reduction and efficiency enhancement to maintain a solid profitability for the CRO business. The gradual recovery of new CRO orders since the second quarter of 2024 will provide a strong support for the Company's business results in the second half of the year. As at June 30, 2024, the Company has cumulatively delivered more than 74,109 protein structures to our clients, approximately 9,074 of which were newly delivered in the first half of 2024. The Company's R&D has accumulated over 2,065 independent drug targets, 79 of which were newly delivered in the first half of 2024. Currently, the Company maintains a leading global position in the industry in the field of protein structure analysis. The cumulative number of CRO clients served had increased to 1,465, including the global top 10 pharmaceutical companies (by reported total revenue for the first half of 2024), and revenue from the top 10 customers accounted for 25.7% of our total revenue. Clients of CRO business are geographically diverse, overseas clients contributed approximately 88.8% of our total revenue, while those from the Chinese Mainland contributed approximately 11.2% of our total revenue. During the Reporting Period, our utilization of synchrotron radiation source reached 873 hours. The Company established long-term cooperation with 13 synchrotron radiation source centers around the world, which are distributed in ten countries/regions, i.e., Shanghai, China, the United States, Canada, Japan, Australia, the United Kingdom, France, Germany, Switzerland and Taiwan, China, thus guaranteeing uninterrupted data collection all year round. Continuing to Expand CDMO Capacity and Increase CMC Projects The Group is committed to building a one-stop service platform for global innovative drugs from research and development to production, and improved the production layout through acquisition of the entire equity interests in Langhua Pharmaceutical. In particular, we continued to expand CDMO capacity to prepare for commercial production of new molecules in the future. In addition, constant efforts were made to optimize and channel resources towards the CMC business during the Reporting Period. In the first half of 2024, Langhua Pharmaceutical's revenue amounted to RMB595.9 million, and its adjusted gross profit amounted to RMB179.0 million, primarily attributable to the impact from the delivery schedule of certain CDMO orders, most of which are expected to be delivered in the second half of 2024. As at June 30, 2024, Langhua Pharmaceutical had served a total of 885 clients, with the top ten clients accounting for 63.2% of its total revenue and a 100% retention rate of top ten clients. In addition, Langhua Pharmaceutical provided CMC and CDMO services to 12 incubator companies of the Group as well as companies channeled from CRO business. During the Reporting Period, in respect of production capacity, our current available total capacity reaches 860 cubic meters. Furthermore, Langhua Pharmaceutical plans to establish a new production capacity of 400 cubic meters between 2024 and 2025 to cater to commercial production of new molecules. The civil engineering project is largely completed while internal fire control facilities are under installation, and the next phase will involve procurement and installation of equipment. This endeavor will provide sufficient guarantee for the Company's revenue growth with the launch of new products and release of reserved capacity. The number of CMC projects continued to grow, but the new business is still in the profit ramp-up phase. Since its establishment, CMC has completed and is currently progressing with a total of 218 new drug projects. During the Reporting Period, CMC generated revenue of nearly RMB21.0 million. In the future, the Group plans to strengthen BD and channeling efforts for acquiring high-quality CMC projects. By fully utilizing internal project resources and implementing cost reduction and efficiency enhancement measures, the Group aims to achieve a balanced financial outcome for its CMC business. In addition, in terms of the number of customer orders, external BD accounted for nearly 75.0%, while channeled accounts from Viva represented approximately 25.0%. In terms of order amount, external BD contributed 49.0%, while channeled accounts from Viva contributed 51.0%. Successful Exits of Certain Incubation Portfolio Companies Continued to Realize Investment Returns, Accretive to the Group's Profits During the Reporting Period, the Company achieved partial investment exits from a number of portfolio companies (Focus-X, Saverna, Dogma and Riparian), realizing corresponding investment returns and generating total proceeds of nearly RMB144.1 million. In addition, the Company also achieved investment exit from one portfolio company (Nerio) subsequent to the Reporting Period in the end of July 2024, but the investment income therefrom will not be recognized in the interim report for the Reporting Period. As at June 30, 2024, the Group had invested in a total of 92 portfolio companies. The portfolio companies are mainly from the United States, Canada, Europe and China. 67.0% of the portfolio companies are from North America and 26.0% are from China. In the first half of 2024, five of our portfolio companies completed or were close to completing a new round of financing, raising approximately US$117.0 million in total. The R&D efforts of the portfolio companies were advancing smoothly, with the total number of pipeline projects reaching close to 222, of which 185 pipelines are in the preclinical stage and 37 pipelines in the clinical stage. So far, the Group has successfully realized 13 investment exits or partial exits. Furthermore, the Group may have several potential exits of our portfolio companies, and it also can be foreseen that a peak season of investment exits will arrive in the next three years. As at the end of the Reporting Period, Viva has strategically invested in a series of high-quality assets, including portfolio companies such as Dogma, Arthrosi, Basking, Triumvira, Deka, Mediar, Cybrexa, VivaVision, Haya and Nerio. In the future, as these portfolio companies continue to develop successfully, secure ongoing financing, and realize exits, the initial investments will gradually enter the harvesting phase, providing sustained cash returns and investment income for the Group. T echnological highlights and R&D Breakthrough s Riding on the rapid development of artificial intelligence (AI) technology recently, Viva has further introduced AI technology on the basis of structure-based drug discovery (SBDD) technology, focusing on new targets, novel mechanisms of action (MOA) and new modality to develop a unique AI-enabled SBDD one-stop R&D service platform for innovative novel drugs. Firstly, from the perspective of current research on new targets, new targets are the most important source of original innovation. During the Reporting Period, our R&D has accumulated over 2,065 independent drug targets, 79 of which were newly delivered in the first half of 2024. So far, the Company has delivered to clients a series of target protein structures that have not been reported in the Protein Structure Database (PDB), and clarified the structural principles of these proteins in functioning, laying a solid foundation for subsequent drug molecular design. For example, in the cancer therapeutic area, industry players are still searching for new targets as breakthroughs, in addition to traditional target proteins such as kinases, proto-oncogenes/tumor suppressor genes, immune checkpoints, etc. In the fields of new tumor target proteins related to cell division control and mRNA stability, we successfully analyzed many previously unreported protein structures and complex structures of proteins and drug candidate molecules, and explained structural details of the interaction between target proteins and compounds, which provide clear guidance for designing more effective compounds and lead to the emergence of a range of new drug candidate molecules. Besides, the Company contributed a number of new structures in the molecular glue protein complex structural field, which further provide effective clues for rational design and improvement of molecular glue drugs. Secondly, regarding novel MOA research progress, our CRO business has successfully established a one-stop platform for novel MOA-based drug discovery and research, and set up relevant technical platforms covering protein production, preparation and structure research, Cryo-EM technology, membrane protein research technology, drug screening technology, bioassay and so on. Moreover, based on the validation and tests of hit compounds, the Company can rely on its strong pharmaceutical chemistry team and computing team to help clients further optimize the structure of hit compounds until they reach the preclinical candidate (PCC) milestone. Meanwhile, the Company's pharmacology and pharmacokinetics platform can also provide clients with systematic compound druggability evaluation services for the development of novel MOA-based compounds. Thirdly, regarding current progress of new modality related technology platforms, during the Reporting Period, Viva Biotech drew upon a wealth of projects completed over the years to gradually integrate its macromolecular drug/antibody platform, peptide platform and micromolecule drug platform into a cross-field XDC platform. Deeply integrating computational chemistry and artificial intelligence technology with XDC technology, the Company explored in a wide range of innovative fields such as coupling site screening design, linker-drug payload design, overall hydrophobicity and stability modification of XDC drugs, and development of novel coupling reactions, expanding new directions for XDC drug R&D. On this basis, the Company further integrated the XDC platform with DNA encoded library (DEL) technology, leveraging strong screening capabilities of the Viva DEL platform to help screen special micromolecule linkers and drugs, and relying on its team's unique experience in nucleic acid conjugation to establish an antibody-oligonucleotide conjugate (AOC) platform. So far, based on full integration of our existing technology platforms across multiple fields, we have established a powerful, comprehensive and one-stop XDC technology service platform. Besides, regarding construction progress in the peptide technology platform, the Company has achieved the capability to synthesize a wide range of peptides, particularly the challenging and technologically advanced peptide chains. Extensive research and technical expertise have been accumulated in peptide coupling, peptide drug conjugates (PDC), radionuclide drug conjugates (RDC), monocyclic peptides, stapled peptides and other complex multi-cyclic peptides (involving peptide folding and selective cyclization), biotin-labeled peptides and fluorescent-labeled peptides. In terms of peptide coupling, our peptide platform works with antibody department to expand the peptide platform to the field of peptide antibody coupled APC, and has delivered relevant products. In the future, Viva's peptide technology platform envisions a collaborative approach with Viva's phage display platform and V-DEL platform, aiming to provide customers with one-stop comprehensive services encompassing the entire process from the discovery and validation of hit peptide chains to the identification and optimization of lead compounds, and ultimately the determination of candidate compounds. In addition, Viva also provides services relevant to PROTAC/molecular glue drug R&D, and revenue generated in this regard accounted for almost 10.87% of total revenue from the CRO business. Our services primarily include studies on protein preparation and structure, screening of PROTAC/molecular glue, kinetics, drug metabolism, pharmaceutical chemistry, Bioassay, computer-aided drug discovery (CADD)/ artificial intelligence in drug discovery (AIDD), etc. As at June 30, 2024, the Company has studied more than 50 E3 ligase complexes and delivered 140 PROTAC ternary complex structures. The PROTAC business also became a revenue contributor to the growth of our CRO business. Last but not least, regarding our AI-enabled SBDD one-stop R&D service platform for innovative novel drugs, our CADD and AIDD platforms employ physical chemistry models and artificial intelligence algorithms to advance drug R&D projects, based on deep understanding of structures and mechanisms of action to truly practice computation-driven drug R&D. Our computing platform has developed a series of project-specific advanced algorithms to solve practical problems in drug design such as covalent and non-covalent free energy perturbations (FEP), resulting in higher computational accuracy and larger adjustable parameter range. Addressing gaps in the traditional computational chemistry methodology, the computing platform introduced generative artificial intelligence algorithms, which break through the limitation of chemical space with ab initio generation, enabling drug design to achieve the breakthrough from zero to one with the aid of computation. Furthermore, ADME/PK prediction models were developed under the platform, enabling comprehensive coverage of various drug R&D stages and systematic integration of computing tools. The methods developed under the computational chemistry and artificial intelligence platform have been applied in the R&D of various drug modalities, such as small molecules, antibodies, peptides and RNA-targeting small molecules. In the process of algorithm development, our platforms maintain the integration of dry-lab and wet-lab and the computational results are verified through experimental validation, during which computational models are iteratively optimized to ultimately achieve breakthroughs. Generally, Viva's CADD and AIDD platforms have the capability to develop proprietary algorithms and enhance platforms and the experience in exploring various drug modalities, and fully leverage our advantages in SBDD, which can comprehensively empower various early drug R&D aspects with the computing power supported by the Shanghai supercomputing cluster. S taff and Facilities As at June 30, 2024, the Group had a total of 2,043 employees, of whom the number of CRO R&D personnel reached 1,117, and the headcount of Langhua Pharmaceutical was 704. The Company has well-established office and laboratory facilities in line with its workforce expansion plans, and is expanding production capacity to meet the fast-growing business needs, including: The Group's new headquarters in Zhoupu, Shanghai with a total area of approximately 40,000 square meters had been put into full operation. The incubation center located in Faladi Road, Shanghai has an actual usable area of approximately 7,576 square meters, including 5,552 square meters of laboratory area. The park in Chengdu has a GFA of approximately 64,564 square meters, of which 12,210 square meters of properties had been put into use as at June 30, 2024, including 10,800 square meters of laboratory area. A park in Suzhou with a total GFA of approximately 7,545 square meters, including nearly 5,305 square meters of laboratory area. A park in Jiaxing with a GFA of approximately 6,362 square meters, including nearly 5,335 square meters of laboratory area. Shanghai Supercomputing Center has been officially put into operation. At present, it can support CADD computation, AIDD related computation, and crystal structure and Cryo-EM (Micro-ED) computation. The factory of Langhua Pharmaceutical in Taizhou, Zhejiang has a GFA of approximately 35,168 square meters, including the Taizhou R&D center with an area of approximately 2,500 square meters. The R&D center of Ningbo Nuobai has an area of approximately 1,300 square meters and the office building of Ningbo Nuobai has an area of approximately 1,500 square meters. Dr. Cheney Mao, Chairman and Chief Executive Officer of Viva Biotech Holdings, stated, "With unique advantages in structure-based drug discovery (SBDD), the company will increase the cross-sell between biological and chemical businesses, continue to strengthen the construction of its one-stop innovative novel drug R&D platform and manufacturing service platform, deepen the synergy between CRO and CDMO business, improve the capacity building for front-end services and drive business to back-end services to further enhance the business funnel effect. Actively building an open collaboration platform and a win-win ecosystem for global biopharma innovators." About Viva Biotech Established in 2008, Viva Biotech (01873.HK) provides one-stop services ranging from early-stage Structure-Based Drug R&D to commercial drug delivery to global biopharmaceutical innovators. We offer leading early-stage to late-phase drug discovery expertise by integrating our dedicated team of experts, cutting-edge technology platforms, and state-of-the-art equipment in X-ray crystallization, Cryo-EM, DEL, ASMS, SPR, HDX-MS, AIDD/CADD, and much more. Our business covers all aspects of therapeutic strategies and drug modalities, including small molecules and biologics across the pharma and biotech spectrum. The experienced chemistry team, led by senior medicinal chemists and drug discovery biologists, provides services for drug design, medicinal chemistry (hit to lead and lead optimization), custom synthesis, chemical analysis and purification, kilogram scale-up, peptide synthesis and corresponding bioassays. With our subsidiary Langhua Pharmaceutical, we offer worldwide pharmaceutical and biotech partners a one-stop integrated CMC (Chemical, Manufacturing, and Control) service from preclinical to commercial manufacturing. Additionally, Viva Biotech embedded an equity for service (EFS) model to high potential startups to address unmet medical needs. As of June 30, 2024, Viva Biotech had cumulatively provided drug R&D and manufacturing services to 2,350 biotech and pharmaceutical clients around the world. We have invested and incubated 92 biotech start-ups in total. In the future, the company will continue to strengthen its technological barriers and improve R&D, production levels, and our service capacity to provide high-quality and diversified services for more drug discovery start-ups, as well as medium and large pharmaceutical enterprises around the world. SOURCE Viva Biotech Holdings

Phase 1 study of MTX-463 initiated after FDA Clearance of IND IND-enabling studies completed for second antibody program with Phase 1 expected to start in Q3 Clinical Advisory Board (CAB) of global experts in fibrosis formed to advance clinical development New preclinical data to be presented at upcoming medical meetings on WISP-1 and EphrinB2 and their roles in Idiopathic Pulmonary Fibrosis (IPF) and Systemic Sclerosis (SSc), respectively BOSTON, May 6, 2024 /PRNewswire/ -- Mediar Therapeutics, Inc., a biotechnology company advancing a portfolio of first-in-class therapies that halt fibrosis progression, today announced that, following FDA clearance of its investigational new drug (IND) application, the first cohort of participants has been dosed in a Phase 1 trial evaluating the safety and tolerability of MTX-463. MTX-463 is a first-in-class human IgG1 antibody designed to neutralize WISP-1-mediated fibrotic signaling to address IPF and other fibrotic diseases. The Phase 1 study for MTX-463 is designed to assess its safety at multiple dose levels, tolerability, and pharmacokinetics, while also assessing the ability of MTX-463 to engage its target, WISP-1. The trial is enrolling healthy participants and consists of staggered single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. "Advancing our first-in-class portfolio to the clinic is an important milestone for Mediar, and an exciting moment envisioned by our founders at Mass General Brigham and advanced by our team," said Mediar's Chief Executive Officer Rahul Ballal, Ph.D. "MTX-463 is the first of two programs to begin clinical trials this year and we look forward to initiating a second Phase 1 study with our first-in-class anti-EphrinB2 molecule, MTX-474, in the third quarter." As Mediar advances MTX-463 and MTX-474 into human studies, it will be guided by its clinical advisory board, comprising world renowned leaders in fibrosis across pulmonology, rheumatology, hepatology, and regulatory. "With the formation of our CAB, we bring together a wealth of experience and expertise to help advance the clinical development of our pipeline as we work to address the significant unmet need in fibrosis," said Mediar's Chief Medical Officer Jeff Bornstein, M.D. The newly appointed members of the clinical advisory board are: Flavia Castelino, M.D., Associate Professor of Medicine, Harvard Medical School, Division of Rheumatology, Massachusetts General Hospital Lara Dimick-Santos, M.D., Medical Director, CTI Clinical Trial & Consulting Services, former FDA medical reviewer Scott Friedman, M.D., Dean for Therapeutic Discovery, Fishberg Professor of Medicine, Director, Institute for Liver Research, Icahn School of Medicine at Mount Sinai Robert Lafyatis, M.D., Professor of Medicine, Division of Rheumatology & Clinical Immunology, University of Pittsburgh Medical Center Rohit Loomba, M.D., MHSc, Professor of Medicine, Chief of the Division of Gastroenterology and Hepatology, University of California San Diego Toby Maher, M.D., Ph.D., Professor of Medicine, Director of Interstitial Lung Diseases, University of Southern California Sydney Montesi, M.D., Assistant Professor of Medicine, Harvard Medical School, Pulmonary and Critical Care Medicine, Massachusetts General Hospital John Varga, M.D., Professor of Medicine, Chief of the Division of Rheumatology, University of Michigan In addition, new preclinical data supporting the application of MTX-463 in IPF will be presented at the 2024 American Thoracic Society (ATS) meeting in San Diego, May 17-22, 2024. Data supporting MTX-474 in Systemic Sclerosis (SSc) will be presented in an oral presentation at the Congress on the EPH/Ephrin System in Parma, Italy, May 16-17, 2024. About MTX-463 MTX-463 is a first-in-class human IgG1 antibody developed against WNT1-inducible signaling pathway protein-1 (WISP-1). WISP-1 is a secreted matricellular protein shown to have a relevant role in fibrosis progression, measurable in human blood, and correlates with disease severity. Initial data indicates that MTX-463 neutralizes WISP-1-mediated fibrotic signaling that spans several fibrotic indications and significantly reduced fibrosis in vitro and in preclinical mouse models. MXT-463 is currently in Phase 1 clinical evaluation to assess its safety and tolerability in healthy participants (NCT06401213). About MTX-474 MTX-474 is a first-in-class human IgG1 antibody designed to neutralize the EphrinB2 signaling that causes the onset and progression of fibrosis. Ephrin ligands and Eph receptors mediate biological processes involved in tissue fibrosis including cell migration, myofibroblast activation, and tissue remodeling. A growing body of evidence has implicated EphrinB2 in the fibrosis of the skin, lungs, and heart. Expression of EphrinB2 and its receptors are measurable in human blood and correlates with disease severity. Initiation of Phase 1 clinical studies for this program is anticipated in Q3-2024. About Mediar Therapeutics Mediar Therapeutics is pioneering a new approach to fibrosis treatment that halts the disease at a different source – the myofibroblast, the key pathogenic cell in fibrosis that drives scarring, disease progression, and ultimately organ failure. Mediar was founded based on a deep understanding of the complex science underlying fibrosis onset and progression. By combining novel targets with reliable, easily detectable blood biomarkers and familiar modalities, Mediar is derisking the path forward for fibrosis therapies in clinical development. For more information, contact [email protected] or follow us on LinkedIn. SOURCE Mediar Therapeutics