Industrial Impact
MOMA Therapeutics | January 04, 2024
MOMA Therapeutics, a biotechnology company focused on identifying and targeting highly dynamic, difficult to drug targets in cancer and other diseases, is pleased to announce a strategic collaboration and licensing agreement with Roche. This partnership provides Roche with access to MOMA’s proprietary KnowledgeBase platform for the identification and prosecution of a certain number of novel drug targets involved in promoting cancer cell growth and survival.
MOMA’s KnowledgeBase comprises integrated structure-function capabilities, advanced lead-finding technologies and computation-enabled lead optimization. It was built upon the concept that functionally related targets lacking sequence homology still possess three dimensional structural motifs that can be exploited to produce highly impactful therapies. To date, MOMA has utilized this bespoke platform to accelerate drug discovery in the ATPase target class, a class with a high number of genetically validated targets for which industry efforts to identify therapeutically viable drugs have been hampered by the extent of dynamic protein motion.
“Given its deep expertise and global footprint in oncology, Roche represents an ideal collaborator with whom to further advance the application of MOMA’s platform in a way that impacts patients’ lives. The vision for this collaboration was crafted jointly with Roche to enable each party to bring its strengths in pursuit of this shared goal. It also contributes to the long-term sustainability of MOMA’s core focus as we advance our rich pipeline of precision oncology programs to the clinic,” said Asit Parikh, M.D., Ph.D., chief executive officer of MOMA.
Through the collaboration, MOMA will receive $66 million as an upfront cash payment and is also eligible to receive discovery, development, and commercialization milestone payments potentially exceeding US$2 billion, as well as tiered royalties. MOMA will be primarily responsible for all activities for selected targets through to development candidate confirmation, whereas Roche will be responsible for IND-enabling activities and clinical development and commercialization. Additionally, if multiple collaboration assets reach pivotal clinical studies, MOMA will receive a right to co-fund late-stage development of one product in exchange for increased royalties in the US on this product.
“We are excited to join forces with MOMA, combining our leadership in oncology with MOMA’s deep expertise in drug discovery for difficult-to-drug and novel targets in oncology. The broader field of cancer dependencies is of high importance for Roche and we are looking forward to further deepening our knowledge and discovering novel targets involved in cancer cell growth and survival leveraging MOMA’s innovative platform,” said James Sabry, M.D., Ph.D., global head of pharma partnering, Roche.
“It is exciting to utilize our industry-leading knowledge in how to identify and drug highly dynamic proteins to deliver on a breadth of discovery programs in partnership with Roche,” added Peter Hammerman, M.D., Ph.D., chief scientific officer and head of development at MOMA. “Along with bringing two MOMA-owned high-impact programs to the clinic next year, we are making exciting progress towards our goal of addressing key unmet needs for patients living with advanced cancer.”
About MOMA Therapeutics
MOMA Therapeutics is committed to discovering the next generation of precision medicines by targeting highly dynamic proteins that underlie human disease. Bringing together seminal scientific advancements in biochemistry, biophysics, structural biology, chemistry, computation, and functional genomics, the company has established the KnowledgeBase platform to exploit a key vulnerability inherent to all dynamic proteins: their dependence on well-coordinated, stepwise changes in protein conformation. By focusing this platform on disease-causing targets, MOMA aims to develop high impact, precision medicines for patients with unmet medical needs. MOMA Therapeutics is a private company launched in 2020 with seasoned leadership, a highly specialized workforce with deep expertise in oncology discovery, world-class scientific founders, and financed by leading biotech investors.
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Medical
Biocytogen | January 15, 2024
Biocytogen Pharmaceuticals Co., Ltd. a global biotech company focusing on the discovery of novel antibody therapeutics, announces that it has entered into an Exclusive Option and License Agreement with Radiance Biopharma Inc. a biotechnology company specializing in developing next generation Antibody Drug Conjugates.
The agreement grants Radiance an option to license from Biocytogen a first-in-class fully human anti-HER2/TROP2 bispecific antibody-drug conjugate (BsADC) for therapeutic product development, manufacturing and commercialization for all human indications worldwide. HER2 and TROP2 are two tumor-associated antigens (TAAs) that have been found to be commonly expressed and co-expressed by multiple tumor types, including breast, gastric, colorectal, bladder, pancreatic, and non-small-cell lung cancer.
Under the terms of the agreement, upon the option exercised, Biocytogen will be entitled to receive an option fee, licensing fee, development and commercialization milestone payments, as well as single-digit royalties on net sales. In addition, Biocytogen has the right to collect the sharing of sublicensing fee, if any, between Radiance and third party.
Dr. Yuelei Shen, President and CEO of Biocytogen, said: “We are excited to collaborate with Radiance, a strong team with extensive experience in drug development, to develop a leading proprietary fully human bispecfic antibody drug conjugate. We are optimistic that the combination of our strength in BsADC discovery and the extensive experience of Radiance’s team will help expedite the commercialization of this dual-targeting BsADC.”
Marc Lippman, MD, Chairman of the Board of Radiance said: “We are excited to enter into this Exclusive Option and License Agreement with Biocytogen for a novel human anti- HER2 and Trop2 Bispecific Antibody Drug Conjugate. Preclinical data from in vitro and in vivo assays of this BsADC shows promising high potency of anti-tumor activities in leading tumor indications. We are eager to work with Biocytogen to move the product to the clinic to benefit patients.”
About Biocytogen
Biocytogen is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice® (RenMab™/RenLite®/RenNano®/RenTCR-mimic™) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR-mimic antibody discovery, and has established an off-the-shelf library of over 400,000 fully human antibody sequences against approximately 1000 targets for worldwide collaboration. As of June 30, 2023, 50 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and 42 target-nominated RenMice® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company’s sub-brand, BioMice™, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen Jiangsu, Shanghai), USA (Boston, San Francisco), and Germany (Heidelberg).
About Radiance Biopharma
Radiance is focused on developing a pipeline of antibody-based cancer therapeutics including mono and bispecific Antibody Drug Conjugates (ADCs) for the treatment of cancer and to address other unmet medical needs. Marc Lippman, MD, a co-founder and Chairman of the Board of Radiance is a renowned oncologist and former founding board member of Seagen, a leader in the field of ADCs, recently acquired by Pfizer. Based in Boston, Massachusetts, Radiance has a world class, proven leadership team that brings together the best of ADC engineering, clinical, managerial expertise and track record. Radiance is an affiliated company to Alphageneron Pharmaceuticals Inc., a clinical-stage biotechnology company developing unique targeted cell and gene therapies for treating cancer and other unmet medical needs.
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Cell and Gene Therapy
Solvias | January 23, 2024
Solvias, a global provider of chemistry, manufacturing, and control (CMC) analytics, announced that it will perform analytical release testing services on the world's first CRISPR/Cas9 genome-edited cell therapy. The company has signed a long-term agreement with Vertex Pharmaceuticals for CASGEVY™ (exagamglogene autotemcel or exa-cel) which received U.S. Food & Drug Administration (FDA) approval for the treatment of sickle cell disease (SCD) in patients 12 years and older with recurrent vaso-occlusive crises.
Solvias and Vertex Pharmaceuticals have worked together for several years to develop and validate test methods that are critical for the final release of patients' own edited cells, so that they can be delivered back to patients. The companies' collaboration included establishing the testing methods that will be scaled for commercializing CASGEVY. Solvias also has invested significantly in preparing one of its global facilities to support the commercial release work for this transformative therapy.
Archie Cullen, Chief Executive Officer, Solvias, stated
"Solvias is honored to be playing a critical role in delivering this breakthrough therapy to patients. Our decades of experience offering comprehensive GMP analytical services uniquely positions us to partner with companies in bringing their therapies to market. This collaboration highlights our deep scientific knowledge and creative solutions serving to advance even the most cutting-edge therapies."
In addition to gaining FDA approval, CASGEVY recently received a positive opinion from the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use for conditional approval of the treatment of severe SCD and transfusion-dependent beta thalassemia (TDT).
About Solvias
Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the pharmaceutical, biotech, material science, and cosmetic industries. Its team of scientists and regulatory experts have years of experience in small molecules, biologics, and cell and gene therapies. The company offers comprehensive solutions from raw materials to drug products to final release testing, as well as API development and manufacturing for small molecules. Headquartered near Basel, Switzerland, Solvias operates five facilities to the highest standards and in accordance with ISO, GMP, GLP and FDA regulations.
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Industrial Impact
Nimbus Therapeutics | January 08, 2024
Nimbus Therapeutics, LLC a biotechnology company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, announced the advancement and expansion of its pipeline with the addition of discovery programs targeting innate immunity pathways. These programs, targeting the salt-inducible kinase (SIK) family and cyclic GMP-AMP synthase (cGAS), represent promising opportunities to leverage Nimbus’ industry-leading computational and structure-based drug design expertise to develop highly selective, potent medicines addressing areas of significant unmet need.
"Building on the success of our TYK2 program, we are broadening our drug discovery engine to unlock new difficult-to-drug targets with compelling biology,” said Peter Tummino, Ph.D., Chief Scientific Officer of Nimbus. “SIK and cGAS are critical targets in highly prevalent diseases that are well suited to Nimbus’ structure-based drug design approach. We look forward to advancing our discovery and development programs across oncology, immunology, and metabolism to deliver transformative medicines to patients.”
Nimbus is advancing its Phase 1/2 trial (NCT05128487) of NDI-101150, a small molecule inhibitor of hematopoietic progenitor kinase 1 (HPK1), and has reported positive dose escalation data showing potential monotherapy clinical benefit for patients with solid tumors. Furthermore, the company expects to initiate IND-enabling activities this year for its oncology program targeting Werner syndrome helicase (WRN). In collaboration with Eli Lilly and Company, Nimbus continues to progress the development of novel targeted therapies that activate AMPK to potentially treat a broad range of metabolic disorders.
Nimbus continues to expand its platform capabilities with ongoing investments in cutting-edge technology for drug discovery. Alongside proprietary computational tools which the company has developed in-house, Nimbus’ platform leverages state-of-the-art technology through collaborations such as its recently announced partnership with Anagenex, a leader in generative AI for drug design.
Jeb Keiper, M.S., MBA, Nimbus’ Chief Executive Officer, will provide an overview of the company’s progress and pipeline and anticipated milestones for 2024 and beyond at the 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024 at 7:30 am PT.
About Nimbus Therapeutics
Nimbus Therapeutics is a clinical-stage, structure-based drug discovery company developing novel small molecule medicines designed to act against well-validated but difficult-to-drug targets implicated in multiple human diseases. Nimbus combines leading-edge computational technologies with a tailored array of machine learning-based predictive modeling approaches. Nimbus’ pipeline includes a clinical-stage HPK1 inhibitor for the treatment of cancer (NCT05128487), as well as a diverse portfolio of preclinical programs focused on cancer, autoimmune conditions, and metabolic diseases. Nimbus is headquartered in Boston, Mass.
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