BUSINESS INSIGHTS

Neurimmune expands drug discovery collaboration with Ono Pharmaceutical in the field of neurodegenerative diseases

Neurimmune | January 17, 2022

Neurimmune AG today announced that it has signed an expanded drug discovery collaboration agreement with Ono Pharmaceutical Co., Ltd. The collaboration is focused on creating antibody drugs against new therapeutic targets in the field of neurodegenerative diseases utilizing Neurimmune's proprietary Reverse Translational Medicine™  technology platform, a unique antibody drug creation approach.

In November 2017, Ono and Neurimmune signed a first drug discovery collaboration agreement to identify and develop human antibodies using the RTM™ technology platform. In the new collaboration, the companies aim to generate and validate human-derived monoclonal antibodies against Ono's newly selected drug targets. Ono will obtain exclusive rights for worldwide development and commercialization of antibody products resulting from the collaboration. Ono will pay to Neurimmune an upfront payment, research fees, success-based milestones on the research and development progress, as well as royalties on product sales.

"We are excited to expand our long-term trusted partnership with Ono, a global pioneer of innovative medicines. The joint goal of the collaboration is to discover novel drug candidates for the treatment of neurodegenerative diseases using RTM technology."

Jan Grimm, CSO of Neurimmune

"We extremely appreciate Neurimmune's RTM™ technology platform as an excellent antibody creation technology through our drug discovery projects." said Toichi Takino, Senior Executive Officer / Executive Director, Discovery & Research of Ono Pharmaceutical. "Through this new collaboration, we will expand our central nervous system disease portfolio and work to deliver innovative medicines to patients with neurodegenerative diseases."

About Neurimmune
Neurimmune is a biopharmaceutical company translating human immune memory into transformative antibody therapeutics. Neurimmune develops drug candidates for CNS and related protein aggregation diseases including Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis, frontotemporal dementia, dementia with Lewy bodies and ATTR cardiomyopathy. Neurimmune discovered aducanumab, a human monoclonal antibody that removes amyloid beta from brains of patients with Alzheimer's disease, and licensed it to Biogen. With its RTM™ technology, Neurimmune also discovered the anti-miSOD1 antibody AP-101 for ALS and the anti-ATTR antibody NI006 for ATTR cardiomyopathy, programs being currently evaluated in clinical trials. Neurimmune has three additional antibody programs in preclinical development, and has recently expanded the spectrum of its treatment modalities by adding a small molecule program and programs involving vectorized expression of human antibody genes.

Spotlight

Pfizer today announced it will increase its commitment to U.S. manufacturing with a $465 million investment to build one of the most technically advanced sterile injectable pharmaceutical production facilities in the world in Portage, Michigan.

Spotlight

Pfizer today announced it will increase its commitment to U.S. manufacturing with a $465 million investment to build one of the most technically advanced sterile injectable pharmaceutical production facilities in the world in Portage, Michigan.

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PHARMA TECH

Merck Drives New Innovation & Adds Capacity to Advance Next Generation Antibody-drug Conjugate (ADC) Therapies

Merck | October 29, 2021

Merck, a leading science and technology company, today announced that its Life Science business sector has launched new technology and expanded capacity to advance ADC therapies. These initiatives underscore Merck's continued investment in novel modalities and support the company's efforts to double its ADC and high-potent active pharmaceutical ingredient (HPAPI) capacity in the near future. "ADCs have experienced remarkable growth, with commercially approved ADCs tripling in the past three yearsWe are a pioneer in this space, involved in 50 percent of the commercially approved ADCs on the market today. This latest innovation and additional capacity help bring novel treatments to cancer patients around the world and reinforce our commitment to shaping the future of these novel modalities. Andrew Bulpin, head of Process Solutions, Life Science, at Merck With the launch of its ChetoSensar™ technology, Merck is one of the front runners working to address the hydrophobicity of ADCs, in tandem with its CDMO services. Many ADC candidates have poor aqueous solubility and Merck estimates that more than 20 percent of ADC clinical terminations are caused by this issue. The company's new ChetoSensar™ technology improves ADC solubility, therefore giving hope to ADCs that were previously terminated. The payloads commonly used for ADCs are highly-complex molecules that take many steps to synthesize. Based on Merck's calculations, its new DOLCORE™ platform significantly reduces the development and manufacturing time required, increasing speed-to-market for a novel Dolostatin-based ADC payload by up to a year. In addition, the company will enhance the ADC capabilities of its clinical manufacturing facility in St. Louis, Missouri, USA, in December. This facility will provide larger footprint to enable large-scale production including chromatographic purification for early phase clinical supply. This follows last year's announcement of a €59 million expansion of Merck's facility near Madison, Wisconsin, USA, which will double its HPAPI kilo lab capacity and enable the company to expedite the manufacture of HPAPIs, ADC linker/payloads, and complex APIs. This innovation and additional capacity support the company's ambition to accelerate growth through investments in the "Big Three," including the Process Solutions business unit within the Life Science business sector as a key driver. With 15 years of experience developing and manufacturing ADCs, Merck offers unique CDMO services streamlined with a single, highly experienced provider. The company leverages its global network and deep expertise to tailor each molecule's unique journey, while creating the dynamic client partnerships drug manufacturers need to help reach their critical milestones. Merck integrates contract development and manufacturing with the industry's broadest product offering across multiple modalities. Customers can also seamlessly integrate BioReliance® services from the company's leading biosafety testing portfolio. Merck recently announced expansion projects in Darmstadt, Germany; Cork, Ireland; Buchs, Switzerland; Carlsbad, California, USA; Madison, Wisconsin, USA; Jaffrey, New Hampshire, USA; and Danvers, Massachusetts, USA. These expansions are part of an ambitious, multi-year program to increase the industrial capacity and capabilities of the Life Science business sector to support growing global demand for lifesaving medications and to make significant contributions to public health. About Merck Merck, a leading science and technology company, operates across healthcare, life science and electronics. Around 58,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene-editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2020, Merck generated sales of € 17.5 billion in 66 countries. Scientific exploration and responsible entrepreneurship have been key to Merck's technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics.

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RESEARCH

DarwinHealth Announces Scientific Collaboration with Prelude Therapeutics in Oncology

Prelude Therapeutics | October 13, 2021

DarwinHealth, Inc. today announced a scientific research collaboration that uses its Biomarker Enrichment Strategies for Assays (BEST platform ) to elucidate novel biomarkers that guide translational trajectories of multiple cancer molecules being developed by Prelude Therapeutics. Under the collaboration, DarwinHealth will use its proprietary, quantitative, systems biology-based algorithms, CLIA-approved technologies, and validated approaches focused on Protein Master Regulator (MR) and tumor checkpoints to identify novel protein-based biomarkers that will add a significant precision a Selection of patient cohorts for clinical trials to be conducted at Prelude's discretion in hematological and solid tumors. The goal of this biomarker-focused collaboration, is to assess and characterize the general and tumor-specific mechanisms of action of molecules in the Prelude pipeline in an attempt to identify new biomarkers that can align these agents with responding patient cohorts. In addition, the The collaboration will mechanically characterize potential therapeutic opportunities for Prelude pipeline molecules that target various oncogenic pathways through multiple hematologic malignancies and solid tumor subtypes, as selected by Prelude Therapeutics.The study will leverage the VIPER algorithm to characterize the activity of these various compounds against key Master Regulator (MR) protein modules (tumor checkpoints) required for subtype-specific tumor viability. - Professor Andrea Califano , Professor and Director of Clyde and Helen Wu , Department of Systems Biology, Columbia Universityand co-founder of DarwinHealth "The BEST initiative will provide accurate and actionable tumor- and compound-specific information to assess the potential of Prelude's pipeline molecules to reverse the activity of subtype-specific tumor checkpoints," explained Dr. Mariano Alvarez , Chief Scientific Officer of DarwinHealth. "The purpose of such studies is to generate a range of validated compound / tumor subtype / biomarker alignments that represent evidence-based roadmaps and mechanisms for biomarker development and patient selection to potentially accelerate clinical studies." As part of the BEST initiative, DarwinHealth will provide a comprehensive reading of the potential clinical value of selected Prelude molecules in a spectrum of tumor types. Using quantitative modeling and biomarker-focused translation pathways, DarwinHealth will also assist in the design of in vivo validation studies to exploit key opportunities that may not be apparent with conventional technologies. "The BEST collaboration addresses one of the critical unmet needs of the biotech and biopharmaceutical spaces focused on cancer drug discovery, that is, the development of highly predictive biomarkers of clinical response to compounds whose ultimate efficacy may be the result of an incompletely decipherable range of both in - and multi-target off-target drug effects of regulatory programs underlying cancer dependencies, These uncertainties lend themselves to extending the concept of biomarkers beyond the primary target (ie, high affinity) of a drug, to multiple protein classifiers identified by our experimental and computational integrative methodologies." - Dr. Gideon Bosker, CEO and Co-Founder of DarwinHealth. These technologies are ideal for identifying mechanical alignments between drug candidates and cancer patients based on the ability of drugs to inactivate patient-specific MR proteins that are necessary for maintenance of tumor status. 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About Prelude Therapeutics Prelude Therapeutics is a precision clinical-stage oncology company developing innovative drug candidates that target critical pathways in cancer cells. The company's main candidate products are designed to be potent and selective oral inhibitors of PRMT5. Prelude's first clinical candidate, PRT543, is in phase 1 development for advanced solid tumors and selected myeloid cancers. Prelude also advances PRT811, a second PRMT5 inhibitor optimized for high brain exposure, in a phase 1 clinical trial that includes glioblastoma multiforme (GBM). The company's portfolio also includes its third clinical candidate, PRT1419,

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PHARMACY MARKET

Kairos Pharma Received FDA Approval of the IND Application for an Investigational New Drug

Kairos Pharma, Ltd. | March 15, 2022

Kairos Pharma, Ltd. a privately-held clinical-stage biotechnology company focused on cancer drug resistance and immunotherapy, announced today that its activated T cell therapy, KROS 201, has received FDA approval to move forward with a Phase 1 clinical trial in patients with recurrent glioblastoma. Kairos Pharma is funding the phase I trial, which will occur at Cedars Sinai Medical Center in Los Angeles. John Yu, M.D., Kairos CEO, commented, "This IND acceptance is the second substantial clinical milestone within the past month as Kairos accelerates toward its clinical goals for 2022. This first-in-man Phase 1 clinical trial will activate T cells against the cancer stem cells at the root of glioblastoma." "This achievement pushes the envelope of immune therapies designed to target T cells against devastating cancers." Neil Bhowmick, Ph.D., Kairos Chief Scientific Officer KROS 201 activated T cells (ATCs) are killer T cells created in cell culture by activating a patient's white blood cells with cytokines or T cell activating signals and priming dendritic cells with antigens specific to glioblastoma cancer stem cells. Patients with recurrent glioblastoma are given the strongly activated T cells intravenously. As a result, cancer stem cells, which are the source of cancer, are killed by these cells. In February, the FDA granted an IND for a Phase 2 trial of ENV105 with apalutamide, in addition to the planned Phase 1 trial of activated T cell treatment for KROS 201. In 2022, an ENV105 Phase 1 trial with Tagrisso (AstraZeneca) for lung cancer is expected. Kairos Pharma also published a notice of allowance of their patent Compositions and Methods for Treating Fibrosis by the United States Patent and Trademark Office, which coincides with the advancement of its clinical milestones. The method of treating fibrosis and certain types of cancer, the composition of matter, and the administration of therapy utilizing KROS-401, a cyclic peptide inhibitor of the IL-4 and IL-13 cytokine receptor complex, are all covered by this patent. This drug has been proven to treat fibrosis and cancer by reversing the M1 to M2 immunosuppressive macrophage shift in cancer and fibrosis. CEO of Kairos Pharma, Dr. John Yu, stated, "This milestone further supports the already substantial and diversified intellectual property portfolio of Kairos and enables the unfettered clinical development of this novel and transformative therapeutic." Dr. Ramachandran Murali, Kairos VP of Research and Development and inventor of the KROS 401 molecule, commented, "KROS-401, in addition to fibrosis and cancer, opens a new avenue in therapeutic development for neurological disorders such as Alzheimer's disease."

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