INDUSTRIAL IMPACT, MEDICAL
Globenewswire | April 19, 2023
Merck known as MSD outside the United States and Canada, and Prometheus Biosciences, Inc. announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, has agreed to acquire Prometheus for $200.00 per share in cash for a total equity value of approximately $10.8 billion.
“At Merck, we are committed to delivering on our purpose to save and improve lives and continue to identify and secure opportunities where compelling science and value creation align,” said Robert M. Davis, chairman and chief executive officer, Merck. “The agreement with Prometheus will accelerate our growing presence in immunology where there remains substantial unmet patient need. This transaction adds diversity to our overall portfolio and is an important building block as we strengthen the sustainable innovation engine that will drive our growth well into the next decade.”
Prometheus is a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases. The company’s lead candidate, PRA023, is a humanized monoclonal antibody (mAb) directed to tumor necrosis factor (TNF)-like ligand 1A (TL1A), a target associated with both intestinal inflammation and fibrosis.
“Prometheus was established to revolutionize the treatment of immune-mediated diseases through the application of a powerful precision medicine approach,” said Mark McKenna, chairman and chief executive officer of Prometheus Biosciences. “This agreement with Merck, a leader in biopharmaceutical research and development, allows Prometheus to maximize the potential for PRA023, while continuing to apply our technology and expertise to fuel further discoveries to address the needs of patients with immune disorders.”
Prometheus is developing PRA023 for the treatment of immune-mediated diseases including ulcerative colitis (UC), Crohn’s disease (CD), and other autoimmune conditions. In December 2022, the company announced positive results for PRA023 from ARTEMIS-UC, a Phase 2, placebo controlled, study evaluating safety and efficacy in patients with moderate to severely active UC and APOLLO-CD a Phase 2A, open-label, study evaluating safety and efficacy in patients with moderate to severe CD. The findings were recently presented at the 18th Congress of European Crohn’s and Colitis Organisation (ECCO).
“By applying a portfolio of powerful analytic tools to a comprehensive collection of IBD samples, Prometheus identified important disease insights that have now yielded a promising late-stage candidate,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “I look forward to working with the talented Prometheus team to establish a new paradigm of precision treatment for immune diseases.”
Under the terms of the acquisition agreement, Merck, through a subsidiary, will acquire all of the outstanding shares of Prometheus. The acquisition is subject to Prometheus Biosciences shareholder approval. The closing of the proposed transaction will be subject to certain conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to close in the third quarter of 2023.
About inflammatory Bowel Disease
Inflammatory bowel disease (IBD) is a term used to collectively describe Crohn’s disease and ulcerative colitis. These conditions are characterized by chronic inflammation of the gastrointestinal (GI) tract. Prolonged inflammation results in damage to the tissues lining the GI tract. Both ulcerative colitis and Crohn's disease usually are characterized by diarrhea, rectal bleeding, abdominal pain, fatigue and weight loss.
About Prometheus Biosciences
Prometheus Biosciences, Inc. is a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases. The company’s precision medicine platform, Prometheus360™, combines proprietary machine learning-based analytical approaches with one of the world’s largest gastrointestinal bioinformatics databases to identify novel therapeutic targets and develop therapeutic candidates to engage those targets.
CELL AND GENE THERAPY, DIAGNOSTICS
Businesswire | March 28, 2023
Vertex Pharmaceuticals Incorporated and CRISPR Therapeutics announced that they have entered into a new non-exclusive licensing agreement for the use of CRISPR Therapeutics’ gene editing technology, known as CRISPR/Cas9, to accelerate the development of Vertex’s hypoimmune cell therapies for type 1 diabetes (T1D).
“We have multiple programs in our T1D portfolio including VX-880 and VX-264, which are in the clinic, as well as our hypoimmune program, in preclinical development,” said Bastiano Sanna, Ph.D., Executive Vice President and Chief of Cell and Genetic Therapies at Vertex. “Having successfully demonstrated clinical proof of concept in T1D in our VX-880 program, we are excited to deepen our relationship with CRISPR Therapeutics with this agreement, which will allow us to further accelerate our goal of generating fully differentiated, insulin-producing hypoimmune islet cells for T1D.”
“We are pleased to expand our long and successful relationship with Vertex with this collaboration which fully leverages our gene editing platform to develop hypoimmune cell therapies for T1D,” said Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics. “In parallel, we continue to expand our capabilities in regenerative medicine and advance our existing allogeneic gene-edited cell therapy programs.”
Under this agreement, Vertex will pay CRISPR Therapeutics $100 million up-front for non-exclusive rights to CRISPR Therapeutics’ technology for the development of hypoimmune gene-edited cell therapies for T1D. CRISPR Therapeutics will be eligible for up to an additional $230 million in research and development milestones and receive royalties on any future products resulting from this agreement.
CRISPR and ViaCyte, Inc., which was acquired by Vertex in 2022, will continue to collaborate on their existing gene-edited allogeneic stem cell therapies, using ViaCyte cells, for the treatment of diabetes under the terms of their collaboration. A Phase 1/2 study of VCTX211, an allogeneic, gene-edited, stem cell-derived product candidate for T1D, which originated under the CRISPR Therapeutics and ViaCyte collaboration, has been initiated and is ongoing. CRISPR Therapeutics will not obtain any interest in Vertex’s pre-existing pipeline of T1D products, including VX-880 and VX-264.
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) — a rare, life-threatening genetic disease — and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust clinical pipeline of investigational small molecule, cell and genetic therapies in other serious diseases where it has deep insight into causal human biology, including sickle cell disease, beta thalassemia, APOL1-mediated kidney disease, pain, type 1 diabetes, and alpha-1 antitrypsin deficiency.
Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including 13 consecutive years on Science magazine's Top Employers list and one of Fortune’s Best Workplaces in Biotechnology and Pharmaceuticals and Best Workplaces for Women.
MEDTECH, INDUSTRY OUTLOOK
PRNewswire | June 01, 2023
Mission Bio, Inc., the pioneer in high-throughput single-cell DNA and multi-omics analysis, announced breakthrough improvements to the Tapestri® Platform and its core chemistry that enable highly confident detection of rare cells for a range of applications. With Tapestri® v3 chemistry, researchers can discover tiny numbers of single cells that, until now, easily escaped detection and influenced disease in invisible ways. At the same time, drug developers can use the new capabilities for a more complete understanding of their advanced therapies, potentially leading to safer, more effective medicines.
The new Tapestri® v3 chemistry increases the number of cells captured per sample by up to four times compared to the prior chemistry, a notable enhancement. With enhanced cell capture, the Tapestri® Platform can more reliably detect rare cells, opening incredible new possibilities like improving the assessment of measurable residual disease (MRD), a key metric used increasingly in clinical settings to estimate the risk of relapse with certain cancers.
In the case of MRD in hematological cancers, rare subclonal variants are commonly missed by bulk NGS due to its averaging effect, hindering the detection of relapse-driving clones that potentially offer new therapeutic targets. With Tapestri®'s expanded capabilities, new integrated multi-omics tools like the Tapestri® scMRD Assay for Acute Myeloid Leukemia (AML) will offer clinicians additional therapeutic insights, rather than providing a binary 'yes or no' answer to the presence of residual disease. A team of investigators from Memorial Sloan Kettering Cancer Center (MSK) using the assay has reported a high sensitivity of 0.01% limit of detection in data presented at Mission Bio's Tapestri® scMRD for AML Summit last year.
Tapestri®'s new capabilities also hold promise for cell and gene therapy developers looking to improve quality assessment throughout the therapy development process. Powered by Tapestri® v3 chemistry, the increase in cell throughput means Tapestri® Genome Editing Solution can measure gene editing outcomes at single-cell resolution – even for very low-frequency events like translocations, which can have significant effects on the safety of the therapy.
Tapestri® v3 is the latest example of Mission Bio's continued focus on customer-centric product and service development. The company has recently implemented additional quality control measurements including design and development, release, and documentation processes compliant with the ISO 9001 standard.
"Our customers' success is at the forefront of our mind," said Adam Abate, PhD, Co-founder and Interim Chief Executive Officer of Mission Bio. "Researchers and drug developers are demanding ever-greater sensitivity and highly robust products to effectively progress their research or advanced therapeutic program, and we are committed to serving our customers and helping them achieve their goals."
The new v3 reagents will be available for shipping starting in mid-June.
About Mission Bio
Mission Bio is a life sciences company that accelerates discoveries and cures for a wide range of diseases by equipping researchers with the tools they need to better measure and predict our resistance and response to new therapies. Mission Bio's multi-omics approach improves time-to-market for new therapeutics, including innovative cell and gene therapies that provide new pathways to health. Founded in 2014, Mission Bio has secured investment from Novo Growth, Cota Capital, Agilent Technologies, Mayfield Fund, and others.