Abveris Announces Multi-Target, Multi-Year Therapeutic Antibody Discovery Collaboration with Prometheus Biosciences

Abveris, Biosciences | November 12, 2021

Abveris, a leader in antibody drug discovery announced that Prometheus Biosciences and Abveris have entered a multi-year collaboration to develop therapeutic antibodies against multiple targets. The partnership will expand Abveris's role in supporting the rapid development of the Prometheus Biosciences portfolio. The results of the collaboration will bring promising new therapeutics to patients suffering from a variety of immune-mediated diseases.

Under this partnership agreement, Abveris will utilize its proprietary DiversimAbTM hyperimmune mouse technology in combination with humanized mice to develop antibodies against several novel therapeutic targets. Capitalizing on the use of its industry-leading rapid B cell screening platform powered by the Berkeley Lights Beacon®, Abveris will identify promising antibody drug candidates via function-forward, high-resolution screening under expedited timelines.

"We are proud to expand our existing partnership with the team at Prometheus Biosciences to help bring novel biologics to the autoimmune spaceThe Abveris antibody discovery platform, combined with the drug development capabilities of the Prometheus team, will provide promising therapeutics to patients around the world."

Tracey Mullen, Chief Executive Officer at Abveris

"Our team has been impressed by Abveris' exceptional level of scientific expertise and ability to discover and deliver antibodies with potential to translate into therapeutic candidates" said Olivier Laurent, Ph.D., Chief Technology Officer of Prometheus. "We look forward to continuing our partnership with Abveris to aid in our portfolio expansion with the common goal of bringing transformational therapies to patients."

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, starting first with inflammatory bowel disease (IBD). 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.

The Company's lead candidate, PRA023, is an IgG1 humanized monoclonal antibody (mAb) for the treatment of the two most common forms of IBD, Ulcerative Colitis (UC) and Crohn's Disease (CD). The Company has initiated enrollment in a Phase 2 trial in UC patients and a Phase 2a trial in CD patients, each utilizing a genetic-based companion diagnostic designed to identify patients more likely to respond to PRA023.

About Abveris
Abveris is Boston's premier antibody discovery company providing contract research services to the biopharma industry. Abveris applies advanced immunization methods combined with B cell screening and hybridoma-based antibody discovery technologies to provide comprehensive gene-to-antibody discovery services. Abveris is developing the next generation of biologics, cell therapies, vaccines, and diagnostics in partnership with global biopharma leaders. 


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Novaliq submits New Drug Application seeking approval for first-of-a-kind Dry Eye Disease Treatment CyclASol®

Novaliq GmbH | August 10, 2022

Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, announced the submission of a New Drug Application to the U.S. Food and Drug Administration seeking approval for CyclASol® a proposed novel treatment for the signs and symptoms of dry eye disease. CyclASol® has demonstrated in two pivotal studies fast onset of therapeutic effect in the indication, clinical meaningful improvement of ocular surface damage, and excellent tolerability. Results from a 12-month long-term study confirmed that the effects are maintained, and even improved for most sign and symptom endpoints. "This is the first submission of a novel product category of water-free topical drug therapies utilizing EyeSol® as a drug carrier. CyclASol® is a first-of-a-kind drug therapy and aims to expand treatment success for patients with dry eye disease and their eye care professionals. If approved by the FDA, CyclASol® addresses important unmet medical needs in DED through its ocular surface healing effect combined with high comfort of administration." Christian Roesky, Ph.D., CEO, Novaliq Dry eye is one of the most common ocular surface disorders, with approximately 18 million Americans diagnosed with DED.1,2 Inflammation and immunologic processes play a key role in the pathology of the disease. A compromised ocular surface secondary to DED may also compromise refractive measurements before keratorefractive and phacorefractive surgeries and adversely impact expected visual outcomes after these surgeries.3,4 The impact of the corneal surface damage secondary to DED on visual function is an underestimated aspect of the disease. Multiple guidelines recommend treatment of the corneal surface damage prior to ocular procedures. A high unmet need remains for better tolerated drugs with an early onset of therapeutic effect, which are compelling to be used and prescribed.5,6 "We are very proud to see another product rapidly moving to the market, which marks yet another important inflection point and milestone in Novaliq's growth trajectory", said Dr. Mathias Hothum, board member and managing director of dievini. "We are currently evaluating the commercialization strategies which includes talking to interested parties." About CyclASol® CyclASol® is a first-of-a-kind topical treatment of cyclosporine, a potent anti-inflammatory and selective immunomodulatory drug. Whilst not water-soluble, cyclosporine is soluble in the EyeSol® excipient perfluorobutylpentane allowing for its improved bioavailability and better efficacy on the target tissue. The product contains no oils, no surfactants and is preservative-free due to the novel carrier. This provides additional clinical benefits for patients, such as improved tolerability and decreased visual disturbances. The NDA is supported by safety and efficacy results in over 1,000 patients with DED from a Phase 2 dose finding study, the Phase 2b/3 ESSENCE-1 study, the Phase 3 ESSENCE-2 study and its open label extension study.7,8 CyclASol® has demonstrated in two independent adequate and well-controlled, multicenter studies clinically meaningful and statistically significant improvements in the indication. Effects on the ocular surface include a statistically significant reduction in total corneal fluorescein staining score favoring CyclASol® in both studies at Days 15 and 29. Up to 71.6% of patients responded within four weeks with a clinically meaningful improvement of ≥ 3 grades in total corneal staining. This proportion of responders was significantly higher compared to vehicle-treated patients in both studies. Responders showed also statistically significant improvements in a variety of symptoms compared to non-responders at day 29. The ASCRS guidelines recognize corneal staining as the single most important clinical sign of DED as it indicates the level of epithelial damage and visual impairment, and if left undertreated, DED can become chronic and more difficult to treat.3 Effect on tear production: In both studies, compared to vehicle at the end of treatment, there was a statistically significant (p<0.05) higher percentage of patients with increases of ≥ 10 mm from baseline in Schirmer's tear test score at Day 85 and Day 29, respectively, confirming a known effect of the active ingredient cyclosporine. Meeting this endpoint in two independent studies is clinically meaningful on its own and considered to demonstrate efficacy for the treatment of signs and symptoms of DED. Head-to-head data versus Restasis™ from the phase 2 study suggest that CyclASol® has a stronger and faster therapeutic effect on the ocular surface.8 Maintenance of effect results from the long-term study CYS-005 confirmed that the effect of CyclASol® was maintained, and even improved for most endpoints, over the 52-week treatment period. Safety and Tolerability: Tolerability of CyclASol® was shown by high drop comfort patient ratings in both studies. The most common adverse reaction observed was instillation site reactions, which was reported in 8.1% of patients in the pooled studies. These were in all but one case mild. The only other adverse reaction reported in > 2% of the patients was visual acuity reduced (2.7%). About Novaliq Novaliq is a biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free technology. EyeSol® is Novaliq's proprietary water-free technology using ultrapure semifluorinated alkanes (SFAs) that are physically, chemically, and physiologically inert with excellent biocompatibility and a very good safety profile. Novaliq offers an industry-leading portfolio addressing today's unmet medical needs of millions of patients with eye diseases.

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SOPHiA GENETICS Launches New Solution to Advance Chronic Lymphocytic Leukemia Care, in Collaboration with IDIBAPS

biotech, biotechnology, cell, gene, tissue | June 10, 2022

SOPHiA GENETICS (Nasdaq: SOPH), the Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) of Barcelona, and the Spanish Diagnóstica Longwood today announced from the European Hematology Association Congress in Vienna that they have combined their expertise to develop a new Chronic Lymphocytic Leukemia (CLL) solution to advance CLL care. This collaboration will unify the wide variety of current guideline recommendations into one single application aiming to improve CLL characterization and CLL research practices in Iberia. SOPHiA GENETICS has already facilitated the analysis of one million genomic profiles through the SOPHiA DDM™ Platform, including a significant amount of onco-hematological-related diseases such as acute myeloid leukemia and lymphomas. The Platform computes a wide array of genomic variants needed to continually hone machine learning algorithms designed to accurately detect rare and challenging cases. The growing number of users of the SOPHiA DDM™ community can share and access insights by pulling the relevant signals detected from the noise, ultimately saving time and helping to make better-informed decisions. The new CLL solution allows for progress of Chronic Lymphocytic Leukemia research using genomic analysis. This could lead to better detection of the disease, which accounts for 25-30% of all leukemia cases in Western countries and affects yearly more than 100,000 people globally[1], and ultimately improve patient care. Thanks to the SOPHiA DDM™ Platform and IDIBAPS, hematopathologists can now access guidelines for the mutational status of TP53, immunoglobulin (IG) gene rearrangements and their somatic hypermutation status, while benefitting from the identification of 23 CLL-specific genes for SNVs, InDels and CNVs including NOTCH1, SF3B1, ATM, IGLV3-21, BTK, PLCG2, BCL2, del13q14, and trisomy 12, all in one single NGS workflow. The new CLL solution has already been used in routine in Spain, with further opportunities throughout the country, and in Latin America through Diagnóstica Longwood's distribution channels. We are proud to work together with some of the most renowned experts in the field of Chronic Lymphocytic Leukemia research around the world. This partnership is a great example of how combining advanced data analytics with emerging CLL strategies can move the possibilities of data-driven medicine forward." Lara Hashimoto, Chief Business Officer at SOPHiA GENETICS. It is a great satisfaction to see how thanks to the partnership with SOPHiA GENETICS and Diagnóstica Longwood we will be able to transfer into clinical practice the relevant information generated for so many years in the research of CLL using a simple and robust assay." Elías Campo, principal investigator and director of IDIBAPS. About SOPHiA GENETICS SOPHiA GENETICS (Nasdaq: SOPH) is a healthcare technology company dedicated to establishing the practice of data-driven medicine as the standard of care and for life sciences research. It is the creator of the SOPHiA DDM™ Platform, a cloud-based SaaS platform capable of analyzing data and generating insights from complex multimodal data sets and different diagnostic modalities. The SOPHiA DDM™ Platform and related solutions, products and services are currently used by more than 790 hospital, laboratory, and biopharma institutions globally. About IDIBAPS The August Pi i Sunyer Biomedical Research Institute (IDIBAPS) is a biomedical research center of excellence that addresses the most common diseases in our environment. It is a public consortium comprising the Catalan Government (Generalitat de Catalunya), the Hospital Clínic Barcelona, the Faculty of Medicine and Health Sciences at the University of Barcelona and the CSIC Institute of Biomedical Research of Barcelona. About 1,500 professionals are organized in a hundred research groups. IDIBAPS undertakes translational research. It focuses on ensuring that the questions that arise at the patient's bedside have a response in the laboratory, and that advances made in the laboratory are promptly applied to patients. With over 1,200 articles published annually, it is the leading biomedical research center in Spain.

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Thermo Fisher Scientific and Qatar Genome Program Partner to Advance Precision Medicine

Thermo Fisher Scientific | May 24, 2022

Thermo Fisher Scientific, the world leader in serving science, and Qatar Genome Program (QGP), a member of Qatar Foundation (QF), have partnered with the goal of accelerating genomic research and clinical applications of predictive genomics in Qatar as a step toward expanding the benefits of precision medicine across Arab populations globally. Under the agreement, Thermo Fisher and Qatar Genome Program will develop an Axiom* custom genotyping array for pan-Arab populations using whole genome sequencing data from 19 Arab countries. The array, with about 800,000 variants, aims to help drive scientific research and insights into conditions including diabetes, cardiovascular and metabolic diseases, autism, inherited genetic disorders and cancer. Once available through Thermo Fisher’s global commercial channels in late 2022, the array is intended to provide a cost-effective alternative to whole genome sequencing for Arab populations, enabling increased diversity in large genome-wide studies. Qatar’s national vision is to provide a high standard of living for our people, and that includes providing access to genomics data, technology and insights to improve population health across the country, Our collaboration with Thermo Fisher will not only help us advance precision medicine in Qatar but also among people of Arab identity worldwide.” Dr. Radja Badji, genome operations manager at Qatar Genome Program. Thermo Fisher began working with Qatar Genome Program in 2018 to establish the first microarray designed specifically for the Qatari population. The Q-Chip detects genetic alterations that increase individuals’ risk of both prevalent and rare diseases. As part of the new agreement, the organizations will continue to refine algorithms and define clinically actionable content to assess polygenic risk scores, a measure of disease risk, and clinically relevant variants, including those related to pharmacogenomics. Thermo Fisher’s Axiom microarray technology is designed to help accelerate precision medicine, and we are honored to partner with the Qatar Genome Program as they take bold steps to leverage the power of genomics to improve the standard of care for human health, Together, we’re creating building blocks for implementing comprehensive precision medicine initiatives at scale for population health.” Chad Carter, vice president and general manager of microarray genetic solutions at Thermo Fisher Scientific. About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. About the Qatar Genome Program The Qatar Genome Program is an ambitious population-based project aimed at positioning Qatar among the pioneering countries in the implementation of precision medicine. Whole genome sequencing and other omics data is being combined with phenotypic data within the Qatar Biobank, providing a resource for breakthrough research discoveries and to help policy makers set future healthcare priorities for Qatar.

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