RESEARCH

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

Abveris, Biosciences | November 12, 2021

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

Spotlight

The launch of the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) is a milestone in FDA’s efforts to assure that quality medicines are available to the American public. As a new super-office within CDER, OPQ is strategically organized to streamline regulatory processes, advance regulatory standards, align areas of expertise, and originate surveillance of drug quality. Supporting these objectives will be an innovative and systematic approach to product quality knowledge management and informatics.

Spotlight

The launch of the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) is a milestone in FDA’s efforts to assure that quality medicines are available to the American public. As a new super-office within CDER, OPQ is strategically organized to streamline regulatory processes, advance regulatory standards, align areas of expertise, and originate surveillance of drug quality. Supporting these objectives will be an innovative and systematic approach to product quality knowledge management and informatics.

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CELL AND GENE THERAPY

Graphite Bio Enrolls First Patient in Phase 1/2 Clinical Trial of GPH101 for Sickle Cell Disease

Graphite Bio | November 26, 2021

Graphite Bio, Inc. a clinical-stage, next-generation gene editing company focused on therapies that harness targeted gene integration to treat or cure serious diseases, announced that the first patient has been enrolled in the company’s Phase 1/2 clinical trial of GPH101, an investigational gene-edited autologous hematopoietic stem cell therapy designed to directly correct the genetic mutation that causes sickle cell disease. The company expects to treat the first patient with GPH101 in the first half of 2022, with initial proof-of-concept data anticipated by the end of 2022. “GPH101 is the first investigational therapy to enter clinical development that uses our next-generation gene editing platform technology to directly correct the mutation in the beta-globin gene that causes sickle cell disease. Using our gene correction approach, we have demonstrated in preclinical studies an ability to decrease the production of harmful sickle hemoglobin and restore the expression of normal adult hemoglobin. This approach has the potential to restore normal physiology and is viewed as the gold standard for curing sickle cell disease. We are thrilled that our first patient is now enrolled in our CEDAR clinical trial, and we look forward to evaluating GPH101’s potential as we continue to advance its development with urgency in hopes of delivering a curative therapy to the sickle cell community.” Josh Lehrer, M.Phil., M.D., chief executive officer at Graphite Bio The CEDAR trial is an open-label, multi-center Phase 1/2 clinical trial of GPH101 designed to evaluate the safety, engraftment success, gene correction rates, total hemoglobin, as well as other clinical and exploratory endpoints and pharmacodynamics of GPH101 in patients with severe SCD. The trial will enroll approximately 15 adult and adolescent participants at up to five clinical trial sites in the United States. Graphite Bio will present information about the CEDAR trial at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition, being held virtually and in Atlanta December 11-14. The company’s poster presentation will take place on Saturday, Dec. 11, at 5:30-7:30 p.m. ET. About Sickle Cell Disease (SCD) SCD is a serious, life-threatening inherited blood disorder that affects approximately 100,000 people in the United States and millions of people around the world, making it the most prevalent monogenic disease worldwide. SCD is caused by a single mutation in the beta-globin gene that leads red blood cells to become misshapen, resulting in anemia, blood flow blockages, intense pain, increased risk of stroke and organ damage, and reduced life span of approximately 20-30 years. Despite advancements in treatment and care, progressive organ damage continues to cause early mortality and severe morbidity, highlighting the need for curative therapies. About GPH101 GPH101 is an investigational next-generation gene-edited autologous hematopoietic stem cell (HSC) therapy designed to directly correct the genetic mutation that causes sickle cell disease (SCD). GPH101 is the first investigational therapy to use a highly differentiated gene correction approach that seeks to efficiently and precisely correct the mutation in the beta-globin gene to decrease sickle hemoglobin (HbS) production and restore normal adult hemoglobin (HbA) expression, thereby potentially curing SCD. Graphite Bio is evaluating GPH101 in the CEDAR trial, an open-label, multi-center Phase 1/2 clinical trial designed to assess the safety, engraftment success, gene correction rates, total hemoglobin, as well as other clinical and exploratory endpoints and pharmacodynamics in patients with severe SCD. About Graphite Bio Graphite Bio is a clinical-stage, next-generation gene editing company harnessing high efficiency targeted gene integration to develop a new class of therapies to potentially cure a wide range of serious and life-threatening diseases. Graphite Bio is pioneering a precision gene editing approach that could enable a variety of applications to transform human health through its potential to achieve one of medicine’s most elusive goals: to precisely “find & replace” any gene in the genome. Graphite Bio’s platform allows it to precisely correct mutations, replace entire disease-causing genes with normal genes or insert new genes into predetermined, safe locations. The company was co-founded by academic pioneers in the fields of gene editing and gene therapy, including Maria Grazia Roncarolo, M.D., and Matthew Porteus, M.D., Ph.D.

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MEDTECH

Avantor® will Increase Global Production of Single-Use Technologies to Meet the Biopharma Demand

Avantor | April 27, 2021

Avantor Inc., a main worldwide supplier of crucial items and administrations to clients in the existing sciences, trend-setting innovations, and applied materials businesses, today declared that it will increment worldwide limit with regards to top-notch single-use advances utilized in the creation of biologics and antibodies. In the U.S. what's more, in Europe, the Company will build its single-use producing impression by 30% and twofold its cleanroom space. The speculation will uphold developing client interest for monoclonal antibodies (mAbs), novel cell and quality treatments for oncology and different illnesses, just as immunizations, including those for COVID-19. Avantor as of late extended its Morrisville, North Carolina, single-use office and expects finish of a cleanroom extension at its Devens, Massachusetts, activity by mid-year. The Company likewise hopes to open its subsequent European single-use office in Hillegom, the Netherlands, by then too. Dr. Ger Brophy, Executive Vice President of Biopharma Production at Avantor, said, "The business' reaction to the COVID-19 pandemic has depended intensely on the incorporation of single-use items into biopharma creation measures. Adequacy and security are critical to our clients, and they look to us to comprehend and uphold their prerequisites as they quickly extend their assembling limit. "These options to our worldwide single-use fabricating biological system are basic strides in empowering our clients to get treatments to patients rapidly," Brophy added. The speculation further fortifies the Company's single-use organization, giving item consistency and abilities near bioproduction clients to help guarantee productive and continuous stock. About Avantor Avantor®, a Fortune 500 organization, is a main worldwide supplier of strategic items and administrations to clients in biopharma, medical care, training and government, and trendsetting innovations and applied materials enterprises. Our portfolio is utilized in essentially every phase of the main examination, advancement, and creation exercises in the enterprises we serve. Our worldwide impression empowers us to serve more than 225,000 client areas and gives us broad admittance to explore research facilities and researchers over 180 nations. We set science underway to make a superior world.

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MEDTECH

FDA Grants ILiAD Biotechnologies Fast Track Designation for Next Generation Pertussis Vaccine BPZE1

ILiAD Biotechnologies | January 04, 2022

ILiAD Biotechnologies, a late stage biotech development company focused on global eradication of disease due to Bordetella pertussis, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BPZE1, a next generation vaccine for active booster immunization against pertussis. BPZE1 is the most advanced next generation pertussis vaccine currently in clinical development. Developed in the laboratory of Camille Locht, PhD, at the Institut Pasteur de Lille and French National Institute of Health and Medical research BPZE1 is a live-attenuated intranasal vaccine designed to overcome deficiencies of current pertussis vaccines, including poor durability of protection and failure to prevent nasopharyngeal Bordetella pertussis infections that lead to escape mutants and transmission to vulnerable infants. Four clinical trials studying BPZE1 in healthy adults have been completed to date, including positive topline results from a 300-participant adult Phase 2b trial demonstrating that BPZE1 induced durable mucosal immunity and reduced nasal colonization — two key factors necessary for the prevention of transmission and reduction of epidemic pertussis cycles. Earlier this month, the Company also announced initiation and enrollment of the first participants in the BPZE1 SUPER Trial (Standing Up to PERtussis) – the fifth clinical BPZE1 study and the first study in school-age children. Section 506(b) of the FD&C Act provides for the designation of a drug as a Fast Track product “…if it is intended, whether alone or in combination with one or more other drugs, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition.” Fast Track provides opportunities for frequent Company interactions with the FDA and the potential for accelerated approval and priority review. “We are pleased that the FDA is aligned with ILiAD’s position that there is an unmet clinical need for a more effective pertussis vaccine and that the evidence to date supports the potential for BPZE1 to address the major gaps in protection against pertussis. We look forward to continuing to work with the FDA and other global Regulatory Agencies to further clinical development of BPZE1 and to safely and efficiently bring BPZE1 to US and global markets.” Dr. Keith Rubin, Chief Executive Officer of ILiAD. Dr. Rubin About Pertussis Pertussis is a life-threatening disease caused by the highly contagious respiratory bacterium Bordetella pertussis. According to U.S. Centers for Disease Control and Prevention, each year pertussis affects approximately 16 million people globally, accounting for nearly 200,000 deaths. Although estimated global vaccination coverage is 84%, current vaccines have failed to control epidemics. In addition, current vaccines do not fully protect infants under age 6 months, since immunization requires multiple injections, usually at 2, 4 and 6 months. About BPZE1 BPZE1 is a next-generation live-attenuated pertussis vaccine designed to induce comprehensive and durable protection against B. pertussis infection and disease. BPZE1 is being developed to block B. pertussis from colonizing adult and adolescent nasal passages, to protect adults and adolescents from whooping cough, and to potentially prevent transmission, including transmission to infants. While ILiAD is currently focused on developing a vaccine to directly protect adults and adolescents and to indirectly protect vulnerable infants, future development aims to immunize neonates directly. About Fast Track Designation Fast Track Designation by the U.S. FDA is a process designed to facilitate the development and expedite the review of investigational products to treat serious conditions and fill an unmet medical need, with the intent of getting important new products to the population in an expedited manner. Specifically, Fast Track Designation provides the option of licensure via the accelerated approval pathway, which allows licensure based on surrogate endpoints. Additionally, Fast Track designation facilitates meetings with the FDA to discuss all aspects of development to support licensure and provides the opportunity to submit sections of a BLA on a rolling basis as data become available. This permits the FDA to review modules of the BLA as they are received instead of waiting for the entire BLA submission. Priority review is an additional benefit that may potentially be available for BPZE1 as part of the Fast Track designation. About ILiAD Biotechnologies, LLC ILiAD Biotechnologies is a privately held, clinical stage biotechnology company dedicated to the prevention and treatment of human disease caused by Bordetella pertussis. The company is developing and acquiring key technologies, working with leading scientists to overcome the limitations of current vaccines, investigating the impact of B. pertussis in a range of human disease, and is focused on validating its proprietary vaccines in human clinical trials.

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