CELL AND GENE THERAPY, INDUSTRIAL IMPACT
ImmunoGen, Inc. | March 02, 2023
On March 1, 2023, ImmunoGen, Inc., a leading firm specializing in antibody-drug conjugates (ADCs), announced a global, multi-target license and option agreement with Vertex Pharmaceuticals. The deal provides Vertex with the rights to use ImmunoGen's ADC technology to research and discover targeted conditioning agents to be used in gene editing.
After each research period, Vertex will have the option to obtain an exclusive worldwide license to research, develop, and commercialize conditioning agents using ImmunoGen's technology for that target. ImmunoGen will hol full rights to the ADC technology for any targets not covered by the Vertex license.
Vertex will pay an upfront payment of $15 million as part of the agreement. In addition, ImmunoGen is eligible to receive up to $337 million in option exercise fees, development, and commercial milestone payments for each target. ImmunoGen will also receive tiered royalties as a percentage of worldwide commercial sales of licensed targeted conditioning agents by Vertex. Vertex will be responsible for all research, development, and commercialization costs.
ImmunoGen's Executive Vice President, Research, Development, and Medical Affairs, Michael Vasconcelles, MD, commented, "Given Vertex's extensive experience discovering and developing transformative medicines for patients with serious diseases, we are thrilled they have chosen to explore ImmunoGen's technology to develop ADCs for transplant conditioning in connection with gene editing." He further emphasized, "This agreement reflects our continued innovation in the ADC space and demonstrates the value of our technology platform and related intellectual property."
(Source – Business Wire)
About ImmunoGen, Inc.
ImmunoGen is dedicated to improving the lives of people with cancer by developing precise, targeted cancer therapies. Its lead product candidate is a first-in-class ADC called mirvetuximab soravtansine, which targets folate receptor alpha (FRα) and is being studied in multiple ovarian cancer trials. The company's second program, IMGN632, is a CD123-targeting ADC being studied for the treatment of BPDCN and AML. ImmunoGen is also developing two earlier-stage assets: IMGC936, an ADAM9-targeting ADC co-developed with MacroGenics, and IMGN151, a next-generation anti-folate receptor alpha ADC. The company aims to keep cancer from disrupting people's lives and get them back to living today, tomorrow, and beyond.
CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Evaxion Biotech A/S | January 23, 2023
Evaxion Biotech A/S, a leading clinical-stage biotechnology firm focused on the development of AI-driven immunotherapies, recently announced that FDA has granted fast-track designation for the Company's customized cancer therapy, EVX-01, in conjunction with KEYTRUDA®.
In December 2022, Evaxion gained FDA clearance to proceed with its phase 2b clinical test, where patients with metastatic melanoma are given EVX-01 in combination with KEYTRUDA®. In addition, Evaxion obtained fast-track designation for the vaccine candidate on January 17, 2023. The fast track is developed to expedite FDA's assessment of innovative, novel medications with the potential to meet an unfulfilled medical need.
EVX-01, a peptide-based immunotherapy for cancer, is Evaxion's most advanced clinical asset. The program generates a unique medicine for each patient based on gene analysis of their malignancies and matching with their immune system. The Company's proprietary AI platform, PIONEER, helps facilitate this process.
Per Norlén, CEO at Evaxion, commented," We are extremely pleased that our cancer vaccine candidate EVX-01 has received the FDA fast track designation, as it enables a potentially faster approval of the vaccine. This is first and foremost to the benefit of the patients. And it is a great validation of our AI platform, PIONEER, and our drug development candidate."
(Source – Globe Newswire)
The ongoing Phase 2b clinical trial is being done at sites in Europe, the United States, and Australia. It is conducted in partnership with Merck, which supplies its PD-1 inhibitor KEYTRUDA®. The trial was launched in Australia when the first patient was enrolled in September 2022.
About Evaxion Biotech A/S
Evaxion is a clinical-stage AI-immunology™ platform company using AI, engineering expertise and drug development knowledge to identify and develop novel immunotherapies for the treatment of various cancers, bacterial diseases and viral infections. It has utilized artificial intelligence to build a diverse pipeline of candidate immunotherapies that target two of the most critical unmet medical needs in the world, cancer and infectious diseases. Its three proprietary AI platforms include PIONEER, EDEN and RAVEN.
CELL AND GENE THERAPY, MEDICAL
Be The Match BioTherapies® | January 18, 2023
On January 17, 2023, Be The Match BioTherapies, a company that provides solutions for organizations that develop and commercialize cell and gene therapies, introduced its offering of CIBMTR® clinical research organization services (CRO services), which significantly reduces the time needed to launch and execute high-impact clinical trials.
These CRO services are the outcome of a collaboration between Be The Match BioTherapies and CIBMTR, resulting in expertise and access to unmatched research, sites, donors, partnerships, scientific and operational knowledge, and other resources.
CIBMTR CRO services offer unique capabilities such as
Established relationships with over 225 clinical locations domestically
Nearly 20 years of expertise in transplant and cellular therapy trials and study management, as well as clinically-trained staff
On-staff transplant physicians provide direct contact with patients and donors for clinical and research insights.
A link to the CIBMTR outcomes database for over 575,000 patients
The new CRO services offer turn-key solutions, including protocol development and approval oversight, site selection, project management, site start-up, research sample/laboratory coordination, data management, study monitoring, patient-reported outcomes, statistical analysis, and financial administration. For certain services, such as data analysis, surveys, site selection and administration, and sample management, businesses may instead rely on the expertise of CIBMTR CRO services.
About Be The Match BioTherapies®
Be The Match BioTherapies is the sole supplier of cell and gene therapy solutions with fully configurable services to assist the cell therapy supply chain. It is committed to accelerating patient access to life-saving cell and gene treatments by delivering the best-quality cellular source material from Be The Match Registry®, the most-varied registry of prospective blood stem cell donors in the world, with over 7 million potential blood stem cell donors. Through global collaborations with apheresis, bone marrow collection, and transplant centers, the firm creates, onboards, trains, and maintains extensive collection networks to advance cell treatments.