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.
Magenta Therapeutics | February 03, 2023
On February 2, 2023, Magenta Therapeutics, a clinical-stage biotech firm focused on enhancing stem cell transplantation, announced that it has completed a business evaluation, including a review of its programs, resources, and capabilities. Magenta has decided to cease further program development and conduct a complete examination of strategic alternatives aimed at maximizing shareholder value.
Magenta will investigate potential strategic options, including, but not limited to, merger, an acquisition, business combination, or other transaction, as part of this review process. There can be no certainty that this review process will result in Magenta seeking a deal or that any such deal if pursued, will be completed on favorable terms.
Magenta has not established a deadline for completing this review process and intends to speak further only if and when the Board of Directors has approved a clear course of action, the review process is completed, or another disclosure is considered to be appropriate.
About Magenta Therapeutics
Founded in 2016, Magenta Therapeutics is a clinical-stage biotechnology firm that develops therapies to help more patients with blood cancers, genetic diseases, and autoimmune diseases benefit from the curative power of stem cell transplant. Magenta is revolutionizing immunological reset for more patients by combining leadership in stem cell biology and biotherapeutics research with clinical and regulatory expertise, a new business model and vast networks in the stem cell transplant community.
INDUSTRIAL IMPACT, DIAGNOSTICS
Kite Pharma and Arcellx | January 31, 2023
On January 30, 2023, Kite and Arcellx, Inc. informed that they have completed their previously-announced global strategic collaboration to co-develop and co-market CART-ddBCMA.
CART-ddBCMA is Arcellx's lead late-stage candidate for treating patients with relapsed or refractory multiple myeloma.
For the majority of patients, multiple myeloma is an incurable disease; hence, there is a continuing demand for treatments that are not only effective but also secure and easily available.
Arcellx's T-cell treatment, CART-ddBCMA, uses the company's unique synthetic binder, the D-Domain, and is now being studied in Phase 2 pivotal trials. Kite and Arcellx will work together to develop and market the CART-ddBCMA asset in the United States, while Kite will handle sales and marketing for the product in all other regions.
About Kite Pharma
Kite, a Gilead company, is a global biopharmaceutical company with its headquarters in Santa Monica (California). Cell therapy, which aims to treat and maybe even cure cancer, is the company's main area of research and development. Kite, the industry leader in cell therapy, has successfully administered CAR T-cell treatment to more patients than any other company. Process development, vector production, clinical trial supply, and commercial product manufacturing are all part of Kite's expansive in-house cell therapy manufacturing network, the most extensive in the world.
Clinical biotechnology firm Arcellx, Inc. is rethinking cell treatment by developing novel immunotherapies for patients with cancer and other fatal diseases. The company considers cell therapies one of the most promising areas of modern medicine. Its goal is to improve the quality of life for people everywhere by creating safer, more effective, and widely available cell therapies. CART-ddBCMA is the principal product candidate being developed by Arcellx and is now in Phase 2 pivotal trials for treating relapsed or refractory multiple myeloma (r/r MM). The FDA has recognized CART-potential ddBCMAs by designating them as a regenerative medicine advanced therapy, an orphan drug, and a fast-track product.