INDUSTRIAL IMPACT, MEDICAL
Kymanox | February 06, 2023
Kymanox, a leading life science-focused professional services firm, recently announced the acquisition of anteris medical GmbH and anteris helvetia AG (collectively anteris). Anteris specializes in assisting the commercialization and development of medical equipment, combination and in-vitro diagnostic products.
This acquisition enables both firms to achieve their common organizational goal of geographic expansion while enhancing their service capabilities by offering clients a greater range of highly specialized services. Customers who bring essential biologics, such as pharmaceuticals, cell and gene therapies (C>s) and biosimilars, medical devices, and drug/device combos to global markets will benefit significantly from the combined service offerings and office locations of the combined firms. In addition, by merging the technological, scientific, and regulatory expertise of both organizations, customers will actually benefit from this synergy to ensure FDA, EMA, Notified Bodies, and other health authorities' compliance and submission excellence.
Anteris, with its offices in Holzkirchen, Germany, and Küssnacht a.R., Switzerland, offers resource-efficient and innovative solutions for end-to-end development, technical documentation, and compliance to the life science and medical device sectors. Members of Anteris' technical, quality, and regulatory teams have decades of collective expertise in combination product and device development, with a focus on biosimilar development and registration, MDR, EU, CE marking, 510(k) submissions, and quality systems regulations across all key markets.
Founded in 2004, Kymanox is a life science professional services firm that provides scientific, engineering, project management, quality, human factors, testing/CQV, QC, and regulatory assistance to firms in the biotechnology, pharmaceutical, medical device, and combination product sectors. It assists in getting products from the bench to the patient and distinguishes itself by providing a wide variety of technical services and products as well as comprehensive project implementation. The company offers its services to clients worldwide from its headquarters in Raleigh (RTP), North Carolina, as well as offices throughout the United States.
MEDTECH, INDUSTRIAL IMPACT
Atreca, Inc. | February 07, 2023
On February 6, 2023, Atreca, Inc. (Atreca), a biotechnology company that develops novel therapeutics through a deep understanding of the human immune response, with a focus on innovative novel cancer immunotherapeutics, and Xencor, Inc., a clinical-stage biopharmaceutical company that develops cytokines and engineered antibodies for the treatment of autoimmune diseases and cancer, announced, as part of their existing strategic collaboration, that they have mutually selected the first program combining an Atreca-discovered antibody with Xencor's XmAb® bispecific Fc domain and a cytotoxic T-cell binding domain (CD3).
The initiative announced is the first of up to two collaborative programs that can be selected by mutual agreement for future development and commercialization, with each partner sharing 50% of expenses and earnings. This program's clinical development, regulatory, and commercialization operations will be led by Atreca, while Xencor will lead the second prospective joint program. Furthermore, the agreement permits each partner to pursue up to two collaborative programs separately.
The unveiled joint program is based on APN-346958, an antibody discovered by Atreca. APN-346958 targets a new RNA-binding protein and is tumor-reactive in at least 50% of samples for six tumor types tested: thyroid, colorectal, head and neck, melanoma, urothelial, and brain cancer. In preclinical tests, the XmAb bispecific antibodies engineered against the target of APN-346958 displayed substantial anti-tumor activity. Atreca and Xencor hope to name a candidate from the program later this year, with Atreca aiming for an investigational new drug (IND) application in early 2025.
Founded in 2011, Atreca is a biopharmaceutical firm that employs its distinct discovery platform to create innovative antibody-based immunotherapeutics. Its Immune Repertoire CaptureTM (IRCTM) technology provides unmatched insight into how cancer patients' immune responses can lead to improved clinical outcomes offering access to an undiscovered terrain in oncology. Atreca was created by industry leaders, scientists, and investors who believe that unlocking today's patients' immune responses is the key to developing a new generation of therapies.
Resilience | February 20, 2023
National Resilience, Inc. (Resilience), a manufacturing company with a technology-focused mission to improve access to complex medications, recently announced a 10-year biomanufacturing partnership with a top pharmaceutical company for its portfolio of services in process and analytical development, drug substance manufacturing, and drug product manufacturing. The extensive agreement covers prospective biologic, vaccine, nucleic acid, cell, and gene therapy manufacturing.
Resilience’s recently acquired facility in Cincinnati, Ohio, is its worldwide center of excellence to produce commercial medicinal products, and will deliver the first product as stipulated under the agreement. The development of complicated pharmaceuticals, such as cell and gene therapies, has not kept up with the rate of scientific advancements that are supporting them. Resilience brings together exceptional minds in science and engineering to bridge this gap with access to state-of-the-art technology.
Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience, said, “The partnership announced today is a major milestone for Resilience.” He further added, “We are grateful to have this opportunity to work with our partner to deliver important, life-saving medicines to patients. We understand the trust placed with us to manufacture the medicine with the highest quality, regulatory compliance, and reliability. We are committed to maintaining a responsible manufacturing operation that exceeds the expectations of our partners and enables us to make a meaningful impact on global healthcare.”
(Source – Business Wire)
With the addition of this alliance to its expanding commercial portfolio, the company anticipates generating record revenues in 2023.
Resilience is a technology-focused biomanufacturing startup. The company intends to increase access to sophisticated medications. The firm is establishing a long-term network of cutting-edge, all-inclusive manufacturing solutions to guarantee that the therapies of today and the future may be produced efficiently, securely, and at scale. Resilience aims to continuously develop the science of biopharmaceutical manufacture and development, so their partners concentrate on the discoveries that enhance patients' lives and safeguard biopharmaceutical supply chains from future disruptions.