eTheRNA | February 04, 2022
eTheRNA immunotherapies NV ("eTheRNA") is pleased to announce the start of a strategic partnership with Merck KGaA, Darmstadt, Germany with the signing of a Research Agreement. The partnership will investigate the application of eTheRNA's proprietary mRNA design expertise and LNP-delivery platforms to disease areas selected by Merck KGaA, Darmstadt, Germany.
The ongoing pandemic has underlined the capability for mRNA vaccines as a new therapeutic modality. eTheRNA and Merck KGaA, Darmstadt, Germany both recognise the potential for using targeted mRNA therapeutics in an expanded range of diseases. With this collaboration, eTheRNA and Merck KGaA, Darmstadt, Germany will assess the feasibility of using eTheRNA's mRNA and LNP technologies to develop therapeutic vaccination approaches in models of disease. If successful, mRNAs encoding antigens nominated by Merck KGaA, Darmstadt, Germany and directly relevant for human diseases will then be designed and evaluated preclinically.
"We are extremely pleased to sign this partnership agreement with Merck KGaA, Darmstadt, Germany, a leading German science and technology company. As two companies committed to innovation and creating patient focused solutions, we are excited about the many advantages such a partnership can offer to improve patient care and address a significant market need".
Steven Powell, eTheRNA CEO
About eTheRNA immunotherapies
eTheRNA immunotherapies NV is developing immunotherapy and vaccine products for the treatment of cancer and infectious disease from its mRNA chemistry, antigen identification, lipid chemistry and delivery and process engineering platforms. The company is headquartered in Belgium and was established in 2013. Its founding shareholders include Progress Pharma and VUB. eTheRNA is supported by an international group of specialised investors; BNP Fortis Private Equity, Boehringer Ingelheim Venture Funds, Everjoy Fortune PTE. LTD, Grand Decade Development Limited, Fund+, LSP, Novalis Lifesciences, Omega Funds, PMV and Ying Zhou Enterprise Management Company Limited who share the Company's ambition to build a world-leading company in the RNA field. To date, the Company has raised €63 million of venture funding.
Enteris BioPharma | May 04, 2021
Enteris BioPharma, Inc., a biotechnology company developing innovative drug products based on its proprietary delivery technologies and a wholly-owned subsidiary of SWK Holdings Corporation, announced today the expansion of its Boonton, NJ manufacturing facility and the launch of its CDMO business segment, which provides custom solutions for the formulation, growth, and manufacturing of pharmaceuticals. Enteris also offers bench to market facilities, such as the development, manufacturing, monitoring, and release of Phase 1 to Phase 3 clinical trial supplies, as well as commercial products.
The 32,000-square-foot expanded facility includes 6,000 square feet of cleanroom space, with approximately 2,500 square feet devoted to the containment and processing of high potency API (HPAPI).
"This is a huge achievement for Enteris and will play an important role in our future growth plans," said Rajiv Khosla, Ph.D., Chief Executive Officer of Enteris. "Our purpose-built manufacturing facility will now manufacture CTM up to Phase 3, as well as product for commercial launch. These enhanced capabilities place Enteris to take advantage of a range of growth opportunities, and we plan to fully utilize this opportunity. Enteris will now seek deeper development and manufacturing collaborations with partners by offering custom solutions from bench to market."
The HPAPI containment area at the manufacturing plant is planned to safely accommodate highly potent APIs. Depending on the physical properties of the solid oral dosage unit, batch sizes can range from a few hundred to hundreds of thousands of dosage units. The facility also features 1,700 square feet of flexible suite space that can be customized to meet the development and manufacturing needs of a partner.
"Delivering on a construction timetable during the COVD-19 pandemic was no easy task, and the Enteris team is to be applauded for fulfilling the challenge," said Paul Shields, Ph.D., Enteris' Chief Operating Officer. "We look forward to using the enhanced manufacturing capabilities to deepen existing manufacturing relationships and strengthen our ability to secure new high-value relationships with companies seeking CDMO capabilities in the United States, regardless of whether the product is a solid oral formulation using our proprietary oral formulation technologies, Peptelligence® or ProPermaTM, or other tablet technology."
About Enteris BioPharma
Enteris BioPharma, Inc. is a wholly-owned subsidiary of SWK Holdings Corporation that provides complete integrated contract development and manufacturing (CDMO) services, including creative formulation methods that use its patented drug delivery technologies, Peptelligence® and ProPermaTM. Numerous feasibility trials and successful research projects have been conducted on the technologies, with many of them now in late-stage clinical development. Furthermore, Enteris BioPharma is developing an internal product pipeline of oral tablet reformulations of drug products that target significant treatment opportunities that do not have an oral delivery option.Ovarest® (oral leuprolide tablet), Enteris BioPharma's most advanced internal product candidate, is an oral peptide being developed for the treatment of endocrine disorders. Enteris BioPharma is also developing TobrateTM (oral tobramycin tablet) for the treatment of uncomplicated urinary tract infection (uUTI).
CELL AND GENE THERAPY
BOSTON LABS | September 23, 2021
Clinical logistics and life science manufacturing leaders Boston Labs and Germfree Laboratories Inc. announced their partnership to launch a new network of mobile CGT manufacturing facilities. The two companies are combining deep logistics, CGT manufacturing expertise and mobile cleanroom technology to deliver CGT point-of-care contract manufacturing services.
The CGT mobile manufacturing platform will launch in Boston, MA in the fourth quarter of 2021 and will scale to a network of global point-of-care mobile contract manufacturing centers.
Boston Labs is embedded within the Boston/Cambridge life science community which is home to more than 1000 biotech companies. 18 of the top 20 biopharmas have a major presence in the area, including Biogen, Novartis, Sanofi and Takeda and other leading companies such as Moderna, Crispr Therapeutics, bluebird bio and Avrobio.
As the cell and gene therapy industry continues to grow, easier on-site access to cleanroom manufacturing facilities will likely be highly valued. Our pivotal partnership with Germfree Laboratories, Inc. enables Boston Labs to readily deploy mobile manufacturing platforms to any clinical site globally where CGT trials are enrolling, eliminating logistical risks associated with transporting patient material under a critical timeline. This is the Future of Point-of-Care Cell and Gene Therapy Delivery.
- Jon Mason, CEO of Boston Labs
This groundbreaking collaboration with Boston Labs should deliver much needed process space and opportunities to showcase how next-generation cleanrooms and manufacturing facilities can accelerate the processes needed for the future.
- Kevin Kyle, CEO of Germfree
This partnership, designed to reduce client CGT manufacturing costs and complexities, delivers secure access to mobile GMP-compliant manufacturing facilities wherever they are needed.
About Boston Labs:
Founded in 2003, Boston Labs is a leading clinical logistics company, working with clients to streamline the complexities of biotech and pharmaceutical logistics and manufacturing.
Germfree Laboratories Inc. creates environments that serve life science innovation and advance global health. They design and manufacture flexible cGMP-compliant cleanroom buildings and high containment facilities which are process or containment ready upon deployment.