Vaxess Technologies | October 27, 2021
Vaxess Technologies, a biotechnology startup developing the MIMIXTM sustained-release intradermal microneedle patch, celebrated the grand opening of their 3,600 square feet pilot GMP (Good Manufacturing Practices) manufacturing facility on Monday. The facility, which is located in Woburn, MA at one of the Cummings Park properties, will feature a state-of-the-art cleanroom where manufacturing of vaccine patches for clinical trials will take place. Using the clinical-grade patches produced in the facility, Vaxess plans to enter the clinic in 2022. In addition to the manufacturing suite, Vaxess has announced plans to expand their Woburn footprint by another 6,300 square feet to provide additional GMP space as well as lab space for a host of other development activities to further the MIMI“ platform.
After years of development, the company is thrilled to establish GMP manufacturing capabilities in Massachusetts for both our lead MIMIX-Flu vaccine program as well as a host of other pipeline products to follow,” said Vaxess CEO Michael Schrader.
Vaxess has experienced tremendous growth over the past year beyond the opening of the manufacturing facility including technological advancement of the platform and the expansion of the organization from 15 full time employees to 35 with additional future growth planned. All the progress that Vaxess has made this past year would not have been possible without the help of the Massachusetts Life Sciences Center (MLSC), which has supported Vaxess’ efforts since its inception. MLSC President and CEO, Kenn Turner, attended the Grand Opening and shared a few words.
“I want to congratulate the Vaxess team on their latest expansion to Woburn Since the Life Science Center’s initial investment in Vaxess, the company has exemplified the type of growth trajectory we aim to accelerate here in the Commonwealth. We will continue to lean in, and support companies seeking to create jobs and expand their footprint regionally, particularly in the manufacturing space.”
Massachusetts Life Sciences Center President and CEO Kenn Turner
In addition to Turner, numerous other individuals from both the Massachusetts biotechnology and political communities attended the event, including Joe Boncore, President of MassBio, Bill Cummings, Founder of Cummings Properties, Eric Anderson, President of Cummings Properties, Scott Galvin, Mayor of Woburn, Representative Richard Haggerty and Senator Cindy Friedman.
“I want to congratulate Vaxess Technologies on their continued job growth and expansion, which offers further proof that opportunities for innovation in life sciences are truly statewide in Massachusetts,” said Massachusetts Housing and Economic Development Secretary Mike Kennealy, who serves as Co-Chair of the MLSC Board of Directors. “The Baker-Polito Administration remains committed to supporting life sciences companies that recognize Massachusetts as the ideal place for companies to grow and thrive.”
About the MIMIX™ Technology
The MIMIX patch is designed to be the easiest and most effective way to deliver vaccines and therapeutics. The patch releases treatments to the body at their most beneficial rate and duration. For vaccines, the controlled release simulates the pace of a natural infection, helping the body produce a slow, strong, and enduring ramp-up of immune response, ultimately boosting a vaccine’s effectiveness. Engineered for stability, Vaxess’ patch does not require refrigeration and can be shipped to and applied in low resource settings. It is virtually painless and resembles an adhesive bandage. After the minutes-long prescribed wear time, the MIMIX patch is removed and discarded while leaving behind microscopic intradermal depots to present the therapeutic payloads to the immune system over ensuing days or weeks.
About Vaxess Technologies
Vaxess Technologies is developing the MIMIX™ sustained release patch technology, originally conceived at MIT and Tufts University. MIMIX™ uses the unique qualities of silk proteins and breakthrough immune activating biology to enable best-in-class vaccines and therapeutics. Vaxess has raised more than $60M in grant and venture capital funding from groups such as The Engine, BARDA, DARPA, NIH, NSF and the Gates Foundation. A MIMIX Phase I proof-of-concept trial using seasonal flu and COVID-19 antigens is slated to begin in the first half of 2022.
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
BioInvent | December 22, 2020
BioInvent International AB ("BioInvent") (OMXS: BINV), a biotech organization focused in on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, and Transgene (Euronext Paris: TNG), a biotech organization that designs and develops infection based for the therapy of cancer, reported they have received administrative endorsement in Belgium for a clinical trial application (CTA) for a Phase l/lla study of the novel oncolytic vaccinia virus BT-001.
BT-001 is a best-in-class oncolytic Vaccinia virus. It has been produced utilizing Transgene's Invir.IO™ stage and its protected large-capacity VVcopTK-RR-oncolytic virus, which has been designed to encode both a Treg- depleting human recombinant anti-CTLA4 antibody response created by BioInvent's proprietary n-CoDeR®/F.I.R.S.T™ stages, and the human GM-CSF cytokine. By specifically focusing on the tumor microenvironment, BT-001 is relied upon to inspire a lot more grounded and more successful antitumoral reaction. Conveying the anti-CTLA4 antibody response straightforwardly to the tumor microenvironment will permit a neighborhood remedial movement and will in this manner enormously increment the security and tolerability profile of the monoclonal immunizer by antibody foundational introduction. BT-001 is being co-created through a 50/50 collaboration among BioInvent and Transgene.