Entos Pharmaceuticals, Inc., BioMarin | November 16, 2021
Entos Pharmaceuticals, Inc. (Entos), a clinical-stage biotechnology company developing genetic medicines with its Fusogenix proteolipid vehicle (PLV) nucleic acid delivery platform, and BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that they have entered into an agreement that will see Entos apply its Fusogenix nucleic acid delivery technology to promising gene therapy candidates in the BioMarin pipeline. Under the agreement, Entos will create specially formulated product candidates for BioMarin, a world leader in developing and commercializing innovative biopharmaceuticals for genetic diseases driven by genetic causes.
Entos' Fusogenix platform utilizes a PLV formulation with a novel mechanism of action to deliver molecular payloads, intact and unmodified, directly into target cells. By combining well-tolerated neutral lipids with proprietary fusion-associated small transmembrane (FAST) proteins, the Fusogenix platform efficiently delivers mRNA or DNA to target tissue with excellent tolerability. Fusogenix technology has been applied to a wide range of therapeutic approaches, including vaccines, gene therapy, and gene editing.
"As a company committed to addressing the unmet therapeutic needs of patients living with genetic diseases, BioMarin values novel technologies that enable the development of transformative therapies," said Brinda Balakrishnan, M.D., Ph.D., Group Vice President, Corporate and Business Development at BioMarin. "We believe that Entos' Fusogenix platform offers potentially unique benefits for safe and effective tissue targeting compared with other lipid-based delivery systems. The Fusogenix PLV formulations generated under this agreement are a critical first step in determining how we may incorporate this promising platform into our drug development efforts."
"With a 20-year track record of successfully discovering, developing, and commercializing first- or best-in-class therapies for diverse rare diseases, the BioMarin team has extensive expertise in harnessing the potential of breakthrough technologies. We believe this licensing agreement helps validate the potential of our Fusogenix platform. It also provides additional opportunities for incorporating our technology into cutting-edge treatments that may have significant clinical and commercial value."
John Lewis, Ph.D., Founder and Chief Executive Officer of Entos
Under the terms of the agreement, Entos will use its Fusogenix nucleic acid delivery system to specially formulate BioMarin products directed at multiple undisclosed genetic disease indications. BioMarin will conduct preclinical studies of the Fusogenix-formulated candidates to evaluate their potential as therapies to prevent or treat these conditions.
Entos' most advanced clinical program is Covigenix VAX-001, a COVID-19 DNA vaccine encoding SARS-CoV-2 Spike protein and two genetic adjuvants engineered to stimulate host adaptive and innate immune systems. Formulated using the Fusogenix platform, Covigenix VAX-001 is the subject of an ongoing phase 2 clinical trial in South Africa, with additional trials planned in other regions. Licensees of the Fusogenix platform include Oisín Biotechnologies and OncoSenX, which are using the technology for age-related diseases and oncology applications, respectively.
pH Partners, LLC served as financial advisor to Entos.
BioMarin is a global biotechnology company that develops and commercializes innovative therapies for patients with serious and life-threatening rare genetic diseases. The company's portfolio consists of seven commercialized products and multiple clinical and preclinical product candidates.
About Entos Pharmaceuticals, Inc.
Entos develops next generation nucleic acid-based therapies using its proprietary Fusogenix proteolipid vehicle (PLV) drug delivery system. Fusogenix is formulated with FAST proteins to deliver mRNA or DNA directly into the cytosol of target cells for translation into protective and therapeutic vaccines and medicines.
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.
Prellis Biologics, Inc. | January 14, 2022
Prellis Biologics, Inc. (Prellis), a Bay Area biotechnology company, announced that it has entered into a multi-target drug discovery collaboration and licensing agreement with Bristol Myers Squibb utilizing Prellis Biologics’ first-in-class externalized human immune system based on human lymph node organoids. The collaboration leverages Prellis’ EXIS platform that can break tolerance mechanisms in vitro to create high affinity human antibodies targeting human proteins.
Under the terms of the agreement, Prellis and Bristol Myers Squibb will collaborate on the generation of human antibody libraries for select targets. Prellis will receive from Bristol Myers Squibb an undisclosed up-front payment, funding for research activities, development, sales milestones and royalties for licensed antibodies.
"With industry leading speed, the EXIS platform provides high affinity antibodies, derived from lymph node organoids printed with Prellis’ foundational technology, using human PBMCs. We are looking forward to working with Bristol Myers Squibb to demonstrate advantages of in vitro human antibody discovery with the EXIS platform."
Melanie P. Matheu, PhD, Founder and CEO of Prellis Biologics
Kevin Chapman, PhD, CSO of Prellis, added, "The EXIS platform effectively breaks tolerance enabling direct discovery of human antibodies to challenging human antigens in less than two weeks."
Prellis Biologics, Inc. is the first company to develop a fully synthetic, animal-free, functional human immune system, EXIS™. The EXIS platform allows Prellis to harness fully human immune responses for the development of antibody therapeutics, disease models, and target discovery. With industry-leading speed and resolution, Prellis’ proprietary holographic printing technology is able to accurately match and rapidly replicate human organ and tissue structures. Prellis is dedicated to improving patient lives by discovering novel therapeutics, utilizing its unique capabilities in antibody discovery and in vitro human disease models. Prellis Biologics, Inc. was founded in 2016 and is a privately held company based in the San Francisco Bay Area.