INDUSTRIAL IMPACT

Vaxess Technologies Announces Grand Opening of GMP Manufacturing Facility

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. 

Spotlight

Scientists are genetically engineering plants to detect environmental hazards. Neal Stewart, a lead researcher on the project, says the plants will react to things like mold, radon gas, or high levels of dangerous organic compounds. Stewart told Science Update the goal is to create an on-off switch in the plants’ DNA. This means its cells would react to exposure of a chemical by producing a signal like a fluorescent protein visible by black light. There are a number of benefits to using a plant instead of an electronic device to monitor your personal space. Popular Mechanics pointed out that plants, unlike home assistants like Amazon’s Alexa, “are not connected to the cloud and definitely can’t hear what you’re saying.”


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INDUSTRIAL IMPACT

FEN Industries Earns USDA Certified Biobased Product Label for Terreplenish® Soil Microbes

FEN Industries | February 22, 2022

FEN announced today that it has earned the U.S. Department of Agriculture (USDA) Certified Biobased Product label. The product, Terreplenish®, has 97% biobased content. Third-party verification for a product's biobased content is administered through the USDA BioPreferred Program, an initiative created by the Farm Bill. The primary goal of the BioPreferred Program is to increase the development, purchase, and use of biobased products. Biobased products have played an increasingly important role in reducing greenhouse gas (GHG) emissions that exacerbate global climate change. Biobased products are cost-comparative, readily available, and perform as well as or better than their conventional counterparts. "Terreplenish® Soil Regenerating Microbes sequester 45-60lbs of nitrogen per growing season, providing an alternative to petroleum derived fertilizer products," Cathy Scratch, FEN Founder "We applaud FEN Industries for earning the USDA Certified Biobased Product label," said Kate Lewis, USDA BioPreferred Program. "Products like Terreplenish® contribute to an ever-expanding marketplace that adds value to renewable agriculture commodities and decreases our reliance on petroleum." According to a report that USDA released in 2019, biobased products contributed more than $500 billion to the U.S. economy and estimated reduction of fossil fuels associated GHG emissions from biobased products equivalent to approximately 12 million metric tons of carbon dioxide (CO2). The increased production of biobased products contributes to the development and expansion of the U.S. bioeconomy - where society looks to agriculture for sustainable sources of fuel, energy, chemicals, and products. About FEN Industries: A fen is a unique ecosystem that nurtures bio-nutrient diversity and conserves water as a necessary buffer between habitats that naturally siphons toxins. FEN Industries is an accelerated composting technology company that creates Terreplenish® - an OMRI Listed, 97% certified biobased product and approved by California Department of Agriculture. The high cost of nitrogen fertilizer can be reduced significantly with the addition of Terreplenish® soil regenerating microbes while providing many other benefits like pathogen control, phosphorous control, and better plant emergence scores. Additional revenue can be generated by participating in the many phosphorous reduction programs and carbon sequestration projects.

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INDUSTRIAL IMPACT

Amnio Technology Launches Two New Dual-Layer Allografts, FDA Recognizes Products as Minimally Manipulated, Homologous Use HCT/Ps

Amnio Technology | February 15, 2022

Amnio Technology, a global leader in the development of and distribution of amniotic tissue allografts is announcing the launch of two new PalinGen® membrane products, PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane. The new allografts, like the entire family of PalinGen® membrane products, are minimally manipulated, homologous use and chorion-free. The dual-layered nature of the allografts allow for unidirectional application with two outward facing epithelial sides. The proprietary Advantek® process used to manufacture PalinGen® membranes preserves the extracellular matrix components and regulatory proteins present in amniotic tissues. Preserving the characteristics of the natural tissue aids in wound management. PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane are indicated for patients suffering from non-healing acute and chronic wounds as well as complex and/or open surgical wounds and burns. Senior Director of New Product Development, Robert Diller, PhD, shared his insight into the motivation for developing a multilayered amniotic product, "The PalinGen® Dual layer membranes have increased durability and slower resorption, which makes them ideal for use in robotic and other surgical applications" "With the application of single-layer PalinGen® membrane products, patients already experience improved clinical outcomes compared to treatment with standard of care. Cytokines, growth factors, and extracellular matrix proteins have been identified in amnion membranes and contribute to the complex wound healing process. Compared to single layer allografts, PalinGen® Dual Layer membranes deliver twice as many of these components to the wound area," lead Research Scientist on the development project, Sarah West The FDA recognized PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane as being minimally manipulated, homologous use human cell, tissue, and cellular and tissue-based products or HCT/Ps. In letters received from the Tissue Reference Group (TRG) within the Office of Tissues and Advanced Therapies (OTAT) on September 30, 2021, and February 8, 2022, respectively, FDA confirmed that PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane would be regulated solely under section 361 of the PHS Act and the regulations in 21 CFR 1271. Amnio Technology has a long history of Good Tissue Practices (GTP) experience and compliance. In recent years, the FDA has issued final guidance on its Framework for the Regulation of Regenerative Medicine Products, making the confirmation of the regulatory status of amniotic products critical for business continuity in the amniotic tissue space. William Brown, Managing Director of Operations at Amnio Technology, recognized the efforts of the entire Amnio Technology Team, "We continue to be successful in the development and launch of new Products in our pipeline, which meet the Regulatory framework of the FDA and other Agencies. With a Team dedicated to compliance from the first step, we continue to expedite new product availability to clinicians for implementation into their practice and, ultimately, the ability to improve quality of life for the patient." Both PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane are available in a variety of sizes suited for the patient's needs. About Amnio Technology Amnio Technology is a clinical stage biotechnology company dedicated to advancing the science of regenerative medicine. Established in 2013, Amnio Technology has developed core competencies in Good Tissue Practice and HCT/P Safety becoming a global leader in the development and distribution of amniotic tissue allografts. The Company has a robust pipeline of products and its liquid allograft for the treatment of chronic ulcers, PalinGen® Flow, is currently in a Phase 2 clinical trial.

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INDUSTRIAL IMPACT

Nuclera Announces Expansion With New US Subsidiary

Nuclera | January 19, 2022

Nuclera, a UK-based biotech company developing cutting-edge benchtop protein printing technologies, announces the opening of its US subsidiary in Boston, MA. The addition of this US facility in the rapidly growing biotechnology hub of greater Boston is a critical step in the company’s plans, paving the way for Nuclera’s revolutionary eProteinTM desktop bioprinter—that offers unprecedented speed and convenience for biotherapeutics, agribiotech and other markets of global importance. Nuclera’s eProtein™ bioprinter is born out of a strategic partnership with E Ink—the pioneers of ePaper—allowing the combination of biopolymer synthesis technologies with digital microfluidics. The US facilities are the result of a $4.5 million E Ink renovation, reinforcing Nuclera’s position as a technological innovator in the bioprinting space. “Our new laboratories and pilot manufacturing facilities in Boston will support Nuclera’s goal to commercialize its eProtein™ technology significantly accelerating drug discovery workflows”, says Dr Michael Chen, CEO and cofounder of Nuclera. “This site opening just outside one of the most important biotech markets is a big step towards Nuclera’s goal to make proteins accessible through desktop bioprinting”, added Chen. “Our new facility has been specifically designed to accommodate our expanding team and will support Nuclera’s ambitious roadmap. We are proud to have operations in both the UK and US, further strengthening our position in the global biotech space.” As part of Nuclera’s global expansion, Richard Paolini Jr, has been appointed Vice President of eDropTM R&D, the first of many US-based appointments. With over 20 years of R&D experience, Rick is an inventor named on over 100 US patents on technologies that have helped E Ink to enable and transform the eReader market. Rick is now leading the development of closely related technologies to enable Nuclera’s eDropTM digital microfluidic systems—requiring integration of complex chemical, biological, electronic, and mechanical elements. "E Ink is very excited about the continuing collaboration and partnership with Nuclera in this expanding biotechnology market sector that is of such global importance. The transfer of Rick and his talented microfluidics team of scientists from E Ink to Nuclera and the renovation of the US-based biotechnology R&D center that Nuclera will occupy will ensure ongoing biotechnology advancements leading to a successful commercial launch of the Nuclera eProtein platform.” Dr Michael McCreary, E Ink’s Chief Innovation Officer and Nuclera Board Director

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INDUSTRIAL IMPACT

Amberstone Biosciences Secures $12 Million Series A Financing to Advance Immuno-Oncology Pipeline of Tumor Microenvironment Activated Therapeutics

Amberstone Biosciences, Inc. | January 04, 2022

Amberstone Biosciences an emerging biotherapeutics company with unique expertise in conditionally active immunotherapeutics, today announced the completion of a $12 million Series A financing round. The funding was led by Viva BioInnovator, Co-win Ventures and Sinovation Ventures, with additional support from ChangRong Capital, Lifespan Investments and existing shareholders. Amberstone will use the proceeds from the financing to advance its highly differentiated tumor microenvironment activated therapeutic programs including bispecific antibodies and immunocytokines to the investigational new drug application (IND) enabling stage. “We are tremendously grateful for the strong support from our new and existing investors. With our unique Tumor Microenvironment Activated Therapeutics programs, we aim to develop safer and more effective therapies to benefit cancer patients. The funding and broad expertise and resources in the field provided by our investors will take us another step closer to our mission.” Amberstone Biosciences President and CEO, George Wu, PhD “Amberstone’s T-MATE therapeutic molecules enabled by its innovative single-cell discovery engine represents a real breakthrough in immune-oncology. We are thoroughly impressed by Amberstone team's rich experience in the cancer biology space. Viva is excited to work with Amberstone and syndicate partners to support its mission to provide next-generation innovative treatment options to patients,” said Han Dai, PhD, Chief Innovation Officer of Viva Biotech and Head of Viva BioInnovator. “T cell immunotherapy has encountered great challenges in the complex microenvironment of solid tumors. The T-MATE molecules discovered through Amberstone’s world-leading cross-disciplinary drug discovery engine will break through the bottleneck of traditional methods and bring new hope to the treatment of solid tumors. Co-win Ventures is thrilled to work with Amberstone’s team and co-investors to explore the next generation of immunotherapies in solid tumors,” said Xin Huang, MD/PhD, a managing partner of Co-win Ventures. “The expertise and strengths of Amberstone core team synergize well with one another. We are optimistic with the company’s uncapped growth potential. Amberstone exemplifies our firm’s investment strategy and mission to support deep-tech innovative entrepreneurs and companies,” said Sinovation Ventures’ partner in healthcare, Mr. Peter Wu. About Amberstone Biosciences, Inc. Incorporated in 2018, Amberstone Biosciences is an emerging biotherapeutics company developing a novel class of targeted and conditionally active immunotherapeutics to treat solid tumor cancers and other diseases. Amberstone Biosciences’ pipeline is driven by an innovative high-throughput single-cell functional discovery platform and strong expertise in an interdisciplinary field of biology, engineering, and therapeutic development. About Viva BioInnovator As the venture arm of Viva Biotech Holdings, Viva BioInnovator is dedicated to investing globally in biotech innovations that address unmet medical needs across multiple therapeutic areas. Leveraging Viva Biotech’s rich experience and technical advantages in novel drug R&D, Viva BioInnovator has built a strong track record in providing both cash and in-kind services its portfolio companies worldwide. About Co-win Ventures Founded in 2009, Co-win Ventures focuses on early-stage companies in healthcare and TMT sectors and advocates a team culture of equality, transparency, sharing and innovation. It has operated 17 independent US dollar and/or RMB funds and has invested in over 140 companies, including Taimei Medical Technology, Genecast, Huake Precision, Cytek, InnoLight Technology, Memsensing, Eastsoft, New Vision, Aolian Electronics, and Sanchao Advanced Material among others. About Sinovation Ventures Founded by Dr. Kai-Fu Lee in 2009, Sinovation Ventures is committed to nurturing the next wave of deep-tech entrepreneurs and companies. Sinovation is headquartered in Beijing and operates in multiple major cities. With over US$2.7 billion under management, Sinovation is a leading tech VC firm with a unique “TECH VC” model that is uniquely enhanced by its Artificial Intelligence Institute led by Dr. Lee. Sinovation invests in artificial intelligence, healthcare tech, robotics/automation, semiconductor, enterprise software, and digital lifestyle areas. To date, Sinovation has invested in over 400 companies.

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Spotlight

Scientists are genetically engineering plants to detect environmental hazards. Neal Stewart, a lead researcher on the project, says the plants will react to things like mold, radon gas, or high levels of dangerous organic compounds. Stewart told Science Update the goal is to create an on-off switch in the plants’ DNA. This means its cells would react to exposure of a chemical by producing a signal like a fluorescent protein visible by black light. There are a number of benefits to using a plant instead of an electronic device to monitor your personal space. Popular Mechanics pointed out that plants, unlike home assistants like Amazon’s Alexa, “are not connected to the cloud and definitely can’t hear what you’re saying.”

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