Pharmaceutical Technology Editors

On Aug 12, 2021, Lykan Bioscience, a US-based contract development and manufacturing organization (CDMO) focused on cell-based therapies, and Vineti, a US-based enterprise software platform company, announced a partnership that will combine Lykan’s purpose-built, multi-product cell therapy manufacturing facility located outside Boston, Mass., and Vineti’s supply chain and data management system with the aim of optimizing cell therapy manufacturing efficiency.

Legacy systems that currently manage the production of cell therapies are often manual and outdated, which slows the scale and speed with which the therapies are produced, which can impact patient safety during development. Consequently, the cell therapy industry requires a new level of visibility, detail, and access across each product and facility within the supply chain, the companies stated in a press release.

Under the partnership, Lykan and Vineti will ensure chain of identity (COI) and chain of custody (COC) visibility as cell therapies go through each step in the manufacturing supply chain. The aim is to ensure patient safety. Advanced and integrated software systems, such as Vineti’s Personalized Therapy Management (PTM) platform, offers a digital solution for advanced therapy data and supply chains. The PTM will enable Lykan to conduct real-time monitoring of the manufacturing process and product at its facility, including electronic batch records that will support real-time testing and release of product from each of Lykan’s eight clinical and commercial current good manufacturing practice manufacturing suites.

“At Lykan, our mission is to be an innovative manufacturer of cell therapy products. We strive to help our biopharma partners achieve a rapid transition from clinical to commercial manufacturing and maximize patient access to cell therapies. The complex nature of cell therapy process development and manufacturing means our partners need innovative technologies, a reliable platform, and strong manufacturing expertise to deliver safe and effective therapies,” said Patrick Lucy, president and CEO of Lykan, in the press release. “Our strategic partnership with Vineti aims to enable our partners’ success with faster and simpler operations using a more robust and traceable control system.”

“Cell therapies are at a point where they require a truly world-class, purpose-built, multiproduct cell therapy manufacturing facility, with the best digital tools, allowing for true

connectivity across the ecosystem,” said Amy DuRoss, CEO and co-founder, Vineti, in the press release. “We are thrilled to partner with Lykan Bioscience to ensure COI and COC visibility as therapies go through each step in the supply chain, to efficiently deliver these therapies to the patients that need them, faster."

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Lykan Bioscience and Vineti will combine their capabilities to streamline process development and manufacturing to move cell therapies through clinical phases to commercialization.

Lykan Bioscience and Vineti Partner to Advance Cell Therapies from Clinic to Commercialization

FDA announced on August 12, 2021 that it has amended the Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines so that certain immunocompromised people 18 years or older (ages 12 and over for Pfizer-BioNTech) can receive an additional dose of the vaccine, administered at least 28 days after the two-dose regimen of the same vaccine. Specifically, the agency mentions solid organ transplant recipients and people with conditions that are considered an equivalent level of immunocompromise. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is meeting on Friday to discuss clinical recommendations regarding immunocompromised people. 

According to FDA, people who are immunocompromised in a similar way to those who have had solid organ transplants are especially vulnerable because they have less of an ability to fight infections. A third dose of the Pfizer-BioNTech or Moderna vaccines may increase the protection for these people, the agency said in a press release. FDA also recommends that immunocompromised individuals who are exposed to COVID-19 should discuss monoclonal antibody treatment options with their doctor.

“The country has entered yet another wave of the COVID-19 pandemic, and [FDA] is especially cognizant that immunocompromised people are particularly at risk for severe disease. After a thorough review of the available data, [FDA] determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna [v]accines,” said Acting FDA Commissioner Janet Woodcock, in a press release. “Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19. As we’ve previously stated, other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time. [FDA] is actively engaged in a science-based, rigorous process with our federal partners to consider whether an additional dose may be needed in the future.”

The agency has amended the emergency use authorizations for the Pfizer-BioNTech and Moderna vaccines to allow certain immunocompromised people to receive an additional dose of the vaccine.

FDA Authorizes Additional COVID-19 Vaccine Dose for Certain Individuals

Recro Pharma, a contract development and manufacturing organization (CDMO) specializing in oral solid dose drug products, has acquired fellow CDMO IRISYS. The company was acquired for approximately $50 million in a combination of cash, shares of Recro common stock, and a seller promissory note.

In a company press release from August 13, 2021, Recro stated that they acquired the company because it would expand their client base and service options. Recro is based out of Exton, PA, whereas IRISYS is based in San Diego. This acquisition complements Recro’s existing services on the East Coast.

The acquisition will expand Recro’s technical focus beyond oral solid dose drug products. They can now also work with sterile injectables, oral liquids, tablets, topicals, liquid/powder filled capsules, ophthalmic droppers, liposomes, and nano/microparticles.

“Today’s acquisition of IRISYS is truly a transformative transaction for Recro.” said David Enloe, president and CEO of Recro. “The joining of these two companies creates an organization that is ideally positioned to achieve Recro’s previously disclosed four-pronged strategy for growth, which includes strengthening the organization’s leadership and talent, expanding and diversifying our client base, fortifying our financial position, and enhancing our capabilities and competencies.”

Recro acquires CDMO IRISYS, establishing a bi-coastal presence in the US.

Recro Acquires IRISYS for $50 Million

On Aug. 11, 2021, the Keck Graduate Institute (KGI), based in Claremont, Calif., announced that its dean of research and research professor, Larry Grill, and his team will work on adapting the low-cost vaccines on which they have been working on for the past decade for use against COVID-19.

Grill and his team have been working for the past 11 years to produce low-cost vaccines for developing countries. They have been primarily focused on animal diseases that significantly impact smallholder farmers in Africa but had not considered developing vaccines for the US market because of the length of time typically needed to get vaccines approved by FDA. Grill has shifted focus based on the current emergency use authorization brought on by the pandemic. He and his team are now working to adapt a vaccine candidate they have been working on for use against COVID-19. Grill’s vaccine is derived from plant viruses, making it distinct from the COVID vaccines currently on the market, according to a KGI press release.

Plant viruses are not known to cause diseases in humans but can still induce an immune response. Viruses from plants can therefore be used to train the immune system to respond appropriately to antigens by disguising the plant virus with a surface protein that mimics the target pathogen.

Grill and his team are taking advantage of this feature by changing the outside surface of the plant virus to resemble a real pathogen. To make the adaptation, they used a virus coat protein fusion to add the genetic information from a SARS-CoV-2 spike protein to the surface of a tobacco mosaic virus (TMV). The TMV fused coat proteins are taken up by antigen presenting cells (APCs) and displayed on class II major histocompatibility complex molecules (MHCs). The class II MHCs interact with CD4+ T cells to trigger an appropriate cellular immune response.

“Your immune system detects the virus and makes antibodies against the SARS-CoV-2 spike protein,” Grill said in the press release. “As a matter of fact, the data that we have shows that memory cells would be ready for the SARS-CoV-2 virus for at least a few years.”

The team can grow the TMV vaccines in plants, allowing for large production volumes of what Grill calls “decorated viruses”. They are working with Botswana Vaccine Institute and the Botswana government to secure funding to build a facility in Botswana to produce the vaccines at low cost for developing countries.

The plants used for vaccine production are grown in growth rooms and leaves are harvested eight to 10 days post introduction. From there, the TMV vaccines are purified with a simple precipitation step. Produced this way, the virus for the vaccine is stable and doesn’t necessarily need to be stored at extremely cold temperatures. Cold-temperature storage would be problematic when transporting the vaccine to developing countries, according to Grill in the press release.

A research team at the Keck Graduate Institute will work to adapt its decade-long low-cost vaccine R&D for developing countries into a COVID-19 vaccine.

KGI Team Adapts Vaccine Development Work to Address COVID-19 

FDA has granted fast-track designation to VTX-801, a gene therapy developed by clinical-stage biotechnology company Vivet Therapeutics in conjunction with Pfizer, for the treatment of Wilson Disease.

VTX-801 is a novel investigational gene therapy that will now be evaluated in a Phase I/II clinical trial to determine the safety, viability, and pharmacological activity of a single intravenous infusion in adults with the disease. The Fast Track designation, given to therapies designed to treat serious conditions with unmet medical need, will facilitate its development and expedite the review process.

Wilson Disease is a rare genetic disorder that reduces the ability of the liver to regulate copper levels. This results in severe hepatic damage, neurological symptoms, and potential death.

“The FDA’s decision to grant VTX-801 Fast Track designation underscores the urgent need for new therapeutic options to address this devastating disease, which, if left untreated, can be fatal,” said Seng Cheng, senior vice-president and chief scientific officer of Pfizer’s Rare Disease Research Unit, in a company press release from August 12, 2021.

“With the FDA’s authorization of the [Investigational New Drug] application for VTX-801—combined with Pfizer’s state-of-the-art gene therapy manufacturing capabilities—we are well-positioned to rapidly advance development of this potential therapy,” said Jean-Philippe Combal, CEO and co-founder of Vivet, in the press release.

FDA has awarded Fast Track designation to Vivet Therapeutics’ novel gene therapy, VTX-801.

FDA Grants Fast-Track Designation to Pfizer and Vivet Therapeutics for Treatment of Wilson Disease

On Aug. 10, 2021, Aldevron, a US-based manufacturer of plasmid DNA, messenger RNA (mRNA), and proteins, and Ginkgo Bioworks, a US-based biotech company, announced that they have achieved a manufacturing breakthrough that improves the yield of the vaccinia capping enzyme (VCE), a component often required to produce mRNA therapies and vaccines.

Under a strategic partnership formed earlier in 2021, Aldevron has the exclusive rights to the protocol conditions of the newly developed manufacturing process, which the company said in a press release is over 10-times more efficient than the previous process.

"Aldevron's [products] and services are the foundation for some of the most exciting advances in biological science today," said Jason Kelly, CEO of Ginkgo Bioworks, in the press release. "This partnership represents a momentous growth opportunity for Aldevron as it continues to bolster its already expansive portfolio of products, and an exciting milestone for Ginkgo as we continue to expand our capabilities into the pharmaceutical ecosystem. Aldevron has been a great partner with us on improving VCE, which we see as a key ingredient to scaling mRNA production globally."

"I'm very excited about combining the additive strengths of Ginkgo Bioworks' development expertise and Aldevron's manufacturing horsepower to yield an optimized manufacturing method for vaccinia capping enzyme," said Tom Foti, president of Aldevron's Protein Business Unit, in the press release. "Historically this enzyme has been difficult to produce, and we believe this yield breakthrough will accelerate mRNA therapeutic and vaccine development for manufacturing teams around the world."

A collaboration between Aldevron and Ginkgo Bioworks has resulted in a manufacturing enhancement that can improve production of an enzyme used for mRNA therapeutics.