Alivia Leon

Moderna announced on March 23, 2023 a collaboration with Generation Bio, a biotechnology company innovating genetic medicines for people living with rare and prevalent diseases, to combine Moderna’s biological and technical expertise with core technologies of Generation Bio’s non-viral genetic medicine platform. The collaboration aims to expand the application of each company’s technology by developing novel nucleic acid therapeutics, including those capable of reaching immune cells, to accelerate their respective pipelines of non-viral genetic medicines. Moderna will fund all research and development activities under the collaboration.

Under the agreement, Generation Bio will receive a $40 million upfront cash payment, a pre-payment of research funding, plus a $36 million equity investment from Moderna, with the potential for additional milestones, fees, and royalties. Moderna has also acquired an option to license Generation Bio’s cell-targeted lipid nanoparticle (ctLNP) and close-ended DNA (ceDNA) technology for two immune cell programs and two liver programs, with an additional option for a third immune cell or liver program.

"Moderna continues to invest in innovative technology to enable us to develop a breadth of transformative medicines for patients," said Rose Loughlin, Moderna's senior vice-president for research and early development, in a company press release. "Through this collaboration, which builds on Generation Bio's non-viral genetic medicines platform, we have the potential to target immune cells with diverse nucleic acid cargos and the liver for gene replacement. We are excited to have Generation Bio as our partner as we continue to broaden our therapeutic pipeline and extend the potential benefit of nucleic acid therapeutics to more patients."

"Non-viral DNA therapeutics may offer durable, redosable, titratable genetic medicines to patients suffering from rare and prevalent diseases on a global scale," said Phillip Samayoa, chief strategy officer of Generation Bio, in the release. "This collaboration represents a foundational investment in our platform science, both deepening our pipeline of rare and prevalent liver disease programs beyond hemophilia A and accelerating our work to reach outside of the liver with nucleic acid therapies. We are thrilled to collaborate with Moderna to extend genetic medicines to new tissues and cell types through the joint development of noveltargeting for our stealth ctLNPs to reach immune cells."

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Moderna and Generation Bio have announced a strategic collaboration to develop non-viral genetic medicines. 

Moderna and Generation Bio Announce Strategic Collaboration

Harm Reduction Therapeutics, a non-profit pharmaceutical company focused on preventing opioid overdose deaths, and Catalent announced on March 23, 2023 that they have signed a commercial supply agreement. Under the agreement, Catalent will manufacture Harm Reduction Therapeutics’ naloxone nasal spray, RiVive, for the emergency treatment of known or suspected opioid overdose.

The agreement comes after FDA granted Harm Reduction Therapeutics priority review status on Dec. 26, 2022, for its over-the-counter (OTC) naloxone nasal spray new drug application. Naloxone has been used extensively for decades to reverse opioid overdoses, according to a company press release. Access to existing naloxone nasal spray is currently limited to behind-the-counter pharmacy distribution through a prescriber or a health department’s standing order.

Harm Reduction Therapeutics has been working on a low-cose, OTC naloxone product since 2017 to act as a critical tool to help prevent death from opioid overdose.

“We are thrilled to partner with Catalent on the commercial manufacturing of RiVive. The opioid epidemic is an ongoing national tragedy, and for OTC naloxone to address this unmet need we needed a manufacturing partner with the capability and bandwidth to help make naloxone much more widely and easily accessible to save lives that will otherwise be lost to opioid overdose,” said Michael Hufford, co-founder and CEO of Harm Reduction Therapeutics, in the release.

“This agreement marks a major milestone for Harm Reduction Therapeutics and is also a significant step forward in tackling a major public health issue in this country,” said Carla Vozone, vice-president of inhalation strategy at Catalent, in the release. “Our company is driven by a ‘patient-first’ culture, which is synergistic with the goals and mission of our partner on this project, and we take great pride in being associated with such a potentially life-changing program.”

Harm Reduction Therapeutics and Catalent have signed a commercial supply agreement for naloxone nasal spray to reverse opioid overdoses. 

Harm Reduction Therapeutics and Catalent Sign Commercial Supply Agreement 

Curia announced on March 23, 2023 that it is collaborating with Corning to expand and accelerate continuous-flow development and manufacturing programs for the chemical and biopharmaceutical industries globally. The collaboration marks the first global installation of Corning’s G1 production system to support higher-quality API-chemical production using flow-chemistry technology.

Continuous flow chemistry is crucial for the development and manufacture of pharmaceutical intermediates and APIs and provides advantages compared with traditional batch processing. It can deliver a faster and more robust material production with a higher selectivity of desired products, according to a company press release. The collaboration will combine Curia’s expertise and global network of facilities with Corning’s continuous flow technology to help drive business efficacies as well as improve patients’ lives.

“Innovation in drug development and production calls for safety at high speed,” said Christopher Conway, president, R&D, Curia, in the release. “The implementation of Corning’s G1 Production Reactor at our Albany facility expands our capability to provide scalable solutions that address complex development and manufacturing requirements facing the pharmaceutical industry. Using advanced technology and standardized workflows, Curia offers continuous flow chemistry from targeted development to commercial scale globally.”

Curia is collaborating with Corning to advance biopharmaceutical continuous-flow development and manufacturing programs.

Curia and Corning Collaborate to Advance Biopharmaceutical Continuous-Flow Development

Evotec announced on March 16, 2023 that there has been progress within its strategic partnership with Bristol Myers Squibb (BMS) relating to building a molecular glue-based pipeline. Performance-based and program-based achievements will total $75 million to Evotec.

The companies entered their strategic protein degradation partnership in 2018 and expanded it in May 2022. Evotec has scaled up its activities to develop compounds from Bristol Myers Squibb’s library of cereblon E3 ligase modulators since the expansion. The partnership’s goal is to develop high-value targets in the field of oncology and more by building a pipeline of novel molecular glue degraders. According to a company press release, molecular glue degraders are compounds that induce interactions between an E3 ubiquitin ligase and a molecular target, which results in ubiquitination and subsequent degradation of the protein. The molecular glue itself is not degraded in the process, meaning it can trigger the degradation process several times over, which can lead to longer-lasting therapeutic effects.

“The recent extension and expansion of our partnership with BMS continues to deliver high value programs,” said Cord Dohrmann, chief scientific officer of Evotec, in a company press release. “Our Omics-based, highly systematic, and industrialized approach to identify very promising molecular glues continually exceeds all expectations and will translate into an extraordinary pipeline of first-in-class product opportunities.”

Evotec and Bristol Myers Squibb have announced progress in their strategic protein degradation partnership. 

Evotec and Bristol Myers Squibb Progress Strategic Partnership

Cancer Research Horizons announced on March 17, 2023 that it has partnered with Predictive Oncology to drive the development of oncology drugs. The collaboration will use Predictive Oncology’s PEDAL artificial intelligence and machine learning platform technology to determine which cancer types and patient populations are most likely to respond to treatment with Cancer Research Horizon’s pre-clinical drug inhibitors of glutaminase. By addressing tumor heterogeneity during pre-clinical stages, the probability of clinical success increases, according to Predictive Oncology.

The agreement joins together non-profit and industry and offers the potential for Cancer Research Horizons to incorporate PEDAL technology into future drug discovery processes.

“Our collaboration with Cancer Research Horizons represents a fundamental shift in drug discovery that could lead to the accelerated development of cancer therapies using compounds originating from the CRUK network and developed by Cancer Research Horizons in partnership with their global network,” said Raymond F. Vennare, CEO of Predictive Oncology, in a company press release. “We now have the ability to impact the most critical stage of early drug discovery in a way that has never been done before.”

“We are committed to working closely with scientists to discover and advance therapies that can help in the fight against cancer. Ensuring that patients receive the right treatment for them is of paramount importance and is why we are excited to work with Predictive Oncology to identify the most suitable population for the further development of our compounds. We look forward to applying Predictive Oncology’s expertise, enabling technology and dedication to progress exciting cancer therapeutics,” explained Tony Hickson, chief business officer for Cancer Research UK and Cancer Research Horizons, in the release. “We consider the potential of this collaboration a win for patients not just in the UK or US, but worldwide.”

Predictive Oncology and Cancer Research Horizons have partnered to pursue development of cancer drugs utilizing the PEDAL platform.

Predictive Oncology and Cancer Research Horizons Partner for Cancer Drug Development

On March 9, 2023, FDA announced that it is requesting $7.2 billion as part of the president’s fiscal year 2024 budget. The request includes an increase of $372 million in budget authority and a $150 million increase in user fees.

The funding will allow the agency to continue to leverage new and emerging technologies, recruit and support a skilled workforce, and adapt oversight to new production and business models. This would have an immediate impact on food, tobacco, and medical product safety in the United States, while also preparing the agency to address rapid innovation across the food and medical products fields.

“This year’s funding request builds on our accomplishments and lessons learned over the past year and adds new funding to continue modernizing [FDA] and its capabilities for the future. We continue to deliver on a wide range of priorities and have strategically focused our request to ensure our program areas have the funding they need to operate with the highest success for the good of public health,” said FDA Commissioner Robert M. Califf in a press release. “Our investments to strengthen medical product safety and availability, along with funding for vital oversight of tobacco products continue to be a central focus. The budget also provides a historic investment to strengthen [FDA’s] food safety and nutrition capacity—especially for infants and young children, demonstrating the Administration’s ongoing commitment to these responsibilities. As always, our foremost focus is on the well-being of patients and consumers, and we look forward to continuing our work with Congress to help meet the critical public health challenges ahead.”

FDA is seeking $7.2 billion to enhance food safety and advance medical product availability. 