Pharmaceutical Technology Editors

On Sept. 30, 2021, Moderna announced that it would be opening the Moderna Science Center in Cambridge, Massachusetts. The 462,000-ft² facility is designed to support Moderna’s continued growth in the messenger RNA (mRNA) medicine sector.

“We have been located in Massachusetts since our founding more than 10 years ago and are proud to be based here,”said Stéphane Bancel, CEO of Moderna, in a company press release. “As we advance our mRNA platform and science, our new science center will integrate digital-first scientific research and development labs along with space for innovation and co-creation with our people and our partners around the world.”

The new building will include custom spaces for research and development, but will also integrate non-scientific spaces to maximize collaboration and innovation. Construction led by Moderna’s long-term partner Alexandria Real Estate Equities has begun, with an expected move-in occurring in 2023.

Moderna highlighted sustainability when discussing the new building. The company is targeting Leadership in Energy and Environmental Design (LEED) Platinum Core & Shell and LEED Zero Energy certifications for the building. According to the press release, Moderna hopes that this site will be the most sustainable commercial lab building in Cambridge. To facilitate these goals, the building will include “ultra-efficient systems” as well as acoustical and light pollution mitigation measures.

“Our commitment to sustainability and accessibility requires us to think differently about space. Even as we grow, we are committed to minimizing our environmental footprint,” said Bancel in the press release. “We will continue to invest in the local economy, work with state and community partners, and leverage the incredible innovation to attract and grow the best talent from the Massachusetts life sciences sector as we work to deliver on the promise of mRNA science.”

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Moderna’s new 462,000-ft² science center is expected to be completed by 2023.

Moderna Opens New Science Center in Cambridge, MA

Sunovion Pharmaceuticals, its parent company Sumitomo Dainippon, and Otsuka Pharmaceutical announced a joint development and commercialization agreement on Sept. 30, 2021. The agreement focuses on joint development of four of Sunovion’s compounds intended to treat neuropsychiatric health conditions: ulotaront (SEP-363856), non-racemic ratio of amisulpride enantiomers (SEP-4199), SEP-378614, and SEP-380135.

Under the agreement, Sunovion will be paid $270 upon completion of the agreement, with additional payments of up to $620 million upon hitting relevant sales milestone payments. Sunovion and Otsuka will share both profits and expenses produced by the collaboration. Additional terms were not disclosed.

Ulotaront is a trace amine-associated receptor 1 (TAAR1) agonist with 5-HTIA agonist activity that is currently in Phase III development for the treatment of schizophrenia. Non-racemic amisulpride (SEP-4199) is in Phase III development for the treatment of major depressive episodes associated with bipolar I disorder. SEP-378614 and SEP-380135 are both in Phase I development.

“Otsuka’s recognition of the significant value of these assets reflects the innovative discovery and development efforts at Sunovion over the past decade, as well as our neuropsychiatry commercialization expertise and capabilities,” said Antony Loebel, president and CEO of Sunovion, in an Otsuka press release. “We look forward to working with Otsuka colleagues as we advance novel compounds to treat patients with serious neuropsychiatric conditions.”

"Otsuka has been committed to providing new antipsychotics that contribute to patients worldwide in the field of neuropsychiatry by leveraging internal capabilities and external collaborations, starting with the launch of antipsychotics in the US [United States] in 2002,” said Makoto Inoue, president and representative director of Otsuka, in the press release. “We are advancing in new areas such as the development of drugs to treat agitation associated with dementia of the Alzheimer’s type and the deployment of the world's first digital medicine. Through this agreement, we are confident the companies will be able to deliver even more value to patients through the experience and networks that we have cultivated over many years worldwide.”

The collaboration between Sunovion, Sumitomo Dainippon, and Otsuka will focus on four compounds designed to treat neuropsychiatric health conditions.

Sunovion, Sumitomo Dainippon, and Otsuka Enter Development and Commercialization Collaboration

Luas Diagnostics announced a partnership with Bond Digital Health on Sept. 30th, 2021, to provide a 15-minute test to determine COVID-19 immunity post-infection or vaccination. The enhanced test involves a smartphone app and data management developed by Bond that is specific to the Luas product.

Luas’ immunity test collects a fingerstick of blood for detection, differentiation, and quantification of immunoglobulin M and immunoglobulin G receptor binding domain antibodies to SARS-CoV-2. These serve as a measure of a person’s level of COVID-19 immunity but can also indicate if a person is currently infected or has been in the past. The results are read and stored in a portable reader, which provides results in either laboratory or remote settings in approximately fifteen minutes.

The Luas Diagnostic app, available in both the Google Play and Apple App stores, uses Bond’s lateral flow data capture platform (Transform) to provide a personalized antibody report. The associated dashboard manages testing, recording, and reporting of results in real time.

“We are excited to work together with Bond Digital Health to provide a comprehensive Immunity Test offering with applications in many locations including the workplace, in-store testing, [care homes,] and GP [general practice] surgeries,” said Brendan Farrell, CEO of Luas Diagnostics, in a company press release. “A recent study has shown that 10–15% of people, particularly among the higher age group, may not produce antibodies even after the second dose of vaccine and thus may have limited protection against the virus. This emphasizes the need for individuals to understand their immunity status through regular testing.”

“Antibody testing is the next tool we should be using in the fight against [COVID]-19,” said Ian Smith, CEO of Bond Digital Health, in the press release. “That’s why we are proud to partner with Luas on their vital Immunity Test. But testing alone isn’t enough. Whether in workplaces, care homes, GP surgeries, or in the community, we need to capture the test data, store it securely and share it to make sure we have a complete picture of immunity. The Luas App, powered by [Transform], does just that.”

The test developed by Luas Diagnostics and Bond Digital uses a smartphone app to enhance a 15-minute COVID-19 immunity test.

Luas Diagnostics Partners with Bond Digital Health to Launch Enhanced COVID-19 Immunity Test

Merck, known as MSD outside of the United States and Canada, and Ridgeback Therapeutics announced on Oct. 1st, 2021, that their investigational oral antiviral medicine molnupiravir significantly reduced severe outcomes associated with COVID-19. According to a planned interim analysis, molnupiravir reduced the risk of hospitalization or death by 50% in non-hospitalized adult COVID-19 patients with mild-to-moderate symptoms.

According to a company press release, 7.3% of patients who received molnupiravir (28/385) were either hospitalized or died through Day 29 of the study. Conversely, 14.1% of patients given placebo (53/377) were either hospitalized or died as a result of COVID-19 through Day 29. Additionally, no patients that were given molnupiravir died, whereas eight of those given the placebo did.

As a result of the positive findings, Merck will be stopping the study early at the behest of an independent data monitoring committee. Merck plans to submit an application for an emergency use authorization to FDA as soon as possible.

“With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic and will add to Merck’s unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most,” said Robert M. Davis, CEO and president, Merck, in the press release. “Consistent with Merck’s unwavering commitment to save and improve lives, we will continue to work with regulatory agencies on our applications and do everything we can to bring molnupiravir to patients as quickly as possible.”

“With the virus continuing to circulate widely, and because therapeutic options currently available are infused and/or require access to a healthcare facility, antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” said Wendy Holman, CEO of Ridgeback Biotherapeutics, in the press release. “We are very encouraged by the results from the interim analysis and hope molnupiravir, if authorized for use, can make a profound impact in controlling the pandemic.”

Merck and Ridgeback Biotherapeutics' oral antiviral medication reduced the risk of hospitalization or death from COVID-19 by 50% relative to placebo in a Phase III clinical study.

Merck and Ridgeback Biotherapeutics’ Oral Antiviral COVID-19 Treatment Reduces Risk of Hospitalization or Death by 50%

Certara, a biosciences company specializing in biosimulation, announced on Oct. 4th, 2021, that their acquisition of Pinnacle 21, a provider of software as a service (SaaS) solutions for clinical data fitness, has been completed. At closing, equity holders of Pinnacle 21 received approximately $250 million in cash considerations and 2,239,717 shares of Certara restricted common stock.

Through this acquisition, Certara can incorporate Pinnacle 21’s software into its support services. The software is a continually updated validation tool used to ascertain compliance to standards imposed by the Clinical Data Interchange Standards Consortium (CDISC).

Compliance with CDISC standards is required by FDA and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for evaluating regulatory submissions. According to a Certara press release, the software has been adopted for use by FDA, PMDA and 22 of the top 25 pharmaceutical companies by R&D spending.

“We are pleased to welcome Pinnacle 21’s talented team to Certara,” said William F. Feehery, CEO of Certara, in the press release. “With Pinnacle 21’s software for high-quality clinical data standardization, we can together provide a broader portfolio of industry-leading software and technology-driven services to our customers worldwide. This transaction amplifies our capabilities to inform critical decisions that further de-risk and expedite the drug development process.”

“This is an exciting day for all of us at Pinnacle 21,” said Max Kanevsky, founder and CEO of Pinnacle 21, in the press release. “Certara’s global footprint and focus on growth fast-forward Pinnacle 21’s journey for continued success. I look forward to expanding our technology capabilities together to advance life-saving therapies to patients.”

Certara’s acquisition of Pinnacle 21 grants them access to their compliance validation software.

Certara Completes Acquisition of Pinnacle 21

Selecta Bioscience, a biotechnology company specializing in the development of tolerogenic therapies, announced an agreement to license its ImmTOR platform to Takeda on Oct. 4th, 2021. Takeda will use the platform to develop gene therapies for lysosomal storage disorders.

For the use of its platform, Selecta will receive an undisclosed upfront payment and up to $1.1 billion in future additional payments. These payments are contingent on Takeda hitting specific commercial and developmental milestones in their research. Selecta is also eligible for additional royalties following commercialization of the product.

The ImmTOR platform enhances transgene expression, addressing adeno-associated virus (AAV) vector immunogenicity constraints in gene therapy development. Takeda will use its capabilities to enable redosing of therapies throughout the development of the treatment.

“Takeda is an ideal partner to maximize the potential of our ImmTOR platform in gene therapy,” said Carsten Brunn, president and CEO of Selecta, in a company press release. “Their extensive capabilities as a global biopharmaceutical leader and expertise in rare diseases gives us a high degree of confidence that Selecta’s vision will be realized. Together, we look forward to overcoming barriers to current efforts in AAV [adeno-associated virus]-driven gene therapy, as well as striving to address immunogenicity constraints and unmet patient needs.”

“Partnerships are critical as we look to build differentiated gene therapy programs where we have the opportunity to combine novel platform technologies that each aim to solve the challenges associated with first-generation gene therapies,” said Madhu Natarajan, head of Takeda’s rare diseases drug discovery unit, in the press release. “Selecta’s ImmTOR platform is designed to mitigate unwanted immune responses allowing for redosing, which could have broad applicability across our gene therapy programs for a range of diseases.”

Takeda will use Selecta Bioscience’s ImmTOR platform to develop gene therapies for lysosomal storage disorders.