Moderna's Non-COVID Pipeline: Exploring New Growth Opportunities

Overview of Moderna's Non-COVID Pipeline

Moderna's non-COVID pipeline includes a robust oncology segment, numerous product milestones across vaccines and therapeutics, and over 40 programs in development. Key areas of focus include RSV, seasonal flu, CMV, and combination vaccines, with several candidates advancing to later-stage development.

"I'm Stephen Hogan, the President of Moderna, and I'm going to be providing a little bit of context upfront for the data we're going to be reviewing today, which will cover our full oncology pipeline." --- (MRNA, event transcript, 2024/06/03)

"In our latest #IRInsights video, members of our executive team sat down to recap this morning’s earnings report for the first quarter of 2024, and provide more insight into upcoming pipeline milestones, and exciting clinical and corporate developments happening at Moderna. Watch the full video: https://t.co/Lr4liMNnCX" --- (MRNA, Twitter, 2024/05/02)

"advancing toward pivotal studies, Moderna continues to advance its pipeline and expects numerous product milestones in 2024 across its vaccines and therapeutics portfolio." --- (MRNA, press release, 2024/05/02)

"We continue to advance the development of variant-specific and next-generation COVID-19 vaccine candidates, and continue to develop our pipeline and advance our product candidates into later-stage development, in particular those in ongoing Phase 3 studies, including our RSV, seasonal flu, CMV and combination vaccine programs, as well as our INT program." --- (MRNA, sec filing, 2024/Q1)

"Moderna has over 40 programs in development. And in the context of R and D spend management, what is your strategy for pipeline prioritization?" --- (MRNA, conference, 2024/06/10)

Therapeutic Areas Targeted by Moderna

Moderna is targeting various therapeutic areas with its non-COVID pipeline, including infectious diseases, immuno-oncology, rare diseases, and autoimmune diseases. The company has discontinued its PD-L1 program to prioritize other areas, and its mRNA-4157 and mRNA-3705 therapies are advancing in melanoma and rare diseases, respectively.

"Since receiving its first greenlight from governments in North America, Europe, and other parts of the world, Moderna, Inc. (NASDAQ:MRNA) continues to work diligently in developing new treatments based on its mRNA therapeutics options." --- (MRNA, press release, 2024/05/01)

"PD-L1 therapeutic: Following a strategic review, and as a result of its decision to prioritize investments in other programs, Moderna is discontinuing development of its preclinical PD-L1 program (mRNA-6981), and is no longer evaluating other mRNA candidates in this area. Moderna Corporate Updates Announced the advancement of multiple vaccine programs to late-stage clinical trials at its fifth Vaccines Day Investor Event on March 27, 2024." --- (MRNA, press release, 2024/05/02)

"By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines. Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune" --- (MRNA, press release, 2024/05/10)

"Moderna and @Merck today announced that mRNA-4157 (V940), an investigational individualized neoantigen therapy, in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, demonstrated sustained improvement in recurrence-free survival and distant metastasis-free survival compared with KEYTRUDA alone in patients with high-risk stage III/IV melanoma following complete resection." --- (MRNA, Twitter, 2024/06/03)

"Center for Biologics Evaluation and Research has chosen mRNA-3705 as one of four investigational medicines for accelerated development to address unmet medical needs for rare diseases CAMBRIDGE, MA / ACCESSWIRE / June 6, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has selected mRNA-3705 for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program." --- (MRNA, press release, 2024/06/06)

Partnerships and Collaborations

Moderna has established significant partnerships, notably with Merck, to advance studies in melanoma and other tumor types. These collaborations are crucial for exploring new growth opportunities in their non-COVID pipeline, although prioritization of specific indications remains under discussion.

"And in partnership with Merck, we've launched a multitude of studies to impact not only melanoma, but a broad range of tumor types." --- (MRNA, event transcript, 2024/06/03)

"Just walk us through the strategies here for project financing and partnerships on the forward." --- (MRNA, conference, 2024/06/10)

"We're very excited about the potential for patients. And in partnership with Merck, we've launched a multitude of studies to impact" --- (MRNA, event transcript, 2024/06/03)

"stage. And then Doctor. Rose Laughlin, who leads all of research for us in the therapeutic space, including oncology, will come and share some of our work in the external partnerships and why we're so excited about those.So without further ado, I'll turn it over to Kyle." --- (MRNA, status update, 2024/06/03)

"However, our partner, Merck and ourselves, we have not yet decided where that fits in the priority of other indications, pathologies, and opportunities we're pursuing." --- (MRNA, earning call, 2024/Q1)

Clinical Trial Progress

Moderna's non-COVID pipeline is showing significant progress, with multiple investigational vaccines demonstrating positive Phase 3 results. The company is advancing its norovirus vaccine candidate towards a pivotal Phase 3 trial and has reported strong efficacy and safety profiles in its clinical trials, underscoring the potential of its platform to address unmet public health needs.

"Each investigational vaccine has independently demonstrated positive Phase 3 clinical trial results. The ongoing Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT06097273) is a randomized, observer-blind, active control study evaluating the safety, reactogenicity and immunogenicity of mRNA-1083 in two independent age group cohorts of approximately 4,000 adults each." --- (MRNA, press release, 2024/06/10)

"So the strong efficacy that we've mentioned, and the fact that we have not seen neuro inflammatory events or others in our clinical trial, we think bodes well for the product." --- (MRNA, conference, 2024/06/10)

"Now, rounding out this portfolio, we presented the positive clinical data from our norovirus vaccine candidate mRNA-1403, and shared that we are advancing that program towards its pivotal Phase 3 trial." --- (MRNA, earning call, 2024/Q1)

"It's an exciting moment for us. It's our 2nd chance to do this at ASCO. We hope to Manny and others' questions, Bonnie and others' questions, that maybe next year we're talking about even more specifics on the progress of the I and T program and some of these milestones behind us. But we also hope to be able to share some of the progress and the clinical data on some of those other programs because we really do believe that we're just the beginning of showing the potential of our platform to impact cancer and help cancer patients across the world." --- (MRNA, event transcript, 2024/06/03)

""With five vaccine programs that have achieved positive Phase 3 results, Moderna's platform is consistently demonstrating its ability to address significant unmet needs in public health." The ongoing Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT05815498) is a randomized, observer-blind, active-controlled study of approximately 11,400 individuals aged 12 years and older." --- (MRNA, press release, 2024/06/13)

Regulatory Challenges

Moderna faces significant regulatory challenges for its non-COVID pipeline, including uncertainty about meeting regulatory standards and limited follow-up periods. Additionally, the regulatory filing speed and submission process for products like 1010 and 1083 are impacted by strategic decisions and data preparation, complicating the regulatory strategy.

"We don't know if it would meet any type of regulatory bar. Secondly, they only have 9 months of follow-up." --- (MRNA, Status Update, 2024/06/03)

"And then with submission, is longer-term vault needed there and are there parallels from 1010 that we can take in terms of regulatory filing speed for 1083 or is that more impacted by the decision for buying one or the other first?" --- (MRNA, earning call, 2024/Q1)

"There's a logical sequence and what we will want to assess once we see the 1083 data is our regulatory strategy as well as our preparation and delivery of data for the submissions to determine which one will go first or second." --- (MRNA, earning call, 2024/Q1)

Market Potential of Non-COVID Products

Moderna anticipates launching a new non-COVID product by fall 2025, highlighting significant market potential. Additionally, the company sees opportunities to innovate in protecting against diseases like the flu, aiming to redefine respiratory health and advance public health.

"We should be able to potentially have a product available in the market through plus COVID single dose as early as fall of 'twenty five, because you could file late summer, early fall for a voucher, get this through the June 2025 ACIP meeting and get this for the fall season." --- (MRNA, conference, 2024/05/31)

"There is a need for innovative approaches to protect our most vulnerable against diseases like #COVID19 and #flu, as well as a potential opportunity to redefine the burden of respiratory season and advance public health." --- (MRNA, Twitter, 2024/06/10)

Technological Innovations

Moderna's technological innovations include a state-of-the-art facility emphasizing sustainability, investments in foundational capabilities, continuous advances in mRNA science, delivery technology, and manufacturing, innovations like the pre-fill syringe for RSV, and the use of GPTs, machine learning, robotics, and 3D printing to accelerate development.

"🎉🍾 Our cutting-edge 460,000-square-foot facility showcases our dedication to science, sustainability, and innovation – and is designed with exceptional energy efficiency, featuring everything from solar panels to geothermal wells." --- (MRNA, Twitter post, 2024/06/26)

"And over the last few years, we have invested purposely into people, processes, and technologies to build foundational capabilities that will allow us to scale efficiently." --- (MRNA, earning call, 2024/Q1)

"Our platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing us the capability to pursue in parallel a robust pipeline of new development candidates." --- (MRNA, sec filing, 2024/Q1)

"Sure. So if you think about it, another innovation that we're bringing in RSV is the pre fill syringe." --- (MRNA, conference, 2024/05/31)

"And then of course now with GPTs, we're doing machine learning everywhere. And also in robotics, we are doing a lot in robotics and we are doing a lot around 3D printing to be able to accelerate our development." --- (MRNA, conference, 2024/05/31)

Future Growth Prospects

Moderna is focusing on its adjuvant setting with pembro to drive future growth, while also working on financial strategies to return to profitability and set the stage for sustained growth in the coming years.

"Now sometime in the future down the road, maybe that will continue to shift at some point. But right now, we think we have the best strategy to continue with INT in the adjuvant setting with pembro adjuvantly." --- (MRNA, event transcript, 2024/06/03)

"So that's pretty exciting. And obviously, a lot going on with financial guidance and trying to get Moderna back to a profitability standpoint and setting the stage for the next few years of growth." --- (MRNA, conference, 2024/06/06)