Pioneering Medicines, an Initiative of Flagship Pioneering, Establishes First-of-its-Kind Partnership with Cystic Fibrosis Foundation to Develop Breakthrough Treatments for CF

Pioneering Medicines and Multiple Flagship Bioplatform Companies to Develop Novel Treatments for People with Cystic Fibrosis Not Served by Current Therapies

Cambridge, MA, November 3, 2021 – Flagship Pioneering today announced a first-of-its-kind strategic partnership with the Cystic Fibrosis Foundation and Flagship’s Pioneering Medicines to develop therapeutics that address the unmet needs of people living with cystic fibrosis by leveraging the innovations and teams of multiple Flagship-founded companies. Through this agreement, the Cystic Fibrosis Foundation has committed up to $110 million to Pioneering Medicines to bring forward multiple development candidates and develop these candidates to human proof of concept.

“Despite recent advances, approximately 10% of individuals living with cystic fibrosis have rare or nonsense mutations and do not have any effective treatment options. We are excited to harness the power of multiple Flagship technologies to create novel medicines for these patients in need,” said Paul Biondi, President, Pioneering Medicines and Executive Partner, Flagship Pioneering. “This is a powerful opportunity to bring together the capabilities of multiple Flagship bioplatform companies, along with the disease expertise and extensive network of the Cystic Fibrosis Foundation, and the drug development capabilities of Pioneering Medicines to deliver innovative treatments for these patients and to explore the possibility of curative treatments for all those living with cystic fibrosis.”

“This partnership highlights the benefits of the Pioneering Medicines model,” continued Biondi. “With expertise and direction from Flagship Executive Partner, John Mendlein, and under the Pioneering Medicines’ scientific leadership of Luciano Rossetti, our head of R&D, and Luisa Salter-Cid, our CSO, we are bringing together an integrated team to develop life-changing treatments and deliver benefits to patients much sooner than any company could independently deliver,” said Biondi.

Through this collaborative agreement, Pioneering Medicines and the Cystic Fibrosis Foundation will partner with multiple companies within the Flagship ecosystem, leveraging emerging technologies including Tessera Therapeutics’ Gene Writing^TM technology, targeted delivery modalities, and RNA technologies. The teams will work together to harness their unique technologies and develop individual asset companies specifically focused on potential treatments for cystic fibrosis.

“There is a tremendous opportunity to expand the impact of Flagship’s innovative bioplatforms by creating medicines in disease areas beyond where the individual companies are initially focused,” said Noubar Afeyan, Founder and CEO of Flagship Pioneering. “Through Pioneering Medicines and our new collaboration with the Cystic Fibrosis Foundation, we have an unparalleled opportunity to create innovative products that combine platform technologies to help address the unmet needs of the cystic fibrosis community.”

“Tessera is pioneering Gene Writing to cure diseases by making the full spectrum of genetic modifications from changing a single base pair, inserting or deleting multiple bases, to writing entire genes into the genome. Through this partnership, we will apply Tessera’s Gene Writers to correct specific mutations in the CFTR gene, as well as to write the full-length CFTR gene using all-RNA therapeutic compositions,” said Geoffrey von Maltzahn, co-founder and CEO of Tessera Therapeutics and General Partner, Flagship Pioneering. “We are eager to address this longstanding unmet need, and ultimately to improve the lives of people living with cystic fibrosis.”

About Pioneering Medicines

Pioneering Medicines is a strategic initiative within Flagship Pioneering that is dedicated to conceiving and developing a broad portfolio of life-changing treatments by leveraging and expanding the use of Flagship’s innovations. By harnessing the power of Flagship's multiple scientific platforms, Pioneering Medicines will create and advance novel medicines with the platform companies to accelerate the extension of their portfolios into novel areas and show that the platform can be applied more broadly, thereby delivering benefits to more patients and platforms, sooner.

About Flagship Pioneering

Flagship Pioneering conceives, creates, resources, and develops first-in-category bioplatform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in more than $200 billion in aggregate value. To date, Flagship has deployed over $2.5 billion in capital toward the founding and growth of its pioneering companies alongside more than $19 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 42 transformative companies, including Axcella Health (NASDAQ: AXLA), Codiak BioSciences (NASDAQ: CDAK) Denali Therapeutics (NASDAQ: DNLI), Evelo Biosciences (NASDAQ: EVLO), Foghorn Therapeutics (NASDAQ: FHTX), Indigo Ag, Kaleido Biosciences (NASDAQ: KLDO), Moderna (NASDAQ: MRNA), Omega Therapeutics (NASDAQ: OMGA), Rubius Therapeutics (NASDAQ: RUBY), Sana Biotechnology (NASDAQ: SANA), Seres Therapeutics (NASDAQ: MCRB), and Sigilon Therapeutics (NASDAQ: SGTX).