Now Closer to Clinical Trials, Codiak BioSciences Refiles IPO Plans

Xconomy Boston — 

Codiak BioSciences, a company developing therapies based on tiny bubbles secreted by cells, is lining up an IPO as it prepares for the first tests of its technology in humans later this year.

In paperwork filed with securities regulators late Wednesday, Codiak set a preliminary $100 million goal for its stock market debut. The Cambridge, MA-based biotech has applied for a Nasdaq listing under the stock symbol “CDAK.”

The research of Codiak focuses on exosomes, extracellular vesicles that carry proteins, genetic material, and other substances in and out of cells. Exosomes function as a messenger system between cells, transporting molecules that alter the function of a recipient cell, Codiak says in its filing. Because these vesicles evolved with humans naturally, they don’t trigger an immune response. Exosomes can also be engineered for selective targeting of particular cells, and they can carry an array of payloads.

Codiak produces its therapies by engineering exosomes to carry drug molecules, either on the surface or the inside of the vesicle. The company says that its proprietary technology, called engEx, can produce therapeutic exosomes at scale and according to pharmaceutical standards.

The lead Codiak program, exoSTING, is being developed as a treatment for solid tumors. This Codiak exosome is engineered to carry molecules inside the vesicle that are intended to elicit an anti-tumor immune response by hitting the stimulator of interferon genes (STING) pathway of the innate immune system. Other attempts to drug this pathway have run into problems delivering the therapy to a cell while also avoiding toxic effects to healthy cells, Codiak says in its filing. The company says its exosome drug could overcome those limitations.

The cancers that Codiak aims to treat with exoSTING include metastatic head and neck squamous cell cancer, triple-negative breast cancer, cutaneous squamous cell carcinoma, and anaplastic thyroid carcinoma. If a Phase 1/2 clinical trial begins later this year as expected, the company says preliminary data could become available by the middle of 2021.

The next program in Codiak’s pipeline is exoIL-12, an exosome that’s engineered with the cytokine interleukin 12 (IL-12) on the surface of the vesicle. Other companies are also pursuing therapies that incorporate IL-12. Codiak notes IL-12 has elicited an anti-tumor immune response in its preclinical research and the clinical studies of others. But the company adds that experimental IL-12 therapies have been hampered by the unwanted spread of the therapy’s effects throughout the body, particularly the liver. Codiak says its exosome-delivered IL-12 drug could avoid such problems.

Codiak is developing exoIL-12 to treat solid tumors for which the IL-12 pathway has been established. These cancers include melanoma, Merkel cell carcinoma, Kaposi sarcoma, glioblastoma, and triple-negative breast cancer. The initial focus for this drug is early-stage cutaneous T cell lymphoma. A Phase 1 study is planned to start later this year; preliminary data are expected by the end of 2020. Additional data, including efficacy results, could become available by the middle of next year.

Other companies developing exosome therapies include Aruna Bio, AstraZeneca (NYSE: AZN), Evox Therapeutics, and PureTech Health. Startups are also getting into the mix. Harvard University spinout Vesigen emerged in July with $28.5 million in Series A financing to fund the development of its extracellular vesicle-based therapies.

The Wednesday IPO filing is Codiak’s second attempt to join the public markets. The company initially filed to go public in April 2019 but withdrew those plans three months later. Codiak’s timeline for the start of clinical trials is unchanged from last year. But Codiak can now make its case to investors with some additional validation. In June, Codiak inked a two-year research deal with Sarepta Therapeutics (NASDAQ: SRPT), which agreed to pay its new partner $72.5 million in upfront and near-term milestone payments. Sarepta is interested in exploring Codiak’s exosome technology as a way to deliver genetic medicines for muscular disorders without triggering an immune response.

The Sarepta deal is Codiak’s second partnership with a larger biopharmaceutical company. Early last year, the company began an alliance with Jazz Pharmaceuticals (NASDAQ: JAZZ), which paid $56 million up front in a deal spanning five cancer therapies.

Codiak launched in 2015 with financial backing from an investor group that included Flagship Pioneering (known then as Flagship Ventures), Arch Venture Partners, and Fidelity Management & Research. Those firms are Codiak’s largest stockholders, owning 28.3 percent, 18.9 percent, and 14.1 percent of the company respectively, according to the filing.

Codiak reported that its cash holdings as of June 30 totaled $50.9 million. The company says it will use the IPO proceeds to fund clinical tests of its two lead exosome drug candidates, and to finance further development of programs in earlier stages of development.

Image: iStock/Meletios Verras

 

Want more Xconomy content? Subscribe today for free newsletters, event and webinar alerts, whitepapers, podcasts, and more.