Health and Healthcare

Moderna Makes Big Post-IPO Strides With Pipeline Update

Chris Lange

Published: January 8, 2019 12:55 pm

Last Updated: January 11, 2020 12:50 pm

Moderna Inc. (NASDAQ: MRNA) shares made a handy gain early Tuesday after the company announced updates to several of its immuno-oncology and rare disease programs and outlined its 2019–2020 corporate objectives.

Overall, Moderna has 21 mRNA development candidates in its pipeline, with 11 programs now in clinical development.

In terms of its program updates the firm detailed:

• OX40L (mRNA-2416): Based on previously reported clinical observations in two patients with advanced ovarian carcinoma in its Phase 1 study, Moderna has submitted an Investigational New Drug (IND) amendment to the U.S. Food and Drug Administration (FDA)…
• OX40L + IL23 + IL36γ (Triplet) (mRNA-2752): Moderna has dosed the first patient in the Phase 1 study of mRNA-2752, an intratumoral injection comprising three mRNAs encoding for OX40L + IL23 + IL36γ for the treatment of advanced or metastatic solid tumor malignancies or lymphoma.
• Personalized Cancer Vaccine (PCV) (mRNA-4157): Moderna and Merck are planning a randomized Phase 2 study comparing PCV and Keytruda against Keytruda alone.
• KRAS vaccine (mRNA-5671): Merck will lead an open-label, multi-center, dose-escalation and dose-expansion Phase 1 study to evaluate the safety and tolerability of mRNA-5671 administered as an intramuscular injection both as a monotherapy and in combination with Keytruda.
• Methylmalonic Acidemia (MMA) (mRNA-3704): An IND application has been submitted to the FDA for mRNA-3704, Moderna’s development candidate for MMA.
• Propionic Acidemia (PA) (mRNA-3927): mRNA-3927 was granted Orphan Drug Designation by the FDA in December 2018 and Rare Pediatric Disease Designation by the FDA in January 2019.

Stéphane Bancel, Moderna’s CEO, commented:

This year we are focused on making significant advances to our pipeline as we work to bring multiple programs into Phase 2 clinical trials, move programs within our rare disease portfolio toward the clinic and leverage our mRNA platform to create both new development candidates and potential new modalities where we believe there is an opportunity to develop therapies for a broad range of diseases. I am pleased with the continued progress of our pipeline, our ability to now manufacture mRNA for clinical development at our new site in Norwood and the relentless work of our team. I believe we are better positioned than we have ever been to deliver on the promise of our science to bring forward mRNA medicines that have the potential to improve the lives of patients.

Shares of Moderna were last seen up about 1% at $16.42, in a post-IPO range of $13.03 to $22.75.