Gritstone, MEI join biotechs using earnings season to reshuffle pipeline priorities

‘Tis the season—earnings season that is. A time for biotechs to sneak out news about their pipeline culls, project delays and partnership terminations. This quarter has been no exception, with a couple more biotechs reporting changes since markets closed yesterday. 

First up is vaccines-focused Gritstone Bio. The California-based biotech has decided to channel resources toward its individual neoantigen vaccine being studied in patients with cold tumors. The priority program has already undergone a phase 1/2 study among patients with metastatic microsatellite stable metastatic colorectal cancer (MSS-CRC) who had received prior chemotherapy treatment.

Now, the company wants to "strategically prioritize" its resources to expand an ongoing phase 2 part of a phase 2/3 study for patients with first-line MSS-CRC.

The consequence is that a phase 2 trial of an off-the-shelf neoantigen vaccine program has been pushed back until 2024. Gritstone believes the program can be applied across solid tumor indications and shared tumor neoantigen classes but is delaying the start of the phase 2 study until next year.  

The biotech is continuing its ongoing work in the infectious disease space—which includes a Gilead-partnered phase 1 vaccine against HIV—with most of its projects funded by external partners.   

For MEI Pharma, earnings season was a chance to confirm that it's severing ties with Japan-based Kyowa Kirin after development of its PI3K B-cell malignancy prospect zandelisib was halted in December. Armed with open-label, single-arm phase 2 data that showed a 70% response rate, MEI had hoped to file for accelerated approval. However, the FDA shut down that prospect by requesting data from a randomized study and later appeared to kill off any hopes of zandelisib coming to the U.S. market altogether.

After meeting with Japan’s regulatory agency, partner Kyowa decided to discontinue development of zandelisib in the country, prompting the companies to terminate a global licensing agreement inked in 2020. At the time, Kyowa had paid out $100 million cash for certain rights to the drug. With the deal in ruins, MEI can wave goodbye to the deal's more than $580 million in biobucks.

The announcements cap off a week that also saw Fusion Pharmaceuticals and Cyteir Therapeutics each reshuffle their pipeline priorities, while Big Pharma Takeda cut two midstage GI assets and BioNTech axed an oral mRNA vaccine project after the tech flunked the early test.