April 22, 2019
Impact Level: High
- Novartis has contributed $75 million towards a Series C financing for CAR-T company Poseida, which totaled $142 million from current and new investors.
- Poseida has two BCMA CAR-Ts: dosing in a pivotal phase 2 trial of autologous P-BCMA-101 is planned for 1H 2019 and an IND filing for allogeneic P-BCMA-ALLO1 is planned for late 2019/early 2020.
- The company also plans to file an IND in 2H 2019 for anti-PSMA CAR-T P-PMSA-101 in castrate resistant prostate cancer and an IND in 2020 for P-MUC1C-101, a CAR-T directed against Mucin 1 protein (MUC1C) in solid tumors.
Novartis was the first company to score an FDA approval for any CAR-T therapy, in 2017, but the company quietly discontinued the development of its own BCMA CAR-T MTV 273, per an SEC form 20-F (page 48) filed in January 2019, most likely due to response rates that lagged behind the leading BCMA CAR-Ts. Investing such a large amount in Poseida is a creative way for Novartis to remain active in the race to develop cell therapies for myeloma.
In January, Poseida filed for an IPO aiming to raise $115 million, but after a government shutdown-related delay in the offering the company apparently turned to venture and corporate investors. This Series C financing should be sufficient to move ahead with its CAR-T program without an IPO and despite the fact that P-BCMA-101 remains unpartnered.
Despite there being over 40 BCMA CAR-T programs in the clinic for multiple myeloma, P-BCMA-101 has emerged as one of the leading pipeline constructs. It holds FDA Regenerative Medicine Advanced Therapy (RMAT) status and has produced respectable response rates of at least 71% at a relatively low dose level (152 million CAR-T cells).
Poseida has positioned P-BCMA-101 as safer and more durable than competitor CAR-Ts due to unique features of its production methodology. These include a proprietary piggyBac DNA Modification System to deliver non-viral DNA and an end product that contains a high percentage of stem cell memory T cells. These technologies are also expected to streamline the manufacturing process.
Now with significant financial backing from Novartis, this is a BCMA CAR-T to keep an even closer eye on. A BLA filing is planned by the end of 2020 and we could see a launch in 2021.
Source: Poseida press release