2021-11-10| Trials & Approvals

Considering Manufacturing and Commercial Advantages, Poseida Makes Strategic Shift Towards Allogeneic CAR-T Products

by Rajaneesh K. Gopinath
Share To

San Diego-based Poseida Therapeutics had always set its goal to move into allogeneic products. In its Q3 earnings announcement yesterday, the company officially announced its strategic shift to an allogeneic CAR-T BCMA clinical program for multiple myeloma.

“While data in the autologous trial showed meaningful responses and a favorable safety profile, the Company’s strategic focus has long been on allogeneic CAR-T therapies, leveraging the learnings of the autologous CAR-T program to provide benefits beyond those of autologous CAR-T, including a more desirable off-the-shelf product profile for future commercialization while maintaining the tolerability advantage of our autologous product candidate,” the company said in a statement.

Related Article: Takeda Inks $3.6 Billion Deal with Poseida to Advance Non-Viral Gene Therapies and Overcome Safety Issues


Allogeneic CAR T-Cell Therapy 

CAR-T cell therapy is a mode of treatment that uses engineered T cells to fight cancer. These cells can either come from the patient (autologous CAR-T therapy) or a donor (allogeneic CAR-T therapy).

While autologous approaches are promising, there are significant challenges. The cells extracted from patients must be shipped, engineered, and re-infused in the patient within a short span of time. Besides, it is labor-intensive and quite expensive. Kymriah, the first CAR-T cell therapy approved in the US, is currently priced at $475,000.

On the contrary, ‘off-the-shelf’ allogeneic treatments have many potential advantages. Since the cells can be extracted from donors and stored in bulk, they can be modified and infused in multiple patients in a short time.

Poseida believes that allogeneic CAR-T is the future and is therefore winding down its lead autologous candidate for multiple myeloma—P-BCMA-101, which is currently in a Phase 1 expansion trial. Instead, it is going to focus on advancing P-BCMA-ALLO1, its first allogeneic CAR-T product for which it recently received IND clearance from the FDA.

The company said that P-BCMA-ALLO1 has the potential to deliver up to hundreds of doses per manufacturing run, thereby dramatically reducing both clinical trial costs and ultimately commercial product cost compared to the autologous P-BCMA-101 program.

“The initiation of our P-BCMA-ALLO1 clinical trial represents the beginning of a long-planned strategic transition to what we believe is the ‘holy grail’ of cell therapy for oncology, a fully allogeneic CAR-T with a fully-humanized heavy chain BCMA binder and a high percentage of TSCM cells which we believe are the key to success,” said Eric Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida.

“While we believe the P-BCMA-101 autologous program has competitive advantages and would be approvable, one long-term strategic benefit of that program has been to inform our highly-differentiated allogeneic approach. With the P-BCMA-ALLO1 clinical program now underway and with very high confidence in our allogeneic platform, we will begin a planned wind down of P-BCMA-101.”

However, Poseida has to overcome the life-threatening complications associated with allogeneic CAR T cells like graft-versus-host disease to obtain market success.

© All rights reserved. Collaborate with us:
Related Post
Taiwan’s Acepodia Closes $100 Million Series C to Accelerate Cancer Assets
Blackstone Chips in $250 Million to Aid Autolus’ CAR-T Therapy
San Diego Startup Nabs $140 Million Following BeiGene, Kite Partnerships
Novel RAGE Antagonist Stirs Hopes for Countering Diabetic Complications
AstraZeneca Blocks Private Equity Buyout of Swedish Pharma Sobi
Coherent Biopharma, WuXi STA Collab Takes a Crack at Peptide-Drug Conjugates
How CDMOs are Restructuring the Biopharma Landscape – An Interview with Bobby Sheng
BeiGene launches IPO on Shanghai’s STAR market to raise $3B
Novartis, UCB Take Aim at Parkinson’s Disease Under $1.65 Billion Collab
Atara Biotherapeutics’ First-In-Class Allogeneic T-Cell Therapy Accepted for EMA Review
Georgia, USA
Hong Kong, China
Scroll to Top

Create an account with us now to say goodbye to all the pop-ups!