Next-IO™ CD22 Therapeutic CAR-T Program

About This Program

This program aims to develop CD22 therapeutic CAR-T for B cell acute lymphoblastic leukemia (B-ALL).

Rationale for our program:

• Although CD19 CAR-T treatment has achieved promising clinical outcomes worldwide, the prognosis associated with relapse and poor prognosis after treatment has become an urgent problem to be solved.
• Studies have shown that CD19 CAR T cell therapy fails in refractory or relapsed B acute lymphoblastic leukemia (r / r B-ALL) in pediatric and adult patients.
• Data indicate that CAR-T cells specific for CD22 (another B cell antigen lineage) are highly effective in inducing durable remission in r / r B-ALL patients.

In view of the above, the novel CAR-T program targeting CD22 we proposed might be an attractive strategy to address the recurrence of antigen escape in B-ALL treatment.

CD22 Emerges as CAR T-Cell Therapy Target

CD22 is a B cell-restricted phosphoglycoprotein of the immunoglobulin superfamily and has attracted widespread attention as a therapeutic target for B cell-directed therapy. Several novel therapeutic agents that selectively target CD22 are being developed as an alternative to B cell cancer therapy.

CD22 is expressed in almost all lymphoid malignancies. It has been reported that CD22 expression among different subtypes of ALL is 83% of Pro-B, 96.4% of normal B cells, 91.9% of Pre-B and 100% of mature B cell ALL. In several subtypes of mature B cell lymphoma, CD22 expression is reported to be higher than 90%. Therefore, CD22 can be used as a potent target for the treatment of B cell malignancies.

Fig.1 CD22 structure and signaling pathway. (Aujla, 2019)

Supporting Data

The following data support the rationale for the development of CD22 CAR-T cells with an improved therapeutic index in B-ALL.

• CD22 CAR T-cells was highly effective in inducing remission in r/r B-ALL patients. The following data demonstrated the long-term outcome of CR patients after received CD22 CAR T-cell therapy. For more details, please click https://www.ncbi.nlm.nih.gov/pubmed/3111021.

Fig.2 Long-term outcome of complete remission CR patients. (Pan. 2019)

Ongoing Clinical Trials

According to the latest report of the 2019 Annual Meeting of the American Association for Cancer Research (AACR), Principal Investigator Nirali Shah, MD, MHS presented their findings in the clinical phase 1, that 72.5% of patients exhibited complete remission of after CD22 CAR therapy. The results support further testing of the CD22 CAR in Phase 2 clinical trials. Of note, this is the only one anti-CD22 CAR cell products are being evaluated in clinical trials. Our project still holds a compelling market.

Program Management

We have extensive knowledge of end-to-end program development. For each program, we are committed to delivering the final complete program to our clients within 1.5 years before entering the IND stage.

Cooperation

Creative Biolabs is looking for potential partners (include but not limit to major pharma or biotech firms) to develop CD22 therapeutic CAR-T program together. Our scientists are dedicated to bringing years of valuable experience to our partner and achieve a meaningful partnership together. For any partners interested in our Next-IO™ programs, Creative Biolabs welcomes collaboration.

Here are two ways for your choice, and please contact us for more details.

1) Collaborate with us and co-develop the programs from the discovery phase to IND enabling. Costs will be shared.
2) Become a licensed candidate for our programs.

With our quality control protocol and knowledge of global regulatory requirements, we can help our partners further their programs with more chances to succeed. Look forward to cooperating with you in the near future.

References

• Aujla, A.; et al. Inotuzumab ozogamicin in clinical development for acute lymphoblastic leukemia and non-Hodgkin lymphoma. Biomarker Research. 2019, 7(1): 1-9.
• Pan, J.; et al. CD22 CAR T-cell therapy in refractory or relapsed B acute lymphoblastic leukemia. Leukemia. 2019, 33(12): 2854-2866.

For Research Use Only | Not For Clinical Use