Avalon GloboCare Announces Successful Completion of Phase I Clinical Study of CAR T-Cell Therapy Candidate AVA-001

Rhea-AI Summary

Avalon GloboCare Corp. (NASDAQ: AVCO) has completed a Phase I clinical study of AVA-001, a CAR-T therapy for relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). The study reported a 90% complete remission (CR) rate among participants, with minimal toxicity and no severe adverse effects. Patients who achieved CR successfully proceeded to allogeneic bone marrow transplantation. The results will be presented on July 11, 2020, at the Lu Daopei Hematology Forum, showcasing potential advancements in cancer treatment.

Positive

• 90% complete remission (CR) rate observed in treated patients.
• Minimal toxicity and adverse effects reported.
• Successful bridging to allogeneic bone marrow transplant.

Negative

• None.

- Completed Phase I Clinical Study of 4-1BB Based Anti-CD19 CAR-T Therapy for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia

- Achieved 90% Complete Remission (CR) Rate with Minimum Toxicity or Adverse Side Effects; Successfully “Bridging” to Allogeneic Bone Marrow Transplant with Curative Intent

- Results will be Presented on July 11, 2020 at The Eighth Annual Lu Daopei Hematology Forum, the largest Hematology Conference in Asia

FREEHOLD, N.J., June 29, 2020 (GLOBE NEWSWIRE) -- Avalon GloboCare Corp. (NASDAQ: AVCO) (Avalon or The Company), a clinical-stage global developer of cell-based technologies and therapeutics, announced today it has successfully completed Phase I first-in-human clinical study of its leading Chimeric Antigen Receptor (CAR) T-cell therapy candidate, AVA-001 (National Institute of Health clinical trial registration number: NCT03952923).  Nine out of ten patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) have achieved complete remission (CR rate of 90%) within one month after the initiation of AVA-001 CAR T-cell therapy treatment.  The treatment with AVA-001 was generally well tolerated with minimal toxicities and adverse side effects.  No neurotoxicity or greater than Grade-1 cytokine release syndrome was observed in this cohort of patients treated with AVA-001.  All patients who achieved CR successfully proceeded to allogeneic bone marrow transplant with curative intent.  AVA-001 is a third generation CAR T-cell therapy which involves the 4-1BB (or CD28) co-stimulation signaling pathway.  Accessary laboratory testing that accompanied this pilot clinical study has demonstrated evidence of enhancement in CAR T cell persistence and protection against CAR T cell exhaustion.  

Avalon will present the results of this AVA-001 Phase 1 clinical trial on July 11,2020 at The Eighth Annual Lu Daopei Hematology Forum, the largest Hematology Conference in Asia (which will be held online according to the organizer due to the COVID-19 pandemic).

“We are excited and pleased to achieve these successful outcomes with our AVA-001 CAR T-cell therapy.  This paradigm of bridging CAR T-cell therapy to bone marrow transplant creates a new therapeutic horizon with curative potential for patients with relapsed/refractory B-ALL and other hematologic cancers,” stated David Jin, M.D., Ph.D., President and Chief Executive Officer of Avalon GloboCare. “We look forward to advancing our mission to improve cancer patient care and save lives,” said Dr. Jin.

About Avalon GloboCare Corp.

Avalon GloboCare Corp. (NASDAQ: AVCO) is a clinical-stage, vertically-integrated, leading CellTech bio-developer dedicated to advancing and empowering innovative, transformative immune effector cell therapy, exosome technology, as well as COVID-19 related diagnostics and therapeutics. Avalon also provides strategic advisory and outsourcing services to facilitate and enhance its clients' growth and development, as well as competitiveness in healthcare and CellTech industry markets.  Through its subsidiary structure with unique integration of verticals from innovative R&D to automated bioproduction and accelerated clinical development, Avalon is establishing a leading role in the fields of cellular immunotherapy (including CAR-T/NK), exosome technology (ACTEX^TM), and regenerative therapeutics. For more information about Avalon GloboCare, please visit www.avalon-globocare.com.

Forward-Looking Statements

Certain statements contained in this press release may constitute "forward-looking statements." Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors as disclosed in our filings with the Securities and Exchange Commission located at their website (http://www.sec.gov). In addition to these factors, actual future performance, outcomes, and results may differ materially because of more general factors including (without limitation) general industry and market conditions and growth rates, economic conditions, and governmental and public policy changes. The forward-looking statements included in this press release represent the Company's views as of the date of this press release and these views could change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of the press release.

Contact Information:
Avalon GloboCare Corp.
4400 Route 9, Suite 3100
Freehold, NJ 07728
PR@Avalon-GloboCare.com

Investor Relations:
Crescendo Communications, LLC
Tel: (212) 671-1020 Ext. 304
avco@crescendo-ir.com

FAQ

What are the results of the AVA-001 CAR-T therapy study by Avalon GloboCare?

The AVA-001 CAR-T therapy study achieved a 90% complete remission rate with minimal toxicity.

When will Avalon GloboCare present the results of the AVA-001 study?

The results will be presented on July 11, 2020, at the Eighth Annual Lu Daopei Hematology Forum.

What kind of leukemia does the AVA-001 therapy target?

AVA-001 targets relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL).

What is the significance of the AVA-001 study's outcomes for patients?

The study indicates a new therapeutic horizon with curative potential for patients with B-ALL.

How well was AVA-001 tolerated in patients?

AVA-001 was generally well tolerated, with no neurotoxicity and only minimal adverse side effects.