Pathway to Cures, NBDF’s venture philanthropy fund, is an investor in Be Biopharma, Inc., a clinical-stage company developing engineered B cell medicines. Be Biopharma recently announced the first participant treated with their therapy BE-101 in the BeCoMe-9 Phase 1/2 clinical trial.
What is BE-101?
BE-101 is a new type of cell therapy. It is created by taking a patient’s own B cells, altering them to produce factor IX using gene editing, and then re-introducing them back into the patient’s body, where they will potentially make enough factor XI to enable sustained levels of FIX and reduce annual bleeding episodes. This approach would greatly reduce the burden on the patient of multiple infusions associated with current therapies.
Why B cells? B cells are the body’s protein-making factories, producing thousands over a long period of time. Gene editing can now be used to alter B cells to produce specific therapeutic proteins. This has resulted in a new class of cellular medicines called engineered B cell medicines, or BCMs, that have the potential to be durable, can be made using donor cells (allogenic), are re-dosable, and can be given without needing to use chemotherapy or immunosuppression.
What is different about it? This therapy for hemophilia B is given in a way that is better for the patient. In many cell or gene therapies, patients have to undergo chemotherapy or immunosuppression first. This innovative approach doesn’t require this, making it less toxic, safer, and more comfortable for the patient. Pathway to Cures strives to invest in and support new approaches to curative therapies for inheritable blood and bleeding disorders. Be Biopharma’s innovative approach is an example of this.
The clinical trial: BeCoMe-9 is a two-part, multi-center, first-in-human Phase 1/2 clinical trial. In the first section of the trial, a small group of adults with moderate to severe hemophilia B will receive gradually increasing amounts of BE-101 to find the safest and most effective dose. Once that dose has been established, more participants will be added in the second phase of the trial. After receiving the therapy, all participants will be monitored for safety and clinical activity for approximately 52 weeks. For more details see www.clinicaltrials.gov under NCT identifier: NCT06611436.
NBDF’s venture philanthropy fund Pathway to Cures is fortunate to be in good company with top tier investors in Be Biopharma, supporting innovation on behalf of our bleeding disorders community. Be Bio was founded in October 2020, and is backed by ARCH Venture Partners, Atlas Venture, RA Capital Management, Nextech, Alta Partners, Longwood Fund, Bristol Myers Squibb, Takeda Ventures, Seattle Children’s Research Institute, Pathway to Cures and others to re-imagine medicine based on the power of engineered B cells. For more information: Be.Bio and Pathway to Cures.
