Emerging Company in the Spotlight sponsored by JFK Communications.
BioNJ is pleased to shine the spotlight on one of our Innovation Members each month featuring their progress and work on behalf of Patients and their impact on the New Jersey life sciences ecosystem. This month’s Emerging Company in the Spotlight is Caladrius Biosciences.
So many of our Members are making a dramatic impact on our State’s innovation ecosystem. We celebrate you! Caladrius Biosciences is one such company.
Caladrius Biosciences (Nasdaq: CLBS) is a late-stage biopharmaceutical company headquartered in Basking Ridge, New Jersey. Caladrius is committed to the development of innovative products that have the potential to restore the health of people with chronic illnesses with a primary focus on select cardiovascular indications. “Our mission is to develop treatments for serious chronic diseases with high unmet medical need,” said David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius Biosciences. “We are focused on delivering innovative treatments to patients and physicians as well as providing value to our shareholders.”
Caladrius relocated its headquarters to New Jersey in 2015. According to Dr. Mazzo, this relocation to the Garden State provides unparalleled access to highly skilled employees and proximity to research institutions, universities and other life sciences companies. “We are also very close to rail and air transportation hubs as well as the NYC global financial center.”
Caladrius possesses proprietary technology that seeks to exploit the potential of human cells by enabling the body to repair the microvasculature system (CD34 Technology) and rebalance the immune system (T Regulatory Technology).
CD34+ Cell Technology
Heart attack, chronic heart failure, critical limb ischemia and stroke are all caused by an acute or chronic deficit in the supply of oxygenated blood. One of the body’s natural responses to areas with low levels of oxygenated blood is the recruitment of CD34+ cells to those tissues.
Caladrius’ CD34 technology leverages the body’s natural repair mechanism to induce the development of new capillaries, preventing tissue death by improving blood flow.
The company’s goal is to build a broad portfolio of novel and versatile products that address important unmet medical needs. Its current product candidates include three developmental treatments for cardiovascular diseases based on a proprietary CD34+ cell therapy platform:
- CLBS12 — A recipient of SAKIGAKE designation, in Phase 2 testing in Japan and eligible for early conditional approval for the treatment of critical limb ischemia. The Japanese SAKIGAKE designation identifies drugs with prominent effectiveness against serious and life-threatening diseases in order to make them available to patients in Japan ahead of the rest of the world. Drugs are designated at a comparatively early stage of development and are given priority for clinical trial consultation and review.
- CLBS14-CMD is in Phase 2 (ESCaPE-CMD Study) proof-of-concept testing for the treatment of coronary microvascular dysfunction.
- CLBS14-NORDA is in late-stage development for no option refractory disabling angina for which it has received regenerative medicine advanced therapy (RMAT) designation from the U.S. FDA. The RMAT designation is granted to regenerative medicine therapies intended to treat a serious condition for which preliminary clinical evidence indicates a potential to address unmet medical needs for that condition. RMAT affords regenerative therapies the advantages of expedited development and review of marketing applications similar to breakthrough therapy designation. The Phase 3 protocol is currently being finalized with the U.S. FDA and Caladrius expects to initiate the trial before year-end 2019.
T Regulatory Cells (Tregs) Technology
Based on a second technology platform, Caladrius has an autoimmune product candidate, CLBS03, in Phase 2a testing. CLBS03 is an autologous ex vivo expanded and activated polyclonal T regulatory cell therapy being developed as a treatment of recent-onset type 1 diabetes. CLBS03 has been awarded Fast Track and Orphan designations by the FDA and Advanced Therapeutic Medicine Product classification by the EMA.
When Tregs function properly, T effector cells preferentially attack harmful foreign materials. In autoimmune disease, however, it is thought that deficient Treg activity permits T effector cells to attack the body’s own beneficial cells. Augmentation of Tregs is thought to restore the immune system to its “native” state and reduces or eliminates autoimmune disease symptoms.
Caladrius has completed enrollment in a Phase 2a study (The Sanford Project: T-Rex Study, a collaboration with Sanford Research) of CLBS03 to treat type 1 diabetes mellitus in adolescents with recently diagnosed disease. Comprehensive analysis of the individual patient data is underway following completion of the 1-year follow-up of all subjects and while awaiting the final, 2-year follow-up of the subjects. Caladrius is considering other clinical indications which may advance this program, including graft versus host disease, chronic obstructive pulmonary disease, multiple sclerosis, inflammatory bowel disease and steroid resistant asthma.
A Vision for the Future
To accomplish their mission and see their vision become reality, Caladrius combines state-of-the-art science with the body’s intricate natural biologic systems. The company is working to leverage the bodies’ development of cell capabilities and believes that each completed clinical study expands the foundations of cell therapy and biologic science contributing to discoveries with meaningful and lasting influence and bringing treatments closer to reality for patients in need.
As Caladrius grows, it continues to seek the best and brightest individuals to join the team. Anyone interested in joining Caladrius, should click here for more information or visit www.caladrius.com.