Lisata Therapeutics focuses on developing innovative therapies for various diseases, leveraging advanced technologies in drug development. The company employs a proprietary platform that integrates cutting-edge approaches to enhance the efficacy and safety of its therapeutic candidates. This platform is designed to optimize the delivery and targeting of biologics, which are crucial for treating complex conditions. By utilizing this technology, Lisata aims to improve patient outcomes and address unmet medical needs in the therapeutic landscape.

In addition to its proprietary platform, Lisata Therapeutics is committed to advancing its pipeline of products through rigorous scientific research and development. The company emphasizes the importance of a robust scientific foundation, utilizing data-driven methodologies to guide its therapeutic innovations. This approach not only supports the development of new treatments but also ensures that the therapies are backed by solid evidence, ultimately contributing to the advancement of healthcare solutions for patients.

United States

(Formally Caladrius Biosciences; NASDAQ: CLBS)
Lisata Inc.,  (LSTA) a clinical-stage biopharmaceutical company, focuses on developing and commercializing cellular therapies to reverse disease and/or promote the regeneration of damaged tissue. Its product candidates include HONEDRA, a recipient of SAKIGAKE designation that is in Phase II clinical trial for the treatment of critical limb ischemia; OLOGO, a regenerative medicine advanced therapy for treating no-option refractory disabling angina; CLBS16 that is in Phase IIb clinical trial for the treatment of coronary microvascular dysfunction; and CLBS201, a CD34+ cell therapy for the treatment of pre-dialysis patients with chronic kidney disease. 

Cancer

Digestive System Diseases

Urogenital Diseases

Lisata Therapeutics

Critical limb ischemia

The goal of HONEDRA® is to prevent the serious adverse &nbsp;consequences of no-option CLI (cases where there is no longer the &nbsp;potential for other treatment beyond amputation) by extending the time &nbsp;of continuous CLI free status through improved blood flow in the &nbsp;affected limb. We also believe a CD34 product would have potential in &nbsp;treating chronic heart failure ("CHF"). Published reports have provided &nbsp;evidence that CD34+ cells administered into the coronary arteries of &nbsp;patients with CHF can improve survival compared to patients treated with &nbsp;standard medical therapy.
<a href="https://www.caladrius.com/product-candidates/honedra-formerly-clbs12/">Source</a>

LSTA12 (HONEDRA®)

Pancreatic cancer

LSTA1 is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to penetrate solid tumors more effectively. LSTA1 actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor. LSTA1 also has the potential to modify the tumor microenvironment, with the objective of making tumors more susceptible to immunotherapies. We and our collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of emerging anti-cancer therapies, including immunotherapies and RNA-based therapeutics. To date, LSTA1 has also demonstrated favorable safety, tolerability and clinical activity in completed and ongoing clinical trials designed to test its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer.

Certepetide (LSTA1)

Glioblastoma

Glioma

LSTA1 + temozolomide

Cholangiocarcinoma

Solid tumor/s

LSTA1 + Standard of care

Colorectal cancer

LSTA1 + FOLFIRINOX (neoadjuvant) + panitumumab

LSTA1 + gemcitabine/nab-paclitaxel

LSTA1 + Durvalumab/gemcitabine/nab-paclitaxel

Gastroesophageal adenocarcinomas

LSTA1 + nivolumab/FOLFIRINOX,

Gemcitabine/nab-paclitaxel + continuous infusion of certepetide/placebo

Chronic kidney disease

CLBS201 is designed to assess the safety and efficacy of CD34+ cell &nbsp;therapy as a treatment for chronic kidney disease (“CKD”). Based on a &nbsp;wealth of published preclinical and early clinical data, it appears that &nbsp;the innate ability of CD34+ cells to promote the growth of new &nbsp;microvasculature could be a means to attenuate the progression of the &nbsp;disease or even reverse the course of CKD. We plan to file an IND for &nbsp;this program by the second quarter of 2021 and to initiate a phase 1/2 &nbsp;proof-of-concept study of CLBS201 in a moderate to severe CKD population &nbsp;shortly thereafter. CKD remains a largely unmet medical need, &nbsp;especially as the general population ages and the incidence of diabetes &nbsp;and hypertension increases.
<a href="https://www.caladrius.com/product-candidates/clbs201-chronic-kidney-disease/">Source</a>

LSTA201 (CLBS201)

Coronary Microvascular Dysfunction

Coronary &nbsp;microvascular dysfunction, previously known as Syndrome X, is a heart &nbsp;disease in which disease of the microcirculation results in severe &nbsp;myocardial ischemia in the absence of blockages in the large arteries. &nbsp;CLBS16 is designed to reduce the serious adverse consequences caused by &nbsp;the damage to the inner walls of the heart’s blood vessels through CD34+ &nbsp;cells’ innate ability to repair small blood vessels or &nbsp;microcirculation.
<a href="https://www.caladrius.com/product-candidates/clbs16/">Source</a>

XOWNA (CLBS16)

Angina

NORDA is a severe end-stage condition which results in disabling &nbsp;symptoms due to extensive coronary disease that has not responded to &nbsp;bypass surgery, stenting or medications. OLOGO™ (CLBS14) has been &nbsp;studied in Phase 1, Phase 2 and Phase 3 randomized, double-blind &nbsp;placebo-controlled clinical trials. 1-3 Recent publications in the&nbsp;European Heart Journal4 and Cardiovascular Revascularization Medicine 5, 6,&nbsp;provide &nbsp;an independent analysis of the evidence from these studies and reveal &nbsp;significant improvements in exercise capacity, angina frequency and &nbsp;mortality in this orphan sized patient population. Under the terms of &nbsp;the RMAT designation, Caladrius is holding discussions with the FDA to &nbsp;determine the most expeditious regulatory pathway to bring this &nbsp;potentially restorative therapy to patients in need.
<a href="https://www.caladrius.com/product-candidates/clbs14/">Source</a>

Lisata Therapeutics

Company Details