1.1.1 Cell therapy is an innovative approach that uses living cells to heal the body by repairing or replacing damaged cells, or, in the case of immune cell therapies, targeting and destroying cancerous and other harmful cells. Over the years, a range of cell types has been developed into effective therapies, including hematopoietic (blood-forming) stem cells (HSCs), embryonic stem cells (ESCs), induced pluripotent stem cells (iPSCs), and adult stem cells like mesenchymal stem cells (MSCs). In addition, immune cells have shown promise in various therapeutic applications, including CAR-T (T cells), TIL (tumor-infiltrating lymphocytes), and CAR-NK (natural killer cells), among others.
1.1.2 The most established form of cell therapy is the transplantation of HSCs, commonly known as bone marrow transplants, primarily used to treat blood cancers and other hematologic conditions. Cell therapies have expanded beyond this application in recent years, however, and they are now approved or being developed for a wide array of indications, including solid tumors, autoimmune and infectious diseases, spinal cord injuries, neurological disorders, and other critical health issues.[1] This broadening scope highlights the transformative potential of cell-based treatments in modern medicine.
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1.2.1 Cell therapies have attracted significant attention as promising treatment options, offering potential improvements in safety and efficacy compared with traditional drug substances. Unlike conventional biologics or small molecule drugs, certain types of cells have the unique ability to migrate to targeted tissues and then multiply, bypassing some of the pharmacokinetic challenges often encountered with standard treatments.
1.2.2 Additionally, many therapeutic cells can sense and respond dynamically to environmental cues, such as cell surface receptors or bioactive molecules. This capability enables them to activate specific biological pathways and produce or secrete essential biomolecules, leading to more targeted and adaptable therapeutic effects.
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1.3.1 Cell and gene therapies, collectively referred to as advanced therapies, attract significant media attention because of their curative potential — particularly for devastating rare genetic diseases — and their extraordinarily high prices. Within the industry, they are also known for their high cost of goods, difficulties in development and manufacturing, and their astounding promise for patients and investors.
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Pioneering Cell Therapy with Hematopoietic Stem Cells
1.4.1 The foundation of cell therapy was laid in the early 1960s when Canadian scientists Ernest McCulloch and James Till discovered the existence of stem cells. Their work provided the first experimental evidence for stem cells, establishing a framework for future advances in hematopoietic stem cell (HSC) research and therapy.[7] In 1958, French oncologist Georges Mathé performed groundbreaking bone marrow transplants in Europe, successfully saving researchers who had suffered from radiation poisoning. A few years later, Mathé extended this approach to treat a patient with leukemia, marking another significant milestone in the development of cell therapy.
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1.5.1 In 1991, Dr. Arnold Caplan described the role of MSCs in embryonic bone and cartilage formation, and in tissue regeneration and repair in adults. He further hypothesized that these cells could be used therapeutically as a form of regenerative medicine.[12] The lack of effective treatment alternatives, combined with a tolerant regulatory framework, resulted in a rapid transition from research to veterinary clinical practice. In 2001, Douglas Herthel published a retrospective study of 100 horses he had treated with intralesional injections of autologous bone marrow over the preceding six years. Of those 100 horses, 84 returned to full work and soundness after 6 months.[13] Shortly afterwards, researchers at the Royal Veterinary College in London published a case study outlining the isolation, characterization, expansion, and reimplantation of autologous MSCs into an 11-year-old polo pony with superficial digital flexor tendon (SDFT) damage.[14]
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1.6.1 The human cell therapy landscape for both approved and pipeline therapeutics is dominated by oncology treatments.[26] In veterinary medicine, however, the development of cell therapies has been driven primarily by the desire to achieve full functional restoration following orthopedic injuries.
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1.7.1 Perhaps unsurprisingly, particularly in the U.S., commercial interest in veterinary applications of stem cell therapies rapidly outpaced regulatory control. While the first companies supplying allogeneic MSCs or services to support the isolation and expansion of autologous MSCs were established in the early 2000s, the FDA guidance for developing cell-based products for animal use wasn’t published until 2015.[31]
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1.8.1 Under the One Health Initiative, which is defined by the World Health Organization (WHO) as an integrated, unifying approach to balance and optimize the health of people, animals, and the environment, some veterinarians suggest that the body of data supporting the use of MSCs for orthopedic indications in animals can and should be considered in the assessment of novel human therapies. In particular, they argue that the lack of fidelity in traditional animal models leads to later clinical failures, and that treatment of naturally occurring diseases in companion animals may therefore provide a better indication of human clinical success. Companion animal models more closely resemble human conditions because their naturally occurring diseases arise from complex interactions between multiple genes and environmental factors. In addition, their longer lifespans and larger size allow for diagnostic and treatment procedures that are more directly translatable to humans.[22]
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1.9.1 Understanding of veterinary species-specific iPSCs and their corresponding regulators of pluripotency lags behind that of human iPSCs, which has delayed their evaluation in veterinary clinical trials.[22] To date, one pilot study has aimed to optimize the generation of neural progenitor cells (NPCs) from canine iPSCs and test their safety in dogs with spinal cord injuries. This study found that, although NPCs derived from canine iPSCs could differentiate into mature neural cells, neither of the two dogs that were injected with canine NPCs experienced any meaningful improvement in their condition.[38]
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1.10.1 In early 2024, we received many questions regarding the funding outlook for biotech. The following is our answer to these questions. While the text was also published on Pharma’s Almanac under the title “Biotech Funding Ups and Downs” in April 2024,[42] we are reproducing it here for the convenience of our readers. The following sections update the history lesson for the 2024 outlook.
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1.11.1 So where do we stand, and what is the outlook for 2024? Analysts consider the bottleneck to be pharma acquisitions, so this is where we must look for forecasting the return of capital to the biotech markets. Although a few large exits, notably in the ADC space, have made news,[55][56][57] exit activity as of Q2 2024 is still depressed. PitchBook reported $14.5B in exits over 39 deals. When compared to the 2023 total ($20B over 97 deals), this indicates the value of the ongoing deals at least is on the rise, even if the total number of exits is not.
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1.12.1 The pharmaceutical industry, once buoyed by the unprecedented demand and rapid innovation triggered by the COVID-19 pandemic, is currently readjusting to a post-COVID world, which has brought its own challenges, including a wave of layoffs that has swept across the biotech and pharma landscape in the past few years. This undercurrent of job reductions and corporate restructuring echoes the industry’s reflex to recalibrate in response to market pressures and strategic realignments, which appears to be at odds with forecasts of robust drug sales and potential market growth.
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