Lilly Acquire Kelonia: What This Means for In Vivo CAR T Therapy
Billion-dollar deals reinforce a growing view: CAR T therapies are moving toward in vivo delivery.
As cell and gene therapies (CGT) move from bespoke, hospital-bound treatments toward scalable medicines, the industry is focused on overcoming one of its most persistent challenges: access.
Ex vivo CAR T therapies have achieved unprecedented success in hematologic malignancies, but their complexity, cost, and manufacturing timelines continue to limit patient reach.
Against this backdrop, Eli Lilly’s acquisition of Kelonia Therapeutics—developers of a proprietary in vivo gene placement system (iGPS®)—marks an inflection point for in vivo gene delivery and next-generation CAR T-cell therapy.
With cross-disciplinary experience in biochemical engineering and immunology, Dr. Aron Gyorgypal, postdoctoral fellow at Harvard Medical School and Massachusetts General Hospital, spoke with Technology Networks to explore this shift. He provided insights into the scientific and manufacturing drivers of change, how in vivo CAR T platforms could reshape access, and his hopes for broader therapeutic applications.
Eli Lilly’s acquisition of Kelonia Therapeutics reflects a broader shift toward in vivo genetic medicine
What does Lilly’s acquisition of Kelonia signal about how large pharma views the future of CAR T therapy?
Gyorgypal made one thing clear: the transaction was not an isolated move but part of Lilly’s broader, multi-year strategy to build an in vivo genetic medicine portfolio.
“Lilly has been systematically building its genetic medicine capabilities for years,” he explained, highlighting previous acquisitions spanning neurological, cardiovascular, and autoimmune diseases. “Now, the acquisition of Kelonia adds oncology value to their portfolio.”
He framed the deal as both validation and acceleration of the move toward in vivo genetic medicine. Industry-wide investment in recent years supports this view, with various multibillion-dollar deals demonstrating momentum toward in vivo CGT platforms.
The shift is also supported by attitudes Gyorgypal has observed across the field: "Venture investors I have spoken with are broadly bullish on in vivo CAR T as a long-term platform, but increasingly skeptical of autologous and allogeneic ex vivo approaches."
Kelonia’s appeal included early clinical validation of its iGPS system and lead asset, KLN-1010. Together, these produce a single-dose in vivo CAR T therapy for relapsed and refractory multiple myeloma. The therapy targets the B-cell maturation antigen, which is heavily expressed in multiple myeloma.
iGPS delivery system
The iGPS system is built around a lentiviral vector. The vector is engineered with a tissue-targeting molecule that guides it to the correct target and a fusogen that bridges and merges the vector with the target cell membrane. Once inside the cell, transgenes are released and integrated into DNA, turning the cell into a biological factory capable of manufacturing its own therapeutic proteins.
The safety and preliminary efficacy of the combination are currently being investigated in phase 1 trials. Recently, Kelonia announced maintenance of a 100% minimal residual disease (MRD)-negative response and 100% overall response rates among the 18 participants who have enrolled thus far.
These results reinforced Lilley’s decision to acquire the company following promising findings at the end of 2025. Peer-reviewed data is yet to be published.
Strategic signals from the deal:
- Large pharma is homing in on in vivo genetic medicine.
- Clinical proof-of-concept is sufficient to drive multibillion-dollar acquisitions.
In vivo CAR T: Balancing precision, scalability, and risk
What are the trade-offs between scalability, precision, and risk as the field moves toward in vivo gene delivery?
In assessing the move from one modality to another, Gyorgypal stressed the importance of acknowledging the limitations of past therapies.
The first human gene therapy was an ex vivo autologous procedure: cells were harvested from the patient, modified in a laboratory, and then reinfused. Although revolutionary, there are two key challenges with this approach: “Persistent bottlenecks come down to two interconnected problems: the starting material and turnaround time,” noted Gyorgypal.
In short, inconsistent starting material makes it difficult to achieve therapeutic consistency, and the time required for manufacturing starting cells into end products is “simply too long” for some patients.
Allogeneic therapies—in which cells are taken from a donor—aimed to overcome this. “The idea was straightforward. Instead of manufacturing a bespoke product for every patient, you produce a single off-the-shelf product from a healthy donor that can be given to anyone,” Gyorgypal explained.
However, he went on to note the limitations with this approach: “Great concept but, in practice, varying immune systems became the major barrier. The host rejects the donor cells and, in the other direction, you run into graft-versus-host complications.”
“Scalability through homogeneity sounds elegant until biology reminds you that human immune systems are anything but homogeneous.” — Dr. Aron Gyorgypal
In vivo CAR T seemingly solves scalability challenges by enabling the body to produce its own therapeutic cells. However, this introduces new considerations. In Gyorgypal’s words: “We are not simply solving the problems of ex vivo CAR T, we are trading one set of biological challenges for another.”
Gyorgypal highlighted several areas to monitor:
- Immune variability: Delivering therapy directly to the patient requires vectors. Patient-specific immune responses to viral vectors can affect efficacy and re-dosing capability.
- Safety: Insertional mutagenesis is a rare but important risk to monitor when therapeutic transgenes are integrated into cellular DNA. Approaches such as lipid nanoparticles, which deliver genetic material without inserting it into DNA, may mitigate these risks.
- Known unknowns: While there is optimism about the scalability gains of in vivo therapy, as with past therapies, there are likely challenges yet to be recognized.
Expanding CAR T: Implications for access and autoimmune diseases
How might in vivo CAR T reshape patient access and disease applications?
By eliminating complex manufacturing processes and expanding access beyond specialized centers, Gyorgypal believes that CAR T could become more like conventional biologics—produced at scale, consistently, and delivered broadly.
“If in vivo CAR T continues to advance, the most immediate impact will be on access.” — Dr. Aron Gyorgypal
However, he is more intrigued by the opportunity to broaden the therapeutic applications of CAR T. He explained why the platform is adaptable, and where he sees potential: “T-cell-directed approaches are relevant wherever you need to eliminate a specific cell population driving disease. Infectious diseases like human immunodeficiency virus, hepatitis, and tuberculosis are credible targets, but as an immunologist, autoimmunity is what I find most compelling.”
Autoimmune diseases
An autoimmune disease occurs when the immune system mistakenly attacks the body’s own healthy cells and tissues, causing inflammation and damage. Conditions can affect many organs and vary widely in severity.
Gyorgypal’s interest in this area is palpable. “When I think about immunological diseases, including autoimmunity and cancer, I'm struck by how extraordinary the human body is, both in health and in disease,” he noted. The “extraordinary” and complex nature of the immune system offers both challenges and opportunities for therapeutic discovery.
For many autoimmune diseases, management involves immunosuppressive treatment that aims to dampen excessive immune activity. While effective at managing autoimmune disorders, this approach also renders patients vulnerable to infection.
Gyorgypal explained how targeted CAR T could overcome this: “CAR T offers the ability to go in and delete autoreactive B cells that drive the pathology in the first place. Instead of suppressing the troublemakers, you are eliminating them.”
Early clinical evidence supports this, including one study investigating mRNA CAR T in myasthenia gravis. The approach achieved meaningful symptom improvement, with one-third of patients achieving minimal symptom expression within 6 months and maintaining this for at least 12 months.
Additionally, anti-CD19 CAR T therapy achieved promising results in lupus erythematosus. In a trial including five patients, all achieved remission, which was maintained at follow-ups conducted a median of eight months later.
As the therapy is specific, it avoids broad immune suppression and the side effects associated with traditional treatment.
Gyorgypal shared enthusiasm about what current findings signal for future development: “If in vivo platforms can deliver that same depth of response without the manufacturing burden of ex vivo CAR T, the implications for autoimmune disease could be as significant as what we have already seen in hematologic malignancies.”
Broadening the horizons of CAR T:
- The simplified manufacturing of in vivo CAR T therapy will increase access.
- Indications could expand beyond oncology, reaching patients with autoimmune and infectious diseases.
- CAR T could result in meaningful autoimmune disease symptom management without the systemic side effects of traditional suppressive approaches.
A transaction that represents a transformation
Eli Lilly’s acquisition of Kelonia reflects growing momentum toward scalable in vivo CAR T therapies that can reach many patients with various conditions.
While questions remain, so long as there is an opportunity to address unmet medical needs, investment and interest will continue to grow.
- In vivo CAR T platforms could dramatically expand patient access by eliminating manufacturing bottlenecks.
- Lilly’s acquisition is part of a broader movement toward scalable CGT.
- The potential is broad: oncology, infectious diseases, and autoimmunity.
- The field faces trade-offs between scalability, precision, and safety that will define long-term success.
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