CAR-T cell therapies have represented a spectacular breakthrough in oncology. This technology, based on the genetic modification of your own T-lymphocytes (“killer cells”) so they can identify and destroy cancer cells, has enabled spectacular advances in tumor treatment and is universally hailed as the next generation of weapons in the fight against cancer. Current CAR-T therapies are about to become the equivalent of the first mobile phones, meaning they are about to be superseded. Their production and logistics are complex, require heavy infrastructure, are fragile, and expensive (€500k/dose).
A major limitation of current CAR-T is that T-lymphocytes must be extracted, modified in the lab, and then re-injected into the patient. This cumbersome and lengthy process restricts availability, efficacy, and financial accessibility. Alaya brings the next generation of therapies through its in-vivo modification technique (inside the patient’s body). Its polymer-based nanoparticle can deliver genetic instructions directly to the patient’s T-lymphocytes, transforming them into CAR-T cells inside the body itself. The patient enters the hospital, then leaves with an immune system fully capable of fighting the tumor.
This in vivo approach, which democratizes CAR-T treatment, is a true quantum leap in immuno-oncology — comparable to the leap that smartphones enabled in our phone usage! —: it solves toxicity and complexity issues, and allows for rapid, standardized, and accessible treatment.
Logically, the pharmaceutical world is showing great interest. This is demonstrated by transactions in recent months exceeding $1 billion involving this type of technology. Alaya’s technology has been recognized by top funds as a clear candidate to become the reference treatment in several types of cancer, with a valuation potential in the multi-billion range. This is why this funding round includes several leading European biotechnology funds (including a major fund with over $4 billion under management and more than 50 exits in the biotech sector), as well as family offices of famous American Tech founders.
Letters of intent are signed, a $14 million funding round will be finalized within 3 to 4 months, and this campaign offers a unique opportunity to invest at a lower valuation than these major players. The time to invest is now, before the deal closes.
Prototype/preclinical
19.237.123€
2026-2027
Biotechnology
1.5%
1.000€
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Many cancers remain resistant to conventional therapies, and relapse rates are high. Over the past decade, immunotherapy has become a transformative approach, leveraging the body’s own immune system to fight cancer.
Specifically, Chimeric Antigen Receptor T-cell (CAR-T cell) therapies—engineered T cells designed to target and destroy cancer cells—have demonstrated remarkable efficacy, particularly in hematological malignancies.
However, current CAR-T therapies rely on a complex ex-vivo production process: patient T cells are harvested, genetically modified in the lab, expanded, and then reinfused.
This approach, while effective, is limited by high production costs estimated to $500,000 per patient, logistical challenges, and scalability issues. As a result, access to these life-saving therapies is severely restricted, and the global need for more accessible, scalable, and cost-effective immunotherapies remains unmet.
Alaya.bio is a biotechnology company pioneering a new generation of in-vivo CAR-T cell therapies to overcome the limitations of current solutions.
Founded in July 2022 by Renaud Vaillant, Cécile Bauche, and Michel Sadelain, Alaya.bio is developing an innovative polymeric platform that enables the direct targeting and reprogramming of patient immune cells inside the body (“in-vivo CAR-T”). The company’s first application is in immuno-oncology, developed in collaboration with Columbia University in New York and Dr. Michel Sadelain, a world-renowned expert in cell therapy.
Unlike traditional ex vivo CAR-T therapies, Alaya’s approach eliminates the need to extract, manipulate, and reinfuse patient cells. Instead, their off-the-shelf CAR-T, based on their proprietary platform delivers genetic instructions directly to T cells within the patient, reprogramming them in situ to recognize and eliminate cancer cells.
By leveraging the body’s own immune system and bypassing the logistical hurdles of cell manufacturing, Alaya aims to set a new standard in cancer treatment, with applications extending beyond oncology, to other diseases where immune modulation is key.
Alaya’s technology is built on robust scientific foundations and addresses the critical bottlenecks in current cell therapies: scalability, cost, and patient accessibility. With a focus on clinical translation and regulatory pathways, Alaya is positioned to deliver transformative impact for patients and health systems worldwide.
Between the commercial launch of the first CAR-T therapies in 2017 and 2024, the sector has generated over $10 billion in cumulative revenue, with more than 30,000 patients treated globally. In 2025, it has accelerated, reaching 50,000 treated patients. The global CAR-T market reached $5 billion in 2024, with a CAGR of nearly 30% through 2028, and could exceed $22 billion as new indications and applications expand.
To date, Alaya.bio has secured $6.5M in equity funding and $4M in non-dilutive funding. It is supported by a seasoned board of directors composed of industry leaders such as Johannes FRUEHAUF, Stefan WILDT, and Loïc VINCENT.
The company recently closed a $3,5M extension of its seed round, with $1.5M from its historical investor Volnay Therapeutics (a Cambridge-based venture-builder specialized in CGT and backed by VC Mission Bio Capital) and a syndicate of experienced Business Angels.
Alaya is now preparing for a much larger 14M€ Series A made of a syndicate of internationally recognized top-tier investors, expected for the end of 2025 (term sheet signed).
This round will finance:
Recent exit activity in the sector underscores the strong appetite from major pharmaceutical players for breakthrough CGT platforms.
These transactions demonstrate the significant exit potential. Alaya.bio’s unique in vivo approach positions it as a highly attractive target for future acquisition. The company will reach the first-in-human stage by 2026, making it an attractive acquisition target.
Alaya.bio offers investors a rare opportunity to participate in the next wave of CGT innovation, with a solution poised to overcome the cost, complexity, and accessibility barriers of current CAR-T therapies. The company’s differentiated technology, strong scientific leadership, and favorable market dynamics make it a compelling candidate for both impactful patient outcomes, and significant financial returns with a first value step-up as of the end of 2025.
CAR-T therapy, first explored in the late 1980s, has reshaped cancer treatment, yet remains limited by high cost and manufacturing complexity. Current processes require extracting, modifying, and reinfusing each patient’s cells: a slow, expensive path often taking over a month. The next frontier is “off-the-shelf” in-vivo CAR-T, where immune cells are reprogrammed directly inside the body. This is precisely where Alaya.bio stands out.
The company has mastered not only the reprogramming technology but also a proprietary delivery vehicle that ensures safe, efficient, and scalable manufacturing, an essential step to make these treatments truly accessible. This delivery vehicle stands out of other in-vivo approaches. It uniquely combines the strengths of both biology and chemistry in a very innovative nanoparticle and unique polymeric composition, going beyond competitors’ approaches. As the CAR-T market grows from $10 billion today to a projected $20 billion by 2030, Alaya.bio is positioned at the forefront of this transformation.
This €14 million Series A round will fund their first-in-human trial within 12 months, with an anticipated exit shortly thereafter. Capital Cell investors can join on the same favorable terms as the seed round, an uncommon and valuable opportunity.
Behind Alaya.bio is a deeply experienced team: co-founders Cécile Bauche and Renaud Vaillant, recognized pioneers in cell and gene therapy, and Michel Sadelain, the 2024 Breakthrough Prize laureate and one of the original CAR-T visionaries. Together, they bring a unique mix of scientific credibility, proven execution, and strategic foresight that gives Alaya.bio a real edge in the race for in-vivo CAR-T.
Alaya.bio operates in a highly competitive landscape, where leading biotech companies and pharma groups are racing to develop in-vivo CAR-T therapies. Standing out will depend on proving superior efficacy, safety, and scalability. Moreover, the regulatory pathway for gene and cell therapies remains complex and demanding, requiring extensive validation to ensure compliance and safety before reaching patients, which could impact time-to-market.
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