Charles River Incubator Cohort to Accelerate CGT Development

Charles River Laboratories International has launched the second cohort of its Cell & Gene Therapy Incubator Program (CIP), a move that highlights the specific scientific and manufacturing challenges that advanced therapy developers must solve to reach first-in-human studies. The latest program cohort includes four therapeutic developers—CureAge Therapeutics, InterAct Therapeutics, Jaan Biotherapeutics, and Kopra Bio—and two enabling technology companies, Grace and HTLab AG’s Biowerkli, according to a Dec. 11, 2025 announcement (1).

Launched in late 2024, the CIP was designed to give emerging biotechnology companies access to scientific mentorship, regulatory guidance, and development and manufacturing capabilities. Each participant that joins the incubator has the opportunity to address challenges that commonly determine whether an advanced therapy can transition into a robust manufacturing strategy, according to Charles River.

“The CIP’s success shows how effectively it attracts top talent and promotes innovation,” said Kerstin Dolph, corporate senior vice-president, Global Manufacturing, in a company press release (1). “By establishing a strong foundation for commercial viability, the CIP is helping participants advance life-saving therapeutics and transform innovative ideas into real-world impact.”

How are the cohort’s therapeutic developers advancing next-gen therapeutic approaches?

Among the new cohort, CureAge Therapeutics is targeting peripheral nerve diseases using genetic delivery strategies intended to precisely reach tumor cells. The company’s work focuses on neurofibromatosis type 1 (NF1), a genetic disorder that causes peripheral nerve tumors (2).

“Our platform expands possibilities for patients with peripheral nerve diseases and offers a new therapeutic path for NF1 patients, with the potential to cure existing tumors and prevent new ones from forming,” said Gonzalo Fernández-Miranda, PhD, CureAge Therapeutics’ CEO and co-founder, in the release (1). “Founded by the Children’s Tumor Foundation and Deep Science Ventures, CureAge’s selection for the Charles River Incubator Program marks a significant milestone that will accelerate our journey toward the clinic.”

InterAct Therapeutics is applying an adeno-associated virus serotype 8-based modality to metastatic disease, initially focusing on breast cancer-derived liver metastases. The team focuses on the need to address the biological drivers of metastatic spread.

“Metastasis accounts for approximately 90% of cancer deaths, and there is a gaping therapeutic void for patients with BC-LM [breast cancer liver metastasis],” said Daniel Hargrove, co-founder and CEO, InterAct Therapeutics (1,3). He added that program participation will support both development activities and scale-up of the company’s computationally guided InterAct Print platform. Meanwhile, Isaac Chan, MD, PhD, the company’s co-founder and chief scientific officer (CSO), highlighted the scientific rationale: “For the first time, we are beginning to crack the biological code on how infiltrating tumor cells create space in distant organs…The Charles River Incubator provides the critical manufacturing and scientific support to translate this foundational discovery into a safe, durable, and liver-directed gene therapy.”

Jaan Biotherapeutics is working on therapeutics intended to activate cardiac regeneration mechanisms following heart damage. “Jaan Biotherapeutics…is honored to be selected to be part of CIP, and we look forward to working with Charles River as we develop our treatments for patients that are at a high risk of death following an acute myocardial infarction and other cardiac diseases where endogenous regeneration of heart muscle and reprogramming is required to restore heart function,” said Bhawanjit Brar PhD, CEO, CSO, and founder of Jaan Biotherapeutics (1).

Kopra Bio, a Y Combinator-backed start-up, is advancing an in-vivo tumor editing platform for solid tumors. “Kopra Bio’s in-vivo tumor editing platform has already generated our first development candidate, which we are advancing in an area of high unmet need, glioblastoma,” said Andrew Bartynski, PhD, the company’s founder and CEO (1). He added that the incubator partnership is intended to accelerate work toward clinical readiness.

How are enabling technologies shaping advanced therapy manufacturing?

Grace is expanding applications of its superparamagnetic silica technology for plasmid DNA pDNA purification. The president of the company’s Material Technologies business, Brenda Kelly, explained, “The incubator program provides a focused environment to fast-track our proof of concept for new applications in therapeutic-grade pDNA purification” (1). She also described the collaboration as a strategic step to broaden technology capabilities for next-generation manufacturing.

HTLab Biowerkli is focused on applying open-source artificial intelligence, digitalization, and smart biomanufacturing tools to streamline data use across development programs. “Disconnected data slows science. We’re here to fix that by turning every data point into a decision point,” said Vitaly Podoplelov, CEO of HTLab and founder of BioWerkli project (1). He emphasized that enhanced analytics could ultimately improve manufacturing predictability and accessibility.

According to Kristen Eisenhauer, corporate vice-president and chief commercial officer of Charles River, the strength of the incubator depends on its ability to create a collaborative environment. “Through Charles River’s comprehensive concept-to-cure portfolio and guidance from proven industry leaders, participants are advancing their programs with confidence and speed,” she said (1).

What impact may this cohort have on industrial CGT progress?

The CIP highlights areas in which early developers most often encounter obstacles, such as scalable vector production, delivery specificity, manufacturing readiness, and data integration. Each company in the cohort contributes a distinct scientific challenge that reflects broader industry needs, from metastasis-targeted vectors to regenerative approaches and improved data infrastructure (1).

As the advanced therapy sector continues to mature, models that blend scientific mentorship with development and manufacturing resources may help emerging technologies reach the thresholds required for clinical advancement and industrial adoption (4). The addition of this new cohort indicates continued investment in areas that could influence future standards in advanced therapy manufacturing, translational strategy, and data-driven process design (5).

References

1. Charles River Laboratories International. Charles River Extends Commitment to Advanced Therapy Developers with Second Incubator Program Cohort. Press Release. Dec. 11, 2025.
2. Lu, Y.; Xu, M.; Chen, X.; et al. Neurofibromatosis Type 1: Genetic Mechanisms and Advances in Therapeutic Innovation. Cancers 2025, 17, 3788. DOI: 10.3390/cancers17233788
3. Seyfried, T. N.; Huysentruyt, L. C. On the Origin of Cancer Metastasis. Crit. Rev. Oncog. 2013, 18 (1–2), 43–73. DOI: 10.1615/critrevoncog.v18.i1-2.40
4. Moutsatsou, P.; Ochs, J.; Schmitt, R. H.; et al. Automation in Cell and Gene Therapy Manufacturing: From Past to Future. Biotechnol. Lett. 2019, 41 (11), 1245–1253. DOI: 10.1007/s10529-019-02732-z
5. NIST. Regenerative Medicine and Advanced Therapies. NIST.gov (accessed Dec. 11, 2025).