Cell and Gene Therapy Today—December 18, 2025

In Today’s Newsletter

Dive deeper

🧬 Link Cell Therapies Launches with $92M to Advance CAR-T in Solid and Liquid Tumors [1] [US • 15 Dec 2025]

https://www.prnewswire.com/news-releases/link-cell-therapies-launches-with-vision-of-advancing-car-t-therapies-in-solid-and-liquid-tumors-302642244.html
Context: Link Cell Therapies emerged from stealth with $92 million in financing to develop CAR-T therapies for both solid and hematologic malignancies. Its platform targets co-expressed tumor antigens while minimizing overlap with healthy tissue.
Key point: Lead program LNK001 targets renal cell carcinoma and is expected to enter Phase I trials in 2026.
Implication: Improved targeting strategies could unlock CAR-T efficacy in solid tumors, a longstanding challenge in oncology.

💡 Kyverna Gains Momentum Toward First CAR-T Approval in Autoimmune Disease [2] [US • 15 Dec 2025]

https://www.fiercebiotech.com/biotech/kyverna-gains-clear-view-first-car-t-approval-autoimmune-disease-after-truly-remarkable-sps
Context: Kyverna Therapeutics reported positive Phase 2 data for mivocabtagene (miv-cel) in stiff person syndrome (SPS), a rare autoimmune neurological disorder.
Key point: Patients demonstrated a 46% improvement in the 25-foot walk test, with 81% achieving clinically meaningful mobility gains.
Implication: Mivocabtagene could become the first CAR-T therapy approved for an autoimmune disease, with an FDA filing planned for 2026.

🧠 Kenai Therapeutics Doses First Patient in Parkinson’s Neuron Replacement Trial [3] [US • 15 Dec 2025]

https://www.prnewswire.com/news-releases/kenai-therapeutics-announces-first-patient-dosed-in-phase-1-replace-clinical-trial-of-neuron-replacement-cell-therapy-rndp-001-for-idiopathic-parkinsons-disease-302640518.html
Context: Kenai Therapeutics dosed the first patient in its Phase 1 REPLACE™ trial evaluating RNDP-001 for Parkinson’s disease.
Key point: RNDP-001 is an allogeneic, off-the-shelf neuron replacement therapy designed to restore dopamine-producing neurons.
Implication: This approach could address the underlying cause of Parkinson’s rather than providing symptomatic relief alone.

🌱 Combining Stem Cell Therapy and BDNF for Parkinson’s Disease [4] [EU • 16 Dec 2025]

https://www.news-medical.net/news/20251216/Combining-stem-cell-therapy-and-BDNF-enhancement-to-manage-Parkinsone28099s-disease.aspx
Context: A new review explores combining stem cell transplantation with brain-derived neurotrophic factor (BDNF) to improve outcomes in Parkinson’s disease.
Key point: Genetically engineered stem cells may continuously secrete BDNF after transplantation.
Implication: This strategy could deliver both neuroprotection and functional recovery, supporting disease modification.

⚙️ CTO1681 Shows Potential to Prevent CRS in CAR-T Therapy [5] [US • 15 Dec 2025]

https://www.cancernetwork.com/view/how-might-cto1681-prevent-crs-after-car-t-cell-therapy-in-dlbcl-
Context: CTO1681, a prostacyclin and prostaglandin agonist, is being evaluated for prevention of cytokine release syndrome (CRS) in CAR-T–treated DLBCL patients.
Key point: Early data suggest suppression of NF-κB–mediated cytokine signaling.
Implication: Reducing CRS risk could significantly improve CAR-T safety and expand patient eligibility.

🧬 Leucid Bio and Syenex Collaborate on In Vivo CAR-T Delivery [6] [EU • 16 Dec 2025]

https://www.bioprocessintl.com/deal-making/leucid-bio-and-syenex-team-up-to-advance-car-t-therapy-administration
Context: Leucid Bio and Syenex announced a strategic collaboration to develop in vivo CAR-T therapies using Syenex’s VivoCell platform.
Key point: The technology enables CAR-T generation directly in patients, bypassing ex vivo manufacturing.
Implication: In vivo delivery could lower costs, shorten timelines, and improve scalability.

🦴 SereNeuro Therapeutics Introduces SN101 for Osteoarthritis Pain [7] [US • 15 Dec 2025]

https://www.sciencedaily.com/releases/2025/12/251214100916.htm
Context: SereNeuro unveiled SN101, a first-in-class therapy derived from iPSC-based nociceptors.
Key point: SN101 absorbs pain signals and releases regenerative molecules that may protect joint tissue.
Implication: The therapy could offer both pain relief and disease-modifying benefits in osteoarthritis.

🏥 UC San Diego’s Gene Therapy Initiative Reaches Key Milestones [8] [US • 16 Dec 2025]

https://today.ucsd.edu/story/from-wish-to-reality-the-gene-therapy-initiative-at-uc-san-diego
Context: UC San Diego’s Gene Therapy Initiative continues to translate academic research into clinical gene therapies for rare diseases.
Key point: A stem cell–based gene therapy for cystinosis has demonstrated meaningful patient benefit.
Implication: The initiative plans to expand into additional rare and neurodegenerative diseases.

🤝 eXmoor Pharma and UCL Form Strategic Cell and Gene Therapy Collaboration [9] [EU • 16 Dec 2025]

https://pharmatimes.com/news/exmoor-pharma-and-ucl-establish-strategic-cell-and-gene-therapy-collaboration/
Context: eXmoor Pharma and University College London announced a strategic collaboration to accelerate development of advanced cell and gene therapies.
Key point: The partnership combines academic innovation with industrial-scale development expertise.
Implication: Such collaborations are critical for accelerating clinical translation.

🏭 RoslinCT and Ayrmid Expand Partnership for Omisirge® Manufacturing [10] [US • 17 Dec 2025]

https://www.roslinct.com/insights/roslinct-gamidacell-strategic-partnership-to-manufacture-omisirge-for-second-fda-approved-indication/
Context: RoslinCT and Ayrmid expanded their strategic partnership to support commercial manufacturing of Omisirge® following FDA approval for severe aplastic anemia (SAA).
Key point: The agreement supports scalable, compliant commercial supply.
Implication: Manufacturing readiness is essential for successful post-approval cell therapy launches.

🧬 FDA Approves Waskyra for Wiskott-Aldrich Syndrome [11] [US • 17 Dec 2025]

https://pmlive.com/pharma_news/fda-approves-first-gene-therapy-for-wiskott-aldrich-syndrome/
Context: The FDA approved Waskyra, the first gene therapy for Wiskott-Aldrich syndrome (WAS), a rare and life-threatening immune disorder.
Key point: Clinical data showed substantial reductions in severe infections and bleeding events.
Implication: Waskyra represents a landmark advance for inherited immunodeficiencies.

Why It Matters

Expansion of CAR-T beyond oncology into autoimmune disease,
Progress toward disease-modifying therapies for Parkinson’s
Increasing maturity of the gene and cell therapy manufacturing ecosystem
Strategic partnerships and regulatory milestones continue to shape the pace of clinical translation.

🚀 Accelerate your success. Contact us now

📂 Explore our case studies. See examples of our work.

💡 Read our insights. Learn from our latest reports and analysis

🎬 Watch on YouTube. Subscribe and never miss a video.

🧰 See our full range of services. Discover how we can help you.

📚 See the full Cell and Gene Therapy archive on our research hub page.

FAQ

What makes Link Cell’s CAR-T platform different?

It targets co-expressed tumor antigens while minimizing damage to healthy tissue.

Why is Kyverna’s mivocabtagene important?

It could become the first CAR-T therapy approved for an autoimmune disease.

What is unique about RNDP-001?

It is an off-the-shelf neuron replacement therapy designed to restore dopamine neurons.

How does BDNF enhance stem cell therapies?

BDNF promotes neuron survival and regeneration, supporting long-term recovery.

Entities / Keywords

Link Cell Therapies; Kyverna Therapeutics; mivocabtagene; CAR-T; Parkinson’s disease; Kenai Therapeutics; BDNF; CTO1681; Leucid Bio; Syenex; SN101; UC San Diego; Gene Therapy; Waskyra; Omisirge; RoslinCT; eXmoor Pharma; UCL; Wiskott-Aldrich syndrome.