MRNA is a kind of nucleic acid molecule that carries genetic information. MRNA vaccine transduces genetic information into the body and produce corresponding antigens, which can induce neutralizing antibodies and stimulate T cell response, fighting the virus through the dual mechanisms of humoral immunity and cellular immunity. Compared with the traditional vaccine, the synthesis and production process of mRNA vaccine is relatively convenient, and has strong immunogenicity and good safety, does not need the adjuvants which is necessary for the traditional vaccine.

MRNA vaccine can well deal with emergency epidemic diseases, such as severe acute respiratory syndrome coronavirus 2. In addition, mRNA technology can also be used to develop new cancer immunotherapy. Regeneron announced the start of a clinical trial of mRNA cancer vaccine immunotherapy BNT111 FixVac combination with anti-PD-1 therapy Libtayo to treat melanoma.

Regeneron plans to conduct a randomized II phase study in patients with PD-1 refractory/recurrent, unresectable advanced (stage III or IV) cutaneous melanoma, with BNT111 FixVac and Libtayo as second-line therapy. Details of the study will be released later.

BNT111 is an mRNA cancer immunotherapy for four antigens (NY-ESO-1, MAGE-A3, tyrosinase, TPTE) often expressed in melanoma patients. FixVac is a fixed vaccine combination composed of cancer-associated antigens highly expressed in tumors.

In an ongoing phase 1 clinical trial, BNT111 has been shown to have antineoplastic activity in patients with advanced melanoma who have previously received checkpoint blocking therapy as a monotherapy in combination with checkpoint inhibitors.

Melanoma is the deadliest skin cancer, and it is estimated that more than 63000 people worldwide died of melanoma in 2020. In recent years, although anti-PD-1 therapy has made progress in the treatment of melanoma, most patients have not achieved lasting clinical benefits.

BNT111 FixVac combined with Libtayo use two kinds of immunotherapy and complementary mechanisms, has the potential to enhance the ability of the immune system to effectively recognize melanoma in many ways, and is expected to improve immune targeting to control cancer.

Advantages of mRNA Vaccine

  • Non-infectious and non-integrating. No potential risk of infection or insertional mutagenesis.
  • In vivo half-life can be regulated via various modifications and delivery methods.
  • The inherent immunogenicity of the mRNA can be down-modulated to further increase the safety profile.
  • Various modifications can be done to make mRNA more stable and highly translatable.
  • mRNA can be formulated into carriers to achieve efficient in vivo delivery.
  • Capacity for low-cost and rapid scalable manufacture.

Creative Biolabs has proprietary mRNA vaccine platform to provide mRNA vaccine physical and chemical optimization, dendritic cell mRNA vaccines development, personalized neoepitope mRNA cancer vaccines development, mRNA GMP synthesis with the clients.