World's First TCR-T Therapy Nears Approval, Combined with Peptide Vaccine to Eradicate Solid Tumors

CAR-TThe astonishing efficacy in treating blood tumors and the tremendous commercial success have placed cell therapy in the spotlight.TCR-TCell therapy follows closely behind, demonstrating unprecedented potential in the treatment of solid tumors., with itsCapable of targeting multiple antigens within tumorsThe advantage has attracted more and more attention from industry giants. In2023By the end of the year,The world's first declared for marketingTCR-TCell Therapyafami-celComplete Rolling Submission for Marketing Authorization, used for the treatment of advanced synovial sarcoma,2024May Witness an Important Milestone in Cell Therapy Shifting from Hematologic Tumors to Solid Tumors。

Recently, Elicio Therapeutics announced in the journal of the American Association for Cancer Research ("AACR") that it is developing a series of novel immunotherapies for cancer treatment, combining peptide vaccines with TCR-T. These preclinical data indicate,The AMP vaccine, developed based on Elicio Therapeutics' Amphiphile Platform, enables precise delivery of homologous peptides and adjuvants to lymph nodes, thereby inducing dendritic cell activation and promoting the in vivo activation of tumor-specific TCR-T cells to enhance the anti-tumor efficacy of adoptively transferred cells., it will generate widespread therapeutic benefits for many previously difficult-to-treat solid tumors, with the hope of transforming the treatment of solid tumorsCut the Grass and RemoveRoot。

The strong efficacy of the AMP vaccine in combination with TCR-T mainly includes:

1.AMP VaccinationSignificantly Enhanced the Anti-Tumor Response of TCR-T Cells, and at the same timeInduction of Epitope Spreading Between Endogenous T Cell Populations, thereby achieving lasting cures for solid tumors in established syngeneic tumor models;

2. Vaccine and TCR-T Cell Therapy GroupThe combination enhanced the in vivo activity of adoptively transferred TCR-T cells and promoted the in situ activation of the endogenous anti-tumor T-cell repertoire., thereby enhancing the anti-tumor efficacy of adoptively transferred cells;

3. In transgenic miceVaccination with AMP-mKRAS peptide significantly enhances the activation, persistence, and specific target lysis of KRAS-specific TCR-T cells in mice；

4.Combination of AMP Vaccine with Related Targets (NY-ESO-1, mKRAS, HPV16 E7)Show AMP vaccineHas clinical potential in enhancing TCR-T cell proliferation, activation, and anti-tumor effects。

5.AMP VaccinePromoted the specific transport and retention of the payload in lymph nodes, enhancing the quantity, persistence, and functional quality of T cells.

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Elicio's main asset ELI-002 is amKRAS-specific AMP VaccineComposed of AMP-modified KRAS mutant peptide antigens and ELI-004 (an AMP-modified immunostimulatory oligonucleotide adjuvant). Preliminary data from the ongoing Phase 1 study show that when used as an adjuvant monotherapy in pancreatic and colorectal cancer patients, it elicited significant T-cell responses, including CD4+ and CD8+. The further enhancement of T-cell responses induced by ELI-002 correlates with a marked improvement in tumor biomarker response and a reduction in patient mortality risk, indicating an association between the mechanism of action of ELI-002 and clinical outcomes.Whether used as a monotherapy or in combination with other strategies, the AMP immunotherapy approach will have a powerful therapeutic effect on patients with solid tumors. Meanwhile, the AMP platform also offers broad and rapid application potential for TCR-T cell projects in clinical and development stages.。

As early as September 2020,Elicio Therapeutics Attempts to Combine AMP Vaccines with CAR-T Therapy for the Treatment of B-cell Malignancies and Various Solid Tumors, and has established a cooperative relationship with Moffitt Cancer Research Center to jointly develop the combination therapy of AMP-CD19, AMP-FITC and CD19 CAR-T cells.

AMP-CD19 is a CAR-binding peptide developed based on the AMP-CAR-T platform. One end of it is an antigen capable of activating CAR-T cells, while the other end is a long "tail" composed of lipid molecules. With the help of this tail,This vaccine can bind with albumin in the blood. In the human body, albumin travels throughout the entire body along the blood vessels. This new type of vaccine also "hitches a ride" and, after entering the lymph nodes, becomes effective in activating CAR-T cells.

AMP-CD19 can activate engineered T cells, enhance their persistence and proliferation capabilities, and boost their activity in treating B-cell malignancies, including diffuse large B-cell lymphoma (DLBCL) and acute lymphoblastic leukemia (ALL).

Traditional vaccines rely on the use of non-active pathogens to elicit an immune response. However, many of these formulations carry a high risk of triggering allergic or autoimmune reactions. Peptide vaccines are increasingly regarded as a cost-effective and safe approach to circumvent this issue.Since polypeptide vaccines are completely synthetic, there is no risk of virulence rebound or incomplete inactivation. The structure and sequence of the immunogen can be precisely controlled, offering advantages such as low cost, high safety, strong specificity, efficient preparation, and easy storage., withAntiviral, Antitumor, Antibacterial, Antiparasitic InfectionAnd other functions`, attracting increasing attention from the industry`. In additionPeptide vaccines have also been proven to have excellent efficacy in enhancing anti-cancer activity when combined with other therapies such as CAR-T and TCR-T.However, as the molecular weight and structural complexity of immunogens decrease, their immunogenicity also significantly decreases. Therefore, these vaccines generally require special structural design, specific delivery systems, or adjuvants, such as the bivalent synthetic peptide vaccine for Foot-and-Mouth Disease serotypes O and A in pigs.

Common forms of polypeptide vaccines include: directly extracted polypeptide vaccines, polypeptide vaccines with modified amino acid residues or sequences, heat shock protein peptide complex vaccines, multivalent polypeptide vaccines, etc. Currently,Most drugs are in phase 1/2 clinical trials, which also means that in the next five years, the market will see a thriving development of various vaccines targeting different types of cancer.。

P01 Injection targets tumor neoantigens and stimulates immune response in patients through subcutaneous injection.Capable of simultaneously activating CD8-positive and CD4-positive T cells that recognize tumor neoantigens, thereby training the immune system to identify tumor-specific neoantigens to achieve the goal of recognizing and killing tumor cells.. August 31, 2023,This peptide vaccine achieves another success, officially entering clinical trials with FDA approval.The indication is for the consolidation treatment of adjuvant therapy post-radical surgery in patients with solid tumors who have a high risk of recurrence (including seven types of cancer). Injectable P01 isCustomized for each patient individually、Peptide vaccines with different components, alsoIt is the first personalized custom drug in China to be approved for clinical trials by both the Chinese and American drug regulatory agencies (NMPA & FDA).。

Another product of Neoantigen BiotechUniversal Cancer Neoantigen Peptide Vaccine Product iNeo-Vac-S01. Neoantigens generated by driver genes are shared among tumors in a certain proportion of patients. Therefore, these patients canTreatment with pre-prepared peptide vaccines eliminates the need to wait for customization, preventing delays in the optimal treatment timeframe.。

On March 19, 2023, 3D Medicines announced its research candidate drug,First-in-class global peptide cancer vaccine 3D189 (galinpepimut-S, GPS) receives approval from the National Medical Products Administration (NMPA).Conduct a Phase III global multicenter clinical trial (MRCT) for acute myeloid leukemia (AML) patients who have achieved a second complete remission.Becoming the First Domestic Tumor Peptide Vaccine to Enter Phase III Clinical Trials in China。

3D189 is aA targeted WT1 peptide tumor vaccine composed of four peptide chains, two of which are modified chains that induce a strong immune response (CD4+/CD8+) to recognize the WT1 antigen and cover a wide range of HLA types.Wilms tumor 1 (WT1) protein is widely present and overexpressed in a series of hematologic malignancies and solid tumors.WT1-Targeted Therapy Shows Promise in Treating Over 20 Types of CancerWhen administered to patients, the immune response induced by 3D189 has the potential to recognize and destroy cancer cells while continuously providing support and memory to the immune system, enabling it to keep targeting and destroying recurrent tumors and residual cancer cells.