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BNT111 is developed for the treatment of advanced melanoma in patients with metastatic tumors and as an adjuvant treatment after tumor resection. It is designed to elicit an immune response to four melanoma-associated antigens.
We are currently studying BNT111 in an ongoing Phase 1 clinical trial. Find out more about the Lipo-MERIT study here.
An earlier version of the BNT111 only targeting NY-ESO-1 and tyrosinase has already completed a first-in-human dose escalation study (MERIT study) evaluating the safety and tolerability of intranodal administration in patients with advanced melanoma. See more information on the clinical study here.
We are currently studying BNT112 in an open-label, multi-center, first-in-human Phase 1/2 individual dose titration study in patients with metastatic Castration Resistant Prostate Cancer (mCRPC) and high-risk localized prostate cancer, or LPC.
BNT113 is designed to elicit an immune response against the well-characterized HPV16-derived oncoproteins E6 and E7, which are strongly immunogenic, viral neoantigens that are found in HPV16-positive solid cancers such as head and neck squamous cell carcinoma. BNT113 is under development for the treatment of HPV-positive head and neck cancer and is currently being studied by the University of Southampton in an ongoing investigator-sponsored Phase 1/2 basket study in HPV-positive cancers, including head and neck cancer. Find out more on the study here.
BNT114 is designed to elicit an immune response to selected antigens that are found in breast cancers. We are evaluating BNT114 for the treatment of triple negative breast cancer in an ongoing three-arm clinical trial as both a monotherapy and in combination with our BNT122 individualized iNeST immunotherapy. Find out more about the ongoing study here.
We are currently studying BNT115 in a Phase 1 trial for the treatment of ovarian cancer.
We are also exploring FixVac development candidates in NSCLC.
We and our collaborator Genentech are developing RO7198457 (BNT122) for the treatment of metastatic melanoma and other solid tumors. We are currently conducting a randomized Phase 2 trial in collaboration with Genentech in first-line melanoma in combination with pembrolizumab. Find out more about the study here.
We are also studying RO7198457 (BNT122) as a monotherapy and in combination with atezolizumab in a Phase 1a/1b basket study of patients with locally advanced or metastatic solid tumors (including in melanoma, non-small cell lung cancer, bladder cancer as well as other solid tumors). Find out more about the study here.
Together with Sanofi we are developing SAR441000 (BNT131) as an intratumoral immunotherapy for the treatment of solid tumors. It utilizes mRNA to encode the cytokines IL-12sc, IL-15sushi, IFNα and GM-CSF. By increasing the concentration of these cytokines in the tumor microenvironment, the immune system may more easily recognize and fight cancer.
SAR441000 (BNT131) is being studied in a Phase 1 basket clinical trial as a monotherapy in patients with advanced melanoma and in combination with an anti-PD-1/PD-L1 checkpoint inhibitor in patients with advanced melanoma and certain solid tumors. Find out more about the study here.
BNT141 is our RiboMab product candidate for the treatment of solid tumors currently in preclinical development. BNT141 is designed to encode secreted IgG antibodies that target multiple epithelial solid tumors, including gastric and pancreatic cancers.
BNT142 is designed to encode a secreted bispecific antibody that targets CD3 and CLDN6. It is currently in preclinical development for the treatment of solid tumors.
BNT151 encodes a modified version of the human interleukin-2, or IL-2, cytokine. It is in preclinical development for the treatment of solid tumors. BNT151 is designed to stimulate T cells without triggering immunosuppression in the tumor microenvironment.
BNT152 and BNT153 are RiboCytokines designed to encode IL-7 and IL-2 for the treatment of solid tumors. The program is currently in preclinical development.
We are collaborating with Pfizer to develop an influenza vaccine based on our mRNA drug classes. Our product candidate BNT161 will encode influenza virus antigens selected by the WHO in advance of the flu season.
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BNT211 is our CAR T cell therapy for the treatment of CLDN6-positive solid tumors. BNT211 targets CLDN6 and will initially be evaluated in combination with a FixVac that encodes CLDN6.
CLDN6 is a highly specific oncofetal cell surface antigen that is found in multiple cancers, including ovarian, testicular and lung cancers, but not in normal cells. We have observed compelling preclinical data, demonstrating potent anti-tumoral efficacy, including eradication of advanced tumors in an ovarian carcinoma xenograft model.
BNT212 is under development for the treatment of CLDN18.2-positive solid tumors and will initially be evaluated in combination with a FixVac that encodes CLDN18.2. BNT212 targets Claudin 18.2, or CLDN18.2. CLDN18.2 is a highly specific target which is only expressed in cancer and in differentiated epithelial cells of the gastric mucosa, but it is absent from the gastric stem cell zone. CLDN18.2 is expressed in numerous epithelial solid tumors, including gastric, pancreatic, esophageal, ovarian and lung tumors.
GEN1046 (BNT311) is a bispecific antibody designed to target PD-L1 and 4-1BB to block the inhibitory PD-1/PD-L1 axis and simultaneously activate essential co-stimulatory activity via 4-1BB.
PD-L1 is a validated target that is expressed on tumor cells. 4-1BB is a trans-membrane receptor belonging to the TNF super-family and is expressed predominantly on activated T cells.
In collaboration with Genmab, we are conducting a Phase 1/2, open-label, single arm safety basket trial of GEN1046 (BNT311). Find out more about the study here. We have announced the dosing of the first patient in June 2019. See the press release here.
GEN1042 (BNT312) is a bispecific antibody designed to activate an anti-tumor immune response through conditional CD40-mediated stimulation of antigen presenting cells crosslinked with conditional stimulation of 4-1BB-positive T cells. The cell surface molecule CD40 is a member of the tumor necrosis factor receptor superfamily and is broadly expressed by a wide range of tumor cells. The candidate has completed preclinical development and entered clinical development in 2019. Find out more about the study here.
MVT-5873 (BNT321) is a fully human IgG1 monoclonal antibody targeting sialyl Lewis A (sLea), an epitope on CA19-9 that is expressed in pancreatic and other gastrointestinal cancers that plays a role in tumor adhesion and metastasis formation, and is a marker of an aggressive cancer phenotype.
MVT-5873 (BNT321) is being investigated in an open-label, multi-center, non-randomized dose escalation Phase 1/2 study evaluating the safety and recommended Phase 2 dose of MVT-5873 (BNT321) both as a monotherapy and in combination with a standard of care chemotherapy. Find out more about the study here.
BNT411 is a TLR7 agonist that is designed to activate both the adaptive and innate immune system through the TLR7 pathway. This activity and the release of cytokines and chemokines are designed to result in the potent stimulation of antigen specific CD8+ T cells, B cells and innate immune cells such as NK cells and macrophages.
We are currently evaluating BNT411 in a Phase 1/2a, first-in-human, dose-escalation trial as a monotherapy in patients with solid tumors and in combination with atezolizumab, carboplatin and etoposide in patients with chemotherapy-naïve extensive-stage small cell lung cancer (ES-SCLC).
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