SANTA ANA, CA, USA I September 08, 2020 I NKMax America, a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, announced today that it has entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer to evaluate the safety and tolerability of SNK01, the company’s autologous natural killer cell therapy in combination with avelumab (BAVENCIO®), a human anti-PD-L1 therapy co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc., in solid tumors.
Under the terms of this agreement, NKMax America will be the study sponsor, and Merck KGaA, Darmstadt, Germany and Pfizer will supply avelumab for a new study arm that will be added to the existing US Phase I clinical trial (NCT03941262) in refractory solid tumors. Under the amendment, up to 18 patients with all solid tumor types refractory to conventional treatment and independent of PD-L1 status will be enrolled to receive SNK01 plus a checkpoint inhibitor until progression or unacceptable toxicity. Enrollment of this arm is expected to begin in September 2020. Both parties will have access to the clinical data.
Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. It has been shown in preclinical models to engage both the adaptive and innate immune functions. Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.
NKMax America has developed its own proprietary NK cell expansion and activation technology platform which allows it to produce unprecedented commercial amounts of autologous and allogenic NK cells from numerous donors which have near total expression of activating receptors like CD16, NKG2D, NKp30, and NKp46. In addition, its unique technology raises the cytotoxicity of the expanded NK cells nearly 8000% with little loss during cryopreservation.
“Much emerging research has identified the vital role NK cells play in tumor response to checkpoint inhibitors in both PD-L1+ and PD-L1 negative tumors. Based on strong clinical results that we presented at ASCO which demonstrated significantly improved response when our SNK01 cells were added to a checkpoint inhibitor, we believe that the IgG1 antibody nature of avelumab along with the greatly enhanced cytotoxicity and CD16 expression of our SNK01 cells may further maximize this anti-tumor potential,” said Paul Song, Vice Chairman and Chief Medical Officer.
Avelumab Approved Indications in the US
Avelumab (BAVENCIO®) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Avelumab in combination with axitinib is approved in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.
Avelumab Important Safety Information from the US FDA-Approved Label
The warnings and precautions for avelumab (BAVENCIO®) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis, and other immune-mediated adverse reactions as a single agent or in combination with axitinib [which can be severe and have included fatal cases]), infusion-related reactions, hepatotoxicity in combination with axitinib, major adverse cardiovascular events (MACE) in combination with axitinib [which can be severe and have included fatal cases], and embryo-fetal toxicity.
Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO® monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction peripheral edema, decreased appetite, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO® in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade 3-4 hematology laboratory value abnormalities reported in at least 10% of patients with Merkel cell carcinoma treated with BAVENCIO® monotherapy include lymphopenia; in patients receiving BAVENCIO® in combination with axitinib, grade 3-4 clinical chemistry abnormalities include blood triglyceride increased and lipase increased.
For full US Prescribing Information and Medication Guide for BAVENCIO®, please see http://www.BAVENCIO.com.
About NKMax America
NKMax America Inc. is a clinical stage biotechnology company dedicated to restoring and enhancing overall immune integrity. Our proprietary natural killer cell expansion and activation technology achieves infinite fold natural killer cell expansion with greatly enhanced cytotoxicity across its autologous, allogenic, and CAR-NK products which are all derived from peripheral blood. Our first in class autologous product, SNK01, is currently in a Phase I clinical trial in advanced refractory solid tumors and in a Phase I/IIa combination trial with Keytruda in Stage IV non-small cell lung cancer. The company and its commercially licensed cGMP facility are headquartered in Santa Ana, California, USA.
BAVENCIO® is a trademark of Merck KGaA, Darmstadt, Germany.
For more information on the company, please visit www.nkmaxamerica.com
SOURCE: NKMax America
Post Views: 42
SANTA ANA, CA, USA I September 08, 2020 I NKMax America, a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, announced today that it has entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer to evaluate the safety and tolerability of SNK01, the company’s autologous natural killer cell therapy in combination with avelumab (BAVENCIO®), a human anti-PD-L1 therapy co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc., in solid tumors.
Under the terms of this agreement, NKMax America will be the study sponsor, and Merck KGaA, Darmstadt, Germany and Pfizer will supply avelumab for a new study arm that will be added to the existing US Phase I clinical trial (NCT03941262) in refractory solid tumors. Under the amendment, up to 18 patients with all solid tumor types refractory to conventional treatment and independent of PD-L1 status will be enrolled to receive SNK01 plus a checkpoint inhibitor until progression or unacceptable toxicity. Enrollment of this arm is expected to begin in September 2020. Both parties will have access to the clinical data.
Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. It has been shown in preclinical models to engage both the adaptive and innate immune functions. Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.
NKMax America has developed its own proprietary NK cell expansion and activation technology platform which allows it to produce unprecedented commercial amounts of autologous and allogenic NK cells from numerous donors which have near total expression of activating receptors like CD16, NKG2D, NKp30, and NKp46. In addition, its unique technology raises the cytotoxicity of the expanded NK cells nearly 8000% with little loss during cryopreservation.
“Much emerging research has identified the vital role NK cells play in tumor response to checkpoint inhibitors in both PD-L1+ and PD-L1 negative tumors. Based on strong clinical results that we presented at ASCO which demonstrated significantly improved response when our SNK01 cells were added to a checkpoint inhibitor, we believe that the IgG1 antibody nature of avelumab along with the greatly enhanced cytotoxicity and CD16 expression of our SNK01 cells may further maximize this anti-tumor potential,” said Paul Song, Vice Chairman and Chief Medical Officer.
Avelumab Approved Indications in the US
Avelumab (BAVENCIO®) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Avelumab in combination with axitinib is approved in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.
Avelumab Important Safety Information from the US FDA-Approved Label
The warnings and precautions for avelumab (BAVENCIO®) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis, and other immune-mediated adverse reactions as a single agent or in combination with axitinib [which can be severe and have included fatal cases]), infusion-related reactions, hepatotoxicity in combination with axitinib, major adverse cardiovascular events (MACE) in combination with axitinib [which can be severe and have included fatal cases], and embryo-fetal toxicity.
Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO® monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction peripheral edema, decreased appetite, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO® in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade 3-4 hematology laboratory value abnormalities reported in at least 10% of patients with Merkel cell carcinoma treated with BAVENCIO® monotherapy include lymphopenia; in patients receiving BAVENCIO® in combination with axitinib, grade 3-4 clinical chemistry abnormalities include blood triglyceride increased and lipase increased.
For full US Prescribing Information and Medication Guide for BAVENCIO®, please see http://www.BAVENCIO.com.
About NKMax America
NKMax America Inc. is a clinical stage biotechnology company dedicated to restoring and enhancing overall immune integrity. Our proprietary natural killer cell expansion and activation technology achieves infinite fold natural killer cell expansion with greatly enhanced cytotoxicity across its autologous, allogenic, and CAR-NK products which are all derived from peripheral blood. Our first in class autologous product, SNK01, is currently in a Phase I clinical trial in advanced refractory solid tumors and in a Phase I/IIa combination trial with Keytruda in Stage IV non-small cell lung cancer. The company and its commercially licensed cGMP facility are headquartered in Santa Ana, California, USA.
BAVENCIO® is a trademark of Merck KGaA, Darmstadt, Germany.
For more information on the company, please visit www.nkmaxamerica.com
SOURCE: NKMax America
Post Views: 42
