Drug/Device Pipeline

Janssen Licenses Two IBD Drug Candidates to New Biopharma Company

Francisco Leon, MD, PhD
Francisco Leon

Provention Bio, a new clinical stage biopharmaceutical company launched earlier this year, announced it has in-licensed two clinical-stage inflammatory bowel disease drug candidates from Janssen.

The first, PRV-6527 (formerly JNJ-40346527) is an oral colony stimulating factor-1 receptor (CSF-1R) small molecule inhibitor in development for Crohn’s disease, and the second, PRV-300 (formerly JNJ-42915925/CNTO 3157), is an anti-toll-like receptor 3 (TLR3) monoclonal antibody in development for ulcerative colitis.

“The in-licensing of PRV-6527 and PRV-300 from Janssen continues to build momentum following our corporate launch last quarter and advances our strategic intent to source clinical-stage programs targeting the interception or prevention of immune-mediated diseases,” Ashleigh Palmer, co-founder and CEO of Provention Bio, said in a press release from the company. “Moreover, these two transactions showcase Provention’s ability to leverage its expertise in translational medicine and ‘rapid go/no-go’ clinical trial design to acquire or in-license well-studied and characterized clinical-stage assets in the field of immune-mediated disease.”

The company expects to begin enrollment for a phase 2a proof-of-concept clinical trial of PRV-6527 in about 80 patients with moderate-to-severe Crohn’s disease in the first half of 2018. This study will assess the drug’s ability to “intercept” myeloid cell differentiation in the bone marrow to prevent the resulting inflammatory dendritic cells and macrophages from migrating to the intestinal mucosa.

“The CSF-1R pathway is overrepresented in Crohn’s disease gut tissue, and unpublished data suggest a potential beneficial effect of PRV-6527 on Crohn’s-like disease in mouse models,” Francisco Leon, MD, PhD, scientific co-founder of Provention, said in the press release. “Our goal with the phase 2a [proof-of-concept] study is to confirm this observation in patients with moderate to severe Crohn’s disease, who are still substantially underserved by conventional therapeutics. In particular, there is no oral medication approved for the treatment of moderate to severe Crohn’s patients at this time.”

The company also plans to evaluate PRV-300 administered by IV in a phase 1/2 proof-of-mechanism, proof-of-concept study in 32 patients with moderate-to-severe ulcerative colitis in the first half of 2018. Data from human biomarker and animal studies show that TLR3 may be involved in the pathogenesis of ulcerative colitis, according to the press release.

“We know that PRV-300 suppresses the effects of viral infections and inflammation in animal models,” Provention’s chief medical officer and COO Eleanor L. Ramos, MD, said in the press release. “While our initial trials will target the demonstration of [proof-of-mechanism] in human patients with moderate to severe UC, we also intend to explore life-cycle expansion opportunities, including severe influenza in the hospital setting, as well as emerging viral diseases.”

Provention was launched in the second quarter of 2017 to develop preventive therapeutics for chronic autoimmune and inflammatory diseases. The company received $28.4 million in founding financing in April, and the addition of these two drug candidates expands its drug development pipeline to three in-licensed programs, including a previously announced enterovirus vaccine platform in development for the prevention of type 1 diabetes.

Disclosures: Palmer, Leon and Ramos are all employed by Provention Bio.

Francisco Leon, MD, PhD
Francisco Leon

Provention Bio, a new clinical stage biopharmaceutical company launched earlier this year, announced it has in-licensed two clinical-stage inflammatory bowel disease drug candidates from Janssen.

The first, PRV-6527 (formerly JNJ-40346527) is an oral colony stimulating factor-1 receptor (CSF-1R) small molecule inhibitor in development for Crohn’s disease, and the second, PRV-300 (formerly JNJ-42915925/CNTO 3157), is an anti-toll-like receptor 3 (TLR3) monoclonal antibody in development for ulcerative colitis.

“The in-licensing of PRV-6527 and PRV-300 from Janssen continues to build momentum following our corporate launch last quarter and advances our strategic intent to source clinical-stage programs targeting the interception or prevention of immune-mediated diseases,” Ashleigh Palmer, co-founder and CEO of Provention Bio, said in a press release from the company. “Moreover, these two transactions showcase Provention’s ability to leverage its expertise in translational medicine and ‘rapid go/no-go’ clinical trial design to acquire or in-license well-studied and characterized clinical-stage assets in the field of immune-mediated disease.”

The company expects to begin enrollment for a phase 2a proof-of-concept clinical trial of PRV-6527 in about 80 patients with moderate-to-severe Crohn’s disease in the first half of 2018. This study will assess the drug’s ability to “intercept” myeloid cell differentiation in the bone marrow to prevent the resulting inflammatory dendritic cells and macrophages from migrating to the intestinal mucosa.

“The CSF-1R pathway is overrepresented in Crohn’s disease gut tissue, and unpublished data suggest a potential beneficial effect of PRV-6527 on Crohn’s-like disease in mouse models,” Francisco Leon, MD, PhD, scientific co-founder of Provention, said in the press release. “Our goal with the phase 2a [proof-of-concept] study is to confirm this observation in patients with moderate to severe Crohn’s disease, who are still substantially underserved by conventional therapeutics. In particular, there is no oral medication approved for the treatment of moderate to severe Crohn’s patients at this time.”

The company also plans to evaluate PRV-300 administered by IV in a phase 1/2 proof-of-mechanism, proof-of-concept study in 32 patients with moderate-to-severe ulcerative colitis in the first half of 2018. Data from human biomarker and animal studies show that TLR3 may be involved in the pathogenesis of ulcerative colitis, according to the press release.

“We know that PRV-300 suppresses the effects of viral infections and inflammation in animal models,” Provention’s chief medical officer and COO Eleanor L. Ramos, MD, said in the press release. “While our initial trials will target the demonstration of [proof-of-mechanism] in human patients with moderate to severe UC, we also intend to explore life-cycle expansion opportunities, including severe influenza in the hospital setting, as well as emerging viral diseases.”

Provention was launched in the second quarter of 2017 to develop preventive therapeutics for chronic autoimmune and inflammatory diseases. The company received $28.4 million in founding financing in April, and the addition of these two drug candidates expands its drug development pipeline to three in-licensed programs, including a previously announced enterovirus vaccine platform in development for the prevention of type 1 diabetes.

Disclosures: Palmer, Leon and Ramos are all employed by Provention Bio.

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