Dipeptides

Bionomics BNC210 Expansion into Social Anxiety Disorder

Monday, May 10, 2021 - 11:00am

The slow absorption of the liquid suspension formulation of BNC210 and the requirement for it to be taken with food for optimal absorption limited its use for the acute treatment of anxiety in patients with SAD.

Key Points: 
  • The slow absorption of the liquid suspension formulation of BNC210 and the requirement for it to be taken with food for optimal absorption limited its use for the acute treatment of anxiety in patients with SAD.
  • A new solid dose tablet formulation of BNC210 has been successfully developed, showing much improved and rapid absorption over the previous liquid suspension formulation, and will be used for the Phase 2 efficacy clinical trials in SAD and PTSD.\n"Anxiety disorders are a significant burden for our communities and approximately 17 million American adults suffer from Social Anxiety Disorder.
  • Premier Research is recognised as a leading CRO supporting industry-sponsored PTSD studies and has conducted ~10 studies in this indication since 2014, including Bionomics\' RESTORE trial.
  • Collaborating again with Bionomics is the ideal way to leverage ourcollective experience in this space," said Krista Armstrong, PhD, Premier Research SVP, Clinical Development Services & Global Head of Neuroscience.

Oncopeptides completes patient enrollment in phase 2 PORT study

Wednesday, May 5, 2021 - 12:45pm

b'STOCKHOLM, May 5, 2021 /PRNewswire/ --Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announces that the Company has completed patient enrollment in the phase 2 PORT study.

Key Points: 
  • b'STOCKHOLM, May 5, 2021 /PRNewswire/ --Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announces that the Company has completed patient enrollment in the phase 2 PORT study.
  • The PORT study is an open-label, randomized, cross-over study which compares safety, tolerability and efficacy of peripheral or central intravenous administration of melflufen (INN melphalan flufenamide) in combination with dexamethasone in relapsed refractory multiple myeloma.
  • Oncopeptides expects topline data in Q3 2021.\n"I am very pleased that we have enrolled the final patient in the PORT study," said Klaas Bakker, MD, PhD and Chief Medical Officer at Oncopeptides.
  • Melphalan flufenamide is evaluated in a comprehensive clinical study program including the global phase 3 studies OCEAN and LIGHTHOUSE.

Oncopeptides completes patient enrollment in phase 2 PORT study

Wednesday, May 5, 2021 - 12:43pm

b'STOCKHOLM, May 5, 2021 /PRNewswire/ --Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announces that the Company has completed patient enrollment in the phase 2 PORT study.

Key Points: 
  • b'STOCKHOLM, May 5, 2021 /PRNewswire/ --Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announces that the Company has completed patient enrollment in the phase 2 PORT study.
  • The PORT study is an open-label, randomized, cross-over study which compares safety, tolerability and efficacy of peripheral or central intravenous administration of melflufen (INN melphalan flufenamide) in combination with dexamethasone in relapsed refractory multiple myeloma.
  • Oncopeptides expects topline data in Q3 2021.\n"I am very pleased that we have enrolled the final patient in the PORT study," said Klaas Bakker, MD, PhD and Chief Medical Officer at Oncopeptides.
  • Melphalan flufenamide is evaluated in a comprehensive clinical study program including the global phase 3 studies OCEAN and LIGHTHOUSE.

Agilex Biolabs Congratulates Bionomics Limited on BNC210 PK Results

Friday, April 30, 2021 - 5:00am

b'ADELAIDE, AUS, Apr 30, 2021 - (ACN Newswire) - Agilex Biolabs, Australia\'s largest and most technologically advanced specialist bioanalytical laboratory for clinical trials, today congratulated client Bionomics Limited (Bionomics) on its positive pharmacokinetic (PK) results from a 7-day dosing study in healthy volunteers using the newly developed solid dose oral tablet formulation of BNC210.\nLiz Doolin, Bionomics\' Vice President Clinical Development commented that "We greatly value our long-standing partnership with Agilex Biolabs who continue to be a partner of choice for Bionomics and have supported the development of BNC210 from the beginning.

Key Points: 
  • b'ADELAIDE, AUS, Apr 30, 2021 - (ACN Newswire) - Agilex Biolabs, Australia\'s largest and most technologically advanced specialist bioanalytical laboratory for clinical trials, today congratulated client Bionomics Limited (Bionomics) on its positive pharmacokinetic (PK) results from a 7-day dosing study in healthy volunteers using the newly developed solid dose oral tablet formulation of BNC210.\nLiz Doolin, Bionomics\' Vice President Clinical Development commented that "We greatly value our long-standing partnership with Agilex Biolabs who continue to be a partner of choice for Bionomics and have supported the development of BNC210 from the beginning.
  • "\nBionomics (ASX: BNO, OTCQB: BNOEF, Germany: AU000000BNO5), is a global, clinical stage biopharmaceutical company.
  • Agilex Biolabs has been working closely with Bionomics for several years, supporting the PK regulated Bioanalysis of BNC210 and is privileged to be a part of this potential new treatment for anxiety and stressor-related disorders.
  • Australian clinical trials have remained open for business and Agilex Biolabs is a designated essential service so clients can be assured of study continuity.

Oncopeptides submits application for conditional marketing authorization of melflufen in the EU

Friday, April 16, 2021 - 7:24am

Pending a positive validation from the EMA, melflufen will be subject to a regulatory assessment according to the standard timelines.\n"Following Oncopeptides launch in the US, we are broadening our geographical footprint and submitting an application for conditional marketing authorization of melflufen in Europe ahead of expectations", says Marty J Duvall, Chief Executive Officer at Oncopeptides.

Key Points: 
  • Pending a positive validation from the EMA, melflufen will be subject to a regulatory assessment according to the standard timelines.\n"Following Oncopeptides launch in the US, we are broadening our geographical footprint and submitting an application for conditional marketing authorization of melflufen in Europe ahead of expectations", says Marty J Duvall, Chief Executive Officer at Oncopeptides.
  • "We believe that melflufen may addressa growing medical need in patients with relapsed refractory multiple myeloma in Europe.
  • The company uses its proprietary peptide-drug conjugate (PDC) platform to develop compounds that rapidly and selectively deliver cytotoxic agents into cancer cells.
  • Melphalan flufenamide is evaluated in a comprehensive clinical study program including the global phase 3 studies OCEAN and LIGHTHOUSE.

Oncopeptides submits application for conditional marketing authorization of melflufen in the EU

Friday, April 16, 2021 - 7:20am

Pending a positive validation from the EMA, melflufen will be subject to a regulatory assessment according to the standard timelines.\n"Following Oncopeptides launch in the US, we are broadening our geographical footprint and submitting an application for conditional marketing authorization of melflufen in Europe ahead of expectations", says Marty J Duvall, Chief Executive Officer at Oncopeptides.

Key Points: 
  • Pending a positive validation from the EMA, melflufen will be subject to a regulatory assessment according to the standard timelines.\n"Following Oncopeptides launch in the US, we are broadening our geographical footprint and submitting an application for conditional marketing authorization of melflufen in Europe ahead of expectations", says Marty J Duvall, Chief Executive Officer at Oncopeptides.
  • "We believe that melflufen may addressa growing medical need in patients with relapsed refractory multiple myeloma in Europe.
  • The company uses its proprietary peptide-drug conjugate (PDC) platform to develop compounds that rapidly and selectively deliver cytotoxic agents into cancer cells.
  • Melphalan flufenamide is evaluated in a comprehensive clinical study program including the global phase 3 studies OCEAN and LIGHTHOUSE.

Oncopeptides announces that the first patients in the United States are being treated with PEPAXTO®

Monday, March 15, 2021 - 12:42pm

"I am very pleased that PEPAXTO is now available as an innovative treatment option for patients with multiple myeloma at hospitals and community practices across the United States," says Marty J Duvall, Chief Executive Officer at Oncopeptides AB.

Key Points: 
  • "I am very pleased that PEPAXTO is now available as an innovative treatment option for patients with multiple myeloma at hospitals and community practices across the United States," says Marty J Duvall, Chief Executive Officer at Oncopeptides AB.
  • "We are committed to working closely with payers and healthcare providers to ensure that all appropriate patients who receive a PEPAXTO prescription have access to the drug".
  • Rolf Gulliksen, Global Head of Corporate Communications, Oncopeptides AB (publ)
    Melphalan flufenamide, also known as melflufen, is the first anticancer peptide-drug conjugate for patients with relapsed or refractory multiple myeloma.
  • Melphalan flufenamide uses innovative technology that links a peptide carrier to a cytotoxic agent, resulting in a lipophilic compound.

Oncopeptides announces that the first patients in the United States are being treated with PEPAXTO®

Monday, March 15, 2021 - 12:41pm

"I am very pleased that PEPAXTO is now available as an innovative treatment option for patients with multiple myeloma at hospitals and community practices across the United States," says Marty J Duvall, Chief Executive Officer at Oncopeptides AB.

Key Points: 
  • "I am very pleased that PEPAXTO is now available as an innovative treatment option for patients with multiple myeloma at hospitals and community practices across the United States," says Marty J Duvall, Chief Executive Officer at Oncopeptides AB.
  • "We are committed to working closely with payers and healthcare providers to ensure that all appropriate patients who receive a PEPAXTO prescription have access to the drug".
  • Rolf Gulliksen, Global Head of Corporate Communications, Oncopeptides AB (publ)
    Melphalan flufenamide, also known as melflufen, is the first anticancer peptide-drug conjugate for patients with relapsed or refractory multiple myeloma.
  • Melphalan flufenamide uses innovative technology that links a peptide carrier to a cytotoxic agent, resulting in a lipophilic compound.

Novamind Announces Strategic Investment in Bionomics to Support PTSD Clinical Trial

Thursday, February 11, 2021 - 12:00pm

In addition, Cedar Clinical Research ("CCR"), a wholly owned subsidiary of Novamind based in Springville, Utah, will be evaluated by Bionomics as a clinical research site to conduct Bionomics' Phase IIb trial examining BNC210.

Key Points: 
  • In addition, Cedar Clinical Research ("CCR"), a wholly owned subsidiary of Novamind based in Springville, Utah, will be evaluated by Bionomics as a clinical research site to conduct Bionomics' Phase IIb trial examining BNC210.
  • Novamind's Strategic Investment is included in Bionomics' latest round of financing, which was underwritten by Apeiron Investments and received commitments for AU$16,000,000 (approximately CAN$15,680,000, the "Bionomics Financing").
  • Proceeds from the Bionomics Financing will support the initiation of a Phase IIb trial for BNC210, planned for mid-2021.
  • "I'm happy to welcome Novamind as a strategic investor in Bionomics," said Dr. Errol De Souza, Executive Chairman of Bionomics.

DGAP-News: Novamind Inc.: Novamind Announces Strategic Investment in Bionomics to Support PTSD Clinical Trial

Thursday, February 11, 2021 - 1:12pm

In addition, Cedar Clinical Research ("CCR"), a wholly owned subsidiary of Novamind based in Springville, Utah, will be evaluated by Bionomics as a clinical research site to conduct Bionomics' Phase IIb trial examining BNC210.

Key Points: 
  • In addition, Cedar Clinical Research ("CCR"), a wholly owned subsidiary of Novamind based in Springville, Utah, will be evaluated by Bionomics as a clinical research site to conduct Bionomics' Phase IIb trial examining BNC210.
  • Novamind's Strategic Investment is included in Bionomics' latest round of financing, which was underwritten by Apeiron Investments and received commitments for AU$16,000,000 (approximately CAN$15,680,000, the "Bionomics Financing").
  • Proceeds from the Bionomics Financing will support the initiation of a Phase IIb trial for BNC210, planned for mid-2021.
  • "I'm happy to welcome Novamind as a strategic investor in Bionomics," said Dr. Errol De Souza, Executive Chairman of Bionomics.