An experimental drug developed out of Norway gains momentum including FDA Fast Track, and its maker, BerGenBio ASA, selected drug development and contract drug manufacturer Piramal Pharma The investigational candidate, bemcentinib, was recently designated by the U.S. Food and Drug to progress the investigational product. The product has achieved Fast Track because there currently are no marketed drugs specifically approved for relapsed Acute Myeloid Leukemia (AML) patients representing a significant unmet need.
Who is BerGenBio ASA High-Level?
Based in Norway, BerGenBio ASA develops AXL inhibitors. A clinical-stage venture, they seek to develop transformative drugs targeting AXL as a potential cornerstone of therapy for aggressive diseases, including immune-evasive, therapy resistant cancers. Based in Bergen, Norway with a subsidiary in Oxford, UK they are publicly listed on the Oslo Stock Exchange (OSE: BGBIO). The firm has several candidates in the clinical pipeline. Founded in 2007, they have raised nearly $80 million. A classical biotech model, their $1 billion valuation ($17.38 per share which historically is quite low for them) is based on a big future–$11 million in revenues led to nearly $200 million in loss. They sit on nearly $300 million in cash. Well capitalized Norwegian investment groups back them.
Inhibition of AXL kinase activity represents a novel approach to addressing a key mechanism in the evolution of cancer cell malignancy and aggressiveness reports the Norwegian group. AXL signaling plays a crucial role in both 1) tumor cells where it promotes immune evasion, drug resistance and cancer spread and 2) immune cells where it suppresses tumor recognition and cell-killing. Hence, the venture raised investment and sought to develop drugs focusing on blocking AXL activity as it represented a novel approach to prevent cancer survival mechanisms and improve the efficacy of chemotherapy, targeted therapy and immuno-oncology drugs.
This offers an opportunity to create important therapeutic options for cancer patients. The company has developed a proprietary lead candidate, bemcentinib, a first-in-class, highly selective potent and orally bioavailable inhibitor of AXL in a broad phase II oncology clinical development program focusing on combination and single agent therapy in lung cancer and leukemia.
BerGenBio believes that BG324, a potent, selective and orally bioavailable AXL inhibitor is the most advanced selective AXL inhibitor in clinical trials today. Their Phase II program focuses on establishing proof of concept that the experimental therapy can reverse and prevent resistance to immune, targeted and chemotherapy thus positioning this asset as a potential cornerstone to cancer therapy. The emerging biophama is conducting six phase II trials across oncology indications with high unmet medical need including 1) advanced non-small-cell lung cancer (NSCLC) 2) triple negative breast cancer (TNBC) and 3) AML and high-risk myelodysplastic syndrome (MDS).
BerGenBio teamed with Piramal Pharma as part of a fully integrated program including intermediaries sources from India, pilot process development and API validation in North America and formulation development in Europe. Moreover Piramal’s contract manufacturing capacity would be leveraged for the making of final product. BeGenBIo was clear to the market that they would need to outsource the development and manufacturing process and consequently, they undertook a rigorous due diligence of partner/vendors. The Norwegian firm’s CEO, Richard Godfrey noted that Piramal Pharma Solutions’ “capabilities especially the Xcelerate Integrated Solutions platform represent an ideal solution for BerGenBio.”
Who is Paramal Pharma Solutions?
An end-to-end Contract Development and Manufacturing Organization (CDMO) this business division of Piramal Enterprises Limited (India) with operations in North America, Europe and Asia. They position their firm as a global leader in integration drug development solutions ranging from drug discovery services to development and commercial manufacturing of drug substances and drug products. They serve branded and generic ventures worldwide. They employ 450 scientists including 155 PhDs committed to research and development programs.