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Lindan Biotech Ltd. Canada. Focus on Anti-Cancer Drug Development WeiDong Xie, Ph.D. Co-founder/ President. Business Focus. Development of innovative anti-cancer drugs targeting unmet medical needs: Tumor types with higher mortality rate: Pancreatic adenocarcinoma;
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Lindan Biotech Ltd.Canada Focus on Anti-Cancer Drug Development WeiDong Xie, Ph.D. Co-founder/ President
Business Focus Development of innovative anti-cancer drugs targeting unmet medical needs: Tumor types with higher mortality rate: Pancreatic adenocarcinoma; Hepatocellular carcinoma(HCC); and Other solid tumors
Facts about Pancreatic Cancer * • Particularly aggressive • Non-specific initial symptoms renderingearly diagnosis difficult • Symptoms are not prevalent until metastasis prevails • Incidence and mortality rates are nearly equal* • A five-year survival rate of 5.2% observed for all stages of disease • The 4th leading death cause of cancer-related mortality in both the US and the world • Few effective treatment modalities available currently * Datamonitor
Currently Available Treatment Options * • For resectable diseases: only 15–20% • Gemzar (gemcitabine; Eli Lilly) regimen (first line treatment) • For unresectable locally advanced and metastatic pancreatic cancer • Associated with Median overall survival of 5.7 months, and a 1-yearsurvival rate of 18% • Gold standard treatment, gemcitabine, first approved for this indication in 1996 • Tarceva (erlotinib; OSI/Genentech/Roche) • First targeted therapy for pancreatic cancer • Gemzar + Tarceva combined regimen (first line treatment) • Median overall survival of 6.2 months, and a 1-year survival rate of 23% * Datamonitor
Market Potential Analysis - 1 • Pancreatic Cancer • U.S.: 42,470 new cases and 35,240 deaths(2009)1 • China: 66,300 new cases • Morbidity: 5.1 out of 100,000 (close to the one in the U.S. figures) • Aging population, smoking and diet change • Hepatocellular Carcinoma • U.S.: 22,620 new cases and 18,160 deaths (2009) 1 • China: 350,000 new cases and 320,000 death (half of the world’s mortalities) • 30 million Hepatitis B patients • Primarily, later stage liver cancer patients: >150,000 annually: the 3rd leading cancer-related mortality worldwide • Thethird leading death cause of cancer-related mortality worldwide 1 National Cancer Institute
Market Potential Analysis - 2 • Gemzar • Sales in 2010: Annual sales US$785 million in USA, based on IMS sales data • Sales in 2009: • Overall: US$1,363 million (Gemzar sales decreased 21% due to generics) • Of which, US $747.4 million in USA • Cost of 6-month treatment: • USA: $23,493(~$4,000/month) • Tarceva • Sales in 2010: US$1.6 billion • Sales in 2009 • Overall: US$1.2 billion • Of which , US$479 million in USA • Cost of 6-month treatment: $16,613 in USA • Nexavar - first line treatment in liver cancer • Sales in 2010: $934 million • Sales in 2009 • Overall : US$815 million • Of which, US$207 million in USA • Cost of one month treatment Nexavar: $5,400 in USA
Opportunities for New Treatments • Unmet Medical Needs* • Associated with exceptionally poor survival rates • Earlierdiagnosis are desperately needed in order to boost survival • Lack of truly effective therapies exists at all stages of disease. • Our promising lead compound, LD0010 with a novel mechanism of action: • A small molecule from natural source * Datamonitor
LD00100: A New Class of Anti-Cancer Drug • A RhoSignal Transduction Pathway Inhibitor • Blocks Rhosignal transductionby binding to Rac-1 kinase. • Down-regulates the expression inStat3/Jak2 to reduce tumor angiogenesis. • Competitive Advantages of LD0010 (in combination) over Gemzar alone: • Significantly lower toxicity than other combination • Cost of the final product is likely to be significantly lower making the product more attractive as first choice of drug • Reduction of cost at the patient level • More effective and expecting to prolong OS
Rac-1 Protein-ligand Binding Affinity Assay Using 3D Protein Structure Model Rac-1 Protein 3D Structure Rac-1 with LD0010 (-146) This clearly indicates that LD0010 is a ligand with strong binding affinity to Rac-1, one of the components (a phosphokinase) in Rho signal transduction pathway.
LD0010 in-vitro&in-vivo Studies Effects of Bing of LD0010 on Rac-1 In vivo tumor growth inhibition
LD0010 +Gemzar Greatly Inhibits Pancreatic Cancer Growth in Xenograft Model The effects of the combined administration of LD0010 and Gemzar is self-explanatory.
Present Status of LD0010 One PCT and one Chinese patents ARE FILED. LD0010 is successfully synthesized in small scale in purity over > 99%. Pre-clinical studies are mostly completed under non-GLP conditions. Prototype of LD0010 in injectable formulation form has been fully developed.
Investment Considerations • Capital Requirements and Use of Funds: • US$10 million is needed to complete the follows: • Animal GLP acute and chronic toxicity studies • Animal PK studies • CMC and clinical protocol compilations studies • Submission of IND and proceeds to clinical phase I trials studies • Complete Phase I/II studies in precede to Phase III in pancreas • Phase I/II in other cancer types • Two years are estimated to be needed to complete Phase I/II trials.
Exit Strategies • IPO after complete phase II clinical trial, investor will have choice to keep their shares or exit part or all of their shares. • Out-licensing the rights after phase II clinical trial, to other pharmaceutical companies. • Acquisition target of other pharmaceutical companies • Partnership with big pharma MNC through phase III clinical trials and product launch.