Genmab er blevet ganske meddelsomme på hjemmesiden...:
In vivo, zalutumumab has demonstrated the best potential overall mechanisms of action compared to competitors:
• Potent inhibition of cell signaling
• Downmodulates EGFr
• Induces apoptosis
• Activates ADCC by NK cells, monocytes and PMN
• Inhibits cell growth & metastasis
Zalutumumab showed a clinical benefit in the study:
• Overall survival (OS) shows a positive trend
• 30% increase in OS
• Clinical meaningful in this patient population for whom there are no other treatment options proven to prolong survival
• Measurement of OS is accurate, reliable and direct measure of benefit
• Improvement in OS observed consistently across subgroups
• Additional follow up of patients ongoing at final analysis confirms positive trend
• ~23% reduced relative risk of death
• Nominal P-value of 0.0648, hazard ratio of 0.77 [97.06% CI 0.57-1.05]
• The P-value was above the adjusted significance level of 0.0294
• Median OS was 6.7 vs. 5.2 months
• Progression free survival (PFS) is substantially increased
• 61% increase in PFS
• Calculated by the relationship between the two curves as given by the hazard ratio
• P-value of 0.0010, hazard ratio of 0.62 [95% CI: ).24-0.83]
• Zalutumumab controlled the patients’ disease better than BSC
• Disease control rate
• Zalutumumab plus BSC – 48%
• BSC – 27%
• P=0.0013
• Includes complete response, partial response and stable disease
• BSC arm may have had active disease control
• 78% of patients in BSC arm used methotrexate
• Methotrexate not allowed in zalutumumab arm
• Recent results point toward methotrexate being an active treatment in head & neck cancer (unknown at time of study design)
• Safety Results
• No unexpected safety findings
• Most common adverse events were infusion related reaction, skin and nail disorders, electrolyte disturbances, gastrointestinal disorders, eye disorders, infections and headache
• Safety profile as expected within this drug class in patients with SCCHN
• 60% of patients received highest dose of zalutumumab (16 mg/kg)
Genmab seeks to out-license zalutumumab to a party with oncology commercialization skills capable of developing the full potential of zalutumumab. Genmab prefers a deal structured in the following manner:
• Worldwide deal or large regional deals
• Licensing party assumes responsibility for:
• Regulatory filings
• Commercialization
• Further clinical development with agreements on anticipated development plan to further broaden the label and expand indications
• Manufacturing/supply chain management
In vivo, zalutumumab has demonstrated the best potential overall mechanisms of action compared to competitors:
• Potent inhibition of cell signaling
• Downmodulates EGFr
• Induces apoptosis
• Activates ADCC by NK cells, monocytes and PMN
• Inhibits cell growth & metastasis
Zalutumumab showed a clinical benefit in the study:
• Overall survival (OS) shows a positive trend
• 30% increase in OS
• Clinical meaningful in this patient population for whom there are no other treatment options proven to prolong survival
• Measurement of OS is accurate, reliable and direct measure of benefit
• Improvement in OS observed consistently across subgroups
• Additional follow up of patients ongoing at final analysis confirms positive trend
• ~23% reduced relative risk of death
• Nominal P-value of 0.0648, hazard ratio of 0.77 [97.06% CI 0.57-1.05]
• The P-value was above the adjusted significance level of 0.0294
• Median OS was 6.7 vs. 5.2 months
• Progression free survival (PFS) is substantially increased
• 61% increase in PFS
• Calculated by the relationship between the two curves as given by the hazard ratio
• P-value of 0.0010, hazard ratio of 0.62 [95% CI: ).24-0.83]
• Zalutumumab controlled the patients’ disease better than BSC
• Disease control rate
• Zalutumumab plus BSC – 48%
• BSC – 27%
• P=0.0013
• Includes complete response, partial response and stable disease
• BSC arm may have had active disease control
• 78% of patients in BSC arm used methotrexate
• Methotrexate not allowed in zalutumumab arm
• Recent results point toward methotrexate being an active treatment in head & neck cancer (unknown at time of study design)
• Safety Results
• No unexpected safety findings
• Most common adverse events were infusion related reaction, skin and nail disorders, electrolyte disturbances, gastrointestinal disorders, eye disorders, infections and headache
• Safety profile as expected within this drug class in patients with SCCHN
• 60% of patients received highest dose of zalutumumab (16 mg/kg)
Genmab seeks to out-license zalutumumab to a party with oncology commercialization skills capable of developing the full potential of zalutumumab. Genmab prefers a deal structured in the following manner:
• Worldwide deal or large regional deals
• Licensing party assumes responsibility for:
• Regulatory filings
• Commercialization
• Further clinical development with agreements on anticipated development plan to further broaden the label and expand indications
• Manufacturing/supply chain management
081110_BioCentury_Networking_antib..
10/11 2010 09:59 troldmanden 0
35762 BioCentury er et KONGE magasin. Jeg har tidliger haft adgang til dette nyhedsbrev og det er SPÆKKET med dybdeborende artikler som denne om genmab.
Men vræææællll har desværre ikke adgang til nyhedsbrevet mere andet end hvad man i ny og næ kan finde på nettet
Men vræææællll har desværre ikke adgang til nyhedsbrevet mere andet end hvad man i ny og næ kan finde på nettet
10/11 2010 10:08 troldmanden 035763 HuMax CD4 fase 3 resuyltater primo 2011
Det her er da hvis nyt
Fra Biocentury (sep 2010)
Genmab A/S (CSE:GEN), Copenhagen, Denmark
TenX Biopharma Inc., Philadelphia, Pa.
Product: Zanolimumab (HuMax-CD4)
Business: Cancer
Molecular target: CD4
Description: Human mAb against CD4
Indication: Treat cutaneous T cell lymphoma (CTCL)
Endpoint: Objective response, complete response, clinical complete
response, partial response and stable disease
Status: Phase III resumed
Milestone: Final Phase III data (early 2011)
TenX resumed the second portion of an open-label, international
Phase III trial to evaluate 14 mg/kg IV zanolimumab given weekly for 12
weeks in 70 patients. After suspending enrollment in 2008 while it
sought to partner the compound, Genmab granted TenX exclusive,
worldwide rights to develop and commercialize zanolimumab earlier
this year (see BioCentury, Feb. 8).
Det her er da hvis nyt
Fra Biocentury (sep 2010)
Genmab A/S (CSE:GEN), Copenhagen, Denmark
TenX Biopharma Inc., Philadelphia, Pa.
Product: Zanolimumab (HuMax-CD4)
Business: Cancer
Molecular target: CD4
Description: Human mAb against CD4
Indication: Treat cutaneous T cell lymphoma (CTCL)
Endpoint: Objective response, complete response, clinical complete
response, partial response and stable disease
Status: Phase III resumed
Milestone: Final Phase III data (early 2011)
TenX resumed the second portion of an open-label, international
Phase III trial to evaluate 14 mg/kg IV zanolimumab given weekly for 12
weeks in 70 patients. After suspending enrollment in 2008 while it
sought to partner the compound, Genmab granted TenX exclusive,
worldwide rights to develop and commercialize zanolimumab earlier
this year (see BioCentury, Feb. 8).
Det er en fremragende artikel og JdW fremstår virkelig som en mand der kan balancere det forskningsmæssige med det kommercielle.
Men der er et afsnit som Solsen/AKA bør nær-studere med henblik på a'jourføring af jeres glimrende Genmab regneark:
According to Eatwell, Genmab expects to have DKK1.4
billion ($250.7 million) in cash at year end, which would give the
company at least a three-year runway based on a projected annual burn rate of DKK450 million ($79.2 million).
If the company is able to get DKK800 million ($145 million) for
the manufacturing facility it purchased from PDL, Eatwell said the
YE10 cash position would increase to DKK2.2 billion ($391.4
million). That would give Genmab almost five years of cash,
excluding any licensing deals or increased Arzerra royalties.
Som jeg læser dette forventer/budgettere GEN med et årligt fremadrettet underskud på 450mio eksklusiv nye licenser og højere-end-nuværende royalty på Azerra.
I så fald er jeres forventning til de årlige omkostninger vist lidt for optimistiske.
Men der er et afsnit som Solsen/AKA bør nær-studere med henblik på a'jourføring af jeres glimrende Genmab regneark:
According to Eatwell, Genmab expects to have DKK1.4
billion ($250.7 million) in cash at year end, which would give the
company at least a three-year runway based on a projected annual burn rate of DKK450 million ($79.2 million).
If the company is able to get DKK800 million ($145 million) for
the manufacturing facility it purchased from PDL, Eatwell said the
YE10 cash position would increase to DKK2.2 billion ($391.4
million). That would give Genmab almost five years of cash,
excluding any licensing deals or increased Arzerra royalties.
Som jeg læser dette forventer/budgettere GEN med et årligt fremadrettet underskud på 450mio eksklusiv nye licenser og højere-end-nuværende royalty på Azerra.
I så fald er jeres forventning til de årlige omkostninger vist lidt for optimistiske.
