Biotech Values

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Genmab... recent comments by Ohad Hammer regarding anti-CD38 Daratumumab

Winners of ASCO 2012

Genmab – Potential breakthrough in myeloma

Genmab presented phase I results for daratumumab, an anti-CD38 antibody for the treatment of multiple myeloma. Daratumumab was given to very heavily pretreated myeloma patients, including patients with a history of 10 (!!!) or more previous treatment lines. Data included multiple objective responses as well as some dramatic reductions in myeloma cells in the bone marrow. Responses appear dose dependent, with 5 partial responses and 2 minor responses in the 12 patients who received the 4 highest doses (response rate of ~42%). This compares to no PRs and 2 minor responses among the 17 patients at the lower doses.

This type of activity is very rare in multiple myeloma, especially in such a challenging patient population. Importantly, daratumumab’s mechanism of action is distinct from the two classes of drugs that are active in myeloma: IMiD’s (Revlimid, pomalidomide) and proteosome inhibitors (Velcade, carfilzomib). Therefore, it is not a direct competitor of these agents and will probably be added to standard therapy.

In fact, daratumumab is the only antibody to date to show such a robust efficacy profile in myeloma. For example, BMS’ elotuzumab, currently in phase III in multiple myeloma leads to no responses as monotherapy. Even antibody drug conjugates such as Immunogen’s IMGN901 demonstrate a response rate of 5-8%.

The only issue with daratumumab was the fact that it was given with dexamethasone in order to minimize side effects. Dexamethasone is known to have activity in myeloma, but the extent of activity and the dose dependent response profile imply daratumumab has intrinsic activity.

Genmab’s results are good news for Immunogen and Morphsys, which also have anti-CD38 antibodies in clinical trials. Immunogen’s antinody is licensed to Sanofi whereas Morphosys fully owns rights to its CD38 antibody, MOR202. Sanofi is evaluating SAR650984 in several CD38+ blood cancers whereas Morphosys is focusing on multiple myeloma. CD38 antibodies could represent an important class of drugs with limited competition and a combined market opportunity of $2-3B in myeloma alone.