Sign up to create alerts for Instruments,
Economic Events and content by followed authors
Free Sign Up Already have an account? Sign In
Quotes
All Instrument Types
- All Instrument Types
- Indices
- Equities
- ETFs
- Funds
- Commodities
- Currencies
- Crypto
- Bonds
- Certificates
Please try another search
💎 Reveal Undervalued Stocks Hiding in Any Market Get Started
Genmab: A Quick View
www.investing.com/analysis/genmab:-a-quick-view-150333
Genmab: A Quick View
By Edison | Jan 10, 2013 12:22PM ET
Investment Summary: Stars Are Realigning
Genmab’s daratumumab has the potential to be a game changer. Activity of the anti-CD38 antibody in myeloma represents a new and complementary mechanism of action, meeting a major unmet medical need. Heavily pre-treated multiple myeloma patients extraordinarily achieved a partial response after short single-agent exposure. Although early stage, the data is sufficiently impressive for J&J and Genmab to communicate an ambitious clinical trial programme this year across a variety of haematological cancers, targeting a market opportunity of c $9bn.
Limited Toxicity Easily Managed With Steroids
In a dose-escalating Phase I/II study, the safety and toxicity of daratumumab (a fully human IgG anti-CD38 monoclonal antibody) were assessed in 32 patients with relapsed and relapsed-refractory multiple myeloma (MM). Daratumumab monotherapy in patients already exposed to two to 11 therapies caused limited toxicity easily managed with steroids. The most common adverse events were infusion-related reactions. It is particularly impressive, the study met its primary safety end point, given the widespread expression of CD38 in normal human tissue.
Extraordinary Efficacy Signal With Single-Agent Exposure
At the higher doses (4-24mg/kg), daratumumab induced a dose-related reduction in the M-component, paraprotein, a marker of disease activity. A disappearance of tumour cells from bone marrow samples was also detected. Moreover, at doses of ≥4mg/kg, a third of patients achieved a partial response and two-thirds achieved at least a minor response. This is an exceptional finding after short single-agent exposure and has never been seen before with a monoclonal antibody. Data on extended exposure (up to 24 months) and combined with Revlimid are expected from 2014.
Massive Market Potential
Genmab estimates the MM market at $3.9bn pa. Daratumumab was partnered with Janssen Biotech (a subsidiary of J&J) in August 2012 in a deal worth up to $1.1bn. This includes potential development in six disclosed haematological cancers, for which the companies estimate a total market potential (including MM) of $9bn pa.
Valuation: Daratumumab Springboard
As well as exciting daratumumab data, albeit early stage, the $55m upfront received from J&J via its out-licensing and an equity investment of $80m, has extended the cash runway to beyond 2016e, sufficient to see Phase III data read-outs of ofatumumab, which, if positive, would significantly expand its label and allow Genmab to develop certain of its antibody-drug conjugates alone to retain more value for shareholders.
To Read the Entire Report Please Click on the pdf File Below.
Genmab’s daratumumab has the potential to be a game changer. Activity of the anti-CD38 antibody in myeloma represents a new and complementary mechanism of action, meeting a major unmet medical need. Heavily pre-treated multiple myeloma patients extraordinarily achieved a partial response after short single-agent exposure. Although early stage, the data is sufficiently impressive for J&J and Genmab to communicate an ambitious clinical trial programme this year across a variety of haematological cancers, targeting a market opportunity of c $9bn.
Limited Toxicity Easily Managed With Steroids
In a dose-escalating Phase I/II study, the safety and toxicity of daratumumab (a fully human IgG anti-CD38 monoclonal antibody) were assessed in 32 patients with relapsed and relapsed-refractory multiple myeloma (MM). Daratumumab monotherapy in patients already exposed to two to 11 therapies caused limited toxicity easily managed with steroids. The most common adverse events were infusion-related reactions. It is particularly impressive, the study met its primary safety end point, given the widespread expression of CD38 in normal human tissue.
Extraordinary Efficacy Signal With Single-Agent Exposure
At the higher doses (4-24mg/kg), daratumumab induced a dose-related reduction in the M-component, paraprotein, a marker of disease activity. A disappearance of tumour cells from bone marrow samples was also detected. Moreover, at doses of ≥4mg/kg, a third of patients achieved a partial response and two-thirds achieved at least a minor response. This is an exceptional finding after short single-agent exposure and has never been seen before with a monoclonal antibody. Data on extended exposure (up to 24 months) and combined with Revlimid are expected from 2014.
Massive Market Potential
Genmab estimates the MM market at $3.9bn pa. Daratumumab was partnered with Janssen Biotech (a subsidiary of J&J) in August 2012 in a deal worth up to $1.1bn. This includes potential development in six disclosed haematological cancers, for which the companies estimate a total market potential (including MM) of $9bn pa.
Valuation: Daratumumab Springboard
As well as exciting daratumumab data, albeit early stage, the $55m upfront received from J&J via its out-licensing and an equity investment of $80m, has extended the cash runway to beyond 2016e, sufficient to see Phase III data read-outs of ofatumumab, which, if positive, would significantly expand its label and allow Genmab to develop certain of its antibody-drug conjugates alone to retain more value for shareholders.
To Read the Entire Report Please Click on the pdf File Below.
Related Articles
E-Mini Final Day of Month
By Al Brooks - Mar 31, 2023
Emini daily charto Today is the final day of the month. The bulls have a bull reversal bar, closing near their high. The bulls will want another bull trend day and paint as little...
Nasdaq 100 Hits 7-Month High With Room to Rally Further
By Matthew Weller - Mar 31, 2023
The Nasdaq 100 is trading at a 7-month high, up more than 20% in three months to enter a new bull market The tech-heavy index recently saw a “golden cross” of the...
3 Stocks With Dividends Paid Out Every Month
By Brett Owens - Mar 31, 2023
It doesn’t get any better than monthly dividends. Getting paid every 30 days aligns nicely with our monthly bill schedule. Today we’ll discuss three monthly dividend...
Genmab: A Quick View
Add Chart to Comment
Confirm Block
Are you sure you want to block %USER_NAME%?
By doing so, you and %USER_NAME% will not be able to see any of each other's Investing.com's posts.
%USER_NAME% was successfully added to your Block List
Since you’ve just unblocked this person, you must wait 48 hours before renewing the block.
Report this comment
I feel that this comment is:
Comment flagged
Thank You!
Your report has been sent to our moderators for review
Add a Comment
We encourage you to use comments to engage with other users, share your perspective and ask questions of authors and each other. However, in order to maintain the high level of discourse we’ve all come to value and expect, please keep the following criteria in mind:
Enrich the conversation, don’t trash it.
Stay focused and on track. Only post material that’s relevant to the topic being discussed.
Be respectful. Even negative opinions can be framed positively and diplomatically. Avoid profanity, slander or personal attacks directed at an author or another user. Racism, sexism and other forms of discrimination will not be tolerated.
Perpetrators of spam or abuse will be deleted from the site and prohibited from future registration at Investing.com’s discretion.