Stopping the Phase II trial of its ADC product IMGN901 on patients with non-small-cell lung cancer is most probably a temporary setback, which we believe would have no negative long-term impact on ImmunoGen’s (IMGN) success and growth. The failure of the drug has nothing to do with ImmunoGen’s TAP technology that has been validated through the approval of HER2 positive breast cancer ADC product Kadcyla® and through many years of experimentation.
Finding that the addition of IMGN901 to etoposide/carboplatin (E/C) was unlikely to demonstrate a sufficient improvement in progression-free survival compared to E/C alone to justify continuation of the trial, the firm was advised to halt the lung cancer clinical trials with the combination.
As ImmunoGen stated in its press release, infection-related toxicity is, indeed, a recognized risk in SCLC trials, including trials with etoposide/carboplatin. With regard to IMGN901 as a single agent, was given to 198 patients with only one incidence of infection-related death deemed possibly drug related.
At no time we heard Genentech or any other large pharmaceutical companies conducting clinical trials with ImunoGen’s CAD return back to ImmunoGen the rights to using its conjugated TAP technology because of side effects. None of the large pharmaceutical firms that licensed mmunoGen’s TAP technology to develop cancer drugs have complained, or stopped using the technology, or halted the development of any drug made through TAP. These firms include Roche (OTCQX:RHHBY), Sanofi (SNY), Bayer (OTCPK:BAYRY), Novartis (NVS), Amgen (AMGN), biotest (OTC:BIESF), and other firms. We never heard them complain of any leak from the linker, or any other defect in the CAD products. On the contrary, after experiencing the advantages of ImmunoGen’s TAP technology with its HER2 breast cancer drug Kadcyla, Genentech has licensed ImmunoGe’s TAP technology to develop several other drugs.
On September 11,2013, ImmunoGen CEO had already answered current critics' claims that the successful outcome of Roche’s/Immunogen drug was because Genentech has improved the technology, including the linker and the toxic drugs used. That was at the Morgan Stanley Global healthcare Conference. When Yigal Nochomovitz from Morgan Stanley asked Dan Junius, Immunogen CEO to “clarify the technology picture with Kadcyla in terms of which components are ImmunoGen technology – linker, payload – and whether you have rights to use the linker and payload in other assets.”
Answering him, ImmunoGen CEO said, “ Yes, I’d actually sort of turn it the other way. We own the linker and payload. We have the composition of matter patent on Kadcyla, so we contributed that technology. The piece of technology that came from Genentech was trastuzumab, the antibody that is marketed as a naked agent as Herceptin. But we own the composition of matter patent on the SMCC linker as well as on the cytotoxin itself, as well as methods of manufacture, et cetera. So the reason I turn it the other way in saying Genentech had to come to us for rights to use that, as opposed to them having any ownership of that technology.”
Logically speaking, one setback among more than 16 studies is not unusual, or a precedent. From what we experienced and heard until now, we do not expect long-term impact on ImmunoGen from this setback.
Kadcyla's sales for HER2 breast cancer will continue to climb and Kadcyla is expected to move up as first line treatment at the end of next year if not before – a move expected to increase Kadcyla’s sales, which are expected to exceed those of Roche’s HER2 breast cancer blockbuster Herceptin’s sales.
With regard to ImmunoGen’s wholly owned products, it is true that the firm might have lost one, but it has recently initiated trials with three wholly owned ADC compounds, including IMGN853 for ovarian, endometrial, and other cancers that highly express folate receptor α; IMGN529 for non-Hodgkin lymphoma; and IMGN289 for lung, head and neck, and other cancers that highly express EGFR.
We hope that the critics do not claim ADC drugs are toxic during dose escalation experiments when the firm pinpoints the toxic dose to avoid it, not to use it.
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