Novartis and Morphosys

[biopearl123]

https://finance.yahoo.com/m/6c767dfa-01 ... yptr=yahoo

[kmall]

My take - not that it means anything: Novartis wants in on the MF market. They were at the Geron table in 2020 (speculation on my part based on the EA hire from Novartis who returned immediately after meetings with the FDA). For some unknown reason they walked. Imetelstat is worth quite a bit more than $2.9B. -Kmall

[biopearl123]

Kamall, yes, there have been claims of symptom improvement and perhaps disease modification but so far I have only seen the goal of OS pursued by Geron. Don't remember if pelabresib data included an assessment of bone marrow fibrosis improvement. When I have time I will go back and look unless anyone else knows and can post. Be interesting to see how Dr. S. spins this. bp

[kmall]

Bp - this article shines a little more light on the finer details.......

"Pelabresib plus Jakafi recently met the primary endpoint of spleen volume reduction in the phase 3 MANIFEST-2 study in myelofibrosis patients who’ve never tried a JAK inhibitor, Novartis and MorphoSys pointed out in their M&A announcement."

"We are excited about the opportunity of bringing pelabresib, a potential next-generation treatment combined with ruxolitinib, to people living with myelofibrosis, a rare and debilitating form of blood cancer,” Novartis Chief Medical Officer Shreeram Aradhye, M.D., said in the release. “With the planned acquisition of MorphoSys, we aim to further strengthen our leading pipeline and portfolio in oncology, adding to our capabilities and expertise.”

https://ftp.tmfsummit.com/biotech/after ... -morphosys

[biopearl123]

Thanks Kmall, Pelabresib along with Rux still seems to keep the focus on the spleen. And yes, not having to carry a bag of blood around in your left upper quadrant probably improves patient comfort by a lot, overall symptoms don’t seem to be impacted, hard to feel well with a disease like that. Again lacking seems to be any emphasis on overall disease modification and life extension, an area where Imetelstat may shine.

[kmall]

According to AF - the Novartis/Morphosys isn't happening......

https://www.statnews.com/2024/02/06/why ... morphosys/

[biopearl123]

That is crazy interesting. I think the door to Dr. Scarlett's office may remain open. What are your thoughts about the IMPRESS study update? This study was supposed to set the stage for understanding the proper dose for a combination study. Clinical trials:

"Overall Hematological Response Rate of Participants after Treatment with Imetelstat
[ Time Frame: After 4 Months of Treatment ]"

Unless they can't find anyone to enroll which seems very unlikely, why add another year to the study? Since the primary end point is ORR and not OS I am having trouble with this one. Clearly if the study showed even worse mortality, they would be forced to stop so that can't be it, perhaps the converse it true? But if so they would have to modify the end point. Curious.

[kmall]

Bp - I found that AF article interesting. And how about the timing? It was down $1 today so maybe he's onto something? Most likely just some profit taking. I guess someone with a serious short position in Morphosys or long in Incyte didn't see Novartis swooping in on this.......AF = Panic Button in my book...... again, what do I know, I'm still sitting around here 11+ yrs on my hands.

As far as the IMpress study goes, I'd like to say I was totally surprised at the now year+ long delay....but this is Geron. Enough said.

Not sure what the setback could be? A little out of my wheelhouse, but I'd say your guess is as good as any......and as you stated Imetelstat targeting OS obviously ratchets up the bar for patients. This has been highlighted so many times here already, I won't bother to elaborate. I will say this, I'm sure I can speak for most who read this board.....it's been a hell of a ride. -Kmall

[rccola335]

maybe it was extended to keep it out of he ADCOM discussion - the impress patients are near life's end and they dont want to complicate their approval for MDS

[kmall]

RC - Interesting theory and plausible, but if the data is as good as Lane and Claudia Bruedigam have suggested, wouldn't that be a positive for MDS approval? -Kmall

https://www.miragenews.com/new-discover ... e_vignette

"Having this extra weapon (Imetelstat) in our arsenal would create so much opportunity particularly in combining this drug, and others like it, with existing treatments like chemotherapy and other novel cancer therapies," Professor Lane said.

"This could transform the way we think about treating patients with blood cancers, especially those who have run out of options."