ImetelChat

Director, Drug Substance (API) Manufacturing https://www.linkedin.com/comm/jobs/view/1404133083?alertAction=markasviewed&savedSearchAuthToken=1%26AQGHdOmPKaeLfAAAAWxi5UccuNLQFULgUn2NvVSUv-6qm-28sIeFQJ4uAdpw8rybP8JN7pX7dnQhsHr54oRk_UzmZc1xMPgWEMjNbDj0TOzd6bKdqBOvpzy4avH966QbzbtT_k-QnRQ5Jwpasp4IFVuCUc...

Associate Director / Regulatory Affairs https://www.linkedin.com/comm/jobs/view/1393446010?alertAction=markasviewed&savedSearchAuthToken=1%26AQEmK-3jFSU3cAAAAWxJLWRkQplpqLm3l6WaU6ye-cHMXJvEka5EXObaXbNVlXhO9shnAw647E3oXTrI5Om1suvgWgtKlUOetoa9HiVBFiDqgMhOfTbwQX0LwGJmcxzo8T7Q_roM4YXO9fbuCuUais5-ZGgXVW3...

Just came across this patent application (http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=9&f=G&l=50&co1=AND&d=PG01&s1=imetelstat&OS=imetelstat&RS=imetelstat) from Janssen dated January 31, 2019 (sorry if this is not new here). The timin...

The study status and study description for the iMbark trial on clinicaltrials.gov was updated today to add a year to the extension phase to continue monitoring for overall survival and adverse events:
https://clinicaltrials.gov/ct2/history/ ... 2&C=merged

Timely question. Janssen is certainly willing to try: https://www.janssen.com/janssen-submits-new-drug-application-us-fda-seeking-approval-erdafitinib-treatment-metastatic "HORSHAM, Pa., Sept. 18, 2018 -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that a New D...

Regarding the effectiveness of various doses of imetelstat, I have been impressed with the responses of the MDS patients, for example, as shown on Slide 11 of the EAH presentation from June ( https://www.geron.com/file.cfm/53/docs/Imetelstat-IMergePart1-EHA-2018.pdf ). The dot represents a dose of 7...

As is common knowledge, Janssen and Geron have a second license agreement signed following the imetelstat collaboration agreement. Janssen licensed additional patents and rights from Geron to develop new drugs outside the field of telomerase inhibition. The agreement provides for annual license fees...

Just a minor curiosity item ... the study status for the withdrawn GRN1005 study in brain metastases from breast or lung cancer continues to be updated quite regularly:

https://clinicaltrials.gov/ct2/history/NCT01679743

I'd love to know what that's all about.

It's been a long quiet period up until the past few days but there are a number of catalysts on the horizon. Here's a quick list of what I anticipate to be the many potentially market-moving events for GERN in the coming weeks and months: 1. 9/13 – JNJ Pharmaceutical Business Conference Call 2. 9/13...

I had not considered the "right to try" or compassionate use as a possible explanation. That would be very compelling.

The study status for GRN1005 was updated again yesterday.
https://clinicaltrials.gov/ct2/history/ ... 5&C=merged
Very curious.

j6p

One of the aspects of the current status of imetelstat's evolution that is so curious to me is the ongoing updates to all of the clinical trials, not just IMbark and IMerge. There was an update on August 7 on an old trial evaluating imetelstat in younger patients with relapsed or refractory solid tu...

There was a second patent issued to Geron on July 31 that I overlooked: m Synthesis of protected 3'-amino nucleoside monomers Abstract Orthogonally protected 3'-amino nucleoside monomers and efficient methods for their synthesis are described. The methods employ selective protection of the 3'-amino ...

A new patent was issued to Geron on July 31, 2018, relating to compounds useful in inhibiting telomere elongation. See: https://tinyurl.com/y976ctrh (link to USPTO patent). I've yet to review and would welcome comments from others who do.

Best regards,
j6p

A postscript:

GERN is confident the continuation decision will be coming in Q3. One way to have such confidence is to know the FDA has a PDUFA decision date prior to September 30, if JNJ has submitted its NDA application. Just thinking out loud.

j6p

My current theory is that JNJ has applied for accelerated approval for MF based on the primary analysis of IMbark and needs the FDA's decision in order to present GERN with a clinical development plan. In other words, JNJ needs to know if a future registration study is still needed for MF or if IMba...

I share your opinion that I expect the continuation decision in the near future. This week will be three full months since the primary analysis began for IMbark. We know that Janssen has to complete the primary analysis and also submit a clinical development plan for Geron's consideration of whether...

Janssen updated the ClinicalTrials.Gov site for the Mayo study today to change the status from "Active, Not Recruiting" to "Complete" with a completion date of May 24, 2018. m Interestingly, results were posted today to a separate study of imetelstat conducted by the Pediatric Br...

I found these articles to be of interest with respect to the FDA's approach to supporting accelerated approvals of single-arm studies that do not include a placebo/control arm. The articles are authored/co-authored by Gideon Blumenthan, MD, who is the Deputy Director (acting) of the Office of Hemato...

Novartis was issued a patent last week for a new molecular entity that inhibits tankyrase, which can have a cascading effect on temolere access to telomerase. The patent is for Novartis's NME but includes its use in combination with other drugs, including imetelstat: http://patft.uspto.gov/netacgi/n...