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Update: Anavex's presentation, Systematic Processing of Full Genomic Analysis of ANAVEX®2-73 Phase 2a Alzheimer’s Disease Study Identifies Biomarkers Enabling a Precision Medicine Approach has been moved from its original timeslot of 5:15-5:30 on 7/25 to 3:00-3:15 on the same day.
It is now grouped into Developing Topics: Recent Developments in Therapeutics which runs from 2:00-4:00 and features 7 oral presentations. The final presentation of the session, getting a half hour timeslot from 3:30-4:00 will be Biogen/Eisai's, Treatment of Early AD subjects with BAN2401, an Anti-Aß Protofibril Monoclonal Antibody, Significantly Clears Amyloid Plaque and Reduces Clinical Decline.
Good point nidan - just want to point out that number 3 on the list is an oral/podium presentation. Note the times given.
I personally find it extremely encouraging that Dr. Harald Hampel is indicated as lead author on both numbers 2 and 3. If you search him on the AAIC site, you will see that he is associated with 18 different posters and presentations at the conference, but I believe his Anavex presentations are the only drug-based works amongst them. It’s definitely worth taking a look at the rest of the presenetations he is a part of at the meeting.
In his own words:
Adam Feuerstein has reported that Biogen/Eisai will indeed be presenting the BAN2401 data at AAIC on the 25th:
Presentation date: Weds. July 25. https://t.co/wCoCpi4S1R
— Adam Feuerstein ✡️ (@adamfeuerstein) July 7, 2018
I don't know why you keep characterizing his answers as "clever". I know exactly the question I asked, and received an answer to that very specific question.
And yes, an MTA can most definitely be cancelled, but more importantly they are usually subject to terms that dictate a maximum time duration. This is simply what I was looking to ascertain.
To the "better question" proposed, those specifics likely would not have been disclosed.
Also worthwhile to keep in mind this exchange from the Q2 earnings call:
But I was warned earlier today that having a deep pipeline was a danger to Anavex's credibility. I'm so confused.
Excellent catch! The Principal, Federico Goodsaid, PhD, who is credited on the 2-73 genomic analysis poster, has an impressive background both at Vertex and with the FDA/CDER:
After the release of the AAIC posters (and presumed trial starts), the company will have much more to discuss. It is my belief that details of the genomic analysis and trial endpoints will create a compelling narrative for potential new investors.
It's nice to see that 1 week after AAIC, the NDD event will give Dr. Missling half an hour on a panel to speak about trial endpoints followed by a half hour solo presentation where he can go into detail about the genomic analysis and other steps that they have taken to increase clinical trial success. Impressive mix of speakers on board: http://www.ndd-summit.com/about/speakers/
I believe these have all been posted to the board previously, but I thought some might find it helpful to review the currently known upcoming conference schedule in one place.
July 25: AAIC 2018 - Chicago, IL
AAIC 2018, July 25th - 2 Developing Topic Posters:
"Full Genomic Analysis of ANAVEX®2-73 Phase 2a Alzheimer’s Disease Study Identifies Biomarkers Enabling Targeted Therapy and a Precision Medicine Approach"
"Sigma-1 Receptor Target Occupancy Study with Dynamic PET Scan Analysis of ANAVEX®2-73, a Clinical Candidate for Neurodegenerative and Neurodevelopmental Diseases"
Search "Anavex" here: https://ep70.eventpilot.us/web/planner.php?id=AAIC18LITE#view1
Interesting twitter thread from Scott Gottlieb today: https://twitter.com/SGottliebFDA/status/1005480281510432770
@SGottliebFDA patient input become a more important part of approval prefixes. New guidance about patient focused drug development coming next week #BIO2018
— ByLisaU (@ByLisaU) June 7, 2018
Excellent points! I'll also add that Parkinson's Dementia presents one of the greatest unmet needs in the overall Parkinson's treatment space, which could potentially bode well for both approval threshold and eventual valuation.
Hey Leo, I know you're not addressing me here, but I want to clarify that my comments earlier are not a representation that I feel this particular event is not important and it obviously does come at a key time as Anavex looks to advance Rett into the clinic.
I absolutely agree that it would be great to hear a continued affirmation from Dr. Kaminsky, but I was just noting that there is a very real possibility we don't hear anything about what actually transpires at the meeting, much like in 2017 (save for the one brief write-up I posted). Anyhow, as non-attendees of the meeting, if we don't hear anything, in my opinion that would have absolutely no bearing on the quality of the discussions held there.
Just wanted to respectfully close the loop on my earlier train of thought. Cheers
If you read my post, you would have learned that this not the FIRST time they have appeared together. They were together at the same conference in 2017; http://anavex.com/world-orphan-drug-congress-usa-2017/ "Roundtable 4: Partnerships- successful collaboration between a rare disease foundation and a pharmaceutical company to advance preclinical and clinical research in Rett Syndrome."
I provided a link in my previous post of the only post-meeting info relayed about that meeting. I am simply of the mind that without some unexpected news of trial initiation, we may not hear any details of this SECOND panel appearance. And that would be an entirely neutral result.
You keep mentioning this, but I keep wondering, are you attending this meeting? Do you know someone who is? If not, I’m not sure that we will hear anything out of it - good or bad. At the 2017 World Orphan Drug Congress, when Dr. Missling and Dr. Kaminsky also appeared on a panel together, we did not get a direct output of the meeting; no company PR or webcast. Sometime after the meeting, the panel was mentioned in this write-up of “7 Lessons from the World Orphan Drug Congress” (#3) http://www.draccon.com/dracaena-report/wodcusa2017, but otherwise unless you were in attendance, it passed by quietly. Not sure if there should be a potentially overblown expectation of anything different this time around.
Well now, that makes absolute sense. Cheers man!
Jonjones, I was at the meeting as well (tall guy in front/closest to Dr. Missling as he presented). I was curious if anyone had followed up on this myself. Toward the beginning of his presentation, I believe while he was still taking a few initial questions, he spoke about the fact that there would be multiple age groups enrolled in the trial then followed up with a statement that they were working with the FDA on "how to start the study with existing toxicology (data)..."
This left me with the same question that Steady_T posed and the feeling that there MAY still need to be a study done. My in-the-moment thought (and uninformed guess) was that maybe they were looking at first enrolling those patients who are old enough to satisfactorily be covered by existing data while completing the juvenile tox study. I had intended to follow up on this in the after meeting conversations, but forgot to in the midst of other discussions.
Anyhow, very positive meeting all around and it was great to have such extensive access to the team.
Also I have to mention, the wrap up and thoughts you shared with the board were fantastic and IMO absolutely spot on with what transpired. Thank you!
Looked back to review this paper, and hadn't realized that Anavex is referenced in the closing paragraph:
Interesting article on a recently published longitudinal AD biomarker study; https://www.alzforum.org/news/research-news/csf-markers-neuronal-injury-drop-when-dementia-arrives#show-more . Anavex SAB member Dr. Harald Hampel, who's quoted at the end of the article, also provides a thorough comment regarding the importance of this research and what the path should be moving forward (usage of blood-based candidate biomarkers), concluding with:
Interesting -- nice catch.
Presentation slides are up: http://anavex.com/my_uploads/Anavex-ASENT-conference-2018-FINAL.pdf
Dr. Missling is still scheduled to present at 4:30pm today. Details are in the press release: http://anavex.com/anavex-life-sciences-present-new-preclinical-data-20th-annual-meeting-american-society-experimental-neurotherapeutics-asent/
There is no webcast indicated for the presentation, but according to the PR, The presentations can be accessed simultaneously with the above presentation times at www.anavex.com, so we should see the website updated with slides from today's presentation at 4:30 as well.
You're conflating 2 separate events here. The World Orphan Drug Congress featuring both Dr. Missling and Dr. Kaminsky isn't until late April. Friday afternoon's presentation is:
March 9: American Society for Experimental Neurotherapeutics 20th Annual Meeting - Rockville, MD
Session: Emerging Therapies: Epilepsy Drugs, Presentation: "ANAVEX 2-73 as a potential treatment for Rett Syndrome and other pediatric or infantile disorders with seizure pathology" - Dr. Missling
Pg. 8 here: https://c.ymcdn.com/sites/asent.site-ym.com/resource/resmgr/docs/Prospectus/18_ASENT_Advance_Program_and.pdf
Pretty cool, Dr. Hampel tweeted a link to your post -- twice.
One of Anavex's Scientific advisors (Harald Hampel) speaking - https://t.co/NpxqAyKDJx #GoogleAlerts
— Harald Hampel, MD, PhD (@harald_hampel) February 18, 2018
Anavex Life Sciences Corp AVXL Post # 141486 https://t.co/HcVRjZZtw8
— Harald Hampel, MD, PhD (@harald_hampel) February 18, 2018
Nice post nidan. If you haven't already, you should check out this Davos panel discussion, held yesterday and featuring Scott Gottlieb, on the future of precision medicine:
Corporate presentations are listed here: https://www.noblelinx.com/presenters_schedule.php
Each time slot, on both days, has 4 simultaneous presentations. Anavex's presentation is in Studio 1 at 3pm.
The NobleCon14 schedule has been posted, and Anavex will be presenting at 3pm on Monday the 29th. https://www.noblelinx.com/presenters_schedule.php
Also--like last year--there is a webcast link:
http://noble.mediasite.com/mediasite/Play/366e7dc8d8e24def8c934a70251ccb001d?catalog=6f8e7abd-96e3-462f-8035-f48126f80846
Thinking Missling may possibly be a panelist here as well, also on the 29th:
Nice find. Thanks for sharing.
No dates or further elaboration, but in an FDA release today, "HEALTHY INNOVATION, SAFER FAMILIES: FDA’S 2018 STRATEGIC POLICY ROADMAP", there is reference to the elusive CNS guidances (pg.13):
"Develop a series of new, disease-focused medical product guidance documents to update and modernize approaches to clinical trial design and other aspects of the development of drugs targeting unmet medical needs. This will include a new suite of guidances and policies focused on the development of drugs targeting a group of serious neurodegenerative disorders"
https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM592001.pdf
Anavex will be there. It was confirmed 1/3 on the conference twitter page: https://twitter.com/Nobleconference
There is also a panel presentation on the agenda that if I were speculating, I would think Missling may be a part of:
They are attending at JPM, and they have meetings at 2 outside events there, Bio One-On-One Partnering @ JPM, and the Trout Annual 1x1 Management Access Event.
Excellent post. EOM
This is where I believe the FDA guidance document, "Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease" issued on 12/15 potentially holds some relevance.
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM588884.pdf
While not the smoking gun 5 CNS guidannces that were promised before year end, I believe this represents current FDA thinking that applies to Anavex's pursuits. The whole document is worth a read, but below is an excerpt on patient identification for targeted clinical trials:
Of interest; targeted therapy draft guidances issued by the FDA on Friday. Apologies if this was previously posted.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm589248.htm
FDA In Brief: FDA recommends new, more efficient approach to drug development for rare pediatric diseases
https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm587862.htm
(Haven't gotten a chance to review yet myself)
Most definitely! I also think this bit of the description; "This session will explain the advantages and complications that drug developers and investors should be aware of as the Cures Act gets implemented" is important to keep in mind as we patiently wait for these first-of-their-kind trials to commence.