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Just catching up, so this follows on from @jive_turkey from 10:54. Re C7 data expected at AACR …
“March 5, 2024: Titles and Text of Regular Abstracts Posted to Online Itinerary Planner (4:30 p.m. ET)
March 5, 2024: Titles of Late-Breaking and Clinical Trial Abstracts Posted to Online Itinerary Planner (4:30 p.m. ET)
April 5, 2024: Text of Late-Breaking and Clinical Trial Abstracts Posted to Online Itinerary Planner (3 p.m. ET)”.
Deadline for .. “Requests to withdraw regular abstracts will be accepted through Friday, February 9, 2024. Requests to withdraw late-breaking or clinical trials abstracts will be accepted through Friday, February 23, 2024”, gone.
So are we in or out? If we’re in, we find out if title and text (‘regular’) on March 5th, or just title (‘late-breaking and clinical trials’) – otherwise wait until April 5th. So in or out, ‘standard’ or ‘special’?
1 week or 6 weeks of pointless speculation? Just tell us the results and the plan Sir Al, we do own the co. after all.
GLA
@Rorkes, interesting thought, but think we should wait a little longer.
AffXell on the ‘cusp’ of IND etc. We own 19%+ (subject to valuation) of AffyXell as the JV heads to IND, in-human trials, series B funding, and targeting IPO in 2026.
Like the enthusiasm of AffyXell CEO Seungho Jeon. Worth a careful read, potentially ‘game changing’ …
http://affyxell.com/bbs/?so_table=news&mode=VIEW&num=38&category=&findType=&findWord=&sort1=&sort2=&page=1
Affimers not far off ‘in-human’ trials then. AffyXell, and Affimers generally, will be worth an awful lot more when this happens.
GLA
Just been reading something (not Avacta) by Paul Hill (PMH Capital and Vox), noticed Sir Al top of his linkedin 'other people view' list.
Probably just a coincidence?
GLA
(Chemo drugs, that are proven to work, delivered just to the TME, therefore with minimal side effects, at higher doses, would probably be a good thing, just a thought ..?).
Quiet can unsettle some. Lot’s of speculation. Lot’s of genuine news to come. For example …
C7 full and detailed data and analysis, plus ongoing patient treatment.
Confirmation of AACR presentation.
Bi-weekly recruitment / progress.
AVA3996/2727D status (eg IND filing progress).
Tx Affimer updates - AVA028/032, AVA021.
Partners – AffyXell (AFX-001 IND), LG Chem (LR19128)
Licensing deals? BP ‘stake’? Acquisition? Nasdaq IPO? Other funding options?
Dx strategy – Affimers for Dx, integration progress, potential ‘spin off’, etc.
Peace and Long Life
So have 19.3m new deferred shares just been confirmed today – plus 250k normal shares?
https://find-and-update.company-information.service.gov.uk/company/04748597/filing-history
22/02/24 Class of Shares: ORDINARY Currency: GBP Number allotted 250000
Class of Shares: DEFERRED ORDINARY SHARES Currency: GBP Number allotted 19327344
Total number of shares: 307533551
Posted on Companies House today. RNS tomorrow?
GLA
@estura, polite question. If a placing is due, will it be …
Placing with an II / BP strategic investor / partner?
Accelerated book build to target II’s?
IPO on Nasdaq?
Full retail offering with discount shares for holders?
Other?
And will the raise pay off the CLN plus fund the co. through 2025?
GLA
Indeed. “Disease surveillance every 6 weeks”. We now have 3 months more trial data.
Time to update shareholders methinks.
GLA
AACR deadline for submissions 5th March. If new data lodged with AACR then must be RNS’d.
Other (not exhaustive) news due, starting with (not dodging), funding …
‘Cash runway into H2 2024’ – so need a funding solution before FY 2023 results in (likely) April.
C7 full / complete / detailed results, and ongoing treatment (whether or not presented at AACR).
Bi-weekly recruitment / progress.
AVA3996/2727D status (eg IND filing progress).
AVA028/032, AVA021 updates.
Licensing deals?
Partners – AffyXell (AFX-001 IND), LG Chem (LR19128)
Dx strategy – Affimers for Dx, integration progress, potential ‘spin off’, etc.
GLA
While I know that Sir Al doesn’t recognise calendars (though he may have some concerns about the proximity of the ‘Ides of March’?), there are some upcoming dates for AACR 2024 that may warrant attention …?
“March 5, 2024: Titles and Text of Regular (and Late-Breaking and Clinical Trial) Abstracts Posted to Online Itinerary Planner (4:30 p.m. ET)”.
“Requests to withdraw late-breaking or clinical trials abstracts will be accepted through Friday, February 23, 2024”.
So, we should at least have a sense of what is being presented – if anything, by March 5th.
Personally, would hope the IP/Patent issues have been dealt with (to our advantage) and we get the missing C7 data summarised and presented (like in an ‘Abstract’) sometime in the next 2 weeks.
GLA
Interesting RNS’s from AZN this morning …
Tagrisso plus chemo (not dox) extends pfs by nearly 9 months in (a particular) lung cancer.
“Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated advanced nonsquamous non-small cell lung cancer”. This one is a ‘targeted’ (to TROP-2 – cell glycoprotein, overexpressed in gastric cancer) ADC.
Comments on the Tagrisso results from Susan Galbraith (EVP Oncology R&D AZN) who, I ithink, is well known to Chris Coughlin.
(AZN sp up >3% = >+£4.8bn at time of posting).
If only one of the most powerful, tried and tested, chemotherapies could be successfully targeted to the TME, with an attendant (substantial) reduction in side effects, thereby enabling a higher dose for an extended period, then surely that would be another big step forward, one might almost go as far to suggest ‘paradigm shifting’ …
GLA
@gmcc, interesting find, thanks. Quick takeaway …
3 (chemically) different FAP targeting ligands (PNT6555, 6952, 6522) with 3 different radioisotopes (177Lu, 225Ac, 161Tb) plus target imaging (PETi) via 68Ga. Complicated, and suggestion that different solutions for different tumour stages.
Work done on mice, some with FAP enhanced tumours. While supportive of “advancement of PNT6555 to the “FAPi Radioligand Open-Label, Phase 1 Study to Evaluate Safety, Tolerability and Dosimetry of [Lu-177]-PNT6555 ... (ClinicalTrials.gov identifier NCT05432193).”, it seems like there’s still a lot of pre-clinical work to do. Needs a very careful read through (please DYOR etc.).
A few general points (no pun intended) re RadioLigandTherapy (RLT) …
Firstly, RLT is not straitforward. Radioisotopes are not inert – you can’t turn radioactivity off (unlike AVA6000 where Doxorubicin is rendered inert until FAP triggered cleavage at the TME), so targeting is critical. Not to mention the supply-chain challenges of radioisotopes.
Lily (Point) and Novartis favour 177Lu and 225Ac (161Tb also mentioned in article). 177Lu is produced by Neutron bombardment of 176Lu, or 177Yb - which then decays to 177Lu. 177Lu has a half-life of 6.6 days, so not long to manufacture the Radioligand. 177Lu decays via beta emission (3 energy levels) and gamma (1 energy level). The beta decay is the treatment.
Most 225Ac came from the Oak Ridge National Laboratory from (slowly) decaying Thorium – but this source is running out. However, you can always batter 232Th with high-energy protons – just need an accelerator next door. 225Ac has a 10-day half-life and decays via alpha emission (high energy, but very short distance, so needs precise targeting).
Lot of work going on working out how to ‘do targeting’ with Radioligands. For example, from Lily (Point) PNT2002 (PSMA), PNT2003 (SSTR - somatostatin receptor) and PNT2004 (FAP).
While there seems to be some progress with PSMA targeting for Prostrate cancer, this mostly involves the use of 68Ga (half-life 68 min) to ‘image’ (via PET) the treatment site, rather than direct targeting.
PNT2003 (collaboration with Lantheus) has just received an ‘abbreviated new drug application (ANDA)’ from the FDA
https://www.cancernetwork.com/view/fda-accepts-abbreviated-nda-for-177lu-pnt2003-in-sstr-gep-nets
Lily (Point) are trying direct PSMA targeting with their PNT2002 ‘splash’ trial (rPFS up from 6 to 9.5 months, though apparently not as good as anticipated, or Novartis’ Pluvicto?) and PNT2001 – which looks like a replacement (already?) for PNT2002. Of course they also now have canSEEK™ (aka pre|CISION™), let’s see where this goes.
In the meantime, we should just ‘get on’ with the AVA6000 trial and ‘accelerate’ the ‘opportunities’ presented by the overall pre|CISION™ platform.
GLA
Re FAP expression, I think that this doc has been referenced by Avacta ..?
https://jnm.snmjournals.org/content/jnumed/60/6/801.full.pdf
GLA
@WeAreGroot, tough decision. Perhaps give Elon a call and deploy joint resources to Mars. The terraforming opportunity needs accelerating anyway, let’s target that paradigm shift. (Think the Dyson round Proxima Centauri was going to be tricky anyway – very energetic flares for a small star).
Peace and Long Life
McMuff, would hope so, i.e. proper business update (RNS, CEO / CC video and slide deck), before any (if really necessary?) SH questions fronted by Myles (whose research and co. knowledge I do think is very good).
Agree with the general sentiment that these ‘private’ meetings and emails are quite unprofessional and potentially reputation damaging. Always a risk of material information ‘leaking’ out.
Do wonder though, how many shares Myles holds under his control, and how many shares his ‘circle’ hold – I suppose it might be enough for some influence?
GLA
“Poolbeg confirms $10bn cancer-immunotherapy opportunity 09:47, 12th February 2024”.
To do with immune system ‘modulation’ to prevent the excessive release of cytokines during cancer immunotherapy …
https://www.voxmarkets.co.uk/articles/poolbeg-confirms-10bn-cancer-immunotherapy-opportunity--1363f92/
Thing is, Affimers can do this as well.
In fact AffyXell seem to be (more-or-less) doing this kind of thing with the ‘Secretory Affimers’ that Avacta are providing the JV with …
http://www.affyxell.com/en/pipeline/pipeline.php
“Affimers secreted to extracellular region from AffyXell reinforce the immune modulating function by combining with innate immune modulators like cytokines. Secreted Affimers can inhibit over-activated immune responses (Immune cells related to innate or adaptive immune system).”
GLA
From the ‘Interim Results for the Six Months Ending 30th June 2023’ …
“Cash at 30 June 2023 was £26 million, whilst cash at 31 August was circa £24.5 million
with the benefit of the FY22 R&D tax credit refund of £2.3 million having been received,
giving a cash runway into H2 2024.”
So ‘runway’ to needing new finance or ‘runway’ to running out of cash – take your pick. (Would assume that Tony Gardiner has a handle on Diagnostics revenue and income).
If we say cash to end Q3 2024, then financing through 2025 into 2026 needs sorting by end Q1, before FY 2023 results in (likely) April.
So, what’s it going to be …
Full takeover, Tx / Dx split (Dx ‘spin out/off’), license (something, plenty of options), money inbound from partner (LG Chem / Daewoong), Nasdaq listing (say, via RTO), issue equity to ‘strategic’ investor / partner, issue equity to market / current investors.
We have some commercial folks on the board – Eliot Forster, Paul Fry, Shaun Chilton, and Simon Bennett focused on Tx. I’m sure these guys are ‘just getting on with it’ and, as conveyed by Sir Al’s ‘mates’, we shouldn’t worry.
GLA
@GrumpyMan, certainly seems to be ‘up our street’.
“Reforming the dose optimization and dose selection paradigm in oncology” …
https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus
GLA
Looks like we have a new (additional) Co-Investigator at MSK …
https://www.mskcc.org/cancer-care/clinical-trials/22-428
Alongside Sujana Movva, now also Alan L. Ho, MD, PhD, joining Dr William D Tap on the AVA6000 trial.
Dr Ho’s specialities – Head & Neck, Mouth and Salivary Gland cancers.
Has to be encouraging?
GLA
@manxgolfer, hope all goes well for your wife. ATB
“GSK presents positive DREAMM-7 phase III data” …
https://www.lse.co.uk/rns/GSK/gsk-presents-positive-dreamm-7-phase-iii-data-4654yveqmrv3ed7.html
“Trial shows Blenrep [belantamab mafodotin] combination nearly tripled median progression-free survival versus standard of care combination in patients with relapsed/refractory multiple myeloma”.
In ‘combination’ with “bortezomib plus dexamethasone (BorDex)”.
However …
“Grade 3 or higher non-ocular adverse events of clinical interest in the belantamab mafodotin combination and daratumumab combination arms, respectively, included thrombocytopenia (55% and 35%; exposure-adjusted event rate: 40 and 29, per 100 person-years), neutropenia (12% and 6%), pneumonia (12% and 4%; exposure-adjusted event rate: 8 and 3, per 100 person-years), and anaemia (8% and 10%).”
Maybe ‘precisely targeted’ delivery would help. We know pre|CISION™ can deliver bortezomib (i.e. AVA3996/2727D), don’t know about blenrep.
It would be interesting to know if AVA3996 could do a better job overall, including a reduction in side effects?
GLA