Member Info for LiveLongnProsper

Fairly simple ‘snapshot’ of ADC tech co.’s from last September.

https://www.rootsanalysis.com/key-insights/top-adc-technologies-providers.html

Outcomes so far …

Ambrx – acquired by J&J for $2bn.

Catalent Biologics – Novo Holdings (Novo Nordisk parent) to acquire for $15bn.

Iksuda – Celltrion (SK) invest $47m.

NBE Therapeutics – owned by Boehringer Ingleheim (Dev 2020 $1.4bn).

Seagen – acquired by Pfizer for $43bn.

Sutro – Ipsen invest $90m for pre-clinical rights.

‘Get the drift’? Perhaps a question of when, who, how (invest, acquire, license, etc.), and how much?

GLA

Thanks gmcc - registered.

This may be of interest ...

https://sofie.com/pipeline/presentations/

AVA6000 mentioned in July 2023 presentation.

GLA

From the AVA6000 pipeline + “A FAPα activated doxorubicin with a significantly improved safety profile should result in an expanded eligible patient population in the indications to which doxorubicin is currently limited because of cardiotoxicity issues, longer dosing regimens and should provide for a much more widespread utility across the field of oncology.”

Perhaps more clearly … ‘Dox is dox’ and Dr Tap suggests that ‘a doxorubicin better than ‘standard doxorubicin’ (i.e. AVA6000) overnight becomes ‘the standard of care’.

In fact, potentially ‘caring’ for even more ‘eligible patients’, and with significantly reduced side effects. Let’s see what the first readout of Q2W brings.

And then, maybe, FDA ‘Fast Track / Breakthrough Therapy / Accelerated Approval / Priority Review’?

GLA

Just updated ...

https://avacta.com/pipeline/

More to come no doubt.

GLA

Yep, pre|CISION™ works.

Yep, pre|CISION™ is a platform – we are testing doxorubicin to the limit (via AVA6000, dox being the first pre|CISION™ ‘warhead’).

The same doxorubicin that has been the ‘first-line standard of care’ for certain cancers for many years. Not only have we not found a MTD at multiples of equivalent max dox dosage, but we are now testing dosing at more frequent (bi-weekly, compared to standard 3-4 weekly) dosing at lower (but still higher than ‘standard’) dosage levels.

Maybe we will see something new with more dox being delivered to the TME?

Whatever the efficacy of more dox, pre|CISION™ works. More ‘warheads’ to come, e.g. AVA3996/2727D (bortezomib).

Coming through - pre|CISION+ half-life extension to deliver biologics to the TME for longer-lasting effect, and pre|CISION-ADC for tumour targeting mab’s or Affimers®.

Pipeline update can’t come soon enough.

GLA

@Energy, apols for duplicate, missed your post. Interesting possibility..?

GLA

More speculation (2+2 now = 6) …

Jan 2 2024 – “Alastair Hay appointed as Argenta’s new Chief Financial Officer” …

https://www.argentaglobal.com/post/alastair-hay-appointed-as-argentas-new-chief-financial-officer

“I [Will Downie, CEO of Argenta] would also like to take this opportunity to express my gratitude to Paul Fry for his significant contribution to Argenta over the last 18 months. He has played a critical role in the company’s growth, including the acquisition of three businesses, and guided major improvements across our Finance function to set us up for future success.”

Paul Fry;s current linkedin …

Non Executive Director and Chair of Audit Committee, Non Executive Director and Chair of Audit Committee, Avacta · Part-time, Avacta · Part-time, Feb 2020 - Present · 4 yrs 4 mos, Feb 2020 to Present · 4 yrs 4 mos, London, England, United Kingdom.

And …

Chief Financial Officer, Chief Financial Officer Argenta · Full-timeArgenta · Full-time Jun 2022 - Apr 2024 · 1 yr 11 mos.

So Paul Fry, experienced CFO, just finished at Argenta, may be seeking a full-time position?

GLA

Just developing the speculation (2+2=5, etc.) ...

AbbVie completed the acquisition Immunogen in Feb for ~$10bn.

Mark A. Godberg MD has (had?) been a board director of Immunogen from 2011.

A few examples of the AvbbVie oncology pipeline ...

Budigalimab – PD-1 targeting mab.

ABBV-303 – target solid tumours.

ABBV-400 – ADC, target colorectal cancer.

ABBV-514 – target NSC lung cancer and head and neck cancers.

Immunogen had history with cancer-targeting, for example Taxane compounds …

https://news.abbvie.com/2002-01-23-ImmunoGen,-Inc-Receives-Patent-on-Taxane-Compounds

Abbvie (now with Immunogen) have a very impressive oncology pipeline, many of the therapies are in phase 1.

The pre|CISION™ platform would sit very well with AbbVie. (Not to mention the PD-1 and PD-L1 checkpoint inhibitors, AVA021 and AVA028).

GLA

Now Mark Goldberg’s (NED) picture updated (though dates to 2021).

https://avacta.com/people/mark-a-goldberg-md/

Last time we had new pictures of Board folks stuff happened the next day.

GLA

Page update ...

https://avacta.com/diagnostics/diagnostics-team/

GLA

Try making a deal.

What kind of deal?

A deal deal … business is business.

GLA

One number 10x out!

I'll take the £18bn though.

GLA

Some discussion on Phase 1: Arm 2 (bi-weekly) timing – parallel or sequential within and across cohorts.

The AACR24 poster shows 4 cohorts (160, 200, 250, 310 mg/M^2 x 6 doses over 12 weeks).

Thus (say) parallel dosing within a cohort, but sequential from cohort to cohort, would take 4 x 12 = 48 weeks, say 1 year. This seems inconsistent with phase 2 commencing in H2 2024?

RNS 30 April - “The Company announced that patients are now being dosed in a two-weekly dose escalation study with the aim of defining the recommended Phase 2 dose (RP2D), allowing dose expansions to begin in H2 2024 followed by the Phase 2 efficacy study in a selected orphan indication”.

If cohort 1 was fully recruited and underway at the beginning of March, and assuming no patient dropouts, the first 12 weeks are just about up. Disease surveillance after 8 weeks, so time for an update and clarity on timelines.

GLA

Also liked - "AffyXell pipeline joint research and development - in discussion with EU-based Company Builder".

Wonder if EU folks are one of @Bella's favourites?

GLA

Thanks @BV.

Inevitable, in any trial, that a patient (for whatever reason) might leave before the end-point.

FWIW, I suspect the ‘Alan calendar’ problem (a well-known issue, now thankfully historical), is a factor here. i.e, simply that the 2-weekly dosing commenced at the beginning of March and will run towards the end of May.

GLA

I’m thinking we should hear something soon on 2-weekly dosing …

RNS 21 Mar – “Update on AVA6000 Phase 1a Clinical Trial Progress”

“Three patients have now been dosed in cohort 1 (160 mg/m2) of the two-weekly dose escalation study in the US and Avacta has received regulatory and ethics approval to open sites in the UK in the two-weekly arm. Avacta anticipates that the SMDC will review the two-weekly cohort 1 data by the end of April.”

RNS 9 April – “Avacta Therapeutics Reports Data from the Ongoing Phase 1 Clinical Trial of AVA6000 at the AACR Annual Meeting Demonstrating Clinical Proof-of-Concept Showing Multiple Patient Responses”

“At the time of the data cut-off [March 11], enrollment continues in the every two weeks ("Q2W") Phase 1 Arm 2 dose cohort.” So, 2-weekly actually started before Mar 11.

“Patients can be dosed in parallel in the two-weekly dose escalation study and Avacta remains on track to begin the dose expansion efficacy study in the second half of 2024 in the US.”

From the AACR24 poster - Phase 1: Arm 2- N=3, 6 x 160mg/m2 = 960 mg/m2 over 12 weeks. Data cut-off Mar 11. In fact 3 patients on 2-weekly by Mar 11.

“Disease surveillance every 8 weeks”. Now in the past.

Coming up to 9 weeks since Mar 11, end of April SDMC review suggests:

1) 2-weekly actually commenced mid-Feb,

2) SDMC review after 8 week ‘surveillance’ period,

3) Alan’s calendar,

4) I’ve missed something (please help)?

GLA

Yorkshire and VS, this portends very well for Avacta.

https://www.fiercebiotech.com/biotech/novartis-further-enthrenches-radiopharma-1b-mariana-buy

“It's almost a perfect marriage, the idea of an early clinical development organization together with a company that knows how to take these drugs to market,” [Mariana CEO] Read said in an interview with Fierce Biotech. “The deal moved very quickly.”

So have Novartis moved ahead of Lily …?

https://www.fiercebiotech.com/biotech/eli-lilly-hops-aboard-mariana-oncologys-175m-series-b-radiopharmaceuticals-mission

Looking forward to the Avacta pipeline ‘unveiling’ showing the range and status of pre|CISION™ platform and Affimer® products. Wonder which BP's already know what’s coming through?

GLA

Probably not the ‘average’ PI then (~380k, so far today) …

2024-05-03T10:27:13+01:00 GBp 45 47744 21,484.8 Off-book XPOL

2024-05-03T10:27:13+01:00 GBp 45 2256 1,015.2 Off-book XPOL

2024-05-03T10:27:29+01:00 GBp 45 50000 22,500 Off-book XPOL

2024-05-03T11:45:30+01:00 GBp 45 12500 5,625 Off-book XPOL

2024-05-03T13:06:06+01:00 GBp 45 12500 5,625 Off-book XPOL

2024-05-03T13:06:10+01:00 GBp 45 9827 4,422.15 Off-book XPOL

2024-05-03T13:13:43+01:00 GBp 45 15173 6,827.85 Off-book XPOL

2024-05-03T13:16:45+01:00 GBp 45 62000 27,900 Off-book XPOL

2024-05-03T13:35:59+01:00 GBp 45 50000 22,500 Off-book XPOL

2024-05-03T13:40:18+01:00 GBp 45 25000 11,250 Off-book XPOL

2024-05-03T13:40:22+01:00 GBp 45 25000 11,250 Off-book XPOL

2024-05-03T13:43:43+01:00 GBp 45 70000 31,500 Off-book XPOL

MIC code ‘XPOL’ (Posit Dark UK) …

https://www.iotafinance.com/en/Detail-view-MIC-code-XPOL.html

https://www.virtu.com/

‘Dark’, seems a bit sinister, eh? Haha.

GLA

@Bella, I have no idea how reliable or up-to-date this source is, or from where they get their information – so with those caveats, FWIW (DYOR etc.) …

https://www.msn.com/en-gb/money/stockdetails/fi-ao67k2?ocid=hpmsn&id=ao67k2&l3=L3_Ownership&investorId=all

(Seems to revert to a ‘start’ page – so select ‘money’, search on ‘avct’, then ‘investors’ tab).

Under the ‘Mutual Fund Ownership’ tab this is showing 2 entries for AXA - +0.65% and + 0.05% for 2 (seemingly?) different AXA funds. Under the ‘Institutional Ownership’ tab it is actually showing Conifer and BG increasing, but also AXA at +0.70% - so probably a duplicate just adding the 2 funds together.

Also worthy of note perhaps (?), the rules for TR1 reporting as per this …

https://ogilvywatson.com/2021/04/disclosure-requirements-for-an-interest-in-uk-listed-shares-3/

Suggest scrolling down to the section in white for “The principal rules for disclosing an interest in UK listed shares are the FCA’s DTR 5 (Vote Holder and Issuer Notification Rules)”.

So with ‘wiggle’ room to 5% for II’s, it may be that Lombard Odier’s 3.3% (as per Avacta website Investor Resources) has just been picked off the share ownership register and no TR1 necessary. Doesn’t explain the Conifer or BG situation though. And what about the so-called ’40 day blackout for US investors’? Have Conifer actually increased a bit, but still less than 5% so no TR1, but we haven’t been told what’s really on the share register? All a bit strange, ‘truth will out’.

GLA

Pure speculation, but I think Gardiner has 1m @ 10p in the Exec Options scheme (AS 4m @ 10p). Perhaps CFO 'cashed in some chips' already?

GLA