Member Info for LiveLongnProsper

Appointment seems very clear and positive.

Chris Coughlin has the experience and credibility to lead Avacta through the ongoing clinical programme. AVA6000 trials, AVA3995 IND, Affimers to in-human trials – whether Avacta, AyyXell, LG Chem, other, or all.

She is an MD (this is key), she has been a CMO, she has an Ocology fellowship. Who better to be working with Dr William Tap, Dr Lee Kranmer, the FDA, et al. Credibility and track record.

We have a NED who is an MD (balanced by others with commercial experience), and we have an impressive Therapeutics SAB who are all Medical Doctors. Having an MD on the board and leading R&D is a great move - and CC has been with Avacta long enough now to know what needs doing.

Seriously hope she gets a decent options package in place immediately – now is the time to ‘accelerate’ all the ‘ongoing’ activities.

GLA

Who knows?

Volume low. Seems many LTH’s just taking a few more (me included) as the ‘Heights cycle’ goes from ‘managing’ the VWAP down to the inevitable selling being slowly ‘soaked’ up.

Of course, would be good to see some II buys. Would have been good if house brokers could have managed a transfer from Heights to an appropriate ‘strategic’ investor’.

Would be good to get an an update on C7 (data cut-off for 13 Dec presentation was 27 November – so ~9 weeks more data), the bi-weekly trial, Tx Affimers, Dx strategy, licensing deals, etc., etc.

Lot’s of good things to come.

GLA

@gmcc, this deserves a lot more attention. 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. 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

Like the enthusiasm of AffyXell CEO Seungho Jeon ...

“When asked about the goal he wants to achieve at Apicell Therapeutics, Seungho Jeon, CEO of Daewoong Pharmaceutical, said, "I want to succeed in the IPO in 2026 and reward the shareholders who trusted and invested in Apicell and the executives and employees who worked hard." He said, "From the perspective of the CEO who first planned the company, I would like to see the company become a moderna in cell therapy for autoimmune diseases and grow into a global unicorn company."

“Recently, Apicell Therapeutics completed an advance clinical trial (IND) meeting with the U.S. Food and Drug Administration (FDA) to enter clinical trials for 'AFX001', a lead pipeline incorporating this technology. AFX001 is an autoimmune disease treatment that targets CD40L, which is involved in the mutual activation of T cells and B cells.”

“Apicell Therapeutics plans to begin phase 1 clinical trials for AFX001 next year if it receives IND approval from the FDA.”

“CEO Jeon said, “The short-term goal is to raise the funds necessary for technology development through Series B fundraising and achieve milestones such as IND success and technology export,” and added, “We will use these milestones as a stepping stone to succeed in the IPO.” “I would like to reward the shareholders who trusted and invested in Apicell and the executives and employees who worked hard,” he said.”

"We are discussing technology transfer and joint research and development with a number of companies. Looking at recent trends, technology transfer is actively taking place after IND. Apicell is also expected to see results in technology exports after IND or before IPO. do."

GLA

Current RNS footnotes seem quite clear about the separation of Tx and Dx …

“Avacta has two divisions: an oncology biotech division harnessing proprietary therapeutic platforms to develop novel, highly targeted cancer drugs, and a diagnostics division, which is executing on an M&A led growth strategy to create a full-spectrum diagnostics business focused on supporting healthcare professionals and broadening access to testing”.

But no Affimer based products (yet) for Launch and Coris to sell.

Also in the current RNS footnote some clear positivity regarding the growth prospects for Dx …

“… a revenue generating, fast-growing diagnostics business …”.

Trinity Delta in their 14 December 2023 update …

https://www.trinitydelta.org/research-notes/tailored-tumour-targetting-with-precision/

Attribute a NPV of £40.4m to Dx (noting that this refers to Launch and Coris).

They also suggest an estimated 2024 revenue of ~£26m for Avacta as a whole. Assuming zero Tx product revenue in 2024 this is would be Dx plus any (possibly ?) factored-in Tx licence revenue.

Assuming just Dx from Launch and Coris, then a multiple of (at least) 4x revenue for acquisition, i.e. ~£100m (IMHO) would represent the start (only the start) of bidding.

Of course, the real prize for any potential acquirer of Dx may well be Affimer-based products coming through (?) and a limited / non-exclusive / ‘tightly’ defined licence for Affimer tech.

Avacta (Tx) retain all IP / Patents etc.

GLA

@gmcc, re “well served”, time running out to show this, I think? Though I do genuinely hope that DX manage to deliver some Affimer based products. @Tim, yes, my sense is of an increasingly poor fit.

Launch cost £24m plus up to £13m (max) earn out, and Coris £7.4m plus (max) £3m, say total £48m, plus costs, say ~£55m. Outstanding bond £40.8m (as at 23 Oct 2023) – probably a bit less after tomorrow?

So, to get our money back / pay off the bond we need (say) ~£55m+, to get our money back and fund TX (independently) for another couple of years we will need ~£100m+ for the sale of DX (i.e. Launch, Coris, plus other bits). How much might private equity pay for DX?

Of course, Avacta (Therapeutics) retain all IP for Affimer® (as well as pre|CISIONTM and TMAC), selectively and non-exclusively license Affimers to the ‘spin-off’.

GLA

Perhaps worth emphasising that Chris Coughlin’s appointment is as an exec board director. Given that Avacta have been running with Sir Al and Tony Gardiner as the only exec directors since 2016, this is hugely significant. Note that Elliot is a non-exec Chairman, with plenty of other things to do.

Senior Therapeutics team looks in great shape, relatively lean, and supported by a strong SAB and (albeit with overall company responsibiliy) CC as Head of R&D and experienced NED’s.

Therapeutics aligned for – successful trials, completion of AVA3996/2727D and Affimer pre-clinical, partner (AffyXell and LG Chem) support and liaison, and licensing, BP stake, acquisition, etc.?

So, what about DX? Messy looking organisation at the senior level, ‘joint’ (?) roles in Launch, and Coris not even on the chart.

While Launch and Coris do appear to be ‘getting on’ with their respective businesses, even possibly a hint of collaboration, but no sign of any DX Affimers coming through.

A reasonable question to ask perhaps (?), does DX fit strategically? How much time is CC going to spend on DX? Now a good time for Sir Al to sort it out?

Expecting things to move quickly now. Interesting times.

GLA

Indeed, what is Sir Al’s focus going to be now? Maybe working with Simon Bennett on the range of (ongoing, accelerating) commercial opportunities?

Perhaps Sir Al has more time to focus on DX?

Great to see that we now have an MD (and former CMO) heading up R&D and one of three exec directors of Avacta (plus we have three Medics on the SAB).

Seems little doubt who’s now running the clinical trials ‘show’ with Dr Tap (MSK) and Dr Lee Kranmer (Fred Hutch), et al.

Also, hopefully, moving forward at pace with the Therapeutic’s Affimer programmes (pipeline update today?).

So has the ‘chemistry’ for AVA3996/2727D been done? Is this now a FDA (for IND) and then commercial / licensing thing?

Oh, and is there any Affimer development being progressed for DX?

GLA

@gmcc, good spot. AVA032 restored, albeit seemingly combined with AVA028.

Hope for some more details soon.

GLA

Silence is deafening …

What’s going on with commercials (most have a ‘handle’ on the options)?

Further update on trials - AVA6000 (C7 and the missing data, e.g. leaving group etc.), update on patients continuing on C5 / C6 regimen, start of bi-weekly?

Further update on AVA3996/2727D and other potential pre|CISION™ (‘it works’ ™) ‘warheads’?

What’s going on with Affimers - Therapeutics pipeline (plus AVA032)?

What’s going on with Partners – LG Chem, AffyXell?

What (‘on earth’) is the DX strategy?

(RomeoNovemberSierra heading ‘bad form’ when not one).

GLA

Huge amount of value to be updated on - soon I expect?

From the Dec 13 2023 presentation.

“AVA6000 phase 1 (ALS-6000-101) data cutoff 27 November 2023”.

“1 Cohorts 5, 6 and 7 have all patients ongoing at the time of the data cutoff, thus safety findings in these cohorts will continue to mature”.

“Disease surveillance every 6 weeks”. We now have 8 more weeks trial data.

From the 15 November 2023 RNS …

“Affimer® biotherapeutics: The next generation of cancer therapies”.

“Our lead Affimer® AVA032 is an anti-PD-L1 Affimer® fused to the pro-inflammatory cytokine interleukin 15 (IL-15) and has dual activity that works to reverse the immunosuppressive tumour micro-environment, inducing a lasting immune response aimed at stimulating a patient’s immune system to destroy cancer cells.”

Also …

https://avacta.com/wp-content/uploads/2023/11/PEGS-Europe-2023-poster.pdf

(Note the distinction – “AVA027, a PD-L1/TGF-b receptor trap combination, and AVA028, a PD-L1/IL2 bispecific.”)

AVA032 gone missing from the Therapeutics pipeline …

https://avacta.com/therapeutics/pipeline/

Well overdue for an update on multiple ‘fronts’ – AVA6000 C7 and bi-weekly, AVA3996 IND, new IP / Patents, Affimers, commercials (licensing platform / product / jurisdictions / indications / etc.), not to mention LG Chem, AffyXell and DX.

GLA

@Yorkshire, interesting article. Mostly about IPO’s – bodes well for AffyXell. One other take away …

“Currently, the most in-favor biotech stocks are on M&A candidates (companies with differentiated, derisked clinical stage assets).”

Guess we’re well down the path of ‘derisking’.

GLA

From the Dec 13 2023 presentation ...

“AVA6000 phase 1 (ALS-6000-101) data cutoff 27 November 2023”.

“1 Cohorts 5, 6 and 7 have all patients ongoing at the time of the data cutoff, thus safety findings in these cohorts will continue to mature”.

“Disease surveillance every 6 weeks”.

We now have 7 more weeks trial data.

Question is - when will (or can) Avacta release another update, and how much detail?

GLA

Just announced at JPM24, J&J to acquire Amrx for $2bn.

“Johnson & Johnson to Acquire Ambrx, Advancing Next Generation Antibody Drug Conjugates to Transform the Treatment of Cancer”.

https://www.businesswire.com/news/home/20240108905189/en/Johnson-Johnson-to-Acquire-Ambrx-Advancing-Next-Generation-Antibody-Drug-Conjugates-to-Transform-the-Treatment-of-Cancer

“ARX517, its proprietary ADC targeting PSMA for metastatic castration-resistant prostate cancer (mCRPC); ARX788, its proprietary ADC targeting human epidermal growth factor receptor 2 (HER2) for metastatic HER2+ breast cancer; and ARX305, its proprietary ADC targeting CD-70 for renal cell carcinoma.”

Just a reminder to BP guys, other (than ADC’s) platforms are available.

GLA

Pre|CISIONTM works. AVA6000 trials being managed by third-parties, primarily in the USA. A small number of senior Avacta management involved in the trials and commercialisation. Good, get on with it Sir Al and team. AVA3996 heading for IND, scientists still working on this. Plenty of IP / Patent work to do, again a small number of people engaged.

No idea what’s going on with Affimers re DX. But Affimers are at the heart of Therapeutics strategy. Judging by the recent posters and articles we have an excellent team of scientists working on this. For example, PD-L1 checkpoint inhibitors are a huge opportunity – and we have Affimer based programmes in late pre-clinical. Not to mention AffyXell heading for IND and (hopefully) in-human trials, and LG Chem with LR19128.

The potential of Affimers should be highlighted and better communicated and not ‘put on the back burner’. Affimers (should) add significantly to the overall (understated) IP / asset value of Avacta, and we have a pipeline extending back to PhD students at Leeds University.

GLA

@B2HS2l and JT, guess I’m just confused with what’s going on with Affimers – AVA028 (21) on the pipeline, AVA032 in the posters. Would welcome a concise and comprehensive update on Affimers (and the rest of course, eg ‘leaving group’ data for AVA6000 alluded to elsewhere). Maybe they are keeping detail back while deals are being discussed (I hope), but for now it seems shareholders have an incomplete picture of progress.

This earlier poster covers AVA032 in some detail …

https://avacta.com/wp-content/uploads/2023/10/AVA32-AACR-2023-poster.pdf

‘An anti-PD-L1 Affimer fused to IL-15 exhibits potent anti-tumour activity’.

Whereas the pipeline page …

https://avacta.com/therapeutics/pipeline/

Describes AVA028 as …

“AVA028 – PD-L1 Affimer® / ImmunoCytokines

The flexibility of Affimer technology allows multiple formatting configurations to generate multispecific molecules. These molecules utilise the tumour cell homing functionality of the PD-L1 inhibitory Affimer to bring immunomodulatory cytokines directly to the tumour and reverse the immunosuppressive tumour microenvironment by enhancing T cell activation but avoiding T cell exhaustion. A number of potential ImmunoCytokines are under development.”

Looks to me (not a biochemist) that the terminology relates to same thing.

GLA

@B2HS2L, a little more recent, read these and AVA032 looks like it’s going very well, but now missing from the Avacta website pipeline page. Why?

From 15 Nov 2023 …

https://avacta.com/affimer-biotherapeutics-the-next-generation-of-cancer-therapies/

And the poster by Fiona McLaughlin et al from Avacta, plus Jong Sang Ryu from AffyXell ...

https://avacta.com/wp-content/uploads/2023/11/PEGS-Europe-2023-poster.pdf

Also from Fiona, 20 Oct 2023 …

https://avacta.com/international-conference-on-molecular-targets-and-cancer-therapeutics/

“Our lead Affimer AVA032 is an anti-PD-L1 Affimer® fused to the pro-inflammatory cytokine interleukin 15 (IL-15). This bispecific molecule has dual activity that works to reverse the immunosuppressive tumour micro-environment, inducing a lasting immune response aimed at stimulating a patient’s immune system to destroy cancer cells. While many single agent PD-L1 inhibiting agents are available to patients, the number of patients who respond to these agents is limited. Combination treatment with immune response-boosting treatments produces a sustained immune response and maximising response to IO therapy.”

GLA

Great find @alextak …

“Excitingly, we have demonstrated AFX001's outstanding efficacy compared to un-transduced MSCs using a humanized Graft versus Host Disease (GvHD) mouse model. Furthermore, AFX001 exhibits comparable efficacy to a pre-clinically verified anti-CD40L antibody. We recently concluded a smooth pre-IND meeting with the US FDA, and we are on track to initiate patient-targeted clinical trials in the second half of next year”.

Looks like the Affimer partnership space is getting exciting. Also, remember LG Chem and LR19128 …

https://innovation.lgchem.com/ResearchDevelopment/Pipeline.do

LR19128 being an anti-PD-L1 Affimer. Now where has AVA032 gone missing to?

GLA

@Bella, Abstract from AACR Journal December 2023 …

https://aacrjournals.org/mct/article/22/12_Supplement/A077/730732/Abstract-A077-A-novel-tumor-targeted

‘Accidentally’ dropping off the pipeline page seems unlikely. Terminating the programme, after a lot of time, money and publicity would be a ‘material’ event and, as such, warrant an RNS.

So, I suspect something ‘going on’.

GLA

Regarding Affimers, the poster below from November 2023 (AffyXell also involved) covers AVA032 …

https://avacta.com/wp-content/uploads/2023/11/PEGS-Europe-2023-poster.pdf

But AVA032 now not showing on the Avacta site pipeline page, why ..?

https://avacta.com/therapeutics/pipeline/

AVA028 and AVA021 both showing as pre-clinical, but no updates.

Affimer update well overdue.

GLA

Examples of a couple of small/mid-cap companies doing ‘precision oncology’ (not necessarily competing with Avacta) presenting at the JPM Healthcare conference next week …

https://investors.erasca.com/news-releases/news-release-details/erasca-present-42nd-annual-jp-morgan-healthcare-conference

‘Precision oncology company’ ERASCA. Nasdaq listed, ~$310m mcap.

Seems to be focused on stopping the formation of cancer cells?

In ‘discovery’ - targeting RAS (presumably mutated RAS genes?).

Phase 1 and 2 – targeting MAPK nodes (‘mitogen-activated protein kinase’), one of / part of a signalling cascade that can lead to cancer.

https://ir.acrivon.com/

'Acrivon is a clinical stage biopharmaceutical company developing precision oncology medicines that it matches to patients whose tumors are predicted to be sensitive to each specific medicine by utilizing Acrivon’s proprietary proteomics-based patient responder identification platform, Acrivon Predictive Precision Proteomics, or AP3.’ Nasdaq listed ~$109m mcap,

ACR-368 jn phase 1 with FDA ‘Breakthrough’ and ‘Fast Track’ designations.

Also declared for JPM – GSK, AZN, Pfizer, AbbVie, Merck, Novartis, Roche (who say - “We are always looking for new strategic partnerships. If you have an idea, we would like to hear from you"), to name a few.

Does anyone know if Sir Al, Fiona, Chris Coughlin, Simon Bennett, et al are attending (if not presenting)?

GLA