Allergy Therapeutics Share Discussion Threads

[jimmyloser] 14/5/2021 15:15

Large sell in the wind here?

[jimmyloser] 11/5/2021 07:57

THE STAKES ARE HIGH! - A reminder for newcomers
January 2021

Allergy Therapeutics PLC

05 January 2021

Allergy Therapeutics plc

("Allergy Therapeutics", "ATL" or the "Group")

Allergy Therapeutics initiates peanut allergy biomarker study with Imperial College London to confirm potential of novel peanut vaccine candidate

- Ex-vivo biomarker study to evaluate VLP-based peanut allergy vaccine candidate's hypoallergic potential and potent immune response

- Findings to support peanut clinical programme with first-in-human trial on track for 2021

- Short-course vaccine candidate represents significant differentiated opportunity in $8bn worldwide food allergy market

- IND application to United States Food and Drug Administration expected in 2021

5 January 2021 Allergy Therapeutics (AIM: AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces that an ex-vivo biomarker study of blood samples from peanut allergy patients has begun at Imperial College London. The study aims to evaluate the Group's novel virus like particle (VLP) based peanut allergy vaccine candidate, to confirm its hypoallergic potential and its potent immune response.

The study at Imperial College London, using human samples and an extensive set of functional and molecular biomarkers, will provide Allergy Therapeutics with important information to establish the starting dose for its first-in-human Phase I study. The data will also act as an early clinical predictor of efficacy of the VLP platform and support the acceptance of the Investigational New Drug (IND) application and a successful Phase I trial outcome. The submission of an IND application to the United States Food and Drug Administration (FDA) for that study is expected in 2021.

Allergy Therapeutic's peanut allergy vaccine programme is supported by a strong preclinical research package, providing pre-clinical proof of concept for sustained immunity and protection against peanut anaphylaxis after a single vaccination.

Importantly, in contrast to current treatment approaches such as desensitisation via oral administration or transdermal patches, which require daily dosing over several years, it is anticipated that the Group's next-generation VLP-based peanut vaccine candidate will use only 3 injections to induce sustained protection.

The potential of an effective short-course peanut allergy vaccine represents a significant opportunity in the $8 billion worldwide food allergy market(1) . Prevalence of peanut allergy in Western countries is on the rise and currently ranges from 1.4-3% of children(2) and, in the US, peanut allergy affects an estimated 1.2% of the overall US population(3) with 1 in 4 children with a peanut allergy requiring a hospital visit each year(4) .

In parallel with the peanut allergy human biomarker study, a broader research project with Imperial College London has also commenced, focussing on the selection, measurement and analysis of pre-clinical and clinical biomarkers for allergen immunotherapy products across Allergy Therapeutics' portfolio. Clinical trials in the allergy immunotherapy area often pose challenges with interpretation as they rely on subjective non-validated endpoints. There is therefore an opportunity to explore alternative, more objective measures of success and develop a greater understanding of the underlying science in this important area.

Under this collaboration agreement, researchers will examine samples from the Group's ongoing Grass MATA MPL exploratory field study (G309), and the pre-clinical and clinical development programme for the Group's VLP-based peanut allergy vaccine candidate. Changes in an extensive set of established and innovative biomarkers will be analysed at baseline and throughout treatment with each of the allergen immunotherapies.

Manuel Llobet, CEO of Allergy Therapeutics , stated: "A safe and effective short-course peanut allergy vaccine would be a significant breakthrough product, offering life-changing benefits to sufferers affected by this condition. The data we have generated so far for our peanut vaccine candidate give us confidence in its potential and through this study we have an opportunity to build on that confidence and provide our upcoming Phase I study with the greatest chances of success.

"At Allergy Therapeutics we are passionate about progressing the science around allergy immunotherapies. Our collaboration with Imperial College London, who are one of the foremost experts in this field, will equip us with a greater depth of knowledge of allergy biomarkers and their relationship to clinical outcomes, which will be applied to future clinical trials and aid in the development of our allergy immunotherapy pipeline."

This announcement contains inside information for the purposes of Article 7 of Regulatory (EU) No596/2014.

[mauricemonkey] 10/5/2021 12:59

The best thing, that the article doesn't mention, is that unlike many early stage drug development companies, AGY have significant revenue streams to help fund the trials. Yes they might need to tap shareholders a bit to help pay for them, but it should only be a modest amount if they even need to do it at all, it won't be 100% funded by dilution, unlike others *cough* FUM *cough*.

[jimmyloser] 10/5/2021 08:43

As a rather erudite poster placed recently, "AGY hasn't even got started"!
With Spring days ticking away, try and imagine the reaction to a positive statement from Imperial London. If this is the reaction to a Telegraph article.

impo/dyor

[jpuff] 09/5/2021 18:46

https://www.telegraph.co.uk/business/2021/05/09/world-first-peanut-allergy-vaccine-begins-human-trials/

[square1] 09/5/2021 17:24

https://www.telegraph.co.uk/business/2021/05/09/world-first-peanut-allergy-vaccine-begins-human-trials/?utm_content=telegraph&utm_medium=Social&utm_campaign=Echobox&utm_source=Twitter#Echobox=1620570095

[jimmyloser] 06/5/2021 11:23

Whilst not explosive news, this for me is really reassuring. It would appear that AGY are making solid and steady progress and have learned from past difficulties in this area. To have the ability, focus and determination to make this vitally important project happen on two continents with all that is at stake and despite the ravages of Covid, is in my eyes highly commendable and yet another confidence boost for us long term holders.

impo

[farmergeorge] 06/5/2021 09:42

Thanks SEV22

[sev22] 06/5/2021 09:21

Latest comment from House broker (more detail on their web-site):

Allergy Therapeutics announced that it has completed the treatment/dosing phase of its exploratory field study (G309) for Grass MATA MPL vaccine in subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis induced by grass pollen. Data readout, consequently, remains on track for H2 2021, the results from which will be used to finalise the design of the pivotal Phase III registration study (G306), which is scheduled to commence dosing in H2 2022 with final readout in H2 2023. This is in line with our expectations and we reiterate our 45p target price. This target excludes the value of US market entry with the Grass MATA MPL vaccine (c.12-17p) or VLP Peanut allergy vaccine (c.5-10p).

[farmergeorge] 28/4/2021 18:43

We're still seeing very low volumes here.

[farmergeorge] 23/4/2021 13:23

...let's hope so!

[sev22] 23/4/2021 13:07

According to Stockopedia AGY's major shareholders account for 93.77% of the shares in issue. There have only been increases in holdings over the last 12 months and no sales.

AGY is classed as a Super stock with a Stock rank score of 89 and a Quality rating of 85.

I think the MMs require stock which means there might be some positive news around the corner.

[farmergeorge] 23/4/2021 12:48

The volume is thin, as always.

[richsawko] 23/4/2021 12:36

Same story every year. I am becoming a bit despondent with these shares having owned for many years the optimism always disappears after results and it drops back down. Now over 20% down - for what reason?

[richsawko] 16/4/2021 13:57

Here we go again drifting down!

[red army] 11/4/2021 17:55

I like the way the business is growing ie slow credible and market demand.

[emso] 11/4/2021 17:28

Hopefully become more liquid and spread reduces to encourage investment

[jimmyloser] 10/4/2021 07:20

Kev
I am with you on that. People ignore at their peril the wide portfolio that they have coming through. Peanuts will bring worldwide attention because it is an area that the media will love and the publicity will do the share price no harm.
This is a remarkable business and on the proviso that AGY do not have any further setbacks then peeps patience will be rewarded beyond any current expectations
Impo

[kevraff] 09/4/2021 22:06

Long road to go guys AGY only getting started

[farmergeorge] 09/4/2021 16:02

I'm sure a decent volume could push this up.

[catch007] 09/4/2021 15:57

30p would be very nice in the short term!