Member Info for RayPointer

Thanks Bob. I like your notes about Avidimab especially the bit about turning down 2 deals. It clearly demonstrates Lindy's confidence in the science. Expect more papers on this area of research.
Lindy and money are a great combination :-)

Maybe so, but any new dilutions are not to keep the company going, but to accelerate the expansion.

It is always interesting to hear Lindy talking about the latest research.
I hope someone is kindly planning to record the meeting.

Thanks for that Bermuda.
It does give the overall impression that safety is by far the most important endpoint.
Perhaps the UK regulatory authority has asked that clinical trial submissions be more exact when specifying safety.

Could be Mark.
It's taken 2 years to recruit the first patient and they are planning on 44 patients
Let's hope things speed up since 88 years is a long wait to complete recruitment :-)

Maybe success in the P1 Covidity trial may influence the rate of recruitment of the SCIB1 trial since these are both Immunobody vaccines.
Interesting that for Covidity Scancell are planning 4 doses for each patient - 2 of SCOV1 and 2 of SCOV2. Here they are talking about at least 183 days to complete the study.

"This is an open label, two-arm Phase 1 study to determine the safety, tolerability and immunogenicity of the SARS-CoV-2 COVIDITY vaccine, when administered using a needle-free injection device.

COVIDITY consists of two doses of the plasmid DNA vaccine SCOV1 (administered on Day 1 and Day 29), followed by two doses of the plasmid DNA vaccine SCOV2 (not before Days 113 and 141 [doses 4 weeks apart]). A final end of study assessment will then be performed 6 weeks after last dose of study vaccine (Day 183 [earliest]).

SCOV1 is expected to be active against the original SARS-CoV-2 strain and the B.1.1.7 (Alpha) variant, and to a slightly lesser extent against the B.1.351 (Beta) and P.1 (Gamma) variants. SCOV2 is expected to boost the effects of SCOV1 while providing further enhanced protection against the B.1.351 (Beta) and P.1 (Gamma) variants.

Each dose of SCOV1 or SCOV2 will be administered via needle-free injection, either intradermally (0.2 mg doses; study Arm 1; PharmaJet Tropis® device) or intramuscularly (1.0 mg doses; study Arm 2; PharmaJet Stratis® device). Eligible injection sites include the outer aspect of the upper left or right arm (medial deltoid muscle) or the left or right outer thigh (lateralis muscle) for intradermal administration (Arm 1), and the outer aspect of the upper left or right arm (medial deltoid muscle) for intramuscular administration (Arm 2).

This study is expected to enrol 40 participants (20 per study arm) at one study centre in South Africa. At least 15 participants in each arm should be negative for antibodies against SARS-CoV-2 upon entry into the study."

https://clinicaltrials.gov/ct2/show/NCT05047445

The primary outcome measures are all about safety.

The secondary outcome measures are again mainly about safety but with the important additions of estimating what effect SCIB1 has :

1 Effect on duration of response of SCIB1 in patients receiving pembrolizumab relative to historical data for pembrolizumab alone in this patient population (Main Study) [ Time Frame: From enrollment through last recorded assessment of response, up to 2 years (Week 97) from the first dose of study drug ]
Duration of response, measured from the point of first response (complete response or partial response) to the date of disease progression (per RECIST 1.1) or death due to any cause.

2 ORR of SCIB1 in participants receiving pembrolizumab relative to historical data for pembrolizumab alone in this patient population, based on the modified RECIST 1.1 for immune-based therapeutics (iRECIST) (Main Study) [ Time Frame: From enrollment through last recorded assessment of response, up to 2 years (Week 97) from the first dose of study drug ]
ORR as determined by iRECIST criteria.

3 Progression Free Survival (PFS) rate. [ Time Frame: At 1 year (Week 49) and 2 years (Week 97) from the first dose of study drug ]
PFS rate is defined as the proportion of participants who have not progressed (per RECIST 1.1 and iRECIST), or started new anticancer therapy, or died.

4 Overall survival (OS) rate. [ Time Frame: At 1 year (Week 49) and 2 years (Week 97) from the first dose of study drug ]
OS rate is defined as the proportion of participants who remain alive.

https://clinicaltrials.gov/ct2/show/NCT04079166

Wild
Well scib1 is less likely to be ignored second time around.
Let's hope that now the first patient has been dosed that others will follow at an increased rate :-)

Hasiba
The thought that Lindy would aim for "non inferior" results in a clinical trial is clearly ridiculous. She is on a mission to cure as many types of cancer as she can. In the Scib1/keytruda trial she is looking to increase the responders from 30 to 60 percent (if my memory serves me correct).

Bermuda
Perhaps the combo of Keytruda and a pint of best bitter would prove "non inferiority".
In which case, Lindy is wasting her time with Scib1.

I think the important point to note is that the world is desperate for a vaccine that gives long lasting immunity.
So Lindy will be looking for good populations of the appropriate memory TCells. Maybe in this phase 1 trial she can compare this to the memory T Cell populations provided by currently approved vaccines.

The accent of current vaccines is on antibodies to neutralise the virus before it infects cells. Covidity provides this but, in addition, it provides strong T Cell activation and clonal expansion ( hallmarks of Immunobody). A proportion of these T Cells differentiate into memory cells before dying. If Sars and Mers survivors are anything to go by these memory T Cells are long lasting. These memory T Cells are awakened from their slumber when Covid19 puts in an appearance. They are activated and go through clonal expansion to give Covid19 infected cells a right kicking.

This is the plan and Lindy may already be seeing signs of the memory T Cells being created.

https://www.pharmaceutical-technology.com/features/covid-19-vaccine-mixing-astrazeneca-pfizer/

This article goes some way in explaining the mix and match approach

But what about the following scenario:
Multiple inflection points mean deals which mean upfront payments which mean no more dilution.

I haven't read the article yet, but I suspect the competition between peptides has been known for some time. It possibly explains why Modi1 only has 3 targets when, at the time it was designed, a lot more cirullinated peptides had been discovered

He has no money!

Oops wrong thread

I think Reginald Roche, in the dining room with the chequebook:-)

I can't remember anyone from Scancell specifically mentioning CEPI apart from sometimes retweeting CEPI's tweets.
However, it would be surprising if Scancell have not applied particularly in the light of CEPI mentioning Scancell.
Remember Scancell has been paid to run a phase 1 trial so the aim is likely to go for a much bigger prize to the ones recently announced on the assumption they get good P1 results.

We know from past experience that Scancell rarely, if ever, disclose who they are talking to. That is surely good practice.

Stay cool and trust in the science.
Further news on the Covidity trial may not come for a while yet.
Lindy may be looking give 2 doses to the majority of patients and also to measure memory T Cell levels. The memory T Cells take a while to appear.

You are very welcome hasiba

Holding strong

https://pixels.com/featured/man-bowler-hat-riding-fireworks-rocket-cartoon-aloysius-patrimonio.html