Hey oxxa!I haven't been this before, no.Blinatumomab/Blincyto...

Hey oxxa!

I haven't been this before, no.

Blinatumomab/Blincyto scores two mentions, along with the CAR-T's.

Further confirmation that they expect to put OnCARlytics into a Phase 1 next year - also flagged as a Milestone in the most recent Investor presentation.

It will be interesting to see how long it takes to get IND designation from the FDA. Given the strength of the preclinical data, and the fact that OnCARlytics is based on CF33 - already looking totally safe in two Phase 1 trials - I would expect IND clearance to be fairly speedy.

Note that this latest document states: "The first clinical trial is anticipated to start in 2023 and will evaluate the safety and efficacy of onCARlytics in combination with a CD19 targeting therapy in patients with solid tumours."

ie. They don't intend to test OnCARlytics for safety as a monotherapy. It will go straight into combo with "a CD19 targeting therapy." Presumably Artemis, at least, because Estrella is stating clearly that they are proceeding to further studies, and I would expect a trial in partnership with Celularity as a combo with their CyCart-19 as well.

This is great, because the strength of the preclinical data would indicate the likelihood of significant clinical effectiveness, which we could see even in a Phase 1 dose escalation study.

It will be fascinating to see whether Amgen "bites" and partners for a Phase 1 in combo with their Blinatumomab/Blincyto.

I am also waiting to see if/when IMU announces the term of further partnership with Estrella and Celularity. The original agreements were just for the preclinical studies, with further work to be negotiated if those studies proved to be successful.

eg the agreement with Estrella was that: "After the results from this research agreement are known and can be quantified, the parties will negotiate in good faith (and without obligation) whether to jointly develop or commercialise on the outcomes of the strategic collaboration on commercially reasonable terms." Source: https://hotcopper.com.au/threads/ann-eureka-strategic-collaboration-supplementary-announcement.6411158/

That original agreement is now just over a year old, and it was with Eureka. A Phase 1 study will be a lot more expensive than the preclinical Mouse studies, so I would think that a new agreement - this time with Estrella - is required. Also a new agreement with Dr Bob over at Celularity, assuming they too decide to go to a Phase 1 combo trial.

Estrella goes public on the Nasdaq in the first half of next year, with a reported likely equity value of $398.5 USD - about $590m AUD at the current exchange rate. Source: https://www.marketscreener.com/quote/stock/TRADEUP-ACQUISITION-CORP-126742201/news/Estrella-Biopharma-Inc-entered-into-a-definitive-business-combination-agreement-to-acquire-TradeUP-41923508/

Cheers

Dave