Don’t think what happened to ARTV cannot happen here. KYTX uses the same fludarabine regimen for its CD19 CART program as ARTV that resulted in 1 of 2 deaths reported today. Cyclophosphamide and fludarabine are toxic medications. ARTV is essentially closing shop.
Waverunner3
Posts (9)
The investment thesis for autologous CAR-T in autoimmune diseases is done. Big pharma and investors have moved on a while ago. In vivo CART and TCEs are the only remaining players in this race. Even after miv-cel gets approved for SPS, it brings minimal value for its future. Do your diligence.
It’s only a two horse race: T-cell engagers or in vivo CART. Kyverna does not have either. Get your money out while you still can.
Autologous CART is like the BlackBerry in the current phone market. Old and archaic and no one wants it. Novartis is another example of moving on with its deal via Abogen.
If you have not paid attention to the recent M&As in this space, you should. All of them have been targeting MOAs of either TCEs or in vivo CART. Big deals are happening despite limited data. Yet, KYTX with Ph2 and Ph3 readouts does not a deal in sight speaks volume about the investment thesis of auto CART. Auto CART is a nice scientific story but not a business model.
Having dealt with the FDA many times in my career of drug development, the CRL does not mean flat out rejection. Several paths may be possible: need for some post-hoc analysis with external expert opinion, some type of post approval commitment, etc.
If anyone wants an inside look at the culture at Kyverna, please look at the Glassdoor postings. Even the CTO cannot endorse the CEO or company fully. Very telling. Also, on a separate note, AZ’s recent acquisition of in vivo CAR-T now has some very promising early clinical data. Again, the investment thesis for auto CAR-T is simply over.
The competition with ex-vivo is not just in-vivo but also TCEs in autoimmune diseases - see multiple publications in last six months. There are also now additional reports of disease relapse following initial disease control with ex-vivo CAR-T which puts this business model in complete disarray considering the COG and complexity to administer. Even if this were to receive an approval for a rare disease in next 1-2 years, no large pharma will want it. Given the already low market cap, the M&A would have already occurred if it were really that attractive. One has to ask why large pharmas like Sanofi and AbbVie recently would make large bids for pre-clinical companies when they probably could have paid the same for this company. Recommend everyone to do their own due diligence. Where there is smoke, there is fire.
Thinking today’s Capstan acquisition by AbbVie is a plus for KYTX is absurd. Instead, it highlights the end of autologous CAR-T and its investment thesis. The Stiff person syndrome trial is a desperation play - extremely rare disease with no preceding clinical demonstration that CAR-T would work even in a case report. Lastly, the turnover in CEO, CMO, CFO, CHRO all in the last 9 months reflects the chaos within the company.