But that does nothing to allay fears over a technology whose economic
viability is still far from proven. TILs are simply extracted from a
person’s tumour and expanded before being reinfused, and academics have
been working on the procedure for years.
Most importantly, the NCI lab of Dr Steven Rosenberg has reported striking remissions by using TILs in melanoma.
This cancer is known to be particularly immunogenic, so the proof of
the TIL approach lies in generating efficacy in additional tumour types,
though admittedly a 35% remission rate in PD-(L)1 refractory patients
is not to be sniffed at.
Iovance is shortly to complete enrolment into a cervical cancer study
of a TIL regimen it codes LN-145, and this should also read out this
year, likely after the melanoma trial.
|Iovance TIL projects with sellside consensus estimates
||Monotherapy in post-PD-(L)1 melanoma
||Cohort 4 (2nd-gen manufacturing) of 178-subject C-144-01 trial reads out in 2020
||Cervical cancer; includes monotherapy (post PD-(L)1) and Keytruda combo
||138-subject C-145-04 trial reads out in 2020
|Source: company presentation & EvaluatePharma.
Importantly, because unlike Car-T cell products TILs are not
genetically modified, they are not patentable per se. Rather, Iovance
relies on IP covering methods of expanding TILs, while a novel process
taking manufacturing down from several weeks to 16 days could provide an
important barrier to competitor entry.
Patentability issues have not curbed enthusiasm over Achilles
Therapeutics, which is using an advanced variation of the TIL approach
and is understood to be close to filing for an IPO.
But they are important when considering the likelihood of an Iovance
takeover, especially at close to $5bn. Stifel analysts yesterday
cautioned that cell therapy acquisitions are difficult to “tuck in”;
Gilead and Celgene found out as much with Kite and Juno respectively.
With Car-T therapy still struggling to prove itself commercially, the
fact that TILs look even less like a drug product and even more like a
hospital procedure should provide a reality check.