With eyes set on the fu­ture of cell ther­a­py, re­searchers are look­ing to lever­age a grow­ing menagerie of im­mune cells to en­gi­neer a bet­ter gen­er­a­tion of tu­mor fight­ers. One type show­ing ear­ly promise is gam­ma delta T cells, and now an­oth­er biotech in that space is trot­ting out promis­ing — if lim­it­ed — re­sults.

Three acute myeloid leukemia pa­tients dosed with IN8bio’s off-the-shelf gam­ma delta T cells re­mained in re­mis­sion af­ter a stem cell trans­plant as long as 20 months af­ter re­ceiv­ing their cells, of­fer­ing an ear­ly vote of con­fi­dence for the small biotech’s ap­proach, the com­pa­ny said Thurs­day.

The three pa­tients were still in re­mis­sion at 20 months, 18 months and around six months af­ter dos­ing, IN8bio said. About 50% of pa­tients with post-trans­plant, high-risk AML re­lapse with­in the first year, the com­pa­ny said in a re­lease.

Gam­ma delta T cells are the lat­est in drug de­vel­op­ers’ ef­forts to en­gi­neer mem­bers of the in­nate im­mune sys­tem to fight stub­born can­cers with­out the oner­ous safe­ty pro­file of cur­rent-gen­er­a­tion T cell ther­a­pies. Off-the-shelf, or al­lo­gene­ic, ther­a­pies are en­gi­neered from donor cells rather than au­tol­o­gous ther­a­pies, which are de­rived from a pa­tient’s own.

Be­cause this pro­gram, dubbed INB-100, re­lies on donor cells, IN8bio is keep­ing a close eye on graft-ver­sus-host dis­ease, and the ear­ly re­sults look promis­ing. There were no treat­ment-re­lat­ed Grade 3 events or high­er, in­clud­ing se­ri­ous cas­es of GVHD 100 days af­ter in­fu­sion, and no cy­tokine re­lease syn­drome or neu­ro­tox­i­c­i­ty events were re­port­ed.

Gam­ma delta T cells, rare cells that bridge the gap in func­tion be­tween the in­nate and adap­tive im­mune sys­tem, have earned re­searchers’ in­ter­est due to their reg­u­la­to­ry and can­cer-fight­ing prop­er­ties as well as a lack of al­pha and be­ta T cell re­cep­tors, which dri­ve GVHD, po­ten­tial­ly crack­ing open more promise as al­lo­gene­ic ther­a­pies. Promis­ing da­ta cuts like these have on­ly helped dri­ve even more in­vest­ment in­to this space.

Ear­li­er this month, Adicet, an­oth­er play­er here, rolled out ear­ly da­ta show­ing its own off-the-shelf can­di­date AD-001 post­ed two com­plete re­spons­es across four pa­tients in an ear­ly Phase I study test­ing the drug in pa­tients with heav­i­ly pre­treat­ed B cell non-Hodgkin’s lym­phoma. Adicet en­gi­neered AD-001 with a CD20-tar­get­ing chimeric anti­gen re­cep­tor (CAR) on­to donor cells.

At a low dose of 30 mil­lion cells, one pa­tient post­ed a com­plete re­sponse with an­oth­er see­ing a par­tial re­sponse, which Adicet de­scribed as a “near CR.” A third evalu­able pa­tient pro­gressed and two oth­er pa­tients in the low-dose arm of the study dropped out be­fore the 28-day mark.

Un­like IN8bio, which ge­net­i­cal­ly mod­i­fies donors’ cells to be re­sis­tant to chemother­a­py, Adicet doesn’t ge­net­i­cal­ly en­gi­neer, cut­ting away the po­ten­tial for un­want­ed mu­ta­ge­n­e­sis, which may have side­lined al­lo cell ther­a­py play­er Al­lo­gene’s lead pro­gram ear­li­er this year.

Ace­po­dia, mean­while, has plans to file an IND for its own CD20-tar­get­ing CAR gam­ma delta T cell lat­er this month. And in Oc­to­ber, Take­da ac­quired Gam­maDelta Ther­a­peu­tics, which is de­vel­op­ing what it calls al­lo­gene­ic vari­able delta 1 (VD1) gam­ma delta T cells that en­tered the clin­ic this sum­mer.

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.